Fully implantable microstimulator for spinal cord stimulation as a therapy for chronic pain

• US 6,871,099 B1
• Filed: 08/13/2001
• Issued: 03/22/2005
• Est. Priority Date: 08/18/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Kuzma, Janusz A., Whitehurst, Todd K., McGivern, James P., Mann, Carla M.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/929,597
• Time in Patent Office: 1,317 Days
• Field of Search: 607/46, 607/40, 607/41, 607/108, 607 58- 62, 607/133, 607116-118, 607/92, 607/148, 607/2, 607/70, 607/72, 607/74, 128/898, 128/899, 600/29, 600/30, 600/377, 604/20
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain

Abstract

An implantable stimulator(s), small enough to be located near or within an area of the spine responsible for sensations in a region experiencing chronic pain uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, it necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.

Claims

1. A method for treating a patient with chronic pain, comprising:

providing at least one stimulator having at least two electrodes;

implanting the at least one stimulator in at least one anterolateral area of the spine responsible for sensations in a region experiencing chronic pain;

providing operating power to the at east one stimulator;

providing stimulation parameters to the at least one stimulator;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerves and tissue of the anterolateral spinal cord via the at least two electrodes;

wherein the at least one area of the spine comprises the ventral commissure; and

wherein the stimulator has a size and shape suitable for placement in the at least one anterolateral area of the spine.

2. The method of claim 1 wherein the stimulation pulses are delivered at greater than about 100 Hz.

3. The method of claim 1 wherein the chronic pain is located in one or both arms, and the at least one stimulator is implanted adjacent to at least one nerve fibers of C5, C6, C7, C8, and T1.

4. The method of claim 1 wherein the chronic pain is located in one or both legs, and the at least one stimulator is implanted adjacent to at least one nerve fiber of L1-L5, S1, and S2.

5. The method of claim 1 wherein the chronic pain is located in the pelvic region, and the at least one stimulator is implanted adjacent to at least one nerve fibers of T10, T11, T12, L1 L5, and S1-S5.

6. The method of claim 1 wherein the chronic pain is located in the back, and the at least one stimulator is implanted adjacent to at least one nerve fibers of T1-T12, L1-L5, and S1.

7. The method of claim 1 wherein the chronic pain is located in the cervical region, and the at least one stimulator is implanted adjacent to at least one nerve fibers of C2, C3, C4, and C5.

8. The method of claim 1 wherein the chronic pain is located in the head/neck region, and the at least one stimulator is implanted adjacent to at least one nerve fiber of C1-C8.

9. The method of claim 1 further comprising:

providing at least one sensor;

using the at least one sensor to sense at least one physical condition; and

determining the stimulation parameters based upon the at least one sensed condition.

10. The method of claim 1 wherein providing stimulation parameters comprises receiving the stimulation parameters from at least one external appliance.

11. The method of claim 1 wherein providing operating power comprises receiving the operating power from at least one external appliance.

12. The method of claim 1 further comprising providing and implanting more than one stimulator.

13. A method for treating a patient with chronic pain, comprising the steps of:

providing at least one means for stimulating tissue;

implanting the at least one stimulating means in at least one anterolateral area of the spine responsible for sensations in a region experiencing chronic pain;

providing operating power to the at least one stimulating means;

providing stimulation parameters to the at least one stimulating means;

generating stimulation pulses in accordance with the stimulation parameters; and

delivering the stimulation pulses to nerves and tissue of the anterolateral spinal cord via the at least one stimulating means;

wherein the at least one area of the spine comprises the ventral commissure; and

wherein the stimulating means has a size and shape suitable for placement in the at least one anterolateral area of the spine and has leads up to 150 mm long.

14. The method of claim 13 wherein the body of the stimulator is no more than 150 mm from the nerve to be stimulated.

15. The method of claim 13 wherein the stimulation parameters are determined using at least one external appliance.

16. The method of claim 13 wherein providing operating power to the at least one stimulator comprises receiving power from at least one external appliance.

17. The method of claim 16 wherein providing power to the at least one stimulator further comprises storing the power received from the at least one external appliance.

18. The method of claim 13 further comprising providing and implanting more than one stimulator.