System and method for assessing the proximity of an electrode to tissue in a body

• US 10,362,959 B2
• Filed: 05/13/2009
• Issued: 07/30/2019
• Est. Priority Date: 12/06/2005
• Status: Active Grant

• Current Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Original Assignee: St. Jude Medical, Atrial Fibrillation Division, Inc. (Abbott Laboratories)
• Inventors: Aiken, Robert D., Deno, D. Curtis, Kastner, Glen H., Miller, Stephan P.
• Primary Examiner(s): Kundu, Sujoy K
• Assistant Examiner(s): Anderson, L.
• Application Number:
  US12/465,337
• Publication Number:
  US 20090275827A1
• Time in Patent Office: 3,730 Days
• Field of Search: 702 81, 702 82, 702 84, 702 94, 702 95, 702152, 702153, 702168
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2218/002 Irrigation
• 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 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/063 using impedance measurements
• CPC Class Codes: A61B 5/068 using impedance sensors

Abstract

A method and system for assessing proximity between an electrode and tissue is provided. The system includes an electronic control unit (ECU). The ECU is configured to acquire values for first and second components of a complex impedance between the electrode and the tissue, and to calculate an electrical coupling index (ECI) responsive to the first and second values. The ECU is further configured to process the ECI to determine the proximity of the electrode to the tissue. The ECU may be configured to calculate an electrical coupling index rate (ECIR) based on the calculated ECI and information relating to the change in location of the electrode, and to assess proximity based on the ECIR. Alternatively, the ECU may be configured to assess the proximity using the calculated ECI, as opposed to the ECIR.

Claims

1. A system for assessing the proximity of an electrode to a tissue in a body, comprising:

a tissue sensing circuit configured to resolve a detected impedance into first and second components of a complex impedance between said electrode and said tissue, said tissue sensing circuit including a tissue sensing signal source configured to generate an excitation signal to be applied to said tissue and a complex impedance sensor coupled to said tissue sensing signal source and configured to measure a response signal and output said first and second components of said complex impedance; and

an electronic control unit (ECU) configured to execute a computer program for assessing said proximity that is configured to;

(i) acquire a plurality of values for said first and second components of said complex impedance from said tissue sensing circuit between said electrode and said tissue as said electrode moves in the body and to calculate a respective electrical coupling index (ECI) for each of said plurality of values of said first and second components of said complex impedance;

(ii) process plural values of said electrical coupling index to determine a respective proximity of said electrode to said tissue as said electrode moves in the body, wherein said ECU, based on said ECI, is configured to determine whether said electrode is deemed not to be in contact with said tissue with said electrode being no more than a predetermined distance from said tissue wherein said predetermined distance is a positive, non-zero distance, said ECU, based on said ECI, being further configured to determine whether said electrode is deemed not to be in contact with said tissue with said electrode being beyond said predetermined distance from said tissue

said ECU being further configured to generate a signal representative of an indicator of proximity between said electrode and said tissue and to transmit said generated signal to at least one of (i) an application and (ii) a device other than said tissue sensing circuit and said proximity assessing program, for control of said at least one of said application and said device.

2. The system of claim 1, wherein said ECU is further configured to

(i) receive location coordinates corresponding to a location of said electrode within said body;

(ii) calculate a change in said ECI over a predetermined time interval;

(iii) calculate a change in said location coordinates of said electrode over said predetermined time interval; and

(iv) calculate an electrical coupling index rate (ECIR) by dividing said change in ECI by said change in said location coordinates of said electrode.

3. The system of claim 2, wherein said ECU is further configured to compare said ECIR with a predetermined range of ECIRs to determine whether said electrode is within said predetermined distance from said tissue, said predetermined range being defined by a first ECIR threshold indicative of said electrode being in contact with said tissue and a second ECIR threshold indicative of said electrode being said predetermined distance away from said tissue.

4. The system of claim 2 further comprising a storage medium configured to store a plurality of previously calculated ECIRs, said storage medium being accessible by said ECU.

