Fitting process for a neural stimulation system

• US 6,609,032 B1
• Filed: 05/17/2002
• Issued: 08/19/2003
• Est. Priority Date: 01/07/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Loeb, Gerald E., Woods, Carla Mann, Meadows, Paul M., Peterson, David K. L.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US10/150,679
• Time in Patent Office: 459 Days
• Field of Search: 607/2, 607/43, 607/46, 607/54, 607/59, 607/66, 607/148
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A programming system and method for use with an implantable tissue stimulator allows a clinician or patient to quickly determine a desired electrode stimulation pattern, including which electrodes of a multiplicity of electrodes in 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 a directional 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. A software wizard provides a software user interface, including the use of easy-to-understand instructional, data-gathering and/or parameter-setting screens, that walks a user step by step through the programming process.

Claims

1. A user interface for fitting a neural stimulation system to a particular user, wherein the neural stimulation system includes a multiplicity of implantable electrodes adapted to contact body tissue that is to be stimulated, and an implantable pulse generator connected to each of the multiplicity of electrodes having means for selectively activating a plurality of the implantable electrodes so that a stimulus current may be applied to the body tissue through selected electrodes, wherein the user interface comprises:

processing means for displaying a series of screens in a wizard process that guides a user of the neural stimulation system through each step of a fitting process;

means for prompting the user through at least one of the displayed screens to select a stimulation channel;

means for prompting the user through at least one of the displayed screens to select an area of the body tissue where pain is felt;

means for determining threshold measurements for stimulus current applied through a first selected plurality of implantable electrodes located in or near the area of body tissue where pain is felt;

means for manipulating the location where the stimulus current is applied to the body tissue;

means for selecting stimulation parameters associated with the stimulus current, said stimulation parameters being selected from the group comprising pulse width and pulse rate;

means for displaying on at least one of the displayed screens a representation of a patient figure;

means for defining on the displayed patient figure where the stimulus sensation is felt; and

means for saving the stimulus parameters and associated activated electrodes for the selected channel so that the stimulus current can subsequently be reapplied to the body tissue as desired by the user.

2. The user interface of claim 1 further including means for determining threshold measurements for stimulus current applied through a second selected plurality of implantable electrodes located in or near the area of body tissue where pain is felt.

3. The user interface of claim 2 further comprising means within the processing means for estimating threshold measurements for stimulus current applied through other selected pluralities of implantable electrodes located in or near the area of body tissue where pain is felt based on the threshold measurements determined for the first and second plurality of implantable electrodes.

4. The user interface of claim 3 wherein the means for estimating threshold measurements includes an interpolation technique.

5. The user interface of claim 1 further comprising means within the processing means for estimating threshold measurements for stimulus current applied through at least one other selected plurality of implantable electrodes located in or near the area of body tissue where pain is felt based on the threshold measurements determined for the first plurality of implantable electrodes.

6. The user interface of claim 1 wherein the means for determining threshold measurements comprises means for determining a perception threshold level and a maximum comfortable threshold level for each selected plurality of implantable electrodes through which a stimulus current is applied.

7. The user interface of claim 6 wherein the means for determining threshold measurements includes means for prompting the user through at least one of the displayed screens to increase the stimulus current level until an indicated threshold is reached.

8. The user interface of claim 7 wherein the at least one displayed screen that prompts the user to increase the stimulus current level includes a graphical representation of the stimulus current level.

9. A user interface adapted for fitting a neural stimulation system to a patient, comprising:

processing means including memory means and user input/output means;

display means for displaying at least one informational screen that provides information regarding the status of a fitting process, wherein the at least one informational screen provides a graphical representation of a fitting path the patient must follow to achieve a successful fitting of the neural stimulation system.

10. The user interface of claim 9 wherein the informational screen is displayed to appear as a treasure map, with a treasure being located at end of the fitting path.

