Brain implantable device

A system includes intracranial electrodes embedded into a cranium, a deep brain stimulation system embedded into the cranium, a brain implantable device embedded into the cranium, and a pulse generator, the deep brain stimulation system and the brain implantable device linked to the intracranial electrodes and to the pulse generator.

STATEMENT REGARDING GOVERNMENT INTEREST

BACKGROUND OF THE INVENTION

The present invention relates generally to treatment of neurologic disease, and more particularly to a brain implantable device.

In general, the treatment of neurologic disease is severely limited by the quality and granularity of data regarding patients' “in the wild” disease burden and response to treatment. The patient experience is filtered through a patient's own subjective recollection and understanding of their condition, and clinicians must interpret these accounts to infer disease burden and response to therapy, and then make adjustments to therapy as deemed necessary based upon these imperfect data. Neural activity biomarkers of disease, monitored chronically, can potentially augment clinical judgment by providing objective data regarding disease burden and response to therapy in a patient's natural environment. Furthermore, these biomarkers may be used to derive control signals for neuromodulation (e.g., closed-loop deep brain stimulation) that regulate disease manifestations in real-time.

However, current implantable neuromodulation devices are limited in their recording and stimulation capabilities, and have minimal on-board processing to implement sophisticated models for transforming neural activity biomarkers to appropriate stimulation patterns.

SUMMARY OF THE INVENTION

In an aspect, the invention features a system including intracranial electrodes embedded into a cranium, a deep brain stimulation system embedded into the cranium, a brain implantable device embedded into the cranium, and a pulse generator, the deep brain stimulation system and the brain implantable device linked to the intracranial electrodes and to the pulse generator.

In another aspect, the invention features a system including intracranial electrodes embedded into a cranium, a brain implantable device embedded into the cranium, and a pulse generator, the brain implantable device linked to the intracranial electrodes and to the pulse generator.

In still another aspect, the invention features a brain implantable device including an input unit, a switch, a power conditioning and buffering unit, a stimulation waveform generator and amplifier array unit, a main logic board, an input/output unit, a signal acquisition and program filtering unit, and a memory.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features and advantages of the invention will become apparent from the description and the drawings, and from the claims.

DETAILED DESCRIPTION

Given the growing acceptance and utilization of deep brain stimulation for a variety of disorders, ranging from movement disorders such as Parkinson's Disease to epilepsy to obsessive compulsive disorder (and many more potential indications in clinical trials), this presents an opportunity to interface with the human brain in potentially thousands of individuals, to expand the basic knowledge and improve the treatment of neurologic disease, if harnessed appropriately.

The brain implantable device described herein, also referred to as a “discovery device,” augments traditional deep brain stimulation systems to expand the capability of those systems to better detect and understand neural activity biomarkers, and to implement more complex, patient-specific algorithms for neuromodulation therapy. In this way, the relatively large experience of deep brain stimulation can be leveraged.

As shown inFIG.1, in a preferred embodiment, an embedded exemplary brain implantable device16, also referred to herein as a “discovery device,” is implanted in a brain12alongside intracranial electrodes14. The discovery device16is linked to a pulse generator battery20with extensions18. InFIG.1, the discovery device16is implanted alongside a standard deep brain stimulation system with relatively little modification of a surgical procedure, and is capable of superseding or overriding the function of the standard deep brain stimulation system under controlled circumstances to enable enhanced acquisition of neural signals and testing of novel algorithms for brain stimulation.

In one alternate embodiment, implantation of the discovery device16is done without the standard deep brain stimulator system, as a stand-alone device for recording neural activity and/or delivering stimulation, when coupled with an appropriate neural tissue interface (e.g., depth electrode for neural signal acquisition or electrical stimulation, electrochemical probe for measuring levels of molecules of interest, such as neurotransmitters or pathologic byproducts of disease, and so forth). The capabilities of the discovery device16would include those necessary for electrochemical measurement, such as cyclic voltammetry. Thus, the discovery device16can serve as a robust, general purpose neuromodulation test-bed.

As shown inFIG.2, in one implementation, the discovery device16includes an input unit100, a switch102, a power conditioning and buffering unit104, a stimulation waveform generator and amplifier array unit106and a main logic board108. The discovery device16also includes an input/output unit112, a signal acquisition and program filtering unit114and a unit116and a memory116.

The switch102enables at least two primary modes of operation, i.e., a “standard mode” and a “discovery mode.” In standard mode, the discovery device16acts as a simple pass-through, enabling traditional neuromodulation protocols to be implemented, as programmed into the standard, existing pulse generator battery system. Input from the pulse generator battery20is received by the input unit100, sent through the switch102to the input/output unit112and on to the intracranial electrodes14.

In research (also referred to as “discovery mode”) mode, the discovery device16receives power from the pulse generator battery20, but records neural activity and delivery stimulation based upon its own on-board algorithms, programmed using separate, device-specific telemetry.

One purpose of the discovery device16is serve as a “discovery engine” for a wide variety of neurologic conditions, ranging from those already approved for clinical use, those currently under investigation, and new neurologic indications that would benefit from objective disease tracking and/or neuromodulation.

As shown and described above, the discovery device16is implanted alongside a traditional, existing, FDA approved device. As such, the discovery device16is powered by the traditional, existing, FDA-approved clinical deep brain stimulation (DBS) pulse generator battery. The discovery device16includes a switch to toggle between a “pass-through” mode and a “discovery” mode.

It would be appreciated by those skilled in the art that various changes and modifications can be made to the illustrated embodiments without departing from the spirit of the present invention. All such modifications and changes are intended to be within the scope of the present invention except as limited by the scope of the appended claims.