System for moving an anatomical model of a fetus inside a mannequin having a birth canal and a childbirth simulator

Information

  • Patent Grant
  • 9852658
  • Patent Number
    9,852,658
  • Date Filed
    Monday, March 31, 2014
    10 years ago
  • Date Issued
    Tuesday, December 26, 2017
    6 years ago
Abstract
The present disclosure relates to a system for moving an anatomical model of a fetus inside a mannequin having a birth canal. The system comprises a descent mechanism and a rotation mechanism. The descent mechanism is integrated in the mannequin and can move an anatomical model of a fetus longitudinally towards the birth canal of the mannequin. The rotation mechanism is mounted to the descent mechanism and can rotate the anatomical model of the fetus. The model of the fetus is inserted in the rotation mechanism. Also provided is a childbirth simulator comprising a mannequin with a birth canal, and the aforementioned system integrated in the mannequin for moving an anatomical model of a fetus inside the mannequin.
Description
TECHNICAL FIELD

The present disclosure relates to the field of simulators. More specifically, the present disclosure relates to a system for moving an anatomical model of a fetus inside a mannequin having a birth canal, and to a childbirth simulator.


BACKGROUND

Simulators attempting to reproduce human body functions are used, for example, in the context of medical training. One very significant example of medical process that requires training is assistance to childbirth.


Obstetric emergencies are very rare. While the vast majority of deliveries can be handled with routine procedures, complications can occur, requiring clinical vigilance, rapid team response, and complex technical skills in order to assure normal maternal and fetal outcome. Opportunities for observing and managing such situations are scarce, and this poses great difficulties for training of labor ward staff.


Therefore, there is a need for devices that better emulate mechanisms of childbirth.


SUMMARY

According to a first aspect, the present disclosure provides a system for moving an anatomical model of a fetus inside a mannequin having a birth canal. The system comprises a descent mechanism and a rotation mechanism. The descent mechanism moves the anatomical model of the fetus longitudinally towards the birth canal of the mannequin. The rotation mechanism is mounted to the descent mechanism and rotates the anatomical model of the fetus. The anatomical model of the fetus is inserted in the rotation mechanism.


In a particular aspect, the descent mechanism comprises a frame, two parallel linear rails mounted on the frame, and a carriage travelling along the two parallel linear rails. The rotation mechanism is fixed to the carriage.


In another particular aspect, the rotation mechanism comprises a rotating ring. The rotating ring may be ovoid shaped and may be capable of rotating 360 degrees and above.


According to another aspect, the present disclosure provides a childbirth simulator. The childbirth simulator comprises a mannequin having a birth canal. The childbirth simulator also comprises the aforementioned system integrated in the mannequin for moving an anatomical model of a fetus inside the mannequin.





BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the disclosure will be described by way of example only with reference to the accompanying drawings, in which:



FIG. 1 is a partial, exploded front elevation view of a human body simulator including a childbirth simulator;



FIG. 2 is a perspective view of a descent mechanism of the childbirth simulator;



FIG. 3A is a detailed perspective view of the descent mechanism and of a rotation mechanism;



FIGS. 3B, 3C and 3D are detailed perspective views of the descent mechanism and of a rotation mechanism according to another embodiment;



FIG. 4 is a rear, right perspective view of the childbirth simulator including the descent mechanism and the rotation mechanism; and



FIG. 5 is a block diagram showing interaction of the childbirth simulator with an instructor computer and with trainee computers according to an embodiment.





DETAILED DESCRIPTION

The foregoing and other features will become more apparent upon reading of the following non-restrictive description of illustrative embodiments thereof, given by way of example only with reference to the accompanying drawings. Like numerals represent like features on the various drawings.


Various aspects of the present disclosure generally address one or more of the problems of emulating mechanisms of childbirth.


The present disclosure introduces a childbirth simulator (CBS) that provides repeatable opportunities for healthcare providers to practice management of labor and delivery, with and without complications. A target audience for the CBS comprises students and professionals in the fields of obstetrics, midwifery, nursing, and emergency medical services. The disclosed CBS includes integrated physiologic models of mother and fetus, providing anatomical, biomechanical, and physiologic realism. The present simulator comprises mechanical, electrical, electronic and software components. No biological component is required in making the CBS. Consequently, in the present disclosure, mentions of fetus, human body and organs are primarily meant to designate anatomical models simulating or emulating biological counterparts.


The CBS comprises an instrumented mannequin in the shape of a full-term pregnant woman. The CBS is controlled by an instructor, through a software application. Other software applications emulate medical monitoring equipment for trainees. The CBS can present situations that occur during pregnancy, labor, delivery, and the postpartum period. Both vertex (head-first) and breech (buttocks-first) vaginal deliveries can be simulated, as well as Caesarean section.









TABLE 1







Feature summary of the Childbirth Simulator.










