Hyperthermia treatment and probe therefor

• US 7,344,529 B2
• Filed: 11/05/2003
• Issued: 03/18/2008
• Est. Priority Date: 06/15/2001
• Status: Expired due to Term

• Current Assignee: Monteris Medical Incorporated (Monteris Medical US, Inc.)
• Original Assignee: Monteris Medical Incorporated (Monteris Medical US, Inc.)
• Inventors: Tyc, Richard, Torchia, Mark G., Pacak, John S., McTaggart, Ken J.
• Primary Examiner(s): FARAH, AHMED M
• Application Number:
  US10/701,834
• Publication Number:
  US 20040249261A1
• Time in Patent Office: 1,595 Days
• Field of Search: 606 13- 16, 606 20- 31, 606191-195, 607/88, 607/89, 607/96, 607/104, 607/105, 607/107, 600410-412, 600/424, 600/437, 600449-493, 128/898
• US Class Current: 606/13
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/2272 with reflective or refractive surfaces for deflecting the beam A61B2018/2261, A61B2018/2266 take precedence
• CPC Class Codes: A61B 2090/374 NMR or MRI

Abstract

A method of using a probe that emits energy to coagulate lesions is disclosed. The probe is constructed and arranged to emit light from its distal end, either at an angle to its longitudinal axis, or along its longitudinal axis. Optionally, an end reflector may be used to direct the energy in a beam to one side of the fiber end. A reinforcing sleeve for the fiber is mounted to a shielded, Piezo-electric motor constructed and arranged to move the fiber both longitudinally and rotationally within an optional elongate cannula. An MRI system is arranged to generate a series of output signals indicative of temperature in the targeted area. The application of energy is stopped when the temperature at the boundary of the lesion reaches the required hyperthermic temperature. Cooling of the tip portion of the probe is effected by expansion of a supplied cooling fluid through a restrictive orifice into an expansion zone at the probe end. The fiber is encased in a stiff tubular titanium probe with a relatively small fluid supply duct inside the probe with the interior of the probe acting as a return duct for the expanded liquid. The temperature of the probe end is monitored by a sensor in the probe end and controlled by controlling the pressure in the supplied cooling fluid.

Claims

1. A method for effecting treatment in a patient comprising:

identifying a volume in the patient the whole of which volume is to be heated to a required temperature, the volume being defined by a peripheral surface of the volume;

providing a heat source and applying heat to the volume within the patient by;

providing the heat source on an invasive probe having a longitudinal axis and an end;

inserting the end of the probe into the volume;

arranging the probe to cause directing of heat from the end in a direction at an angle to the longitudinal axis such that a heating effect of the probe lies in a disk surrounding the axis;

arranging the direction of the heat so as to define a heating zone which forms a limited angular orientation of heating within the disk such that, as the probe is rotated, the probe causes heating of different angular segments of the volume within the disk;

with the probe at a fixed axial position, rotating the probe about the axis so that the heating zone lies in a selected segment;

wherein the application of heat by the probe to the selected segment causes heat to be transferred from the segment into parts of the volume outside the segment surrounding the end of the probe;

and applying cooling to the end of the probe so as to extract heat from the parts surrounding the probe by conduction of heat therefrom;

wherein the end of the probe is cooled by;

providing on the probe a supply duct for a cooling fluid extending from a supply to the end of the probe;

providing an expansion zone of reduced pressure at the end of the probe so as to cause the cooling fluid to expand as a gas thus generating a cooling effect;

and providing on the probe a return duct for return of the expanded gas from the end of the probe, wherein the return duct is of larger cross-sectional area than the supply duct by a factor of the order of 200 to 250 times.

2. The method according to claim 1 including arranging the amount of cooling to the probe relative to the heating such that the parts of the volume surrounding the end of the probe are cooled sufficiently to cause a net heating effect by which substantially only the segment of the heating zone is heated to the required temperature and the parts outside the segment are not heated to the required temperature.

3. The method according to claim 2 wherein the cooling is arranged to maintain the parts outside the segment below a temperature sufficient to cause coagulation of the tissues therein.

4. The method according to claim 1 including moving the end of the probe axially within the volume so as to move the disk of the heating effect axially within the volume from a first disk position to second disk position.

5. The method according to claim 1 including the steps of:

operating a non-invasive detection system to generate a series of output signals over a period of time representative of temperature in the patient as the temperature of the patient changes during that time;

using the output signals to monitor at least one temperature of the volume as the temperature changes over the period of time;

wherein the temperature at the peripheral surface of the volume is monitored and a measure of the temperature of the segment at the peripheral surface of the volume is used as the determining factor as to when to halt heating by the probe to the segment.

