Methods and apparatuses for navigating the subarachnoid space

• US 7,150,737 B2
• Filed: 12/23/2002
• Issued: 12/19/2006
• Est. Priority Date: 07/13/2001
• Status: Expired due to Fees

• Current Assignee: Endophys Holdings, LLC, Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation), Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Bashiri, Mehran, Nair, Ajit, Purdy, Phillip D., Ramzipoor, Kamal, Pham, Pete Phong
• Primary Examiner(s): Sirmons, Kevin C.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/328,560
• Publication Number:
  US 20030097082A1
• Time in Patent Office: 1,457 Days
• Field of Search: 604/500, 604/506, 604/508, 604/510, 604/522, 604/39, 604/93.01, 604/96.01, 604/113, 604/117, 604/151, 604/152, 604/153, 604/264, 604/272, 604/523, 128/898
• US Class Current: 604/506
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 : Guide tubes
• 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
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Disclosed are methods and devices for navigating a subarachnoid space in a vertebrate organism including percutaneously introducing a device into the spinal subarachnoid space at an entry location. Navigation of the spinal subarachnoid space is disclosed for the purpose of reaching a desired location in the subarachnoid space or the intracranial space, including areas in and around the spinal cord and brain. Once a desired location is reached, methods and devices for cooling or heating the desired location to cause physiologic changes are suggested.

Claims

1. A method of treating the CSF in a subarachnoid space of a vertebrate organism, the method comprising:

providing a catheter having a proximal end, a distal end, and an elongate shaft extending therebetween, the catheter coupled to a device having the capacity for moving a fluid;

percutaneously introducing the catheter with the device into the subarachnoid space at an entry location corresponding to a spinal portion of the subarachnoid space;

advancing the caterer within the sub arachnoid space so that the device is at least partially within the subarachnoid Space; and

activating the device to treat the CSF within the subarachnoid space.

2. The method of claim 1, wherein treating the CSF includes creating flow of CSF, and the step of activating the device results in creation of a flow of CSF within the subarachnoid space.

3. The method of claim 2, wherein the device comprises an Archimedean screw engaged with an elongate shaft for turning the Archimedean screw.

4. The method of claim 3, wherein the Archimedean screw comprises a collapsible member.

5. The method of claim 4, further including the steps of:

introducing the Archimedean screw into the spinal subarachnoid space in a collapsed state;

advancing the Archimedean screw to a desired location;

causing the Archimedean screw to convert from the collapsed state into an operational state; and

rotating the Archimedean screw to cause movement of the CSF.

6. The method of claim 2, wherein the device includes a first electrode and a second electrode, and the method further includes the Step of inducing an electrostatic force between the first electrode and the second electrode to cause displacement of the fluid.

7. The method of claim 6, wherein the device further includes a flexible member, wherein the first electrode is fixed to the flexible member and the induced electrostatic force causes a change in shape of the flexible member.

8. The method of claim 7, wherein the flexible member is made of a shape memory material.

9. The method of claim 7, wherein the flexible member is disposed under tension.

10. The method of claim 2, wherein the elongate shaft includes a lumen, and the step of activating the device causes the CSF to pass through a distal portion of the lumen.

11. The method of claim 1, further including providing a heat exchanger adapted to perform a heat exchange with the CSF.

12. The method of claim 11, wherein the catheter includes a conduit enabling a heat-exchanging fluid to pass therethrough between a proximal location and the heat exchanger.

13. The method of claim 11, wherein the conduit includes a section disposed within the spinal subarachnoid space.

14. The method of claim 11, wherein the heat exchanger includes a balloon.

15. The method of claim 14, further comprising the steps of:

inflating the balloon with a heat exchanging fluid; and

deflating the balloon.

16. The method of claim 15, further including the step of repeating the steps of inflating the balloon with a heat exchanging fluid and deflating the balloon.