5. The system of claim 4, wherein said ECU is configured to calculate a rate of change of said ECIR between at least one of said plurality of previously calculated ECIRs and a current calculated ECIR over a predetermined period of time, and to determine the proximity of said electrode to said tissue based on said rate of change of said ECIR.

6. The system of claim 2, wherein said ECU is further configured to filter said ECIR calculation in response to induced perturbations in the location of said electrode.

7. The system of claim 2, wherein said ECU is further configured to calculate a second spatial derivative of said ECI by calculating a change in said ECIR as a result of perturbations in the position of said electrode over said change in location of said electrode and over said predetermined time interval, and to determine the proximity of said electrode to said tissue based on said second spatial derivative.

8. The system of claim 1, wherein said ECU is further configured to compare said calculated ECI with a predetermined range of ECIs to determine whether said electrode is no more than said predetermined distance from said tissue, said predetermined ECI range being defined by a first ECI threshold indicative of said electrode being in contact with said tissue, and a second ECI threshold indicative of said electrode being said predetermined distance away from said tissue.

9. The system of claim 1 further comprising a storage medium configured to store a plurality of previously calculated ECIs, said storage medium being accessible by said ECU.

10. The system of claim 9, wherein said ECU is configured to calculate a rate of change in said ECI between at least one of said plurality of previously calculated ECIs and a current calculated ECI, and to determine the proximity of said electrode to said tissue based on said rate of change of said coupling index.

11. The system of claim 1 wherein said one of said application and device comprises a display monitor, said ECU further configured to control said display monitor to visually display said indicator represented by said signal.

12. The system of claim 11 wherein said visual display of said indicator is selected from the group comprising a meter and a beacon.

13. The system of claim 12 wherein said electrode is displayed on said display monitor as said beacon whose appearance changes depending on the value of said ECI.

14. The system of claim 13 wherein a color of said beacon changes depending on the value of said ECI.

15. The system of claim 1, wherein said one of said application and device comprises a robotics application, and wherein said ECU is further configured to transmit said generated signal to a controller for said robotics application.

16. The system of claim 1 wherein said first and second components of said complex impedance comprises resistance and reactance, and wherein said electrical coupling index corresponds to a combination of a first term including resistance and independent of reactance and a second term including reactance and independent of resistance.

17. The system of claim 1 wherein said ECU via said proximity assessing program is configured to determine when said electrode is deemed in contact with said tissue, and wherein said at least one of said application and device controls the generation of ablation energy for or adjusts the power delivered to said electrode.

18. The system of claim 1 wherein said ECU via said proximity assessing program is configured to determine when said electrode is deemed in contact with or in close proximity to said tissue for purposes of enabling one of mapping and electrophysiological (EP) measurements via said electrode.

19. The system of claim 18 wherein said ECU is connected to a visualization, mapping, and navigation apparatus for making said mapping and EP measurements.

20. The system of claim 1 wherein said excitation signal has a frequency within a range of about 2 kHz to 200 kHz and wherein said complex impedance sensor includes a bandpass filter configured to permit an excitation frequency of said excitation signal to pass, said bandpass filter being further configured to block frequencies other than said excitation frequency.

21. An article of manufacture, comprising:

a non-transitory computer storage medium having a computer program encoded thereon for assessing the proximity of an electrode to a tissue in a body, said computer program including code for;

(i) calculating a respective electrical coupling index (ECI) responsive to a plurality of values for first and second components of a complex impedance between said electrode and said tissue as said electrode moves in the body; and

(ii) processing plural values of said calculated ECI to determine a respective proximity of said electrode to said tissue as said electrode moves in the body, said computer program further including code for determining, based on said ECI, whether said electrode is deemed not to be in contact with said tissue with said electrode being no more than a predetermined distance from said tissue, wherein said predetermined distance is a positive, non-zero distance, said computer program further including code for determining, based on said ECI, whether said electrode is deemed not to be in contact with said tissue with said electrode being beyond said predetermined distance from said tissue, and generating a signal representative of an indicator of proximity between said electrode and said tissue and transmitting said generated signal to at least one of (i) an application and (ii) a device other than said program, for control of said at least one of said application and device, wherein said at least one of said application and said device comprises a display monitor, said computer program further including code for controlling said display monitor to visually display said indicator of proximity represented by said generated signal.

