ELECTROCARDIOGRAPH AND BLOOD PRESSURE SIGNALS SIMULATOR

Abstract

System, methods, and apparatuses produce simulated human physiological waveforms such as electrocardiograph (ECG) and blood pressure signals where the microcontroller and/or digital-to-analog converters may be switched to a lower power-consuming state by programmable instructions and switched on in response to a programmable sleep timer.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

Reference is now made to the following description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is an exemplary functional block diagram of an embodiment of the present invention;

FIG. 2 is an exemplary strip chart of waveforms and signals across regions;

FIG. 3 is an exemplary circuit of an embodiment of the present invention;

FIG. 4A is a side view of an exemplary mechanical receiving system embodiment of the present invention;

FIG. 4B is a side view of the exemplary mechanical receiving system embodiment of the present invention;

FIG. 4C is a bottom-side perspective view of the exemplary mechanical receiving system embodiment of the present invention;

FIG. 4D is a top-side perspective view of the exemplary mechanical receiving system embodiment of the present invention;

FIG. 4E is a top-side perspective view showing the exemplary mechanical receiving system embodiment of the present invention in cross-section; and

FIG. 5 is an exemplary strip chart of waveform outputs and modes for an embodiment of the present invention.

DETAILED DESCRIPTION

A block diagram of an exemplary embodiment of the present invention is shown in FIG. 1. A power supply, external battery, or as shown in FIG. 1, an internal battery 101, provides power to a processing unit such as a microcontroller 102 through, what is shown in this example as a power switch 134. The microcontroller executes instructions at one or more rates based on its oscillator 104, which preferably is an oscillator that can be switched into a low power-consuming state by programmable instructions. In the event the oscillator may be switched to low power-consuming, the microcontroller ceases execution of instructions until a programmable sleep timer (PST) 103, counts down or times out using a rate of a second oscillator, for example, an oscillator that is run separately from the normal oscillator 104 of the microcontroller 102.

ECG simulation may be accomplished via one or more circuits that output analog signals based in discrete inputs, which may be accomplished, for example, by dual digital-to-analog converters (DACs) 112 and 118, where of these two DACs, the ECG High Side DAC 112 drives the high side of the ECG ladder 123 via a first hold circuit 121, and the ECG Low Side DAC 118 drives the low side of the ECG ladder via a second hold circuit 122. This dual DAC scheme allows for bipolar ECG output signals while using a single positive supply, and with both output signals nominally at ground. Each DAC has a data input connection, i.e., an ECG High Side DAC data input 113 and an ECG Low Side DAC data input 119. Both of these date inputs 113,119 connect 116 the DACs to the micro-controller 102. In addition, an ECG High Side DAC input signaling 117 and an ECG Low Side DAC input signaling 115 may place each respective DAC into a very low or zero power consumption mode 114 and 120 under the enabling control of the microcontroller via the input signaling 115, 117. The ECG ladder 123 is connected to the ECG connector array 124 where the signals are made available to the user. The ECG ladder 123 creates various linearly scaled versions of the ECG signal, each of which is connected to one or more positions of the ECG connector array 124, in order to mimic or otherwise simulate the signals seen generated by human patients at the various commonly used electrode placement locations.

When invasive blood pressure (IBP) simulation is desired, the user connects transducer cables to the IBP connectors, i.e., IBP1 connector 125 through IBPn connector 126. These transducer cables will provide one of several different transducer excitation signals, which are routed to the IBP supply generation circuit 129 via IBP1 signal path 130 through IBPn signal path 131. The IBP supply generation circuit 129 supplies positive and negative supply voltages 132 to the IBP1 DAC circuit 127 through the IBPn DAC circuit 128, and a positive supply voltage to the power switch 134, such that while IBP simulation is occurring, no current need be drawn from the internal battery 101. The IBP1 DAC circuit 127 and the IBPn DAC circuit 128 are shown in this example as being driven by the microcontroller 102 via a signal path 133.

A voltage reference 107 is normally off, but may be turned on by the micro-controller intermittently via a signal path 105 and its output read via signal path 106 and passed via an analog-to-digital (ADC) that may be internal to the microcontroller. This reading of voltage allows the microcontroller to assess the supply voltage 135 and adjust the data values written to the ECG DACs 112, 118 such that the ECG output waveform is of constant size irrespective of moderate variations in supply voltage. A simplified user interface 108 may be connected 111 to the microcontroller 102 and may include a single push button 109 and a single mode indicator lamp or an array of mode indicator lamps 110.