Functional Area
Feature







Reproductive
Anatomically Correct Pelvis




Realistic Birth Canal and




Genitalia




Leopold's Maneuvers




Fetal Heart Sounds




Automated Fetal Descent and




Rotation




Vertex and Breech Delivery




Shoulder Dystocia




Vaginal Bleeding




Boggy/Contracted Uterus




Inverted Uterus



Baby
Fetal Head with realistic




Fontanels




Palpable Fontanels and




Sagittal Suture




Forceps Application




Vacuum Extractor Application




Fetal Head Traction Sensing




Umbilical Cord




Intact/Fragmented Placenta



Circulatory
Pulses




Electrocardiogram (ECG)




Electrical Therapy




Chest Compression




Intravenous (IV) Access




Heart Sounds




Sphygmomanometry



Respiratory
Airway




Audible Breathing




Basic Airway Management




Bag and/or Mechanical




Ventilation




Lung Sounds




Chest Excursion




Exhalation and/or Inhalation



Nervous
Seizure




Reactive Pupils




Blinking




Vocalization, Live and




Prerecorded



Digestive and Urinary
Urinary Catheterization



Software
Integrated Physiological




Models of Mother and Fetus




Emulated Electronic Fetal




Monitor




Emulated Patient Monitor (PM)










Referring now to the drawings, FIG. 1 is a partial, exploded front elevation view of a human model simulator incorporating a childbirth simulator. The CBS can be made part of a human body simulator (HBS) (not all components shown). The HBS comprises a mannequin 10 having a general female shape, including a head 12, a torso 14, a pelvis 16, arms 18 (only one shown), and legs 20 (only one shown). An anatomical model of a fetus 22 is also provided. The foregoing will simply refer to a ‘fetus 22’ for simplicity. The CBS comprises a descent mechanism 30 for initiating movement of the fetus 22 through a birth canal 24 of the pelvis 16, and a rotation mechanism 40 for causing fetal rotation. The descent mechanism 30 moves the fetus 22 through the birth canal, up to the passage of the shoulders of the fetus 22 out of the birth canal 24.



FIG. 2 is a perspective view of a descent mechanism of the childbirth simulator. The descent mechanism 30 is a driven mechanism that may utilize for example a timing belt (not shown) and two timing pulleys 32 mounted on a frame 34, or any other components which are known in the art for driving descent of the fetus through the childbirth canal of the pelvis 16. The frame 34 could have a U-shaped cross-section as shown on FIG. 2, or any appropriate shape. The timing belt is fixed to a carriage 36 that travels along two parallel linear rails 38 mounted on the frame 34. One of the timing pulleys 32 is fixed to a motor (not shown), for example a brushless direct current motor or a stepper motor, which drives the mechanism. The motor is selected to withstand pushing and pulling forces of 20 pounds. An encoder or linear potentiometer (not shown) is used to continuously sense descent location by tracking a position of the carriage 36 along the rails 38. The descent mechanism 30 is configured to provide about eight to nine (8-9) inches or about 23 cm of travel of the carriage 36 along the rails 38.



FIGS. 3A, 3B, 3C and 3D are detailed perspective views of the descent mechanism and of a rotation mechanism. FIG. 3A and FIGS. 3B-D respectively represent two alternatives of a rotation mechanism 40. The rotation mechanism 40 is fixed to the carriage 36 (visible in FIG. 3A, but not in FIGS. 3B and 3C) of the descent mechanism 30. The rotation mechanism 40 comprises a rotating ring 42 captured within a housing, which in the embodiment of FIG. 3A includes an upper housing 44 and a lower housing 46. The inside of the rotating ring 42 is ovoid shaped such that the fetus 22 can be inserted in two (2) different ways for each style of birth, including vertex and breech. An outer flange of the rotating ring 42 has a gear profile 48 that meshes with two (2) driving pinions 50, as shown on FIG. 3A, but only one driving pinion could be used. The rotation mechanism illustrated in FIGS. 3B-D uses a single pinion (not represented in the Figures). The pinions 50 are secured to motors 52 that are mounted to the lower housing 46 as shown in FIG. 3A. Alternatively, only one motor 52 may be used when a single driving pinion is used as shown in FIGS. 3B and 3C. An encoder (not shown) located on the back of one of the motors 52 senses a rotational position of the fetus 22. The rotation mechanism 40 is capable of rotating 360 degrees or above. Inside the rotating ring 42 are one or several (at least two (2) pneumatic bladders 54 shown in FIG. 3A). When inflated, the bladder(s) 54 act as a fetal clamp holding the fetus 22 during the descent (by applying a pressure on the fetus 22), and releasing the fetus 22 during the final stage of the delivery process (by releasing the pressure on the fetus 22), i.e. extraction of the body and legs of the fetus 22 from the birth canal.


The fetus 22 may be partially or integrally inserted in a basket 56 shown in FIG. 3D but not in FIG. 3A, for simulating the placenta of the mother. The basket 56 may consist of a net, of a bag or any other means allowing a realistic simulation of the size and shape of the placenta. The basket 56 may be attached to the rotation mechanism 40, for example to the upper housing 44 shown in FIG. 3A, and extending in a direction opposite to the birth canal 24. Alternatively, as shown in FIG. 3D, the basket 56 may be attached to the rotation mechanism 40 via a cover 57, the cover 57 being secured to a ring 58 containing the pneumatic bladder(s), the ring 58 being secured to the rotating ring 42. In yet another alternative, the basket 56 is not attached to the rotation mechanism 40, but may be directly attached to the fetus 22, and extending in a direction opposite to the birth canal 24.



