Radio frequency ablation system and method linking energy delivery with fluid flow

• US 6,666,862 B2
• Filed: 03/01/2001
• Issued: 12/23/2003
• Est. Priority Date: 03/01/2001
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Morris, Milton M., KenKnight, Bruce, Jain, Mudit K.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/797,435
• Publication Number:
  US 20020169445A1
• Time in Patent Office: 1,027 Days
• Field of Search: 606/32, 606/34, 606/35, 606/38, 606/41, 606/46, 606/48-51, 607/101-102, 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00726 Duty cycle
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00863 Fluid flow
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/1273 including multiple generators in one device
• CPC Class Codes: A61B 2018/1286 having a specific transformer
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

Abstract

Information indicative of the flow rate of fluid through a biological organ is provided to a processor. Using this information the processor assesses whether the fluid-flow rate is high or low and controls a generator such that the generator provides energy to an electrode positioned within the organ to effect tissue ablation. Energy of a first level is provided during periods of high fluid-flow and energy of a second level, less than the first level, during periods of low fluid-flow. The flow rate information may be provided by an electrocardiograph (ECG) device or a flow sensor. A temperature sensor provides temperature signals to the processor indicative of the electrode temperature. The processor further controls the generator based on the electrode temperature to maintain the temperature at or near a target temperature and below a maximum threshold temperature.

Claims

1. A system for applying energy to biological tissue within a biological organ having fluid flowing therethrough, said system comprising:

a generator for providing energy;

a catheter carrying an electrode system at its distal end, the distal end adapted to be positioned in a biological organ and the electrode system adapted to receive energy from the generator;

a device adapted to provide flow rate information indicative of the flow rate of the fluid through the biological organ; and

a processor adapted to receive the flow rate information, process the flow rate information to assess whether the fluid-flow rate is high or low and control the generator such that the generator provides energy of a first level to the electrode during periods of high fluid-flow and energy of a second level, less than the first level, during periods of low fluid-flow.

2. The system of claim 1 wherein the processor is adapted to control the generator to increase the energy level to the first energy level at the beginning of the high flow period and to decrease the energy level to the second energy level toward the end of the high flow period and before the beginning of the next low flow period.

3. The system of claim 2 wherein the processor is adapted to increase the energy level by ramping up the energy level and to decrease the energy level by ramping down the energy level.

4. The system of claim 1 further comprising:

a temperature sensor adapted to provide temperature signals to the processor, the signals indicative of the temperature at the electrode system;

wherein the processor is adapted to determine the temperature at the electrode system based on the temperature signals and to control the generator such that the level of energy applied to the electrode system maintains the temperature of the electrode system at or near a target temperature.

6. The system of claim 4 wherein, during periods of high fluid-flow, the target temperature is a high target temperature and, during periods of low fluid-flow, the target temperature is a low target temperature, less than the high target temperature.

7. The system of claim 6 wherein the high target temperature is in the range between approximately 50°

C. and approximately 100°

C. and the low target temperature is in the range between approximately 37°

C. and approximately 49.9°

C.

8. The system of claim 1 further comprising:

a temperature sensor is adapted to provide temperature signals to the processor, the signals indicative of the temperature at the electrode system;

wherein the processor is adapted to determine the temperature at the electrode system based on the temperature signals and to control the generator such that the level of energy applied to the electrode system maintains the temperature of the electrode system below a maximum threshold temperature.

9. The system of claim 8 wherein the processor is adapted to shut off the generator when the temperature of the electrode system exceeds the maximum threshold temperature.

10. The system of claim 9 wherein the threshold temperature is 100°

C.

11. The system of claim 1 wherein the flow rate information device comprises an electrocardiograph (ECG) device adapted to monitor changes in electrical activity and the flow rate information comprises ECG signals.

12. The system of claim 11 wherein the ECG device comprises at least one of an external ECG sensor.

13. The system of claim 11 wherein the ECG device comprises at least one of an internal ECG sensor.

14. The system of claim 11 wherein the ECG device comprises at least one ECG filter in electrical communication with the electrode system, the ECG filter adapted to receive electrical signals from the electrode system and output them as ECG signals.

15. The system of claim 14 wherein the electrode system comprises a single tip electrode.

16. The system of claim 14 wherein the electrode system comprises a plurality of band electrodes and the ECG device comprises a plurality of ECG filters, one in electrical communication with each of the band electrodes.

17. The system of claim 11 wherein, for an ECG signal providing a waveform having a sequence of alternating P waves and T waves, the processor is adapted to identify the periods between a P wave and its subsequent T wave as high fluid-flow periods and the periods between a T wave and the next P wave as low fluid-flow periods.

18. The system of claim 11 wherein, for an ECG signal providing a waveform having a sequence of alternating QRS complex waves and T waves, the processor is adapted to identify the periods between the onset of a QRS complex wave and the subsequent T wave as high fluid-flow periods and the periods between a T wave and the next QRS complex wave as low flow periods.

19. The system of claim 1 wherein the flow rate information device comprises at least one flow sensor located near the electrode system and adapted to sense fluid flow and the flow rate information comprises velocity values.

