Real-time monitoring and mapping of ablation lesion formation in the heart

• US 7,001,383 B2
• Filed: 10/21/2002
• Issued: 02/21/2006
• Est. Priority Date: 10/21/2002
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Keidar, Yaron
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/277,079
• Publication Number:
  US 20040078036A1
• Time in Patent Office: 1,219 Days
• Field of Search: 606/41, 606 32- 35, 606/42, 606 45- 50, 600/374, 600/509, 600/515, 600/523, 607/122
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems

Abstract

A method is provided for ablating tissue in a heart of a subject during an ablation procedure. The method includes applying a local treatment to the heart at a plurality of sites designated for ablation. At each respective site, a parameter is sensed that is indicative of a level of ablation at the site. The method preferably includes displaying a map of the heart, and designating, on the map, during the ablation procedure, indications of the respective levels of ablation at the sites, responsive to the respective sensed parameters.

Claims

1. A method for ablating tissue in a heart of a subject and mapping a level of ablation of the tissue during an ablation procedure, comprising:

applying a local treatment to the heart at a plurality of sites designated for ablation;

sensing at each respective site a parameter that is indicative of a level of ablation at the site;

displaying a map of the heart;

designating, on the map, during the ablation procedure, indications of the respective levels of ablation at the sites, responsive to the respective sensed parameters, and

calculating a weighted average of levels of ablation at each respective site and at secondary sites in a vicinity of each respective site, such that the weighting of each secondary site decreases as the distance of the secondary site from each respective site increases.

2. A method according to claim 1, further comprising determining a location of each respective site, and designating on the map during the ablation procedure the indications of respective levels of ablation at the sites, responsive to the respective sensed parameters and the determined locations at the respective sites.

3. A method according to claim 1, wherein applying the local treatment comprises applying a cryogenic source to induce ablation.

4. A method according to claim 1, wherein applying the local treatment comprises applying a radioactive source to induce ablation.

5. A method according to claim 1, wherein applying the local treatment comprises applying a chemical to induce ablation.

6. A method according to claim 1, wherein designating the indications of the respective levels of ablation at the sites comprises translating each indication into a color on a color scale.

7. A method according to claim 1, wherein displaying the map comprises displaying an electroanatomical activation map.

8. A method according to claim 1, wherein displaying the map comprises displaying an electroanatomical voltage amplitude map.

9. A method according to claim 1, wherein displaying the map comprises displaying a map generated using a modality selected from the list consisting of:

CT scanning, magnetic resonance imaging, fluoroscopy, echocardiography, single-photon computed tomography, and positron emission tomography.

10. A method according to claim 1, comprising segmenting a mapping volume including the sites into voxels, wherein designating the indications of the respective levels of ablation at the sites comprises designating the indications with respect to respective voxels of the mapping volume.

11. A method according to claim 1, wherein sensing the parameter comprises sensing a measure of electrical impedance at the site.

12. A method according to claim 1, comprising segmenting a surface area including the sites into planar segments, wherein designating the indications of the respective levels of ablation at the sites comprises designating the indications with respect to respective planar segments of the surface area.

13. A method according to claim 12, wherein segmenting the surface area comprises segmenting the surface area into triangular segments.

14. A method according to claim 1, wherein applying the local treatment comprises applying energy to the heart.

15. A method according to claim 14, wherein applying the energy comprises applying radiofrequency energy.

16. A method according to claim 14, wherein applying the energy comprises applying energy generated by a laser.

17. A method according to claim 14, wherein applying the energy comprises applying ultrasound energy.

18. A method according to claim 14, wherein sensing the parameter comprises sensing a measure of the energy applied at the site.

19. A method according to claim 18, wherein sensing the parameter comprises calculating a measure of a total amount of energy applied at the site.

20. A method according to claim 1, wherein sensing the parameter comprises sensing a temperature of the site.

21. A method according to claim 20, wherein sensing the parameter comprises determining a maximum temperature sensed at the site.

22. A method according to claim 20, wherein sensing the parameter comprises determining a maximal temperature time-gradient at the site.

