BACKGROUND OF INVENTION The APGAR score is the very first test given to a newborn infant, and it occurs right after the baby's birth in the delivery or birthing room. The APGAR score is a daily routine in delivery rooms across the United States and in many other countries. Virginia Apgar, M. D. , developed the APGAR score in 1953 as a way to provide medical science with an objective method of observation and evaluation of a newborn infant's need for resuscitation immediately after delivery.

The test is routinely performed at one minute and again at five minutes after birth.

Typically, one qualified person in the delivery room evaluates the infant using five signs in an objective, standard and measurable method. The five factors observed and scored after birth are heart rate, respiratory rate, reflex irritability, muscle tone and color. Each factor is scored on a scale of 0 to 2 and the factor scores are summed to calculate the APGAR score. Although 10 is the highest possible score, babies almost never receive it because the hands and feet of even healthy newborns are usually still slightly bluish 5 minutes after birth.

In determining the APGAR factors, the first sign tested is heart rate. An infant with a heart rate between 100-140 receives a score of two. A heart rate under 100 receives a score of one, and if the heart beat is absent, a score of zero is assigned. In determining the second factor, respiratory rate, an infant who breathes and cries forcefully receives a score of two, while one with irregular breathing a score of one, and an infant not breathing receives a score of zero. The third factor, reflex irritability, is determined as a response to physical stimulation. Physical stimulation may include suctioning the throat or nose or tapping on the foot. An infant who responds by coughing or turning away from the stimulation receives a score of two. An infant that responds with a facial grimace scores a one, and a non-responsive infant receives a score of zero.

Muscle tone, the fourth sign, is determined by observing the activity of the infant. An active infant with flexed arms and legs receives a two. One with extended arms or legs receives a one and a completely limp infant receives a score of zero. In determining the fifth factor, the color of the skin is observed. A completely pink infant receives a two.

An infant with a pink body and blue extremities receives a one, and an infant with an overall bluish-gray color receives a zero. As such, the total number of points available in the APGAR score is ten, with each of the five factors having a maximum value of two.

It has been shown through research that the APGAR score is a predictor of the need for resuscitation. A score of four or below one minute after birth indicates the need for prompt diagnosis and resuscitation. When resuscitation is deemed necessary, the score can then be taken again five minutes after resuscitation has been initiated to evaluate how the baby is responding to the resuscitation.

Neonatal resuscitation skills are essential for all health care providers who are involved in the delivery of newborns. The transition from fetus to newborn requires intervention by a skilled individual or team in approximately 10% of all deliveries. Of specific concern are the 81% of babies in the United States that are born in non-teaching hospitals in delivery rooms where personnel experienced in high-risk deliveries are unavailable.

Respiratory distress and extreme prematurity are the two complications of pregnancy that most frequently require a complex resuscitation by skilled personnel.

Approximately 80% of low birth weight infants require resuscitation and stabilization at delivery. Nearly one half of newborn deaths, many of which are extremely premature infants, occur during the first 24 hours following birth. A number of these early deaths also have a component of asphyxia and/or respiratory depression as an etiology. For the surviving infants, effective management of respiration in the first few minutes of life may influence long-term outcome.

Obviously, accurate APGAR scoring and competent performance of neonatal resuscitation is of major importance in the effort to prevent infant deaths at the time of delivery. A neonatal resuscitation course available through the American Heart Association and the American Academy of Pediatrics entitled, Textbook of Neonatal Resuscitation, provides the materials and training necessary for health care professionals to perform successful neonatal resuscitation. To develop the accuracy and competency required by delivery room personnel, in addition to the training materials and guidelines, it is necessary to provide a training mechanism that provides a life-like situation for demonstration, teaching and rehearsing skills. The incorporation of a life-like neonatal resuscitation and APGAR scoring simulator will result in improved skill acquisition and retention and ultimately improved outcomes of actual neonatal resuscitation.

Neonatal resuscitation training simulators are known in the art. One such system is described in U. S. Patent No. 5,509, 810 to Schertz et al. , incorporated herein by reference, in which an intelligent, interactive neonatal resuscitation training simulator and method employing an infant android of life-like appearance and response is provided.

While Schertz provides a training mechanism for neonatal resuscitation, Schertz does not describe a method whereby the APGAR score of a newborn can be determined. The infant android described by Schertz does not possess the features necessary to determine all five factors essential for the APGAR scoring.

Therefore, a need exists in the art for a life-like neonatal training simulator possessing the elements necessary to instruct medical professionals in the proper techniques for determination of the APGAR score for a newborn infant and to train and evaluate neonatal resuscitation skills.

