Maternal simulator

Device for simulating birth and birth related complications, the device being adapted to be attached to a real human being 5 and having an outer skin 1 with a simulated vaginal opening 6, said opening being adapted to be situated adjacent the lower part of the person 5, further having a simulated uterus 18 adapted to contain a foetus manikin 29, said uterus 18 having an opening 20 coinciding with the vaginal opening 6 of the outer skin 1, said uterus 18 further a uterus simulator 51 for simulating uterus conditions between a simulated atonic state and a simulated contracted state, and further comprising a first conveyor 27 for conveying simulated blood from a blood container 33 to the simulated vaginal opening 6, when the simulated uterus 53 is in the atonic state.

TECHNICAL FIELD

The following invention relates to a teaching device for simulating pregnancy, birth and birth related complications.

BACKGROUND ART

The risk for death of mother as well as newborn varies dramatically between the developed and the developing countries. WHO estimates that over 98% of maternal and infant deaths occur in the developing countries. Over half of these deaths occur when deliveries take place in the home without health care personnel present. But also when deliveries take place in health care institutions, maternal and death rates are more than 10 times higher in developing countries.

One main reason for this is that there are too few birth attendants available and that many of these have not been adequately trained to handle obstetric or newborn emergency cases. The invention described herein aims at addressing this problem.

The causes for these deaths are in many cases related to conditions that could have been easily avoided or remedied. It has been experienced that the death rate can be substantially lowered if the midwife or other persons helping the mother and newborn is given some basic training in handling the most usual complications that can occur. It is also a great advantage if the simulator also can be used for building awareness and knowledge for a mother as preparation in advance of the birth.

The above devices are generally too complicated to be used under primitive conditions in a developing country, most of them even requiring electricity to work.

Newly developed training device is shown in US 20090298035. This device has the advantage of being simple and easy to use. It can be put on a person acting as the expecting mother like a pair of trousers. The “mother” then puts a foetus manikin into a doll-containing portion, i.e. a pocket, the trousers and pushes it out through a hole simulating the vagina.

Although, this device is very simple to use and appropriate for low resource settings, it does not sufficiently support training for basic and more advanced situations and interventions relevant during the three stages of birth. It is also not possible to simulate a number of usual complications after the delivery.

SUMMARY OF INVENTION

It is therefore an object of the present invention to provide a device for simulating pregnancy, birth and complications relating to birth, which can be attached to a person acting as the mother. It is also envisaged that the person acting as the mother will be controlling the simulation and act as the instructor. The device is intended to serve as a general birth simulator that can support the relevant situations and interventions where assistance is needed during birth.

The simulator is therefore designed with a simulated uterus from which a baby manikin can be delivered.

In a preferred embodiment the uterus will have at least two states; atonic and contracted. This is preferably achieved having an inflatable part simulating the contracted uterus, but may also be achieved by pulling ropes that acts to fold the uterus from big and soft to small and compact. The skin could have an indication for a navel, since this is a landmark when it comes to assessing uterine contraction.

With the simulator of the present invention it is an object to be able to simulate various conditions connected to birth, both relating to the mother and the child. The foetus/baby manikin is a simulator in itself. The simulator of the present invention therefore enables training on the care of two patients at the same time and can be an important tool in the work to fulfil the UN millennium goals; No. 4—to reduce child mortality—and No. 5—to reduce maternal mortality. It will make it easier for health workers to see the connection between child health and maternal health.

The foetus manikin comprises a plastic foil material that is shaped to enclose a water tight compartment. By filling the compartment with water or possibly another liquid, such as oil, the foetus manikin will get approximately the same weight as a real human foetus.

