System and method for assessing the formation of a lesion in tissue

• US 9,610,119 B2
• Filed: 11/22/2013
• Issued: 04/04/2017
• Est. Priority Date: 12/06/2005
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Fish, Jeffrey M., Byrd, Israel A., Clark, Lynn E., Dando, Jeremy D., Geurkink, Christopher J., Puryear, Harry A., Paul, Saurav
• Primary Examiner(s): FOWLER, DANIEL WAYNE
• Application Number:
  US14/087,991
• Publication Number:
  US 20140194867A1
• Time in Patent Office: 1,229 Days
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/1079 using optical or photographic means
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 : Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence

Abstract

A method and system for assessing lesion formation in tissue is provided. The system includes an electronic control unit (ECU) configured to acquire magnitudes for a component of a complex impedance between an electrode and tissue, and the power applied to the tissue during lesion formation. The ECU is configured to calculate a value responsive to the complex impedance component and the power. The value is indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, or a predicted tissue temperature. The method includes acquiring magnitudes for a component of a complex impedance between an electrode and tissue and the power applied during lesion formation. The method includes calculating a value responsive to the complex impedance component and the power, the value being indicative of a predicted lesion depth, a likelihood the lesion has reached a predetermined depth, and/or a predicted tissue temperature.

Claims

1. A system for assessing tissue of an anatomical structure during an ablation procedure, the system comprising:

an elongate medical device comprising;

at least one sensing element configured for sensing contact of the elongate medical device with the tissue, and

at least one electrode configured for sensing at least one component of a complex impedance between the at least one electrode and the tissue; and

an electronic control unit (ECU) configured to;

acquire a signal from the sensing element to confirm that the elongate medical device is in contact with the tissue;

acquire a power magnitude associated with a power applied to the tissue;

acquire magnitudes for a plurality of components of the complex impedance between the at least one electrode and the tissue; and

calculate a value responsive to;

(a) the signal from the sensing element; and

(b) a coupling index calculated based on the power magnitude, the magnitudes of the plurality of components of the complex impedance, and the signal from the sensing element, said value indicative of one of a predicted depth of a lesion in the tissue, a likelihood of the lesion having a predetermined depth in the tissue and a predicted temperature of the tissue, wherein the coupling index is indicative of a degree of coupling between the at least one electrode and the tissue.

2. The system of claim 1, wherein the value is indicative of at least one of a predicted temperature of the tissue at a prescribed tissue depth or a lesion size.

3. The system of claim 1, wherein the ECU is configured to:

acquire a magnitude associated with each of first and second components of the complex impedance, wherein the first and second components comprise two of a resistance between the electrode and the tissue, a phase angle between the electrode and the tissue, an impedance magnitude between the electrode and the tissue, and a reactance between the electrode and the tissue; and

calculate the value based on the magnitudes of the first and second components of the complex impedance.

4. The system of claim 1, wherein the ECU is configured to:

acquire a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of an ablative energy to the tissue commences to a subsequent point in time for which the value is calculated, wherein the magnitude of power is a magnitude of the average power applied to the tissue during the time interval; and

calculate the value based on the average power magnitude.

5. The system of claim 1, wherein the elongate medical device comprises a catheter including a proximal end, a distal end, and a temperature sensor disposed at or near the distal end, and wherein the ECU is further configured to:

acquire a temperature of the distal section of the catheter at a point in time for which the value is to be calculated; and

calculate the value based on the temperature magnitude.

6. The system of claim 1, wherein the ECU is configured to generate a lesion formation assessment map based on the value.

7. The system of claim 1, wherein the value is indicative of a likelihood of the lesion having a predetermined depth in the tissue, and wherein the ECU is configured to compare the value with a predetermined threshold to determine whether the lesion has reached a determined depth within the tissue.

8. The system of claim 1, wherein the value is indicative of a likelihood of a lesion having a predetermined depth in the tissue, and wherein the ECU is configured to:

compare the value with a first lesion depth threshold to determine whether the lesion depth is greater than a maximum desired lesion depth within the tissue; and

compare the value with a second lesion depth threshold to determine whether the lesion depth is less than a minimum desired lesion depth within the tissue.

9. The system of claim 1, wherein the sensing element comprises one or more of a technology selected from the group consisting of an electrical-based technology, an electromechanical-based technology, a force-based technology, and an optically-based technology.

10. The system of claim 9, wherein the ECU is further configured to:

acquire a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of an ablative energy to the tissue commences to a subsequent point in time for which the value is calculated;

calculate a change in said at least one component of the complex impedance and the force over the time interval; and

compare the value with a threshold value to determine whether the lesion has reached a determined depth within the tissue.

