WO2009009820A1

WO2009009820A1 - Simulating patient examination and/or assessment

Info

Publication number: WO2009009820A1
Application number: PCT/AU2008/001013
Authority: WO
Inventors: Cyle Duane Sprick; Karen Jane Reynolds; Harry Owen
Original assignee: Flinders University
Priority date: 2007-07-13
Filing date: 2008-07-11
Publication date: 2009-01-22

Abstract

A system (100) for simulating patient examination and/or assessment is disclosed. The system includes a control station (1 10) for interacting with a software model (120) modelling physiological characteristics of a patient to obtain information and activating a communications interface (150) to transmit a signal encoding the obtained information. One or more instrument modules (130) receive the signal from the control station (1 10) and decode the signal to provide an output indicative of a physiological characteristic modelled by the software model (120). A method of generating a simulated patient examination and/or assessment environment is also disclosed.

Description

SIMULATING PATIENT EXAMINATION AND/OR ASSESSMENT

This international patent application claims priority from Australian provisional patent application no. 2007903808 filed on 13 July 2007, the contents of which are to be taken as incorporated herein by this reference.

Field of the Invention

The present invention relates to the field of medical training. In a typical application the invention may be used for educating a health care worker, such as a nurse, paramedic, or a doctor, in patient examination and/or assessment skills.

Background of the Invention

Training students in patient monitoring typically involves an education process comprising a number of stages. Usually, the process begins with a theoretical component in which the student is introduced to the monitoring procedures and techniques. Generally speaking, the theoretical component is subsequently followed by a practical component involving the student practicing their newly acquired skills on actual patients. Unfortunately, allowing student contact with real patients can be stressful for both the student and the patient, and may lead to a potential for serious adverse events.

There are two significant and interrelated aspects in training a student in patient monitoring. First, a student should be trained in the correct use of the various monitoring instruments and devices. Second, a student should be trained to interpret and manage information from different types of instruments and, in particular, to analyse that information so as to analyse a patient's condition and response to medical treatment.

Recently, educational practices have developed which revolve around case- based learning in small groups. In conjunction with this method, patient simulators (such as manikins) have been developed to provide students with a way to practice procedures and techniques before contacting real patients. These simulators have gradually improved in complexity, realism, and naturally cost. Despite that, from a student's perspective the extent to which the educational experience mimics a realistic clinician-patient interaction, and available contact time with these simulators is limited.

Another technique used to allow students to practice is the use of standardized patients. In this approach, an actor may play the part of the patient and pretend to exhibit the signs and symptoms appropriate for a physiological condition. One benefit of standardized patients is much more realistic clinician-patient interaction since using a standardized patient restores all of the missing patient interaction skills. However, one drawback to standardized patient is that their physical examination is unrealistic.

In view of the above, there exists a need for a system that provides an educational environment which exhibits physiologic measurements appropriate for a simulated disease state, while maintaining a realistic clinician-patient interaction. To date, such an environment has typically been provided using a real patient.

The discussion of the background to the invention herein is included to explain the context of the invention. This is not to be taken as an admission that any of the material referred to was published, known or part of the common general knowledge as at the priority date of any of the claims.

Summary of the Invention

The present invention provides a system for simulating patient examination and/or assessment, including: a control station for interacting with a software model modelling physiological characteristics of a patient to obtain information, and activating a communications interface to transmit a signal encoding the obtained information; and one or more instrument modules for receiving the signal from the control station and decoding the signal to provide an output indicative of a physiological characteristic modelled by the software model.

The present invention also provides a system for providing a simulated patient examination and/or assessment environment, the system including: a memory device for storing a software model modelling physiological characteristics of a patient; a control station including: a processor; an associated memory device for storing a series of instructions for execution by the processor to cause the processor to interact with the software model to obtain simulation information; and a communications interface for transmitting a signal encoding the obtained information; and a plurality of instrument modules, each module including a communications interface for receiving the signal from the control station, a decoder for decoding the signal, and an output device responsive to the decoded signal to provide an output indicative of a physiological characteristic modelled by the software model.

The communications interface may be a wired or wireless communications interface. The present invention also provides a method of generating a simulated patient examination and/or assessment environment, including: interacting with a software model modelling physiological characteristics of a patient to obtain information; transmitting a signal encoding the obtained information to one or more instrument modules; and the one or more instrument modules receiving the signal from the control station and decoding the signal to provide an output indicative of a physiological characteristic modelled by the software model. The present invention also provides a method of providing a simulated patient examination and/or assessment environment, the method including: providing a memory device for storing a software model modelling physiological characteristics of a patient; providing a control station including: a processor; an associated memory device for storing a series of instructions for execution by the processor to cause the processor to interact with the software model to obtain simulation information; and a communications interface for transmitting a signal encoding the obtained information; and providing a plurality of instrument modules, each module including a communications interface for receiving the signal from the control station, a decoder for decoding the signal, and an output device responsive to the decoded signal to provide an output indicative of a physiological characteristic modelled by the software model. The present invention also provides a computer software program embodied on a computer readable memory, the computer software program being executable by a computer to cause the computer to: interact with a software model modelling physiological characteristics of a patient to obtain simulation information; and activate a communications interface to transmit a signal encoding the obtained information, the signal for transmission to one or more instrument modules for receiving the signal from the computer and decoding the signal to provide an output indicative of a physiological characteristic modelled by the software model.

The present invention also provides an instrument module for providing an output indicative of a simulated physiological characteristic of a patient, the instrument module including: a communications interface for receiving and decoding a signal from a control station, the signal encoding simulation information obtained from an interaction between the control station and a software model modelling physiological characteristics of the patient; and an output device for providing an output indicative of a physiological characteristic modelled by the software model according to the decoded information.

In some embodiments, each instrument module may further include sensors to sense actions of the user. For example, in some embodiments an instrument module may include one or more sensors for sensing actions of the user, and a processing means for modifying the performance and/or output indication of the instrument module in response thereto. Another embodiment of an instrument module may communicate a signal encoding information derived from, or representing, a value of a sensed parameter for processing by the control station. Such processing may result in either the sensed value itself, or another value or command that has been derived from or using the sensed value, being communicated to other instrument modules.

