System of implantable devices for monitoring and/or affecting body parameters

Abstract

A system for monitoring and/or affecting parameters of a patient's body and more particularly to such a system comprised of a system control unit (SCU) and one or more other devices, preferably battery-powered, implanted in the patient's body, i.e., within the envelope defined by the patient's skin. Each such implanted device is configured to be monitored and/or controlled by the SCU via a wireless communication channel. In accordance with the invention, the SCU comprises a programmable unit capable of (1) transmitting commands to at least some of a plurality of implanted devices and (2) receiving data signal from at least some of those implanted devices. In accordance with a preferred embodiment, the system operates in closed loop fashion whereby the commands transmitted by the SCU are dependent, in part, on the content of the data signals received by the SCU. In accordance with the invention, a preferred SCU is similarly implemented as a device capable of being implanted beneath a patient's skin, preferably having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm. Wireless communication between the SCU and the implanted devices is preferably implemented via a modulated sound signal, AC magnetic field, RF signal, or electric conduction.

We claim:  
     
         1 . A system for monitoring and/or affecting at least one parameter of a patient's body, said system comprising: 
 at least one implantable device operable to sense and/or stimulate a patient's body parameter in accordance with one or more controllable operating parameters; and    a system control unit for controlling said controllable operating parameters, said system control unit comprising: 
 a sealed elongate housing configured for implantation in a patient's body;  
 a signal transmitter in said housing for transmitting command signals;  
 a signal receiver in said housing for receiving status signals; and  
 a programmable controller in said housing responsive to received status signals for producing command signals for transmission by said signal transmitter to said implantable devices.  
   
     
     
         2 . The system of  claim 1  wherein said sealed housing has an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm suitable for injection into the patient's body.  
     
     
         3 . The system of claim A 1  comprising at least one said implantable device operable as a sensor and at least one said implantable operable as a stimulator and wherein said controller is responsive to status data signals received from said sensor for generating said addressable command data signals to said stimulator to perform closed loop control of the operation of said stimulator.  
     
     
         4 . The system of  claim 1  wherein said system control unit additionally comprises a power source contained within said sealed housing for providing operating power to said data signal transmitter, said data signal receiver, and said programmable controller.  
     
     
         5 . The system of  claim 1  wherein said signal receiver includes a coil responsive to status signals defined by a modulated magnetic field.  
     
     
         6 . The system of  claim 1  wherein said signal receiver includes a transducer responsible to status signals defined by a modulated ultrasonic signal.  
     
     
         7 . The system of  claim 1  wherein said signal transmitter includes means for transmitting command signals in the form of a modulated magnetic field.  
     
     
         8 . The system of  claim 1  wherein said signal transmitter includes means for transmitting command signals in the form of a modulated ultrasonic signal.  
     
     
         9 . The system of  claim 1  wherein said system control unit additionally includes: 
 at least one electrode;  
 sensor/stimulator circuitry; and wherein  
 said sensor stimulator circuitry is configurable to generate a data signal representative of an electrical signal conducted by said electrode and/or supply a sequence of drive pulses to said electrode.  
 
     
     
         10 . The system of  claim 1  wherein each of said implantable devices includes a power source having a capacity of at least 1 microwatt-hour.  
     
     
         11 . The system of  claim 10  wherein each said implantable device includes means for monitoring status of its power source and said system control unit is configured to transmit command signals to each said implantable device and to responsively receive status signals corresponding to said power source status.  
     
     
         12 . The system of  claim 1  further including: 
 program storage means in said housing for specifying the operation of said programmable controller; and  
 means to modify said program storage means in response to signals received by said signal receiver.  
 
     
     
         13 . The system or  claim 12  wherein said program storage means includes means to cause said system control unit to transmit a programmable list of command signals to said implantable devices.  
     
     
         14 . The system of  claim 13  wherein said means to cause said system control unit to transmit a programmable list of command signals includes: 
 a magnetic sensor for generating a signal responsive to a DC magnetic field; and wherein  
 said programmable list of command signals is transmitted in response to said magnetic sensor signal.  
 
