Means and method for the intracranial placement of a neurostimulator

• US 6,427,086 B1
• Filed: 04/21/2000
• Issued: 07/30/2002
• Est. Priority Date: 10/27/1997
• Status: Expired due to Term

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Potts, Dennis R., Fischell, David R., Pless, Benjamin D., Fischell, Robert E., Upton, Adrian R. M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/557,168
• Time in Patent Office: 830 Days
• Field of Search: 607/45, 607/58, 607/116, 607/139
• US Class Current: 607/45
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

Disclosed is a means and method for placing an implantable neurostimulator control module into a place in the cranium where cranial bone has been removed. The method for accomplishing this cranial implantation is by first removing a patient'"'"'s hair over the site of the implant, then cutting the scalp at that site and pulling it back to expose the cranium. A neurosurgeon would then remove a portion of the cranial bone to accept a control module to be implanted within that hole. The control module would then be placed into that hole. It is also conceived that the control module would be fixed in place by the use of one or more attachment devices such as a multiplicity of bone screws placed through holes in one or more flanges that extend over the cranium beyond the control module. The implantation could also include a fairing placed around the control module to provide a smooth contour under the patient'"'"'s scalp. Also described is a spacer shim placed under the flange(s) to adjust the position of the control module so that its bottom surface does not put pressure on the dura mater lying directly over the brain tissue at the bottom of the hole. It is also envisioned that a resorbable disk could be placed under the bottom surface of the control module to further protect the brain and/or to elute an anti-biotic or anti-inflammatory substance to reduce the possibility of infection and/or inflammation.

Claims

1. A neurostimulator system for the treatment of a neurological disorder of a human subject, the system comprising:

at least one electrode adapted to be placed within the head of the human subject;

a control module adapted to be implanted beneath the scalp of the human subject for transmitting an output signal into the nervous system of the human subject for the treatment of the neurological disorder, the control module having a bottom surface and a top surface; and

,

electrical conducting means for providing electrical connection between the control module and the at least one electrode.

2. The system of claim 1 wherein the control module is adapted to be implanted within a hole that is made in the cranium of the human subject.

3. The system of claim 1 wherein the control module is removably attached to the cranium by means of at least one attachment device.

4. The system of claim 3 wherein the at least one attachment device is at least one bone screw.

5. The system of claim 1 wherein the control module is fixedly attached to at least one flange that extends from the control module and an attachment device penetrates through the at least one flange that extends from the control module to removably attach the control module to the cranium of the human subject.

6. The system of claim 5 wherein there is exactly one flange.

7. The system of claim 5 wherein there are exactly three flanges.

8. The system of claim 5 wherein the at least one flange is adapted to be bent so as to allow placement of the control module into the hole in the cranium with at least 0.1 mm clearance between the bottom of the control module and outer surface of the dura mater of the human subject that is located at the bottom of the hole in the cranium.

9. The system of claim 5 further including a spacer shim placed between the at least one flange and the cranium, the spacer shim being adapted to adjust the distance between the outer surface of the dura mater at the bottom of the hole in the cranium and the bottom surface of the control module.

10. The system of claim 1 wherein a fairing is placed exterior to the control module, the fairing being adapted to form a smooth outer contour beneath the scalp of the human subject.

11. The system of claim 10 including an attachment device for attaching the fairing to the control module.

12. The system of claim 10 including an attachment means for attaching the fairing to the pericranium tissue that surrounds the cranium of the human subject.

13. The system of claim 12 wherein the attachment means is a multiplicity of sutures.

14. The system of claim 1 wherein a resorbable disk is placed between the bottom of the control module and the dura mater at the bottom of the hole made in the cranium.

15. The system of claim 14 wherein the resorbable disk elutes an anti-biotic substance to decrease the rate of occurrence of infection.

16. The system of claim 14 wherein the resorbable disk elutes an anti-inflammation substance to reduce the rate of occurrence of inflammation.