Pregnant abdominal system and associated devices, systems, and methods

Simulated pregnant abdominal systems and associated devices, systems, and methods are provided. The pregnant abdominal systems allow an interactive scenario simulating a routine gestation palpation of a fetal baby, the performance of an external cephalic version as well as the Leopold's Maneuvers. Further, the pregnant abdominal systems can be used as a platform to physically hear the fetus heartbeat using stethoscope, Doppler instrument, or a prenatal monitor. Further, in some implementations the fetus can be visualized using standard ultrasound systems.

BACKGROUND

As medical science has progressed, it has become increasingly important to provide non-human interactive formats for teaching patient care. While it is desirable to train medical personnel in patient care protocols before allowing contact with real patients, textbooks and flash cards lack the important benefits to students that can be attained from hands-on practice. On the other hand, allowing inexperienced students to perform medical procedures on actual patients that would allow for the hands-on practice cannot be considered a viable alternative because of the inherent risk to the patient. Non-human interactive devices and systems can be used to teach the skills needed to successfully identify and treat various patient conditions without putting actual patients at risk.

For example, patient care education has often been taught using medical instruments to perform patient care activity on a simulator, such as a manikin. Such training devices and systems can be used by medical personnel and medical students to teach and assess competencies such as patient care, medical knowledge, practice based learning and improvement, systems based practice, professionalism, and communication. The training devices and systems can also be used by patients to learn the proper way to perform self-examinations.

While these simulators have been adequate in many respects, they have not been adequate in all respects. Therefore, what is needed is an interactive education system for use in conducting patient care training sessions that is even more realistic and/or includes additional simulated features.

SUMMARY

Simulated pregnant abdominal systems and associated devices, systems, and methods are provided.

A pregnant abdominal system is provided that includes a platform; one or more support structures coupled to the platform; an amniotic sac containing a fetus, the amniotic sac positioned on the one or more support structures; and a skin layer coupled to the platform such that the one or more support structures and the amniotic sac are positioned within a space between the skin layer and the platform. The platform is sized and shaped for mating engagement with a torso of a patient simulator, such as a birthing simulator, in some instances. The one or more support structures can be formed of foam. In some implementations, the skin layer is configured to facilitate palpation of the fetus and the fetus is sized and shaped to simulate a third-term fetus. The amniotic sac can be filled with a medium having a similar viscosity to natural amniotic sac fluid. In some instances, the fetus is visible through the skin layer and within the amniotic sac using ultrasound. In that regard, the fetus can include embedded skeletal structures identifiable via ultrasound. The fetus can be palpable by a user through the skin layer and within the amniotic sac.

A patient simulator is provided that includes a torso sized and shaped to simulate a pregnant woman, the torso including a tummy cover that includes: a platform; one or more support structures coupled to the platform; an amniotic sac containing a fetus, the amniotic sac positioned on the one or more support structures; and a skin layer coupled to the platform such that the one or more support structures and the amniotic sac are positioned within a space between the skin layer and the platform. The patient simulator can further include arms, legs, and a head coupled to the torso. The patient simulator can also include a birthing mechanism positioned within the torso. In some implementations, the fetus is visible through the skin layer and within the amniotic sac using ultrasound and can include embedded skeletal structures identifiable via ultrasound.

A method of manufacturing a pregnant abdominal system is provided that includes positioning an amniotic sac containing a fetus on a platform; coupling one or more support structures to the platform adjacent to the amniotic sac; and coupling a skin layer to the platform such that the one or more support structures and the amniotic sac are positioned within a space between the skin layer and the platform. Coupling the one or more support structures to the platform includes gluing the one or more support structures to the platform in some instances. Similarly, coupling the skin layer to the platform includes gluing the skin layer to the platform in some instances. The method can also include forming the fetus using a rotational mold. The method can also include forming the fetus using an injection mold, wherein the fetus includes embedded skeletal structures identifiable via ultrasound.

Additional aspects and features of the present disclosure will be apparent from the following detailed description.