     
     
         15 . A system control unit configured for implantation in a patient's body for controlling/monitoring the operation of one or more other implantable addressable devices, said system control unit comprising: 
 a sealed elongate housing;    a data signal transmitter for wireless transmission of command data signals;    a data signal receiver for wireless reception of status data signals;    a controller capable of accepting status data signals from said data signal receiver and sending addressable command data signals to said data signal transmitter in response thereto to control and/or monitor the operation of one or more other implantable devices in accordance with one or more controllable operating parameters;    program storage means for specifying the operation of said controller; and wherein    said data signal transmitter, data signal receiver, said controller, and said program storage means are disposed within said sealed housing.    
     
     
         16 . The system control unit of  claim 15  wherein said sealed housing has an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm suitable for injection into the patient's body.  
     
     
         17 . The system control unit of  claim 15  additionally comprising a power source contained within said sealed housing for providing operating power to said data signal transmitter, said data signal receiver, said controller, and said program storage means.  
     
     
         18 . The system control unit of  claim 15  wherein said data signal receiver includes a coil responsive to a status data signal defined by a modulated magnetic field.  
     
     
         19 . The system control unit of  claim 15  wherein said data signal receiver includes a transducer responsive to a status data signal defined by a modulated ultrasonic signal.  
     
     
         20 . The system control unit of  claim 15  wherein said transmitter includes means for transmitting a command data signal in the form of a modulated magnetic field.  
     
     
         21 . The system control unit of  claim 15  wherein said transmitter includes means for transmitting a command data signal in the form of a modulated ultrasonic signal.  
     
     
         22 . The system control unit of  claim 15  further including means to modify said program storage means in response to signals received by said data signal receiver.  
     
     
         23 . The system control unit of  claim 15  additionally including: 
 at least one electrode;  
 sensor/stimulator circuitry; and wherein  
 said sensor stimulator circuitry is configurable to generate a data signal representative of an electrical signal conducted by said electrode and/or supply a sequence of drive pulses to said electrode.  
 
     
     
         24 . A system for monitoring and/or affecting at least one parameter of a patient's body, said system comprising: 
 a system control unit positioned outside of the patient's body comprising: 
 means for providing wireless transmission of command data signals;  
 means for providing wireless reception of status data signals; and  
 means capable of accepting status data signals from said data signal receiver and sending addressable command data signals to said data signal transmitter in response thereto to control and/or monitor the operation of one or more implantable devices; and  
   at least one addressable device configured for implantation in a patient's body responsive to said command data signals, said implantable devices selected from one or more of the following groups: 
 stimulators having at least one electrode configured to produce an electrical current for stimulating body tissue to affect a parameter of the patient's body; and  
 sensors having at least one electrode configured to produce a data signal corresponding to an electrical signal conducted by said electrode and representative of a parameter of the patient's body; and wherein  
   each of said implantable devices includes a power source having a power capacity of at least 1 microwatt-hour.    
     
     
         25 . The system of  claim 24  wherein said implantable devices include: 
 at least one stimulator and at least one sensor; and wherein  
 said system control unit is responsive to status data signals received from said sensor for generating said addressable command data signals to said stimulator to perform closed loop control of the operation of said stimulator.  
 
     
     
         26 . The system of  claim 24  wherein said groups of implantable devices further include transponders for transmitting a data signal related to a command signal received by said transponder.  
     
     
         27 . The system of  claim 24  wherein said implantable devices include: 
 at least one stimulator, at least one sensor and at least one transponder; and wherein  
 said system control unit is responsive to status data signals received from said sensor for generating said addressable command data signals to said stimulator to perform closed loop control of the operation of said stimulator.  
 
     
     
         28 . The system of  claim 27  wherein said status data signal received from said sensor is received via said transponder.  
     
     
         29 . The system of  claim 27  wherein said stimulator is responsive to said command data signals received via said transponder.  
     
     
         30 . The system of  claim 24  wherein said wireless reception means includes a coil responsive to a status data signal defined by a modulated magnetic field.  
     
     
         31 . The system of  claim 24  wherein said wireless reception means includes a transducer responsive to a status data signal defined by a modulated ultrasonic signal.  
     
     
         32 . The system of  claim 24  wherein said wireless transmission means includes means for transmitting a command data signal in the form of a modulated magnetic field.  
     
     
         33 . The system of  claim 24  wherein said wireless transmission means includes means for transmitting a command data signal in the form of a modulated ultrasonic signal.