FIG. 4 is a rear, right perspective view of the childbirth simulator including the descent mechanism and the rotation mechanism. The Figure shows how the descent mechanism 30 and the rotation mechanism 40 are integrated within the torso 14 of the mannequin 10 such that the descent mechanism 40 terminates proximally to the birth canal 24, the rotation mechanism 40 being substantially aligned with a perimeter of the birth canal 24. The descent mechanism 30 may be activated independently of the rotation mechanism 40, allowing simulations where only the descent mechanism 30 operates, and simulations where the descent mechanism 30 and the rotation mechanism 40 operate simultaneously.


In an embodiment, the mannequin 10 is instrumented and includes a plurality of sensors, including the aforementioned encoders. These sensors are linked to one or more processors, computers and like machines that form, with the childbirth simulator, a childbirth simulation system. Without limitation, examples of sensors incorporated within the mannequin 10 may comprise a fetal head traction sensor, a fetal head torque sensor, a fetal neck traction sensor, a sensor cervix pressure applied by the fetus 22, a longitudinal fetal position sensor, a rotational fetal position sensor, a cervix dilation sensor, a cervix effacement sensor, a uterine pressure sensor, a suprapubic pressure sensor, one or more sensors of manual pressure applied at various points on the mannequin 10, one or more mannequin 10 position sensors. A particular embodiment may comprise any combination of these sensors. In the context of the present disclosure, at least some of the sensors provide actual data. For example the fetal head traction sensor can provide a measure of traction on the head of the anatomical model of the fetus 22. In another example, the fetal neck traction sensor can provide a measure of the pressure applied by the descent mechanism 30 and/or rotation mechanism 40 on the neck of the fetus 22. The fetal neck traction sensor can also provide a measure of the pressure applied on the neck of the fetus 22 by a user of the childbirth simulator pushing the head of the fetus 22 during the simulation. Additionally, the sensors may concurrently measure applied traction and applied pressure by a trainee or user of the childbirth simulator.


Further integration of the CBS and its components is described in FIG. 5, which is a block diagram showing interaction of the childbirth simulator with an instructor computer and with trainee computers according to an embodiment. In this embodiment, the CBS introduced in earlier Figures is driven by computational models of physiology of the mother and fetus and a collection of state machines. The simulator detects interventions performed by trainees, which are recorded and may trigger changes to the simulation. Included among the detected interventions is, for example, traction applied to assist delivery of the fetus, the magnitude of which is quantified.


A childbirth simulation system 60 includes the CBS including the mannequin 10. A server component and multiple client components communicate with the mannequin 10. The server component may reside inside the childbirth simulation system 60, and client applications may run on hosts that join with the mannequin 10 to form a simulation network.


The childbirth simulation system 60 may comprise two computers 62 and 64, for example single board computers that connect via any known communication means, wired or wireless, such as for example Ethernet, USB, Controller Area Network (CAN) bus, Bluetooth™, Wi-Fi, WLAN, cellular, etc. The childbirth simulation system 60 may comprise additional peripheral boards (not shown) connected to various sensors, actuators and motors, to monitor and control various features such as pulses, chest movement and bleeding. The two computers 62 and 64 are operably connected to the mannequin 10 and with its actuators, motors and sensors. One or both of the computers 62 and 64 may be physically integrated within the mannequin 10. They may alternatively be remotely located. FIG. 5 shows that the two computers 62 and 64 are at least logically integrated with the mannequin 10.


The server component residing in the computer 62 comprises a database 66 for simulation contents storage, a web server 68 for contents retrieval and a core service 70 for real-time data generation.


The childbirth simulation system 60 may also comprise an instructor computer 72 and two (2) trainee computers 74, 76, which are connectively coupled to the core service 70 and to the database 66. An instructor 78 operates the instructor computer 72. A trainee 80 obtains information from the trainee computers 74, 76 and performs manual operations on the mannequin 10.


Though not required in all embodiments, the childbirth simulation system 60 may be implemented as a mobile, untethered operation. The childbirth simulation system 60 could be self-contained.


Optionally, the instructor 78 and the trainee 80 may be requested to provide authentication before gaining access to the childbirth simulation system 60.


Software components present in the childbirth simulation system 60 may thus include:

    • Instructor Workstation (IWS) 82—a Flash™ application running in a web browser on the instructor computer 72, which provides an interface for the instructor 78 to create training scenarios and conduct simulation training.
    • Patient monitor (PM) 84—a Flash™ application running in a web browser on the trainee computer 74, which emulates a bedside patient monitor, displaying vital signs of the simulated patient and other physiologic data, such as electrocardiogram waveforms.
    • CTG Monitor Emulator 86—a Flash™ application running in a web browser on the trainee computer 76, which emulates a cardiotocograph (CTG), also known as an electronic fetal monitor or maternal-fetal monitor, displaying fetal heart rate, uterine activity (contractions), and maternal vital signs.
    • Core Service 70—a software application running on the computer 62, optionally embedded in the mannequin 10, responsible for running computational models of physiology and training scenarios and for communication with the IWS 82, PM 84, CTG monitor emulator 86, and with a Firmware Application Layer.
    • Firmware Application Layer—acquisition and control software 88 running on one or both of the computers 62 and 64, implementing sensor data acquisition and actuator control.
    • Hardware Abstraction Layer—low level software running on one or both of the computers 62 and 64, supporting the acquisition and control software 88 in implementing sensor data acquisition and actuator control.
    • MySQL™—a database server running on one or both of the computers 62 and 64 and utilized by the core service 70, IWS 82, PM 84, and CTG monitor emulator 86.
    • PHP—a script interpreter running on the computers 62 and 64.
    • Apache—software platform of the web server 68.
    • Adobe™ Flash Player™—a web-browser plugin running on the instructor computer 72 and on other computers of the childbirth simulation system 60.


