Surgery – Miscellaneous – Devices placed entirely within body and means used therewith
Reexamination Certificate
2000-06-30
2002-03-12
Kamm, William E. (Department: 3762)
Surgery
Miscellaneous
Devices placed entirely within body and means used therewith
Reexamination Certificate
active
06354299
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the field of devices implantable within the head of a human being, and more particularly to intracranially implantable medical devices useful in the treatment of neurological disorders.
BACKGROUND OF THE INVENTION
The current state of the art in treating neurological disorders such as epilepsy or Parkinson's disease involves either drugs or the open-loop electrical stimulation of neurologic tissue. Drug therapy has been shown to have significant short and long-term side effects and is often ineffective. In U.S. Pat. No. 3,850,161, Liss describes a continuous closed-loop feedback system which will always feedback part of the brain EEG signal to separate electrodes so that if a large EEG signal occurs it will be fed back in an attempt to cancel out the original signal. This system does not take advantage of recently developed digital signal processing and microcomputer technology by which feedback signals can be activated only when a neurological event occurs, nor does it provide a practical means to recognize and intervene during early stages in the evolution of a neurological event. In addition, the Liss device is not programmable and it does not provide a means to record EEG signals. Examples of a “neurological event” are the occurrence of an epileptic seizure or the occurrence of a migraine headache. A “neurological event” is defined herein as either the precursor of an event such as an epileptic seizure, or the epileptic seizure itself. This concept of detecting an electrical precursor that is a first type of neurological event that occurs some time before the “real” event (i.e. anomalous brain electrical activity associated with clinical symptoms) is an important aspect of the present invention. It has been shown that both epileptic seizures and Parkinson's tremors have precursors that occur before and can be used to predict the onset of the clinical symptom. It is also very likely that other neurological events such as migraine headaches and depression would have anomalous electrical activity predictive of the onset of clinical symptoms. Methods for the prediction of epileptic seizures have been published by Elger and Lehnertz, 1998 European Journal of Neuroscience, 10, 786-789 “Seizure Prediction by Non-linear Time Series Analysis of Brain Electrical Activity”, and Osorio, Frei and Wilkinson, Epilepsia 39 (6):615-627, 1998 “Real-time automated detection and quantitative analysis of seizures and short-term prediction of clinical onset”.
Maurer and Sorenson in U.S. Pat. No. 4,019,518 describe a combined internal/external system for electrical stimulation of the body with biphasic pulses but do not describe any means of detecting neurological events. Fischell, in U.S. Pat. No. 4,373,527, describes a programmable medication infusion system but does not anticipate its use in response to a detected neurological event.
More recently, a device has been approved for human use to stimulate the vagus nerve in a continuous fashion with the objective of decreasing the rate of epileptic seizures. Clinical reports on such devices indicate only a modest degree of success in that only 50% of the patients experience a greater than 20% reduction in the rate of epileptic seizures. Another device that has been recently introduced into clinical practice utilizes continuous stimulation of the thalamus for the treatment of involuntary motion disorders such as Parkinson's syndrome.
Neither of these two open-loop devices described above is highly effective for the treatment of a neurological disorder such as epilepsy, and neither anticipates the use of decision making in order to optimize a response to turn off the neurological event nor the recording of EEG signals.
The automatic implantable cardiac defibrillator is an example of a decision making device having data recording capability that has been successfully used in a decision based closed-loop mode for the treatment of ventricular fibrillation. However, the requirements for detection and treatment of ventricular fibrillation are significantly simpler and certainly different from the requirements for a device to detect and treat an impending epileptic seizure. Specifically, an implantable cardiac defibrillator requires only a single signal, namely the heart's ECG, in order to detect a fibrillation event. What is more, only a single pair of electrodes is required for detection of the fibrillation event and that same pair of electrodes can be used to provide an electrical stimulus for electrical defibrillation. A heart defibrillator electrode is adapted to be placed on or in close proximity to the heart and is not suitable for use as a brain electrode.
Coker and Fischell in U.S. Pat. No. 4,581,758 describe sophisticated signal processing techniques using the sum of squared signals from two microphones to identify the direction with respect to a person from whom human speech originates. Although the Coker and Fischell patent teaches several signal processing techniques which may be applied with others to detect neurological events, the Coker and Fischell method is aimed at identifying the location of the speech source, while one of the goals of the present invention is to utilize the known location of the source of EEG signals to help identify an abnormal EEG which signifies an impending neurological event.
The NeuroCybernetic Prosthesis System, recently made available for the treatment of epileptic seizures, utilizes continuous open-loop stimulation of the vagus nerve. This device does not sense the onset of an epileptic seizure, and it utilizes wires that are placed in the neck. Because of the frequent motions of such wires, they will have a tendency to fracture. No existing system utilizes electrodes, electrical wires and a control module that are entirely contained within the patient's scalp and essentially all contained within the patient's cranium. Such systems would not have any repeated bending of connecting wires thereby improving long-term reliability. Furthermore, the NeuroCybernetic Prosthesis System does not use a rechargeable battery, nor does it utilize a separate external device controlled by the patient to activate the implanted system at the start of a neurological event in order to decrease the severity or time duration of the neurological event.
Various cochlear and ossicular implant devices are available that amplify ambient sounds and accordingly stimulate the nerves or bones of the inner or middle ear to provide hearing assistance to individuals with hearing loss. See, e.g., Loizou, P. (1998), “Mimicking the human ear,” IEEE Signal Processing Magazine, 15(5), 101-130. Such devices are directed to receiving, amplifying and transmitting sounds present in the external environment; they do not provide any therapy or additional information (not derived from environmental sound) to their users.
SUMMARY OF THE INVENTION
The present invention is a multiple electrode, closed-loop system for the treatment of certain neurological disorders such as epilepsy, migraine headaches and Parkinson's disease. A purpose of the present invention is to overcome the shortcomings of all prior art devices for the treatment of such disorders. Specifically, the present invention combines a multi-electrode array with sophisticated signal processing techniques to achieve reliable detection of the onset of a neurological event (such as an epileptic seizure or migraine headache) typically originating from a focus of limited spatial extent within the brain. It is well known that in certain patients, epileptic seizures consistently originate from a single location within the brain. However, the system described herein is also adaptable for the treatment of a neurological event that involves a major portion or possibly all of the brain tissue.
The present invention also provides means for generating an ensemble of coordinated electrical stimuli designed to terminate the neurological event immediately upon (or even prior to) its onset. Thus, the present invention is a resp
Archer Stephen T.
Fischell David R.
Fischell Robert E.
Upton Adrian R. M.
Kamm William E.
NeuroPace, Inc.
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