Apparatus and method for thermal ablation

• US 5,697,925 A
• Filed: 06/09/1995
• Issued: 12/16/1997
• Est. Priority Date: 06/09/1995
• Status: Expired due to Term

• Current Assignee: Vante, Inc.
• Original Assignee: Engineering & Research Associates Inc. (Machine Solutions, Inc.)
• Inventors: Taylor, Junius E.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/488,887
• Time in Patent Office: 921 Days
• Field of Search: 128/642, 128/736, 606/34, 606/38, 606/40, 606/41, 606/49, 607/122, 607/99
• US Class Current: 606/34
• 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 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00892 Voltage
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

A catheter for use in an electrophysiological procedure to ablate a site includes a metallic tip having a first work function and energized by a source of RF energy. The RF energy return path is through a relatively large plate of a metallic material having a second work function and disposed at a location removed from the ablation site. The difference in work functions of the tip and the plate, operating in the presence of an electrolyte represented by the intermediate tissue, produces an exchange of electrical charges through chemical reaction to create a galvanic cell. By loading the galvanic cell with a shunt resistor, it becomes a current source providing a current linear with and highly dependent on the tissue temperature at the ablation site. This accurate representation of the tissue temperature at the ablation site is used to regulate the RF energy applied to maintain the tissue at the ablation site at a predetermined temperature during the ablation procedure.

Claims

1. Apparatus for ablating tissue at an ablation site in the heart of a human being, said apparatus comprising in combination:

(a) a source of RF energy for irradiating the tissue at the ablation site to cause a temperature rise of the tissue at the ablation site;

(b) a catheter having a catheter tip for contactingly engaging the ablation site and for irradiating the tissue with RF energy to heat the tissue at the ablation site, said tip comprising a first electrode of material having a first work function;

(c) transmission means for conveying RF energy from said source to said tip;

(d) a second electrode displaced from said first electrode and of material having a second work function different from the first work function for electrically contacting an area of tissue of the human being;

(e) a galvanic cell formed by said first electrode, said second electrode and the tissue of the human being serving as an electrically interconnecting electrolyte for generating an electrical current corresponding with the temperature rise of the tissue at the ablation site; and

(f) a control circuit responsive to said electrical current generated by said galvanic cell for regulating the operation of said source of RF energy to control RF irradiation of the ablation site and thereby control the temperature of the tissue at the ablation site.

2. The apparatus of claim 1 wherein the material of said first electrode is platinum and the material of said second electrode is copper.

3. The apparatus of claim 1 including a catheter mounted probe for supporting said tip.

4. The apparatus of claim 1 wherein said catheter includes a thermistor for sensing the temperature of said tip.

5. The apparatus of claim 4 including a calibration circuit receiving an input signal from said thermistor for correlating said electrical current generated by said galvanic cell with the temperature sensed by said thermistor located at the ablation site.

6. The apparatus of claim 5 wherein the material of said first electrode is platinum and the material of said second electrode is copper.

7. The apparatus of claim 1 wherein said second electrode is a plate.

8. The apparatus of claim 1 wherein said second electrode is a plate adapted to electrically contact the skin on the back of the human being.

9. The apparatus of claim 1 including an indicator for indicating the temperature of the ablation site.

10. A catheter assembly for irradiating tissue at an ablation site of a living being to raise the temperature of the ablation site to a predetermined range and to maintain the temperature of the ablation site within the predetermined range for a period of time, said catheter assembly comprising in combination:

(a) a catheter having a tip locatable at the ablation site, said tip being formed of a material having a first work function;

(b) an electrode displaced from said tip and adapted to be in electrical contact with the tissue of the living being, said electrode being formed of a material having a second work function different from the first work function;

(c) a galvanic cell formed by said tip, said electrode, and the tissue of the living being serving as an electrolyte intermediate said tip and said electrode for generating a current corresponding to the temperature of the tissue at the ablation site;

(d) an RF generator interconnected with said tip and said electrode for applying RF energy through said tip to the tissue at the ablation site to heat the tissue at the ablation site; and

(e) a control circuit for regulating said RF generator as a function of the current generated by said galvanic cell to control the temperature of the tissue at the ablation site.

11. The catheter assembly of claim 10 wherein the material of said electrode is copper.

12. The catheter assembly of claim 10 wherein the material of said tip is platinum.

13. The catheter assembly of claim 10 wherein said electrode is a plate locatable in electrical contact with and in overlying relationship to the skin of the living being.