23. A method for ablating tissue in an organ of a subject, and mapping a level of ablagtion of the tissue during an ablation procedure comprising:

applying a local treatment to the organ at a plurality of sites designated for ablation;

sensing at each respective site a parameter that is indicative of a level of ablation at the site;

displaying a map of the organ;

designating, on the map, during the ablation procedure, indications of the respective levels of ablation at the sites, responsive to the respective sensed parameters, and

calculating a weighted average of levels of ablation at each respective site and at secondary sites in a vicinity of each respective site, such that the weighting of each secondary site decreases as the distance of the secondary site from each respective site increases.

24. A method according to claim 23, wherein the organ includes a liver of the subject, and wherein applying the local treatment comprises applying the treatment to the liver.

25. A method according to claim 23, wherein the organ includes a prostate of the subject, and wherein applying the local treatment comprises applying the treatment to the prostate.

26. A method according to claim 23, wherein the organ includes a breast of the subject, and wherein applying the local treatment comprises applying the treatment to the breast.

27. Apparatus for ablating tissue in a heart of a subject during an ablation procedure, comprising:

a probe, adapted to be inserted into the heart;

an ablation device, adapted to apply a local treatment to the heart so as to ablate tissue of the heart;

at least one sensor, adapted to sense a parameter that is indicative of a level of ablation;

a display monitor; and

a computer, adapted to;

drive the ablation device to apply the local treatment to the heart at a plurality of sites designated for ablation, receive respective sensed parameters from the sensor, sensed when the sensor is located at or adjacent to the plurality of sites designated for ablation,

display on the display monitor a map of the heart, designate, on the map, during the ablation procedure, indications of the respective levels of ablation at the sites, responsive to the respective sensed parameters, and

calculate a weighted average of levels of ablation at each respective site and at secondary sites in a vicinity of each respective site, such that the weighting of each secondary site decreases as the distance of the secondary site from each respective site increases.

28. Apparatus according to claim 27, wherein the sensor is adapted to be fixed to the probe.

29. Apparatus according to claim 27, wherein the probe comprises a catheter.

30. Apparatus according to claim 27, comprising an ablation power generator, coupled to the ablation device, adapted to generate power for use by the ablation device for performing ablation.

31. Apparatus according to claim 27, comprising one or more body surface electrodes, adapted to be coupled to a surface of a body of the subject, and an electrocardiogram (ECG) monitor, adapted to receive signals from the body surface electrodes and to provide an ECG synchronization signal to the computer.

32. Apparatus according to claim 27, comprising a position sensor, adapted to be fixed to the probe and to generate respective position sensor signals responsive to respective locations of the sites, wherein the computer is adapted to:

receive the respective position sensor signals and, responsive thereto, determine respective locations of the sites, when the position sensor is respectively located at or adjacent to the plurality of sites designated for ablation, and

designate the indications of respective levels of ablation at the sites, responsive to the respective sensed parameters and to the respective determined locations.

33. Apparatus according to claim 27, wherein the ablation device comprises a cryogenic element.

34. Apparatus according to claim 27, wherein the ablation device is adapted to apply radioactivity to induce ablation of the tissue.

35. Apparatus according to claim 27, wherein the ablation device comprises a chemical applicator, adapted to apply a chemical to induce ablation of the tissue.

36. Apparatus according to claim 27, wherein the computer is adapted to translate each indication into a color on a color scale, and to designate the translated indications on the map.

37. Apparatus according to claim 27, wherein the map comprises an electroanatomical activation map, and wherein the computer is adapted to display the electroanatomical activation map on the display monitor.

38. Apparatus according to claim 27, wherein the map comprises an electroanatomical voltage amplitude map, and wherein the computer is adapted to display the electroanatomical voltage amplitude map on the display monitor.

39. Apparatus according to claim 27, wherein the map comprises a map generated using a modality selected from the list consisting of:

CT scanning, magnetic resonance imaging, fluoroscopy, echocardiography, single-photon computed tomography, and positron emission tomography, and wherein the computer is adapted to display the map on the display monitor.

40. Apparatus according to claim 27, wherein the computer is adapted to segment a mapping volume including the sites into voxels, and wherein the computer is adapted to designate, on the map, the indications of the respective levels of ablation at the sites with respect to respective voxels of the mapping volume.

41. Apparatus according to claim 27, wherein the parameter comprises a measure of electrical impedance, and wherein the sensor comprises an electrode, adapted to sense the measure of electrical impedance.

42. Apparatus according to claim 27, wherein the computer is adapted to segment a surface area including the sites into planar segments, and to designate the indications of the respective levels of ablation with respect to respective planar segments of the surface area.

