Implantable pulse generator systems and methods for providing functional and /or therapeutic stimulation of muscles and/or nerves and/or central nervous system tissue

Abstract

Improved assemblies, systems, and methods provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation systems and methods include an implantable pulse generator adapted for wireless telemetry and having a unique signature to enable secure communications. An external controller includes circuitry adapted for wireless telemetry. The secure communications includes at least a first communication from the external controller to the pulse generator. The first communication includes the pulse generator's unique signature. A response communication from the pulse generator to the external controller includes data elements that indicate the response communication is a response, and not a command from an external controller.

1 . A secure wireless telemetry communication system comprising: 
 a pulse generator adapted for implantation in a body in subcutaneous tissue, the pulse generator including circuitry enabled for transcutanous real-time wireless telemetry with an external controller, the pulse generator also including a unique signature to enable secure communications,    wherein the external controller is enabled for transcutaneous real-time wireless telemetry with the pulse generator, the external controller being adapted to perform secure communications using wireless telemetry, the secure communications adapted to confirm there is no wireless telemetry interference with one or more additional wireless telemetry links between one or more additional external controllers and one or more additional implanted pulse generators, the external controller being preconfigured with the unique signature of the pulse generator, and    wherein the secure communications includes at least a first communication from the external controller to the pulse generator, the first communication including the pulse generator's unique signature, and a response communication from the pulse generator to the external controller, the response communication including data elements that indicate the response communication is a response, and not a command from an external controller.    
     
     
         2 . The communication system according to  claim 1   wherein the unique signature included in communications from the external controller limits the wireless telemetry to between only the preconfigured external controllers configured with the unique signature and the pulse generator having the matching unique signature.    
     
     
         3 . The communication system according to  claim 1   wherein the secure communications between the external controller and the pulse generator is operational within arm's reach of the patient having the implanted pulse generator.    
     
     
         4 . The communication system according to  claim 1   wherein the pulse generator is adapted to be implanted in subcutaneous tissue at an implant depth of between about five millimeters and about twenty millimeters.    
     
     
         5 . The communication system according to  claim 1   wherein the real-time wireless telemetry communication is at a radio frequency in the range of about 402 MHz to about 405 MHz.    
     
     
         6 . The communication system according to  claim 1   wherein the pulse generator circuitry includes a transceiver chip, the transceiver chip adapted to be off about 99 percent or more of the time and is pulsed on periodically to listen for commands from the external controller.    
     
     
         7 . The communication system according to  claim 1   wherein the unique signature is stored in non-volatile memory, the non-volatile memory being coupled to the circuitry.    
     
     
         8 . The communication system according to  claim 1   wherein the pulse generator circuitry further includes a microcontroller, the microcontroller configured to generate a serial data stream, the serial data stream being converted by the pulse generator circuitry into a pulsing carrier signal during a transmit process, and the pulse generator circuitry configured to convert a varying radio frequency signal strength into a serial data stream during a receive process.    
     
     
         9 . The communication system according to  claim 1   wherein the pulse generator comprises a thickness of between about 5 mm and 15 mm, a width of between about 30 mm and 60 mm, and a length of between about 45 mm and 60 mm.    
     
     
         10 . A method of establishing secure wireless telemetry communication between an external controller and an implanted pulse generator comprising: 
 providing a pulse generator adapted for implantation in a body in subcutaneous tissue, the pulse generator including circuitry enabled for transcutanous real-time wireless telemetry with an external controller, the pulse generator also including a unique signature to enable secure communications,    providing an external controller enabled for transcutaneous real-time wireless telemetry with the pulse generator, the external controller being adapted to perform secure communications using wireless telemetry, the secure communications adapted to confirm there is no wireless telemetry interference with one or more additional wireless telemetry links between one or more additional external controllers and one or more additional implanted pulse generators,    configuring the external controller with the unique signature of the pulse generator,    initiating at least a first wireless telemetry communication from the external controller to the pulse generator, the first communication including the pulse generator's unique signature, and    initiating a response wireless telemetry communication from the pulse generator to the external controller, the response communication including data elements that indicate the response communication is a response, and not a command from an external controller.    
     
     
         11 . A method according to  claim 10   wherein the secure wireless telemetry communication is at a radio frequency in the range of about 402 MHz to about 405 MHz.    
     
     
         12 . A method according to  claim 10   wherein the unique signature is stored in non-volatile memory, the non-volatile memory being coupled to the circuitry.    
     
     
         13 . A method according to  claim 10   wherein the pulse generator comprises a thickness of between about 5 mm and 15 mm, a width of between about 30 mm and 60 mm, and a length of between about 45 mm and 60 mm.