11. The system of claim 1, wherein the ECU is configured to:

acquire a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of an ablative energy to the tissue commences to a subsequent point in time for which the value is calculated;

calculate a change in the ECI over the time interval; and

compare the value with a threshold value to determine whether the lesion has reached a determined depth within the tissue.

12. The system of claim 1, wherein the ECU is further configured to at least one of generate and acquire one of an image and a model of the tissue, and to generate an indicator indicative of the value and to place the indicator on said one of said image and model of the tissue.

13. The system of claim 1, wherein the ECU is configured to control at least one of a movement of the elongate medical device and the delivery of ablation energy to the tissue in response to the value.

14. An apparatus for assessing tissue during an ablation procedure using an ablation catheter, the apparatus comprising:

an electronic control unit (ECU) configured to;

acquire a power magnitude associated with a power applied to the tissue;

acquire a plurality of components of a complex impedance between an electrode of the catheter and the tissue;

acquire a signal indicating whether the catheter is in contact with the tissue;

calculate a value based on the power magnitude, the plurality of components of the complex impedance, and the signal indicating whether the catheter is in contact with the tissue, wherein the value is indicative of one of a predicted depth of a lesion in the tissue, a likelihood of the lesion having a predetermined depth in the tissue and a predicted temperature of the tissue; and

output the value to a display device.

15. A method for assessing tissue of an anatomical structure during an ablation procedure using an ablation catheter, the method comprising:

acquiring a signal from a sensing element of the catheter to confirm that the catheter is in contact with the tissue, wherein the signal from the sensing element is a force signal indicating a force of the catheter against the tissue;

acquire a plurality of components of a complex impedance between at least one electrode and the tissue;

acquiring magnitudes for the plurality of components of a complex impedance between the at least one electrode of the catheter and the tissue;

acquiring a magnitude for an applied power;

calculating a value responsive to;

(a) the force signal and at least one component of the complex impedance; and

(b) a coupling index calculated based on the power magnitude, the magnitudes of the plurality of components of the complex impedance, and the force signal indicating the force of the catheter against the tissue, said value indicative of one of a predicted depth of a lesion in the tissue, a likelihood of the lesion having a predetermined depth in the tissue and a predicted temperature of the tissue, wherein the coupling index is indicative of a degree of coupling between the at least one electrode and the tissue; and

outputting the value to a display device.

16. The method of claim 15, further comprising

acquiring a magnitude associated with each of first and second components of the complex impedance, wherein the first and second components comprise two of a resistance between the electrode and the tissue, a phase angle between the electrode and the tissue, an impedance magnitude between the electrode and the tissue, and a reactance between the electrode and the tissue;

and

calculating the value based on the magnitudes of the first and second components of the complex impedance.

17. The method of claim 15, further comprising:

acquiring a magnitude of a power applied by the catheter to the tissue; and

calculating the value based on the power.

18. The method of claim 17, further comprising:

acquiring a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of an ablative energy to the tissue commences to a subsequent point in time for which the value is calculated, wherein the magnitude of power is a magnitude of the average power applied to the tissue during the time interval; and

calculating the value based on the average power magnitude.

19. The method of claim 15, further comprising:

acquiring a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of an ablative energy to the tissue commences to a subsequent point in time for which the value is calculated;

calculating a change in said at least one component of the complex impedance and said force over the time interval; and

compare the value with a threshold value to determine whether the lesion has reached a determined depth within the tissue.

20. The method of claim 15, wherein the value comprises an electrical coupling index (ECI) associated with the formation of a lesion in the tissue, and further comprising:

acquiring a magnitude of a change in time corresponding to a time interval extending from a point in time at which application of an ablative energy to the tissue commences to a subsequent point in time for which the value is calculated; and

calculating a change in the ECI over the time interval; and

comparing the value with a threshold value to determine whether the lesion has reached a determined depth within the tissue.

21. The method of claim 15, wherein the ablation catheter comprises a temperature sensor, and further comprising:

acquiring a temperature of the catheter at a point in time for which the value is to be calculated; and

calculating the value based on the temperature magnitude.

22. The method of claim 15, further comprising:

calculating the value based on a location of the anatomical structure.

23. The method of claim 15, wherein the sensing element of the catheter comprises one or more of a technology selected from the group consisting of an electrical-based technology, an electromechanical-based technology, a force-based technology, and an optically-based technology.