Thrombectomy catheter with control box having pressure/vacuum valve for synchronous aspiration and fluid irrigation

• US 9,510,854 B2
• Filed: 10/13/2008
• Issued: 12/06/2016
• Est. Priority Date: 10/13/2008
• Status: Active Grant

• Current Assignee: Walk Vascular, LLC
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Mallaby, Mark
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US12/250,286
• Publication Number:
  US 20100094201A1
• Time in Patent Office: 2,976 Days
• Field of Search: 604/22, 604/31, 604/65, 604/67, 604/70, 604118-120, 604/525, 606/159
• US Class Current: 1/1
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means

Abstract

A thrombectomy system comprising an aspiration catheter having an aspiration lumen and a high pressure irrigation lumen, the aspiration catheter having a proximal end and a distal, and a control box fluidly connected to the aspiration catheter and configured to synchronously provide irrigation and vacuum through the aspiration catheter.

Claims

1. A thrombectomy system, comprising:

an aspiration catheter having an aspiration lumen and a high pressure irrigation lumen, the aspiration catheter having a proximal end and a distal end;

a fluid source;

a vacuum source producing a vacuum; and

a control box fluidly connecting the fluid source and the vacuum source to the high pressure irrigation lumen and the aspiration lumen, respectively;

wherein the control box is configured to provide high pressure irrigation fluid to the high pressure irrigation lumen when the vacuum is present in the aspiration lumen, and to prevent high pressure irrigation fluid from being provided to the irrigation lumen when the vacuum is not present in the aspiration lumen;

wherein the aspiration lumen has a distal opening and wherein the high pressure irrigation lumen has a distal orifice directed into the aspiration lumen and configured to release a jet of irrigation fluid across the width of the aspiration lumen against an opposing wall of the aspiration lumen, wherein the distal orifice is proximal of the distal opening by at least 0.02 cm;

wherein the jet forms a spray pattern that interacts with the opposing wall of the aspiration lumen in such a way that embolic material is diluted for aspiration and not forced out of the distal opening;

wherein the control box includes a pressure/vacuum valve interposed along the aspiration lumen between the vacuum source and the distal opening;

wherein the pressure/vacuum valve turns the vacuum source on and off synchronously with the high pressure irrigation fluid.

2. The system of claim 1, wherein providing irrigation through a first passage in the control box opens a second passage fluidly connected to the aspiration lumen.

3. The system of claim 2 wherein the control box further includes a displacement pump providing irrigation pressure.

4. The system of claim 3 further comprising tubing fluidly connecting the control box to the aspiration and high pressure irrigation lumens.

5. The system of claim 4 wherein operation of the pump produces fluid pressure pulses and wherein the tubing operates to damping the fluid pressure pulses.

6. The system of claim 5 wherein the catheter irrigation lumen has a compliancy along a proximal region thereof and wherein the tubing has a compliancy that is greater than that of the proximal region of the catheter aspiration lumen.

7. The system of claim 5 wherein the tubing comprises a compliant polymeric material.

8. The system of claim 4 further comprising an interface connector disposed between the tubing and the aspiration catheter whereby the aspiration catheter is detachable and reattachable to the tubing.

9. The system of claim 8 wherein the connector fluidly connects the tubing and the high pressure irrigation lumen.

10. The system of claim 4 wherein the control box is permanently attached to the tubing and wherein the tubing is permanently attached to the aspiration catheter.

11. The system of claim 10 further comprising an interface connector disposed between the tubing and the aspiration catheter.

12. The system of claim 3, further comprising a control board, wherein the control board is configured to cut power to the pump when a sensed current at the pump is out of a predetermined range.

13. The system of claim 3, further comprising a control board, wherein the control board is configured to cut power to the pump when a sensed current at the pump drops faster than a preset limit.

14. The system of claim 3, further comprising a control board, wherein the control board is configured to cut power to the pump when a sensed vacuum pressure at the second passage is out of a predetermined range.

15. The system of claim 3, wherein the vacuum source is a vacuum bottle.

16. The system of claim 3, wherein the fluid source is a saline bottle.

17. The system of claim 2 wherein the pressure/vacuum valve is a mechanical valve such that fluid pressure in the first passage operates the valve.

18. The system of claim 2 wherein the pressure/vacuum valve is controlled electronically.

19. The system of claim 2 further comprising a priming valve fluidly connecting the first and second passages when opened.

20. The system of claim 1 wherein the distal orifice is further configured such that the jet of irrigation fluid is released normal to a longitudinal axis of the aspiration lumen.

21. A method of removing a thrombus, comprising the steps of:

inserting the aspiration catheter of the thrombectomy system of claim 1 percutaneously into a body vessel lumen;

advancing the aspiration catheter to a region of interest; and

operating the control box to synchronously provide high pressure irrigation and aspiration through the aspiration catheter to draw the thrombus into the aspiration lumen.

22. The method of claim 21, wherein the system of claim 1 further provides irrigation through a first passage in the control box opening a second passage fluidly connected to the aspiration lumen,

wherein the pressure/vacuum valve is a mechanical valve such that fluid pressure in the first passage operates the valve.

23. The method of claim 21, wherein the system of claim 1 further provides irrigation through a first passage in the control box opening a second passage fluidly connected to the aspiration lumen,

a priming valve fluidly connecting the first and second passages when opened, and

further comprising the step of, prior to the step of inserting the aspiration catheter, operating the priming valve to evacuate air from the pump.