The simulator and the microcontroller in particular may have instruction loaded, or may have accessible memory, either or both of which may contain data or information reflective of a desired output waveform and particularly its profile which has particular features. The simulator generally attempts to output one or more of these waveforms and in doing so exploits one or more features of the profile of the waveform to economize on the power being used to generate such waveforms. Generation of an exemplary ECG signal is shown in FIG. 2. The output waveform 201, or desired output waveform profile, shown here may be described as having two features: following a first time range 206, or “Region 0,” there is a low slope and amplitude feature 251 in a second time range 207, or “Region 1,” and, following a third time range 208, or “Region 3,” there is a high slope and amplitude feature 252 in a fourth time range 209, or “Region 4.” The value of the programmable sleep timer (PST) 203 represents the time remaining until the microcontroller, particularly its oscillator, will be awakened from a sleeping state in that its normal oscillator is turned back on so that the microcontroller may again execute instructions responsive to the normal oscillator. In this example, the instruction execution, via the microcontroller, typically only occurs when the PST value is zero. During the entire time between the waveform features 206, 208, and 210 the PST value is non-zero 270, 272, 274 and both the microcontroller and the ECG DACs may be placed in very low power consumption sleep states.

During the time range of the low slope feature 251 in Region 1207, the micro-controller is awakened from its very low power state with a moderate frequency, and values written 261 to the DACs 202. Once the DAC values are written, the PST value is written with a non-zero value 271. Because the waveform is positive, only the high DAC enable signal 204 need be used and the low DAC 205 can be remain shut down. The length of time that the DAC needs to be enabled may be quite short as the data will be held by the hold circuit 121 until the next DAC write may be made.

During the time range of the high slope feature 252 of Region 4209, the microcontroller 102 is awakened from its low power state, and values 262 are written to the DACs 202 with a higher frequency so that the voltage granularity of the high slope feature is the same as the low slope feature. Once the DAC values are written, the PST value 203 is written with a non-zero value 273. At the edges 253, 254 of Region 4209, the waveform feature goes negative so the High DAC enable 204 is left off and the Low DAC enable 205 is briefly pulsed on 291, 292 after each write of data to the DACs. During the center part of the high slope region, the waveform feature 252 is positive so the High DAC enable 204 may be used 282. As the waveform feature 252 grows in amplitude, the length, or the width when one references the timeline, of the High DAC enable pulses 283 increases to insure that the hold circuit 121 is fully charged to the brief peak of the waveform feature 252. The PST value (203) in this example is a function of the waveform feature where for the low slope feature 251, the PST durations 271 are of a moderate length, for a high slope feature 252, the PST durations 273 are of a smaller length, and for periods of no output waveform, the PST durations 270, 272, 274 are of a longer length.

Detail of the IBP power generation circuit 129 is shown in FIG. 3. The IBP power generation circuit 129 provides for the generation of positive supply voltage to power the IBP simulator and does so by drawing from an excitation signal path from, for example, a device under test, like a monitor, and provides for the generation of a negative supply voltage to provide a voltage reference signal for a multiplying DAC and does so from the same or a different excitation signal path from the monitor. This may be embodied by example with the switching of charged capacitors and is preferably embodied by the use of a charge pump inverter. Accordingly, the return path to the monitor is an excitation signal path. When in use, one or more invasive blood pressure transducer cables are connected to the device. Each connected transducer cable supplies an excitation voltage 300-302. These excitation voltages 300-302 may be of various DC voltages, or may be AC signals with various sine waves or, for example, square wave properties, voltages, and frequencies. The various excitation voltages are converted to positive DC signals via peak capture diodes 303-305 and a capacitor 306. The positive DC signal 308 is converted to a negative DC signal 309 via a charge pump inverter 307. The positive DC signal 308 supplies power to the ECG circuitry, for example, via power switch 134 (FIG. 1) and blood pressure simulating circuitry, and the negative DC signal 309 supplies negative power to the blood pressure simulating circuitry, e.g., the IBP1 DAC circuit 127 (FIG. 1).