However, in view of the prior art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how the identified need could be fulfilled.

SUMMARY OF INVENTION The present invention provides an interactive training simulator, which includes a life-like robotic mannequin and an interactive control mechanism.

According to a preferred embodiment, the interactive training simulator system is an interactive APGAR training simulator system for training individuals in the determination of an APGAR score for an infant.

In an additional embodiment, the interactive training simulator system comprises a life-like robotic mannequin, the robotic mannequin further comprises a plurality of sensors, a rigid motion effecting device located within the robotic mannequin, a flexible motion effecting device located within the robotic mannequin, an audible heartbeat simulator, and an interface module. The plurality of sensors, the motion effecting devices and the audible heartbeat simulator being in circuit communication with the interface module. An interactive control system is in circuit communication with the interface module. The interactive control system further comprises, a mechanism for physically simulating life-like activity of the robotic mannequin, and a mechanism responsive to the plurality of sensors within the robotic mannequin.

In another embodiment, the robotic mannequin further comprises a plurality of internally embedded light sources, the light sources are used to provide a localized realistic external surface color to the robotic mannequin. The light sources are in circuit communication with the interface module and are controlled by the interactive control system.

In an additional embodiment, the plurality of sensors of the robotic mannequin includes at least one magnetic intubation sensor, the magnetic intubation sensor positioned to sense the presence of magnetized material within an airway tube of the robotic mannequin. The magnetic intubation sensor being of a giant magnetoresistance type.

In yet another embodiment, the plurality of sensors of the robotic mannequin includes at least one humidity sensor, the humidity sensor positioned to sense the humidity within a ventilation channel of the robotic mannequin.

In an additional embodiment, the plurality of sensors of the robotic mannequin includes at least one lung pressure sensor, the lung pressure sensor positioned to sense changes in the pressure state of an artificial lung apparatus within the robotic mannequin.

The lung pressure sensor may be a silicon micromachined sensor.

In an additional embodiment, the plurality of sensors of the robotic mannequin includes at least one airflow sensor, the airflow sensor positioned to measure the mass airflow to a lung region within the robotic mannequin. The airflow pressure sensor may be a silicon micromachined sensor.

In yet another embodiment, the plurality of sensors of the robotic mannequin includes at least one temperature sensor, the temperature sensor positioned to sense localized temperature measurements throughout the robotic mannequin.

In an additional embodiment, the plurality of sensors of the robotic mannequin includes at least one chemical sensor, the chemical sensor positioned to sense the introduction of chemical substances within the fluidic system of the robotic mannequin.

In another embodiment, the plurality of sensors of the robotic mannequin includes at least one touch pressure sensor, the touch pressure sensor positioned to sense the pressure across the chest area of the robotic mannequin. In an enhanced embodiment the at least one touch pressure sensor further comprises an array of touch pressure sensors.

In an additional embodiment, the plurality of sensors includes at least one accelerometer, the accelerometer positioned to sense a motion of the robotic mannequin.

In an enhanced embodiment the at least one accelerometer, further comprises a plurality of accelerometers embedded within the robotic mannequin, the plurality of accelerometers positioned to sense a motion of the robotic mannequin and an impulse force applied upon the robotic mannequin.

In yet another embodiment, the rigid motion effecting device of the robotic mannequin further comprises a plurality of rigid skeletal structure members and a rigid motion system for moving the plurality of rigid skeletal structure members, the rigid motion system being controlled by the interactive control system. The rigid skeletal structure members further comprises a chest plate, the movement of the chest plate being controlled by the interactive control system.

In yet another embodiment, the flexible motion effecting device of the robotic mannequin further comprises a plurality of flexible muscular members and a flexible motion system for simulating life-like muscular movement, the flexible motion system being controlled by the interactive control system. The flexible muscular members can be pneumatic, and control by the interactive control system provides randomized life-life movement. The randomized life-like movement is established by a centralized pattern generator within the interactive control system to simulate a network of neural oscillators for motion control. The centralized pattern generator is configurable to provide random and prescribed patterns.

In an additional embodiment, a fluidics system is provided within the robotic mannequin, the fluidic system being controlled by the interactive control system.

In a preferred embodiment of the present invention the robotic mannequin resembles a human infant having an external skin similar to that of a newborn infant.

In an enhanced embodiment of the present invention, the interactive training simulator, further comprises a resuscitation training simulator system. The resuscitation training simulator system provides an additional means for training individuals on proper resuscitation technique.

