Thrombectomy and soft debris removal device

• US 7,959,608 B2
• Filed: 04/27/2004
• Issued: 06/14/2011
• 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.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Osinski; Bradley J
• Application Number:
  US10/832,830
• Publication Number:
  US 20050240146A1
• Time in Patent Office: 2,604 Days
• Field of Search: 604/32, 604/33, 604/35, 604/43, 604/118, 604/131, 604/152, 604/155, 604/171
• US Class Current: 604/155
• 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 catheter body having a proximal end, a distal end, a central lumen, and a guidewire lumen that runs side-by-side the central lumen from the proximal end to near the distal end;

a rotary helical aspiration pump, contained within the central lumen in the catheter body, wherein the rotary helical aspiration pump has a proximal end and a distal end, wherein the rotary helical aspiration pump comprises an elongate cylindrical core and a helical member that is secured to an outer surface of the core along an entire axial length of the helical member; and

a working head having a distal end, and a proximal end located near the distal end of the rotary helical aspiration pump, wherein the working head comprises a cap having a solid outer wall, wherein the helical member extends into the working head and distally beyond a plurality of inlet ports in the walls of the cap, wherein the cap is generally aligned and continuous with the catheter body and encloses and separates the distal end of the rotary helical aspiration pump from the outside environment except for the plurality of inlet ports which are sized based on a desired suction velocity and an amount of material desired to enter into the cap as the helical member rotates within the central lumen and the working head, wherein the guidewire lumen terminates near the working head, wherein the helical member extends beyond the termination of the guidewire lumen, and wherein the working head comprises a tapered flexible atraumatic tip that is at the very distal end of the catheter system, the tip having a tip lumen at the distal end that is separate from the guidewire lumen such that a guidewire may exit the guidewire lumen, pass alongside the working head and then pass through the tip lumen.

2. The flexible catheter system of claim 1, wherein said rotary helical aspiration pump comprises a rotor within the central lumen of the catheter body and a clearance between said rotor and the inner surface of the central lumen, said clearance being 33% or less of the rotor diameter and 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.

3. The flexible catheter system of claim 1, wherein at least one of the inlet ports has a sharp cutting edge forming the periphery thereof, said at least one inlet port being arranged to allow the passage of the occlusive material therethrough to said rotary helical aspiration pump;

whereby said occlusive material will be cut by the sharpened edge of the inlet port to form fragments of a size capable of being conveyed by the aspiration pump.

4. The guidewire following means of claim 1, wherein the flexible atraumatic tip comprises a biocompatible material selected from the group consisting of nitinol, silicone, latex, and polytetrafluoroethylene.

5. The guidewire following means of claim 1, wherein the flexible atraumatic tip further comprises a lubricious coating layer.

6. The flexible catheter system of claim 1, further comprising a distal protection measure, wherein the distal protection measure is selected from a group consisting of balloons and umbrella filters.

7. The flexible catheter system of claim 1, wherein the helical aspiration pump comprises a helical coil member and a core member, wherein said helical coil member is coiled around at least a portion or portions of the core member, and wherein the helical coil member does not extend uninterrupted for the entire length of the core member, thereby providing increased flexibility in the regions where there is no helical coil member.

8. The flexible catheter system of claim 1, wherein the helical coil member is formed having a cutting edge at or near the distal end.

9. The flexible catheter system of claim 1 further comprising a rotary helical or reciprocating infusate pump.

10. The flexible catheter system of claim 9, wherein said working head further comprises at least one outlet port, said at least one outlet port being arranged to allow a flow of infusate fluid therethrough to the vessel, duct or lumen.

11. The flexible catheter system of claim 10, wherein said working head further comprises at least one outlet port, said at least one outlet port directs the flow of said infusate fluid radially, towards a wall of the vessel, duct or lumen;

or distally, into the vessel, duct or lumen;

or proximally, towards said inlet port.

12. The flexible catheter system of claim 10, further comprising a safety mechanism, said safety mechanism comprising a valve means being arranged to selectively open and close 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.

13. The safety mechanism of claim 12, 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.

14. The safety mechanism of claim 13, 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.

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

16. The flexible catheter system of claim 9, wherein said rotary helical aspiration pump comprises a 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 infusate pump to the vessel, duct or lumen.

17. The flexible catheter system of claim 9, wherein said rotary helical aspiration pump and said rotary infusate pump are both driven by said source of rotary power.

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

19. The flexible catheter system of claim 9, wherein said rotary helical aspiration pump operates to create an aspiration flow rate, and said rotary infusate pump operates to create an infusate now rate, said aspiration now rate being at least that of the infusate flow rate.

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 driveshaft having a proximal and a distal end, 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 wherein the helical aspiration pump comprises an aspiration catheter body that is configured to be inserted into a body lumen, and;

b. a helical infusate pump serving to deliver infusate fluid in a distal direction into the living being, wherein the infusate pump comprises an infusate catheter body that, is separate from the aspiration catheter body and that is configured to remain outside a body lumen;

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 such that there is no overlap between windings of the helical aspiration pump and windings of the helical infusate pump.

21. The flexible catheter system of claim 20, wherein each of said helical aspiration pump and helical infusate pump comprises a helical coil member and a core member, wherein said helical coil member is coiled around at least a portion or portions of the core member, forming a flexible screw conveyor.

