Rheolytic catheter

• US 6,135,977 A
• Filed: 01/25/1995
• Issued: 10/24/2000
• Est. Priority Date: 02/16/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• 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
• Application Number:
  US08/377,995
• Time in Patent Office: 2,099 Days
• Field of Search: 604/22, 604/27, 604/30, 604/35, 604/41, 604/43-45, 604/48, 604/97, 604/118, 604/119, 604/132, 604/140, 604/141, 604/151, 604/152, 604/173, 604/96, 604/268-269, 128/DIG. 12, 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 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter

Abstract

A technique for treatment of plaque deposits on the arterial wall of a patient. The technique employs a high pressure jet of sterile saline solution directed at the plaque deposit. The high pressure jet is located at the distal end of a guide wire or catheter which is advanced through the vascular system to the site of the plaque deposit. Optional removal of the debris is via an evacuation lumen within the catheter. This particular technique directs the high pressure jet of fluid distal to the distal tip of the guide wire or catheter. This permits treatment of arteries, which are totally occluded, because the device need not transit the lesion to be effective. Some applications will use the high pressure jet of fluid to open a sufficient passage within the occlusion to permit further dilatation using a balloon integral to or passed over the device. An ultrasonic transducer array located adjacent the high pressure jet permits the attending physician to monitor the procedure. This may be particularly important for those embodiments for which the high pressure jet of fluid may be inadvertently directed toward the vessel wall at short range. The ultrasound device ensures that the jet of fluid is directed at plaque, rather than the native vessel.

Claims

1. A device with fluid jets for breaking apart tissue or other material in a biological or synthetic body vessel or cavity comprising:

a. a tubular member having a proximal end and a distal end, having a plurality of passages including a first passage and a second passage extending along the length thereof, each passage with a proximal end and a distal end, each passage providing communication between said proximal end and said distal end;

b. said first passage comprising tubular means for carrying a flow of high pressure fluid from said proximal end to said distal end, the distal portion of said tubular means having at least two orifices;

c. said orifice(s) forming fluid jet(s) from the flow of high pressure fluid, at least one of the fluid jets being directed by said orifice(s) to impinge upon the tissue;

d. at least one of said orifices directing at least one of the fluid jets in a direction which is largely distal to said distal end of said first passage;

e. said proximal end of said first passage having means to connect to a high pressure fluid source which drives a flow of fluid into said first passage;

f. said second passage provides for passage of fluid between said distal end and said proximal end, said distal end of said second passage having an opening; and

g. at least one of said orifices directing at least one fluid jet emanating from said distal end of said tubular means to impinge on said opening in said distal end of said second passage.

2. The device of claim 1, wherein said first passage is connected to a high pressure fluid source that supplies fluid to said tubular means at a pressure greater than approximately 5000 psi.

3. The device of claim 1, wherein at least one of said orifices directs at least one jet emanating from said distal end of said tubular means to impinge on said opening in said distal end of said second passage, and to provide stagnation pressure which tends to drive a flow of fluid and emulsified tissue from said distal end of said second passage towards said proximal end of said second passage, thereby aiding in the removal of emulsified tissue from the body vessel.

4. The device of claim 3, wherein said first passage is connected to a high pressure fluid source that supplies fluid to said tubular means at a pressure greater than approximately 5000 psi.

5. The device of claim 1, wherein at least one of said orifices directs at least one jet emanating from said distal end of said tubular means to impinge on said opening in said distal end of said second passage, and to provide stagnation pressure which is sufficient to drive a flow of fluid and emulsified tissue from said distal end of said second passage towards said proximal end of said second passage, thereby providing removal of emulsified tissue from the body vessel, and channel particulate or emulsified material toward said distal end of said second passage.

6. The device of claim 5, wherein said first passage is connected to a high pressure fluid source that supplies fluid to said tubular means at a pressure greater than approximately 5000 psi.

7. The device of claim 3, 5 or 6, wherein said proximal end of said second passage is connected to a metering means to control the flow of fluid and emulsified tissue along said second passage at a rate of flow less than the rate of flow which would result without said metering means.

8. The device of claim 7, wherein the proximal end of said second passage is connect to a roller pump which controls the outflow resistance in said second passage and hence the roller pump controls the flow of emulsified tissue along said second passage.

9. The device of claim 7, wherein said proximal end of said second passage is connected to a metering means to control the rate of flow of fluid and emulsified tissue in said second passage and thereby controls a net volume infusion.

10. The device of claim 3, 5 or 6, wherein said proximal end of said second passage is connected to a suction means to augment the flow of fluid and emulsified tissue along said second passage.

11. The device of claim 10, wherein said proximal end of said second passage is connected to a suction means to provide control of the rate of flow of fluid and emulsified tissue in said second passage to control a net volume infusion.

12. The device of claim 1, wherein said tubular means of said first passage carries a flow of high pressure fluid at a pressure greater than approximately 5000 psi to said distal end of said first passage.

13. The device of claim 1, 5 or 6, wherein at least one of said orifices directs at least one fluid jet primarily parallel to a longitudinal axis of said tubular member.

