Patient interactive neurostimulation system and method

• US 6,654,642 B2
• Filed: 12/11/2000
• Issued: 11/25/2003
• Est. Priority Date: 09/29/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sieracki, Jeffrey Mark, North, Richard Boydston, Holland, Lon Hodges, Fowler, Kim Randal
• Primary Examiner(s): PASCHALL, MARK H
• Application Number:
  US09/732,759
• Publication Number:
  US 20010007950A1
• Time in Patent Office: 1,079 Days
• Field of Search: 607/43-46, 607/48, 607/55-59, 607/63, 607/64, 607/117, 607/118, 607/137
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

A fully automated computer controlled system is provided for adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction which includes a patient interactive computer, and a universal transmitter interface integrally embedded in the patient interactive computer or built into the antenna which is capable of stimulating any type of implanted neurostimulation devices by imitating programming codes. The patient interacts with the system through the patient interactive computer. The universal transmitter interface includes a direct digital synthesizer, a transistor circuitry driving the antenna in ON-OFF fashion and a gating unit for driving the transistor circuitry under control of the processing means in the patient-interactive computer. Alternatively, the universal transmitting interface includes a balanced modulator for modulation of the carrier signal generated at the direct digital synthesizer.

Claims

1. A patient-interactive neurostimulation system, comprising:

a plurality of neurological stimulator devices implanted in the body of a patient, said neurological stimulator devices being adapted for receiving a specific one of a plurality of predetermined programming codes and responding thereto to provide electrical stimulation to nervous tissue according to said specific one predetermined programming code;

a patient-interactive computer having processing means, said processing means defining which one of said plurality of said specific predetermined programming codes has to be transmitted to said neurological stimulator devices; and

a transmitter interface unit operatively coupled to said patient interactive computer and controlled by said processing means to generate either of said plurality of said predetermined programming codes, and to transmit said specific one predetermined code towards said neurological stimulator devices,

said transmitter interface unit comprising;

a control interface unit communicating with said patient-interactive computer through a communication channel to transmit data defined by said processing means;

a data memory unit adapted to store a plurality of parameters for said plurality of said specific predetermined programming codes, said data memory unit interfacing with said control interface unit and exchanging data therewith;

a direct digital synthesizer interfacing with said control interface unit for receiving data therefrom and outputting a carrier signal in response thereto;

antenna means actuated for transmitting signals corresponding to said predetermined programming codes to said neurological stimulator devices,

transistor circuitry operatively coupled to said antenna means for driving said antenna means in an ON/OFF manner, and

a driving unit interfacing with said direct digital synthesizer for generating gating pulses supplied to said transistor circuitry to drive same in a manner defined by said processing means within said patient-interactive computer.

2. The patient interactive neurostimulation system of claim 1, wherein said transmitter interface unit is integrally embedded within said patient-interactive computer.

3. The patient-interactive neurostimulation system of claim 1, wherein said transmitter interface unit is integrally embedded within said antenna means.

4. The patient-interactive neurostimulation system of claim 1, wherein said direct digital synthesizer includes a digital-to-analog converter outputting an analog carrier signal, and wherein said driving unit includes at least one analog comparator having a pair of inputs and coupled by one input thereof to the output of said digital-to-analog converter and receiving an analog reference signal at another input thereof, an output of said at least one analog comparator being coupled to an input of said transistor circuitry.

5. The patient-interactive neurostimulation system of claim 1, wherein said driving unit includes at least one digital comparator coupled by one input thereof to the output of said direct digital synthesizer to receive a digital carrier signal generated at said direct digital synthesizer, and receiving a digital reference code at another input thereof, an output of said at least one digital comparator being coupled to an input of said transistor circuitry.

6. The patient-interactive neurostimulation system of claim 1, wherein said transistor circuitry includes a tuned tank circuit for generating an RF field.

7. The patient-interactive neurostimulation system of claim 1, wherein said transistor circuitry includes an H-bridge circuit having four transistors each driven independently via a respective input of said H-bridge circuit.

8. The patient-interactive neurostimulation system of claim 1, wherein said transistor circuitry includes an H-bridge circuit having two pairs of transistors, each said pair of the transistors being independently driven through a respective input of said H-bridge circuit.

9. The patient-interactive neurostimulation system of claim 8, wherein said H-bridge circuit further includes a non-inverting buffer amplifier at a first input and an inverting buffer amplifier at a second input of said H-bridge circuit.

10. The patient-interactive neurostimulation system of claim 5, wherein said transistor circuitry comprises a modulator unit coupled to said carrier signal for modulating the same under command of said processing means.

11. The patient-interactive neurostimulation system of claim 10, wherein said modulator unit includes a balanced modulator.

12. The patient-interactive neurostimulation system of claim 10, wherein said direct digital synthesizer includes a phase accumulator interfacing with said control interface unit and a digital-to-analog converter coupled to said phase accumulator, wherein said transmitter interface unit further includes:

a low pass filter coupled between the output of said digital-to-analog converter and a first input of said modulator unit to couple the carrier signal in analog form to said first input of said modulator unit, and

switching means for intermittently connecting a second input of said modulator unit to either said output of said at least one digital comparator and an output of said control interface unit;

wherein said one input of said at least one digital comparator is coupled to the output of said phase accumulator, and wherein said another input of said at least one digital comparator is coupled to said control interface unit.

13. The patient interactive neurostimulation system of claim 1, wherein said patient interactive computer includes a display means, screen graphics and a screen worded message to the patient corresponding to said screen graphics displayed substantially simultaneously on said display means of said patient-interactive computer, said screen worded message describing to the patient an action expected from the same to operate an indication means.

14. The patient-interactive neurostimulation system of claim 12, wherein said screen graphics includes images of a human'"'"'s body, wherein said screen worded message requests the patient to outline, by means of an indication means, an area of the pain being experienced to be aligned with respective areas of said images of the human'"'"'s body, and

wherein said screen worded message further includes a request to the patient to outline, by means of said indication means, a topography of paresthesias in response to the electrical stimulation by said specific predetermined programming code transmitted by said transmitter interface unit towards said neurological stimulator devices.

15. The patient-interactive neurostimulation system of claim 1, wherein said patient interactive computer includes a pen-top computer.

16. The patient-interactive neurostimulation system of claim 1, further including a physician'"'"'s computer telemetrically communicating with said patient-interactive computer, a plurality of optimization protocols being stored in said physician'"'"'s computer, each of said optimization protocols for defining a predetermined optimization session.

17. The patient-interactive neurostimulation system of claim 16, wherein data corresponding to responses entered by the patient into said patient-interactive computer are archived in said physician'"'"'s computer.

18. The patient-interactive neurostimulation system of claim 1, further including printing means in communication with said patient interactive computer.

19. The patient-interactive neurostimulation system of claim 1, further including means adapted to provide communication with a remote computer server.