Electroconvulsive therapy testing and training device

Details Electroconvulsive therapy testing and training device Electroconvulsive therapy testing and training device

1999-08-23

2001-03-13

Getzon, Scott M. (Department: 3737)

Surgery: light, thermal, and electrical application

Light, thermal, and electrical application

Reexamination Certificate

active

06200331

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to medical devices and more particularly to devices for the testing of ECT (electroconvulsive therapy) instruments and for training in the usage of such instruments.
BACKGROUND OF THE INVENTION
The present invention relates to an ECTOBRAIN (TM of Somatics, Inc.) dual function device. It is a computer controlled device that simulates a patient undergoing ECT. It can be used for two separate but related purposes, namely:
(1) To train psychiatrists in the correct use of ECT devices, including the accurate interpretation of the printed and auditory output of ECT devices;
(2) To test the integrity, calibration and functioning of ECT devices used to administer electroconvulsive therapy (ECT).
Training Function
Over the past 60 years modern ECT (electroconvulsive therapy) has evolved into a highly sophisticated procedure conducted under general anesthesia (Abrams, 1997). Successful ECT requires the treating psychiatrist to have intimate knowledge of the several parameters of the electrical stimulus, as well as the ability to monitor and interpret the electroencephalogram (EEG), electrocardiogram (ECG), and electromyogram (EMG) records now routinely obtained during each ECT treatment. For example, U.S. Pat. Nos. 4,878,498 and 5,260,302: Electroconvulsive Therapy Apparatus and Method for Automatic Monitoring of Patient Seizures; and U.S. Pat. No. 5,871,517: Convulsive Therapy Apparatus to Stimulate and Monitor the Extent of Therapeutic Value of the Treatment, describe ECT instruments which monitor one or more of EEG, ECG and EMG. The American Psychiatric Association Task Force Report (1990) recommends monitoring of EEG and ECG during ECT.
These above-named patents and articles and other patents and articles mentioned herein are incorporated by reference.
Specific training and skill in the administration of modern ECT is required for hospital accreditation and for board-certification in psychiatry. However, many hospitals and psychiatric residency training programs lack either sufficient trained personnel to instruct psychiatric residents and staff to the requisite level of skill, or lack a sufficient number of patients receiving ECT to provide the necessary clinical experience. In a survey of ECT usage in New York hospitals, Asnis et al (1976) concluded that “training programs were minimal and unplanned.” Pippard (1992), following up on the results of an earlier, highly-critical survey of the quality of ECT administration in the United Kingdom (Pippard and Ellam 1981), found that despite the specific recommendations of their 1981 study “stimulus-dosing is [still] usually by habit rather than rational strategy, and routine instrument settings differ fourfold between clinics.” An Australian ECT training survey (Halliday and Johnson, 1995) found that “in most centres, training typically consists of registrars [psychiatric residents] being supervised once or twice by another registrar, and thereafter administering ECT alone.”
This world-wide deficiency in ECT training has led several medical educational centers (e.g., Columbia University, Duke University, Long Island Jewish-Hillside Hospital Medical Center) to establish continuous, year-round ECT workshops for the purpose of training psychiatrists in ECT. These workshops last from 1 to 5 days and provide a range of didactic and clinical experience in various aspects of ECT.
Although such extramural training programs are important, they are too few to make up for the inadequate training in ECT received by hundreds of psychiatric residents graduated each year from U.S. medical schools and hospitals. Moreover, even these specialized ECT courses may lack sufficient patients receiving ECT to provide each trainee with “hands-on” experience in administering the treatment and interpreting the monitored recordings obtained. No medical educational center possesses all of the various available ECT devices required to train doctors in the use of any ECT device they might reasonably expect to encounter in clinical practice.
ECT Device Testing Function
The electronically sophisticated circuitry used by modern ECT devices to generate therapeutic electrical stimuli, and to monitor and display the physiological functions of interest (EEG, ECG, EMG) is necessarily sensitive—requiring frequent calibration—and subject to occasional malfunction. When such a malfunction occurs, patients may suffer from not being able to receive their scheduled ECT treatment, due to the time and effort required for a biomedical analysis of the problem. Such problems often require that the malfunctioning ECT device be returned to the manufacturer for testing and repair. When such return is required, the hospital incurs the cost of renting a “loaner” device to temporarily replace the malfunctioning one, the cost of evaluation or repair, and the shipping costs. Alternatively, the hospital incurs the cost of having the manufacturer send a technician to examine the ECT device on site. Moreover, the experience of one ECT device manufacturer (Somatics, Inc., Lake Bluff, Ill.) is that a substantial number of allegedly malfunctioning ECT devices returned for testing actually have nothing wrong with them—operator error is determined to be the problem.
SUMMARY OF THE INVENTION
In accordance with the present invention there is provided a device called ECTOBRAIN (TM of Somatics, Inc.) which may perform either one, or two, functions. One function is to test ECT instruments by generating a sequence of electrical outputs that simulate the EEG, EKG and EMG of various types of patients. That set of generated electrical stimuli is a standard set of data. That standard data set is compared with the responses of the ECT instrument to the simulated data generated by the ECTOBRAIN. If the responses of the ECT instrument are outside of pre-set limits, the instrument is considered to be malfunctioning and should be re-calibrated or repaired.
One embodiment of the present invention is a metal box (“ECTOBRAIN”) containing battery-powered electronic components (e.g., microprocessor, resistors, printed circuit board, analog-to-digital converter, externally programmed chips). It generates three different electrical wave-forms which simulate the waveforms of a patient, namely, an EEG wave-form, an ECG wave-form, and an EMG wave-form. These wave-forms have been derived from FM (analog) tape recordings of EEG, ECG and EMG in actual patients undergoing ECT. One or more 30-second segments of the analog recordings are de-artifacted, digitized, and stored on chips, or other digital storage devices, to provide a complete service “continuous-loop” repetitive output function. The surface of the box contains separate connectors, e.g., banana-plug receptacles, for attaching the ECT stimulus leads of an ECT device, and for attaching the EEG, ECG and EMG recording leads of an ECT device, e.g., post connectors.
With the ECTOBRAIN powered on, the ECT stimulus and recording cables are connected to their respective receptacles, and the ECT device is powered on. The ECTOBRAIN then provides a set of wave forms which are a complete simulation of a patient, as follows:
1. Initiating the impedance testing function of the ECTOBRAIN by applying an impedance-testing current to connect a resistance within the ECTOBRAIN, for example, 200 ohms impedance. That resistance causes an impedance test value to be displayed on the ECT device, which should be, for example, 200 ohms, with a range of ±20 ohms. In another embodiment, this resistance value can be varied by the operator (usually the instructor), for training purposes, to produce a number that is too high, too low, or in the correct range.
2. Pressing the TREAT (stimulus) button of an ECT device automatically initiates its chart recorder. The ECTOBRAIN generates a continuous-loop signal of each of the three wave-forms (EEG, ECG, EMG), which appear as tracings on the paper record of the chart recorder according to the number and type of channels selected on the ECT device. For example, if the ECT device ha

Affiliated with

Also associated with

Rating

Electroconvulsive therapy testing and training device does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Electroconvulsive therapy testing and training device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Electroconvulsive therapy testing and training device will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-2492053