22. The flexible catheter system of claim 20, 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.

23. The flexible catheter system of claim 20, 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.

24. The flexible catheter system of claim 23, 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.

25. The flexible catheter system of claim 24, wherein said first valve is arranged to shunt fluid flow of said helical infusate pump towards the living being, and said second valve is arranged to allow proximal material flow out of said living being.

26. The flexible catheter system of claim 25, wherein said first valve is a diaphragm valve, and said second valve is a ball and spring check valve.

27. The flexible catheter system of claim 20, 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.

28. The flexible catheter system of claim 27, 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.

29. The flexible catheter system of claim 28, wherein a tip lumen is provided in said atraumatic tip to slidably accept a guidewire.

30. The flexible catheter system of claim 27, wherein the windings of the helical aspiration pump comprise a helical coil wire, wherein said helical aspiration pump comprises a core member, wherein said helical coil wire is formed having a cutting surface at or near the distal end.

31. The flexible catheter system of claim 30, wherein said inlet ports further comprise a cutting surface.

32. The flexible catheter system of claim 27, further comprising an external guidewire lumen, said guidewire lumen being attached proximally of said working head, and extending proximally for a portion of said catheter assembly.

33. The flexible catheter system of claim 27, wherein said at least one outlet port is arranged to deliver said infusate fluid in the form of a stream.

34. The flexible catheter system of claim 33, wherein said stream is capable of dislodging and suspending occlusive material in said living being.

35. The flexible catheter system of claim 20, wherein said infusate fluid is selected from the group consisting of water, buffers, saline, therapy, blood, contrast medium and combinations thereof.

36. The flexible catheter system of claim 35, wherein said infusate fluid further comprises solids.

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

38. 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 catheter body having a proximal end, a distal end, a central lumen, and an external guidewire lumen side-by-side with the central lumen;

a rotary helical aspiration pump contained within the central lumen in the catheter body, wherein the rotary helical aspiration pump has a proximal end and a distal end, wherein the aspiration pump comprises an elongate cylindrical core and a helical coil member that is secured to an outer surface of the core along an entire axial length of the helical member; and

a working head having a distal end and a proximal end located near the distal end of the rotary helical aspiration pump, wherein the working head comprises a cap having a solid outer wall, wherein the helical coil member extends into the working head and beyond a plurality of inlet ports in the walls of the cap, wherein the cap is generally aligned and continuous with the catheter body and encloses and separates the distal end of the rotary helical aspiration pump from the outside environment except for the plurality of inlet ports which are sized based on a desired suction velocity and an amount of material desired to enter into the cap as the helical coil member rotates within the central lumen and the working head, wherein the guidewire lumen terminates near the working head, wherein the helical coil member extends distally beyond the termination of the guidewire lumen, and wherein the working head comprises a tip that is at the very distal end of the catheter system, the tip having a tip lumen at the distal end that is separate from the guidewire lumen such that a guidewire may exit the guidewire lumen, pass alongside the working head and then pass through the tip lumen; and

wherein the catheter body has a size of 3-8 French.

39. The flexible catheter system of claim 38, wherein the helical coil member is formed having a cutting edge at or near the distal end.

40. The flexible catheter system of claim 38, further comprising a rotary helical or reciprocating infusate pump.

41. The flexible catheter system of claim 38, wherein the working head comprises a tapered flexible atraumatic tip having a short tip lumen at the distal end that is configured to receive a guidewire.

42. 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 catheter body having a proximal end, a distal end and a central lumen and an external guidewire lumen side-by-side with the central lumen;

a rotary helical aspiration pump contained within the central lumen in the catheter body, wherein the rotary helical aspiration pump has a proximal end and a distal end, wherein the aspiration pump comprises an elongate cylindrical core and a helical member that is secured to an outer surface of the core along an entire axial length of the helical member; and

a working head having a distal end and a proximal end located near the distal end of the rotary helical aspiration pump, wherein the working head comprises a cap having a solid wall, wherein the helical coil member extends into the working head and distally beyond a plurality of inlet ports in the walls of the cap, wherein the cap is generally aligned and continuous with the catheter body and encloses and separates the distal end of the rotary helical aspiration pump from the outside environment except for the plurality of inlet ports which are sized based on a desired suction velocity and an amount of material desired to enter into the cap as the helical member rotates within the central lumen and the working head, wherein the working head further comprises a tapered flexible atraumatic tip having a short tip lumen at the distal end that is configured to receive a guidewire.

43. A catheter system as in claim 42, wherein the catheter body has a size of 3-8 French, and wherein the rotary helical aspiration pump comprises a helical wire that is wound about a hollow core lumen, but is not affixed thereto.

44. A catheter system as in claim 42, wherein the external guidewire lumen terminates proximal to the tip lumen.

45. The flexible catheter system of claim 42, wherein the helical coil member is formed having a cutting edge at or near the distal end.

46. The flexible catheter system of claim 42, further comprising a rotary helical or reciprocating infusate pump.

47. The flexible catheter system of claim 46, wherein said working head further comprises at least one outlet port, said at least one outlet port being arranged to allow a flow of infusate fluid therethrough to the vessel, duct or lumen.