6. The method according to claim 1 wherein the heat source comprises a laser, an optical fiber for communicating light from the laser and a light directing element at an end of the fiber for directing the light from the laser to the predetermined direction relative to the fiber and for forming the limited angular orientation within the disk.

7. The method according to claim 1 wherein the temperature of the probe is cooled to a temperature in the range of about zero to about minus 20 degrees Celsius.

8. The method according to claim 1 wherein the power of the heat source is reduced during heating of each segment from an initial high value to a lower value.

9. The method according to claim 1 wherein the probe comprises an outer tube, wherein the supply duct is arranged inside the outer tube and wherein the return duct is defined by an inside surface of the outer tube.

10. The method according to claim 9 wherein the supply duct is attached to an inside surface of the outer tube.

11. The method according to claim 10 wherein the probe comprises an outer tube and wherein there is provided a temperature sensor mounted on the inside surface of the tube at the end of the probe.

12. The method according to claim 9 wherein the probe includes a heat energy supply conduit for transporting the heat energy from a supply to the end of the probe and wherein the heat energy supply conduit is attached to the inside surface of the outer tube.

13. The method according to claim 1 wherein the cooling fluid is a gas which is expanded through a restricting orifice.

14. The method according to claim 13 wherein the supply duct comprises a tube and the restricting orifice is formed by a reduced necking of the tube at an end thereof at the expansion zone.

15. The method according to claim 14 wherein the probe includes an outer tube and the supply duct is mounted within the outer tube with the end thereof including the necking extending beyond an end of the outer tube.

16. The method according to claim 1 wherein the heat source comprises a laser, an optical fiber for communicating light from the laser, and a light directing element at an end of the fiber, wherein the light directing element comprises a chamfered end of the fiber and wherein the chamfered end is located in the gas in the expansion zone.

17. The method according to claim 16 wherein the chamfered end is arranged at 45 degrees.

18. The method according to claim 16 wherein the chamfered end carries a coating arranged to reflect light at two different wavelengths.

19. The method according to claim 1 wherein there is provided a temperature sensor at the end of the probe.

20. The method according to claim 1 wherein the temperature at the end of the probe is controlled by varying the pressure in the fluid as supplied through the supply duct.

21. A method for effecting treatment in a patient comprising:

identifying a volume in the patient to be heated to a required temperature;

providing a heat source for applying heat to the volume within the patient;

providing a probe mounting the heat source allowing invasive insertion of an end of the probe into the patient;

providing a position control system for moving the end of the probe to a required position within the patient;

inserting the end of the probe into the volume;

providing on the probe a supply duct for a cooling fluid extending from a supply to the end of the probe;

providing an expansion zone of reduced pressure at the end of the probe so as to cause the cooling fluid to expand as a gas thus generating a cooling effect; and

,

providing on the probe a return duct for return of the expanded gas from the end of the probe;

wherein the heat source comprises a laser, an optical fiber for communicating light from the laser, and a light directing element at an end of the fiber, wherein the light directing element comprises a chamfered end of the fiber and wherein the chamfered end is located in the gas in the expansion zone.

22. The method according to claim 21 wherein the temperature of the probe is cooled to a temperature in the range of about zero to about minus 20 degrees Celsius.

23. The method according to claim 21 wherein the return duct is of larger cross-sectional area than the supply duct.

24. The method according to claim 23 wherein the return duct is of the order of 200 to 250 times larger than the supply duct.

25. The method according to claim 21 wherein the probe comprises an outer tube, wherein the supply duct is arranged inside the outer tube and wherein the return duct is defined by an inside surface of the outer tube.

26. The method according to claim 25 wherein the supply duct is attached to an inside surface of the outer tube.

27. The method according to claim 25 wherein the probe includes a heat energy supply conduit for transporting the heat energy from a supply to the end of the probe and wherein the heat energy supply conduit is attached to the inside surface of the outer tube.

28. The method according to claim 21 wherein the cooling fluid is a gas which is expanded through a restricting orifice.

29. The method according to claim 28 wherein the supply duct comprises a tube and the restricting orifice is formed by a reduced necking of the tube at an end thereof at the expansion zone.

30. The method according to claim 29 wherein the probe includes an outer tube and the supply duct is mounted within the outer tube with the end thereof including the necking extending beyond an end of the outer tube.

31. The method according to claim 21 wherein the chamfered end is arranged at 45 degrees.

32. The method according to claim 21 wherein the chamfered end carries a coating arranged to reflect light at two different wavelengths.

