Implantable growth tissue stimulator and method operation

• US 5,565,005 A
• Filed: 02/17/1993
• Issued: 10/15/1996
• Est. Priority Date: 02/20/1992
• Status: Expired due to Term

• Current Assignee: AMER Technology Limited (AMER International Group Company Limited)
• Original Assignee: AMER Technology Limited (AMER International Group Company Limited)
• Inventors: Brosche, William C., Turi, Greg, Pilla, Arthur A., Erickson, John H., Varrichio, Anthony J., Tepper, John C., Thacker, Ike C., Bettin, Mark A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/018,944
• Time in Patent Office: 1,336 Days
• Field of Search: 607/9, 607/32, 607/50, 607/51, 128/903
• US Class Current: 607/51
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A hand-held programmer/monitor (500) for programming and monitoring an implantable tissue growth stimulator (10) is provided. The stimulator (10) includes circuitry (46) for implementing selected operations in response to a down-link signal transmitted by the programmer/monitor (500). The stimulator (10) also includes circuitry (46) for transmitting up-link signals to the programmer/monitor (500). The programmer/monitor (500) includes a control circuit (518) for generating the down-link signal. The control circuit (518) also processes the up-link signal to monitor the status of the implantable tissue growth stimulator (10). The programmer/monitor (500) also includes a transmit/receive circuit (514) for transmitting the down-link signal to and for receiving the up-link signal from the implantable tissue growth stimulator (10). The transmit/receive circuit (514) also couples the up-link signal to the control circuit (518).

Claims

1. A remote unit for controlling and monitoring an implantable tissue growth stimulator via a two-way wireless communications protocol, the remote unit comprising:

a control circuit having means for generating a down-link message to be transmitted to the stimulator and for decoding an up-link message from the stimulator; and

a transmit/receive circuit coupled to and in communication with said control circuit;

said transmit/receive circuit having a pulse generator coupled to receive said down-link message from said control circuit;

said transmit/receive circuit further including a transmit coil coupled to an output of said pulse generator having means for transmitting said down-link message to the stimulator;

said transmit/receive circuit further including a receive coil for receiving said up-link message from the stimulator; and

a power circuit, coupled to and in communication with said control circuit and said transmit/receive circuit, said power circuit having means for powering down the remote unit when a down-link message is not generated for a predetermined period of time.

2. The remote unit of claim 1 further comprising a display, coupled to and in communication with said control circuit, for displaying a status of the stimulator, decoded from said up-link message, in response to a display signal from said control circuit.

3. The remote unit of claim 1 further comprising:

an input device, coupled to and in communication with said control circuit, having means for providing data to said control circuit; and

wherein said control circuit generates said down-link message in response to said data.

4. The remote unit of claim 3, said control circuit further comprising means for generating a disable Signal so as to disable the receive coil when the remote unit is transmitting said down-link message.

5. The remote unit of claim 3 further comprising:

a display, coupled to and in communication with said control circuit, having means for displaying a plurality of data choices; and

wherein said input device is activated to select said data from said data choices.

6. The remote unit of claim 1 wherein said control circuit comprises:

a processor having means for executing an interactive program for generating said down-link message and for decoding said up-link message; and

a memory, coupled to and in communication with said processor, having means for storing said interactive program.

7. The remote unit of claim 1 further comprising a data port coupled to said control circuit, said data port having means for providing a communication pathway between said control circuit and an external device.

8. A remote control unit for programming and monitoring an implantable tissue growth stimulator having a status via a two-way wireless communications protocol, the remote control unit comprising:

a processor having means for executing an interactive program for converting a stimulator instruction into a down-link signal in response to choice selection data, for generating at least one choice prompt, and for decoding the status of the stimulator from an up-link signal;

a memory, coupled to and in communication with said processor, having means for storing said interactive program;

a display, coupled to and in communication with said processor, having means for displaying said choice prompt and the status of the stimulator;

an input device, coupled to and in communication with said processor, having means for receiving said choice selection data and providing said choice selection data to said processor; and

a transmit/receive circuit coupled to and in communication with said processor;

said transmit/receive circuit having a pulse generator coupled to receive said down-link signal from said processor, said pulse generator having an output;

said transmit/receive circuit further including a transmit coil coupled to an output of said pulse generator having means for transmitting said down-link signal to the stimulator;

said transmit/receive circuit further including a receive coil for receiving said up-link signal from the stimulator; and

a power circuit, coupled to and in communication with said processor, said memory, said display, said input device and said transmit/receive circuit, said power circuit having means for powering down the remote control unit when said choice selection data is not provided by said input device for a predetermined period of time.

9. The remote control unit of claim 8 said processor further comprising means for generating a disable signal so as to disable the receive coil when the remote control unit is transmitting said down-link signal.

10. The remote control unit of claim 8 wherein said display is divided into first and second portions, said first portion having means for displaying a first choice prompt and said second portion having means for displaying a second choice prompt.

11. The remote control unit of claim 10 wherein said input device comprises a first selector corresponding to said first portion of said display and a second selector corresponding to said second portion of said display, and

wherein said first selector is activated to provide choice selection data indicated by said first choice prompt to said processor and said second selector is activated to provide choice selection data indicated by said second choice prompt to said processor.

12. The remote control unit of claim 8 further comprising:

a housing with a hollow interior having disposed therein said processor, said memory, said display, said input device and said transmit/receive circuit.

13. The remote unit of claim 8 wherein said processor further comprises means for converting said stimulator instruction into said down-link signal, said stimulator instruction for commanding a power circuit disposed within the growth stimulator to provide power to the growth stimulator.

