Methods for planning and performing thermal ablation

• US 7,871,406 B2
• Filed: 08/04/2006
• Issued: 01/18/2011
• Est. Priority Date: 08/04/2006
• Status: Active Grant

• Current Assignee: Isys Medizintechnik Gmbh
• Original Assignee: INTIO, Inc.
• Inventors: Gustafson, David E., Nadadur, Desikachari, Nields, Morgan W.
• Primary Examiner(s): Gibson; Roy D
• Assistant Examiner(s): LEE, BENJAMIN HYOUNGSOL
• Application Number:
  US11/499,418
• Publication Number:
  US 20080033420A1
• Time in Patent Office: 1,628 Days
• Field of Search: 606 32- 40, 606/27
• US Class Current: 606/27
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 6/027 characterised by the use of a particular data acquisition trajectory, e.g. helical or spiral
• CPC Class Codes: A61B 6/4464 the source unit or the detector unit being mounted to ceiling
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A thermal ablation system is operable to perform thermal ablation using an x-ray system to measure temperature changes throughout a volume of interest in a patient. Image data sets captured by the x-ray system during a thermal ablation procedure provide temperature change information for the volume being subjected to the thermal ablation. Intermediate image data sets captured during the thermal ablation procedure may be fed into a system controller, which may modify or update a thermal ablation plan to achieve volume coagulation necrosis targets. The thermal ablation may be delivered by a variety of ablation modes including radiofrequency ablation, microwave therapy, high intensity focused ultrasound, laser ablation, and other interstitial heat delivery methods. Methods of performing thermal ablation using x-ray system temperature measurements as a feedback source are also provided.

Claims

1. A method of performing a thermal ablation procedure within a Volume Of Interest (VOI) in a patient comprising the steps of:

(a) capturing a baseline digital image with an x-ray system of a VOI in a patient, wherein said baseline digital image is comprised of a first set of detected image signal data corresponding with each spatial location in an array of spatial locations throughout said VOI;

(b) performing a thermal ablation procedure on at least a first sub-volume of said VOI according to a first thermal ablation plan, wherein said first thermal ablation plan comprises expected temperature changes at each said spatial location within said array of spatial locations as a function of time during said thermal ablation procedure;

(c) capturing a first temperature differential digital image with said x-ray system of said VOI multiple times during said thermal ablation procedure, wherein each said first temperature differential digital image is comprised of a corresponding second set of detected image signal data corresponding with each said spatial location in said array of spatial locations throughout said VOI;

(d) registering each said first temperature differential digital image to said baseline digital image;

(e) inferring, based at least in part on said baseline digital image and each said first temperature differential digital image, an amount of temperature change at each of said multiple times at each said spatial location within said array of spatial locations throughout said VOI; and

(f) comparing said inferred temperature changes at said multiple times at each said spatial location within said array to said expected temperature changes at each said spatial location within said array as a function of time during said thermal ablation.

2. A method as set forth in claim 1, wherein said first thermal ablation plan further comprises at least one additional parameter selected from a group consisting of:

thermal ablation applicator quantity;

thermal ablation applicator types;

thermal ablation applicator power level;

thermal ablation applicator position;

thermal ablation applicator target;

temperature differential image triggering parameters;

supplemental imaging modalities;

patient positioning; and

temperature differential image capture schedule.

3. A method as set forth in claim 2, wherein said first thermal ablation plan further comprises a plurality of parameters from said group.

4. A method as set forth in claim 1, wherein said patient remains substantially stationary throughout said thermal ablation procedure.

5. A method as set forth in claim 1 further comprising:

positioning a patient on a bed prior to said capturing said baseline digital image;

maintaining said position of said patient relative to said bed during and between all steps of said thermal ablation procedure subsequent to said positioning step,

wherein said patient and bed are not moved substantially more than a maximum lineal dimension of said VOI during and between all steps of said thermal ablation procedure subsequent to said positioning step.

6. A method as set forth in claim 1, further comprising:

retrieving said first thermal ablation plan from a memory storage module prior to performing thermal ablation.

7. A method as set forth in claim 1, wherein said capturing of said baseline digital image comprises:

illuminating said VOI with x-rays;

detecting a plurality of portions of said x-rays that passed through said VOI; and

at least partially generating said baseline digital image based on said detected x-rays.

8. A method as set forth in claim 7, further comprising calibrating said baseline digital image, said calibration comprising:

measuring temperature of at least a first spatial location within said VOI; and

correlating said measured temperature at said at least first spatial location within said VOI to said baseline digital image at said at least first spatial location within said VOI.

