Integration of control software with a medical device and system

Abstract

A medical device for diagnosis or treatment of tissue is disclosed. The device includes an electronically-controlled tool configured for diagnosis or treatment, an electrical connector, and a computer readable memory. The electrical connector is configured for connection with an electronic control unit and configured to receive control signals, including signals concerning the operation of the tool, from the electronic control unit. The computer readable memory is accessible through the connector. The memory can include a set of programming instructions for control of the tool, and the programming instructions can be configured to be downloadable from the memory upon connection of the electrical connector with the electronic control unit. A system is also disclosed in which the electronic control unit is configured to transmit a data log from memory in the electronic control unit to the memory in the medical device upon the occurrence or detection of a predetermined event.

1 . (canceled) 
     
     
         2 . A method of operating a medical device, comprising:
 providing a medical system including an electronic control unit having a computer readable memory and a detachable medical device having a computer readable memory including a set of operating instructions for the medical device;   connecting the detachable medical device to the electronic control unit;   copying the set of operating instructions for the medical device from the computer readable memory of the medical device into the computer readable memory of the electronic control unit; and   delivering control signals from the electronic control unit to the medical device according to the operating instructions for the medical device copied into the computer readable memory of the electronic control unit.   
     
     
         3 . The method according to  claim 2 , further comprising:
 disconnecting the detachable medical device from the electronic control unit; and   installing a revised set of operating instructions for the medical device into the computer readable memory of the medical device after disconnecting the detachable medical device from the control unit.   
     
     
         4 . The method according to  claim 2 , wherein the operating instructions for the medical device comprise at least one of instructions to operate the medical device in an ablation mode and instructions to operate the medical device in a diagnostic mode. 
     
     
         5 . The method according to  claim 2 , further comprising transferring data from the electronic control unit to the computer readable memory of the medical device while delivering control signals from the electronic control unit to the medical device. 
     
     
         6 . The method according to  claim 5 , wherein the data transferred from the electronic control unit to the compute readable memory of the medical device comprises data regarding at least one of a fault detected by the medical system and an FDA reportable event detected by the medical system. 
     
     
         7 . The method according to  claim 6 , wherein the step of transferring data from the electronic control unit to the computer readable memory of the medical device is automatically initiated upon the medical system detecting the at least one of the fault and the FDA reportable event. 
     
     
         8 . The method according to  claim 5 , wherein the step of transferring data from the electronic control unit to the computer readable memory of the medical device is user-initiated. 
     
     
         9 . A method of operating a medical system, the medical system including an electronic control unit having a computer readable memory and a detachable medical device having a computer readable memory including a set of operating instructions stored therein, the method comprising:
 copying the set of operating instructions from the computer readable memory of the detachable medical device to the computer readable memory of the electronic control unit upon connection of the detachable medical device to the electronic control unit; and   delivering control signals from the electronic control unit to the detachable medical device according to the operating instructions copied to the computer readable memory of the electronic control unit.   
     
     
         10 . The method according to  claim 9 , further comprising transferring data from the electronic control unit to the computer readable memory of the medical device while delivering control signals from the electronic control unit to the detachable medical device. 
     
     
         11 . The method according to  claim 10 , wherein the data transferred from the electronic control unit to the computer readable memory of the medical device comprises data regarding at least one of a fault detected by the medical system and an FDA reportable event detected by the medical system. 
     
     
         12 . The method according to  claim 11 , wherein the step of transferring data from the electronic control unit to the computer readable memory of the medical device is automatically initiated upon the medical system detecting the at least one of the fault and the FDA reportable event. 
     
     
         13 . The method according to  claim 10 , wherein the step of transferring data from the electronic control unit to the computer readable memory of the medical device is user-initiated. 
     
     
         14 . The method according to  claim 9 , wherein the medical device comprises an ablation catheter. 
     
     
         15 . The method according to  claim 9 , wherein the operating instructions for the medical device comprise at least one of instructions to operate the medical device in an ablation mode and instructions to operate the medical device in a diagnostic mode. 
     
     
         16 . A method of generating a data log in a medical system including a detachable medical device, the method comprising:
 providing a medical system including an electronic control unit having a computer readable memory and a detachable medical device having a computer readable memory;   with the detachable medical device connected to the electronic control unit, delivering control signals from the electronic control unit to the detachable medical device according to a set of operating instructions for the detachable medical device stored in the computer readable memory of the electronic control unit; and   transferring data from the electronic control unit to the computer readable memory of the detachable medical device while delivering control signals from the electronic control unit to the detachable medical device.   
     
     
         17 . The method according to  claim 16 , wherein the data transferred from the electronic control unit to the computer readable memory of the detachable medical device comprises data regarding at least one of a fault detected by the medical system and an FDA reportable event detected by the medical system. 
     
     
         18 . The method according to  claim 17 , wherein the step of transferring data from the electronic control unit to the computer readable memory of the medical device is automatically initiated upon the medical system detecting the at least one of the fault and the FDA reportable event. 
     
     
         19 . The method according to  claim 16 , wherein the step of transferring data from the electronic control unit to the computer readable memory of the medical device is user-initiated. 
     
     
         20 . The method according to  claim 16 , further comprising transferring the set of operating instructions for the detachable medical device from the computer readable memory of the detachable medical device to the computer readable memory of the electronic control unit upon connection of the detachable medical device to the electronic control unit.