Method and system for radiofrequency ablation of cardiac tissue

• US 5,573,533 A
• Filed: 04/10/1992
• Issued: 11/12/1996
• Est. Priority Date: 04/10/1992
• Status: Expired due to Term

• Current Assignee: Medtronic Cardiorhythm (Medtronic Plc)
• Original Assignee: Medtronic Cardiorhythm (Medtronic Plc)
• Inventors: Strul, Bruno
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US07/866,683
• Time in Patent Office: 1,677 Days
• Field of Search: 606/27-34, 606/37-42, 606/45-50, 128/784-786, 128/642
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00779 Power or energy
• 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 2018/00892 Voltage
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2018/1226 powered by a battery
• 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 2018/1286 : having a specific transformer
• CPC Class Codes: A61B 2090/0814 : Preventing re-use

Abstract

A system for delivering radiofrequency energy to ablate cardiac tissue comprises a radiofrequency generator and an intravascular catheter. The catheter includes both a radiofrequency ablation electrode and a temperature sensor within its distal end. Delivery of power to the ablation electrode may then be controlled based on electrode temperature using a cascade control system wherein analog temperature controller adjusts the set point to a secondary power controller. Alternatively, power delivered to the patient can be controlled directly based on a power set point. Reuse of the catheter is prevented by a fuse within the catheter which is sensed prier to power delivery and broken prior to disconnection of the catheter.

Claims

1. A system for radiofrequency ablation of cardiac tissue, said system comprising:

a catheter having a proximal end, a distal end, an electrode near said distal end, and a temperature sensor near said distal end, said electrode being coupled to an electrode connection wire extending to said proximal end, and said temperature sensor being coupled to a temperature sensor connection wire extending to said proximal end; and

a radiofrequency power generator connectable to the proximal end of the catheter, said generator including;

(a) a power source which delivers radiofrequency power to the electrode based on a power output signal;

(b) means for measuring radiofrequency power from the power source to produce an actual power signal;

(c) an analog temperature controller which receives a temperature set point signal and an actual temperature signal from the temperature sensor and based on a difference therebetween produces power set point signal;

(d) an analog power controller coupled to the means for measuring radiofrequency Dower and to the analog temperature controller, wherein the analog power controller receives the power set point signal and the actual power signal and based on a difference therebetween produces the power output signal; and

means for connecting said power source to said electrode connection wire and for connecting said temperature controller to said temperature sensor connection wire.

2. A system as in claim 1, wherein the electrode is at the distal tip of the catheter.

3. A system as in claim 1, wherein the power source comprises a radiofrequency oscillator coupled to a power transformer.

4. A system as in claim 3, wherein the power transformer is coupled to the power controller to receive said power output signal.

5. A system as in claim 1, wherein the power set point signal is proportional to the difference between the actual temperature signal and the temperature set point signal.

6. A system as in claim 1, wherein the power output signal is proportional to the difference between the power set point signal and the actual power signal.

7. A system as in claim 1 further comprising means for optically isolating the temperature sensor from the radiofrequency power generator.

8. A system for radiofrequency ablation of tissue, said system comprising;

a catheter having a proximal end, a distal end, an electrode near said distal end, and a temperature sensor near said distal end, said electrode being coupled to an electrode connection wire extending to said proximal end, and said temperature sensor being coupled to a temperature sensor connection wire extending to said proximal end; and

a radiofrequency power generator connectable to the proximal end of the catheter, said generator including;

(a) power supply means for delivering radiofrequency power to the electrode based on a power output signal;

(b) means for controlling temperature at the temperature sensor, said means being connected to receive an actual temperature signal from the sensor and to modulate the power output signal based on the difference between said actual temperature signal and a temperature set point, wherein the means for controlling temperature comprise an analog temperature control circuit which produces a power set point signal based on the difference between said actual temperature signal and the temperature set point and an analog power control circuit which modulates the power output signal based on a difference between the actual power output from the power source and the power set point signal; and

(c) a battery connected to said power supply means and said means for controlling as the sole source of power for said radiofrequency power generator to reduce or eliminate spurious ground differential currents;

(d) means for connecting said power supply means to said electrode connection wire and for connecting said temperature control means to said temperature sensor connection wire.