9. A method as set forth in claim 7, wherein said illuminating and said detecting are performed with an x-ray Computed Tomography (CT) scanner.

10. A method as set forth in claim 7, wherein said illuminating and detecting are performed with an x-ray CT C-arm scanner.

11. A method as set forth in claim 7, wherein said illuminating is performed with a conical x-ray beam.

12. A method as set forth in claim 7, wherein said illuminating is dynamically shaped by at least one multi-leaf collimator.

13. A method as set forth in claim 7, further comprising at least partially generating said baseline digital image using at least one of the methods selected from a group consisting of:

ultrasound, ultrasound with ARFI capabilities, ultrasound with elastography capabilities, PET, SPECT, and MRI.

14. A method as set forth in claim 7, wherein said capturing said baseline digital image further comprises:

capturing supplemental information about said VOI using a supplemental imaging modality; and

employing software to enhance said supplemental information.

15. A method as set forth in claim 14, wherein said supplemental imaging modality is selected from a group consisting of:

ultrasound, ultrasound with ARFI capabilities, ultrasound with elastography capabilities, PET, SPECT, and MRI.

16. A method as set forth in claim 15, wherein said supplemental imaging modality further comprises:

using at least one contrast agent.

17. A method as set forth in claim 1, further comprising:

spatially filtering said baseline digital image.

18. A method as set forth in claim 17, wherein said spatially filtering said baseline digital image is performed with a Gaussian filter.

19. A method as set forth in claim 1, further comprising:

automatically identifying structures within said baseline digital image.

20. A method as set forth in claim 1, wherein each spatial location is a voxel representing a volume of at most 1 cm³.

21. A method as set forth in claim 20, wherein each voxel represents a volume of at most 1 mm³.

22. A method as set forth in claim 1, further comprising:

spatially displaying said baseline digital image.

23. A method as set forth in claim 1, further comprising:

accessing a preliminary thermal ablation plan, wherein said preliminary thermal ablation plan comprises expected temperature changes at substantially each spatial location within said array as a function of time during said thermal ablation; and

comparing said baseline digital image to said preliminary thermal ablation plan.

24. A method as set forth in claim 23, wherein said preliminary thermal ablation plan further comprises at least one additional parameter selected from a group consisting of:

thermal ablation applicator quantity;

thermal ablation applicator types;

thermal ablation applicator power level;

thermal ablation applicator position;

thermal ablation applicator target;

temperature differential image triggering parameters;

supplemental imaging modalities;

patient positioning; and

temperature differential image capture schedule.

25. A method as set forth in claim 24, wherein said preliminary thermal ablation plan further comprises a plurality of parameters from said group.

26. A method as set forth in claim 23, further comprising:

employing software to register said baseline digital image to an image from said preliminary thermal ablation plan without the use of artificial fiducial markers.

27. A method as set forth in claim 26, further comprising:

spatially displaying said baseline digital image along with a planned thermal distribution throughout said VOI at a selectable point of said first thermal ablation plan, wherein said planned thermal distribution throughout said VOI is visually discernable.

28. A method as set forth in claim 26, further comprising:

spatially displaying said baseline digital image along with a planned coagulation necrosis target volume.

29. A method as set forth in claim 23, further comprising:

modifying said preliminary plan to produce said first thermal ablation plan based, at least in part, on said comparison of said baseline digital image to said preliminary thermal ablation plan.

30. A method as set forth in claim 1, wherein said performing thermal ablation further comprises:

positioning at least one thermal ablation applicator; and

modifying a non-positional aspect of said first thermal ablation plan based on said positioned at least one thermal ablation applicator.

31. A method as set forth in claim 1, wherein said performing thermal ablation is performed using a mode of thermal ablation delivery selected from a group consisting of:

RFA, laser ablation, microwave, extracorporeal focused ultrasound ablation, direct focused ultrasound ablation, and cryoablation.

32. A method as set forth in claim 31, wherein said performing thermal ablation is performed using a plurality of modes of thermal ablation delivery selected from said group.

33. A method as set forth in claim 1, further comprising:

using a stereotactic location system to aid a user in the positioning of a thermal ablation applicator into a position to deliver said thermal ablation.

34. A method as set forth in claim 1, further comprising:

using an automated insertion system to insert a thermal ablation applicator into a position to deliver said thermal ablation.