Software client applications such as the IWS 82, the PM 84 and the CTG emulator monitor 86 provide the instructor 78 and the trainee 80 with visual representations of parameters of the ongoing simulation. The IWS 82 provides simulation controls such as start and stop of a simulation. The PM 84 application provides waveform and vital sign display. CTG emulator monitor 86 specifically provides monitoring of a fetus uterine activity (UA) and fetal heart rate (FHR). Both the PM 84 and the CTG emulator monitor 86 are designed for trainee access. In an embodiment, the software client applications are web-based. So that no specific installation is required at the client side other than provision of an ordinary web browser.


Educational contents are represented as simulated clinic experiences (SCE). An SCE definition includes a patient that is defined by various physiologic parameters and multiple scenarios that simulate the medical conditions.


The SCEs are stored in the database 66. The core service 70 provides mathematical simulation of the physiologic models and generates real-time physiologic data to feed back to the software client applications.


A typical simulation involves the following operations, some of which may be executed in a variable order, some of the operations possibly being executed concurrently, some of the operations being optional:

    • A) The core service 70 starts and sets up a transmission control protocol (TCP) server for client application connections.
    • B) The instructor 78 opens a web browser and type in the uniform resource locator (URL) to access the server side of the web server 68.
    • C) A Flash™ object is loaded to the IWS 82 and starts to communicate with the web server 68 via Hypertext Preprocessor (PHP) common gateway interface (CGI).
    • D) The Flash™ object accesses the database 66 via PHP, and fetches the educational contents, and displays the contents on the IWS 82.
    • E) The instructor 78 starts the simulation.
    • F) The Flash™ object starts to communicate with the core service 70 and conducts the command.
    • G) The core service 70 accesses the database 66 to fetch an educational content and to feed it to the mathematical model.
    • H) The simulation starts.
    • I) The trainee 80 stays close to the mannequin 10 and to the computers 74, 76, and monitors physiologic signals via either PM 84 or CTG emulator monitor 86.
    • J) The instructor 78 adjusts patient control via the IWS 82, or loads a training scenario from the database 66, via the web server 68, into the simulation.
    • K) The Flash™ object conducts the commands to the core service 70.
    • L) The simulation is ongoing.
    • M) The trainee 80 checks pulse, does cardiopulmonary resuscitation (CPR), checks eye blinking, and performs specific childbirth procedures as directed by the training scenario.
    • N) Interventions done by the trainee 80 are fed back to the core service 70, which may impact next events in the training scenario.
    • O) The core service 70 continues to feed data to the client applications and saves simulation results and logs into the database 66.
    • P) The instructor 78 stops the simulation.
    • Q) The Flash™ object sends a stop command to the core service 70, and the simulation stops.


In a non-limiting embodiment, a typical simulation command comprises the following operations:

    • i) The instructor 78 clicks on a heart control on the IWS 82.
    • ii) The instructor 78 sets the heart rate (HR) to 120 using a text field or slider of the IWS 82.
    • iii) The Flash™ object wraps the “set HR 120” command into an appropriate format and sends it to the core service 70.
    • iv) The core service 70 gets the command and makes it into a data block in an internal memory.
    • v) A model running in the core service 70 picks up the new data and drives the simulation.
    • vi) The core service 70 logs these events in the database 66.


As mentioned hereinabove, the CBS can be integrated in a full human body simulator (HBS). The HBS may in turn additionally provide a variety of simulation components to simulate additional functions of the human body related to and/or affected by childbirth. Table 2 provides a detailed list of features of a fully integrated CBS; this list is not limiting and some embodiments may comprise more or less than the features set of Table 2.









TABLE 2







Detailed list of features of the Childbirth Simulator








Name
Description





External Cephalic
External cephalic version can be performed on the


Version
mannequin to rotate the fetus in the uterus.


Mobile Fetal
Fetal heart sounds emanation source changes


Heart Sounds
appropriately with the fetal delivery progress. For



instance, a location where the fetal heart can be heard



changes as the fetus descends and rotates to more



properly reflect reality.


Anatomically
The simulator's pelvis is of gynecoid shape and has


Correct Maternal
anatomically correct dimensions and palpable


Pelvis
landmarks including pubic bone and the ischial spines.


Palpable Uterine
Uterine contractions can be detected by palpating the


Contractions
fundus.



Time interval between uterine contractions may vary



from 10 minutes to 1 minute with less than 4 minutes



during normal labor. Each contraction lasts between 30



to 90 seconds with an average of about 1 minute.



Contraction generates between 20 to 60 mm of mercury



(Hg) of amnionic fluid pressure with an average of about



40 mm Hg.



Hypercontactility refers to a smaller than 2 minutes



interval between contractions or contractions lasting



more than 2 minutes (hypertonus uterus).



“Rock-hard” uterus refers to a contraction above a



predetermined pressure level.


