Thrombectomy device

• US 5,370,609 A
• Filed: 01/15/1993
• Issued: 12/06/1994
• Est. Priority Date: 08/06/1990
• 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): Yasko, John D.
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/006,076
• Time in Patent Office: 690 Days
• Field of Search: 604/22, 604/43, 606/127, 606/128, 606/159, 606/190
• US Class Current: 604/22
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy

Abstract

A method of and apparatus for removing a thrombus deposit from the cardiovascular system of a patient without the need to surgically access the location of the thrombus deposit via a cut-down or other surgical procedure. A catheter is inserted percutaneously into the patient at a convenient location either directly or over a previously positioned guide wire. The distal end of the catheter is advanced under fluoroscopy to the site of the thrombus deposit. A balloon is inflated to stabilize the position of the distal end of the catheter within the center of the vessel lumen. A flexible metal tube conveys an extremely high pressure stream of sterile saline solution to at least one jet at the distal end of the catheter. At least one jet positions the thrombus deposit for emulsification by at least one other jet. By directing the jets toward the orifice of the large evacuation lumen of the catheter, a stagnation pressure is induced which propels the emulsion proximally for disposal. The rate of proximal flow of effluent is metered to correspond with the distal flow of saline solution to ensure minimal local impact on the vasculature at the site of the thrombus deposit.

Claims

1. A device for removing thrombus or other tissue from an occluded or obstructed biological or synthetic body vessel comprising:

a. a tubular member having a proximal end and a distal end, having a first passage and a second passage extended along the length thereof, each passage with a proximal and distal end;

b. the first passage comprising tubular means for carrying high pressure liquid from the proximal end to the distal end;

c. the second passage comprising tubular means for carrying liquid and emulsified tissue from the distal end to the proximal end;

d. one or more liquid jets emanating from the distal end of the first passage to produce a low pressure region which tends to bring the tissue towards the jet(s) thereby avoiding the need to move the jet(s) into immediate juxtaposition with the tissue or aiming the jets directly at the tissue;

e. the proximal end of the first passage is connected to a high pressure liquid source; and

,

f. the open proximal end of the second passage provides removal of the tissue fragments from the body.

4. The device of claim 2, 1, or 3 wherein a metering means is connected to the proximal end of the second passage to control the flow of liquid and emulsified tissue at a rate of flow less than the rate of flow which would result without the metering means.

5. The device of claim 4 wherein the metering means consists of a roller pump which controls the outflow resistance in the second passage, and hence controls the rate of flow of emulsified tissue.

6. The device of claim 4 wherein the metering means controls the rate of flow of liquid and emulsified tissue in the second passage at a rate of flow approximately equal the rate of flow of high pressure liquid in the first passage.

7. The device of claim 2, 1, or 3 wherein one or more liquid jets emanating from the distal end of the first passage are directed with some radial component.

8. The device of claim 7 wherein a metering means is connected to the tubular member to control the flow of liquid and emulsified tissue at a rate of flow less than the rate of flow which would result without the metering means.

9. The device of claim 2, 1, or 3 wherein the high pressure liquid source is a positive-displacement piston pump.

10. The device of claim 9 wherein the piston pump provides the high pressure liquid flow in a largely pulsatile or periodic unsteady flow.

11. The device of claim 9 wherein the piston pump provides the high pressure liquid flow in a largely steady flow.

12. The device of claim 2, 1, or 3 wherein the second passage also provides passage for a guidewire, ultrasound catheter, angioscopic catheter, or other catheter device.

13. The device of claim 2, 1, or 3 wherein the distal end of the first passage is formed into an arcuate shape extending beyond the second passage to direct one or more jets onto the distal end of the second passage.

14. The device of claim 2, 1, or 3 wherein the distal end of the first passage is formed into a toroidal shape which is oriented in a plane perpendicular to the axis of the tubular member.

15. The device of claim 14 wherein the toroidal shape facilitates movement of the tubular member along a guidewire, thereby directing the distal end of the tubular member in the body vessel.

16. The device of claim 14 wherein a plurality of liquid jets emanate from various points along the toroidal-shaped portion of the first passage;

when a guidewire is in position through the toroidal shape, the jets are therefore oriented at various points circumferentially around the guidewire, thereby decreasing any effect that the guidewire may have in shielding any tissue from the effects of the jets.

17. The device of claim 2, 1 or 3 wherein the first passage comprises a metal tube.

2. A device for removing thrombus or other tissue from an occluded or obstructed biological or synthetic body vessel comprising:

a. a tubular member having a proximal end and a distal end, having a first passage and a second passage extended along the length thereof, each passage with a proximal and distal end;

b. the first passage comprising tubular means for carrying high pressure liquid from the proximal end to the distal end;

c. the second passage comprising tubular means for carrying liquid and emulsified tissue from the distal end to the proximal end;

d. one or more liquid jets emanating from the distal end of the first passage and impinging on the open distal end of the second passage with a component in the direction of the flow of the emulsified tissue in the second passage, said liquid jet(s) providing sufficient stagnation pressure without any suction means required to drive the flow of emulsified tissue from the distal end of the second passage towards the proximal end of the second passage;

e. the proximal end of the first passage is connected to a high pressure liquid source; and

,

f. the open proximal end of the second passage provides removal of the tissue fragments from the body.

3. A device for removing thrombus or other tissue from an occluded or obstructed biological or synthetic body vessel comprising:

a. a tubular member having a proximal end and a distal end, having a first passage and a second passage extended along the length thereof, each passage with a proximal and distal end;

b. the first passage comprising tubular means for carrying high pressure liquid from the proximal end to the distal end;

c. the second passage comprising tubular means for carrying liquid and emulsified tissue from the distal end to the proximal end;

d. one or more liquid jets emanating from the distal end of the first passage and impinging on the open distal end of the second passage with a component in the direction of the flow of the emulsified tissue in the second passage, the liquid in the first passage being under high pressure greater than approximately 1000 psi at the proximal end of the first passage providing sufficient energy in said jets to cut or emulsify harder tissue;

e. the proximal end of the first passage is connected to a high pressure liquid source, said source providing liquid at pressure sufficient to supply the proximal end of the first passage with liquid at grater than approxiamtely 1000 psi, allowing for pressure losses along the first passage, resulting in decreased pressure at the distal end of the first passage; and

,

f. the open proximal end of the second passage provides removal of the tissue fragments from the body.