35. A method as set forth in claim 1, further comprising:

displaying a real-time image of said VOI wherein a current position of at least one thermal ablation applicator is visually discernable, wherein said real-time image is generated by at least one of CT and ultrasound;

registering said real-time image to a planning image of said VOI from said first thermal ablation plan wherein a planned position of at least one thermal ablation applicator is visually discernable in said planning image;

displaying said registered real-time image and said planning image by overlaying one of said real-time image and said planning image over the other of said real-time image and said planning image; and

outputting data relating to a relative position of said at least one thermal ablation applicator relative to said planned position of said at least one thermal ablation applicator.

36. A method as set forth in claim 1, further comprising:

periodically measuring temperature at a predetermined location within said VOI; and

triggering said capturing of said first temperature differential digital image based at least in part on said periodic measuring.

37. A method as set forth in claim 1, further comprising:

periodically imaging a predetermined location within said VOI; and

triggering said capturing of said first temperature differential digital image based at least in part on said periodic imaging.

38. A method as set forth in claim 37, wherein said periodic imaging is performed by a method selected from a group consisting of:

ultrasound, ultrasound with ARFI capabilities, and ultrasound with elastography capabilities.

39. A method as set forth in claim 1, further comprising:

actively controlling the performance of the thermal ablation with a closed-loop feedback thermal ablation delivery control system.

40. A method as set forth in claim 1, wherein said capturing of said first temperature differential digital image comprises:

illuminating said VOI with x-rays;

detecting a plurality of portions of said x-rays that passed through said VOI; and

at least partially generating said first temperature differential digital image based on said detected x-rays.

41. A method as set forth in claim 40, further comprising calibrating said first temperature differential digital image, said calibration comprising:

measuring temperature of at least a first spatial location within said VOI; and

correlating said measured temperature at said at least first spatial location within said VOI to said first temperature differential digital image at said at least first spatial location within said VOI.

42. A method as set forth in claim 40, further comprising at least partially generating said first temperature differential digital image using at least one of the methods selected from a group consisting of:

ultrasound, ultrasound with ARFI capabilities, ultrasound with elastography capabilities, PET, SPECT, and MR.

43. A method as set forth in claim 40, wherein said capturing said baseline digital image further comprises:

capturing supplemental information about said VOI using a supplemental imaging modality; and

employing software to enhance said supplemental information.

44. A method as set forth in claim 43, wherein said supplemental imaging modality is selected from a group consisting of:

ultrasound, ultrasound with ARFI capabilities, ultrasound with elastography capabilities, PET, SPECT, and MRI.

45. A method as set forth in claim 44, wherein said supplemental imaging modality further comprises:

using at least one contrast agent.

46. A method as set forth in claim 1, further comprising:

spatially filtering said first temperature differential digital image.

47. A method as set forth in claim 1, further comprising:

displaying said first temperature differential digital image.

48. A method as set forth in claim 1, further comprising:

registering said baseline digital image to an external coordinate system; and

registering said first temperature differential digital image to said external coordinate system.

49. A method as set forth in claim 1, further comprising:

employing software to register said first temperature differential digital image to said baseline digital image without the use of artificial fiducial markers.

50. A method as set forth in claim 1, further comprising:

calculating image signal data changes between said baseline digital image and said first temperature differential digital image for substantially each spatial location within said array of spatial locations.

51. A method as set forth in claim 50, wherein said calculating determines Hounsfield Unit changes for substantially each spatial location within said array of spatial locations.

52. A method as set forth in claim 1, further comprising:

calculating a predicted coagulation necrosis volume based, at least in part, on said inferred amount of temperature change at substantially each spatial location within said array of spatial locations.

53. A method as set forth in claim 52, further comprising:

displaying said predicted coagulation necrosis volume.

54. A method as set forth in claim 52, further comprising:

comparing said predicted coagulation necrosis volume to a planned coagulation necrosis volume.

55. A method as set forth in claim 1, further comprising:

displaying said temperature changes in the form of isothermal regions wherein said isothermal regions represent temperature ranges of at most 15°

C.

56. A method as set forth in claim 55, wherein said isothermal regions represent temperature ranges of at most 1°

C.

57. A method as set forth in claim 1, further comprising:

displaying an image of at least a portion of said VOI in which said inferred temperature changes are visually discernable.

58. A method as set forth in claim 57, further comprising:

displaying at least a portion of said image of at least a portion of said VOI as shaded isothermal three-dimensional volumes within said VOI.

59. A method as set forth in claim 57, further comprising:

displaying at least a portion of said image of at least a portion of said VOI as a selectable two-dimensional slice through said VOI.

60. A method as set forth in claim 57, further comprising:

displaying at least a portion of said image of at least a portion of said VOI as isothermal regions in a selectable two-dimensional slice through said VOI.

