Localization of body lumen junctions

• US 9,974,459 B2
• Filed: 06/29/2007
• Issued: 05/22/2018
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US12/305,520
• Publication Number:
  US 20090182287A1
• Time in Patent Office: 3,980 Days
• Field of Search: 600300, 600301, 600481, 600547, 600454, 606 41, 606 23, 606 24
• 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 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]

Abstract

Devices, systems, and methods for the localization of body lumen junctions and other intraluminal structure are disclosed. Various embodiments permit clinicians to identify the locations of intraluminal structures and medical devices during non-surgical medical techniques, such as cardiac ablation, by determining the intralumen conductance and/or cross-sectional area at a plurality of locations within the body lumen.

Claims

1. A system, comprising:

a device having a proximal end and a distal end, the distal end of the device for placement into a body lumen, the device comprising a first pair of excitation electrodes configured to emit a charge and a first pair of detection electrodes configured to obtain conductance data indicative of a change in voltage of the charge at a plurality of locations over a distance within the body lumen, the conductance data indicative of identified changes in relative cross-sectional areas at each of the plurality of locations, the conductance data obtained at each of the plurality of locations when both the first pair of excitation electrodes and the first pair of detection electrodes are immersed in a fluid within the body lumen, wherein the change in voltage is inversely proportional to a cross-sectional area of the body lumen, and

wherein a processor connected to the first pair of detection electrodes of the device is configured to generate a profile of the body lumen from the conductance data, the profile depicting the conductance data at each of the plurality of locations, wherein the relative cross-sectional areas can be calculated by the processor for each of the plurality of locations within the body lumen using an equation Δ

V=I/CSA such that a junction between two lumina can be identified within the profile through a change in relative conductance between at least two locations of the plurality of locations and wherein the identification of the junction between two lumina is used for localizing the device in the body lumen in relation to a target tissue for ablation;

wherein Δ

V is equivalent to the change in voltage at a location, I is equivalent to a magnitude of the charge detected by the first pair of detection electrodes, and CSA is equivalent to the cross-sectional area of the body lumen at the location; and

wherein a distance between the first pair of excitation electrodes and the first pair of detection electrodes is comparable to a vessel diameter.

2. The system of claim 1, wherein:

the body lumen comprises a lumen selected from the group consisting of at least a portion of an atrium, a pulmonary vein-atrial junction, a blood vessel, a biliary tract, and an esophagus; and

wherein the distance between the first pair of excitation electrodes and the first pair of detection electrodes is determined using finite element analysis.

3. The system of claim 1, wherein:

the fluid comprises blood.

4. The system of claim 1, wherein:

the processor is further capable of calculating an absolute cross-sectional area of the body lumen at each of the plurality of locations within the body lumen using conductance data obtained by operation of the first pair of excitation electrodes and the first pair of detection electrodes.

5. The system of claim 4, wherein:

the device further comprises a passageway for passing fluid through the device to the location of the first pair of detection electrodes, such that fluid passing through the passageway comes in contact with the first pair of detection electrodes;

the fluid within the body lumen comprises a first fluid having a first conductivity and a second fluid having a second conductivity; and

the conductance data is determined at each of the plurality of locations when both the first set of excitation electrodes and the first set of detection electrodes are immersed in each of the first fluid and the second fluid.

6. The system of claim 5, wherein:

the conductance data comprises a first conductance value determined at each of the plurality of locations when both the first set of excitation electrodes and the first set of detection electrodes are immersed in the first fluid and a second conductance value determined at each of the plurality of locations when both the first set of excitation electrodes and the first set of detection electrodes are immersed in the second fluid.

7. The system of claim 6, wherein:

the profile of the body lumen is determined from the first and second conductance values collected from each of the plurality of locations, the first conductivity of the first fluid, and the second conductivity of the second fluid.

8. The system of claim 1, wherein:

the first pair of detection electrodes are located between the first pair of excitation electrodes; and

the device further comprises a balloon positioned proximal to the first pair of excitation electrodes and the first pair of detection electrodes, the balloon configured for inflation and deflation.

9. The system of claim 1, wherein:

the device further comprises at least one ablation contact positioned at the distal end of the device, the at least one ablation contact being configured to remove or destroy a targeted tissue within the body lumen.

10. The system of claim 9, wherein:

the targeted tissue comprises tissue located at or adjacent to a pulmonary vein-atrial junction.

11. The system of claim 9, wherein:

the targeted tissue at least partially surrounds the pulmonary vein-atrial junction.

12. The system of claim 9, wherein:

the targeted tissue substantially surrounds the pulmonary vein-atrial junction.