In an additional preferred embodiment, the interactive control mechanism further comprises a user interface for a trainee using the simulator. The user interface may be a personal computer further comprising network capability to allow remote monitoring of the system. Through the use of the user interface, the interactive control mechanism adjusts the physical simulation of the robotic mannequin in response to the mechanism responsive to the plurality of sensors within the robotic mannequin. As such, an intelligent, interactive, feedback situation is established between the sensors of the robotic mannequin and the user interface.

In an enhanced embodiment, the interactive training simulator further comprises a recording device for recording the simulated activity of the robotic mannequin and an interaction with a trainee providing a mechanism whereby the results of the trainee training session can be replayed providing enhanced training capabilities.

In a preferred method of conducting an interactive APGAR scoring training simulation as disclosed by the present invention, a robotic mannequin resembling a human infant having an outer skin, the outer skin resembling the skin texture and feel of a human infant is provided, the robotic infant is physically simulated to provide a condition corresponding to a newborn infant, the heart beat of the robotic mannequin is evaluated, the respiration of the robotic mannequin is evaluated, the reflex irritability of the robotic mannequin is evaluated, the muscle tone of the robotic mannequin is evaluated, and the outer skin color of the robotic mannequin. A score is assigned to each evaluation to provide an APGAR score for the robotic infant utilizing the well known scoring criteria of the APGAR scoring system. The method may also provide an interactive respiration training simulation if it is determined upon evaluation of the simulated respiration of the robotic mannequin that artificial respiration is necessary. The APGAR score may then be evaluated following the artificial respiration simulation.

The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the description set forth hereinafter and the scope of the invention will be indicated in the claims.

Other aspects and advantages of the present invention can be seen upon review of the figures, the detailed description, and the claims, which follow.

BRIEF DESCRIPTION OF THE DRAWINGS For a fuller understanding of the nature and objects of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which: FIG. 1 is block diagram illustrating the present invention; FIG. 2 is a diagrammatic view of the present invention; FIG. 3 is a diagrammatic illustration of the sensor system of the present invention; FIG. 4 is a diagrammatic illustration of the heartbeat simulation of the present invention; FIG. 5 is a diagrammatic illustration of the embedded light sources of the present invention; FIG. 6 is a diagrammatic illustration of the fluidic system of the present invention; FIG. 7 is a diagrammatic illustration of the rigid motion system of the present invention; FIG. 8 is a diagrammatic illustration of the flexible motion system of the present invention; FIG. 9 is an exploded view of the flexible motion system of the present invention; FIG. 10 is an additional exploded view of the flexible motion system of the present invention; FIG. 11 is a flow diagram representing a method of APGAR determination training as described by the present invention; and FIG. 12 is a flow diagram representing a method of APGAR determination training and resuscitation as described by the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A need exists in the field of teaching mannequins for a mannequin possessing improved life-like behavior. The need for more realistic models that mimic both physiologic and behavioral symptoms is a real necessity in modern day teaching systems.

In the case of humans, many of the necessary diagnostic procedures must be performed on moving patients and this adds a considerable dimension to the educational program. If the student learns only with the use of flaccid mannequins, then the actual conditions that are faced in reality can present a difficult situation that the student has been unprepared to address. The ability to perform the functions necessary for diagnosis of a living patient is critical to the success of the student.

One instance wherein a life-like teaching mannequin is of particular importance is the neonatal milieu. At present devices that are used in teaching neonatal resuscitation are rudimentary and non-lifelike. One of the key skills required by delivery room personnel is the determination of an APGAR score for a newborn infant. Therefore, a simulation mannequin for the purposes of training personnel in the delivery room in the performance of the APGAR scoring system is provided. In training to determine an APGAR score, it is necessary that the simulation mannequin provide an audible heartbeat, simulated resuscitation, simulated muscle tone, simulated movement and simulated skin color.

The interactive training simulator of the present invention is a robotic system providing an integrated electromechanical, optical, chemical and pneumatic system. The robotic mannequin offers an airway to simulate endotracheal tube placement and audible and palpable heart rate to simulate normal and abnormal cardiovascular changes. In addition to this the invention can simulate color changes through the use of filtered light internal to the mannequin, simulating states common to the newborn both in normal circulatory transition and distress states, as well as muscle tone and reactivity typical of normal and distress states. The invention makes it possible to evaluate all the physiologic parameters as described by the APGAR scoring system. Furthermore, the simulator can mimic appropriate responses to drugs through the fluidic lines embedded throughout the cavity of the mannequin and connected via an umbilical. The robotic system also contains a recording device for real-time evaluating and playback of an individual trainee's performance. The robot's construction and control is derived from the APGAR scoring system. The system contains a suite of custom mechanical components and actuators, electronic control and signal processing hardware, structural material and sensor fabric and sensor networking as part of the requirements for operation. Software routines for control of the behavior of the robot, and non-deterministic interaction of the robot with a user are a key feature of the invention.