An advantage of the present invention is that it provides a simulation environment which permits a realistic clinical-patient interaction without endangering a real patient. Thus, the present invention is expected to permit student training that improves the confidence or competency of students prior to contact with real patients. The present invention may be used in a simulation environment that involves real people playing the role of a real patient (such as an actor) or, alternatively, a "dumb" manikin.

General Description of the Invention As summarised above, the present invention provides a system and method for providing a simulated patient examination and/or assessment environment for training a user (typically a student). In one aspect, the present invention provides a computer enabled system and method that includes a control station for interacting with a patient software model to obtain information for communication to one or more instrument modules. The one or more instrument modules receive and decode the signal to provide an output indication to the student. The output is indicative of a physiological characteristic of the patient modelled by the software model. Thus, the patient modelled by the software model is effectively a "virtual patient" or a "simulated patient". Preferably, the interaction between the control station and the software model is such that the simulation environment is a real-time simulation environment.

Each of the instrument modules may include an actual medical monitoring instrument or device that is adapted to receive the communication from the control station so that the output of the medical monitoring instrument or device may be manipulated in accordance therewith. For example, each instrument module may be interfaced with an adapter for receiving the communication from the control station and for controlling the output of the instrument module in accordance therewith. Alternatively, each instrument module may include a training device that provides an output indication in a form that is representative of the output indication that would have been provided by an actual medical monitoring instrument or device. In one embodiment, for example, each instrument module may be a training device that is programmable, or otherwise configurable, to provide an output indication that simulates the output indication that would be provided by an actual medical monitoring device or instrument.

Irrespective of the configuration of the instrument modules, instead of outputting actual measurement information for a "real" patient, each instrument module will provide a synthesised output. In other words, each instrument module will provide an output that has been generated, or derived from, information that has been obtained from the interaction between the control station and the software model, as opposed to from an interaction between actual medical monitoring devices or instruments, and a real patient.

In a typical application, each of the instrument modules may provide an output indicative of a particular physiological characteristic. Thus, a system embodiment may include separate instrument modules for providing outputs indicative of different particular physiological characteristics such as, for example, temperature, blood pressure, blood-oxygen saturation, pulse-rate, and the like.

Preferably, each of the modelled physiological characteristics will be consistent with a physiological condition modelled by the software model. Examples of physiological conditions which may be modelled by the software model include ananaphylaxis, asthma, a cardiac arrest, hyperthermia, hypoglycaemia, hypothermia, and pneumonia, though it will of course be appreciated that present invention may simulate a variety of physiological conditions. In an embodiment, the behaviour of the output indication provided by each of the instrument modules will characterise the physiological condition simulated by the software model. As a result, each of the instrument modules will typically provide output indications that are synchronised. Thus, for example, if the software model is activated to simulate an asthmatic episode, the respective instrument modules may generate outputs indicative of a low blood-oxygen saturation, a higher than usual pulse-rate, and a higher than usual temperature. The software model may be manipulated, either automatically or manually, in response to the actions of the student during a simulated exercise. Such manipulation may occur in response to an instructor interacting with the control station to manually update parameters for modelled physiological characteristics whilst observing the actions of the student. For example, if during a simulated asthmatic episode the instructor observes the student simulating the administration of salbutamol, then the software model may respond by providing updated information for communication to the instrument modules to provide an output indication that indicates, for example, that the blood-oxygen saturation levels have improved and the pulse-rate has increased. The updated information may also result in an audio output indicative of a reduction in "wheezing".

During a simulated exercise, a student will typically interact with a standardized patient or manikin. The interaction will typically entail the student applying or utilising the instrument modules to simulate actions associated with examining and/or assessing physiological characteristics of the patient. In the case of a manikin, the student actions may include invasive or non-invasive actions.

Brief Description of the Drawings

The present invention will now be described in relation to various embodiments illustrated in the accompanying drawings. However, it must be appreciated that the following description is not to limit the generality of the above description. In the drawings:

Figure 1 is a high-level block diagram of a system in accordance with an embodiment of the present invention; Figure 2 is a block diagram of a control station suitable for incorporation in the system shown in Figure 1 ;

Figure 3 is a block dagram of a first embodiment of an instrument module suitable for incorporating with the system shown in Figure 1 ;

Figure 4 is a schematic diagram of the instrument module shown in Figure 3; Figure 5 is a block dagram of a second embodiment of an instrument module suitable for incorporating with the system shown in Figure 1 ;

Figure 6 is a block dagram of a third embodiment of an instrument module suitable for incorporating with the system shown in Figure 1 ;

Figure 7 is a schematic diagram of an example implementation of the system shown in Figure 1 ; and

Figure 7 A is a screen shot of an example GUI suitable for use with the system shown in Figure 7; Figure 8 and Figure 9 are graphs showing different approaches for changing the values of parameter characteristics over a simulation period;

Figure 10 is a front view of an embodiment of an instrument module for providing an output indication that simulates the output indication of a stethoscope; Figure 1 1 is a front view of an embodiment of an instrument module for providing an output indication that simulates the output indication of a pulse oximeter;

Figure 12 is a front view of an embodiment of an instrument module for providing an output indication that simulates the output indication of a blood pressure monitor; Figure 13 is a front view of an embodiment of an instrument module for providing an output indication that simulates the output indication of a thermometer;

Figure 14 is a front view of an embodiment of an instrument module for providing an output indication that simulates the output indication of a glucometer;

Figure 15 is an example of a GUI for simulating the output indication of an ECG monitor;

Figure 16 is an interface diagram depicting the interfaces between the instrument modules and a control station in accordance with the embodiment shown in Fig.1 ; and

Figure 17 is a block diagram of a system in accordance with another embodiment of the present invention.

All figures are drawn for ease of explanation of the basic teachings of the present invention only. The details of the figures with respect to number, position, relationship, and dimensions of the parts to form the illustrated embodiment will be explained, or will be within the skill of a person skilled of the art after the following description has been read and understood.

