Electro-convulsive therapy (ECT) system with enhanced safety features

• US 6,014,587 A
• Filed: 09/18/1997
• Issued: 01/11/2000
• Est. Priority Date: 11/24/1995
• Status: Expired due to Term

• Current Assignee: MECTA Corporation
• Original Assignee: MECTA Corporation
• Inventors: Sunderland, Richard A., Shaw, John B.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/933,186
• Time in Patent Office: 845 Days
• Field of Search: 607/45, 607/46, 607/63, 607/72
• US Class Current: 607/45
• CPC Class Codes: A61N 1/38 for producing shock effects

Abstract

An electro-convulsive therapy (ECT) system includes both hardware and software safety detectors and monitors generator that generates a pulse train of a plurality of pulses with parameters specified by the user. The safety monitors monitor these user-specified parameters as well as other important pulse parameters both during treatment of a patient and prior to treatment in order to ensure that the system is operating according to specification and, therefore, will not injure the patient. The pulse generator is responsive to the safety monitors in that if any of the safety detectors detect a parameter that is out of tolerance, the safety monitor disables the pulse generator so that no further pulses are delivered to the patient. The safety detectors detect the plurality of pulse characteristics including pulse width, frequency, voltage, current, treatment duration, as well as energy. In addition to these real time safety checks, the system includes a pre-treatment arming routine that applies a pre-treatment ECT pulse train to an internal load and monitors these same parameters during this internal test. If all of these parameters are within tolerance, the system moves to an armed state in which the user can proceed to apply an ECT treatment pulse train. If any one of these safety checks fails, however, the system does not arm and, therefore, prohibits treatment.

Claims

1. An electro-convulsive therapy (ECT) system comprising:

means for applying a train of ECT treatment pulses to a patient, each treatment pulse having a pulse width, the elapsed time of the pulse train defining a pulse train duration, and the time between adjacent pulses defining a frequency;

a pulse width detector that measures the pulse width of each applied ECT treatment pulse; and

a pulse width monitor coupled to the pulse width detector that disables the applying means if a detected pulse width exceeds a predetermined maximum pulse width.

2. An electro-convulsive therapy (ECT) system according to claim 1 wherein the pulse width monitor includes:

a safety processor; and

a pulse width monitoring routine executed by the safety processor, wherein the safety processor under control of the pulse width monitoring routine measures the pulse width of an applied pulse and disables the applying means if a detected pulse width is outside of a predetermined pulse width tolerance.

3. An electro-convulsive therapy (ECT) system according to claim 2 further comprising:

an internal load;

a switch coupled between the internal load and the applying means, the switch having a first state wherein the load is disconnected from the applying means and a second state wherein the internal load is connected to the applying means;

the safety processor coupled to the switch and the applying means;

a pre-treatment "arming" routine executed by the safety processor, wherein the safety processor under control of the "arming" routine performs the following steps;

switches the state of the switch from the first state to the second state, and

applies a pre-treatment pulse train to the internal load, whereafter the pulse width detector detects the pulse width of each pre-treatment pulse and the pulse width monitor disables the applying means if the detected pulse width of a pre-treatment pulse is outside a predetermined range.

4. An electro-convulsive therapy (ECT) system according to claim 1 wherein the means for applying an ECT treatment pulse to a patient includes:

a programmable timer that generates a first signal responsive to the expiration of a first programmed timer value and a second signal responsive to the expiration of a second programmed timer value;

a pulse generator for generating an ECT treatment pulse; and

a safety processor coupled to the timer to receive the first and second signals and coupled to the pulse generator to initiate a leading edge of an ECT treatment pulse responsive to the first signal and a trailing edge of the ECT treatment pulse responsive to the second signal.

5. An electro-convulsive therapy (ECT) system according to claim 4 wherein the pulse width detector includes:

means for detecting the leading edge of an ECT treatment pulse;

means for detecting the trailing edge of an ECT treatment pulse; and

means for determining the pulse width of the ECT treatment pulse responsive to the detected leading and trailing edges.

6. An electro-convulsive therapy (ECT) system according to claim 5 further comprising:

a pulse frequency detector that measures the pulse frequency of the applied ECT treatment pulse train; and

a pulse frequency monitor coupled to the pulse frequency detector that disables the applying means if the detected pulse frequency exceeds a predetermined limit.