9. A system for radiofrequency ablation of tissue, said system comprising:

a catheter having a proximal end, a distal end, an electrode near said distal end, and a temperature sensor near said distal end, said electrode being coupled to an electrode connection wire extending to said proximal end, and said temperature sensor being coupled to a temperature sensor connection wire extending to said proximal end; and

a radiofrequency power generator connectable to the proximal end of the catheter, said generator including

(a) power supply means for delivering radiofrequency power to the electrode based on a power output signal wherein the power output signal is proportional to the difference between the power set point signal and the actual power signal;

(b) means for controlling temperature at the temperature sensor, said means being connected to receive an actual temperature signal from the sensor and to modulate the power output signal based on the difference between said actual temperature signal and a temperature set point; and

(c) a battery connected to said power supply means and said means for controlling as the sole source of power for said radiofrequency power generator to reduce or eliminate spurious around differential currents;

(d) means for connecting said power supply means to said electrode connection wire and for connecting said temperature control means to said temperature sensor connection wire.

10. A system for radiofrequency ablation, said system comprising:

a catheter having a proximal end including connecting means, a distal end, an electrode near the distal end, and a fuse, said electrode being coupled to an electrode connection wire extending to said proximal end and said fuse being coupled to first and second fuse connecting wires coupled to said connecting means;

a radiofrequency power generator connectable to the connecting means at the proximal end of the catheter for supplying radiofrequency power to said electrode through said electrode connection wire;

means in the generator coupled to said first and second fuse connecting wires, for (a) sensing the integrity of the fuse when the catheter is initially connected to the generator, (b) disabling operation of the generator if the fuse is initially broken, and (c) breaking the fuse if the fuse is initially intact, whereby the catheter cannot be reused; and

means for connecting the radiofrequency power generator to the electrode connection wire and for connecting said sensing, disabling and breaking means to said fuse.

11. A system as in claim 10, wherein the electrode is at the distal tip of the catheter.

12. A system as in claim 10, wherein the means for sensing is a voltage sensor coupled to a microprocessor and coupled to said connecting means.

13. A system as in claim 10, wherein the means for disabling operation of the generator is a relay coupled to a microprocessor and coupled to said connecting means for electrically decoupling the electrode connection wire from the generator.

14. A system as in claim 10, wherein the means for breaking the fuse is a current source coupled to said connecting means and monitored by a microprocessor for applying a current to the fuse.

15. A system as in claim 10, wherein the fuse is disposed in the proximal end of the catheter and coupled between a pair of conductors for coupling to said connecting means.

16. A system for radiofrequency ablation of tissue, said system comprising:

a catheter having a proximal end, a distal end, an electrode near said distal end, and a temperature sensor near said distal end, said electrode being coupled to an electrode connection wire extending to said proximal end, and said temperature sensor being coupled to a temperature sensor connection wire extending to said proximal end;

a radiofrequency power generator connectable to the proximal end of the catheter, said generator including

(a) a power source which delivers radiofrequency power to the electrode based on a power output signal;

(b) means for controlling temperature at the temperature sensor, said means being connected to receive a actual temperature signal from the sensor and to modulate the power output signal based on a control signal having a magnitude indicating the difference between said actual temperature signal and a temperature set point;

(c) means for connecting said power source to said electrode connection wire and for connecting said temperature control means to said temperature sensor connection wire; and

(d) means for providing an alternative control signal having a magnitude indicating a selected power level;

(e) means, coupled to said means for providing said alternative control signal for limiting the radiofrequency power delivered to said electrode according to the magnitude of said alternative control signal and irrespective of said actual temperature signal or said temperature set point;

first means for disabling said operation of said radiofrequency power generator comprising a microprocessor coupled to said power source, said microprocessor controlled by software program programmed to disable said radiofrequency power generator based on a first parameter selected from the group including impedance of said electrode, radiofrequency power delivered to said electrode, and said actual temperature signal if at least one of said first parameters exceeds a first limit; and

second means for disabling operation of said radiofrequency power generator based on a second parameter selected from the group including radiofrequency power delivered to said electrode and said actual temperature signal.

17. A system as in claim 16 wherein said second disabling means comprises at least one comparator coupled to the radiofrequency power source and the connecting means to disable said radiofrequency power source if at least one of said second parameters exceeds a second limit.