Patent Description:
This disclosure is related in general to patient simulator systems for teaching patient care and, more particularly, to a simulated respiratory system for use with a patient simulator system in conducting patient care activity.

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 physical simulator, such as a manikin-a manikin may be a life-sized anatomical human model used for educational and instructional purposes. 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. However, existing simulators fail to exhibit accurate symptoms and to respond appropriately to student stimuli, thereby failing to provide realistic medical training to the students. Existing simulators also fail to look and feel lifelike, which fails to improve the training process. Thus, while existing physical simulators have been adequate in many respects, they have not been adequate in all respects. As such, there is a need to provide a simulator for use in conducting patient care training sessions that overcomes the above deficiencies of existing stimulators by, for example, being even more realistic and/or including additional simulated features. <CIT> relates to a lung simulator for practicing ventilation of a newborn's liquid filled lungs.

It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.

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 simulators by increasing the realism of the look, feel, and functionality of the simulators that can be used to train medical personnel in a variety of clinical situations. The patient simulator systems disclosed herein offers a training platform on which team-building scenarios can be performed for the development of medical treatment skills and the advancement of patient safety.

In particular, the patient simulator system disclosed herein may be, include, or be part of a maternal patient simulator, an associated fetal patient simulator, and/or a newborn patient simulator that have improved realism and functionality compared to previously available simulators. Some of the various features that facilitate the improved realism and functionality are described in detail below. The patient simulator systems of the present disclosure allow users to practice a range of different simulated birthing and/or neonatal scenarios.

Thus, the patient simulator system facilitates the training of user's across the range of birthing and/or neonatal scenarios and corresponding assessment of the user's response to the different simulated birthing and/or neonatal scenarios. Accordingly, the user's medical treatment skills can be obtained and/or improved in a simulated environment without endangering a live patient.

Moreover, the patient simulator system allows for multiple users to simultaneously work with the patient simulator during a particular birthing and/or neonatal scenario, thereby facilitating team training and assessment in a realistic, team-based environment. By allowing multiple users to simultaneously interact with the patient simulator system, the system facilitates the real-time training and assessment of the cooperative efforts of an OB/GYN or pediatric team in a wide variety of birthing scenarios, neonatal scenarios, and/or patient safety scenarios, such as, by way of non-limiting example, a fire in the hospital. In some embodiments, the patient simulator system provides for pre-operative care simulation as well as post-operative care simulation, thereby allowing users to experience, address, and assess pre-operative and post-operative management, including pre-operative acquisition of the patient history and management of post-operative complications.

For example, in some embodiments, the patient simulator system allows for the realistic reception and transport of the patient simulator through a hospital (e.g., from an emergency room to an operating room) during operation of a particular birthing and/or neonatal scenario. In addition, the patient simulator systems can be used to conduct patient safety drills in an actual hospital or other medical setting.

In some embodiments, the patient simulator system includes features designed to enhance the educational experience. For example, in some embodiments, the system includes a processing module to simulate different medical and/or surgical scenarios during operation of the patient simulator system. In some embodiments, the system includes a camera system that allows visualization of the procedure for real-time video and log capture for debriefing purposes. In some embodiments, the patient simulator system is provided with a workbook of medical scenarios that are pre-programmed in an interactive software package, thereby providing a platform on which team-building scenarios can be performed for the development of medical treatment skills and general patient safety. Thus, the patient simulator system disclosed herein provides a system that is readily expandable and updatable without large expense and that enables users to learn comprehensive medical and surgical skills through "hands-on" training, without sacrificing the experience gained by users in using standard surgical instruments in a simulated patient treatment situation.