DETAILED DESCRIPTION

One of the aims of healthcare simulation is to establish a teaching environment that closely mimics key clinical cases in a reproducible manner. The introduction of high fidelity tetherless simulators, such as those available from Gaumard Scientific Company, Inc., over the past few years has proven to be a significant advance in creating realistic teaching environments. The present disclosure is directed to a patient simulator system that expands the functionality of the stimulators by providing a pregnant abdominal assembly for use with patient simulators, including birthing simulators such as the NOELLE® line of birthing simulators available from Gaumard Scientific Company, Inc. in Miami, Fla. In that regard, the pregnant abdominal and its component assembly described herein allow an interactive scenario simulating a routine gestation palpation of a fetal baby, the performance of art external cephalic version as well as the Leopold's Maneuvers. Further, the pregnant abdominal system can be used as a platform to either physically hear the fetus heartbeat using stethoscope, Doppler Instrument, or a prenatal monitor as well as ultrasound the fetus within the system's skin directly or through the means of sensor activation and virtual ultrasound clips and/or actual ultrasound of the fetus disposed within the abdominal.

The pregnant abdominal system of the present disclosure offers a realistic interpretation of a fetal baby palpation, ultrasound, prenatal heartbeat monitor and performance of procedures such as external cephalic version as well as Leopold's Maneuvers with the expected dermal layers for added realism. Delivering a pregnant abdominal unit relevant in its anatomical size, geometry and pigmentation, surgical recognition and familiarity can be obtained in order to successfully perform the procedures providing realistic effects. The practitioner can achieve the medical experience of successfully assessing the fetal baby's location and position through Leopold's Maneuvers or performing an external cephalic version as well as attain the skills of physically recognizing the fetus condition and placement that will lead to choosing the optimum pregnancy care and delivery approach in a stress free environment. Anatomical sites such as the pubic bone are found in the system to effectively recognize adequate fetal baby placement for birthing being it vaginal or caesarian section. Moreover, fetal baby and amniotic sac are consistent in size and feel to that of a woman in the last trimester of pregnancy.

Referring now toFIG. 1, shown therein is a perspective view of a pregnant abdominal system100according to an embodiment of the present disclosure. As shown, the pregnant abdominal system includes a platform or supporting tray102, support structures104,106, an amniotic sac108containing a fetus110, and an abdominal skin overlay112. These components are arranged to provide a lifelike simulation of a pregnant abdomen of a female such that the pregnant abdominal system100is configured for use in training simulations, including palpation for placement and location of the fetus consistent with a pregnancy in its third trimester, performance of the external cephalic version for vaginal birthing prep, analysis of the fetus using a stethoscope, Doppler ultrasound, a prenatal monitor, and/or ultrasonic imaging.

As shown inFIG. 2, the pregnant abdominal system100is configured to mate with a patient simulator120. In that regard, the pregnant abdominal system100is sized and shaped such that it properly sits and adapts within the lower and upper abdomen opening of the patient simulator120to provide an accurate anatomical procedural platform. In that regard, in some implementation the pregnant abdominal system100is sized and shaped for use as a tummy cover on a birthing simulator and/or other patient simulator, such as those described in U.S. patent application Ser. No. 13/223,020, U.S. patent application Ser. No. 13/031,116, U.S. patent application Ser. No. 13/031,087, U.S. patent application Ser. No. 13/031,102, U.S. patent application Ser. No. 12/856,903, U.S. patent application Ser. No. 12/708,682, U.S. patent application Ser. No. 12/708,659, U.S. patent application Ser. No. 11/952,606, U.S. patent application Ser. No. 11/952,669, U.S. Pat. No. 8,016,598, U.S. Pat. No. 7,976,313, U.S. Pat. No. 7,976,312, U.S. Pat. No. 7,866,983, U.S. Pat. No. 7,114,954, U.S. Pat. No. 7,192,284, U.S. Pat. No. 7,811,090, U.S. Pat. No. 6,758,676, U.S. Pat. No. 6,503,087, U.S. Pat. No. 6,527,558, U.S. Pat. No. 6,443,735, U.S. Pat. No. 6,193,519, and U.S. Pat. No. 5,853,292, and U.S. Pat. No. 5,472,345, each herein incorporated by reference in its entirety. In that regard, in some particular implementations the pregnant abdominal system100is configured for use on a birthing simulator such that a user can palpate and perform related procedures with the fetus within the pregnant abdominal system100and then simulate a complete birth with a separate birthing fetus contained within the birthing simulator.