22. The article of manufacture of claim 21 wherein said computer program includes code for

(i) calculating a change in said ECI over a predetermined time interval;

(ii) calculating a change in location coordinates of said electrode over said predetermined time interval; and

(iii) calculating an electrical coupling index rate (ECIR) by dividing said change in ECI by said change in said location coordinates of said electrode.

23. The article of manufacture of claim 22 wherein said computer program further includes code for comparing said calculated ECIR with a predetermined range of ECIRs to determine whether said electrode is no more than said predetermined distance from said tissue, said predetermined ECIR range being defined by a first threshold ECIR indicative of said electrode being in contact with said tissue and a second threshold ECIR indicative of said electrode being said predetermined distance away from said tissue.

24. The article of manufacture of claim 22 wherein said computer program further includes code for calculating a rate of change in said ECIR between at least one of a plurality of previously calculated ECIRs and a current calculated ECIR, and to determine the proximity of said electrode to said tissue based on said rate of change in said ECIR.

25. The article of manufacture of claim 22 wherein said computer program further includes code for filtering said ECIR calculation in response to induced perturbations in the location of said electrode.

26. The article of manufacture of claim 22 wherein said computer program further includes code for calculating a second spatial derivative of said ECI by calculating a change in said ECIR as a result of perturbations in the position of said electrode over said change in location of said electrode and over said predetermined time interval to determine the proximity of said electrode to said tissue based on said second spatial derivative.

27. The article of manufacture of claim 21 wherein said computer program further includes code for comparing said calculated ECI with a predetermined range of ECIs to determine whether said electrode is no more than said predetermined distance from said tissue, said predetermined coupling index range being defined by a first ECI threshold indicative of said electrode being in contact with said tissue and a second ECI threshold indicative of said electrode being said predetermined distance away from said tissue.

28. The article of manufacture of claim 21 wherein said computer program further includes code for calculating a rate of change in said ECI between at least one of a plurality of previously calculated ECIs and a current calculated ECI, and for determining the proximity of said electrode to said tissue based on said rate of change in said ECI.

29. The article of manufacture of claim 21 wherein said one application and device comprises a robotics application, and wherein said computer program further includes code for transmitting said generated signal to a controller for said robotics application.

30. The article of manufacture of claim 21 wherein said computer program further includes code to visually display said indicator selected from the group comprising a meter and a beacon.

31. The article of manufacture of claim 30 wherein said computer program further includes code to change an appearance of said beacon depending on the value of said ECI.

32. The article of manufacture of claim 30 wherein said computer program further includes code to change a color of said beacon depending on the value of said ECI.

33. A method for assessing the proximity of an electrode to a tissue in a body, comprising:

resolving, using a tissue sensing circuit, a detected impedance into first and second components of a complex impedance between said electrode and said tissue by generating, using a tissue sensing signal source of said tissue sensing circuit, an excitation signal to be applied to said tissue and measuring, using a complex impedance sensor coupled to said tissue sensing signal source, a response signal;

acquiring a plurality of values for said first and second components of said complex impedance between said electrode and said tissue as said electrode moves in the body;

calculating, using an electronic control unit, a respective electrical coupling index (ECI) for each of said plurality of values of said first and second components of said complex impedance; and

processing, using said electronic control unit, plural values of said calculated ECI to determine a respective proximity of said electrode to said tissue as said electrode moves in the body, wherein said electronic control unit, based on said ECI, is configured to determine whether said electrode is deemed not to be in contact with said tissue with said electrode being no more than a predetermined distance from said tissue, wherein said predetermined distance is a positive, non-zero distance, said electronic control unit, based on said ECI, is further configured to determine whether said electrode is deemed not to be in contact with said tissue with said electrode being beyond said predetermined distance from said tissue, said electronic control unit generating a signal representative of an indicator of proximity between said electrode and said tissue and transmitting said generated signal to at least one of (i) an application and (ii) a device, for control of said at least one of said application and said device.