43. Apparatus according to claim 42, wherein the computer is adapted to segment the surface area into triangular segments.

44. Apparatus according to claim 27, wherein the sensor comprises a temperature sensor.

45. Apparatus according to claim 44, wherein the computer is adapted to receive, from the temperature sensor, a sequence of sensed temperatures at one of the sites, and to determine responsive thereto a maximum temperature sensed at the site.

46. Apparatus according to claim 44, wherein the computer is adapted to receive, from the temperature sensor, a sequence of sensed temperatures at one of the sites, and to determine responsive thereto a maximal temperature time-gradient at the site.

47. Apparatus according to claim 27, wherein the ablation device is adapted to apply energy to the heart so as to ablate tissue of the heart.

48. Apparatus according to claim 47, wherein the ablation device comprises a laser.

49. Apparatus according to claim 47, wherein the ablation device comprises an ultrasound transducer, adapted to apply ultrasound energy to the heart so as to ablate tissue of the heart.

50. Apparatus according to claim 47, wherein the ablation device comprises an ablation electrode, adapted to apply RF energy to the heart so as to ablate tissue of the heart.

51. Apparatus according to claim 50, wherein the ablation electrode comprises a monopolar ablation electrode, and wherein the apparatus comprises a return electrode, adapted to be placed against skin of the subject and to complete an electrical circuit with the monopolar ablation electrode.

52. Apparatus according to claim 50, wherein the ablation electrode comprises a bipolar electrode.

53. Apparatus according to claim 50, wherein the sensor comprises the ablation electrode, and wherein the ablation electrode is adapted to sense the parameter indicative of the level of ablation.

54. Apparatus according to claim 47, wherein the sensor comprises an energy sensor, adapted to sense a measure of the energy applied by the ablation device.

55. Apparatus according to claim 54, wherein the computer is adapted to receive, from the sensor, respective sensed measures of energy applied at each of the sites, and to calculate for each site a measure of a total amount of energy applied.

56. Apparatus for ablating tissue in an organ of a subject during an ablation procedure, comprising:

a probe, adapted to be inserted into the organ;

an ablation device, adapted to apply a local treatment to the organ so as to ablate tissue of the organ;

at least one sensor, adapted to sense a parameter that is indicative of a level of ablation;

a display monitor; and

a computer, adapted to;

drive the ablation device to apply the local treatment to the organ at a plurality of sites designated for ablation, receive respective sensed parameters from the sensor, sensed when the sensor is located at or adjacent to the plurality of sites designated for ablation,

display on the display monitor a map of the organ, and

designate, on the map, during the ablation procedure, indications of the respective levels of ablation at the sites, responsive to the respective sensed parameters, and

calculate a weighted average of levels of ablation at each respective site and at secondary sites in a vicinity of each respective site, such that the weighting of each secondary site decreases as the distance of the secondary site from each respective site increases.

57. Apparatus according to claim 56, wherein the organ includes a liver of the subject, and wherein the ablation device is adapted to apply the local treatment to the liver.

58. Apparatus according to claim 56, wherein the organ includes a prostate of the subject, and wherein the ablation device is adapted to apply the local treatment to the prostate.

59. Apparatus according to claim 56, wherein the organ includes a breast of the subject, and wherein the ablation device is adapted to apply the local treatment to the breast.

60. Apparatus for ablating tissue in a heart of a subject during an ablation procedure, comprising:

a probe, adapted to be inserted into the heart;

an ablation device, adapted to apply a local treatment to the heart so as to ablate tissue of the heart;

at least one ablation sensor, adapted to be fixed to the probe and to sense a parameter that is indicative of a level of ablation;

a position sensor, adapted to be fixed to the probe and to generate position sensor signals;

a display monitor; and

a computer, adapted to;

drive the ablation device to apply the local treatment to the heart at a plurality of sites designated for ablation, receive respective sensed parameters from the ablation sensor, sensed when the ablation sensor is located at or adjacent to the plurality of sites designated for ablation, receive respective position sensor signals from the position sensor and, responsive thereto, determine respective locations of the sites, when the position sensor is respectively located at or adjacent to the plurality of sites designated for ablation,

display on the display monitor a map of the heart, and designate, on the map, during the ablation procedure, indications of the respective levels of ablation at the sites, responsive to the respective sensed parameters and to the respective determined locations, and

calculate a weighted average of levels of ablation at each respective site and at secondary sites in a vicinity of each respective site, such that the weighting of each secondary site decreases as the distance of the secondary site from each respective site increases.