Detailed Description of the Invention

Figure 1 shows an example computer enabled system 100 for educating a student in patient examination and/or assessment. As shown, the system 100 includes a control station 1 10 for access by a user (such as an instructor), a software model 120 for modelling physiological characteristics of a patient, and a plurality of instrument modules 130. The control station 1 10 and the instrument modules 130 are configured to communicate by way of a communications protocol 140, such as a Bluetooth compatible protocol, using a suitable communications interface 150. However, it will be appreciated that other wireless or wired protocols may be used.

The system 100 may be implemented using hardware, software or a combination thereof and may be implemented in one or more computer systems or processing systems. In particular, the functionality of the control station 1 10 may be provided by one or more computer systems.

As is shown in Figure 2, the control station 1 10 includes one or more processors, such as processor 202. The processor 202 is connected to a communication infrastructure 204, such as a bus. The control station 1 10 may include a display interface 206 that forwards graphics, texts and other data from the communication infrastructure 204 for supply to a display unit 208. The control station 1 10 may also include a main memory 210, preferably random access memory, and may also include a secondary memory 212. The secondary memory 212 may include, for example, a storage unit 213 such as a hard disk drive, flash memory, or the like. The secondary memory 212 may also include a removable storage drive 214 which reads from and/or writes to a removable storage unit 216 in a well known manner. The removable storage unit 216 represents a floppy disk, magnetic tape, optical disk, or the like. As will be appreciated, the removable storage unit 216 may include a computer usable storage medium having stored therein computer software in a form of a series of instructions to cause the processor 202 to carry out desired functionality. In alternative embodiments, the secondary memory 212 may include other similar means for allowing computer programs or instructions to be loaded into the control station 1 10. Such means may include, for example, a removable storage unit 218 and associated interface 215.

The control station 1 10 may also include a communications interface 220, which is additional to the communications interface 150 which, in this example, is shown as a wireless communications interface 222 for communicating with the instrument modules 130 (ref. Figure 1 ). Communications interface 220 may allow software and data to be transferred between the control station 1 10 and an external device (not shown). Examples of communication interface 220 may include a modem, a network interface, a communications port, a PCMIA slot and card or the like. Software and data may be transferred via the communications interface 220 in the form of signals which may be electromagnetic, electronic, optical, or other signals capable of being transmitted and/or received by the communications interface 220. The signals are provided to communications interface 220 via a communications path 221 such as a wire or cable, fibre optics, phone line, cellular phone link, radio frequency or other communications channels. As described above, the illustrated control station 1 10 also includes a wireless communications interface 222 for transmitting a wireless communication signal to one more of the instrument modules 130 (ref. Figure 1 ). Any suitable wireless communications interface 222 may be used, including, for example, a Bluetooth compatible wireless interface, an IEEE802.1 1 compatible wireless interface, a wireless USB compatible interface, a ZigBee compatible wireless interface, or a modulated FM wireless signal. However, in this embodiment the wireless communications interface is a Bluetooth compatible wireless interface.

Figure 3 shows a block diagram for an embodiment of a first type of instrument module 130-a. The first type of instrument module 130-a may be suitable for, for example, providing an output indicative of a measure of a physiological characteristic, such as temperature, blood glucose concentrations, oxygen saturation, haemoglobin, cardiac enzymes, or other blood chemistry measurement. As will be appreciated, such physiological characteristics would usually be measured using real medical instruments and/or devices such as a thermometer, a glucometer, a pulse oximeter, or an analytical device for point of care testing respectively.

As shown the instrument module 130-a includes a wireless communications interface 300, output device(s) 310 and power supply battery 330.

As is shown in Figure 4, in the present embodiment, the wireless communications interface 300 of the instrument module 130-a is implemented as a Bluetooth module (such as a National Semiconductor LMX9838, or BlueGiga WT12, or CSR BlueCore, or similar) comprising a RISC processor 410, antenna 420, 2.4GHz radio 430, and associated circuitry comprising a crystal 440 and memory 450.

Returning again to Figure 3, the output device 310 may be any device(s) known to those skilled in the art for generating an output indicative of a particular physiological characteristic. Suitable output devices 310 may include a display (such as a three digit LED or LCD display or a bar graph LED display), or custom LCD display, an audio speaker, or individual indicators. The output device 310 of the embodiment illustrated in Figure 4 is depicted as including a seven segment LED display for providing a numerical indication. The illustrated embodiment also includes switches 460 in the form of an on/off switch, a "Bluetooth connect" pushbutton, and a "display output" switch, and may also include an external power connector (not shown) to charge the on-board LiPoIy battery 330. The connect pushbutton is used to establish and maintain the Bluetooth connection in a conventional manner (similar, for example, to standard Bluetooth headsets). Other switches or user interface elements may also be provided. For example, a BCD rotary switch (also not shown) may also be provided to set a "group ID". The "group ID" may be used to control the formation of the Bluetooth piconet and thus allow multiple sets of instrument modules 130 to operate independently in the same physical space. Advantageously, this feature can be used for completely separate simulations, or for several patients in a multi-casualty incident controlled by one control station 1 10 (ref. Figure 1 ). Alternately, the BCD switch may select one of several control stations addresses with which to connect. Methods for storing and selecting which devices to connect to each other would be known to a skilled addressee. In the illustrated embodiment, the processor 410 in the Bluetooth module allows for a user program to run in a virtual machine while a main application controls complex Bluetooth operations. Such an approach is expected to eliminate the need for a separate processor to control the user interface.