17. The method of claim 15, further including the steps of:

monitoring a cardiac cycle of the vertebrate organism; and

performing the step of inflating the balloon with a heat exchanging fluid at a time chosen to correspond to a portion of the cardiac cycle of the vertebrate organism.

18. The method of claim 15, further including the steps of:

monitoring a cardiac cycle of the vertebrate organism; and

performing the step of deflating the balloon at a time chosen to correspond to a portion of the cardiac cycle of the vertebrate organism.

19. The method of claim 11, wherein the device comprises a flexible member, the method further including:

passing a heat exchanging fluid to the device; and

causing the flexible member to change shape.

20. The method of claim 19, wherein the flexible member has shape memory properties such that, when disposed at the body temperature of the vertebrate organism, the flexible member assumes a first shape, and passing the heat exchanging fluid to the device causes the flexible member to assume a second shape.

21. The method of claim 1, wherein the device includes a flexible member, and wherein the step of activating the device includes the step of causing the flexible member to move.

22. The method of claim 21, wherein the step of causing the flexible member to move includes applying an electrostatic force.

23. The method of claim 21, wherein the step of causing the flexible member to move includes applying a magnetostatic force.

24. The method of claim 21, wherein the step of causing the flexible member to move includes applying an acoustic wave.

25. The method of claim 21, wherein the step of causing the flexible member to move includes the step of providing an ultrasonic signal.

26. The method of claim 1, wherein said treating involves reducing cellular metabolic rates in a portion of tissue of a patient;

wherein the step of advancing the catheter includes advancing the catheter through the spinal subarachnoid space to location within either the spinal subarachnoid space or an adjacent intracranial subarachnoid space;

wherein the catheter has an infusion port, and the step of treating includes providing a cooling fluid at a temperature below the patient'"'"'s normal body temperature, and pumping the cooling fluid through the infusion port.

27. The method of claim 1, wherein said treating involves cooling tissue in a subarachnoid space of a vertebrate organism;

wherein the step of providing a catheter includes providing a catheter including an elongate shaft having a proximal end, a distal end, a first lumen, a second lumen, and a heat exchanger disposed adjacent the distal end in fluid communication with the first lumen and the second lumen;

wherein the step of advancing the catheter includes advancing the distal end of the catheter within the subarachnoid space and positioning the heat exchanger adjacent the tissue;

wherein the step of activating the device includes providing a flow of cooling fluid through the first lumen to the heat exchanger and removing the cooling fluid from the heat exchanger through the second lumen.

28. The method of claim 1, wherein said treating involves cooling CSF in a subarachnoid space of the vertebrate organism, wherein the step of providing a catheter includes providing a catheter including an elongate shaft having a distal end, a proximal end, a first lumen having an output ports, and a second lumen having an intake port, wherein the output port is disposed distally of the input port;

wherein the step of advancing the catheter includes advancing the distal end of the catheter at least ten centimeters within the suharachnoid space;

wherein the step of treating includes removing CSF from the subarachnoid space through the intake port and the second lumen, cooling the removed CSF, and introducing the cooled CSF back into the subarachnoid space through the first lumen and the output port.

29. The method of claim 28, wherein the step of advancing the distal end of the catheter at least ten centimeters within the subarachnoid space is performed with the assistance of robotic means.

30. The method of claim 1 wherein the step of providing a catheter includes providing a catheter having a fluid moving apparatus for moving a fluid disposed proximate the distal end, and a heat exchanger for providing heat exchange with a fluid or tissue disposed proximate the distal end;

wherein the step of activating the device includes activating the fluid moving apparatus and/or the heat exchanger.

31. The method of claim 30, wherein the heat exchanger includes a thermally conductive member, and the step of activating the heat exchanger involves flowing a heat exchanging fluid in thermal communication with the thermally conductive member.

32. The method of claim 30, wherein the heat exchanger is pan of the fluid moving apparatus.

33. The method of claim 30, wherein the fluid moving apparatus includes a collapsible member, wherein the step of activating the fluid moving apparatus includes creating movement of a fluid by causing the collapsible member to move from a collapsed state to a non-collapsed state.