14. The catheter assembly of claim 10 including a temperature input circuit for setting the temperature of the ablation site.

15. The catheter assembly of claim 14 including an indicator for indicating the temperature of the ablation site.

16. The catheter assembly of claim 10 including a calibration circuit for calibrating the current generated by said galvanic cell with the temperature of the ablation site.

17. The catheter assembly of claim 16 wherein the area of said tip in contact with the ablation site tissue is less than the area of said electrode in contact with the tissue of the living being.

18. The catheter assembly of claim 10 wherein the area of said tip in contact with the ablation site is less than the area of said electrode in contact with the tissue to produce a current density and temperature rise greater at the ablation site tissue than at the interface between said electrode and the tissue.

19. The catheter assembly of claim 10 wherein said galvanic cell includes a load resistor for generating the current reflective of the temperature rise of the ablation site tissue.

20. Apparatus for ablating tissue at an ablation site, said apparatus comprising in combination:

(a) a first electrode having a first work function locatable at the ablation site tissue;

(b) a second electrode having a second work function different from the first work function locatable in electrical contact with tissue for creating a galvanic cell in combination with said first electrode and the tissue acting as an electrolyte to provide a current output signal corresponding with the temperature at the ablation site tissue;

(c) an RF generator for applying RF energy to the ablation site tissue through said first and second electrodes to heat the ablation site tissue; and

(d) a control circuit for regulating the RF energy generated by said RF generator as a function of said current output signal to regulate the temperature of the ablation site.

21. The apparatus of claim 20 wherein said first and second electrodes are metallic.

22. The apparatus of claim 21 wherein said first electrode is platinum and wherein said second electrode is copper.

23. The apparatus of claim 20 including an indicator for indicating the temperature of the ablation site tissue.

24. The apparatus of claim 20 including a temperature input circuit for setting the temperature of the ablation site tissue.

25. The apparatus of claim 20 including means for correlating said current output signal with the temperature of the ablation site tissue.

26. Apparatus for ablating tissue at an ablation site, said apparatus comprising in combination:

(a) an RF generator for applying RF energy to the ablation site to heat ablation site tissue;

(b) a probe adapted to be in contact with the ablation site tissue for irradiating the ablation site tissue with RF energy;

(c) a transmission line for conveying RF energy from said RF generator to the probe;

(d) an electrode displaced from said probe and adapted to be in contact with tissue displaced from the ablation site;

(e) a temperature sensor for sensing the temperature of the ablation site tissue and for producing a signal reflective of the temperature sensed, said temperature sensor comprising said probe, said electrode, and an electrolyte in electrical contact with said probe and said electrode; and

(f) a control circuit responsive to said signal produced by said temperature sensor for regulating the RF energy applied to said probe to establish the temperature at the ablation site tissue within a predetermined range.

27. The apparatus of claim 26 including a temperature input circuit for setting the temperature of the ablation site tissue.

28. The apparatus of claim 26 including an indicator for indicating the temperature of the ablation site tissue.

29. A method for ablating tissue at an ablation site in the heart of a human being, said method comprising the steps of:

(a) generating RF energy from a source of RF energy;

(b) conveying RF energy from the source to a tip in contact with the ablation site;

(c) irradiating the tissue at the ablation site with RF energy from the tip to heat the tissue at the ablation site, the tip comprising a first electrode of material having a first work function;

(d) electrically contacting an area of tissue of the human being with a second electrode displaced from the first electrode and of material having a second work function different from the first work function;

(e) generating an electrical current corresponding with the temperature rise of the tissue at the ablation site by a galvanic cell formed by the first electrode, the second electrode and the tissue of the human being serving as an electrically interconnecting electrolyte; and

(f) regulating the operation of the source of RF energy with a control circuit responsive to the electrical current generated by said generating step to control RF irradiation of the ablation site and thereby control the temperature of the tissue at the ablation site.

30. A method for ablating tissue at an ablation site, said method comprising the steps of:

(a) generating RF energy with an RF generator;

(b) conveying RF energy from the RF generator through a transmission line to a probe;

(c) irradiating the ablation site with RF energy through the probe proximate the ablation site;

(d) sensing the temperature at the ablation site tissue with a temperature sensor and producing a signal reflective of the temperature sensed, the temperature sensor comprising the probe, an electrode displaced from the probe and an electrolyte in electrical contact with the probe and the electrode; and

(e) regulating the output of the RF generator with a control circuit responsive to the signal produced by said sensing step to establish the temperature at the ablation site tissue within a predetermined range.