Detail of the ECG connector is shown in FIG. 4A. The user may need to connect ECG devices to the simulator which may utilize various connector types, generally standard female snap type connectors or “banana jack” type connectors of two possible diameters. FIG. 4A shows the male ECG snap 400 on the simulator, which may be fastened to the simulator body 401 and thereby allows for the connection to a female snap connector. The simulator body 401 may also have two cavities 402 and 403, one on either side, and both adjacent to, the ECG snap 400, which allow a volume for the insertion of the various diameter banana jack connectors in such a way that they may be mechanically forced into electrical connection with the male ECG snap 400. FIG. 4B shows a side view where the means of fastening is shown in this example to be a threaded bolt portion 405 engaged by a nut 404 turned to secure itself against the under wall 406 of the simulator case 401. FIG. 4C shows a side-bottom perspective view of the male ECG snap 400 engaging the simulator body 401. FIG. 4D shows a side-top perspective view of the male ECG snap 400 engaging the simulator body 401. FIG. 4E is a cross-sectional view taken from FIG. 4D at reference 4E where portions of the male ECG snap 400 may be addressed. The exemplary male ECG snap 400 may be described as having an inverted frustroconical top portion 406, a disc portion 407, a cylindrical or barrel portion 408 that may or may not be threaded, and a threaded cylindrical portion 405. The exemplary male ECG snap 400 may be axisymmetric and thread through a cylindrical aperture that may be equidistant between the two cavities 402, 403 and the diameter of the disc portion 407 is typically longer than the width between the two cavities 402, 403 or grooves, thereby allowing for the engagement of various connectors.

Detail of the user interface scheme is shown in FIG. 5. The simulator may be operated in several exemplary modes 500-505, each of which provides output of a specific simulated waveform. A single button press as shown as a directed arc 506 advances the unit to the next mode. In some of the modes such as the exemplary “ARR Sequence” 501 and the exemplary “HR Sequence” 502, the waveform may include a sequence of waveform types such that the simulator may output a specific waveform for a fixed number of simulated heart beats or a fixed time before transitioning on to a next specific waveform. The sequence of specific waveforms may represent either a physiologically significant sequence of events or a group of useful tests. While the simulator is performing one of these sequences the user may press and hold the user interface button for an extended period, typically a second or more, to activate what may be termed a “fast forward” function, as shown by the directed arcs 507 and 508. When activated, the fast forward function may operate to advance the simulation to the next specific waveform type of the sequence offered by the current mode. In some embodiments, the simulator may continue to output the next specific waveform type and not advance beyond that until the user again presses the button.

In another exemplary embodiment, the mode changing operation shown as arc 506 may be initiated by a double click of the button by the operator. For ease of use and to exploit user familiarity, the double click may have a timing interval similar to that of the double click of a computer mouse. As an aide to the operator, the mode LED may remain lit briefly on the release of the first click, and a second click while the LED is still lit is interpreted as a double click by the micro-processor, and, accordingly, a second click after the LED is turned off is interpreted as a successive single click.

The exemplary waveform advancements, shown as a first directed arc 507 and a second directed arc 508, may be initiated by a single click of the button. In such exemplary embodiments, the simulator may repeat a single waveform in the waveform sequence indefinitely, that is, until the mode button is single-clicked so as to advance the simulator to the next waveform.

The operation of “Push and Hold” of the mode button may effect a function that drives the invasive blood pressure waveforms to a ‘zero’ reference value for a period of time and may start other sequences.

Although this invention has been disclosed in the context of certain embodiments and examples, it will be understood by those or ordinary skill in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of ordinary skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above.

Claims

1. A physiological waveform simulator comprising: a sleep timer; anda microcontroller comprising: means for waking, responsive to an output from the sleep timer;means for writing a portion of a physiological waveform profile; andmeans for sleeping.

2. The physiological waveform simulator of claim 1 wherein the sleep timer comprises a sleep timer oscillator and the microcontroller further comprises a microcontroller oscillator.

3. The physiological waveform simulator of claim 1 wherein the sleep timer is invoked when a time slope of the physiological waveform profile becomes zero.

4. The physiological waveform simulator of claim 1 wherein the means for writing comprises a writing module for writing a plurality of physiological waveform values representative of a physiological waveform profile to a digital-to-analog converter.