34. The method of claim 33 further comprising:

receiving location coordinates corresponding to a location of said electrode within said body;

calculating a change in said ECI over a predetermined time interval;

calculating a change in location coordinates of said electrode over said predetermined time interval; and

calculating an electrical coupling index rate (ECIR) by dividing said change in ECI by said change in said location coordinates of said electrode.

35. The method of claim 34 further comprising comparing said calculated ECIR with a predetermined predefined range of ECIRs to determine whether said electrode is no more than said predetermined distance from said tissue, said predetermined ECIR range being defined by a first ECIR threshold indicative of said electrode being in contact with said tissue and a second ECIR threshold indicative of said electrode being said predetermined distance away from said tissue.

36. The method of claim 34 further comprising calculating a slope between at least one of a plurality of previously calculated ECIRs and a current calculated ECIR, and determining the proximity of said electrode to said tissue based on said slope calculation.

37. The method of claim 34 further comprising:

inducing perturbations in the position of said electrode;

calculating a second derivative of said ECI by calculating a change in said ECIR as a result of said perturbations over said change in location of said electrode and over said predetermined time interval; and

determining the proximity of said electrode to said tissue based on said second spatial derivative.

38. The method of claim 33 further comprising comparing said calculated ECI with a predetermined range of ECIs to determine whether said electrode is no more than said predetermined distance from said tissue, said predetermined ECI range being defined by a first ECI threshold indicative of said electrode being in contact with said tissue and a second ECI range threshold indicative of said electrode being said predetermined distance away from said tissue.

39. The method of claim 33 further comprising calculating a slope of a line between at least one of a plurality of previously calculated ECIs and a current calculated ECI, and determining the proximity of said electrode to said tissue based on said slope calculation.

40. The method of claim 33 wherein said generated signal is representative of an indicator that said electrode is within said predetermined distance from said tissue.

41. The method of claim 40 further comprising displaying said indicator represented by said signal on a display monitor.

42. The method of claim 40 wherein said at least one of said application and device comprises a robotics application, said method further comprising transmitting said generated signal to a controller for said robotics application.

43. A system for assessing the proximity of an electrode to a tissue in a body, comprising:

a tissue sensing circuit configured to resolve a detected impedance into first and second components of a complex impedance between said electrode and said tissue, said tissue sensing circuit being configured to generate an excitation signal to be applied to said tissue and to measure a response signal; and

an electronic control unit (ECU) configured to execute a computer program for assessing said proximity that is configured to;

(i) acquire a plurality of values for said first and second components of said complex impedance between said electrode and said tissue as said electrode moves in the body and to calculate a respective electrical coupling index (ECI) for each of said plurality of values of said first and second components of said complex impedance;

(ii) process plural values of said electrical coupling index to determine a respective proximity of said electrode to said tissue as said electrode moves in the body, wherein said ECU, based on said ECI, is configured to determine whether said electrode is deemed not to be in contact with said tissue with said electrode being no more than a predetermined distance from said tissue wherein said predetermined distance is a positive, non-zero distance, said ECU, based on said ECI, being further configured to determine whether said electrode is deemed not to be in contact with said tissue with said electrode being beyond said predetermined distance from said tissue, said ECU being further configured to generate a signal representative of an indicator of proximity between said electrode and said tissue and to transmit said generated signal to at least one of (i) an application and (ii) a device other than said tissue sensing circuit and said proximity assessing program, for control of said at least one of said application and said device;

wherein said one of said application and device comprises a robotics application, and wherein said ECU is further configured to transmit said generated signal to a controller for said robotics application; and

wherein said robotics application is configured to drive a catheter comprising said electrode, said controller of said robotics application being configured to adjust a speed of approach of said catheter in response to said generated signal.

44. The system of claim 43 wherein said speed adjustment comprises a reduction in speed.