7. An electro-convulsive therapy (ECT) system according to claim 6 wherein the pulse frequency detector includes:

means for detecting an edge of a first ECT treatment pulse;

means for detecting a corresponding edge of a subsequent ECT treatment pulse; and

means for determining the frequency of the ECT treatment pulse responsive to the detected edge of the first pulse and the detected corresponding edge of the subsequent pulse.

8. An electro-convulsive therapy (ECT) system according to claim 5 wherein the safety processor includes a pulse width feedback control routine for changing the programmed timer values responsive to the determined pulse width to adjust the pulse width of a subsequent ECT treatment pulse.

9. An electro-convulsive therapy (ECT) system according to claim 5 further comprising:

an internal load;

a switch coupled between the internal load and the applying means, the switch having a first state wherein the load is disconnected from the applying means and a second state wherein the internal load is connected to the applying means;

a safety processor coupled to the switch and the applying means;

a pre-treatment "arming" routine executed by the safety processor, wherein the safety processor under control of the "arming" routine performs the following steps;

switches the state of the switch from the first state to the second state,

applies a pre-treatment pulse to the internal load,

whereafter the pulse frequency detector detects the frequency of the pre-treatment pulse and the pulse frequency monitor disables the applying means if the detected pulse frequency of the pre-treatment pulse is outside a predetermined range.

10. An electro-convulsive therapy (ECT) system according to claim 1 further comprising:

a pulse train duration detector that measures the duration of the applied ECT treatment pulse train; and

a pulse train duration monitor coupled to the pulse train duration detector that disables the applying means if the detected pulse duration exceeds a maximum pulse train duration.

11. An electro-convulsive therapy (ECT) system according to claim 1 further comprising:

a power detector that measures the power of each applied ECT treatment pulse; and

a power monitor coupled to the power detector that disables the applying means if the detected power exceeds a predetermined limit.

12. An electro-convulsive therapy (ECT) system according to claim 1 further comprising a pulse width limiter circuit that limits the pulse width of an applied ECT treatment pulse if the detected pulse width exceeds a predetermined maximum pulse width.

13. An electro-convulsive therapy (ECT) system comprising:

means for applying a train of ECT treatment pulses to a patient, each treatment pulse having a pulse width, the elapsed time of the pulse train defining a pulse train duration, and the time between adjacent pulses defining a frequency;

a pulse train duration detector that measures the duration of the applied ECT treatment pulse train; and

a pulse train duration monitor coupled to the pulse train duration detector that disables the applying means if the detected pulse train duration exceeds a maximum pulse train duration.

14. An electro-convulsive therapy (ECT) system according to claim 13 wherein the pulse train duration detector includes a fixed duration timer that is reset at a beginning of each treatment pulse train;

and wherein the pulse train duration monitor includes a shut-down circuit coupled to the fixed duration timer that shuts down the applying means if the timer exceeds the maximum pulse train duration.

15. An electro-convulsive therapy (ECT) system according to claim 14 further including:

a safety processor; and

a timer monitor routine, wherein the safety processor under control of the timer monitor routine monitors the fixed duration timer and disables the applying means if the fixed duration timer fails to expire at the expiration of the maximum pulse train duration.

16. An electro-convulsive therapy (ECT) system according to claim 15 further wherein the safety processor includes an internal timer for monitoring the fixed duration timer.

17. An electro-convulsive therapy (ECT) system according to claim 15 further including an error handling routine executed by the safety processor, wherein the safety processor under control of the error handling routine displays an error if the fixed duration timer fails to expire at the expiration of the maximum pulse train duration.

18. An electro-convulsive therapy (ECT) system according to claim 13 further comprising:

a current detector that measures the current of the applied ECT treatment pulses; and

a current monitor coupled to the current detector that disables the applying means if the detected current is not within a predetermined range of acceptable currents.

19. An electro-convulsive therapy (ECT) system according to claim 18 further comprising:

a voltage detector that measures the voltage of the applied ECT treatment pulses; and

a voltage monitor coupled to the voltage detector that disables the applying means if the detected voltage exceeds a predetermined limit.