33. The method according to claim 21 wherein there is provided a temperature sensor at the end of the probe.

34. The method according to claim 21 wherein the probe comprises an outer tube and wherein there is provided a temperature sensor mounted on the inside surface of the outer tube at the end of the probe.

35. The method according to claim 21 wherein the temperature at the end of the probe is controlled by varying the pressure in the cooling fluid as supplied through the supply duct.

36. The method according to claim 21 wherein the heat source comprises a laser and an optical fiber for communicating light from the laser to the end of the probe, and wherein the probe includes an outer tube and a transparent capsule enclosing an end of the outer tube with the fiber extending to a position beyond the end of the tube into the capsule.

37. A probe for use in effecting treatment in a patient comprising:

a heat source for applying heat to a volume within the patient;

a probe body mounting the heat source thereon for allowing invasive insertion of an end of the probe into the patient;

a supply duct on the probe body for a cooling fluid extending from a supply to the end of the probe;

the probe body being arranged to provide an expansion zone of reduced pressure at the end of the probe body so as to cause the cooling fluid to expand as a gas thus generating a cooling effect; and

,

a return duct on the probe body for return of the expanded gas from the end of the probe;

wherein the heat source comprises a laser, an optical fiber for communicating light from the laser, and a light directing element at an end of the fiber, wherein the light directing element comprises a chamfered end of the fiber and wherein the chamfered end is located in the gas in the expansion zone.

38. The probe according to claim 37 wherein the temperature of the probe is cooled to a temperature in the range of about zero to about minus 20 degrees Celsius.

39. The probe according to claim 37 wherein the return duct is of larger cross-sectional area than the supply duct.

40. The probe according to claim 39 wherein the return duct is of the order of 200 to 250 times larger than the supply duct.

41. The probe according to claim 37 wherein the probe body comprises an outer tube, wherein the supply duct is arranged inside the outer tube and wherein the return duct is defined by an inside surface of the outer tube.

42. The probe according to claim 41 wherein the supply duct is attached to an inside surface of the outer tube.

43. The probe according to claim 41 wherein the outer tube includes a heat energy supply conduit for transporting the heat energy from a supply to the end of the probe and wherein the heat energy supply conduit is attached to the inside surface of the outer tube.

44. The probe according to claim 37 wherein the cooling fluid is a gas which is expanded through a restricting orifice.

45. The probe according to claim 44 wherein the supply duct comprises a supply tube and the restricting orifice is formed by a reduced necking of the supply tube at an end thereof at the expansion zone.

46. The probe according to claim 37 wherein the probe body comprises an outer tube and the supply duct is mounted within the outer tube with the end thereof including the necking extending beyond an end of the outer tube.

47. The probe according to claim 37 wherein the chamfered end is arranged at 45 degrees.

48. The probe according to claim 37 wherein the chamfered end carries a coating arranged to reflect light at two different wavelengths.

49. The probe according to claim 37 wherein there is provided a temperature sensor at the end of the probe.

50. The probe according to claim 37 wherein the probe body comprises an outer tube and there is provided a temperature sensor mounted on the inside surface of the outer tube at the end of the probe.

51. The probe according to claim 37 wherein the temperature at the end of the probe is controlled by varying the pressure in the cooling fluid as supplied through the supply duct.

52. The probe according to claim 37 wherein the heat source comprises a laser and an optical fiber for communicating light from the laser to the end of the probe, and wherein the probe includes an outer tube and a transparent capsule enclosing an end of the outer tube with the fiber extending to a position beyond the end of the outer tube into the capsule.

53. A method of applying heat to tissue in vivo comprising:

identifying a quantity of tissue as a target;

inserting an elongate transmitting medium percutaneously and feeding said elongate transmitting medium toward said target until a distal end of said elongate transmitting medium is operationally proximate said target;

applying energy to said target by sending energy through said elongate transmitting medium, said energy exiting said distal end and heating said target;

monitoring said energy application to ensure surrounding non-targeted tissue is not damaged by heat;

determining whether the entire targeted area has been heated;

if necessary, translating said elongate transmitting medium to an unheated area of said target;

applying energy to said unheated area of said target.

54. The method of claim 53 wherein identifying a quantity of tissue as a target comprises analyzing magnetic resonance images and mapping out the extents of a tumor imaged thereby.

55. The method of claim 53 wherein identifying a quantity of tissue as a target comprises conducting a body contouring analysis to determine areas of fatty tissue to be removed.

