Treatment of pain by brain stimulation

• US 7,013,177 B1
• Filed: 07/03/2002
• Issued: 03/14/2006
• Est. Priority Date: 07/05/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd K., Woods, Carla Mann, Meadows, Paul M.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/188,582
• Time in Patent Office: 1,350 Days
• Field of Search: 607/3, 607 46- 47
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Systems and methods for introducing one or more stimulating drugs and/or applying electrical stimulation to the brain to alleviate pain use at least one implantable system control unit (SCU), producing electrical pulses delivered via electrodes implanted in the brain and/or producing drug infusion pulses, wherein the stimulation is delivered to targeted areas in the brain. In some embodiments, one or more sensed conditions are used to adjust stimulation parameters.

Claims

1. A method of treating patients with pain, comprising:

implanting at least one system control unit including at least one infusion outlet in at least one of the skull and the brain of the patient, wherein the at least one unit controls the delivery of at least one stimulating drug through the at least one outlet to at least one area of the brain affecting pain;

applying the at least one stimulating drug to the at least one area of the brain in order to at least in part alleviate the pain of the patient being treated;

wherein the area of the brain is selected from at least one of the ventrobasal (VB) area of the thalamus, the ventral posteromedial (VPM) nucleus, the ventral posterolateral nucleus (VPL), the ventrolateral nucleus (VL), the posterior complex of the thalamus (PO), the motor cortex, the sensory cortex, the cingulate gyrus, the medial lemniscus, the internal capsule, the periventricular grey (PVG) matter, and the periaqueductal grey (PAG) matter.

2. The method of claim 1 wherein the at least one stimulating drug increases excitement of at least one area of the brain affecting pain that exhibits chronic decreased activity.

3. The method of claim 2 wherein the at least one stimulating drug is applied to at least one of the motor cortex, the cingulate gyrus, the medial lemniscus, the internal capsule, the periventricular grey (PVG) matter, and the periaqueductal grey (PAG) matter.

4. The method of claim 2 wherein the stimulating drug is at least one of an excitatory neurotransmitter agonist, an inhibitory neurotransmitter antagonist, an agent that increases the level of an excitatory neurotransmitter, and an agent that decreases the level of an inhibitory neurotransmitter, and an analgesic medication.

5. The method of treatment of claim 2 wherein the system control unit is connected to at least two electrodes, and wherein the method further comprises delivering electrical stimulation via the at least two electrodes, and wherein the electrical stimulation is delivered at a frequency less than about 100 Hz.

6. The method of claim 1 wherein the at least one stimulating drug decreases excitement of at least one area of the brain affecting pain that exhibits chronic increased activity.

7. The method of claim 6 wherein the at least one stimulating drug is applied to at least one of the ventrobasal (VB) area of the thalamus, the ventral posteromedial (VPM) nucleus, the ventral posterolateral nucleus (VPL), the ventrolateral nucleus (VL), the sensory cortex, and the posterior complex of the thalamus (PO).

8. The method of claim 6 wherein the stimulating drug is at least one of an excitatory neurotransmitter antagonist, an inhibitory neurotransmitter agonist, an agent that increases the level of an inhibitory neurotransmitter, an agent that decreases the level of an excitatory neurotransmitter, and a local anesthetic agent, and an analgesic medication.

9. The method of claim 8 wherein the stimulating drug is at least one of MK801, an agonist thereof, and an opiate.

10. The method of treatment of claim 6 wherein the system control unit is connected to at least two electrodes, and wherein the method further comprises delivering electrical stimulation via the at least two electrodes, and wherein the electrical stimulation is delivered at a frequency greater than about 100 Hz.

11. The method of treatment of claim 1 wherein the system control unit is connected to at least two electrodes, and wherein the method further comprises delivering electrical stimulation via the at least two electrodes.

12. The method of claim 1 further comprising sensing at least one condition and using the at least one sensed condition to automatically determine the stimulus to apply.

13. The method of claim 12 wherein the at least one sensed condition is at least one of electrical activity of a neural population, impedance, pH, muscle activity, neural activity, acceleration, a neurotransmitter level, change in a neurotransmitter level, a neurotransmitter breakdown product level, change in a neurotransmitter breakdown product level, a medication level, change in a medication level, a drug level, change in a drug level, a hormone level, change in a hormone level, an interleukin level, change in an interleukin level, a cytokine level, change in a cytokine level, a lymphokine level, change in a lymphokine level, a chemokine level, change in a chemokine level, a growth factor level, change in a growth factor level, an enzyme level, change in an enzyme level, a ketone level, change in a ketone level, an electrolyte level, change in an electrolyte level, level of a substance in the blood plasma, change in level of a substance in the blood plasma, level of a substance in the local interstitial fluid, change in level of a substance in the local interstitial fluid, level of a substance in the cerebrospinal fluid, and change in level of a substance in the cerebrospinal fluid.

14. A method of treating patients with pain, comprising;

implanting at least one system control unit in at least one of the skull and the brain of the patient, wherein the at least one unit controls the delivery of at least one stimulus to at least one area of the brain affecting pain;

applying the at least one stimulus to the at least one area of the brain in order to at least in part alleviate the pain of the patient being treated; and

sensing at least one condition and using the at least one sensed condition to automatically determine the stimulus to apply;

wherein the system control unit is connected to at least one infusion outlet and at least two electrodes, and wherein the method further comprises delivering at least one stimulating drug through the at least one outlet and delivering electrical stimulation via the at least two electrodes.