20. An electro-convulsive therapy (ECT) system according to claim 19 further comprising:

a power detector that measures the power of each applied ECT treatment pulses; and

a power monitor coupled to the power detector that disables the applying means if the detected power exceeds a predetermined limit.

21. An electro-convulsive therapy (ECT) system comprising:

means for applying a train of ECT treatment pulses to a patient, each treatment pulse having a pulse width, the elapsed time of the pulse train defining a pulse train duration, and the time between adjacent pulses defining a frequency;

a pulse train energy detector coupled to the applying means that measures the energy in the applied ECT treatment pulse train; and

a pulse train energy monitor coupled to the pulse train energy detector that disables the applying means if the detected pulse train energy exceeds a predetermined limit.

22. An electro-convulsive therapy (ECT) system according to claim 21 wherein the pulse train energy detector includes:

a power detector that generates a power signal having a signal level corresponding to the power of each applied ECT treatment pulse; and

an integrator coupled to the power detector for receiving the power signal, the integrator generating an energy signal corresponding to the level of energy of the applied ECT treatment pulse train.

23. An electro-convulsive therapy (ECT) system according to claim 22 wherein the power detector includes:

a voltage detector that generates a voltage signal proportional to the voltage level of an ECT treatment pulse;

a current detector that generates a current signal proportional to the current level of an ECT treatment pulse; and

a multiplier coupled to the voltage detector for receiving the voltage signal and coupled to the current detector for receiving the current signal, the multiplier generating a power signal that corresponds to the product of the voltage signal and the current signal.

24. An electro-convulsive therapy (ECT) system according to claim 22 wherein the integrator includes:

a voltage to frequency converter coupled to the multiplier for receiving the power signal, the converter generating a clock signal having a frequency proportional to the level of the power signal; and

a counter having a clock input coupled to the converter for receiving the clock signal, a reset input for receiving a reset signal, and having a counter output for producing a count signal corresponding to a number of transitions on the clock signal since a last reset signal, wherein the count signal represents the detected energy of the ECT treatment pulse train.

25. An electro-convulsive therapy (ECT) system according to claim 24 further including a comparator having a first set of inputs for receiving a number corresponding to the predetermined limit, a second set of inputs coupled to the counter output for receiving the count signal, and an output for generating an output signal when the count signal is equal to or greater than the predetermined number.

26. An electro-convulsive therapy (ECT) system according to claim 25 wherein the pulse train energy monitor includes a logic block coupled to the comparator that disables the applying means if the output signal indicates that the count signal is equal to or greater than the predetermined number.

27. An electro-convulsive therapy (ECT) system according to claim 25 further including a jumper block interposed between the counter and the comparator for setting the number.

28. An electro-convulsive therapy (ECT) system according to claim 24 further including a clock divider interposed between the converter and the counter for dividing the clock frequency by a predetermined number during a testing mode.

29. An electro-convulsive therapy (ECT) system according to claim 28 wherein the clock divider includes a multiplexer coupled to the counter for selecting one of two counter outputs.

30. An electro-convulsive therapy (ECT) system according to claim 21 further comprising:

an amplifier for receiving a patient monitoring signal; and

means for removing the patient monitoring signal from the amplifier during each ECT treatment pulse.

31. An electro-convulsive therapy (ECT) system according to claim 21 further including:

means for dynamically measuring patient impedance during application of the ECT treatment pulse train; and

means for disabling the applying means if the measured dynamic impedance exceeds a predetermined maximum dynamic impedance.

32. An electro-convulsive therapy (ECT) system according to claim 21 further including:

means for measuring a static impedance of a patient prior to treatment; and

a graphical display coupled to the static impedance measuring means that displays a graphical representation of the measured static impedance.

33. An electro-convulsive therapy (ECT) system according to claim 32 further including means for indicating on the graphical display an acceptable range of static impedance.

34. A method of ensuring the safety of a patient during electro-convulsive therapy (ECT) comprising:

applying a train of ECT treatment pulses to a patient;

measuring a pulse train parameter of the treatment pulse train applied to the patient; and

terminating the treatment pulse train if the measured pulse train parameter of the treatment pulse train fails to satisfy a predetermined criteria.