Treatment of epilepsy by brain stimulation

• US 7,003,352 B1
• Filed: 05/02/2003
• Issued: 02/21/2006
• Est. Priority Date: 05/24/2002
• 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.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/428,743
• Time in Patent Office: 1,026 Days
• Field of Search: 607/1, 607/2, 607/45
• US Class Current: 607/45
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Introducing one or more stimulating drugs to the brain and/or applying electrical stimulation to the brain is used to treat epilepsy. At least one implantable system control unit (SCU) produces electrical pulses delivered via electrodes implanted in the brain and/or drug infusion pulses delivered via a catheter implanted in the brain. The stimulation is delivered to targeted brain structures to adjust the activity of those structures. The small size of the SCUs of the invention allow SCU implantation directly and entirely within the skull and/or brain. Simplicity of the preferred systems and methods and compactness of the preferred system are enabled by the modest control parameter set of these SCU, which do not require or include a sensing feature.

Claims

1. A method of treating a patient with epilepsy, comprising:

implanting at least one system control unit entirely within 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 epilepsy;

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

applying the at least one stimulus to decrease activity of at least one of the main trigeminal sensory nucleus, the spinal trigeminal nucleus, and the mesencephalic trigeminal nucleus;

wherein the at least one system control unit is a microstimulator implanted entirely within the brain.

2. The method of claim 1 wherein the system control unit is connected to at least one electrode, and wherein the stimulus comprises electrical stimulation delivered via the at least one electrode.

3. The method of claim 1 wherein the system control unit is connected to at least one infusion outlet, and wherein the stimulus comprises stimulation via one or more drugs delivered through the at least one outlet.

4. The method of claim 1 wherein the system control unit is connected to at least one electrode and to at least one infusion outlet, and wherein the stimulus comprises both electrical stimulation delivered via the at least one electrode and stimulation via one or more drugs delivered through the at least one outlet.

5. The method of claim 1 wherein the stimulating pulses are at least relatively high-frequency electrical pulses applied at greater than about 100–

150 Hz.

6. The method of claim 1 wherein the stimulating pulses are at least infusion pulses of at least one of an inhibitory neurotransmitter, an inhibitory neurotransmitter agonist, an agent that increases the level of an inhibitory neurotransmitter, an excitatory neurotransmitter antagonist, an agent that decreases the level of an excitatory neurotransmitter, a local anesthetic agent, and an analgesic medication.

7. The method of claim 6 wherein the infusion pulses are pulses of at least one of dopamine, glycine, and gamma-aminobutyric acid, muscimol, prazosin, metoprolol, acetylcholinesterase, bicuculline methiodide, and lidocaine.

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

9. The method of claim 1 wherein the at least one system control unit is programmed manually.

10. A method of treating a patient with epilepsy, comprising:

providing at least one system control unit that generates stimulating pulses in accordance with prescribed parameters, which stimulating pulses are at least one of infusion pulses and electrical stimulation pulses;

providing, connected to the at least one system control unit, at least one catheter with at least one discharge portion or at least one lead with at least one electrode;

implanting at least one of the at least one discharge portion and the at least one electrode adjacent to at least one brain structure affecting epilepsy;

implanting the at least one system control unit in the patient, wherein the at least one unit controls the delivery of the stimulating pulses applied to the at least one brain structure to be stimulated;

tunneling at least one of the at least one catheter and the at least one lead between the at least one brain structure and the system control unit location;

applying the stimulating pulses to decrease activity of the at least one brain structure in order to at least in part alleviate the epilepsy of the patient being treated; and

wherein the at least one brain structure is at least the nucleus of tractus solitarius (NTS).

11. The method of claim 10 wherein the stimulating pulses are at least relatively high-frequency electrical pulses applied at greater than about 100–

150 Hz.

12. The method of claim 10 wherein the stimulating pulses are at least infusion pulses of at least one of an inhibitory neurotransmitter, an inhibitory neurotransmitter agonist, an agent that increases the level of an inhibitory neurotransmitter, an excitatory neurotransmitter antagonist, an agent that decreases the level of an excitatory neurotransmitter, a local anesthetic agent, and an analgesic medication.

13. The method of claim 12 wherein the infusion pulses are pulses of at least one of dopamine, glycine, and gamma-aminobutyric acid, muscimol, prazosin, metoprolol, acetylcholinesterase, bicuculline methiodide, and lidocaine.

14. The method of claim 10 further comprising sensing at least one condition and using the at least one sensed condition to automatically determine the stimulating pulses to apply.

15. The method of claim 10 wherein the at least one system control unit is programmed manually.

16. A method of treating a patient with epilepsy, comprising the steps of:

providing at least one system control unit that generates stimulating pulses in accordance with prescribed parameters, which stimulating pulses are at least one of infusion pulses and electrical stimulation pulses;

providing, connected to the at least one system control unit, at least one catheter with at least one discharge portion or at least one lead with at least one electrode;

implanting at least one of the at least one discharge portion and the at least one electrode adjacent to at least one brain structure affecting epilepsy;

implanting the at least one system control unit in the patient, wherein the at least one unit controls the delivery of the stimulating pulses applied to the at least one brain structure to be stimulated;

tunneling at least one of the at least one catheter and the at least one lead between the at least one brain structure and the system control unit location;

applying the stimulating pulses to decrease activity of the at least one brain structure in order to at least in part alleviate the epilepsy of the patient being treated; and

wherein the at least one brain structure is at least the nucleus of tractus solitarius (NTS).

17. The method of claim 16 wherein the stimulating pulses are at least relatively high-frequency electrical pulses applied at greater than about 100–

150 Hz.

18. The method of claim 16 wherein the stimulating pulses are at least infusion pulses of at least one of an inhibitory neurotransmitter, an inhibitory neurotransmitter agonist, an agent that increases the level of an inhibitory neurotransmitter, an excitatory neurotransmitter antagonist, an agent that decreases the level of an excitatory neurotransmitter, a local anesthetic agent, and an analgesic medication.

19. The method of claim 18 wherein the infusion pulses are pulses of at least one of dopamine, glycine, and gamma-aminobutyric acid, muscimol, prazosin, metoprolol, acetylcholinesterase, bicuculline methiodide, and lidocaine.