61. Apparatus according to claim 60, wherein the probe comprises a catheter.

62. Apparatus according to claim 60, comprising an ablation power generator, coupled to the ablation device, adapted to generate power for use by the ablation device for performing ablation.

63. Apparatus according to claim 60, comprising one or more body surface electrodes, adapted to be coupled to a surface of a body of the subject, and an electrocardiogram (ECG) monitor, adapted to receive signals from the body surface electrodes and to provide an ECG synchronization signal to the computer.

64. Apparatus according to claim 60, wherein the ablation device comprises a cryogenic element.

65. Apparatus according to claim 60, wherein the ablation device is adapted to apply radioactivity to induce ablation of the tissue.

66. Apparatus according to claim 60, wherein the ablation device comprises a chemical applicator, adapted to apply a chemical to induce ablation of the tissue.

67. Apparatus according to claim 60, wherein the computer is adapted to translate each indication into a color on a color scale, and to designate the translated indications on the map.

68. Apparatus according to claim 60, wherein the map comprises an electroanatomical activation map, and wherein the computer is adapted to display the electroanatomical activation map on the display monitor.

69. Apparatus according to claim 60, wherein the map comprises an electroanatomical voltage amplitude map, and wherein the computer is adapted to display the electroanatomical voltage amplitude map on the display monitor.

70. Apparatus according to claim 60, wherein the map comprises a map generated using a modality selected from the list consisting of:

CT scanning, magnetic resonance imaging, fluoroscopy, echocardiography, single-photon computed tomography, and positron emission tomography, and wherein the computer is adapted to display the map on the display monitor.

71. Apparatus according to claim 60, wherein the computer is adapted to segment a mapping volume including the sites into voxels, and wherein the computer is adapted to designate, on the map, the indications of the respective levels of ablation at the sites with respect to respective voxels of the mapping volume.

72. Apparatus according to claim 60, wherein the parameter comprises a measure of electrical impedance, and wherein the ablation sensor comprises an electrode, adapted to sense the measure of electrical impedance.

73. Apparatus according to claim 60, wherein the computer is adapted to segment a surface area including the sites into planar segments, and to designate the indications of the respective levels of ablation with respect to respective planar segments of the surface area.

74. Apparatus according to claim 73, wherein the computer is adapted to segment the surface area into triangular segments.

75. Apparatus according to claim 60, wherein the ablation sensor comprises a temperature sensor.

76. Apparatus according to claim 75, wherein the computer is adapted to receive, from the temperature sensor, a sequence of sensed temperatures at one of the sites, and to determine responsive thereto a maximum temperature sensed at the site.

77. Apparatus according to claim 75, wherein the computer is adapted to receive, from the temperature sensor, a sequence of sensed temperatures at one of the sites, and to determine responsive thereto a maximal temperature time-gradient at the site.

78. Apparatus according to claim 60, wherein the ablation device is adapted to apply energy to the heart so as to ablate tissue of the heart.

79. Apparatus according to claim 78, wherein the ablation device comprises a laser.

80. Apparatus according to claim 78, wherein the ablation device comprises an ultrasound transducer, adapted to apply ultrasound energy to the heart so as to ablate tissue of the heart.

81. Apparatus according to claim 78, wherein the ablation device comprises an ablation electrode, adapted to apply RF energy to the heart so as to ablate tissue of the heart.

82. Apparatus according to claim 81, wherein the ablation electrode comprises a monopolar ablation electrode, and wherein the apparatus comprises a return electrode, adapted to be placed against skin of the subject and to complete an electrical circuit with the monopolar ablation electrode.

83. Apparatus according to claim 81, wherein the ablation electrode comprises a bipolar electrode.

84. Apparatus according to claim 81, wherein the ablation sensor comprises the ablation electrode, and wherein the ablation electrode is adapted to sense the parameter indicative of the level of ablation.

85. Apparatus according to claim 78, wherein the ablation sensor comprises an energy sensor, adapted to sense a measure of the energy applied by the ablation device.

86. Apparatus according to claim 85, wherein the computer is adapted to receive, from the ablation sensor, respective sensed measures of energy applied at each of the sites, and to calculate for each site a measure of a total amount of energy applied.