34. The method of claim 33, wherein the heat exchanger includes the surface of the collapsible member.

35. The method of claim 30, wherein the fluid moving apparatus includes an inflatable member;

wherein the step of activating the fluid moving apparatus includes creating fluid movement by inflating the inflatable member.

36. The method of claim 35, wherein the fluid movement is created by repeated inflation and deflation of the inflatable member.

37. The method of claim 36, wherein the fluid moving apparatus causes fluid flow within a lumen in the elongate shaft.

38. The method of claim 37, wherein the inflatable member includes two segments, a first segment proximate the second segment, the first segment adapted to inflate before the second segment, the inflation of the first segment providing a valving function controlling the direction of fluid flow through the lumen.

39. The method of claim 30, wherein the heat exchanger includes an inflatable member.

40. The method of claim 39, wherein the heat exchanger effects heat exchange by repeated inflation and deflation of the inflatable member.

41. The method of claim 40, wherein the heat exchanger effects heat exchange by passing a fluid through the inflatable member.

42. The method of claim 30, wherein the fluid moving apparatus includes a rotatable member adapted to cause fluid movement when rotated.

43. The method of claim 30, wherein the fluid moving apparatus includes a collapsible member that causes fluid movement when deployed from a collapsed position.

44. The method of claim 30, wherein the fluid moving apparatus includes a collapsible member that causes fluid movement when collapsed from a deployed position.

45. The method of claim 1, wherein the step of providing a catheter includes providing a catheter having a proximal end, a distal end, a fluid displacer disposed along a location between the proximal end and the distal end, and a pumping lumen extending from a location proximal the fluid displacer to a location distal the fluid displacer;

wherein the step of activating the device includes activating the fluid displacer to cause a fluid to move within the pumping lumen.

46. The method of claim 45, wherein the fluid displacer comprises a propeller, and the step of activating the device includes activating the propeller.

47. The method of claim 46, wherein the propeller is attached to a rotation shaft;

wherein the step of activating the propeller includes rotating the rotation shaft, causing the propeller to turn, causing fluid to move within the pumping lumen.

48. The method of claim 46, wherein the propeller comprises an inflatable member.

49. The method of claim 48, wherein the step of activating the propeller includes rotating the inflatable member once the inflatable member is at least partially inflated, thereby causing fluid displacement.

50. The method of claim 45, wherein the fluid displacer comprises an inflatable member.

51. The method of claim 50, wherein the step of activating the fluid displacer involves inflation of the inflatable member, thereby reducing the cross sectional area of the pumping lumen.

52. The method of claim 50, wherein the fluid displacer further includes a valve for providing flow selectivity in the pumping lumen.

53. The method at claim 45, wherein the fluid displacer is disposed near the distal end of the catheter.

54. The method of claim 45, wherein the catheter is adapted so that, during the step of advancing the catheter to a desired location within the body of a patient, the fluid displacer is located internally with respect to the patient.

55. The method of claim 45, wherein the fluid displacer includes a first electrode and a second electrode disposed on opposing sides of the pumping lumen.

56. The method of claim 55, wherein a portion of the pumping lumen adjacent the first electrode is flexible;

wherein the method further comprises the step of applying a voltage to the first and second electrodes, thereby causing an electrostatic force between the first electrode and the second electrode, reducing the cross sectional area of the pumping lumen.

57. The method of claim 45, wherein the catheter further includes a heat exchanger for heating or cooling the fluid in the pumping lumen.

58. The method of claim 57, wherein the heat exchanger includes an inflatable member.

59. The method of claim 58, wherein the fluid displacer uses the inflatable member.

60. The method of claim 58, wherein the catheter further includes an inflation lumen in fluid communication with the inflatable member.

61. The method of claim 60, wherein the catheter further includes a deflation lumen in fluid communication with the inflatable member.

62. The method of claim 1, further including the step of advancing the catheter into an intracranial portion of the subarachnoid space.