Cervix
The mannequin has a cervix that can be assessed by



vaginal examination. Various stages of dilation (0 to 10



cm) and effacement (from 0% to 100%) are



represented.


Fetal Heart
The simulator produces fetal heart sounds that are


Sounds
audible by auscultation.


Fetal Descent
The fetus is delivered by an active mechanism that


and Rotation
properly responds to maneuvers used to assist delivery.


Suprapubic
The mannequin can withstand the application of


Pressure Support
suprapubic pressure to relieve shoulder dystocia.


McRoberts
The mannequin detects the correct execution of


Maneuver
McRoberts maneuver to resolve shoulder dystocia.


Detection


Rubin II
The simulator supports application of the Rubin II


maneuver
maneuver to resolve shoulder dystocia.


Support


Wood's Screw
The simulator supports the application of the Wood's


Maneuver
screw maneuver.


Support


Postpartum
The mannequin can be made to bleed from the vagina


Vaginal Bleeding
after delivery.


Episiotomy
Episiotomy can be performed on the mannequin.


Intrapartum
The mannequin can be made to bleed from the vagina


Vaginal Bleeding
while in labor.


Delivery of the
The simulator supports the delivery of the posterior arm


Posterior Arm
to resolve shoulder dystocia.


Wood's Screw
The simulator detects proper application of the Wood's


Maneuver
screw maneuver.


Detection


Detection of
The mannequin detects and measures the rotational


Rotational
maneuvers performed by the care provider.


Maneuvers


Breech Delivery,
A vaginal or C-Section breech delivery can be


Frank and
performed with the simulator for frank and complete


Complete
breech.


Caesarean
Simplified Caesarean Section can be performed on the


Section
simulator. An appropriate opening is provided to allow



the obstetrician to pull out the fetus and the placenta.


Suprapubic
The simulator detects the proper application of


Pressure
moderate suprapubic pressure to resolve shoulder


Detection
dystocia.


Zavanelli
The mannequin detects the execution of Zavanelli


Maneuver
maneuver.


Detection


Rubin II
The simulator detects proper application of the Rubin II


Maneuver
maneuver.


Detection


Breech Delivery,
A C-Section breech delivery can be performed with the


Single and
simulator for single and double footling breech


Double Footling
presentation.


Childbirth
The simulator provides a childbirth supportive breathing


Breathing Pattern
pattern: high respiratory rate on contraction.


Chest Excursion,
The mannequin's chest may move asymmetrically with


Asymmetric
breathing.


CPR Analysis
The simulator analyzes chest compression.


Spontaneous
The simulator is able to spontaneously breathe to a


Breathing
given respiratory rate exhibiting appropriate perceptible



cues.


Normal Breathing
The simulator provides a normal breathing pattern.


Pattern


International
The simulator complies with the regulatory requirements


Operation
of various countries.


IV Therapy
The mannequin can receive IV Therapy.


Support


Right Mainstem
The simulator can detect right mainstem intubation


Intubation
when an endotracheal tube is inserted.


Detection


Intubation
The system detects proper intubation.


Detection


CTG MNIBP User
The emulated CTG provides control over the display of


Interface (UI)
the Maternal Non-Invasive Blood Pressure (MNIBP).


CTG TOCO
The emulated CTG provides a Tocodynamometer


ZERO UI
(TOCO) Zero reset capability.


Fetal Head with
The fetal head deforms realistically under pressure.


realistic Fontanels


CTG Historical
The simulator provides a mechanism whereby relevant


Data Generation
CTG related data just anterior to a scenario start can be



generated.


Fetal Airway
The fetal nose and mouth accommodate suctioning.


Suctioning


Fetal Spiral Scalp
A spiral ECG electrode can be attached to the fetal


Electrode
scalp.


Placement


Trendelenberg
The simulator detects positioning of the mannequin in


Detection
the Trendelenberg position.


Fetal Applied
The instructor interface dynamically displays information


Torque Display
on the torque forces applied by the trainee to the fetus



head and neck.


Umbilical Cord
The fetus has a realistic umbilical cord that may be



positioned as prolapsed or nuchal and can be cut.


Pulses, Brachial
The simulator has bilateral brachial pulses.


Breath Sounds
The simulator's breathing can be made audible for



auscultation. The breaths sounds are synchronized with



the respiratory cycle and have an audible volume



control. Sounds can be positioned across one or more



of the following sites:



Bronchial, Right/Left (expansion of current



capability) - 2 channels, 2 sites (shares upper



heart sound speakers);



Bronchovesicular, Right/Left Upper Posterior - 2



channels, 4 sites;



Vesicular, Right/Left Upper Anterior - 2 channels,



4 sites;



Vesicular, Right/Left Lower Anterior - 2 channels,



4 sites;



Vesicular, Right/Left Lower Posterior - 2



channels, 4 sites;



Bronchovesicular, Sternum (expansion of current



capability) - 1 channel, 1 site.



Normal sound is included.


CTG Control UI
The Emulated CTG provides a set of controls that



allows its user to direct its operation.


Alarm Control UI
The emulated CTG provides the capability to set, clear,



and control alarms on physiological data.