5. The physiological waveform simulator of claim 1 wherein the means for writing comprises a writing module for executing one or more writing events including a first writing event wherein the microcontroller transmits a first physiological waveform value based on the physiological waveform profile; and wherein the microcontroller is placed in a lower power-consuming state after the writing module transmits the first physiological waveform value.

6. The physiological waveform simulator of claim 5 wherein the writing module for executing one or more writing events further includes a second writing event wherein the microcontroller wakens and transmits a second physiological waveform value based on the physiological waveform profile;wherein the microcontroller is placed in a lower power-consuming state after the writing module transmits the second physiological waveform value; andwherein a time interval between the first writing event and the second writing event is based on the physiological waveform profile.

7. The physiological waveform simulator of claim 6 wherein a time interval between the first writing event and the second writing events is inversely related to non-zero time rates of change in the physiological waveform profile.

8. A physiological waveform simulator comprising: a sleep timer; anda microcontroller comprising: a writing module for executing one or more writing events including a first writing event wherein the microcontroller transmits a first physiological waveform value based on the physiological waveform profile, to a digital-to-analog converter; and wherein the microcontroller is adapted to be placed in a lower power-consuming state after the writing module transmits the first physiological waveform value; andwherein the digital-to-analog converter is adapted to be placed in an on state to receive the first transmitted physiological waveform value and the digital-to-analog converter is adapted to be placed in a lower power-consuming state after receiving the first physiological waveform value transmission.

9. The physiological waveform simulator of claim 8 wherein the sleep timer comprises a sleep timer oscillator and the microcontroller further comprises a microcontroller oscillator.

10. The physiological waveform simulator of claim 8 further comprising a sample-and-hold circuit for receiving an output of the digital-to-analog converter prior to the digital-to-analog converter being placed in a lower power-consuming state.

11. The physiological waveform simulator of claim 8 wherein the writing module for executing one or more writing events further includes a second writing event wherein the microcontroller transmits a second physiological waveform value to a digital-to-analog converter; andwherein the digital-to-analog converter is adapted to be placed in an on, or awake, state to receive the second transmitted physiological waveform value and the digital-to-analog converter is adapted to be placed in a lower power-consuming state after receiving the second physiological waveform value transmission and wherein a time interval between the first writing event and the second writing event is based on the physiological waveform profile.

12. The physiological waveform simulator of claim 8 wherein the digital-to-analog converter is adapted to be placed in an on state responsive to the sleep timer.

13. The physiological waveform simulator of claim 8 wherein the sleep timer is invoked when a time slope of the physiological waveform profile becomes zero.

14. The physiological waveform simulator of claim 8 wherein a time interval between the first writing event and the second writing events is inversely related to non-zero time rates of change in the physiological waveform profile.

15. The physiological waveform simulator of claim 8 wherein the digital-to-analog converter is output-enabled to output a value for a duration wherein the digital-to-analog converter output-enabled duration is based on the physiological waveform profile.

16. The physiological waveform simulator of claim 8 wherein the digital-to-analog converter is output-enabled to output a value for a duration wherein the digital-to-analog converter output-enabled duration is based on a magnitude of the physiological waveform profile.

17. The physiological waveform simulator of claim 8 wherein the digital-to-analog converter is output-enabled to output a value for a duration wherein the digital-to-analog converter output-enabled duration is based on a time rate of change of the physiological waveform profile.

18. A physiological waveform simulator comprising: a microcontroller;an electrocardiograph (ECG) ladder having a high side and a low side;a first digital-to-analog converter (DAC); anda second DAC; wherein the first DAC drives the high side of the ECG ladder via a first hold circuit, and the wherein the second DAC drives the low side of the ECG ladder via a second hold circuit.

19. A physiological waveform simulator comprising: a microcontroller comprising a means for writing a physiological waveform value to a digital-to-analog converter (DAC) wherein the DAC has a reference voltage; andwherein a positive supply voltage to the physiological waveform simulator is drawn from a monitor excitation signal and a negative supply voltage to the physiological waveform simulator is drawn from an output of a charge pump inverter driven by the monitor excitation signal.

