System for normalizing amplitude programming of a tissue stimulator

• US 9,050,473 B2
• Filed: 07/08/2014
• Issued: 06/09/2015
• Est. Priority Date: 01/07/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Woods, Carla Mann, Peterson, David K. L., Meadows, Paul M., Loeb, Gerald E.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/325,924
• Publication Number:
  US 20140324124A1
• Time in Patent Office: 336 Days
• Field of Search: 607/59
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An implantable pulse generator includes a current steering capability that allows a clinician or patient to quickly determine a desired electrode stimulation pattern, including which electrodes of a group of electrodes within an electrode array should receive a stimulation current, including the amplitude, width and pulse repetition rate of such current. Movement of the selected group of electrodes is facilitated through the use of remotely generated directional signals, generated by a pointing device, such as a joystick. As movement of the selected group of electrodes occurs, current redistribution amongst the various electrode contacts takes place. The redistribution of stimulus amplitudes utilizes re-normalization of amplitudes so that the perceptual level remains fairly constant. This prevents the resulting paresthesia from falling below the perceptual threshold or above the comfort threshold.

Claims

1. A programmer for a tissue stimulator coupled to an array of electrodes implanted within a patient, comprising:

a user-controlled input device configured for generating a control signal;

a processor configured for, in response to the control signal, selecting for one of the electrodes an actual stimulation amplitude value from a programmable amplitude range normalized to a perception threshold for the one electrode, and generating a programming signal containing the selected actual stimulation amplitude value; and

a transmitter configured for transmitting the programming signal to the tissue stimulator.

2. The programmer of claim 1, wherein the programmable amplitude range has arbitrary levels respectively correlated to actual stimulation amplitude values from which the actual stimulation amplitude value is selected.

3. The programmer of claim 2, wherein the first arbitrary level is equal to the perception threshold.

4. The programmer of claim 3, wherein the last arbitrary level is equal to a discomfort or pain threshold for the one electrode.

5. The programmer of claim 1, wherein the programmable amplitude range spans a comfort zone for the one electrode.

6. The programmer of claim 1, wherein the actual stimulation amplitude value is a fractionalized electrical current value.

7. The programmer of claim 6, wherein the actual stimulation amplitude is selected in accordance with the equation:

I=F×

P×

X for 0≦

X≧

1;

I=F×

[{(M−

P)/9}×

(X−

1)+P] for X>

1, where

X=Amplitude Level (0-10), 0 level=0 mA;

I=Fractionalized Electrical Current value;

P=Perception Threshold;

mA for the one electrode;

M=Maximum Threshold;

mA for the one electrode;

F=Fractional Stimulation (±

100%), % on the one electrode.

8. The programmer of claim 1, wherein the processor is configured for selecting the actual stimulation amplitude value in accordance with one of a table-based algorithm and a formula-based algorithm.

9. The programmer of claim 1, wherein the user-controlled input device is configured for generating control signals, and the processor is configured for, in response to the control signals, shifting electrical current between the one electrode and another one of the electrodes by selecting actual stimulation amplitude values from the programmable amplitude range for the one electrode, and generating programming signals containing the selected actual stimulation amplitude values, and wherein the transmitter is configured for transmitting the programming signals to the tissue stimulator.

10. The programmer of claim 1, wherein the transmitter is a wireless transmitter.

11. The programmer of claim 1, further comprising a case containing the user-controlled input device, processor, and transmitter.

12. A tissue stimulation system, comprising:

an implantable array of electrodes;

an external programmer configured for receiving user input, selecting for one of the electrodes, in response to the user input, an actual stimulation amplitude value from a programmable amplitude range normalized to a perception threshold for the one electrode, and transmitting a programming signal containing the selected actual stimulation amplitude value; and

a tissue stimulator configured for receiving the programming signal and delivering electrical current to the one electrode in accordance with the programming signal.

13. The tissue stimulation system of claim 12, wherein the programmable amplitude range has arbitrary levels respectively correlated to actual stimulation amplitude values from which the actual stimulation amplitude value is selected.

14. The tissue stimulation system of claim 13, wherein the first arbitrary level is equal to the perception threshold.

15. The tissue stimulation system of claim 14, wherein the last arbitrary level is equal to a discomfort or pain threshold for the one electrode.

16. The tissue stimulation system of claim 13, wherein the programmable amplitude range spans a comfort zone for the one electrode.

17. The tissue stimulation system of claim 13, wherein the actual stimulation amplitude value is a fractionalized electrical current value.

18. The tissue stimulation system of claim 17, wherein the actual stimulation amplitude is selected in accordance with the equation:

I=F×

P×

X for 0≦

X≧

1;

I=F×

[{(M−

P)/9}×

(X−

1)+P] for X>

1, where

X=Amplitude Level (0-10), 0 level=0 mA;

I=Fractionalized Electrical Current value;

P=Perception Threshold;

mA for the one electrode;

M=Maximum Threshold;

mA for the one electrode;

F=Fractional Stimulation (±

100%), % on the one electrode.

19. The tissue stimulation system of claim 13, wherein the external programmer is configured for selecting the actual stimulation amplitude value in accordance with one of a table-based algorithm and a formula-based algorithm.

20. The tissue stimulation system of claim 13, wherein the external programmer is configured for, in response to the user input, shifting electrical current between the one electrode and another one of the electrodes by selecting actual stimulation amplitude values from the programmable amplitude range for the one electrode, and transmitting programming signals containing the selected actual stimulation amplitude values, and wherein the tissue stimulator is configured for receiving the programming signals and delivering electrical current to the one electrode in accordance with the programming signals.