CTG Paper strip
The emulated CTG provides the capability to display on



screen a reproduction of the paper strip produced by



real CTG with Fetal Heart Rate (FHR) and optional



Maternal Heart Rate (MHR) graphs in a top grid part,



Uterine Activity (UA) graph in a lower grid part.


CTG Alarms
The emulated CTG provides the capability to set and



trigger alarms for out of stated bounds physiological



data.


Vocalization, Live
The simulator can mix-in the vocalization sounds,



speech and vocal sounds created live by an operator via



wireless microphone. Live speech and sounds are



subjected only to the vocalization adjustable volume



control. Live speech and sounds are not disabled by



apnea or loss of consciousness or repeated based on a



specified pattern.


Urinary
The simulator has a urinary bladder that can be filled


Catheterization
with fluid and catheterized.


Blinking
The simulator's eyes blink.


Vocalization
The simulator produces prerecorded speech and vocal



sounds. Speech can be localized to a given language.


Positive Pressure
The mannequin can be mechanically ventilated,


Ventilation
exhibiting realistic airway/bronchial resistance,



lung/chest compliance, and chest excursion. The



simulator detects ventilation.


Reactive Pupils
The simulator's pupils can be set to fixed size or made



to react automatically to light.


Left Lateral Tilt
The simulator detects positioning of the mannequin in


Detection
the left lateral tilt position.


Sphygmomanometry
The simulator's blood pressure can be evaluated by



sphygmomanometry.


Pulses, Radial
The simulator has bilateral radial pulses.


Pulses, Carotid
The simulator has bilateral carotid pulses.


SpO2 Probe
A simulated oxygen saturation (SpO2) finger probe can



be physically placed on the mannequin, enabling the



display of optoplethysmography data on a simulated



patient monitor.


Seizure
The simulator exhibits seizure: arm, eye, jaw movement,



and stertorous inhalation.


Custom
The SCE system maintains vocalization integrity of


Vocalizations
exported SCE that uses custom vocalization.


SCE Support


CBS Script
The system accepts CBS related events as conditional


Trigger
trigger within a scenario script.


Scripted Fetal
The system provides scripted control over fetal descent


Descent and
and rotation.


Rotation


CPR
The instructor interface provides CPR effectiveness


Effectiveness
analysis.


Assessment


CBS Data
The existing instructor interface is extended to capture


Logging
the evolution over time of CBS specific physiological



and training data for later debriefing and analysis.


CBS Event
The existing instructor interface is extended to log


Logging
notification events for CBS specific conditions or change



of states.


Fetal Applied
The instructor interface dynamically displays information


Traction Display
on the traction forces applied by the trainee to the fetus



head and neck.


12-Lead ECG
The maternal patient monitor provides 12-Lead ECG


Report
reporting capabilities.


IV Access,
Intravenous cannulas can be introduced into the veins


Forearm
of the forearm.


APGAR Score
The physiological models generate Appearance, Pulse,



Grimace, Activity, Respiration (APGAR) scores for the



newly born fetus.


CTG User
The emulated CTG provides the capability to locally set


Configuration UI
some behavioral aspects.


CTG
The simulator provides the capability to configure the


Configuration UI
operation and the look of the emulated cardiotocograph



(CTG).


Articulated Fetal
The fetal body articulates realistically for the following


Body
joints:



neck;



shoulders;



elbows;



hips;



knees.


Postpartum
The instructor interface provides control over post-


Hemorrhage UI
partum vaginal bleeding.


Neonate Crying
The instructor interface provides control over neonate


UI
crying.


Maternal Heart UI
The instructor interface provides control over the



maternal heart parameters; e.g. cardiac rhythms, heart



sounds.


Fetal Soft Tissue
The fetal body is realistically pliable such that it is



possible to differentiate between cephalic and breech



delivery.


Pulses UI
The instructor interface provides control over pulses



settings


Audible Breathing
The instructor interface provides control over audible


UI
breathing settings.


Breath Sounds UI
The instructor interface provides control over breath



sounds settings.


Chest Excursion
The instructor interface provides the capability to control


UI
operation of the chest excursion mechanism.


Seizure UI
The instructor interface provides the capability to control



operation of the seizure mechanism.


Eye Control UI
The instructor interface provides control over the



mannequin eyes.


Vocalization UI
The instructor interface provides control over the



vocalization playback parameters.


Emulated
The simulator includes an emulated cardiotocograph


Cardiotocograph
that provides the most common features found on



typical real CTG monitors. It displays mother and fetus



physiological data as numeric values along with an on-



screen reproduction of the paper strip produced by real



CTG printer. It handles singleton.


Live vocalization
The instructor interface provides control over the live


UI
vocalization parameters.


Laboratory
The instructor Interface supports use of laboratory


Results UI
results within a training session.


Physiological
The existing instructor interface is extended to display


Data Display
selected additional CBS physiological data values.


ECG Signals
The instructor interface can display up to 12-Lead ECG


Display
signals; e.g. 3-Lead, 5-Lead and 12-Lead traces are



available


Caesarean
A high fidelity caesarean section can be performed on


Section, High
the simulator.


Fidelity


CBS Related
The patient simulator instructor interface historical data


Historical Data
management can manage the CBS related data.


Instructor
The patient simulator instructor interface supports the


interface CBS
CBS simulator. View(s), control(s), and physiological


Support
data specific to the CBS are provided.


