Minimally Invasive Monitoring Systems for Monitoring a Patient's Propensity for a Neurological Event
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.
1 . A minimally invasive method for monitoring a patient who has a neurological or psychiatric condition, the method comprising:
sampling brain activity signals with the one or more implanted devices that are positioned between at least one layer of scalp and the skull of the patient;
wirelessly transmitting a data signal that is encoded with data indicative of the sampled brain activity signals from the one or more implanted devices to an external device;
processing the data signal in a processing assembly of the external device to estimate the patient's propensity for a neurological event; and
generating an output in response to the processing of the data signal.
2 . The method of claim 1 wherein the output comprises a communication output to the patient from the external device that indicates the patient's propensity for the neurological event.
3 . The method of claim 1 wherein the neurological condition comprises epilepsy and the neurological event comprises a seizure.
4 . The method of claim 1 wherein the neurological event comprises a migraine headache.
5 . The method of claim 1 wherein the neurological condition comprises depression and the neurological event comprises an episode of depression.
6 . The method of claim 1 wherein the one or more implanted devices are leadless and sampling brain activity is facilitated by receipt of a wireless signal from the external device that powers and interrogates the one or more leadless devices,
wherein the external device is portable.
7 . The method of claim 1 wherein the output generated in response to the processing of the data signal is a control signal that facilitates delivery of a therapy to the patient.
8 . The method of claim 1 wherein sampling and wirelessly transmitting is performed substantially continuously,
further comprising storing the substantially continuous data signal in a memory of the external device.
9 . (canceled)
10 . The method of claim 1 further comprising providing an output communication when the data signal from the one or more devices are not being received by the external device.
11 . The method of claim 1 further comprising encrypting the data signal prior to wirelessly transmitting.
12 . A minimally invasive method of monitoring a patient's propensity for a neurological event, the method comprising:
transmitting a signal from an external device that is configured to interrogate and provide power to one or more implanted devices that are positioned in between one or more layers of the patient's scalp and skull;
wirelessly receiving a data signal from the one or more implanted devices that is encoded with data indicative of sampled brain activity signals, wherein the received data signal is derived from the transmitted signal from the external device;
processing the data signal in a processing assembly of the external device to provide a real-time estimate of the patient's propensity for the neurological event; and
generating an output communication to the patient that provides an indication of the patient's propensity for the neurological event.
13 . The method of claim 12 wherein the generating the output is performed substantially continuously so as to provide a substantially continuous output to the patient.
14 . The method of claim 12 wherein the neurological event comprises a seizure.
15 . The method of claim 12 wherein the neurological event comprises a migraine headache.
16 . The method of claim 12 wherein the neurological event comprises an episode of depression.
17 . The method of claim 12 wherein the processing comprise extracting one or more features from the brain activity signal and classifying the one or more features to estimate the patient's propensity for the seizure.
18 . The method of claim 12 wherein the one or more implanted devices are leadless.
19 . The method of claim 12 further comprising storing the brain activity signals from the one or more devices in a memory in the external device.
20 . The method of claim 12 further comprising providing an output communication when the data signal from the one or more implanted devices are not being received by the external device.
21 . A minimally invasive method of monitoring a patient's EEG signals for use in monitoring a patient's propensity for a neurological event, the method comprising:
receiving a substantially continuous interrogation signal in an implanted device that is positioned between at least one layer of the patient's scalp and skull from a device external to the patient's body;
in response to the interrogation signal, substantially continuously sampling an EEG signal from the patient;
substantially continuously transmitting a wireless data signal encoded with data that is indicative of the sampled EEG signal from the patient to the device external to the patient's body,
wherein the sampled EEG signal is processed in the external device to estimate the patient's propensity for a neurological event.
22 . The method of claim 21 wherein the interrogation signal provides power to electronic components of the implanted device.
23 . The method of claim 21 wherein the neurological event comprises a seizure.
24 . The method of claim 21 wherein the neurological event comprises a migraine headache.
25 . The method of claim 21 wherein the neurological event comprises an episode of depression.
26 . The method of claim 1 further comprising powering the one or more implanted device by deriving and storing power from patient-based energy sources.