20. The system of claim 19 wherein the processor is adapted to identify periods during which the sensor signals provide a velocity value greater than or equal to a predetermined velocity value as high fluid-flow periods and those periods during which the velocity value is less than the predetermined velocity value as low fluid-flow periods.

21. The system of claim 20 wherein the electrode system comprises a tip electrode and the at least one flow sensor is at the surface of the tip electrode.

22. The system of claim 21 further comprising at least one additional flow sensor at the surface of the tip electrode at a distance from the other flow sensor;

wherein the processor is adapted to control the energy provided by the generator based on the lowest velocity value.

23. The system of claim 19 wherein the electrode system comprises a plurality of band electrodes, the at least one flow sensor is at the outer surface of one of the band electrodes and the processor is adapted to control the energy provided by the generator to each of the electrodes based on the flow rate information provided by the at least one flow sensor.

24. The system of claim 23 wherein the band electrodes are arranged in a linear array and the at least one flow sensor is at the surface of one of the electrodes near the longitudinal center of the array.

25. The system of claim 19 wherein the electrode system comprises a plurality of band electrodes, the flow rate information devices comprises a plurality of flow sensors, one flow sensor associated with one band electrode and the processor is adapted to control the energy provided by the generator to each of the electrodes based on the flow rate information provided by the flow sensor associated with that electrode.

26. The system of claim 25 wherein the distal end of the catheter is precurved to have a radius of curvature comprising and inside portion and an outside portion and the flow sensor is positioned on the inside portion.

5. The system of 4 wherein, during a sequence of alternating high flow rate periods and low flow rate periods, the processor is adapted to adjust the level of energy output by the generator during a subsequent low/high period based on the temperature of the electrode system during the previous low/high period.

27. A method of applying energy to biological tissue within a biological organ, said method comprising the steps of:

positioning an electrode within the biological organ, such that a portion of the electrode contacts the biological tissue;

determining the biological fluid-flow rate within the biological organ;

during periods of high biological fluid flow, applying energy of a first level to the biological tissue; and

during periods of low biological fluid flow, reducing the level of energy applied to a second level, less than the first level.

28. The method of claim 27 wherein the first level of energy is substantially constant and the second level of energy is substantially zero.

29. The method of claim 27 wherein the steps of applying energy of a first level and reducing the level of energy to a second level comprises:

increasing the energy to the first energy level at the beginning of a high flow period; and

decreasing the energy level to the second energy level toward the end of the high flow period and before the low flow period.

30. The method of claim 29 wherein, other than during periods of increasing energy and decreasing energy, the first level of energy and the second level of energy are substantially constant.

31. The method of claim 27 further comprising:

monitoring the temperature of the electrode; and

adjusting the level of energy applied to the electrode to maintain the temperature of the electrode at or near a target temperature.

32. The method of claim 31 further comprising the step of, for a sequence of alternating high flow rate periods and low flow rate periods, adjusting the level of energy during a subsequent low/high period based on the temperature of the electrode during the previous low/high period.

33. The method of claim 31 wherein, during periods of high fluid-flow, the target temperature is a high target temperature and, during periods of low fluid-flow, the target temperature is a low target temperature, less than the high target temperature.

34. The system of claim 33 wherein the high target temperature is in the range between approximately 50°

C. and approximately 100°

C. and the low target temperature is in the range between approximately 37°

C. and approximately 49.9°

C.

35. The method of claim 27 further comprising the steps of:

monitoring the temperature of the electrode; and

adjusting the level of energy applied to the electrode to maintain the temperature of the electrode below a maximum threshold temperature.

36. The method of claim 35 wherein the maximum threshold temperature is approximately 100°

C.

37. The method of claim 27 wherein the step of determining the biological fluid-flow rate comprises the steps of:

measuring changes in voltage occurring in the human body with each heart beat to produce an electrocardiogram waveform having a sequence of alternating P waves and T waves; and

identifying high fluid-flow periods as those periods between a P wave and its subsequent T wave and low fluid-flow periods are those periods between a T wave and the next P wave.

38. The method of claim 27 wherein the step of determining the biological fluid-flow rate comprises the steps of:

measuring changes in voltage occurring in the human body with each heart beat to produce an electrocardiogram waveform having a sequence of alternating QRS complex waves and T waves; and

identifying high fluid-flow periods as those periods between the onset of a QRS complex wave and the subsequent T wave and low fluid-flow periods are those periods between a T wave and the next QRS complex wave.

39. The method of claim 27 wherein the step of determining the biological fluid-flow rate comprises the steps of:

measuring the velocity of the fluid flow; and

identifying those periods during which the sensor signals provide a velocity value greater than or equal to a predetermined velocity value as high fluid-flow periods and those periods during which the velocity value is less than the predetermined velocity value as low fluid-flow periods.