14. The remote unit of claim 8 wherein said processor further comprises means for converting said stimulator instruction into said down-link signal, said stimulator instruction commanding a driver controller disposed within the growth stimulator to set to a predetermined value the amplitude of a waveform generated by the growth stimulator.

15. The remote unit of claim 8 wherein said processor further comprises means for converting said stimulator instruction into said down-link signal, said stimulator instruction commanding a driver controller disposed within the growth stimulator to set to a predetermined value a duty cycle of a waveform generated by the growth stimulator.

16. The remote unit of claim 8 wherein said processor further comprises means for determining from the stimulator status a condition of a battery powering the growth stimulator.

17. The remote unit of claim 8 wherein said processor further comprises means for determining from the stimulator status a impedance between a pair of output leads across which the stimulator generates a waveform.

18. The remote unit of claim 8 wherein said processor further comprises means for determining from the stimulator status whether a power circuit disposed within the growth stimulator is providing power to the growth stimulator.

19. The remote unit of claim 8 wherein said processor further comprises means for determining from the stimulator status a mode in which the growth stimulator is operating.

20. The remote unit of claim 8 wherein said processor further comprises means for determining from the stimulator status a duty cycle of a waveform generated by the growth stimulator.

21. The remote unit of claim 8 wherein said processor further comprises means for determining from the stimulator status a amplitude of a waveform generated by the growth stimulator.

22. The remote unit of claim 8 wherein said processor further comprises means for testing said memory, display, input device and transmit/receive circuit for proper functioning.

23. The remote unit of claim 8 further comprising an audio tone generator, coupled to and in communication with said processor, for generating an audible tone associated with the stimulator status in response to a signal from said processor.

24. A method for programming an implantable tissue growth stimulator and for monitoring a status of the stimulator with a remote control unit via a two-way communication protocol, the method comprising the steps of:

providing data from an input device to a control circuit, said control circuit coupled to said input device;

generating a down-link message in response to said data;

transmitting said down-link message to the stimulator with a transmit coil of a transmit/receive circuit coupled to said control circuit;

receiving an up-link message with a receive coil of said transmit/receive circuit;

providing said received up-link message to said control circuit;

decoding said up-link message with said control circuit; and

powering down the remote control unit when said data is not received from said input device for a predetermined period of time.

25. The method of claim 24 further comprising the steps of:

decoding the status of the growth stimulator from said up-link message with said control circuit;

displaying the stimulator status on a display coupled to said control circuit in response to a signal from said control circuit.

26. The method of claim 24 further comprising the step of disabling said receive coil when said transmit coil transmits a down-link message.

27. The method of claim 24 further comprising the steps of:

displaying a plurality of data choices on a display coupled to said control circuit; and

selecting said data from said data choices with said input device.

28. The method of claim 24 further comprising the steps of:

executing with a processor of said control circuit an interactive program for generating said down-link message and for decoding said up-link message; and

storing said interactive program in a memory coupled to said processor.

29. The method of claim 24 further comprising the step of providing a communication pathway between said control circuit and an external device with a data port circuit coupled to said control circuit.

30. A system for therapeutic stimulation of a tissue site comprising:

an implantable tissue growth stimulator having a status, said stimulator including,

first and second plate electrodes, having first and second voltages respectively, for subcutaneous implantation at a predetermined distance from the tissue site,

a thin elongate member of elastomer for generally maintaining a predetermined distance between said first and second electrodes;

a driver coupled to said first and second plate electrodes having means for generating an alternating current between said first and second electrodes, said alternating current operative to stimulate tissue growth at the tissue site,

a receiver coupled to said driver for receiving a down-link signal, and

a transmitter coupled to said drive having means for transmitting an up-link signal; and

a remote unit for programming and monitoring the stimulator via a two-way communication protocol, the remote unit including,

a control circuit having means for converting a stimulator instruction into said down-link signal and for decoding said status from said up-link signal, and

a transmit/receive circuit, coupled to and in communication with said control circuit, having means for transmitting said down-link to said stimulator and for receiving said up-link from said stimulator.

31. The system of claim 30 wherein said remote unit further comprises a display, coupled to and in communication with said control circuit, having means for displaying said status in response to a display signal from said control circuit.

32. The system of claim 30 wherein said remote unit further comprises:

an input device, coupled to and in communication with said control circuit, having means for providing data to said control circuit; and

wherein said control circuit converts said stimulator instruction into said down-link signal in response to said data.

33. The system of claim 32 wherein said remote unit further comprises:

a display, coupled to and in communication with said control circuit, having means for displaying a plurality of data choices; and

wherein said input device is activated to select said data from said data choices.

34. The system of claim 30 wherein said control circuit comprises:

a processor having means for executing an interactive program for converting said instruction into said down-link signal and for decoding said status from said up-link signal; and

a memory, coupled to and in communication with said processor, having means for storing said interactive program.

35. The system of claim 30 wherein said implantable tissue growth stimulator further comprises:

a decoder, coupled to and in communication with said receiver, having means for decoding said stimulator instruction from said down-link; and

a driver controller, coupled in and in communication with said decoder, having means for adjusting a parameter of said alternating current in response to said stimulator instruction.

36. The system of claim 35 wherein said driver controller further comprises means for adjusting a duty cycle of said alternating current in response to said stimulator instruction.

37. The system of claim 35 wherein said driver controller further comprises means for adjusting a amplitude of said alternating current in response to said stimulator instruction.

38. The system of claim 30 wherein said implantable tissue growth stimulator further comprises a modem circuit, coupled to and in communication with said transmitter, having means for converting said status into said up-link signal.

39. The system of claim 38 wherein said modem circuit further comprises means for converting said status into said up-link signal in response to said down-link signal.