Referring now toFIG. 3, shown therein is a perspective view of the platform or tray102of the pregnant abdominal system100according to an embodiment of the present disclosure. The platform102is configured to support the pregnant abdominal system100. Further, the platform102is sized and shaped to facilitate mating engagement with the patient simulator's120torso opening. In that regard, the platform102is designed to conform to the torso of the patient simulator120so as to produce at least a complete, full-torso simulator experience. Additionally, the platform102features pubic bone structure114as a routine anatomical landmark. The material selected for the platform may be any that is rigid in its nature and able to support approximately 50-70 lbf in a dynamic scenario. For the pregnant abdominal system100, polyethylene terephthalate (PETG) in clear is utilized in some instances because it provides the stipulated support force and a clear window to visualize the fetus position and placement.

Referring now toFIG. 4, shown therein is a perspective view of the fetus110of the pregnant abdominal system100according to an embodiment of the present disclosure. The fetus110is sized and shaped to simulate of a fetus of gestational age between 20 weeks and 40 weeks. The fetus110is formed of material(s) that allow realistic palpation of the fetus through the abdominal skin overlay112and the amniotic sac108. In some instances, the fetus110has an increased hardness relative to a natural fetus in order to allow its successful palpation. The fetus110is produced in vinyl material to achieve this goal, in some implementations. However, the fetus110can also be constructed from softer material(s) while localizing hard regions such as the head, the fundus, and/or the spinal cord/back region for added realism. In some embodiments, the fetus110is further configured to facilitate realistic ultrasound imaging of the fetus110. To that end, the fetus110includes simulated skeletal structural components, simulated organs, and/or other simulated anatomical features that are detectable and identifiable via ultrasound imaging. In some instances, the fetus110is contained within an anatomically correct endoskeleton to simulate an effective ultrasound of the pregnancy. For the ultrasound fetus' construction, different layer of silicon and urethane may be selected to produce the desired imaging effect.

Referring now toFIG. 5, shown therein is a perspective view of the amniotic sac108of the pregnant abdominal system100according to an embodiment of the present disclosure. In that regard, the amniotic sac108is configured to contain the fetus110. The amniotic sac108also contains a medium, such as a fluid or gel, that surrounds the fetus110. The medium found within the amniotic sac108renders a life-like lubricious consistency similar to that felt in the typical human pregnant abdomen. In some instances, the selected medium is composed of a chemical composition containing powdered silica. However the medium selection can be arty that portrays similar characteristics to natural amniotic sac fluid, including its appearance and viscosity. The amniotic sac108construction is designed with a clear plastic film that will properly simulate the seamless feel of the amniotic sac. In some instances, CRYOVAC® material is utilized for the amniotic sac108due to its effectiveness in extending the enclosed shelf life. However, other materials may also be used for the outer layer of the amniotic sac108.

Referring now toFIG. 6, shown therein is a perspective view of the abdominal skin overlay according to an embodiment of the present disclosure. The abdominal skin overlay112of the pregnant abdominal system100provides a relatively soft feel representative of the common human skin in the range of 10 and 50 in hardness in the scale under the Rockwell hardness standard. In some instances, the abdominal skin overlay112is formed using platinum cured silicone as primary material as well as the appropriate lifelike skin pigmentation and geometry composition. For example, in some instances the platinum cured silicone utilized is ECOFLEX® 0030 Medium, SMOOTH-ON®, Inc., Easton, Pa. Such materials have been found to be the most successful for the use and construction of the outer skin layer material due to its effective endurance and behavior to needle puncture, cutting, and suture retention while maintaining relevant to a high degree of realism.