The instant system of the invention is considered to be a robotic system and is comprised of mechanical, electromechanical, optical, chemical and pneumatic systems.

These systems are housed in a robotic mannequin and are connected to an interactive control system via an interface module and are responsive to a software program run on a computer controlling the interactive control system. This software program regulates the movements of the mannequin in addition to collating the feedback from the sensors of the mannequin to measure the appropriateness of the activities of a trainee.

With reference to Figure 1, in which is shown a functional block schematic of the system of the present invention 20. A user interface 1 provides a network-enabled computer, allowing both collaborative instruction and remote monitoring. The computer provides the user interface to the user. In the preferred embodiment the computer is preferably a laptop type of computer, since that type is most suitable for portable systems.

Any such computer may be used as known to those of ordinary skill in the art. The computer system may also include a display monitor and a printer for retrieval of the results.

A custom user interface is supplied to present and control the various sensor and actuator systems. The controller interface to the mannequin is established through an interface module 10. The interface module 10 being an input/output digital and analog multi-channel card. The digital and analog inputs and outputs are configured so as to permit the sensing of the embedded sensors and provide feedback control for the actuation of movement. The interface module 10 provides an intelligent, interactive communication channel between the interactive control system 5 of the present invention and the robotic mannequin, represented by the block 15. Within the block 15 are provided rigid skeletal members 16, flexible muscle members 22, fluidic lines 18, embedded light sources 24, sensors 20, a motion system 27 and an audible pulse generator 26. Included within the sensors 20 of the robotic mannequin are included, magnetic intubation sensors 28, lung pressure sensors 30, lung mass airflow sensors 32, chest/touch pressure sensors 34, ventilated humidity sensors 36, flexible temperature sensors 38, solid-state chemical sensors 40, and accelerometers 42.

As shown in Figure 2, the robotic mannequin 15 is controlled by the user interface 1 through the interactive control system 5 utilizing the input/output capabilities of the interface module 10. Supplemental software that creates chaotic, unpredictable movement 44 and response 48 of the robotic system is also integral to this system to realize lifelike movement and behavior. This randomized, life-like behavior is implemented through a centralized pattern generator 46. The centralized pattern generator 46 comprises a mathematical, or cellular automata based simulation of a network of neural oscillators used for movement control. The pattern generator translates the computer commands into muscle control. Additionally, the pattern generator is dynamically configurable to provide either random or prescribed patterns on demand to establish lifelike movement of the robotic mannequin. The computer is network capable and can be controlled and monitored from a remote monitoring site. Entirely wireless systems are also possible within the scope of the instant invention, with the power supply in the mannequin being battery operated and the sensors relaying the information via suitable wavelengths to the interactive control module.

A key feature of the robotic system is the reliance on microelectromechanical systems (MEMS) based sensors for sensor function due to size constraints of the smaller format mannequin. As shown in Figure 3, a plurality of sensors 20 are provided within the robotic mannequin. The sensors 20 being in circuit communication with the interface module 10 through a plurality of electrical connections 50 throughout the body of the mannequin. While a variety of sensors are employable by the present invention, those integral to the operation include a magnetic intubation sensor which may be of the giant magnetoresistance (GMR) type, which sensitively senses the presence of magnetized material such as a magnetized insert within the airway tube. A humidity sensor is strategically placed in a ventilated channel to give proper operation of the humidity sensor. A lung pressure sensor is of the silicon micromachined type and can detect changes in the pressure state of the artificial lung apparatus. Similarly, an micromachined airflow sensor is used to measure the mass airflow to the lung region. Multiple, flexible style temperature sensors are distributed throughout the body to give localized, focused temperature measurements. An optional sensor to insert is a solid-state pH chemical sensor in the umbilical cable that holds both pneumatic working fluid and electrical cabling. For tactile sensing and chest force distribution during resuscitation exercises a touch pressure sensor array is provided to sense the pressure across the chest area.

Micromachined accelerometers are also embedded within the mannequin to create an ability to sense motion of the body and impulse force delivered by a user. The sensor network 20 is coupled to an interface module 10 to establish intelligent, interactive control by a user.

The key distinguishing feature of this arrangement of miniature sensors needed for this small format mannequin is the creation of a simulator environment for the APGAR rating system used in the neonatal health professional field and in addition for the creation of a real-time, life-like simulator for resuscitation training and practice.

