Functional ferrule

• US 8,140,152 B2
• Filed: 05/05/2010
• Issued: 03/20/2012
• Est. Priority Date: 12/07/2006
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: John, Michael S., Wingeier, Brett, Tcheng, Thomas K., Pless, Benjamin D.
• Primary Examiner(s): Manuel, George
• Application Number:
  US12/774,707
• Publication Number:
  US 20100217341A1
• Time in Patent Office: 685 Days
• Field of Search: 607/2
• US Class Current: 607/2
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• 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

Abstract

Described here are intracranial ferrules, systems, and methods for sensing and stimulating neural tissues. The ferrules are generally designed to include a holding area for retaining an implantable device. In some variations, the ferrule itself may perform the sensing and stimulating functions. In other variations, the ferrule may function to sense data from neural tissues and the implantable device may function to stimulate neural tissues. In yet other variations, the ferrule may function to stimulate, and the implantable device may function to sense data from, the neural tissues. The sensing and stimulating functions may be used to detect and/or treat various neurological conditions.

Claims

1. A method for manipulating a neural tissue comprising:

placing a ferrule within a portion of a cranium or a neural tissue proximate the cranium, the ferrule comprising;

a bottom portion having a dorsal surface and a ventral surface, the ventral surface of the bottom portion being adjacent the neural tissue;

a holding area attached to the bottom portion adjacent the dorsal surface for retaining an implantable device therein, the holding area comprising;

a wall portion attached to and extending upwardly from the dorsal surface of the bottom portion and disposed around a portion of the holding area, the wall portion having an outer surface and an inner surface;

a shelf portion attached to the wall portion and extending inwardly from the inner surface of the wall portion, the shelf portion having a dorsal surface and a ventral surface, defining one or more apertures and coupling the bottom portion with the wall;

a securing mechanism coupled with the wall portion and configured for removably securing the implantable device within the ferrule, wherein the implantable device, while being retained, is secured between the dorsal surface of the shelf portion, the inner surface of the wall portion, and the securing mechanism; and

one or more modulators disposed on the bottom portion, the one or more modulators configured to be coupled to the implantable device while the holding area retains the implantable device therein; and

performing a function using the one or more modulators on the neural tissue adjacent the one or more modulators.

2. The method of claim 1 wherein performing the function comprises sensing data from the neural tissue.

3. The method of claim 2 wherein sensing data is performed by sensor probes in the one or more modulators.

4. The method of claim 2 wherein the sensed data is selected from the group consisting of EEG data, neuronal recordings, ultrasound data, doppler shift ultrasound data, oximetry data, optical sensing data, blood pressure recordings, impedance measurements, measurements of blood gases, measurements of chemical composition, measurements of temperature, measurements of acceleration, measurements of emitted radiation and measurements of absorbed radiation, and combinations thereof.

5. The method of claim 1 wherein performing the function comprises stimulating the neural tissue.

6. The method of claim 5 wherein stimulating the neural tissue increases activity of the neural tissue.

7. The method of claim 5 wherein stimulating the neural tissue decreases activity of the neural tissue.

8. The method of claim 5 wherein stimulating the neural tissue comprises electrically stimulating the neural tissue.

9. The method of claim 5 wherein stimulating the neural tissue comprises sonically stimulating the neural tissue.

10. The method of claim 5 wherein stimulating the neural tissue comprises delivering a therapeutic agent to the neural tissue.

11. The method of claim 10 wherein the therapeutic agent is selected from the group consisting of calcium chelators, chemotherapeutic agents, cytokines, genetic therapy agents, immunotherapeutic agents, ion channel blockers, ion channel activators, neuropeptides, neuroregulators comprising neuromodulators, neuroregulators comprising neurotransmitters, nutrients, receptor agonists, receptor antagonists, photoreactive compounds, and electroactive compounds, and combinations thereof.

12. The method of claim 5 wherein stimulating the neural tissue alters a temperature of the neural tissue.

13. The method of claim 5 wherein stimulating the neural tissue alters intracranial pressure.

14. The method of claim 1 wherein the function comprises detecting a neurological condition.

15. The method of claim 14 wherein the neurological condition is selected from the group consisting neurologically-mediated cardiac and cardiovascular disorders, headache disorders, inadequate cerebral perfusion, movement disorders, neurodegenerative disorders, pain, mood disorders, psychiatric disorders other than mood disorders, seizure disorders, spinal cord disorders, and voiding disorders.

16. The method of claim 15, wherein the neurological condition is a headache disorder and the headache disorder includes a migraine headache.

17. The method of claim 15 wherein the neurological condition is a seizure disorder and the seizure disorder is epilepsy.

18. The method of claim 1 wherein the function comprises treating a neurological condition.

19. The method of claim 18 wherein the neurological condition is selected from the group consisting neurologically-mediated cardiac disorders, neurologically-mediated cardiovascular disorders, headache disorders, inadequate cerebral perfusion, movement disorders, neurodegenerative disorders, pain, mood disorders, psychiatric disorders other than mood disorders, seizure disorders, spinal cord disorders, and voiding disorders.

20. The method of claim 19 wherein the neurological condition is a headache disorder and the headache disorder includes migraine headache.

21. The method of claim 19 wherein the neurological condition is a seizure disorder and the seizure disorder is epilepsy.

22. The method of claim 1 wherein the neural tissue is a meningeal membrane.

23. The method of claim 22 wherein the meningeal membrane is the dura mater.

24. The method of claim 1 wherein the neural tissue is a portion of the cerebral cortex.

25. The method of claim 24 wherein the portion of the cerebral cortex is the motor cortex.

26. The method of claim 24 wherein the portion of the cerebral cortex is the premotor cortex.

27. The method of claim 24 wherein the portion of the cerebral cortex is the sensory cortex.

28. The method of claim 1 wherein the one or more modulators are configured as a grid on the dorsal surface.

29. The method of claim 1 wherein the one or more modulators are configured as a grid on the ventral surface.

30. The method of claim 1 wherein the ferrule further comprises one or more connectors configured to reversibly attach the ferrule to the implantable device.

31. The method of claim 1 wherein the implantable device comprises a neurostimulator.

32. The method of claim 1, further comprising:

placing an implantable device in the holding area of the ferrule.

33. The method of claim 32 wherein the ferrule further comprises:

one or more cranial attachment tabs coupled to the wall portion and configured to secure the intracranial ferrule to the cranium in an orientation having the ventral surface of the bottom portion adjacent the neural tissue and to prevent movement of the ferrule while the implantable device is placed into the holding area and coupled to the ferrule or while the implantable device is removed from the holding area and decoupled from the ferrule.

34. The method of claim 33 wherein the implantable device comprises a neurostimulator.

35. The method of claim 33 wherein the implantable device comprises one or more interface connectors configured to reversibly secure the implantable device to the ferrule.

36. The method of claim 33 wherein the implantable device comprises a control subsystem, performing the function comprising sensing data from the neural tissue and stimulating the neural tissue, and the control subsystem is configured to coordinate sensing and stimulating.

37. The method of claim 33 wherein the securing mechanism comprises one or more retainer tabs for reversibly securing the implantable device within the ferrule.