Operation Mode
The instructor interface provides control and


UI
visualization over the operating mode of the mannequin.


Fetal Heart
The instructor interface provides controls over the fetal


Sounds UI
heart sounds.


Cervix UI
The instructor interface provides control and



visualization over the cervix operation.


Shoulder
The instructor interface provides control over Shoulder


Dystocia UI
Dystocia.


Fetal Descent
The instructor interface provides control and


and Rotation UI
visualization over fetal descent and rotation.


Exhalation
The mannequin exhales air (or any other inhaled gas)



such that it minimally provides required cues to



stimulate ventilator.


Chest
The simulator detects and properly reacts when chest


Compression
compression is applied.


Detection


Chest
Chest compression can be performed on the


Compression
mannequin.


Emulated
The simulator provides an emulated patient monitor for


Maternal Patient
the maternal vital signs.


Monitor


Airway
The simulator has an anatomically correct airway.


Electrical Therapy
The simulator can be paced, cardioversed and



defibrillated.


Audible Breathing
The simulator's breathing can be made audible for



unaided listening. The breathing sound is synchronized



with the respiratory cycle and has an audible volume



control.


5-Lead ECG,
A real 5-lead electrocardiograph can be connected to


Real
the simulator. This includes the capability to connect a



real 3-Lead electrocardiograph.


Heart Sounds
The simulator produces realistic heart sounds



associated with a variety of conditions at the 4



precordial auscultation areas. Each of the 4 auscultation



sites is independently controllable.


Catheterization
The mannequin provides an immediate urinary output


Immediate Urine
upon catheter insertion.


Output


IV Access, Dorsal
Intravenous cannulas can be introduced into the veins


Hand
of the dorsum of the hand.


Laboratory
The simulator provides a mechanism whereby patient


Results
laboratory results can be communicated.


Chest Excursion,
The simulator's chest rises and falls with spontaneous


Spontaneous
breathing.


IV Drug
Intravenous drugs administered to the mannequin are


Recognition
automatically detected.


Fraction of
The simulator senses and measures the amount of


Inspired Oxygen
oxygen provided to it.


Sensing


Rectum
The simulator has an anal sphincter and rectal cavity for



administration of some amount of medicine (micro-



enema and suppository).


Epidural
The simulator supports the epidural procedure.


Articulated
The simulator provides an articulated maternal full-body


Maternal Body
to allow a variety of birthing positions for:



interventions for delivery complications;



interventions for maternal emergencies;



realistic patient transport.



The maternal body is an implementation of a human



body simulator with added maternity specific features.


Leopold's
Leopold's maneuvers can be performed on the


Maneuvers
mannequin to determine the position and lay of the fetus



in the uterus and to estimate fetal weight.


Vagina
The mannequin has a realistic birth canal.


Vulva/Perineum
The mannequin has external female genitalia and



perineum. Provides an intact perineum and one for



episiotomy.


Shoulder
Descent of the fetus can be halted by shoulder dystocia.


Dystocia


McRoberts
The McRoberts maneuver can be applied to the


Maneuver
mannequin.


Support


Zavanelli
Zavanelli maneuver can be applied to the mannequin.


maneuver


Support


Postpartum
The mannequin has a palpable postpartum uterus.


Uterus


Inverted Uterus
The mannequin can be configured with a fully or



partially inverted uterus.


Intact Placenta
The placenta can be delivered in an intact state.


Fragmented
The placenta can be delivered in a fragmented state.


Placenta


Palpable
Anterior and posterior fontanels and the sagittal suture


Fontanels and
are palpable on the fetal head.


Sagittal Suture


Forceps
Forceps can be applied to the fetus to assist delivery.


Application


Vacuum Extractor
A vacuum extractor can be applied to the fetus to assist


Application
delivery.


Physiological
The simulator may be driven by models of maternal and


Models
fetal physiology.


Untethered
The simulator operates untethered.


Operation


Crying
The neonate cries.


Fetal Head
The simulator senses the magnitude of torque applied


Torque Sensing
by the care taker on the fetal head and indicates when



excessive force is used. No force is reported for



spontaneous activity.


Fetal Neck
The simulator senses the magnitude of traction force


Traction Sensing
applied by the care taker on the fetal head and indicates



when excessive force is used. No force should be



reported for spontaneous activity.









Those of ordinary skill in the art will realize that the description of the childbirth simulator and its applications are illustrative only and are not intended to be in any way limiting. Other embodiments will readily suggest themselves to such persons with ordinary skill in the art having the benefit of the present disclosure. Furthermore, the disclosed childbirth simulator may be customized to offer valuable solutions to existing needs and problems of providing a realistic childbirth simulation.


In the interest of clarity, not all of the routine features of the implementations of the childbirth simulator are shown and described. It will, of course, be appreciated that in the development of any such actual implementation of the childbirth simulator, numerous implementation-specific decisions may need to be made in order to achieve the developer's specific goals, such as compliance with application-, system-, and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the field of biomedical engineering having the benefit of the present disclosure.


In accordance with the present disclosure, the components, process operations, and/or data structures described herein may be implemented using various types of operating systems, computing platforms, network devices, computer programs, and/or general purpose machines. In addition, those of ordinary skill in the art will recognize that devices of a less general purpose nature, such as hardwired devices, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), or the like, may also be used. Where a method comprising a series of operations is implemented by a computer or a machine and those operations may be stored as a series of instructions readable by the machine, they may be stored on a tangible medium.