In an exemplary embodiment, as illustrated in <FIG>, a patient simulator system is generally referred to by the reference numeral <NUM>. The patient simulator system <NUM> includes a simulated head <NUM>, a simulated neck <NUM>, a simulated torso <NUM>, simulated arms 18a and 18b, simulated legs 20a and 20b, and simulated skin <NUM>. A simulated umbilicus <NUM> is operably coupled to the simulated torso <NUM>. The simulated umbilicus <NUM> includes an upper portion <NUM> and a closed-system base portion <NUM>. In several exemplary embodiments, the upper portion <NUM> is detachably coupled to the closed-system base portion <NUM>. The upper portion <NUM> includes a simulated umbilical cord <NUM>, an umbilical cord plug <NUM>, umbilical cord barb fittings 34a and 34b, and O-rings 36a and 36b. The O-rings 36a and 36b sealingly engage the exterior of the umbilical cord barb fittings 34a and 34b, which fittings are operably coupled to, and extend through, the umbilical cord plug <NUM>. The umbilical cord plug <NUM> is also operably coupled to a lower end of the simulated umbilical cord <NUM>. Moreover, encased within the simulated umbilical cord <NUM> is a y-shaped simulated umbilical artery (not shown) having upper ends positioned adjacent an upper end of the simulated umbilical cord <NUM>, and a simulated umbilical vein (not shown) having an upper end positioned adjacent the upper end of the simulated umbilical cord <NUM>. Respective lower ends of the simulated umbilical vein and the y-shaped simulated umbilical artery are connected to the umbilical cord barb fittings 34a and 34b.

The closed-system base portion <NUM> includes a receptacle <NUM>, a skin layer <NUM>, an upper umbilical plug receiver <NUM>, a lower umbilical plug receiver <NUM>, plug receiver barb fittings 46a and 46b, O-rings 48a and 48b, and a lock ring <NUM>. The skin layer <NUM> inlays with the simulated skin <NUM> on the simulated torso <NUM>, and defines a pocket <NUM> containing the upper umbilical plug receiver <NUM>. The umbilical cord plug <NUM> is received by the upper umbilical plug receiver <NUM> so that the umbilical cord barb fittings 34a and 34b are operably coupled to, and extend through, the upper umbilical plug receiver <NUM>. As a result, the O-rings 36a and 36b are sealingly engaged with the upper umbilical plug receiver <NUM>. Moreover, the plug receiver barb fittings 46a and 46b are operably coupled to, and extend through, the lower umbilical plug receiver <NUM>, which receiver engages both the upper umbilical plug receiver <NUM> and the skin layer <NUM> adjacent the pocket <NUM>. As a result, the O-rings 48a and 48b are sealingly engaged between the plug receiver barb fittings 46a and 46b and the umbilical cord barb fittings 34a and 34b, respectively. In addition to, or instead of, being sealingly engaged between the plug receiver barb fittings 46a and 46b and the umbilical cord barb fittings 34a and 34b, respectively, the O-rings 48a and 48b may be sealingly engaged between the upper umbilical plug receiver <NUM> and the lower umbilical plug receiver <NUM>. A portion of the skin layer <NUM> is engaged, and received, by the receptacle <NUM> so that a gasket <NUM> is disposed between, and sealingly engages, the receptacle <NUM> and the skin layer <NUM>. Moreover, the lower umbilical plug receiver <NUM> is operably coupled to, and extends through, the receptacle <NUM> (vie the lock ring <NUM>).

In several exemplary embodiments, one or both of the upper ends of the y-shaped simulated umbilical artery (not shown) may be used to perform a training procedure for an umbilical artery catheterization. To facilitate the training procedure for the umbilical artery catheterization, a simulated circulatory system (not shown) is operably coupled to the plug receiver barb fitting 46b, which fitting is operably coupled to the simulated umbilical artery via at least the umbilical cord barb fitting 34b. During the training procedure for the umbilical artery catheterization, the simulated circulatory system provides a pneumatic or hydraulic pulse to the simulated umbilical artery via at least the plug receiver barb fitting 46b and the umbilical cord barb fitting 34b.

In several exemplary embodiments, the upper end of the simulated umbilical vein (not shown) may be used to perform a training procedure for an umbilical vein catheterization. To facilitate the training procedure for the umbilical vein catheterization, a drainage line <NUM> is operably coupled to the plug receiver barb fitting 46a, which fitting is operably coupled to the simulated umbilical vein via at least the umbilical cord barb fitting 34a. As shown in <FIG>, the drainage line <NUM> defines a unique geometry similar to that of a plumbing (sink) trap. This unique geometry allows pre-loading of fluid into the drainage line <NUM> for later use during the training procedure for the umbilical vein catheterization. More particularly, during the training procedure for the umbilical vein catheterization, the pre-loaded fluid may be removed from the drainage line <NUM> via the simulated umbilical vein, or additional fluid may be introduced into the drainage line <NUM> via the simulated umbilical vein. In the case where additional fluid is introduced into the drainage line <NUM> via the simulated umbilical vein, the pre-loaded fluid drains through the rear of the patient simulator system <NUM>.