13. The system of claim 9, wherein:

the at least one ablation contact comprises a heating element such that the at least one ablation contact is capable of transferring heat to the targeted tissue.

14. The system of claim 9, wherein:

the at least one ablation contact is positioned circumferentially around a substantially circular portion of the device.

15. The system of claim 9, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by cryoablation.

16. The system of claim 9, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by delivering an electrical current to the targeted tissue.

17. The system of claim 16, further comprising:

a grounding electrode configured to be placed on the body such that the electrical current flows from the targeted tissue to the grounding electrode.

18. The system of claim 17, wherein:

the grounding electrode comprises an adhesive for removably connecting the grounding electrode to the body.

71. The system of claim 1, wherein the device is selected from the group consisting of a wire and a catheter.

72. The system of claim 1, wherein the device comprises a wire inserted through a guide catheter, where the infusion of a bolus can be made through a lumen of the guide catheter.

73. The system of claim 1, wherein the profile identifies a body lumen junction.

79. The system of claim 8, wherein the device further comprises a distendable stent positioned around the balloon and a second pair of excitation electrodes and a second pair of detection electrodes positioned within an interior of the balloon.

19. A system for ablating a targeted tissue, comprising:

a device having a proximal end and a distal end, the distal end of the device for placement into a body lumen, the device comprising

two excitation electrodes configured to emit a charge and at least two detection electrodes, and

at least one ablation contact positioned at the distal end of the device, the at least one ablation contact being configured to remove or destroy a targeted tissue within the body lumen;

wherein the at least two detection electrodes of the device are configured to obtain conductance data indicative of a change in voltage of the charge at a plurality of locations over a distance within the body lumen, the conductance data indicative of identified changes in relative cross-sectional areas at each of the plurality of locations, the conductance data obtained at each of the plurality of locations when the two excitation electrodes and at least two detection electrodes are immersed in a fluid within the body lumen, wherein the change in voltage is inversely proportional to a cross-sectional area of the body lumen; and

a processor connected to the two excitation electrodes and the at least two detection electrodes of the device, the processor configured to generate a profile of the body lumen from the conductance data, the profile depicting the conductance data at each of the plurality of locations, wherein the relative cross-sectional areas can be calculated by the processor for each of at the plurality of locations within the body lumen using an equation Δ

V=I/CSA such that a junction between two lumina can be identified within the profile through a change in relative conductance between at least two locations of the plurality of locations and wherein the identification of the junction between two lumina is used for localizing the device in the body lumen in relation to a target tissue for ablation;

wherein Δ

V is equivalent to the change in voltage at a location, I is equivalent to a magnitude of the charge detected by the first pair of detection electrodes, and CSA is equivalent to the relative cross-sectional area of the body lumen at the location; and

wherein a distance between the excitation electrodes and detection electrodes is comparable to the body lumen diameter.

20. The system of claim 19, wherein:

the body lumen comprises a lumen selected from the group consisting of at least a portion of an atrium, a pulmonary vein-atrial junction, a blood vessel, a biliary tract, and an esophagus.

21. The system of claim 19, wherein:

the fluid comprises blood.

22. The system of claim 19, wherein:

the processor is further capable of calculating an absolute cross-sectional area of the body lumen at each of the plurality of locations within the body lumen using conductance data obtained by operation of the at least two excitation electrodes and the at least two detection electrodes.

23. The system of claim 22, wherein:

the device further comprises a passageway for passing fluid through the device to the location of the insert two excitation electrodes and the at least two detection electrodes, such that fluid passing through the passageway comes in contact with the two excitation electrodes and the at least two detection electrodes;

the fluid within the body lumen comprises a first fluid having a first conductivity and a second fluid having a second conductivity; and

the conductance data is determined at each of the plurality of locations when the two excitation electrodes and the at least two detection electrodes are immersed in each of the first fluid and the second fluid.

24. The system of claim 23, wherein:

the fluid further comprises a first fluid having a first conductivity and a second fluid having a second conductivity; and

the conductance data comprises a first conductance value determined at each of the plurality of locations when the two excitation electrodes and the at least two detection electrodes are immersed in the first fluid and a second conductance value determined at each of the plurality of locations when the two excitation electrodes and the at least two detection electrodes are immersed in the second fluid.

25. The system of claim 24, wherein:

the profile of the body lumen is determined from the first and second conductance values collected from each of the plurality of locations, the first conductivity of the first fluid, and the second conductivity of the second fluid.

26. The system of claim 19, wherein:

the at least two detection electrodes are located between the two excitation electrodes.

27. The system of claim 19, wherein:

the targeted tissue comprises tissue located at or adjacent to a pulmonary vein-atrial junction.

