Implantable device programmer

• US 6,622,048 B1
• Filed: 11/21/2000
• Issued: 09/16/2003
• Est. Priority Date: 12/06/1999
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Meadows, Paul M., Mann, Carla M.
• Primary Examiner(s): FOX, JOHN C
• Application Number:
  US09/718,648
• Time in Patent Office: 1,029 Days
• Field of Search: 607/46, 607/59
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A patient and/or a clinician may program an implant device, e.g., an implanted spinal cord stimulator (SCS), through the use of a programming computer, or clinician programmer, linked with the implant device so that the paresthesia resulting from an applied electrical stimulus pattern is adjusted or programmed so as to match the area of perceived pain or other need. Data is initially stored in the computer that relates to known information regarding the anatomical relationships between the spine and the body. The body is divided into dermatomes and/or subdivisions of dermatomes, and a representation of the body, including its dermatomes and/or subdivisions of dermatomes are displayed on the screen (or other display device) associated with the computer. The patient moves a cursor over the regions of the body displayed on the computer screen to select the region of pain, or a region of paresthesia, by a click of a mouse or the press of a button. The patient may select as many dermatomes or body segments/regions/subdivisions as necessary to communicate the area of pain or paresthesia to the computer. The computer uses the patient-provided information, as well as the pre-programmed data therein, to quickly zero in on an electrode combination and appropriate stimulus parameters that create a match (or as close of a match as is possible) between the pain region and the paresthesia region.

Claims

1. A method of programming an implant device, the implant device comprising an implantable pulse generator having an implantable electrode array connected thereto, the implantable pulse generator having electrical circuitry therein that generates electrical stimulation pulses in accordance with programming data, which electrical stimulation pulses are delivered to body tissue of a patient through a selected combination of a multiplicity of electrodes on the electrode array, wherein the programming method comprises:

(a) creating a data base that maps various electrode combinations to paresthesia regions of the body;

(b) storing the data base in a programming computer;

(c) displaying a human figure on a screen of the programming computer, and dividing the human figure into a multiplicity of regions;

(d) selecting at least one region on the displayed human figure where the patient feels pain;

(e) selecting a combination of electrodes and stimulation parameters adapted to produce paresthesia in the same at least one region of pain;

(f) generating stimulation pulses and delivering the stimulation pulses to the selected combination of electrodes through the implantable pulse generator;

(g) identifying at least one region of paresthesia on the displayed human figure where the stimulation pulses generated in step (f) produce paresthesia;

(h) determining the degree of mismatch between the at least one region of paresthesia identified in step (f) and the at least one region of pain selected in step (d);

(i) if the degree of mismatch exceeds a prescribed level, selecting a new combination of electrodes and stimulation parameters including stimulus amplitude and pulsewidth for each independently programmable electrode, in order to steer a stimulus current field, which selecting of electrodes and parameters is based on the identified at least one region of paresthesia and the degree of mismatch, and repeating steps (f), (g) and (h); and

(j) if the degree of mismatch is less than the prescribed level, programming the implantable pulse generator with the programming data that produces the least mismatch.

2. The method of programming set forth in claim 1 wherein steps (c), (e), (f), (h), (i) and (j) are carried out automatically by the programming computer as controlled by an operating program and program data stored in the computer.

3. The method of programming set forth in claim 2 wherein steps (d) and (g) are performed by selecting regions on the displayed human figure by manually moving a computer-generated marker over the region to be selected.

4. The method of programming set forth in claim 3 wherein moving the computer marker is accomplished by at least one of the following:

pressing a key, moving a mouse, moving a track ball, moving a finger over a touch-sensitive screen, moving a light beam, or speaking voice commands.

5. The method of programming set forth in claim 3 wherein step (g) further comprises quantifying the degree of paresthesia that is felt in the identified region of the displayed human figure.

6. A system for programming an implantable pulse generator having an implantable electrode array connected thereto, and wherein the implantable pulse generator has electrical circuitry therein that generates electrical stimulation pulses in accordance with programming data, which electrical stimulation pulses are delivered to body tissue of a patient through a selected combination of a multiplicity of electrodes on the electrode array, wherein the system for programming comprises:

a programming computer linked to the implantable pulse generator, the programming computer having a display screen, and means for generating a cursor on the screen that may be manually moved about the screen by a user;

means for displaying a human figure on a screen of the programming computer, the human figure being divided into a multiplicity of regions;

means for selecting at least one region on the displayed human figure where the patient feels pain;