In several exemplary embodiments, fluid leakage during the training procedure for the umbilical artery catheterization and/or the training procedure for the umbilical vein catheterization is prevented, or at least reduced, by the sealing engagement of the O-rings 36a and 36b with the upper umbilical plug receiver <NUM>, the sealing engagement of the O-rings 48a and 48b between the plug receiver barb fittings 46a and 46b and the umbilical cord barb fittings 34a and 34b, respectively, the sealing engagement of the O-rings 48a and 48b between the upper umbilical plug receiver <NUM> and the lower umbilical plug receiver <NUM>, the sealing engagement of the gasket <NUM> between the receptacle <NUM> and the pocket <NUM>, or any combination thereof.

In an exemplary embodiment, as illustrated in <FIG>, a pneumothorax system <NUM> is operably coupled to the simulated torso <NUM>. The pneumothorax system <NUM> includes an insert <NUM> and a cage <NUM>. In several exemplary embodiments, the insert <NUM> is detachably coupled to the cage <NUM>. In several exemplary embodiments, the cage <NUM> is "floated" during the injection molding procedure to ensure proper orientation within the simulated skin <NUM> of the simulated torso <NUM>. The insert <NUM> includes a skin layer <NUM>, adipose tissue <NUM>, ribs <NUM>, endothoracic fascia <NUM>, and a pleura cavity <NUM>. In several exemplary embodiments, the skin layer <NUM> is, includes, or is part of, the simulated skin <NUM> of the patient simulator system <NUM>. The skin layer <NUM> defines a pocket that receives the adipose tissue <NUM>, the ribs <NUM>, the endothoracic fascia <NUM>, and the pleura cavity <NUM>. More particularly, the adipose tissue <NUM>, the ribs <NUM>, and the endothoracic fascia <NUM> are sandwiched between the skin layer <NUM> and the pleura cavity <NUM>, and the ribs <NUM> are sandwiched between the adipose tissue <NUM> and the endothoracic fascia <NUM>. Moreover, the adipose tissue <NUM> engages the skin layer <NUM>, and the endothoracic fascia <NUM> engages the pleural cavity <NUM>. The pleura cavity <NUM> includes parietal pleura <NUM> and visceral pleura <NUM>. In several exemplary embodiments, the pneumothorax system <NUM> bleeds when cut between the ribs <NUM> on the midaxillary line of the simulated torso <NUM>, allowing drainage of fluid and escape of trapped air.

In an exemplary embodiment, as illustrated in <FIG>, the simulated arms 18a and 18b are operably coupled to an upper torso bracket <NUM>. Also connected to the upper torso bracket <NUM> are arm motors 80a and 80b for actuating the simulated arms 18a and 18b, as will be discussed in further detail below. The upper torso bracket <NUM> includes a back plate <NUM>, side plates 84a and 84b, and a neck plate <NUM>. The neck plate <NUM> extends upwardly (as viewed in <FIG>) from the back plate <NUM>, and the side plates 84a and 84b extend transversely from opposing sides of the back plate <NUM>. Moreover, the side plates 84a and 84b include mounting plates 88a and 88b, respectively, extending transversely therefrom, and the neck plate <NUM> includes a mounting plate <NUM> extending transversely therefrom. The simulated arms 18a and 18b are operably coupled to the mounting plates 88a and 88b, respectively, via articulation joints 92a and 92b, and the simulated head <NUM> is operably coupled to the mounting plate <NUM> via an articulation joint <NUM>. In several exemplary embodiments, the articulation joints 92a, 92b, and <NUM> are substantially identical to one another, and, therefore, in connection with <FIG>, only the articulation joint 92a will be described in detail below; however, the description below applies to every one of the articulation joints 92a, 92b, and <NUM>.