28. The system of claim 19, wherein:

the targeted tissue at least partially surrounds the pulmonary vein-atrial junction.

29. The system of claim 19, wherein:

the targeted tissue substantially surrounds the pulmonary vein-atrial junction.

30. The system of claim 19, wherein:

the at least one ablation contact comprises a heating element such that the at least one ablation contact is capable of transferring heat to the targeted tissue.

31. The system of claim 19, wherein:

the at least one ablation contact is positioned circumferentially around a substantially circular portion of the device.

32. The system of claim 31, wherein:

the at least one ablation contact comprises a plurality of ablation contacts positioned circumferentially around a substantially circular portion of the device.

33. The system of claim 19, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by cryoablation.

34. The system of claim 19, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by delivering an electrical current to the targeted tissue.

35. The system of claim 34, further comprising:

a grounding electrode configured to be placed on the body such that the electrical current flows from the targeted tissue to the grounding electrode.

36. The system of claim 35, wherein:

the grounding electrode comprises an adhesive for removably connecting the grounding electrode to the body.

74. The system of claim 19, wherein the device is selected from the group consisting of a wire and a catheter.

75. The system of claim 19, wherein the device comprises a wire inserted through a guide catheter, where the infusion of a bolus can be made through a lumen of the guide catheter.

76. The system of claim 19 wherein the profile identifies a body lumen junction.

80. The system of claim 19, wherein the conductance data is indicative of a change in voltage at the plurality of locations over the distance within the body lumen, wherein the change in voltage is proportional to a cross-sectional area of the body lumen.

37. A system, comprising:

a device having a proximal end and a distal end, the distal end of the device for placement into a body lumen, the device comprising at least one pair of excitation electrodes configured to emit a charge and at least one pair of detection electrodes configured to obtain conductance data indicative of a change in voltage of the charge at a plurality of locations over a distance within the body lumen, the conductance data indicative of identified changes in relative cross-sectional areas at each of the plurality of locations, the conductance data obtained at each of the plurality of locations when the at least one pair of excitation electrodes and the at least one pair of detection electrodes are immersed in a fluid within the body lumen, wherein the change in voltage is inversely proportional to a cross-sectional area of the body lumen; and

wherein a processor connected to each of the pairs of excitation and detection electrodes of the device is configured to generate a conductance profile of the body lumen using the conductance data, the profile depicting the conductance data at each of the plurality of locations, wherein the relative cross-sectional areas can be calculated by the processor for each of the plurality of locations within the body lumen using an equation Δ

V=I/CSA such that a junction between two lumina can be identified within the profile through a change in relative conductance between at least two locations of the plurality of locations and wherein the identification of the junction between two lumina is used for localizing the device in the body lumen in relation to a target tissue for ablation;

wherein Δ

V is equivalent to the change in voltage at a location, I is equivalent to a magnitude of the charge detected by the first pair of detection electrodes, and CSA is equivalent to the relative cross-sectional area of the body lumen at the location; and

wherein a distance between the at least one pair of excitation electrodes and the at least one pair of detection electrodes is comparable to the body lumen diameter.

38. The system of claim 37, wherein:

the processor is further capable of using conductance data obtained by operation of the at least one pair of excitation electrodes and the at least one pair of detection electrodes to calculate an absolute cross-sectional area of the body lumen at each of the plurality of locations within the body lumen.

39. The system of claim 37, wherein:

the device further comprises at least one ablation contact positioned at the distal end of the device, the at least one ablation contact being configured to remove or destroy a targeted tissue within the body lumen.

40. The system of claim 39, wherein:

the targeted tissue comprises tissue located at or adjacent to a pulmonary vein-atrial junction.

41. The system of claim 39, wherein:

the targeted tissue at least partially surrounds the pulmonary vein-atrial junction.

42. The system of claim 39, wherein:

the targeted tissue substantially surrounds the pulmonary vein-atrial junction.

43. The system of claim 39, wherein:

the at least one ablation contact comprises a heating element such that the at least one ablation contact is capable of transferring heat to the targeted tissue.

44. The system of claim 39, wherein:

the at least one ablation contact is positioned circumferentially around a substantially circular portion of the device.

45. The system of claim 39, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by cryoablation.

46. The system of claim 39, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by delivering an electrical current to the targeted tissue.

47. The system of claim 46, further comprising:

a grounding electrode configured to be placed on the body such that the electrical current flows from the targeted tissue to the grounding electrode.

48. The system of claim 47, wherein:

the grounding electrode comprises an adhesive for removably connecting the grounding electrode to the body.