40. A system for applying energy to biological tissue within a biological organ having fluid flowing therethrough, said system comprising:

a generator for providing energy;

a catheter carrying an electrode system at its distal end, the distal end adapted to be positioned in a biological organ and the electrode system adapted to receive energy from the generator;

a device adapted to provide flow rate information indicative of the flow rate of the fluid through the biological organ; and

a processor adapted to control the generator such that the generator provides energy to the electrode system in response to the fluid flow through the biological organ as indicated by the flow rate information, wherein a preset flow rate and a maximum energy level are programmed into the processor and the processor is adapted to;

compare the measured flow rate to the preset flow rate;

set the provided energy level to the maximum energy level when the measured flow rate is greater than or equal to the preset flow rate; and

determine the rate of reduction of the measured flow rate relative to the preset flow rate and set the provided energy level to a value less than the maximum energy level, the provided level being a multiple of the maximum energy level, the multiple being set based on the determined reduction rate when the measured flow rate is less than the preset flow rate.

41. A system for applying energy to biological tissue within a biological organ having fluid flowing therethrough, said system comprising:

a generator for providing energy;

a catheter carrying an electrode system at its distal end, the distal end adapted to be positioned in a biological organ and the electrode system adapted to receive energy from the generator;

a device adapted to provide flow rate information indicative of the flow rate of the fluid through the biological organ; and

a processor adapted to control the generator such that the generator provides energy to the electrode system in response to the fluid flow through the biological organ as indicated by the flow rate information, wherein a preset flow rate, a high target temperature, and a low target temperature are programmed into the processor and the processor is adapted to;

monitor the temperature of the electrode;

compare the measured flow rate to the preset flow rate;

when the measured flow rate is greater than or equal to the preset flow rate,

determine the rate of increase of the measured flow rate relative to the preset flow rate;

set the applied energy level to a value greater than the current energy level, the applied level being a multiple of the current energy level, the multiple being set based on the determined increase rate;

compare the electrode temperature to the high target temperature;

adjust the applied energy level to maintain the electrode temperature near the high target temperature; and

when the measured flow rate is less than or equal to the preset flow rate,

determine the rate of reduction of the measured flow rate relative to the preset flow rate;

set the applied energy level to a value less than the current energy level, the applied level being a multiple of the current energy level, the multiple being set based on the determined reduction rate;

compare the electrode temperature to the low target temperature;

adjust the applied energy level to maintain the electrode temperature near the low target temperature.

42. A method of ablating biological tissue within a biological organ having biological fluid flowing therethrough, said method comprising:

positioning an electrode within the biological organ such that a portion of the electrode contacts the biological tissue;

measuring the biological fluid-flow rate within the biological organ; and

applying energy to the electrode in response to the fluid-flow rate within the biological organ as indicated by the flow rate measurement, wherein

the step of measuring the biological fluid-flow rate comprises the steps of;

positioning a flow sensor within the biological fluid; and

determining the flow rate of the biological fluid; and

the step of applying energy to the electrode based on the flow rate measurement comprises the steps of;

establishing a preset flow rate and a maximum energy level;

comparing the measured flow rate to the preset flow rate;

when the measured flow rate is greater than or equal to the preset flow rate, setting the applied energy level to the maximum energy level; and

when the measured flow rate is less than the preset flow rate, determining the rate of reduction of the measured flow rate relative to the preset flow rate and setting the applied energy level to a value less than the maximum energy level, the applied level being a multiple of the maximum energy level, the multiple being set based on the determined reduction rate.

43. A method of ablating biological tissue within a biological organ having biological fluid flowing therethrough, said method comprising:

positioning an electrode within the biological organ such that a portion of the electrode contacts the biological tissue;

measuring the biological fluid-flow rate within the biological organ;

applying energy to the electrode in response to the fluid-flow rate within the biological organ as indicated by the flow rate measurement;

monitoring the temperature of the electrode; and

adjusting the level of energy applied to the electrode to maintain the temperature of the electrode at or near a target temperature;

wherein the steps of applying energy to the electrode based on the flow rate measurement and adjusting the level of energy applied to the electrode to maintain the temperature of the electrode at or near a target temperature comprise the steps of;

establishing a high target temperature, a low target temperature and a preset flow rate value;

monitoring the temperature of the electrode;

comparing the measured flow rate to the preset flow rate;

when the measured flow rate is greater than or equal to the preset flow rate,

determining the rate of increase of the measured flow rate;

setting the applied energy level to a value greater than the current energy level, the applied level being a multiple of the current energy level, the multiple being set based on the determined increase rate;

comparing the electrode temperature to the high target temperature;

adjusting the applied energy level to maintain the electrode temperature near the high target temperature; and

when the measured flow rate is less than or equal to the preset flow rate,

determining the rate of reduction of the measured flow rate;

setting the applied energy level to a value less than the current energy level, the applied level being a multiple of the current energy level, the multiple being set based on the determined reduction rate;

comparing the electrode temperature to the low target temperature;

adjusting the applied energy level to maintain the electrode temperature near the low target temperature.

44. The system of claim 43 wherein the high target temperature is in the range between approximately 50°

C. and approximately 100°

C. and the low target temperature is in the range between approximately 37°

C. and approximately 49.9°

C.