With the simulator it is inter alia possible to simulate one or more of the following situations and interventions:Normal deliveryBreech deliveryIncomplete placentaAtonic uterusEclampsiaTrapped placentaRetained placentaPlacenta previaPlacenta abruptioBreech delivery with trapped headShoulder dystociaMalpresentationHeavy bleedingDelayed bleedingConstant checks of the uterus conditionMassage for uterine contractionControlled cord tractionsManual removal of placentaFrequent assessment of bleedingEstimation of blood lossIV dripMassive volume resuscitationBimanual compressionBalloon tamponadeAortic compression

It is a further object of the present invention that the instructor can control one or more of the following parameters:Acting—talking, expressing feelings, pain etcBleeding—amount and natureUterus conditionFetal heart soundsPosition of the foetusProgress of the birth

The simulator of the present invention may also have a number of other advantages compared to the devices mentioned above:Improved integration of communication between health worker and mother in the simulation.Easy preparations and clean upLow maintenance needs

DETAILED DESCRIPTION OF THE INVENTION

When in the following orientation or position terms are used, this refers to the device in an intended position of use.

For simplicity, in the following description the parts of the device of the invention simulating human body parts and organs will sometimes be referred to by the name of that body part or organ.

InFIGS. 1-4a device according to the invention for simulating birth and maternal complications is shown. It comprises a simulated skin (hereinafter called skin)1, to which is attached a waist strap2to be placed around the instructor5who acts as the expecting mother.

The skin2will extend over a substantially part of the front of the instructor/mother5. Between the legs of the mother5there will be a space for simulated internal organs, which will be explained in the following.

The skin1has a convex shape near the thigh and extends party between the thighs of the mother5. In this area the skin1has an opening6, simulating the vaginal opening.

FIGS. 12-17show a skeleton part7of the device of the present invention. This forms a part of the above mentioned internal organs. A dome shaped part8simulates the pelvis, including hip bones and pubic bones.

An elongate part15simulating the lower part of the spine extends from the pelvis8. The spine will be explained in detail below.

The pelvis8is generally concave and a pelvic aperture17is defined in the bottom thereof. The pelvis8has on each side concave portions9,10that are shaped to fit well against the thighs of an instructor wearing the simulator.

The spine15is hollow and accommodates a flexible blood container (not shown. The Blood container is preferably made of a transparent plastic sheet material. An opening of the blood container is welded, glued or in another suitable way fixed to a fill opening in the spine15. A lid70is received by threads in the fill opening.

A flexible tube27(seeFIG. 9) extends from the blood container to within the vagina. The tube extends through a lever mechanism71(seeFIGS. 16 and 17). The lever mechanism71comprises a lever72that is rotatable about an axis73and has a cam74. The cam acts on a flexible arm75. The arm in turn acts on the tube (not shown) from the blood container. With the lever mechanism71it is possible to pinch the tube from the blood container, so that the flow of blood through the hose can be adjusted from maximum to zero. The lever72interacts with three notches76in the lever mechanism71so that it can rest in the three positions fully open, half open and closed.

In addition to the blood container, there is also a urine container36. This is situated at the inside of the top/front of the pelvis8. This position is advantageous as it will be a high point of most birth positions and therefore ensure that the simulated urine inside the urine container will flow out of the container when catheterization is performed. The urine container is also preferably made of a transparent flexible plastic sheet material.

The position at the inside of the pelvis8also protects the urine container36against damage.

The urine container36is equipped with a valve mechanism38. The valve mechanism38is of a type known per se that will open when a catheter is inserted. The opening of the valve mechanism is at the upper/front end of the vagina opening.

The skeleton part is moulded in two parts, as shown inFIG. 15; a ventral (front) part15acomprising the pelvis8and a dorsal (back) part15b. The two parts are snap-fitted together. The compartment for the blood container is formed between the two parts15aand15b.

The simulated uterus part18of the device of the present invention is shown in detail inFIG. 22. It comprises a ventral part18aand a dorsal part18b. Close to the posterior (lower end) the two parts18aand18bare connected by seams19, leaving an opening20at the posterior end. The edge of the opening20is sewn to the edges of the vaginal opening6of the outer skin1. At the anterior end the two parts18aand18bof the uterus18are equipped with a zipper22. The zipper is adapted to close an insertion opening23for the foetus manikin29.

At the edge of the opening23is also a strap25with a hook and loop system that can be used as an alternative means to close the opening23when it is desirable for the instructor to be able to reach into the uterus18.