56. The method of claim 53 wherein identifying a quantity of tissue as a target comprises analyzing magnetic resonance images to locate an lesion imaged thereby.

57. The method of claim 53 wherein inserting an elongate transmitting medium percutaneously and feeding said elongate transmitting medium toward said target until a distal end of said elongate transmitting medium is operationally proximate said target comprises:

determining a safest straight path between the skull and the target;

forming a hole in the skull;

inserting a cannula into said hole until a distal end of said cannula is operably proximate said target;

securing the cannula relative the skull;

inserting said elongate transmitting medium through said cannula toward said target until said distal end of said elongate transmitting medium is operationally proximate said target.

58. The method of claim 53 wherein inserting an elongate transmitting medium percutaneously and feeding said elongate transmitting medium toward said target until a distal end of said elongate transmitting medium is operationally proximate said target comprises:

inserting said elongate transmitting medium in an artery;

feeding said elongate transmitting medium through the artery until a distal end of the elongate transmitting medium is operationally proximate a lesion.

59. The method of claim 53 wherein inserting an elongate transmitting medium percutaneously and feeding said elongate transmitting medium toward said target until a distal end of said elongate transmitting medium is operationally proximate said target comprises percutaneously inserting the elongate transmitting medium proximate an area of fat targeted for heat treatment.

60. The method of claim 53 wherein applying energy to said target by sending energy through said elongate transmitting medium comprises sending light through optical fiber.

61. The method of claim 60 wherein sending light through optical fiber comprises sending collimated light through optical fiber.

62. The method of claim 61 wherein sending collimated light through optical fiber comprises sending laser light through optical fiber.

63. The method of claim 53 wherein applying energy to said target by sending energy through said elongate transmitting medium, said energy exiting said distal end and heating said target comprises:

a) causing said energy to exit said distal end at an angle, greater than zero, to a longitudinal axis of the elongate transmitting medium;

b) rotating said elongate transmitting medium around said longitudinal axis, thereby creating a shaped area of treated tissue;

c) advancing said elongate transmitting medium;

d) repeating steps a)-c) until the entire target has been heated.

64. The method of claim 63 wherein step a) comprises causing said energy to exit said distal end approximately perpendicularly to said longitudinal axis of the elongate transmitting medium such that performing step b) results in a shaped area of treated tissue that is disc-shaped.

65. The method of claim 63 wherein step a) comprises causing said energy to exit said distal end at an angle other than perpendicular to said longitudinal axis of the elongate transmitting medium such that performing step b) results in a shaped area of treated tissue that is cone-shaped.

66. The method of claim 53 wherein applying energy to said target by sending energy through said elongate transmitting medium, said energy exiting said distal end and heating said target comprises allowing said energy to exit said distal end along a longitudinal axis of the elongate transmitting medium.

67. The method of claim 53 wherein monitoring said energy application to ensure surrounding non-targeted tissue is not damaged by heat comprises taking temperature readings on non-targeted tissue immediately adjacent said targeted tissue.

68. The method of claim 53 wherein monitoring said energy application to ensure surrounding non-targeted tissue is not damaged by heat comprises cycling cooling fluid to and from the distal end of the elongate transmitting medium as necessary to prevent damaging said surrounding non-targeted tissue.

69. A method of applying heat to tissue in vivo comprising:

identifying a quantity of tissue as a target;

inserting an elongate transmitting medium percutaneously and feeding said elongate transmitting medium toward said target until a distal end of said elongate transmitting medium is operationally proximate said target;

applying energy to said target by sending energy through said elongate transmitting medium, said energy exiting said distal end and heating said target;

wherein heating said target by sending energy through said elongate transmitting medium comprises directing laser energy through an optical fiber contained within said transmitting medium and deflecting said laser energy off of a chamfered end of said optical fiber;

monitoring said energy application to ensure surrounding non-targeted tissue is not damaged by heat;

determining whether the entire targeted area has been heated;

if necessary, translating said elongate transmitting medium to an unheated area of said target;

applying energy to said unheated area of said target; and

cooling said distal end of said elongate transmitting medium so as to extract heat from parts of said target surrounding said elongate transmitting medium by conduction of heat therefrom comprising;

directing fluid to said distal end of said elongate transmitting medium through a supply duct in said elongate transmitting medium;

vaporizing said fluid in an expansion zone of reduced pressure in said distal end of said elongate transmitting medium; and

retrieving the gas from said elongate transmitting medium through a return duct in said elongate transmitting medium that is between 200 and 250 times larger in cross-sectional area than said supply duct.