Referring now toFIGS. 7 and 8, shown therein are perspective views of support structures104,106of the pregnant abdominal system100according to an embodiment of the present disclosure. The support structures104,106are sized and shaped to be positioned within the pregnant abdominal system100between the platform102and the abdominal skin overlay110to help maintain the desired, realistic position of the amniotic sac108and fetus110, while still allowing some movement. Generally, the support structures104,106may take on any shape or geometry. Further, any number of support structures may be utilized. The two support structures104,106are for example only. In some instances, the support structures104,106are formed of a foam material, such as FOAM IT Ill®, SMOOTH-ON®, Inc., Easton, Pa.

Referring now toFIGS. 9-19, aspects of processes suitable for manufacturing the pregnant abdominal systems of the present disclosure will be described. These are understood to be exemplary in nature and in no way limit the manner in which any of the components of the pregnant abdominal system100can be made and/or assembled.

Referring toFIGS. 9-12, shown therein are aspects of a mold assembly130for forming the abdominal skin overlay112of the pregnant abdominal system110according to an embodiment of the present disclosure. In that regard,FIG. 9provides a perspective view of the mold assembly130according to an embodiment of the present disclosure;FIG. 10provides a perspective view of a cope132of the mold assembly130according to an embodiment of the present disclosure;FIG. 11provides a perspective view of a drag134of the mold assembly130according to an embodiment of the present disclosure; andFIG. 12provides a perspective view of a base136of the mold assembly130according to an embodiment of the present disclosure.

Using the mold assembly130, the abdominal skin overlay112can be formed. For example, in some implementations the following steps are performed to form the abdominal skin overlay112using the mold assembly130.1. Set both sides of mold open (cope132and drag134) and generously spray mold release, EASE RELEASE® 200 Ease Release 200, MANN RELEASE TECHNOLOGIES®.2. Properly allocate square nuts in square openings.3. Insert screws in from cope132to drag134direction and tighten.4. Pour 2000 grams of platinum cured ECOFLEX® 0030 part B into container.5. Add 0.11% of flesh skin pigmentation and two of old blood pigmentation SLIC-PIG® into container.6. Pour 2000 grams of platinum cured ECOFLEX® 0030 part A into different container.7. Vacuum mixture to approximately 25 psi.8. Allow mixture to sit approximately 5 minutes in order to permit passage of entrapped air.9. Open valve and remove container from inside vacuum.10. Transfer mixture independently into cartridges.11. Inject cartridges into mold at approximately 80 psi.12. Allow 4-6 hours curing time.13. Demold.

Referring now toFIGS. 13 and 14, shown therein are aspects of mold assemblies for forming the support structures104,106of the pregnant abdominal system110. In that regard,FIG. 13provides a perspective view of a mold140for forming support structure104according to an embodiment of the present disclosure; andFIG. 14provides a perspective view of a mold150for forming support structure106according to an embodiment of the present disclosure. Using the molds140and150, the support structures104,106can be formed. For example, in some implementations the following steps are performed to form the support structures104,106using the molds140and150.1. Set open mold140of top foam support structure104and open mold150of bottom foam support structure106on table and generously spray mold release, EASE RELEASE® 200, MANN RELEASE TECHNOLOGIES®.2. Pour 140 grams of FOAM IT III®, SMOOTH-ON® B into container.3. Optional step: Add 0.11% of flesh skin pigmentation and two of old blood pigmentation SLIC-PIG® into container.4. Pour 70 grams of FOAM IT III®, SMOOTH-ON® part A into container.5. Rigorously hand mix combination for a minute6. Pour half of mixture into each mold.7. Allow an hour before trimming overflowing excess material from top using a knife, blade, or saw.8. Demold.

The platform102of the pregnant abdominal system110can be made using any suitable process. In some embodiments, the platform102is created using a vacuum form process for PETG in clear. In that regard, the vacuum form process creates the platform102having the desired shape and structure features.

As discussed above, in some instances the fetus110is formed using vinyl to provide for realistic palpation. In some implementations the following steps are performed to form the fetus110out of a vinyl material.1. Pour liquid vinyl into a rotational mold.2. Insert rotational mold into oven chamber and allow curing.3. Demold part and allow cooling to set.