Figure 5 shows a block diagram for a second type of instrument module 130-b according to an embodiment. The second type of instrument module 130-b may be suitable for, for example, providing an output indicative of a measure of a physiological characteristic after the instrument module 130-b has sensed that the student has performed an action necessary to obtain that measurement. For example, the second type of instrument module 130-b may be suitable for providing an output, such as oxygen saturation, as would usually be measured using an actual pulse oximeter, but only after the instrument module 130-b has sensed, using sensor 500, that the instrument module 130-b has been attached to the "patient's" finger. As will be appreciated, the type of sensor will depend on the action required to be sensed, and may include a position sensor, a temperature sensor, an optical sensor, an electromagnetic sensor, or a mechanically actuated sensor (such as a microswitch). In an embodiment, the sensor(s) 500 may be electrically connected to the I/O module 470 of Bluetooth module 300. Of course, it will be appreciated that other connection arrangements may be used for other types of wireless or wired communication interfaces. Figure 6 shows a block diagram for a third type of instrument module 130-c according to an embodiment. The third type of instrument module 130-c may be suitable for, for example, providing an output indicative of a measure of a physiological characteristic after the instrument module 130-b has sensed that the student has performed an action necessary to obtain a measurement and for operating an actuator 600 and/or speaker 610 in order to simulate the effect of the physiological characteristic.

For example, the third type of instrument module 130-c may be suitable for providing an audio output indicative of a physiological characteristic, such as an inflamed airway, as would usually be detected using an actual stethoscope, but only after the instrument module 130-c has sensed, using sensor 500, that the instrument module 130-b is in contact with the "patient". After having described three examples of different types of instrument modules 130, an example implementation will now be described with reference to Figure 7. It will be appreciated that although the following example describes a "wireless implementation", the present invention is not to be construed as being limited to a wireless implementation. Indeed, and as has been explained previously, a wired implementation could also be implemented using, for example, conventional wired interfaces between the interface modules and the control station (for example, such as an RS232, RS422, or Ethernet interface or the like). It will also be appreciated that a combination of wired and wireless interfaces may be used. Example 1 :

Figure 7 shows a schematic diagram for an example implementation of a system 100 in accordance with an embodiment of the present invention. As shown, the system 100 includes a memory device 700 for storing a software model modelling physiological characteristics of a patient. As described previously with reference to Figure 2, the system 100 also includes a control station 1 10 that itself includes a processor 202, an associated main memory 210, and a wireless communications interface 222 for transmitting a wireless signal encoding the obtained information. The memory 210 stores a series of instructions, in the form of a computer program, for execution by the processor 202 to cause the processor 202 to interact with the software model to obtain simulation information and a GUI displayed on display 208 to allow the instructor 720 to interact with the model via the control station 1 10.

A plurality of instrument modules 130-1 to 130-6 are also included. In the present example, instrument modules 130-1 , 130-2, 130-3, 130-4, and 130-5 are provided to provide an output indication that would usually be provided by an actual stethoscope, pulse oximeter, blood pressure monitor, thermometer, and glucometer respectively. Instrument module 130-6 is provided to generate a signal that is representative of a simulated physical characteristic, which in this example is the simulated patient's pulse. As previously explained with reference to the Figures 3 to 6, each instrument module 130-1 to 130-6 includes a wireless communications interface 300 for receiving and decoding the wireless signal from the control station 1 10 and an output device 310 responsive to the decoded signal to provide an output indicative of a physiological characteristic modelled by the software model. In some embodiments, a standard Bluetooth profile may be used to implement the wireless connectivity. However, in some embodiments a standard Bluetooth profile may require customisation to achieve the desired functionality. For example, a lower layer of the Bluetooth stack (such as the RFCOMM or L2CAP layer) may be used as the basis for a custom profile. The extent of the customisation may depend on the capabilities of the computing device used to provide the control station function. For example, a "pocket PC" only supports two virtual serial ports, thus precluding use of the Serial Port Profile with more than two instruments.

The software model 120 holds the physiological model of the patient. The control station 1 10 interacts with the software model 120 to obtain information, provides a graphical user interface (GUI) 710 for the instructor 720 to control the simulation, and also act as the Bluetooth master to connect and communicate with all of the instrument modules 130-1 to 130-6.

The GUI 710 may be configured to provide the instructor 720 with an ability to pre-program a general path of a simulation using conventional techniques. One example of a suitable GUI 710 is depicted in Figure 7A.

In one embodiment, the GUI 710 provides a scenario editor that permits the instructor 620 to create trends and more complex scripted simulations. For example, in one embodiment the GUI 710 permits the use of pre-programmed scripts that provide the instructor 720 with the ability to create trends, and at the same time, retain the ability to modify parameters of the modelled physiological characteristics manually as necessary. The programmed scripts may support multiple general clinical examinations and/or emergency scenarios for multiple patients simulateously.

In an embodiment, the programmed scripts may include basic data-point or step function scripts. A basic data-point set may simply involve a list of parameter values that are selectable by the instructor 720 to quickly set multiple physiological characteristics of the patient to a known condition. This condition could then be manually adjusted as the simulation progressed according to the actions of the student and the knowledge of the instructor 720. On the other hand, and as is depicted the example shown in Figure 8, a step-function script may include a script that modifies values of one or more of the physiological characteristics (such as pulse rate) in a stepwise manner, over the simulation period. In another embodiment, the programmed scripts may include sophisticated multi-step or algorithmic scripts. For example, and with reference now to the example shown in Figure 9, parameter values may be calculated or modelled using an algorithm that varies the value of the physiological characteristics over time in accordance with a predefined function, or perhaps in response to the actions of the student 730 (ref. Figure 7) during a simulation exercise. Such responses may be communicated to the control station 1 10 by the instrument modules 130, or may be entered into the control station 1 10 by an instructor 720 observing the actions of the student 730. One example of a software model that provides sophisticated multi-step or algorithmic scripts is the "Body Simulator" from Advanced Simulation Corp (www.advsim.com).

The control station 1 10 may be implemented on a variety of platforms including, for example, a PocketPC (Windows Mobile 2003 or 5.0), an Ultra Mobile PC (UMPC) or tablet PC, or a conventional laptop or desktop PC. In the present case the control station is a HP iPaq4700 which includes a 4" VGA resolution screen. This configuration has been found to provide sufficient screen size for the GUI 710.

Turning now to the instrument modules 130, and as explained above, in the present case the plurality of instrument modules 130 will each provide an output that simulates the output indication of one or more actual medical instruments and/or devices, such as, a stethoscope, a pulse oximeter, a blood pressure sensor, an ECG monitor, an ETCO2 monitor, a glucometer, a suction catheter, or a hematocrit/trop- T/blood gas analyser.