61. A method as set forth in claim 57, further comprising:

displaying at least a portion of said image of at least a portion of said VOI in a Multi-Planar Reformatted display.

62. A method as set forth in claim 57, further comprising:

displaying at least a portion of said image of at least a portion of said VOI as a three-dimensional volume rendered display.

63. A method as set forth in claim 57, further comprising:

displaying said inferred temperature changes relative to a display of planned temperature changes from said first thermal ablation plan.

64. A method as set forth in claim 1, further comprising:

continuing thermal ablation according to at least a portion of said first thermal ablation plan.

65. A method as set forth in claim 1, further comprising:

(g) adjusting said first thermal ablation plan to create a second thermal ablation plan, wherein said adjusting is based at least in part on said comparison; and

(h) continuing thermal ablation on at least one of said first sub-volume within said VOI and a second sub-volume within said VOI according to at least a portion of said second thermal ablation plan, wherein said second plan comprises expected temperature changes at substantially each spatial location within said VOI as a function of time during said continuing thermal ablation.

66. A method as set forth in claim 65, wherein said second thermal ablation plan further comprises at least one additional parameter selected from a group consisting of:

thermal ablation applicator quantity;

thermal ablation applicator types;

thermal ablation applicator power level;

thermal ablation applicator position;

thermal ablation applicator target;

temperature differential image triggering parameters;

supplemental imaging modalities;

patient positioning; and

temperature differential image capture schedule.

67. A method as set forth in claim 66, wherein said second thermal ablation plan further comprises a plurality of parameters from said group.

68. A method as set forth in claim 65, further comprising:

storing said second thermal ablation plan in a memory module.

69. A method as set forth in claim 65, further comprising adjusting at least one of the following parameters:

thermal ablation applicator power,

thermal ablation applicator delivery direction, and

thermal ablation applicator target point.

70. A method as set forth in claim 65, further comprising:

adjusting thermal ablation applicator position.

71. A method as set forth in claim 65, further comprising:

adjusting position of a thermal ablation applicator position by a user.

72. A method as set forth in claim 65, further comprising:

adjusting position of a thermal ablation applicator position by a robotic system.

73. A method as set forth in claim 65, further comprising adjusting at least one of the following:

thermal ablation applicator quantity, and

thermal ablation applicator type.

74. A method as set forth in claim 65, further comprising:

adjusting thermal ablation in a closed-loop feedback control system.

75. A method as set forth in claim 65, wherein said first sub-volume is substantially the same as said second sub-volume.

76. A method as set forth in claim 65, further comprising:

performing steps b, c, d, e, f, g and h at least one additional time.

77. A method as set forth in claim 65, further comprising:

performing steps b, c, d, e, f, g and h until a coagulation necrosis goal is achieved.

78. A method as set forth in claim 65, wherein said first sub-volume is substantially different than said second sub-volume.

79. A method as set forth in claim 1, further comprising:

capturing at least one additional temperature differential digital image;

registering said at least one additional temperature differential digital image to a previously captured digital image, wherein said previously captured digital image is a previously captured temperature differential digital image;

inferring an amount of temperature change at substantially each spatial location within said array of spatial locations between said previously captured digital image and said at least one additional temperature differential digital image; and

performing additional thermal ablation.

80. A method as set forth in claim 1, further comprising:

performing steps b, c, d, e and f until a coagulation necrosis goal is achieved.

81. A method as set forth in claim 1, further comprising:

generating a post-procedure report describing the performed thermal ablation.

82. A method as set forth in claim 81, wherein said post-procedure report at least partially conforms to the DICOM standard.

83. A method of performing a thermal ablation procedure within a Volume Of Interest (VOI) in a patient comprising the steps of:

(aa) positioning a patient on a bed so that a VOI within said patient is within a field of view of an x-ray imaging device, wherein said imaging device encircles less than all of said VOI;

(bb) capturing a baseline digital image of said VOI with said imaging device, wherein said baseline digital image is comprised of a first set of detected image signal data corresponding with each spatial location in an array of spatial locations throughout said VOI;

(cc) performing thermal ablation on at least a first sub-volume of said VOI according to a first thermal ablation plan, wherein said first thermal ablation plan comprises expected temperature changes at each said spatial location within said array of spatial locations as a function of time during said thermal ablation procedure;

(dd) capturing a first temperature differential digital image of said VOI with said x-ray imaging device multiple times during said thermal ablation procedure, wherein each said first temperature differential digital image is comprised of a corresponding second set of detected image signal data corresponding with each said spatial location in said array of spatial locations throughout said VOI;