31. Apparatus for mapping tissue to locate a site to be ablated and for ablating the site located, said apparatus comprising in combination:

(a) a probe having a plurality of electrodes disposed therealong for placement adjacent the tissue to be mapped, each electrode of said plurality of electrodes having a first work function;

(b) a further electrode having a second work function different from the first work function, said further electrode being locatable in electrical contact with tissue for creating a galvanic cell in combination with said plurality of electrodes and the tissue acting as an electrolyte to provide a current output signal corresponding with the located site to be ablated;

(c) a data acquisition circuit for performing mapping functions in response to signals generated by each electrode of said plurality of electrodes proximate the tissue to identify and locate at least a tissue site to be ablated;

(d) an RF generator for generating RF energy to ablate a located ablation site;

(e) a switching circuit for selectively interconnecting said data acquisition circuit and said RF generator to each electrode of said plurality of electrodes;

(f) a control circuit for regulating the RF energy generated by said RF generator as a function of said current output signal to regulate the temperature of the site being ablated; and

(g) a plurality of conductors interconnecting said switching circuit with said plurality of electrodes.

32. The apparatus of claim 31 including a temperature input circuit for setting the temperature of the site to be ablated.

33. The apparatus of claim 32 including an indicator for indicating the temperature of the site during ablation.

34. Apparatus for ablating tissue at an ablation site, said apparatus comprising in combination:

(a) a catheter having a tip for contacting the ablation site to irradiate the ablation site with RF energy to heat the tissue;

(b) a source of RF energy for transmitting RF energy to said tip;

(c) a galvanic cell using the tissue as an electrolyte for generating an electrical signal as a function of the temperature of the ablation site; and

(d) a control circuit responsive to the electrical signal for controlling the RF energy transmitted to said tip.

35. A method for ablating tissue at an ablation site, said method comprising the steps of:

(a) contacting the ablation site with a tip to irradiate the ablation site with RF energy to heat the tissue;

(b) transmitting RF energy to the tip from a source of RF energy;

(c) generating an electrical signal as a function of the temperature of the ablation site with a galvanic cell having tissue as a constituent element; and

(d) controlling the RF energy transmitted to the tip with a control circuit responsive to the electrical signal.

36. Apparatus for sensing the temperature excursion of tissue at an ablation site during a tissue ablation procedure, said apparatus comprising in combination:

(a) a catheter having a tip for irradiating the ablation site with RF energy to perform the ablation procedure;

(b) a source of RF energy for transmitting RF energy to said tip;

(c) an electrode adapted to be adjacent tissue;

(d) a galvanic cell formed by said tip, said electrode and the tissue for generating an electrical signal responsive to the temperature of the tissue at the ablation site; and

(e) a control circuit responsive to the electrical signal for controlling the RF energy transmitted to said tip.

37. A method for sensing the temperature excursion of tissue at an ablation site during a tissue ablation procedure, said method comprising the steps of:

(a) transmitting RF energy to a tip from a source of RF energy

(b) irradiating the ablation site with RF energy from the tip to perform the ablation procedure;

(c) locating an electrode adjacent tissue;

(d) generating an electrical signal responsive to the temperature of the tissue at the ablation site with a galvanic cell formed by the tip, the electrode and the tissue; and

(e) controlling the RF energy transmitted to the tip with a control circuit responsive to the electrical signal.

38. Apparatus for sensing the temperature excursion of tissue at an ablation site during a tissue ablation procedure, said apparatus comprising in combination:

(a) a catheter having a tip for irradiating the ablation site with RF energy to perform the ablation procedure;

(b) a source of RF energy for transmitting RF energy to said tip;

(c) an electrode adapted to be adjacent the tissue;

(d) a generator for generating an electrical signal responsive to the temperature of the tissue at the ablation site, said generator comprising said tip, said electrode and the tissue; and

(e) a control circuit for controlling the RF energy transmitted to said tip as a function of the temperature excursion and in response to the electrical signal.

39. A method for sensing the temperature excursion of tissue at an ablation site during a tissue ablation procedure, said method comprising the steps of:

(a) transmitting RF energy from a source of RF energy to a tip;

(b) irradiating the ablation site with RF energy from the tip to perform the ablation procedure;

(c) locating an electrode adjacent the tissue;

(d) generating an electrical signal responsive to the temperature of the tissue at the ablation site with a generator formed by the tip, the electrode and the tissue; and

(e) controlling the RF energy transmitted to the tip with a control circuit as a function of the temperature excursion and responsive to the electrical signal.