The illustrated example includes an instrument module 130-1 that provides an output indication that simulates the output indication of a stethoscope. In the present case, the instrument module 130-1 plays sounds to the student 730 under the direction of the control station 1 10. In this respect, Figure 10 shows a front view of an example of an instrument module 130-1 for providing an output indication that simulates the output indication of a stethoscope. The selected sounds may be stored in memory on-board the instrument module

130-1 as audio files (for example, a waveform audio file, a MPEG-1 Audio Layer 3 file, or a Windows Media Audio file) which are selected for playing based on command information encoded in the wireless signal. Alternatively, the wireless communication may communicate a signal encoding a suitable audio signal such as by the SCO Bluetooth channel (in a Bluetooth embodiment) or by streaming an audio file for playing on the instrument module 130-1 using a suitable streaming protocol. Suitable streaming protocols would be well known to a person skilled on media streaming.

During a simulation exercise the instructor 720 may operate the control station 1 10 to selects which sound to queue. The selected sound is then played when the diaphragm 1000 of the instrument module 130-1 touches a surface, which will typically be a surface of the "patient".

The selection of a sound by the instructor 620 may entail the instructor 720 (ref. Figure 7) operating the control station 1 10 to queue sounds in groups (for example, heart, various lung positions, bowel, BP (Karotkoff), and may involve, for example, the instructor 720 selecting the sounds with a radio button on the GUI 710. Such an approach may permit multiple sounds to be selected quickly. In another embodiment, the sound(s) selected for playing on the instrument module 130-1 may be activated according to the position of the stethoscope "bell". For example, a position sensor or algorithm (such as the "flock of birds" from Ascension lnc (www.ascension-tech.com)) may be used to determine position of the device (again, in this case the stethoscope bell) with respect to the patient so that the selected sound corresponds to a region of the patient. Such an embodiment may permit automatic sound selection and queuing.

In the present case, the instrument module 130-1 includes a real stethoscope

1002 and an electronics unit 1004 located in a housing that is inserted in-line with the stethoscope tubing. The electronics unit 1004 includes the wireless communications interface 300 and a speaker (not shown) that is connected to the ear tubes 1006 of the stethoscope for outputting the selected sound(s) to the student 730.

A switch, or other suitable sensor, is mounted under the diaphragm 1000 of the stethoscope and connected to a sensing circuit of the electronics unit 1004 to detect contact of the diaphragm 1000 with a surface and thus cause the audio output to be generated by a suitable method. In the present case, the electronics unit also includes two LED indicators 1006-1 , 1006-2 a pushbutton, and an on/off switch 1008.

As previously described, the example system illustrated in Figure 7 includes an instrument module 130-2 that provides an output indication that simulates the output indication of a pulse oximeter. In this example, instrument module 130-2 provides a visible indication to the student 730 under the direction of the control station 1 10. In this respect, Figure 1 1 shows a front view of an example of an instrument module 130-2 for providing an output indication that simulates the output of a pulse oximeter.

The instrument module 130-2 includes three multi-segment LED displays 1 100, a "Bluetooth connect pushbutton" 1 102, a "pulse oximeter" finger probe 1 104, and an LED indicator 1 106.

An LED (not shown) and photodetector are incorporated into the finger probe 1 104 to form an interruptible light beam to detect when something (typically a finger) is placed in the finger probe 1 104. The circuit is arranged such that any commercial finger probe, or a simulated one may be used.

In use, after connecting to the control station 1 10, the instrument module 130-2 enters a low power state. After the "measure" button 1 102 is pressed, the instrument module 130-2 wakes up and checks for a "finger" in the finger probe 1 104. If one is found, values for pulse and SPO2 are requested from the control station 1 10 and displayed on the instrument module 130-2. In the present case, the bar graph shows a simulated "signal strength" indication in time with the pulse. The instrument module 130-2 will remain on while the finger remains in the finger probe 1 104. A short time after the finger is removed, the instrument module 130-2 will resume its low power state.

As previously described, the example system illustrated in Figure 7 also includes an instrument module 130-3 that provides an output indication that simulates the output indication of a blood pressure monitor. This instrument module sends a value indicative of a current pressure in the blood pressure cuff to the control station 1 10 for communicating to the instrument modules simulating the Stethoscope or Pulse bands to "display" the blood pressure audibly or tactically in the traditional way.

One example of a suitable instrument module 130-3 is shown in Figure 12. In the illustrated example, the instrument module 130-3 establishes a connection to the control station 1 10 via the wireless communications interface 300 and then switches to low power state from which it periodically "wakes up" to check the pressure in a BP cuff. If the instrument module 130-3 detects that the pressure is above a preset limit it renews the connection to the control station 1 10 and begins transmitting pressure readings at a much more rapid rate (TBD) until the pressure falls below the threshold when it resumes its previous low power state.

The control station 1 10 receives pressure information and triggers other instrument modules (such as instrument module 130-1 and 130-6) as appropriate to provide an output indicative of the blood pressure to the student 730. In the present case, the instrument module 130-3 includes an electronics unit

1200 that interfaces with a normal pressure gauge 1202. The electronics unit 1200 includes a pressure transducer (not shown) that is connected to the tubing of the pressure gauge. In addition, the instrument module 130-3 also includes two pushbuttons 1204 (one not shown) and two LEDs 1206. Although the above described embodiment of an instrument module 130-3 provides an output indicative of an actual blood-pressure monitor, it will be appreciated that other embodiments my employ different mechanisms. For example, an alternative embodiment of an instrument module 130-3 may include means for manipulating the pressure gauge needle to simulate pulsations that are sometimes evident when measuring blood pressure. For example, the instrument module 130-3 may include an electrically actuated gauge driven from the pressure transducer.