15. The method of claim 14 wherein the at least one sensed condition is at least one of electrical activity of a neural population, impedance, pH, muscle activity, neural activity, acceleration, a neurotransmitter level, change in a neurotransmitter level, a neurotransmitter breakdown product level, change in a neurotransmitter breakdown product level, a medication level, change in a medication level, a drug level, change in a drug level, a hormone level, change in a hormone level, an interleukin level, change in an interleukin level, a cytokine level, change in a cytokine level, a lymphokine level, change in a lymphokine level, a chemokine level, change in a chemokine level, a growth factor level, change in a growth factor level, an enzyme level, change in an enzyme level, a ketone level, change in a ketone level, an electrolyte level, change in an electrolyte level, level of a substance in the blood plasma, change in level of a substance in the blood plasma, level of a substance in the local interstitial fluid, change in level of a substance in the local interstitial fluid, level of a substance in the cerebrospinal fluid, and change in level of a substance in the cerebrospinal fluid.

16. The method of claim 14 wherein the at least one area of the brain is selected from at least one of the ventrobasal (VB) area of the thalamus, the ventral posteromedial (VPM) nucleus, the ventral posterolateral nucleus (VPL), the ventrolateral nucleus (VL), the posterior complex of the thalamus (PO), the motor cortex, the sensory cortex, the cingulate gyms, the medial lemniscus, the internal capsule, the periventricular grey (PVG) matter, and the periaqueductal grey (PAG) matter.

17. The method of claim 14 wherein the system control unit is connected to at least one infusion outlet, and wherein the method further comprises delivering at least one stimulation drug through the at least one outlet.

18. The method of claim 14 wherein the system control unit is connected to at least two electrodes, and wherein the method further comprises delivering electrical stimulation via the at least two electrodes.

19. A method of treating patients with pain, comprising:

implanting at least one system control unit in at least one of the skull and the brain of the patient, wherein the at least one unit controls the delivery of at least one stimulus to at least one area of the brain affecting pain;

applying the at least one stimulus to the at least one area of the brain in order to at least in part alleviate the pain of the patient being treated; and

sensing at least one condition and using the at least one sensed condition to automatically determine the stimulus to apply;

wherein the stimulation increases excitement of at least one area of the brain affecting pain that exhibits chronic decreased activity.

20. The method of claim 19 wherein the stimulation is applied to at least one of the motor cortex, the cingulate gyrus, the medial lemniscus, the internal capsule, the periventricular grey (PVG) matter, and the periaqueductal grey (PAG) matter.

21. The method of claim 19 wherein the stimulation is provided by at least one stimulating drug and wherein the at least one stimulating drug is at least one of an excitatory neurotransmitter agonist, an inhibitory neurotransmitter antagonist, an agent that increases the level of an excitatory neurotransmitter, an agent that decreases the level of an inhibitory neurotransmitter, and an analgesic medication.

22. The method of claim 19 wherein the stimulation is electrical stimulation delivered at a frequency less than about 100 Hz.

23. A method of treating patients with pain, comprising:

implanting at least one system control unit in at least one of the skull and the brain of the patient, wherein the at least one unit controls the delivery of at least one stimulus to at least one area of the brain affecting pain;

applying the at least one stimulus to the at least one area of the brain in order to at least in part alleviate the pain of the patient being treated; and

sensing at least one condition and using the at least one sensed condition to automatically determine the stimulus to apply;

wherein the stimulation decreases excitement of at least one area of the brain affecting pain that exhibits chronic increased activity.

24. The method of claim 23 wherein the stimulation is applied to at least one of the ventrobasal (VB) area of the thalamus, the ventral posteromedial (VPM) nucleus, the ventral posterolateral nucleus (VPL), the ventrolateral nucleus (VL), the sensory cortex, and the posterior complex of the thalamus (PO).

25. The method of claim 23 wherein the stimulation is provided by at least one stimulating drug and wherein the at least one stimulating drug is at least one of an excitatory neurotransmitter antagonist, an inhibitory neurotransmitter agonist, an agent that increases the level of an inhibitory neurotransmitter, an agent that decreases the level of an excitatory neurotransmitter, a local anesthetic agent, and an analgesic medication.

26. The method of claim 25 wherein the drug is at least one of MK801, an agonist thereof, and an opiate.

27. The method of claim 23 wherein the stimulation is electrical stimulation delivered at a frequency greater than about 100 Hz.

28. A system for treating patients with pain, comprising:

at least one system control unit configured for implantation entirely within at least one of a brain and a skull;

at least one of a) a pump coupled to an infusion outlet and b) at least two stimulating electrodes;

means for operably connecting the at least one system control unit to at least one of the infusion outlet and the electrodes;

means for providing operating power to the at least one system control unit;

means for providing stimulation parameters to the at least one system control unit; and

means for generating stimulation pulses in accordance with the stimulation parameters;

wherein the pump and infusion outlet and the electrodes are configured to deliver the stimulation pulses through at least one of the infusion outlet and the electrodes to at least one area of the brain affecting pain.

29. The system of claim 28 wherein the system control unit is configured to conform to the profile of the skull.

30. The system of claim 28 wherein the system control unit is a microstimulator implanted entirely within the brain.

31. The system of claim 28 further comprising means for sensing at least one condition indicating a need for treatment for pain.

32. The system of claim 31 further comprising means for using the at least one sensed condition to automatically determine the stimulus to apply.