means for selecting a combination of electrodes and stimulation parameters adapted to produce paresthesia in the same at least one region of pain;

means for generating stimulation pulses and delivering the stimulation pulses to the selected combination of electrodes through the implantable pulse generator;

means for identifying at least one region of paresthesia on the displayed human figure where the generated stimulation pulses produce paresthesia;

means for determining the degree of mismatch between the identified at least one region of paresthesia and the selected at least one region of pain;

means for selecting a new combination of independently programmable electrodes and stimulation parameters, including stimulus amplitude and pulsewidth, in order to steer a stimulus current field based on the identified at least one region of paresthesia and the degree of mismatch if the degree of mismatch exceeds a prescribed level and determining a new degree of mismatch with the newly selected combination of electrodes and stimulation parameters, whereby the degree of mismatch may be minimized; and

means for programming the implantable pulse generator with the programming data that produces the least mismatch.

7. The system of claim 6 wherein the human figure displayed on the displayed screen is divided into at least 25 regions.

8. The system of claim 6 wherein the means for selecting at least one region on the displayed human figure where the patient feels pain comprises means for marking the regions of pain with a first color.

9. The system of claim 8 wherein the means for identifying at least one region on the displayed human figure where the generated stimulation pulses produce paresthesia comprises means for marking the paresthesia regions with a second color, wherein the second color is transparent so that the presence of the first color may be seen therethrough.

10. Programming system for programming an implantable pulse generator, wherein the implantable pulse generator comprises electrical circuitry that generates electrical stimulation pulses in accordance with programming data, and an electrode array having a multiplicity of electrodes coupled to the electrical circuitry, each electrode independently programmable for amplitude and pulsewidth, the system comprising:

a programming computer linked to the implantable pulse generator, the programming computer having a display screen, and means for generating a cursor on the display screen that may be manually moved anywhere on the screen by a user;

first program data stored in the programming computer that causes a human figure to be displayed on the display screen of the programming computer, wherein the human figure is divided into a multiplicity of regions;

means for marking at least one region on the displayed human figure to represent a location whereat the patient feels pain;

second program data stored in the programming computer that causes a combination of electrodes and stimulation parameters to be selected that are adapted to produce paresthesia in the same general location where the patient feels pain;

means for marking at least one region on the displayed human figure to represent a location whereat the patent feels paresthesia;

third program data stored in the programming computer that determines the degree of mismatch between the location where the patient feels pain and the location where the patient feels paresthesia as a result of stimulation pulses produced by the second program data;

fourth program data stored in the programming computer that selects a combination of independently programmable electrodes and new stimulation parameters for each selected electrode to directionally steer the stimulus current in order to minimize the degree of mismatch between the location where the patient feels pain and the location where the patient feels paresthesia as a result of recently applied stimulation pulses; and

fifth program data stored in the programming computer that causes the combination of electrodes and stimulation parameters that minimize the degree of mismatch to be included in programming data that thereafter controls the operation of the implantable pulse generator.

11. The programming apparatus of claim 10 wherein the human figure displayed on the display screen is divided into at least twenty-five regions.

12. The programming apparatus of claim 10 wherein the programming computer comprises a lap top computer having a display screen.

13. The programming apparatus of claim 10 wherein the means for marking at least one of the multiplicity of regions on the human figure whereat the patient feels pain includes:

a pressable key, a movable mouse, a movable track ball, a touch-sensitive screen, a light-beam sensitive screen, or means for recognizing spoken voice commands.

14. The programming apparatus of claim 13 wherein the means for marking further includes means for displaying marked regions of the displayed human figure where the patient feels pain with a first display characteristic.

15. The programming apparatus of claim 14 wherein the first display characteristic comprises a first color.

16. The programming apparatus of claim 15 wherein the first color comprises red.

17. The programming apparatus of claim 10 wherein the means for marking at least one of the multiplicity of regions on the human figure whereat the patient feels paresthesia includes:

a pressable key, a movable mouse, a movable track ball, a touch sensitive screen, a light-beam sensitive screen, or means for recognizing spoken voice commands.

18. The programming apparatus of claim 17 wherein the means for marking further includes means for displaying marked regions of the displayed human figure where the patient feels paresthesia with a second display characteristic that is transparent relative to the first display characteristic, wherein the presence of the first display characteristic may be seen through the second display characteristic.

19. The programming apparatus of claim 18 wherein the second display characteristic comprises a second color different from the first color.

20. The programming apparatus of claim 19 wherein the second color comprises green or blue.