As previously described, the example system illustrated in Figure 7 also includes an instrument modules 130-4 and 130-5 that provide output indications that simulates the output indication of an actual glucometer and thermometer respectively. Instrument modules 130-4 and 130-5 provide a simple user interface consisting of a "connection" pushbutton, a "measure" button, a 3-digit LED display, and 2 separate LED indicators. In these examples, rather than replicating the appearance of an actual medical device and/or instrument, the instrument modules 130-4 and 130-5 are "generic" devices.

In use, once a connection is established to the control station 1 10, pushing the "measure" button 1302, 1402 requests a temperature or blood sugar concentration value respectively from the control station 1 10 and displays it on the 3-digit led display 1300, 1400 respectively.

Referring again to Figure 7, the instrument module 130-6 is a pulse band in the form of wrist-bands and/or a collar worn by the "patient" that incorporates actuators to simulate pulses, such as bi-lateral radial and carotid pulses. These two pulses may be actuated individually by signals from the control station 1 10 to provide for pulse strength changes with different blood pressures. The actuator may take a variety of forms including electrical (such as a solenoid, memory alloy, or the like), or pneumatic/hydraulic (such as by inflating a flexible tube).

As shown in Figure 7, the example system 100 also includes an intercom 740 to actor for coaching, or a speaker 740 for manikin "voice".

In the illustrated example, the intercom/speaker 740 provides one-way audio link from the control station 1 10 to the "patient". In the present case, the intercom/speaker is incorporated into the instrument module 130-6.

The intercom/speaker 740 may be a dual mode device such that in an intercom mode, the intercom/speaker 740 will provide an earpiece that allows the instructor 720 to provide verbal coaching to the "patient" regarding their performance or details of the simulation in real time. Alternatively, if the "patient" is a "dumb manikin" then the earpiece could be replaced with an amplified speaker to provide either a pre-recorded, or a real-time "voice" for the "patient". As described previously, an embodiment of the present invention may communicate an audio signal to both the "stethoscope" instrument module 130-1 and the intercom/speaker 740. However, an embodiment that employs a Bluetooth wireless protocol may not support two audio channels. In such a case, one of the audio channels may be allocated to a Bluetooth audio channel, and the other to a different wireless communications interface, for example: stream Bluetooth (SCO) audio to the stethoscope instrument module 130-1 and commercial FM mic/receiver for the intercom; streaming Bluetooth (SCO) audio for the intercom and activate stored sounds on the "stethoscope" instrument module 130-1. Sounds and ECG waveforms can be uploaded in real time; or use of the A2DP profile to stream multiple channels of audio asynchronously. Although the above described example has been described as including instrument modules 130-1 to 130-6 it will be understood that other instrument modules may also be included to provide output indications for other physiological characteristics that would usually be provided by other actual medical instruments and/or devices.

For example, the system 100 may also include an instrument module 130 that provides an output indication that simulates the output indication that would be provided by an actual ECG monitor/defibrillator. Such an instrument module may provide an output indication for plural physiological characteristics, such as ECG, SPo2, ETCO2, NIBP, ArtP and the like.

In such an embodiment, the instrument module 130 may include an adapter for interfacing with an actual medical device so as to allow the clinician/student to use actual equipment for training purposes. Alternatively, the instrument module 130 may be implemented as a GUI on a display device (such a computer display) for displaying a simulated output indication of an ECG. Such a device may also include a touch screen for providing a user interface to the user to interact with virtual buttons, settings, controls and switches displayed on the GUI. In this respect, one example of a suitable GUI is shown in Figure 14.

As will be appreciated, an ECG monitor/defibrillator is a multi-function having a somewhat complex user interface. In addition, different monitors/defibrillators typically have different interfaces. To date, such devices have typically been entirely simulated. As a result, such simulated devices were not provided with an external signal encoding information representing an actual physiological signal. An instrument device for providing an output indication for simulating the output indication of an actual ECG monitor/defibrillator could be constructed in this way as well, but would further be adapted to receive signals from the control station 1 10. Alternatively, such a device may be implemented using an actual medical device that has been adapted to receive the signal from the control station 1 10 and then to measure and display the resultant output indication in the usual way. For example, the sensors or input leads of the ECG may be connected to an adapter for producing input signals that replicate the input signal that would normally be input to the ECG. In such an embodiment, the adapter would receive the signal encoding information for one or more physiological characteristics from the control station 1 10 and convert that signal into an appropriate input signal, or stimulus, for the sensors or input leads of the ECG. The benefit of such an approach is that the student can use whatever equipment they normally use. An instrument module 130 providing an output indication that simulates an output indication of an actual ECG monitor may incorporates some or all of the following functions three-lead ECG, twelve-lead ECG, pulse oximeter, non-invasive blood pressure, end tidal CO2, arterial pressure, defibrillation, cardioversion and pacing.

Again, it will be appreciated that the present invention is not to be construed as being limited to the above-described examples of instrument modules 130. Indeed, it is expected that other types of instrument modules will also be supported. For example, other embodiments may include an intercom/speaker, an ETCO₂ monitor, a POV cam/Scene cam, an ophthalmoscope/otoscope, other blood chemistry analysers such as hemaglobin, cardiac enzymes, pH pO2, and an ultrasound unit.

An ETCO₂ monitor, such as a colour change CO₂ detector is often placed in-line with an advanced airway (ETT, LMA) to indicate End Tidal CO₂ readings.

The present invention may provide an instrument module 130 that indicates a colour change in response to flow through the device and appropriate input from the control station 720. In an embodiment, an instrument module modelling the output of an ETCO₂ monitor may be implemented as an array of tri-colour LED's behind a white translucent diffuser. Such an instrument module may also include a simple flow indicator (such as a thermistor, or a mechanical "flap" that interrupts one or more optical beams to indicate flow direction).

In an embodiment, a Point of View (POV) and/or Scene camera is provided to send a video stream (possibly at a reduced resolution and/or frame rate), via wireless communications interface, of the students actions during a simulation exercise to the control station 1 10 for viewing by the instructor 620. Such a device may permit several views and permit storage of video images to a hard disk for mixing and playback. An instructor may be able to operate the control station 1 10 to set bookmarks in real-time in response to observing events.