20. The physiological waveform simulator of claim 19 wherein the monitor excitation signal is rectified.

21. A method of energy management for a physiological waveform simulator comprising: waking a microcontroller of the physiological waveform simulator from a sleep mode via a sleep timer;transmitting a first physiological waveform value, based on physiological waveform profile, to at least one of: a first receiving digital-to-analog converter and a second receiving digital-to-analog converter;putting the microcontroller into the sleep mode after the transmission of the first physiological waveform value; andenabling at least one of: (a) the first receiving digital-to-analog converter to be powered for a duration to drive a first hold circuit and (b) the second receiving digital-to-analog converter to be powered for a duration to drive a second hold circuit.

22. The method of energy management for a physiological waveform simulator of claim 21 wherein the enabling duration of the at least one of the first receiving digital-to-analog converter and the second receiving digital-to-analog converter is based on the physiological waveform profile.

23. The method of energy management for a physiological waveform simulator of claim 21 wherein the enabling duration of the at least one of: the first receiving digital-to-analog converter and the second receiving digital-to-analog converter is based on a magnitude of the physiological waveform profile.

24. The method of energy management for a physiological waveform simulator of claim 21 wherein the enabling duration of the at least one of: of the first receiving digital-to-analog converter and the second receiving digital-to-analog converter is based on a time rate of change of the physiological waveform profile.

25. A method of energy management for the physiological waveform simulator of claim 21 further comprising, when a monitor excitation source is available, powering a portion of the physiological simulator via the monitor excitation source.

26. The method of energy management for a physiological waveform simulator of claim 21 further comprising: waking, after a time interval, the microcontroller from a sleep mode via the sleep timer; andtransmitting a second physiological waveform value, based on physiological waveform profile, to at least one of a first receiving digital-to-analog converter and a second receiving digital-to-analog converter;wherein the time interval is based on the physiological waveform profile.

27. A method of energy management for the physiological waveform simulator of claim 26 further comprising inverting the monitor excitation source to drive at least one of: the first receiving digital-to-analog converter and the second receiving digital-to-analog converter.

28. A method of energy management for a physiological waveform simulator comprising: waking a microcontroller of the physiological waveform simulator from a sleep mode via a sleep timer;writing a first physiological waveform value, based on physiological waveform profile; andputting the microcontroller into the sleep mode after the writing of the first physiological waveform value.

29. The method of energy management for a physiological waveform simulator of claim 28 further comprising: waking, after a time interval, the microcontroller from a sleep mode via the sleep timer; andwriting a second physiological waveform value, based on physiological waveform profile;wherein the time interval is based on the physiological waveform profile.

30. A method of energy management for the physiological waveform simulator of claim 28 further comprising, when a monitor excitation source is available, powering a portion of the physiological waveform simulator via the monitor excitation source.

31. A method of energy management for the physiological waveform simulator of claim 30 further comprising inverting the monitor excitation source to drive at least one digital-to-analog converter.

32. A display system for a physiological waveform simulator having at least two output modes, the display system comprising: a button;a lighting circuit;an output mode lamp array comprising two or more lamps; andwherein a depression and release of the button advances the physiological waveform simulator to a successive output mode and switches the lighting circuit to a lamp associated with the successive output mode; andwherein, for at least one of the output modes, a depression and continued depression of the button advances the physiological waveform simulator to a successive waveform output series of the at least one output mode.

33. A display system for a physiological waveform simulator having at least two output modes, the display system comprising: a button;a lighting circuit;an output mode lamp array comprising two or more lamps; andwherein a double click of the button advances the physiological waveform simulator to a successive output mode and switches the lighting circuit to a lamp associated with the successive output mode; andwherein, for at least one of the output modes, a single click of the button advances the physiological waveform simulator to a successive waveform output series of the at least one output mode.

34. An electrical connector receiving system for a physiological waveform simulator comprising: a snap portion comprising: a disc portion having a top side, a bottom side and an edge; andthe snap portion further comprising an inverted frustroconical portion fixedly attached to the top side of the disc portion; anda mounting element having planar surface proximate to a first aperture; andwherein the bottom side of the disc portion is proximate to the planar surface of the mounting element, and a first sector of the bottom side of the disc portion extends over a portion of the first aperture.

35. The electrical connector receiving system for a physiological waveform simulator of claim 34 wherein the planar surface of the mounting element is interposed between the first aperture and a second aperture; and wherein a second sector of the bottom side of the disc portion extends over a portion of the second aperture.