Systems and modules described herein may comprise software, firmware, hardware, or any combination(s) of software, firmware, or hardware suitable for the purposes described herein. Software and other modules may reside on servers, workstations, personal computers, computerized tablets, personal digital assistants (PDA), and other devices suitable for the purposes described herein. Software and other modules may be accessible via local memory, via a network, via a browser or other application or via other means suitable for the purposes described herein. Data structures described herein may comprise computer files, variables, programming arrays, programming structures, or any electronic information storage schemes or methods, or any combinations thereof, suitable for the purposes described herein.


Although the present disclosure has been described hereinabove by way of non-restrictive, illustrative embodiments thereof, these embodiments may be modified at will within the scope of the appended claims without departing from the spirit and nature of the present disclosure.

Claims
  • 1. A childbirth simulator for moving an anatomical model of a fetus inside a human model simulator having a birth canal, comprising: a descent mechanism for moving the anatomical model of the fetus longitudinally towards the birth canal of the human model simulator, the descent mechanism comprising a frame, two rails mounted on the frame and a carriage traveling along the two rails; anda rotation mechanism comprising: a housing mounted to the carriage of the descent mechanism; anda rotating ring captured within the housing, an inside of the rotating ring being ovoid shaped for allowing insertion of the anatomical model of the fetus in two different ways in the rotating ring corresponding to two different styles of birth, the inside of the rotating ring comprising at least one pneumatic bladder acting as a fetal clamp when inflated for retaining the anatomical model of the fetus within the rotating ring in either style of birth and while moving the anatomical model of the fetus longitudinally towards the birth canal of the human model simulator.
  • 2. The childbirth simulator of claim 1, wherein the two rails are parallel and linear.
  • 3. The childbirth simulator of claim 1, wherein the frame has a U-shaped cross-section.
  • 4. The childbirth simulator of claim 1, wherein the descent mechanism further comprises: two timing pulleys mounted on the frame;a timing belt fixed to the carriage; andwherein rotation of the two timing pulleys generates longitudinal movement of the timing belt along the two parallel linear rails, thereby moving the carriage along the two parallel linear rails.
  • 5. The childbirth simulator of claim 4, wherein one of the timing pulleys is fixed to a motor for driving the descent mechanism.
  • 6. The childbirth simulator of claim 5, wherein the motor is selected to withstand pushing and pulling forces of 20 pounds.
  • 7. The childbirth simulator of claim 1, wherein the descent mechanism further comprises one of an encoder or a linear potentiometer for continuously sensing descent location by tracking a position of the carriage along the rails.
  • 8. The childbirth simulator of claim 1, wherein the descent mechanism is configured to provide about 8 to 9 inches of travel of the carriage along the rails.
  • 9. The childbirth simulator of claim 1, wherein the rotating ring is capable of rotating 360 degrees or above.
  • 10. The childbirth simulator of claim 1, wherein an outer flange of the rotating ring has a gear profile that meshes with at least one driving pinion, the at least one driving pinion being secured to a motor.
  • 11. The childbirth simulator of claim 10, wherein an encoder located on the motor senses a rotational position of the anatomical model of the fetus.
  • 12. The childbirth simulator of claim 1, further comprising a basket for simulating a placenta, the basket being attached to the rotating mechanism.
  • 13. A childbirth simulator, comprising: a human model simulator having a birth canal; anda system integrated in the human model simulator for moving an anatomical model of a fetus inside the mannequin comprising: a descent mechanism for moving the anatomical model of the fetus longitudinally towards the birth canal of the human model simulator, the descent mechanism comprising a frame, two rails mounted on the frame and a carriage traveling along the two rails; anda rotation mechanism comprising a housing mounted to the carriage of the descent mechanism and a rotating ring captured within the housing, the rotating ring being ovoid shaped for allowing insertion therein of the anatomical model of the fetus in two different ways corresponding to two different styles of birth within the rotating ring, the inside of the rotating ring comprising at least one pneumatic bladder acting as a fetal clamp when inflated for retaining the anatomical model of the fetus within the rotating ring in either style of birth while moving the anatomical model of the fetus longitudinally towards the birth canal of the human model simulator.
  • 14. The childbirth simulator of claim 13, wherein the mannequin is an instrumented mannequin.
  • 15. The childbirth simulator of claim 13, further comprising a user interface for controlling a longitudinal movement of the descent mechanism and for controlling a rotation of the rotation mechanism.
  • 16. The childbirth simulator of claim 13, wherein the descent mechanism terminates proximally to the birth canal of the mannequin and the rotation mechanism is substantially aligned with a perimeter of the birth canal.
  • 17. The childbirth simulator of claim 13, further comprising a mechanism located at the bottom of the birth canal for blocking forward movement via the descent mechanism of the anatomical model of the fetus, to simulate shoulder dystocia.
  • 18. The childbirth simulator of claim 13, further comprising a basket for simulating a placenta, the basket being attached to the rotating mechanism.
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Related Publications (1)
Number Date Country
20150004583 A1 Jan 2015 US
Provisional Applications (1)
Number Date Country
61841250 Jun 2013 US