Similarly, the present invention may provide an instrument module 130 that receives a video image via wired or wireless means, and displays them to the clinician on a display mounted in an appropriately shaped tool such as an ophthalmoscope or otoscope. Such an instrument module may include a position sensor to locate the position of the instrument module 120 for real-time rendering of the video image. Such an approach may be similar to other existing technologies (cardiac catheterization, and ultrasound) which manipulate a hand piece and a separate monitor displays appropriate images.

Example 2 Figure 16 shows an interface diagram illustrating various interfaces in a system embodiment that includes plural instrument modules 130.

During a simulation exercise, signals communicated between the instrument modules 130 and the control station 1 10 may encode information that causes, or otherwise results in, synchronisation of the output indications of plural instrument modules 130. In other words, multiple instrument modules 130 may provide an output indication of a physical characteristic that is synchronised in time.

By way of example, an instructor 720 (ref. Figure 7) may program the control station 1 10 with upper and lower levels of blood pressure values, with the upper blood pressure value representing systolic pressure and the lower pressure value representing diastolic pressure.

In use, a student may operate an instrument module 130-3, of the type previously described, to inflate the cuff by squeezing the bulb to until a simulated occlusion of the patient's artery has occurred. During operation of the instrument module 130-3, the module will periodically or continuously communicate a signal to the control station 1 10 that encodes the measured pressure level of the BP cuff, or information derived from the measured pressure level, such as message data or a command.

The student then releases pressure in the cuff in the conventional manner. As the pressure is reduced, the control station 1 10 processes the received measured pressure level or information and compares the received measured pressure level with the threshold levels. When the received measured pressure level reaches the systolic blood pressure level, the control station 1 10 then communicates a signal to the instrument module 130-1 to active an audio output indication simulating the first Korotkoff sounds. In addition to providing the audio indication, the instrument modules 130-6 (i.e. the pulse bands) may also be activated, under the control of the control station 1 10, to replicate palpations that may be felt by hand. In other words, the output indication of the instrument module 130-3 (that is the pressure as displayed on the pressure dial) is synchronised with the audio indication of the instrument module 130-1 and the instrument module 130-6.

As the BP cuff pressure is further released, the control station 1 10 continues to communicate a signal which activates the instrument module 130-1 to provide an audio output indication simulating the sound of the flow of blood in an artery. However, when the control station 1 10 detects that the measured pressure value has reached the diastolic pressure the control station 1 10 deactivates the audio indication of the instrument module 130-1. It will be appreciated that the above-described example of synchronized instrument modules 130 is exemplary. It will be appreciated that other instrument modules 130 may also be synchronized so as to provide other output indications that are synchronised time-wise. For example, a pulse reading that is communicated to the instrument module 130-2 for output indication as a numerical display indicative of the pulse rate of the patient may be synchronised with the audio indication provided by the instrument module 130-1 in the form of a "beat" at the frequency of the pulse rate indicated on the instrument module 130-2. Example 3 Figure 17 shows a block diagram of another embodiment of a system 1700 for simulating patient examination and/or assessment. In this example, the system 1700 is implemented as a web-delivered application which is able to simulate the wide variety of medical devices and/or instruments.

As is shown, in this application the system 1700 includes a database 1701 which stores information concerning the identity and progress of the student(s). Stored information may be accessed by the system 1700 to identify and track students and their progress, and to provide relevant tutorials and device selection to each student.

The system 1700 includes a GUI 1702 that provides, in a graphical way, an instrument module that replicates a simulated device 1704, which in this example is a simulated ECG. The simulated device 1704 permits a student to gain confidence operating the simulated device 1704 at their own pace, irrespective of their location. This also allows for tracking of student competence before the student enters the worksite where the actual device is used. In this example, the simulated device 1702 replicates a "LifePak12" ("LP12") from Medtronics/PhysioControl. However, it will be appreciated that any device could be substituted including, for example, other monitor/defib's, ventilators, IV pumps, and the like.

In the present example, the GUI 1702 includes photographic images of an actual LP12. Of course, it will be appreciated that other forms of images could be used, such as a diagrammatic image.

In use, a student operates (using a user interface, such as a mouse, track-ball, touch pad, joystick, keyboard or the like) virtual buttons, switches, controls or the like (such as buttons 1706). The system 1700 processes user inputs and provides a simulated "display" portion 1708 (in this example, a live "scrolling" display) which accurately simulates the LP12 screen. The students interacts with a graphical representation of a patient to, for example, "attach" the appropriate leads and sensors. These actions are communicated to the simulator device 1702 which then reacts accordingly.

In an embodiment, the system 1700 may operate in one of several selectable modes, such as:

1 . A tutorial mode; and

2. A guide mode;

In the tutorial mode, the system 1700 presents the student with structured lessons of device operation. In the guide mode, the system 1700 presents the student with hints and tips depending on the current situation - including, for example, button and display highlighting. Such hints may be categories in tolerance from, for example,

"None" to "I'm really lost"

The above example thus relates to a web delivered, working ECG monitor simulator that provides a re-configurable appearance and operation to match various manufacturers' models, and an associated student tracking and curriculum database.

The system 1700 of Example 3 addresses significant requirements for effective adult learning, such as an authentic experience, experiential learning and deliberate practice with feedback. In contrast, training programs supplied with actual clinical devices tend to provide instructions on how to use the devices but are not designed to provide learning to use the device in context. Moreover, emergency care training programs generally assume that users can use monitoring equipment appropriately.

In conclusion, it must be appreciated that there may be other various and modifications to the configurations described herein which are also within the scope of the present invention.

Claims

The Claims:

1. A system for simulating patient examination and/or assessment, including: a control station for interacting with a software model modelling physiological characteristics of a patient to obtain information and activating a communications interface to transmit a signal encoding the obtained information; and one or more instrument modules for receiving the signal from the control station and decoding the signal to provide an output indicative of a physiological characteristic modelled by the software model.