At the inside of the dorsal part18bof the uterus18is a pocket26(in dotted lines) for placement of the placenta80.

At the outside of the dorsal part18bis also a pocket28(full lines). This pocket28has two slits30,31through which a strap56for a uterus contraction simulator (seeFIGS. 18 and 19). This will be explained in detail in connection withFIGS. 18 and 19.

The skin1and the uterus part18can be made from the same type of material. This can be a suitable web material of fabric, foil or other flexible sheet material. Preferably the material has some elasticity that simulates the elasticity of the real human tissue.

Near the posterior end of the uterus18are ribbons82(only one shown). These form handles for the mother when simulating labour, as will be explained below.

Close to the vaginal opening20is a ribbon40that can be tightened to restrict the expansion of the cervix and the vagina or to control the diameter of the cervix to simulate the cervix dilation that is the first stage of labour. The ribbon40extends around the cervix and has several punched out holes41that can be slipped onto a knob (not shown) on a buckle42, so that the opening adjusted can be maintained without the need for the instructor to hold the ribbon40. By selecting a different hole the cervical opening can be changed. The instructor can easily feel the holes and may count the holes to set the desired opening size.

A simulated placenta80is can be releasably attached to the inside of the uterus, e.g. by a hook and loop fastener, in order to withhold the placenta80in place after the delivery of the baby. The placenta is connected to the foetus by an umbilical cord81. The fastening of the placenta is such that a pull in the umbilical cord81will free the placenta80from the uterus.

FIG. 3shows the insertion of the foetus manikin29through the opening23into the uterus18.

When the foetus manikin29has been fully inserted, the delivery may commence. As shown inFIGS. 5 and 6the labour contractions are simulated by the mother5pressing on the uterus with her hands and thereby pushing the foetus manikin downwards towards and into the vagina. To facilitate this there are provided handles82, e.g. straps, on the outside of the uterus18. There may be one strap82for each hand. The mother can grip these straps82with the four fingers of both hands and press on the top of the uterus with the thumbs.

The cervix and vagina are made of an elastic material which will stretch under the pressure from the foetus manikin29and allow the foetus manikin to pass through. The circumference and elasticity of the cervix and vagina are adapted to simulate a real baby delivery. The foetus manikin29has a size and weight of the same magnitude as a real baby. This can be achieved by filling the baby manikin body with water or similar fluid.

After the baby has been delivered, the simulator may be used to simulate a variety of common complications. The mother may hold the placenta80to prevent the midwife from pulling it out, thus simulating a retained placenta.

The placenta may also have a part that can be taken off by the mother and retained inside the uterus. This simulates a condition where the placenta splits and a part of the placenta is not expelled.

In order to simulate bleeding the mother5may toggle the lever72to open up the flow of artificial blood from the blood container. This way the mother can adjust the bleeding to simulate various conditions. Through a window in the blood container compartment in the mother can watch the blood level in the container and thereby control the total amount of bleeding.

A possible scenario of a birth may be as follows:

The simulator is attached to the mother5as shown inFIG. 1. The blood container33, if not already filled with artificial blood, may be filled by unscrewing the cap70as shown inFIG. 2. The foetus manikin29is placed inside the uterus18as shown inFIG. 3and also described above.

Catheterization is performed by inserting a catheter (not shown) into the simulated urethra90(seeFIG. 12). The catheter is inserted until it enters through the valve91in the urine container36and opens this. Thereby the simulated urine (which conveniently is plain water) runs through the catheter.

The labour is started by the mother5squeezing the uterus18in an intermittent fashion in order to simulate real labour. The mother may place the thumbs against the end of the uterus18furthest away from the vagina20and grip the straps82with the remaining fingers and use these as a lever to push on the foetus manikin29inside the uterus18. For each squeeze the foetus manikin29is pressed further into the birth channel formed by the cervix and the vagina. The mother may fold the uterus18in order to increase the pressure on the foetus manikin29.