14. The device of claim 1, 5 or 6, wherein at least one of said orifices directs at least one fluid jet emanating from said distal end of said tubular means primarily nonparallel to a longitudinal axis of said tubular member.

15. The device of claim 1, 5 or 6, wherein said second passage provides passage for a catheter device taken from a list comprising a guidewire, ultrasound catheter, angioscopic catheter, and balloon catheter.

16. The device of claim 1, 5 or 6, wherein said first passage is connected to a high pressure fluid source that comprises a positive displacement piston pump.

17. The device of claim 16, wherein said tubular means carries a flow of high pressure fluid in a largely pulsatile or periodic unsteady flow.

18. The device of claim 16, wherein said tubular means carries a flow of high pressure fluid in a largely steady flow.

19. The device of claim 1, 5 or 6, wherein said distal end of said tubular mean is formed into an arcuate shape.

20. The device of claim 1, 5 or 6, wherein said distal end of said tubular means is formed into a toroidal shape which is oriented in a plane perpendicular to a longitudinal axis of said tubular member.

21. The device of claim 1, 5 or 6, wherein a plurality of said orifices direct a plurality of jets along said distal end of said first passage;

when a guidewire device is in position at said distal end of said tubular member, said plurality of orifices decrease any effect that the guidewire may have in shielding any tissue from the plurality of jets directed by said orifices.

22. The device of claim 1, 5 or 12, further comprising a multiple jet nozzle assembly at said distal end of said tubular means which provides high pressure fluid from said distal end of said tubular means to a plurality of said orifices.

23. The device of claim 1, 5 or 12, wherein said tubular means comprises a high strength tube constructed of a high strength material taken from a group comprising metal, high strength polymer, and polyimide.

24. A device with fluid jets for breaking apart and removing tissue or other material from a biological or synthetic body vessel or cavity comprising:

a. a tubular member having a proximal end and a distal end, having a plurality of passages including a first passage and a second passage extending along the length thereof, each passage with a proximal end and a distal end, each passage providing communication between said proximal end and said distal end;

b. said first passage comprising tubular means for carrying a flow of high pressure fluid from said proximal end to said distal end, the distal portion of said tubular means having one or more orifices;

c. said orifice(s) forming fluid jet(s) from the flow of high pressure fluid, at least one of the fluid jets being directed by said orifice(s) to impinge upon the tissue;

d. at least one of said orifices directing at least one of the fluid jets in a direction which is largely distal to said distal end of said first passage;

e. said proximal end of said first passage having means for connection to a high pressure fluid source which drives a flow of fluid into said tubular means, the high pressure fluid source providing fluid to said tubular means at a pressure between approximately 500 psi and 5000 psi for treatment of relatively softer material;

f. said second passage provides for removal of fluid and emulsified tissue from said distal end to said proximal end, said distal end of said second passage having an opening; and

g. at least one of said orifices directing at least one fluid jet emanating from said distal end of said tubular means to impinge on said opening in said distal end of said second passage.

25. A device with fluid jets for breaking apart and removing tissue or other material from a biological or synthetic body vessel or cavity comprising:

a. a tubular member having a proximal end and a distal end, having a plurality of passages including a first passage and a second passage extending along the length thereof, each passage with a proximal end and a distal end;

b. said first passage comprising tubular means for carrying high pressure fluid from said proximal end to said distal end, the distal portion of said tubular means having at least two orifices;

c. said orifices forming fluid jets from the flow of high pressure fluid, at least one of the fluid jets being directed by said orifice(s) to impinge upon the tissue;

d. at least one of said orifices directing at least one fluid jet in a direction which is largely distal to said distal end of said first passage;

e. said proximal end of said first passage is connected to a high pressure fluid source which drives a flow of fluid into said tubular means;

f. said second passage provides for passage of a catheter device, said distal end of said second passage having an opening; and

,

g. at least one of said orifices directing at least one fluid jet emanating from said distal end of said tubular means to impinge on said opening in said distal end of said second passage.

26. The device of claim 25, further comprising a jet nozzle assembly at said distal end of said tubular means which provides the high pressure fluid from said first passage to said orifices.

27. The device of claim 25, wherein at least one of said orifices direct at least one fluid jet emanating from said distal end of said tubular means in a direction approximately parallel to the axis of said tubular member.

28. The device of claim 25, wherein at least one of said orifices which direct fluid jet(s) emanating from said distal end of said tubular means is directed nonparallel to a longitudinal axis of said tubular member.

29. The device of claim 25, wherein said proximal end of said second passage is connected to a metering means to control a flow of fluid and emulsified tissue along said second passage at a rate of flow less than the rate of flow which would result without said metering means.

30. The device of claim 25, wherein said proximal end of said second passage is connected to a suction means to augment a flow of fluid and emulsified tissue along said second passage.

31. The device of claim 25, wherein a plurality of said orifices are positioned along said distal end of said tubular means;

when a catheter device is in position at said distal end of said tubular member, said plurality of orifices are not shielded from the tissue by the guidewire or other catheter device.