Thrombectomy and soft debris removal device

• US 20050240146A1
• Filed: 04/27/2004
• Published: 10/27/2005
• Est. Priority Date: 04/27/2004
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Sauro, Dennis M., Walters, Greg, Eberhart, Mark, Nash, John E., Fisher, William T.
• Granted Patent: US 7,959,608 B2
• Time in Patent Office: Days
• US Class Current: 604/35
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• 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 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A device suitable for removing material from a living being is provided, featuring an infusate pump, and an aspiration pump, both powered by a motor. The aspiration pump and infusate pump preferably feature a helical pumping mechanism, and operate at a high rate of rotation, thereby ensuring adequate pumping performance and flexibility. Additionally, a narrow crossing profile is maintained, ensuring that the device may reach more tortuous regions of the vasculature.

Claims

1. A flexible catheter system for clearing an accumulation of occlusive material from a vessel, duct or lumen in a living being, said flexible catheter system comprising a rotary helical aspiration pump, a rotary helical infusate pump, and a source of rotary power.

2. The flexible catheter system of claim 1, wherein said rotary helical aspiration pump comprises a rotor and a surrounding catheter jacket, said rotor comprising a hollow core lumen and a helical wire, said hollow core lumen being arranged to allow delivery of an infusate fluid from said rotary helical infusate pump to the vessel, duct or lumen.

3. The flexible catheter system of claim 2, wherein said rotary helical aspiration pump further comprises a clearance between said rotor and said surrounding catheter jacket, said clearance being arranged to allow free rotation of said rotor within said surrounding catheter jacket while flexed, said free rotation being of sufficiently high speed to overcome leakage due to said clearance.

4. The flexible catheter system of claim 2, further comprising a working head located at a distal end of said rotary helical aspiration pump, said working head comprising at least one inlet port, and at least one outlet port, said at least one outlet port being arranged to allow flow of said infusate fluid therethrough to the vessel, duct or lumen, and said at least one inlet port being arranged to allow the passage of the occlusive material therethrough to said rotary helical aspiration pump rotor.

5. The flexible catheter system of claim 4, wherein said at least one outlet port directs the flow of said infusate fluid radially, towards a wall of the vessel, duct or lumen.

6. The flexible catheter system of claim 4, wherein said at least one outlet port directs the flow of said infusate fluid distally, into the vessel, duct or lumen.

7. The flexible catheter system of claim 4, wherein said at least one outlet port directs the flow of said infusate fluid proximally, towards said inlet port.

8. The flexible catheter system of claim 1, wherein said rotary helical aspiration pump and said rotary helical infusate pump are both driven by said source of rotary power.

9. The flexible catheter system of claim 1 wherein said rotary helical aspiration pump and said rotary helical infusate pump are both driven at the same rotary speed.

10. The flexible catheter system of claim 4 wherein said rotary helical aspiration pump operates to create an aspiration flow rate, and said rotary helical infusate pump operates to create an infusate flow rate, said aspiration flow rate being at least that of the infusate flow rate.

11. The flexible catheter system of claim 10, further comprising a safety mechanism, said safety mechanism comprising a valve means being arranged to allow said infusate fluid flow to said vessel, duct or lumen in response to aspiration flow from said vessel, duct or lumen through operation of the rotary helical aspiration pump.

12. The safety mechanism of claim 11, wherein said valve means comprises a first valve and a second valve, said first valve and second valves enabling infusate fluid flow in response to a detected pressure increase through the operation of the helical aspiration pump.

13. The safety mechanism of claim 12, wherein said first valve is arranged to shunt fluid flow of said helical infusate pump towards the living being, and said second is arranged to allow proximal material flow out of said living being.

14. The safety mechanism of claim 13, wherein said first valve is a diaphragm valve, and said second valve is a ball and spring check valve.

15. The working head of claim 4, further comprising a guidewire following means.

16. The guidewire following means of claim 15, comprising a flexible atraumatic tip, a recessed channel, and a guidewire opening.

17. The guidewire following means of claim 16, wherein the flexible atraumatic tip comprises a biocompatible material selected from the group consisting of nitinol, silicone, latex, and polytetrafluoroethylene.

18. The guidewire following means of claim 16, wherein the flexible atraumatic tip further comprises a lubricious coating layer.

19. The flexible catheter system of claim 1, further comprising a distal protection measure.

51. The flexible catheter assembly system of claim 1, substantially as shown and described.

20. A flexible catheter system for clearing an accumulation of occlusive material from a vessel, duct or lumen in a living being, said flexible catheter system comprising a rotary helical aspiration pump, a reciprocating infusate pump and a source of rotary power.

21. The flexible catheter system of claim 20, wherein said rotary helical aspiration pump operates to create an aspiration flow rate, and said reciprocating infusate pump operates to create an infusate flow rate, said aspiration flow rate being at least that of the infusate flow rate.

22. The flexible catheter system of claim 20, wherein said rotary helical aspiration pump comprises a rotor and a surrounding catheter jacket, said rotor comprising a hollow core lumen and a helical wire, said hollow core lumen being arranged to allow delivery of an infusate fluid from said reciprocating helical infusate pump to the vessel, duct or lumen.