By placing the foetus manikin the other way around a breech delivery can also be simulated. Other complications can also be simulated by choosing different positions of the foetus manikin29.

While the foetus manikin is being pressed through the birth channel the person being trained as a midwife can practice on receiving the baby, as shown inFIG. 7. When the foetus manikin, which now is better to call a baby manikin29, has been pressed completely out, a cord81simulating the umbilical will extend from the baby though the vagina20and into the uterus18. The inner end of the umbilical is fixed to a simulated placenta80(seeFIG. 5) situated inside the uterus18.

Mounting the placenta80to uterus18using hooks and loops simulates very well manual removal of the placenta, an operation where placenta is peeled off the inside of the uterus. It is also possible that the mother may withhold the placenta by hand. The placenta is preferably divided into two parts, so that a rupture and division of the placenta can be simulated, whereupon a part of the placenta remains inside the uterus. To this end the two parts of the placenta may be attached to one another by hook and loop fasteners. Preferably one part of the placenta is attached to the umbilical and the other part is withheld by the mother5. This means that the mother5can decide to release the placenta so that the whole placenta follows the umbilical out, or retain a part of the placenta, whereupon only a part of the placenta80attached to the umbilical will be pulled out of the uterus.

The placenta preferably has a gel-like feel and appearance with hooks and loops or fabric on the side being mounted to the uterine wall.

It is also possible to simulate a trapped placenta (placenta accrete), when the placenta is unable to pass the cervix. The mother5can simulate this by manually restricting the opening of the cervix21or by holding back the placenta.

Placenta accreta is a very serious condition that may result in sever bleeding from the uterine wall and may also cause the mother to bleed to death. This condition can be simulated by the mother5opening the flow from the blood container33after the placenta80has been delivered, so that blood is flowing out of the tube from the blood container and out through the birth channel.

The simplest method of stopping this bleeding is to massage the uterus. At this point in time of the birth the uterus will normally have shrunk to a much smaller and compact size. This can be simulated by the mother5by the device described in detail inFIGS. 18-19, which will increase the tactile feeling of atonic and contracted uterus simulations. It is also possible to realistically simulate conditions between atonic and contracted state.

FIG. 18shows a cross section of the dorsal uterus wall50and simulates the uterus in atonic state.FIG. 19shows a cross section of the dorsal uterus wall50and simulates the uterus in contracted state. Reference is also made toFIG. 20, showing the uterus with the contraction simulator51in dorsal plan view.

At the dorsal side of the uterus18, i.e. opposite of the side facing the skin1is a pocket26containing a device51for simulating contractions. The device51comprises a first or internal flexible container53inside the pocket28and facing the dorsal uterus wall50, and a second or external flexible container54outside the pocket28. The external and internal containers are connected by flexible material strips56aand56b, which extends through the slits30,31(seeFIG. 20). The material strips may be a continuous strap or may be integrated with one or both of the containers. The two containers53,54and the flexible strips56a,56bform an endless loop with a central opening57. One or both of the strips56aand56bact as a fluid conduit, fluidly connecting the interior of the two containers53,54. Alternatively, a separate tube may extend between the two containers53,54

The two containers53,54have approximately the same internal volume, but the external container54can also have a larger volume than the internal container53. The two containers53,54and the fluid conduit form a fluid tight system, which is filled with an amount of fluid constituting more than the internal volume of the internal container. The amount is however depending on the volume ratio between the internal and external containers. The fluid is preferably air or another suitable gas, but may also be a liquid, e.g., oil or water. The internal container has a fill inlet or valve58to fill the device51with the correct amount of fluid.

When the external container54is squeezed the fluid will flow through the conduit to the internal container53and inflate this. When the external container54is released, the fluid will flow back again to the external container, leaving the internal container53limp.

In atonic state the internal container53will not be completely deflated, as the amount of fluid in the system is adapted so that when the fluid is free to flow unobstructed, equilibrium is created that leaves the internal container53in a semi-filled state.