81. The system of claim 37, wherein the conductance data is indicative of a change in voltage at the plurality of locations over the distance within the body lumen, wherein the change in voltage is proportional to a cross-sectional area of the body lumen.

49. A system for ablation of a targeted tissue, comprising:

a device having a proximal end and a distal end, the distal end of the device for placement into a body lumen, the device comprising

at least one pair of excitation electrodes configured to emit a charge and at least one pair of detection electrodes, and

at least one ablation contact positioned at the distal end of the device, the at least one ablation contact being configured to remove or destroy a targeted tissue within the body lumen;

wherein the at least one pair of detection electrodes of the device is configured to obtain conductance data indicative of a change in voltage of the charge at a plurality of locations over a distance within the body lumen, the conductance data indicative of identified changes in relative cross-sectional areas at each of the plurality of locations, the conductance data obtained at each of the plurality of locations when the at least one pair of excitation electrodes and the at least one pair of detection electrodes are immersed in a fluid within the body lumen, wherein the change in voltage is proportional to a cross-sectional area of the body lumen;

a processor connected to the at least one pair of excitation electrodes and the at least one detection pair of electrodes, the processor configured to generate a profile of the body lumen from the conductance data, the profile depicting the conductance data at each of the plurality of locations, wherein the relative cross-sectional areas can be calculated by the processor for each of the plurality of locations within the body lumen using an equation Δ

V=I/CSA such that a junction between two lumina can be identified within the profile through a change in relative conductance between at least two locations of the plurality of locations and wherein the identification of the junction between two lumina is used for localizing the device in the body lumen in relation to a target tissue for ablation;

wherein Δ

V is equivalent to the change in voltage at a location, I is equivalent to a magnitude of the charge detected by the first pair of detection electrodes, and CSA is equivalent to the relative cross-sectional area of the body lumen at the location; and

wherein a distance between the at least one pair of excitation electrodes and the at least one pair of detection electrodes is comparable to the body lumen diameter.

50. The system of claim 49, wherein:

the processor is further capable of calculating an absolute cross-sectional area at each of the plurality of locations in the body lumen using conductance data obtained by operation of the at least one pair of excitation electrodes and the at least one pair of detection electrodes.

51. The system of claim 49, wherein:

the targeted tissue comprises tissue located at or adjacent to a pulmonary vein-atrial junction.

52. The system of claim 49, wherein:

the targeted tissue at least partially surrounds the pulmonary vein-atrial junction.

53. The system of claim 49, wherein:

the targeted tissue substantially surrounds the pulmonary vein-atrial junction.

54. The system of claim 49, wherein:

the at least one ablation contact comprises a heating element such that the at least one ablation contact is capable of transferring heat to the targeted tissue.

55. The system of claim 49, wherein:

the at least one ablation contact is positioned circumferentially around a substantially circular portion of the device.

56. The system of claim 49, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by cryoablation.

57. The system of claim 49, wherein:

the at least one ablation contact is configured to remove or destroy the targeted tissue by delivering an electrical current to the targeted tissue.

58. The system of claim 57, further comprising:

a grounding electrode configured to be placed externally on the body such that the electrical current flows from the targeted tissue to the grounding electrode.

59. The system of claim 58, wherein:

the grounding electrode comprises an adhesive for removably connecting the grounding electrode to the body.

60. The system of claim 49, wherein:

the at least one pair of detection electrodes are positioned on the device between the at least one pair of excitation electrodes.

61. A method for localizing a junction or other structure within a body lumen, comprising the steps of:

introducing at least part of a system into a body lumen, the system comprising;

a device having a proximal end and a distal end, the distal end of the device for placement into a body lumen, the device comprising a first pair of excitation electrodes configured to emit electrical current flow and a first pair of detection electrodes configured to obtain conductance data indicative of a change in voltage of the electrical current flow at a plurality of locations over a distance within the body lumen, the conductance data indicative of identified changes in relative cross-sectional areas at each of the plurality of locations, the conductance data obtained at each of the plurality of locations when the first pair of excitation and the first pair of detection electrodes are immersed in a fluid within the body lumen, wherein the change in voltage is inversely proportional to a cross-sectional area of the body lumen;

wherein a distance between the first pair of excitation electrodes and the first pair of detection electrodes is comparable to the body lumen diameter; and

a processor connected to the first pair of detection electrodes of the device, the processor configured to generate a profile of the body lumen from the conductance data, the profile depicting the conductance data at each of the plurality of locations, wherein the relative cross-sectional areas can be calculated by the processor for each of the plurality of locations within the body lumen using an equation Δ

V=I/CSA such that a junction between two lumina can be identified within the profile through a change in relative conductance between at least two locations of the plurality of locations and wherein the identification of the junction between two lumina is used for localizing the device in the body lumen in relation to a target tissue for ablation;

wherein Δ

V is equivalent to the change in voltage at a location, I is equivalent to a magnitude of the electrical current flow detected by the first pair of detection electrodes, and CSA is equivalent to the relative cross-sectional area of the body lumen at the location;

providing electrical current flow to the body lumen through the device;

measuring a first conductance value at a first location in the body lumen;

moving the device to a second location in the body lumen;

measuring a second conductance value at a second location in the body lumen; and

determining the profile of the body lumen based on the first conductance value of the first location and the second conductance value of the second location.

