Apparatus and method for positioning spinal cord stimulation leads

• US 6,027,456 A
• Filed: 07/10/1998
• Issued: 02/22/2000
• Est. Priority Date: 07/10/1998
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Feler, Claudio A., Rhines, Steven P., Erickson, John H.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/113,390
• Time in Patent Office: 592 Days
• Field of Search: 600/554, 600/643, 607/863, 607/117
• US Class Current: 600/554
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

An apparatus for assisting in the placement of a spinal cord stimulation lead with respect to the dorsal column of a patient. The apparatus detects evoked potentials which result from the controlled stimulation of spinal nerves and provides information to an operator to allow a stimulation lead to be positioned relative to a physiological midline and/or positioned along the dorsal column in a longitudinal direction.

Claims

1. An apparatus comprising:

a signal generating device for generating a stimulation signal;

at least two stimulation electrodes coupled to the signal generating device and adapted to deliver a stimulation signal from the signal generating device to the spinal nerves of a patient;

at least two detection electrodes adapted to be positioned at a region of the body of the patient to detect a bodily reaction to the stimulation signal from the signal generating device; and

a feedback device coupled to the at least two detection electrodes to display information corresponding to at least a position of the at least two stimulation electrodes relative to the dorsal column of the patient.

2. An apparatus in accordance with claim 1, wherein the position relative to the dorsal column of the patient is a medial/lateral position relative to a physiological midline.

3. An apparatus in accordance with claim 1, further comprising one or more additional detection electrodes adapted to be positioned about the body of the patient to detect a bodily reaction to the stimulation signal from the signal generating device, wherein a position of each additional detection electrode corresponds to a bodily region subject to manageable pain.

4. An apparatus in accordance with claim 3, wherein the position relative to the dorsal column of the patient is a longitudinal position along the dorsal column.

5. An apparatus in accordance with claim 3, further comprising an analysis device, coupled between the at least two detection electrodes and the one or more additional detection electrodes and the feedback device, to prepare for display the information corresponding to at least the position of the at least two stimulation electrodes relative to the dorsal column of the patient.

6. An apparatus in accordance with claim 1, further comprising a controller coupled to the signal generating device for selectively defining a stimulation signal.

7. An apparatus in accordance with claim 1, wherein the at least two stimulating electrodes is a plurality of stimulating electrodes, and further comprising a controller coupled to the signal generating device for selecting two or more of the plurality of stimulating electrodes.

8. An apparatus in accordance with claim 1, further comprising an analysis device, coupled between the at least two detection electrodes and the feedback device, to prepare for display the information corresponding to at least the position of the at least two stimulation electrodes relative to the dorsal column of the patient.

9. A spinal cord stimulation lead positioning apparatus having a signal generating device for generating a stimulation signal, the apparatus comprising:

at least two stimulation electrodes adapted to be positioned approximately adjacent to the dura matter of a patient, wherein the at least two stimulation electrodes are electrically coupled to the signal generating device to deliver a stimulation signal from the signal generating device;

at least two detection electrodes adapted to be positioned at or about the head of the patient to detect a bodily reaction to the stimulation signal from the signal generating device;

an analysis unit, coupled to the at least two detection electrodes, to output a signal representative of a detected bodily reaction resulting from the stimulation signal; and

an output device coupled to the analysis unit and responsive to the signal therefrom to display information corresponding to at least a position of the at least two stimulation electrodes relative to the dorsal column of the patient.

10. An apparatus in accordance with claim 9, wherein the position relative to the dorsal column of the patient is a medial/lateral position relative to a physiological midline.

11. An apparatus in accordance with claim 9, further comprising one or more additional detection electrodes adapted to be positioned about the body of the patient to detect a bodily reaction to the stimulation signal from the signal generating device, wherein a position of each additional detection electrode corresponds to a bodily region subject to manageable pain.

12. An apparatus in accordance with claim 11, wherein the position relative to the dorsal column of the patient is a longitudinal position along the dorsal column.

13. An apparatus in accordance with claim 11, wherein the analysis unit is further coupled to the one or more additional detection electrodes and outputs a signal representative of a bodily reaction detected by the one or more additional detection electrodes.

14. An apparatus in accordance with claim 9, further comprising a controller coupled to the signal generating device for selectively defining a stimulation signal.

15. An apparatus in accordance with claim 9, wherein the at least two stimulating electrodes is a plurality of stimulating electrodes, and further comprising a controller coupled to the signal generating device for selecting two or more of the plurality of stimulating electrodes.

16. A method of positioning dorsal column stimulation electrodes relative to the dorsal column of a patient, the steps comprising:

providing sensors at or about the head of the patient to detect bodily reaction to stimulation applied to the spinal nerves thereof, wherein the sensors are coupled to a feedback device to display information corresponding to at least a position of the stimulation electrodes relative to the dorsal column of the patient;

electrically stimulating the spinal nerves of the patient;

detecting a bodily reaction to the applied electrical stimulation;

determining a position of the stimulation electrodes relative to the dorsal column of the patient based upon the detected bodily reaction; and

displaying on the display device information corresponding to the determined position of the stimulation electrodes.

17. A method in accordance with claim 16, further comprising the step of rendering the patient unconscious prior to the step of electrically stimulating the spinal nerves of the patient.

18. A method in accordance with claim 16, wherein the position relative to the dorsal column is a position relative to a physiological midline.

19. A method in accordance with claim 16, further comprising the step of providing sensors about the body of the patient to detect a bodily reaction to the stimulation signal from the signal generating device, wherein a position of each additional detection electrode corresponds to a bodily region subject to manageable pain.

20. A method in accordance with claim 19, wherein the position relative to the dorsal column is a longitudinal position along the dorsal column.