The instructor may put his/her hand into the opening defined by the two containers53,54and the flexible strips56a,56b. This enables the instructor to squeeze the external container and move the contraction simulation device51to the correct position, using one hand only. This enables the instructor to toggle the lever72for adjusting the bleeding with the other hand.

The device51may also have a soft shield placed between the internal container53and the opening57so that the student does not feel the hand of the instructor when palpating the uterus from outside the skin1.

In a contracted state the internal container53will be inflated to a relatively hard spherical state and press against the skin1. The person training will then sense only the internal container53when he or she massages the uterus area. The instructor (mother) will place the device51in the right position and orientation to facilitate this simulation.

This device makes it possible to simulate an atonic uterus as a soft flat dome with a clear edge on the top and a contracted uterus as a hard padded sphere approximately 10 cm below an atonic uterus.

The device also makes it possible to simulate all conditions between the atonic state and the completely contracted state, enabling the person training to feel the result of the massage of the uterus as the uterus gradually contracts. Thereby it is possible for the instructor to give feedback on how the student is performing by contracting the uterus according to the efficiency of the massage. When the student performs productive massage, the instructor will squeeze the external container to inflate the internal container as well as move the uterus contraction simulation device51downward in the abdomen. At the same time the instructor will also gradually reduce the bleeding by closing the valve71.

The spine15has openings so that the instructor can touch the flexible blood container to check how much blood is left. A thin plate can be placed over the blood container to make it easier for the instructor to press blood out of the blood container if a significant bleeding is to be simulated.

FIG. 10shows the device for simulation the uterus condition in atonic state. The instructor holds the external container in a position high up on the abdomen without squeezing the external container.

When a contracted uterus is to be simulated, the instructor squeezes the external container54and gradually moves it downward to the lower part of the abdomen. The midwife (student) may check the condition of the uterus by touching the abdomen (the skin1of the simulator) from the outside.

FIGS. 21aand21bshows a snap fit coupling for the umbilical cord. It comprises two parts, a male part90and a female part91. The two parts have a sleeve shaped section92,93that are adapted to receive the end of a tube simulating an umbilical cord81(seeFIG. 6). The connection between the tube and the sleeve section is made by a firm press fit or by the use of adhesive, welding or similar. At the opposite end the male part90has a flange94and a dome95. The female part91has a flange96and a pair of slits97,98extending into the sleeve section93. There may be a small rib at the inside of the sleeve93, that will grip behind the dome95, which in turn has a portion of smaller diameter close to the flange94.

When the dome95is inserted into the female part91, as shown inFIG. 21b, the two parts will snap fit. Due to this snap fit, it is difficult to separate the two parts90,91by an axial pull. However, if the two parts are bent relative to one another they will easily unsnap. Thereby the umbilical cord will not easily separate due to pulling on the cord during birth, but when it is desired to sever the umbilical cord from the newborn, this can be facilitated by bending and unsnapping the coupling90,91. The umbilical cord can thus be reused a great number of times.

In addition to having a connector90,91on the umbilical cord81close to the foetus manikin29, the umbilical cord may also be equipped with such a connector90,91closer to the placenta80so that the student can practice pulling out of the placenta with the risk of the umbilical cord snapping.

FIGS. 22aand22bshow a head cap100for a foetus manikin29. Since the foetus manikin29is made of a relatively thin plastic foil material forming a compartment that is filled with a liquid, e.g., water, the skull is relatively soft and flexible. In order for the foetus manikin to have a more realistic skull, the manikin can be equipped with a harder cap100. The cap100may also have softer parts simulating the fontanel areas of the skull. The cap100may be fastened with a simple strap101.

Modifications to the simulator are also possible:

By including a zipper in appropriate place on the skin1and uterus18a cesarean section can be simulated.

By including a simulated aorta along the spine (skeleton part7) compression of this to stop bleeding can be simulated.

It is also possible to simulate mounting of an intrauterine device by inserting an appropriately shaped object and attach it to the uterus by hooks and loops.

The uterus may also comprise a defined cervix attached to or formed unitary with the uterus, the cervix having a free edge situated within the vagina, so that a pocket is formed between the vagina and the cervix.