In addition to the sensor network 20 provided by the robotic mannequin 15, the robotic mannequin 15 also employs an audible heart beat simulator 26, as shown in Figure 4. The heartbeat simulator being in circuit communication with the interface module 10. Evaluation of the heartbeat is an essential element in the determination of an APGAR score and in the determination of the need for resuscitation.

As shown in Figure 5, the robotic mannequin 15 includes a plurality of custom embedded light sources 24 to create controllable skin color for recreating health states and permitting the color aspect for APGAR color rating. The light sources 24 are in circuit communication with the interface module 10 through lines 52 and are controlled by the interactive control system 5.

As shown in Figure 6, fluidic lines 18 are embedded within the robotic mannequin 15 to provide a simulated drug delivery situation. The condition of the fluidic lines is controlled by the interactive control system through the interface module 10.

With reference to Figure 7 and Figure 8, the robotic system of the present invention includes limb actuators using pneumatic muscles for life-like fluid motion. The rigid skeletal motion of the mannequin 15 is provided by skeletal members 16, which are driven by a motion system 27, controlled by the interactive control system 5 through the interface module 10. The skeletal members simulate the skeletal bone structure and joints 54 of an infant. The motion system provides movement through the use of a motor or equivalent motion-producing device capable of providing the torque necessary to produce the movements dictated by the interactive control system. In addition to the skeletal structure, as shown in Figure 8, the mannequin contains flexible muscle members 22, which serve to simulate the functions of actual muscles in the appendages of the mannequin 15. As detailed in Figure 9, the simulated muscle movement is provided using small pneumatic tubes 56 filled with air or other fluid in response to commands provided by the user through the interactive control system. An air or other fluid supply 58 is also connected to the muscle members 22 through the interface module 10 to supply the necessary fluid pressure for the pneumatic tubes 56. As shown in Figure 10, the tubes 56 may comprise a single member, or a plurality of members may also be used as shown.

By virtue of this system, the instant mannequin is able to mimic programmed normal or abnormal movements, thus enabling the trainee the ability to learn in an environment that simulates actual, life-like conditions. In a further the entire skeletal and muscle systems are comprised of pneumatic members. Additionally the entire movement apparatus, including the skeletal members and flexible members may be constructed from electromechanical parts without the use of any pneumatic devices.

All of these systems described above are interconnected with each other and the computer user interface via the interface module 10. The computer program servces to direct the motion of the muscles as well as the simulated bone members along with the plurality of physical sensors to display specific conditions. As manipulations are made to the mannequin, the computer program also serves to produce feedback which is sent to a printer or video device, and additionally provides parameter adjustments as treatment is effected.

As shown in Figure 11, a method of determining an APGAR score as disclosed by the present invention includes providing a robotic mannequin resembling a human infant 60, physically simulating within the robotic infant a condition corresponding to a newborn infant 62, evaluating the simulated heartbeat of the robotic mannequin 64, evaluating the simulated respiration of the robotic mannequin 66, evaluating the simulated reflex irritability of the robotic mannequin 68, evaluating the simulated muscle tone of the robotic mannequin 70, evaluating the skin color of the robotic mannequin 72, and assigning a score to each evaluated element to provide an APGAR score 74 as is known in the art.

Additionally, as shown in Figure 12, when based on evaluated heartbeat and respiration of the robotic mannequin, it is determined that resuscitation is necessary, an additional step is provided wherein resuscitation is performed 76. After resuscitation an additional APGAR scoring is performed to evaluate the effectiveness of the resuscitation procedure.

The novel interactive training simulator of the present invention provides a teaching tool utilizing sensor arrays and simulated life-like motion. The features of the present invention provide the necessary elements for a teaching device for APGAR scoring and resuscitation training.

Although the instant device is capable of simultaneous motion and physical parameter display, it is also contemplated that the instant device be utilized as a teaching mechanism absent the motion and the motion added in a second tier of study for learning progression flexibility.

Although described with respect to an infant system, the instant invention is applicable to a variety of human and other animal species mannequins.

Modification and variation can be made to the disclosed embodiment of the instant invention without departing from the scope of the invention as described. Those skilled in the art will appreciate that the applications of the present invention herein are varied, and that the invention is described in the preferred embodiment. Accordingly, additions and modifications can be made without departing from the essence of this invention. In this regard it is intended that such changes would still fall with in the scope of the present invention. Therefore, this invention is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the present invention as defined in the appended claims.

It will be seen that the objects set forth above, and those made apparent from the foregoing description, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention, which as a matter of language, might be said to fall therebetween.

Now that the invention has been described,