11. The user interface of claim 10 wherein the processing means includes means for printing the treasure map.

12. A method for fitting a neural stimulation system to a patient, the neural stimulation system including a multiplicity of implantable electrodes adapted to contact body tissue that is to be stimulated, and an implantable pulse generator connected to each of the multiplicity of electrodes having means for selectively activating a plurality of the implantable electrodes so that a stimulus current may be applied to the body tissue through selected electrodes, the fitting method comprising:

prompting the user to select an area of the body tissue where pain is felt;

determining and recording threshold measurements for stimulus current applied through a first selected plurality of implantable electrodes located in or near the area of body tissue where pain is felt;

manipulating the location where the stimulus current is applied to the body tissue;

selecting and recording stimulation parameters associated with the stimulus current, said stimulation parameters being selected from the group comprising pulse width and pulse rate;

displaying a representation of a patient figure;

defining an area on the displayed patient figure where the stimulus sensation is felt; and

recording the stimulus parameters and associated activated electrodes so that stimulus current having the recorded stimulation parameters can subsequently be reapplied to the body tissue in the area where pain is felt.

13. The fitting method of claim 12 wherein determining and recording threshold measurements includes determining and recording a perception threshold level and a maximum comfortable threshold level for each selected plurality of implantable electrodes through which a stimulus current is applied.

14. The fitting method of claim 12 further including determining and recording threshold measurements for stimulus current applied through a second selected plurality of implantable electrodes located in or near the area of body tissue where pain is felt.

15. The fitting method of claim 14 further comprising estimating threshold measurements for stimulus current applied through other selected pluralities of implantable electrodes located in or near the area of body tissue where pain is felt based on the threshold measurements determined for the first and second plurality of implantable electrodes.

16. The fitting method of claim 15 wherein estimating threshold measurements for other selected pluralities of implantable electrodes comprises interpolating threshold measurements based on the threshold measurements determined for the first and second plurality of implantable electrodes.

17. A neural stimulation system comprising:

a multiplicity of implantable electrodes adapted to contact body tissue that is to be stimulated;

an implantable pulse generator connected to each of the multiplicity of electrodes;

means within the implantable pulse generator for selectively activating a plurality of the implantable electrodes so that a stimulus current may be applied to the body tissue through selected electrodes;

an external processor adapted to be coupled to the implantable pulse generator, the external processor including memory means, input/output (I/O) means, and display means; and

a software architecture configured within the memory means that includes a core program comprising;

a main section that invokes a main operating program wherein the underlying programs that control the operation of the neural stimulation system reside, and

a navigator section that invokes a navigator wizard program wherein setup programs reside to aid in the initial set up of the neural stimulation device.

18. The neural stimulation system of claim 17 wherein the navigator wizard program includes means for generating and displaying a series of screens on the display means that guide a user step by step through a data collection, measurement and programming process.

19. The neural stimulation system of claim 18 wherein one of the screens generated by the navigator wizard program provides a depiction of a human body, and wherein the neural stimulation system further includes means for identifying an area on the depicted human body where pain is felt.

20. The neural stimulation system of claim 19 including means responsive to the means for identifying a pain area for initially activating electrodes which are, as a first attempt, those electrodes adapted to treat the pain area identified.

21. The neural stimulation system of claim 20 further including means for prompting the user to increase the stimulus current level applied through the activated electrodes in order to measure and record a prescribed threshold.

22. The neural stimulation system of claim 21 wherein said prescribed threshold is selected from the group comprising a stimulation perception level threshold and a maximum comfortable level threshold.

23. The neural stimulation system of claim 20 further including:

manipulation means for moving the area where the stimulus current is applied to the body tissue through various configurations of activated electrodes; and

means for selecting and recording a particular activated electrode configuration where the stimulus current is most effective at treating the pain felt by the patient.

24. The neural stimulation system of claim 23 further including means for allowing the user to select which of plural activated electrode configurations provide a stimulus current that is most effective at treating the pain felt by the patient.

25. The neural stimulation system of claim 20 further including means for prompting the user to select stimulation parameter settings associated with the stimulus current, said stimulation parameter settings being selected from the group comprising pulse width, pulse rate and pulse amplitude.

26. The neural stimulation system of claim 25 further including means for allowing the user to select which of plural stimulation parameter settings is most effective at treating the pain felt by the patient.

27. The neural stimulation system of claim 18 wherein one of the screens generated by the navigator wizard program provides a depiction of a human body, and wherein the neural stimulation system further includes means for prompting a user to identify an area on the depicted human body where stimulation is felt.