23. The flexible catheter system of claim 22, wherein said rotary helical aspiration pump further comprises a clearance between said rotor and said surrounding catheter jacket, said clearance being arranged to allow free rotation of said rotor within said surrounding catheter jacket while flexed, said free rotation being of sufficiently high speed to overcome leakage due to said clearance.

24. The flexible catheter system of claim 22, further comprising a working head located at a distal end of said rotary helical aspiration pump, said working head comprising at least one inlet port, and at least one outlet port, said at least one inlet port being arranged to allow the passage of the occlusive material therethrough to said rotary helical aspiration pump rotor, and said at least one outlet port being arranged to allow flow of said infusate fluid therethrough.

25. The flexible catheter system of claim 24, wherein said at least one outlet port directs the flow of said infusate fluid radially, towards a wall of the vessel, duct or lumen.

26. The flexible catheter system of claim 24, wherein said at least one outlet port directs the flow of said infusate fluid distally, into the vessel, duct or lumen.

27. The flexible catheter system of claim 24, wherein said at least one outlet port directs the flow of said infusate fluid proximally, towards said inlet port.

28. The flexible catheter system of claim 20, wherein said rotary helical aspiration pump and said reciprocating infusate pump are both driven by said source of rotary power.

29. The flexible catheter system of claim 20, further comprising a distal protection measure.

30. A flexible catheter system for clearing an accumulation of occlusive material from a vessel, duct or lumen in a living being, said flexible catheter system comprising a driveshaft, a source of rotary power, a helical aspiration pump and a helical infusate pump;

wherein said driveshaft is operatively connected to a source of rotary power and said driveshaft serves to actuate rotation for both;

a. a helical aspiration pump serving to draw material in a proximal direction out of the living being, and;

b. a helical infusate pump serving to deliver infusate fluid in a distal direction into the living being.

31. The flexible catheter system of claim 30, wherein said driveshaft has a proximal and distal end, further wherein said helical aspiration pump is operatively attached to said distal end of said driveshaft, and said helical infusate pump is operatively attached to said proximal end of said driveshaft.

32. The flexible catheter system of claim 30, wherein said helical aspiration pump comprises an aspiration helical coil member and an aspiration core member, wherein said aspiration helical coil member is coiled around substantially the length of the aspiration core member, forming a flexible, aspiration screw conveyor.

33. The flexible catheter system of claim 32, wherein said helical infusate pump comprises an infusate helical coil member and an infusate core member, wherein said infusate coil member is coiled around substantially the length of the aspiration core member, forming an infusate screw conveyor.

34. The flexible catheter system of claim 30, wherein said driveshaft is operatively coupled to an infusate pump core member, and said infusate pump core member is operatively coupled to a hollow aspiration pump core member, wherein the rotation of said driveshaft effectuates rotation of both the infusate pump and said aspiration pump.

35. The flexible catheter system of claim 30, further comprising a safety mechanism, said safety mechanism comprising at least 1 valve means being arranged to allow fluid flow delivery to said living being from said infusate pump in response to material flow from said patient through operation of the aspiration pump.

36. The flexible catheter system of claim 35, wherein said valve means comprises a first valve and a second valve, said first valve and second valves enabling fluid flow in response to a pressure increase through the operation of the helical aspiration pump.

37. The flexible catheter system of claim 36, wherein said first valve responds is arranged to shunt fluid flow of said helical infusate pump towards the living being, and said second is arranged to allow proximal material flow out of said living being.

38. The flexible catheter system of claim 37, wherein said first valve is a diaphragm valve, and said second valve is a ball and spring check valve.

39. The flexible catheter system of claim 30, further comprising a working head located at a distal end of said flexible catheter system, said working head comprising a plurality of inlet ports, at least one outlet port, and at least one cutting surface, said working head being arranged to sever and fragment said occlusive material for removal from the living being.

40. The flexible catheter system of claim 39, wherein said working head further comprises a tapered flexible atraumatic tip, said atraumatic tip enhancing the ability of the catheter assembly to navigate into the vasculature of a living being.

41. The flexible catheter system of claim 39, wherein said helical aspiration pump comprises a helical coil wire and a core member, wherein said helical coil wire is formed having a cutting surface at or near the distal end.

42. The flexible catheter system of claim 41, wherein said inlet ports further comprise a cutting surface.

43. The flexible catheter system of claim 40, wherein said atraumatic tip is arranged to slidably accept a guidewire through a guide wire following means.

44. The flexible catheter system of claim 39, further comprising a guidewire lumen, said guidewire lumen being attached proximally of said working head, and extending proximally for a portion of said catheter assembly.

45. The flexible catheter system of claim 39, further comprising a guidewire following means.

46. The flexible catheter system of claim 39, wherein said at least one outlet port is arranged to deliver said infusate fluid in the form of a stream.

47. The flexible catheter system of claim 39, wherein said stream is capable of dislodging and suspending occlusive material in said living being.

48. The flexible catheter system of claim 30, wherein said infusate fluid is selected from the group consisting of water, buffers, saline, therapy, blood, contrast medium and combinations thereof.

49. The flexible catheter system of claim 48, wherein said infusate fluid further comprises solids.

50. The flexible catheter system of claim 30, further comprising a distal protection measure.