Systems and methods of regulation energy delivery during an ablation procedure

Abstract

The present invention provides systems and methods for temperature-controlled ablation using radiometric feedback. An interface module may include (a) a processor; (b) a first input/output (I/O) port to receive digital radiometer and digital thermocouple signals from an integrated catheter tip (ICT); (c) a second I/O port to receive ablative energy from a generator; (d) a temperature display; (e) a patient relay; (f) a computer-readable medium storing instructions for causing the processor to: (i) calculate a temperature adjacent to the ICT based on the digital radiometer and thermocouple signals and operation parameters; (ii) cause the temperature display to display the calculated temperature; and (iii) close the patient relay to pass ablative energy received on the second I/O port to the first I/O port; and (g) a temperature control subsystem to regulate the ablative power based on the calculated temperature.

1 . (canceled) 
     
     
         2 . An interface module for use with an ablation energy generator and an integrated catheter tip (ICT), the ICT including a radiometer, an ablative tip, and a thermocouple, the interface module comprising:
 a processor; a first input/output (I/O) port configured to receive a digital radiometer signal and a digital thermocouple signal from the ICT;   a second I/O port configured to receive ablative energy from the ablation energy generator; a temperature display; a patient relay in communication with the first I/O port, the second I/O port, and the processor;   a non-transitory computer-readable medium storing operation parameters for the radiometer and for the thermocouple, and further storing instructions for causing the processor to execute the steps of:
 (a) calculating a temperature adjacent to the ICT based on the digital radiometer signal, the digital thermocouple signal, and the operation parameters; 
 (b) causing the temperature display to display the calculated temperature; and 
 (c) closing the patient relay such that the patient relay passes ablative energy received on the second I/O port to the first I/O port; and 
   a temperature control subsystem configured to regulate the power of the ablative energy based on the calculated temperature.   
     
     
         3 . The interface module of  claim 2 , wherein the ablation energy generator comprises a power control, and wherein the temperature control subsystem comprises:
 a processor; a power control interface configured to be operatively coupled to the power control of the ablation energy generator; and a memory storing a setpoint and instructions for causing the processor to execute the steps of:
 (a) comparing the calculated temperature to the setpoint, 
 (b) if the calculated temperature is below the setpoint, increasing the ablation energy power with the power control interface; and 
 (c) if the calculated temperature is above the setpoint, reducing the ablation energy power with the power control interface. 
   
     
     
         4 . The interface module of  claim 3 , wherein the power control of the ablation energy generator comprises a knob, and wherein the power control interface comprises a stepper motor configured to mechanically turn the knob. 
     
     
         5 . The interface module of  claim 3 , wherein the power control interface is configured to allow a clinician to manually adjust the ablation energy power. 
     
     
         6 . The interface module of  claim 2 , further comprising a load relay and a dummy load, and wherein the computer-readable medium further stores a safety cutoff temperature and instructions for causing the processor to execute the steps of:
 (d) comparing the calculated temperature to the safety cutoff temperature while the patient relay is closed; and   (e) if the calculated temperature exceeds the safety cutoff temperature, opening the patient relay and closing the load relay such that the load relay passes ablative energy received on the second I/O port to the dummy load.   
     
     
         7 . The interface module of  claim 2 , wherein the instructions cause the processor to maintain the patient relay in a normally closed state and to open the patient relay upon detection of an unsafe condition. 
     
     
         8 . The interface module of  claim 2 , wherein the computer-readable medium further stores instructions for causing the processor to execute the steps of:
 (d) initially calculating a temperature adjacent to the ICT based on the digital thermocouple and the operation parameters but not the digital radiometer signal;   (e) causing the temperature display to display the initially calculated temperature; and   (f) if the temperature calculated in step (d) is in the range of 35° C. to 39° C. and if the second I/O port is receiving ablative energy from the ablation energy generator, then executing steps (a)-(c).   
     
     
         9 . The interface module of  claim 2 , further comprising a third I/O port configured to receive a signal from an indifferent electrode and a fourth I/O port configured to provide the signal from the indifferent electrode to the ablation energy generator. 
     
     
         10 . The interface module of  claim 2 , wherein the ablative energy is selected from the group consisting of RF energy, microwave energy, cryoablation energy, and high frequency ultrasound energy. 
     
     
         11 . The interface module of  claim 2 , wherein the ablative energy is RF energy. 
     
     
         12 . A method of using an interface module with an ablation energy generator and an integrated catheter tip (ICT), the ICT including a radiometer, an ablative tip, and a thermocouple, the method of using the interface module comprising the steps of:
 (a) receiving at a first I/O port of the interface module a digital radiometer signal and a digital thermocouple signal from the ICT;   (b) receiving at a second I/O port of the interface module ablative energy from the ablation energy generator;   (c) calculating at the interface module a temperature adjacent to the ICT based on the digital radiometer signal, the digital thermocouple signal, and the operation parameters;   (d) displaying on a temperature display of the interface module the calculated temperature;   (e) passing ablative energy received on the second I/O port to the first I/O port by closing a patient relay of the ablation module; and   (f) automatically regulating the power of the ablative energy based on the calculated temperature.   
     
     
         13 . The method of  claim 12 , wherein the ablation energy generator comprises a power control, the method further comprising the steps of:
 (g) operatively coupling a power control interface to the power control of the ablation energy generator;   (h) storing a setpoint;   (i) comparing the calculated temperature to the setpoint;   (j) if the calculated temperature is below the setpoint, increasing the ablation energy power with the power control interface; and   (k) if the calculated temperature is above the setpoint, reducing the ablation energy power with the power control interface.   
     
     
         14 . The method of  claim 12 , wherein the power control of the ablation energy generator comprises a knob, wherein the power control interface comprises a stepper motor, and wherein steps (j) and (k) comprise mechanically turning the knob with a stepper motor. 
     
     
         15 . The method of  claim 12 , wherein the power control interface is configured to allow a clinician to manually adjust the ablation energy power. 
     
     
         16 . The method of  claim 12 , further comprising the steps of:
 (g) storing at the interface module a safety cutoff temperature;   (h) at the interface module, comparing the calculated temperature to the safety cutoff temperature while the patient relay is closed; and   (i) if the calculated temperature exceeds the safety cutoff temperature, opening the patient relay and closing a load relay of the ablation module such that the load relay passes ablative energy received on the second I/O port to a dummy load of the ablation module.   
     
     
         17 . The method of  claim 12 , wherein the patient relay is maintained in a normally closed state and opened upon detection of an unsafe condition. 
     
     
         18 . The method of  claim 12 , further comprising the steps of:
 (g) initially calculating at the interface module a temperature adjacent to the ICT based on the digital thermocouple and the operation parameters but not the digital radiometer signal;   (h) displaying on the temperature display the initially calculated temperature; and   (i) if the temperature calculated in step (f) is in the range of 35° C. to 39° C. and if the second I/O port is receiving ablative energy from the ablation energy generator, then performing steps (c)-(e).   
     
     
         19 . The method of  claim 12 , further comprising the steps of:
 (f) receiving at a third I/O port of the ablation energy generator a signal from an indifferent electrode; and   (g) providing at a fourth I/O port the signal from the indifferent electrode to the ablation energy generator.   
     
     
         20 . The method of  claim 12 , wherein the ablative energy is selected from the group consisting of RF energy, microwave energy, cryoablation energy, and high frequency ultrasound energy. 
     
     
         21 . The method of  claim 12 , wherein the ablative energy is RF energy.