(ee) registering each said first temperature differential digital image to said baseline digital image;

(ff) inferring, based at least in part on said baseline digital image and each said first temperature differential digital image, an amount of temperature change at each of said multiple times at each said spatial location within said array of spatial locations throughout said VOI; and

(gg) comparing said inferred temperature changes at said multiple times at each said spatial location within said array to said expected temperature changes at each said spatial location within said array as a function of time during said thermal ablation; and

,

(hh) maintaining said position of said patient relative to said bed during and between each of said capturing of said baseline digital image, said performing thermal ablation, and said capturing of said first temperature differential digital image steps,

wherein said patient and bed are not moved substantially more than a maximum lineal dimension of said VOI during and between each of said capturing of said baseline digital image, said performing thermal ablation, and said capturing of said first temperature differential digital image steps.

84. A method as set forth in claim 83, wherein said patient remains substantially stationary throughout said thermal ablation procedure.

85. A method as set forth in claim 83, further comprising:

accessing said thermal ablation plan, wherein said plan comprises expected temperature changes at substantially each spatial location within said array as a function of time during said thermal ablation.

86. A method as set forth in claim 85, wherein said accessing is from a memory storage module.

87. A method as set forth in claim 85, further comprising:

adjusting said thermal ablation plan based at least in part on differences between said baseline digital image and said first temperature differential digital image; and

continuing thermal ablation after said capturing of said first temperature differential image on at least one of said first sub-volume within said VOI and a second sub-volume within said VOI.

88. A method as set forth in claim 87, wherein said plan further comprises at least one additional parameter selected from a group consisting of:

thermal ablation applicator quantity;

thermal ablation applicator types;

thermal ablation applicator power level;

thermal ablation applicator position;

thermal ablation applicator target;

temperature differential image triggering parameters;

supplemental imaging modalities;

patient positioning; and

temperature differential image capture schedule.

89. A method as set forth in claim 88, wherein said plan further comprises a plurality of parameters from said group.

90. A method as set forth in claim 87, wherein said adjusting said thermal ablation plan creates an adjusted thermal ablation plan, said method further comprising:

storing said adjusted thermal ablation plan in a memory module.

91. A method as set forth in claim 83, wherein said imaging device is capable of illuminating a VOI with a conical beam of x-rays, wherein said beam of x-rays is detected by a two-dimensional flat panel sensor array.

92. A method as set forth in claim 83, further comprising calibrating said baseline digital image, said calibration comprising:

measuring temperature of at least a first spatial location within said VOI; and

correlating said measured temperature at said at least first spatial location within said VOI to said baseline digital image at said at least first spatial location within said VOI.

93. A method as set forth in claim 83, further comprising calibrating said first temperature differential digital image, said calibration comprising:

measuring temperature of at least a first spatial location within said VOI; and

correlating said measured temperature at said at least first spatial location within said VOI to said first temperature differential digital image at said at least first spatial location within said VOI.

94. A method as set forth in claim 83, wherein said performing thermal ablation is performed using a mode of thermal ablation delivery selected from a group consisting of:

RFA, laser ablation, microwave, extracorporeal focused ultrasound ablation, direct focused ultrasound ablation, and cryoablation.

95. A method as set forth in claim 94, wherein said performing thermal ablation is performed using a plurality of modes of thermal ablation delivery selected from said group.

96. A method as set forth in claim 83, further comprising adjusting at least one of the following parameters:

thermal ablation applicator power,

thermal ablation applicator delivery direction, and

thermal ablation applicator target point.

97. A method as set forth in claim 83, further comprising:

adjusting thermal ablation applicator position.

98. A method as set forth in claim 83, further comprising:

adjusting position of a thermal ablation applicator position by a user.

99. A method as set forth in claim 83, further comprising:

adjusting position of a thermal ablation applicator position by a robotic system.

100. A method as set forth in claim 83, further comprising adjusting at least one of the following:

thermal ablation applicator quantity, and

thermal ablation applicator type.

101. A method as set forth in claim 83, further comprising:

adjusting thermal ablation in a closed-loop feedback control system.

102. A method as set forth in claim 83, further comprising:

capturing at least one additional temperature differential digital image;

registering said at least one additional temperature differential digital image to a previously captured digital image, wherein said previously captured digital image is a previously captured temperature differential digital image;

inferring an amount of temperature change at substantially each spatial location within said VOI between said previously captured digital image and said at least one additional temperature differential digital image; and

performing additional thermal ablation.

103. A method as set forth in claim 83, further comprising:

performing steps cc, dd, and ee until a coagulation necrosis goal is achieved.