Minimally Invasive Monitoring Systems for Monitoring a Patient's Propensity for a Neurological Event

Abstract

The present invention provides systems and methods for ambulatory, long term monitoring of a physiological signal from a patient. At least a portion of the systems of the present invention may be implanted within the patient in a minimally invasive manner. In preferred embodiments, brain activity signals are sampled from the patient with an externally powered leadless implanted device and are transmitted to a handheld patient communication device for processing to estimate the patient's propensity for a seizure.

Description

CROSS-REFERENCED TO RELATED APPLICATIONS [0001] The present application claims benefit of U.S. Provisional Patent Application Ser. No. 60 / 805,710, filed Jun. 23, 2006, to Harris et al., entitled “Implantable Ambulatory Brain Monitoring System,” the complete disclosure of which is incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The present invention relates generally to systems and methods for sampling one or more physiological signals from a patient. More specifically, the present invention relates to long term, ambulatory monitoring and analysis of one or more neurological signals from a patient using a minimally invasive system to estimate the patient's propensity for a seizure. [0003] Epilepsy is a disorder of the brain characterized by chronic, recurring seizures. Seizures are a result of uncontrolled discharges of electrical activity in the brain. A seizure typically manifests itself as sudden, involuntary, disruptive, and often destructive sensory, motor, a...

AI Technical Summary

Benefits of technology

[0009] The present invention provides methods and systems for monitoring one or more physiological signals from the patient. In preferred embodiments, the present invention provides minimally-invasive systems that provide for the long-term, ambulatory monitoring of patient's brain activity to facilitate the estimation of the patients propensity for a neurological event (e.g., seizure, migraine headache, episode of depression, etc.). The systems of the present invention will typically include one or more implantable devices that are capable of sampling and transmitting a signal that is indicative of the patient's brain activity to a data collection device that is external to the patient's body.

[0010] The ambulatory systems of the present invention provide for substantially continuous sampling of brain wave electrical signals (e.g., electroencephalography or “EEG” and electrocorticogram “ECoG”, which are hereinafter referred to collectively as “EEG”). A patient could wear their external data collection device at all times of the day (except while showering, etc.). At the physicians' office, the data from the external data collection device could be uploaded into a physician's computer, which could then automatically analyze the stored EEG data and calculate certain metrics that would provide insight into the patient's condition. For example, such metrics may allow the epileptologist to assess seizure frequency, monitor for sub-clinical seizures, determine the efficacy of treatment, determine the effect of adjustments of the dosage of the AED, determine the effects of adjustments of the type of AED, adjust parameters of electrical stimulation, or the like.

[0011] The systems of the present invention typically include one or more low power implantable devices for sampling the patient's EEG signal. The implantable devices are in communication with a device that is external to the patient's body which comprises algorithms that estimate the patient's propensity for a neurological event. The external device is typically configured to transmit power into the implantable device and to store the EEG signal that is sampled by the implantable device. The implantable device and the external device will be in communication with each other through a wireless communication link. While any number of different wireless communication links may be used, in preferred embodiments the systems of the present invention uses a high-frequency communication link. Such a communication link enables transmission of power into the implantable device and facilitates data transfer to and from the implantable device.

Problems solved by technology

A seizure typically manifests itself as sudden, involuntary, disruptive, and often destructive sensory, motor, and cognitive phenomena.

Seizures are frequently associated with physical harm to the body (e.g., tongue biting, limb breakage, and burns), a complete loss of consciousness, and incontinence.

A single seizure most often does not cause significant morbidity or mortality, but severe or recurring seizures (epilepsy) results in major medical, social, and economic consequences.

Epilepsy is most often diagnosed in children and young adults, making the long-term medical and societal burden severe for this population of patients.

People with uncontrolled epilepsy are often significantly limited in their ability to work in many industries and usually cannot legally drive an automobile.

This continuous seizure activity may lead to permanent brain damage, and can be lethal if untreated.

The risk of social embarrassment resulting from unforewarned seizures causes epileptic subjects to remove themselves from society.

Unfortunately, many of the proposed systems are highly invasive and such invasiveness could reduce the number of patients that would take advantage of such technology.

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