62. The method of claim 61, wherein:

the body lumen comprises a blood vessel; and

the fluid comprises blood.

63. The system of claim 61, wherein:

the body lumen comprises a lumen selected from the group consisting of at least a portion of an atrium, a biliary tract, and an esophagus.

64. The method of claim 61, wherein:

the device further comprises a passageway for passing fluid through the device to the location of the first pair of detection electrodes, such that fluid passing through the passageway comes in contact with the first pair of detection electrodes;

the fluid within the body lumen comprises a first fluid having a first conductivity and a second fluid having a second conductivity; and

the conductance data is determined at each of the plurality of locations when the first pairs of excitation and detection electrodes are immersed in each of the first fluid and the second fluid.

65. The method of claim 64, further comprising:

injecting a first solution having a first conductivity into the body lumen;

injecting a second solution having a second conductivity into the body lumen, wherein the second conductivity does not equal the first conductivity;

measuring a second conductance value at the first location in the body lumen;

calculating the conductance data at the first location in the body lumen;

measuring a first conductance value at a second location in the body lumen; and

calculating the conductance data at the second location in the body lumen.

66. The method of claim 65, wherein:

the step of determining a profile of the body lumen comprises determining a profile of the body lumen based on the conductance of the first location, the conductance data of the first location, the conductance data of the second location, and the conductivities of the first and second solutions.

67. The method of claim 61, wherein:

the first pair of detection electrodes are located between the first pair of detection electrodes.

77. The method of claim 61, wherein the device is selected from the group consisting of a wire and a catheter.

78. The method of claim 61, wherein the profile identifies a body lumen junction.

68. A method for ablating a targeted tissue, comprising the steps of:

introducing at least part of a system into a body lumen, the system comprising;

a device having a proximal end and a distal end, the distal end of the device for placement into a body lumen, the device comprising;

at least one pair of excitation electrodes configured to emit a charge and at least one pair of detection electrodes, wherein a distance between the at least one pair of excitation electrodes and the at least one pair of detection electrodes is comparable to the body lumen diameter,

at least one ablation contact positioned at the distal end of the device, the at least one ablation contact being configured to remove or destroy a targeted tissue within the body lumen;

wherein the at least one pair of detection electrodes of the device is configured to obtain conductance data indicative of a change in voltage at a plurality of locations over a distance within the body lumen, the conductance data indicative of identified changes in relative cross-sectional areas at each of the plurality of locations, the conductance data obtained at each of the plurality of locations when the at least one pair of excitation electrodes and the at least one pair of detection electrodes are immersed in a fluid within the body lumen, wherein the change in voltage is proportional to a cross-sectional area of the body lumen; and

a processor connected to the at least one pair of excitation electrodes and the at least one pair of detection electrodes of the device, the processor configured to generate a profile of the body lumen from the conductance data, the profile depicting the conductance data at each of the plurality of locations, wherein the relative cross-sectional areas can be calculated by the processor for each of the plurality of locations within the body lumen using an equation Δ

V=I/CSA such that a junction between two lumina can be identified within the profile through a change in relative conductance between at least two locations of the plurality of locations and wherein the identification of the junction between two lumina is used for localizing the device in the body lumen in relation to a target tissue for ablation;

wherein Δ

V is equivalent to the change in voltage at a location, I is equivalent to a magnitude of the charge detected by the first pair of detection electrodes, and CSA is equivalent to the relative cross-sectional area of the body lumen at the location;

providing electrical current flow to the body lumen through the device;

measuring a first conductance value at a first location in the body lumen;

moving the device to a second location in the body lumen;

measuring a second conductance value at a second location in the body lumen;

determining a profile of the body lumen based on the first conductance value of the first location and the second conductance value of the second location;

using the profile to locate the device in the body lumen in relation to the targeted tissue; and

ablating the targeted tissue using the device.

69. The method of claim 68, wherein the profile comprises conductances.

70. The method of claim 68, wherein:

the at least one pair of detection electrodes are located between the at least one pair of excitation electrodes.