Systems and methods for monitoring and controlling use of medical devices

Abstract

A device carries an use monitoring element that possesses a state or condition that changes in response to use of the device and that is sensed when the device is presented for use. Reuse of the device is not permitted, if the use monitoring element indicates a prior use.

We claim:  
     
         1 . A system for treating a tissue region comprising 
 a device including a usage regulating mechanism having a logic state being operable to be set to either a logic state of one or a logic state of zero, and    a reader to sense the logic state and enabling operation of the device if the sensed logic state is a pre-established one of the logic state of one and the logic state of zero, the reader further operating, in response to enabling operation of the device, to change the sensed logic state to the other one of the logic state of one and the logic state of zero to prevent subsequent operation of the device.    
     
     
         2 . A system as in  claim 1   wherein the usage regulating mechanism is a magnetic core.    
     
     
         3 . A system as in  claim 1   wherein the use regulating mechanism is a latching relay.    
     
     
         4 . A system as in  claim 3   wherein the latching relay includes a switch arm operable to be set to a first position corresponding to a logic state of one or a second position corresponding to a logic state of zero.    
     
     
         5 . A system as in  claim 1   wherein the device is adapted to apply radio frequency energy to the tissue region.    
     
     
         6 . A system for treating a tissue region comprising 
 a controller, and    a device including a use register that senses time-of-use of the device and inputs the time-of-use to the controller,    the controller including a processing function for processing the time-of-use to enable operation of the device if the time-of-use is less than a prescribed maximum time period and to disable operation of the device if the time-of-use equals or exceeds the prescribed maximum time period.    
     
     
         7 . A system as in  claim 6   wherein the use register comprises an array of magnetic cores.    
     
     
         8 . A system as in  claim 6   wherein the use register comprises a magnetic strip.    
     
     
         9 . A system as in  claim 6   wherein the use register comprises a stepper motor.    
     
     
         10 . A system as in  claim 6   wherein the use register comprises a RFID tag element.    
     
     
         11 . A system as in  claim 6   wherein the device is adapted to apply radio frequency energy to the tissue region.