2. A system for providing a simulated patient examination and/or assessment environment, the system including: a memory device for storing a software model modelling physiological characteristics of a patient; a control station including: a processor; an associated memory device for storing a series of instructions for execution by the processor to cause the processor to interact with the software model to obtain simulation information; and a communications interface for transmitting a signal encoding the obtained information; and a plurality of instrument modules, each module including a communications interface for receiving the signal from the control station, a decoder for decoding the signal, and an output device responsive to the decoded signal to provide an output indicative of a physiological characteristic modelled by the software model.

3. A system according to claim 1 or claim 2 wherein the communications interface includes either a wired or a wireless communications interface.

4. A system according to any one of claims 1 to 3 wherein the modelling of the physiological characteristics simulates a physiological condition of the patient, and wherein the modelled physiological characteristics have a value and/or property that is based on the simulated physiological condition.

5. A system according to any one of claims 1 to 4 wherein the software model is manipulable automatically and/or manually to update the values and/or properties of the physiological characteristics.

6. A system according to claim 5 wherein the manipulation of the software model includes a user operating the control station to select a physiological condition for simulation.

7. A system according to claim 5 wherein the manipulation of the software model includes executing pre-programmed scripts modelling trends in the patient's physiological condition.

8. A system according to any one of claims 1 to 7 wherein the control station is one of: a. a personal computer; b. a laptop computer. c. a personal digital assistant; or d. a hand-held computer.

9. A system according to any one of claims 1 to 8 wherein the information obtained from the software model is attributable to a value or level of a physiological characteristic modelled by the software model.

10. A system according to claim 9 wherein the obtained information includes a command for activating an instrument module to operate an actuator to generate the output.

1 1. A system according to claim 9 wherein the information includes a command for activating an instrument module to display the output.

12. A system according to claim 9 wherein the information includes a command for activating an instrument module to provide the output as an audio effect.

13. A system according to any one of claims 3 to 12 wherein the wireless communications interface is one of: a. a Bluetooth compatible wireless interface; b. a 802.1 1 (Wi-Fi) compatible wireless interface; c. a wireless USB compatible interface; or d. a ZigBee compatible wireless interface.

14. A system according to any one of claims 1 to 13 wherein the plurality of instrument modules simulate an output indication from one or more of: a. a stethoscope; b. a pulse oximeter; c. a blood pressure sensor; d. an ECG monitor; e. an ETCO₂ monitor; f. a glucometer; and g. an analytical instrument and/or device for point of care testing.

15. A system according to claim 9 wherein the output indicative of a physiological characteristic modelled by the software model includes one or more of: a. a visible output indication in the form of a text display indicative of the value or level of a physiological parameter modelled by the software model; and b. a visible output indication in the form of a numerical display in the form of a numerical display indicative of the value or level of a physiological parameter modelled by the software model.

16. A system according to any one of claims 1 to 14 wherein the output is an audio file that stored on the instrument module, the audio file for simulating one or more physiological parameters of the patient.

17. A system according to claim 16 wherein at least one of the instrument modules stores a plurality of audio files, and wherein the output audio file is selected based on the encoded information.

18. A system according to any one claims 1 to 17 wherein one or more of the instrument modules include an actual medical device or instrument having an adapter coupled to inputs thereof, the adapter for receiving the signal from the control station and converting the received signal into one or more stimulus signals for input into the actual medical device or instrument to thereby cause the medical device or instrument to provide the output indication.

19. A system according to any one of claims 1 to 18 wherein each instrument module furthers includes one or more sensors for sensing actions of a user and and a processing means for modifying the performance and/or output indication of the instrument module in response thereto.

20. A system according to any one of claims 1 to 18 wherein each instrument module communicates a signal encoding information derived from, or representing, a value of a sensed parameter for processing by the control station, the processing providing either the sensed value, or another value or command derived from or using the sensed value, for communication to other instrument modules.

21. A method of generating a simulated patient examination and/or assessment environment, including: interacting with a software model modelling physiological characteristics of a patient to obtain information; transmitting a signal encoding the obtained information to one or more instrument modules; and the one or more instrument modules receiving the signal from the control station and decoding the signal to provide an output indicative of a physiological characteristic modelled by the software model.

22. A method according to claim 21 wherein transmitting the signal encoding the obtained information includes either a wired or a wireless communication.

23. A method according to claim 21 to 22 wherein wherein modelling the physiological characteristics simulates a physiological condition of the patient, and wherein the modelled physiological characteristics have a value and/or property that is based on the simulated physiological condition.

24. A method according to any one of claims 21 to 23 wherein the software model is manipulable automatically and/or manually to update the values and/or properties of the physiological characteristics.

25. A method of providing a simulated patient examination and/or assessment environment, the method including: providing a memory device for storing a software model modelling physiological characteristics of a patient; providing a control station including: a processor; an associated memory device for storing a series of instructions for execution by the processor to cause the processor to interact with the software model to obtain simulation information; and a communications interface for transmitting a signal encoding the obtained information; and providing a plurality of instrument modules, each module including a communications interface for receiving the signal from the control station, a decoder for decoding the signal, and an output device responsive to the decoded signal to provide an output indicative of a physiological characteristic modelled by the software model.

26. A computer software program embodied on a computer readable memory, the computer software program being executable by a computer to cause the computer to: interact with a software model modelling physiological characteristics of a patient to obtain simulation information; and activate a communications interface to transmit a signal encoding the obtained information, the signal for transmission to one or more instrument modules for receiving the signal from the computer and decoding the signal to provide an output indicative of a physiological characteristic modelled by the software model.

27. An instrument module for providing an output indicative of a simulated physiological characteristic of a patient, the instrument module including: a communications interface for receiving and decoding a signal from a control station, the signal encoding simulation information obtained from an interaction between the control station and a software model modelling physiological characteristics of the patient; and an output device for providing an output indicative of a physiological characteristic modelled by the software model according to the decoded information.

28. A system for providing a simulated patient examination and/or assessment environment, the system substantially as hereinbefore described with reference to the accompanying figures.

29. A method of providing a simulated patient examination and/or assessment environment, the method substantially as hereinbefore described with reference to the accompanying figures.