As discussed above, in some instances the fetus110is formed from materials to facilitate ultrasound imaging of the fetus. In some implementations the following steps are performed to form the fetus110suitable for ultrasound imaging.1. Set both sides of mold open (cope and drag) and generously spray mold release, EASE RELEASE® 200, MANN RELEASE TECHNOLOGIES®.2. Properly allocate square nuts in square openings.3. Insert screws in from cope to drag direction and tighten.4. Produce skeletal parts using urethane.5. Place internal bone-like parts within mold,6. Pour platinum cured ECOFLEX® 0030 part B into container.7. Add 0.11% of flesh skin pigmentation and two of old blood pigmentation SLIC-PIG® into container.8. Pour platinum cured ECOFLEX® 0030 part A into different container.9. Vacuum mixture to approximately 25 psi.10. Allow mixture to sit approximately 5 minutes in order to permit passage of entrapped air.11. Open valve and remove container from inside vacuum.12. Transfer mixture independently into cartridges.13. Inject cartridges into mold at approximately 40 psi.14. Allow 4-6 hours curing time.15. Demold.

With the fetus110formed, the amniotic sac108with the fetus110embedded therein can be created. In that regard,FIG. 15shows a perspective view of the fully assembled amniotic sac108with the fetus110therein. In some implementations the following steps are performed to form the amniotic; sac108of the pregnant abdominal system100.1. Create die cut 2D geometry on 4 layers of CRYOVAC® material.2. Place fetus110within the double two layers center.3. Heat seal perimeter on two double layers, leaving filling port with open access.4. Inject at low psi gel medium to completely fill formed sac selected optimum weight but not limited to 17.5 lbs.5. Set system aside overnight to allow entrapped air to escape.6. Fold filling port inwards and heat seal at its perimeter.

With the various components of the pregnant abdominal system100individually formed, including the platform102, the support structures104,106, the amniotic sac108with fetus110, and the abdominal skin overlay112, the pregnant abdominal system100can be fully assembled. In some instances, the following steps are utilized to assemble the pregnant abdominal system100.1. Clean platform102thoroughly with isopropanol to remove oil and/or dust particles collected and set on a flat surface.2. Place amniotic sac108at center and proximate to the pubic bone114of the platform102.3. Place 3D top and bottom foam support structures104,106at their designed locations on platform.4. Dispense two drops of LOCTITE® 401 glue at opposite side on the platform102directly under each foam pad (top and bottom support structures104,106) in order to properly secure their placement.5. Center and place abdominal skin overlay112over amniotic sac108verifying the skin step has a direct match with platform perimeter.FIG. 16provides a perspective view of this step being performed.6. Apply primer at adhesion points: skin under step as well as on the platform side edges.7. Initiate adhesion process from either top or bottom in order to secure adequate pregnant abdominal skin overlay112placement.8. Adhere bottom of pregnant abdominal skin overlay112step to side and top edges of the platform102using LOCTITE® 401 glue. Follow and repeat adhesion process through the platform's102perimeter at every inch.9. Powder complete system to remove tackiness from the pregnant abdominal system's100surfaces.10. The fully assembled pregnant abdominal system100is complete.FIG. 17provides a perspective view of the assembled pregnant abdominal system100.

Referring now toFIGS. 18 and 19, with the pregnant abdominal system100complete, the pregnant abdominal system100can be placed onto a patient simulator to ensure proper fit. In that regard,FIG. 18provides perspective view of the pregnant abdominal system100positioned on a portion of a patient simulator160according to an embodiment of the present disclosure. The patient simulator160may be the actual patient simulator to which the pregnant abdominal system100will be attached for use or it can be a corresponding form or fit test structure to ensure that the pregnant abdominal system100will fit properly on another, separate patient simulator for actual use.FIG. 19similarly provides a perspective view of the pregnant abdominal system100positioned on a portion of a patient simulator170having a birthing mechanism according to an embodiment of the present disclosure.

The foregoing outlines features of several embodiments so that those skilled in the art may better understand the aspects of the present disclosure. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for other devices that simulate medical scenarios and situations, including those involving human tissue. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions, and alterations to the embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Also, it will be fully appreciated that the above-disclosed features and functions, and variations thereof, may be combined into other methods, systems, apparatus, or applications.