Turning to <FIG>, the articulation joint 92a includes a ball <NUM>, a clamp <NUM>, and a clamp screw <NUM>. The clamp <NUM> is a generally U-shaped bracket including jaws 102a and 102b having openings 104a and 104b, respectively, formed therethrough. The openings 104a and 104b receive and maintain the ball <NUM> between the jaws 102a and 102b. The jaws 102a and 102b further include a through-hole 106a and a threaded hole 106b, respectively. The clamp screw <NUM> extends through the through-hole 106a and threadably engages the threaded hole 106b to adjust the clamping force exerted by the jaws 102a and 102b on the ball <NUM>. As discussed above, the simulated arm 18a is operably coupled to the mounting plate 88a via the articulation joint 92a. More particularly, the ball <NUM> of the articulation joint 92a is connected to the mounting plate 88a of the upper torso bracket <NUM>, and the clamp <NUM> of the articulation joint 92a is connected to the simulated arm 18a. As a result, the clamping force exerted by the jaws 102a and 102b on the ball <NUM> determines the arm 18a's resistance to motion about the articulation joint 92a. Referring back to <FIG>, a clamp <NUM> is connected to the back plate <NUM> of the upper torso bracket <NUM>, opposite the neck plate <NUM>. The clamp <NUM> is substantially identical to the clamp <NUM> and forms part of an articulation joint that is substantially identical to the articulation joint 92a, as will be discussed in further detail below.

In several exemplary embodiments, the manner in which simulated arm 18b is operably coupled to the mounting plate 88b via the articulation joint 92b is identical to the manner in which the simulated arm 18a is operably coupled to the mounting plate 88a via the articulation joint 92a, and therefore will not be discussed in further detail. In several exemplary embodiments, the manner in which simulated head <NUM> is operably coupled to the mounting plate <NUM> via the articulation joint <NUM> is identical to the manner in which the simulated arm 18a is operably coupled to the mounting plate 88a via the articulation joint 92a, and therefore will not be discussed in further detail.

In several exemplary embodiments, the simulated arms 18a and 18b are substantially identical to one another, and, therefore, in connection with <FIG>, only the simulated arm 18a will be described in detail below; however, the description below applies to both of the simulated arms 18a and 18b. Turning to <FIG>, the simulated arm 18a includes an upper arm <NUM>, a forearm <NUM>, and a hand <NUM>. The clamp <NUM> of the articulation joint 92a is connected to the upper arm <NUM>. The upper arm <NUM> includes a pivot bracket <NUM>, opposite the clamp <NUM>. A shoulder insert <NUM> and a pulse module <NUM> (to which the simulated circulatory system provides the pneumatic or hydraulic pulse) are operably coupled to the upper arm <NUM>. To simulate the pronation and supination of a forearm and the planar rotation of an elbow joint, the forearm <NUM> is operably coupled to the upper arm <NUM> via a spindle <NUM>. The spindle <NUM> includes a hub <NUM> and a pivot bracket <NUM>. The pivot bracket <NUM> of the spindle <NUM> is pivotably coupled to the pivot bracket <NUM> of the upper arm <NUM>. The forearm <NUM> includes a swivel ring <NUM>, a pivot bracket <NUM> opposite the swivel ring <NUM>, and a mounting plate <NUM> to which one or more guide tube fittings <NUM> are operably coupled. The swivel ring is <NUM> rotatably and detachably coupled to the hub <NUM> of the spindle <NUM>. Additionally, a cage <NUM> is attached to the simulated skin (not shown) of the forearm <NUM>, and a flange <NUM> is connected to the spindle <NUM>. The flange <NUM> includes tabs <NUM>. The cage <NUM> includes an internal raceway <NUM> to accommodate the tabs <NUM> of the flange <NUM>, and coil pins <NUM> to lock the tabs <NUM> into position within the internal raceway <NUM>. In this manner, the cage <NUM> is rotatably and detachably coupled to the flange <NUM> so that the forearm <NUM> and the simulated skin of the forearm <NUM> are each permitted to rotate relative to, and detach from, the spindle <NUM>. The hand <NUM> includes a pivot bracket <NUM> pivotably coupled to the pivot bracket <NUM> of the forearm <NUM>, a mounting plate <NUM> to which an electronic circuit board <NUM> is connected, and an actuation plate <NUM> to which an arm actuation line (not shown) of the simulated arm 18a is connected.

Referring back to <FIG>, the arm motor 80a is connected to the side plate 84a of the upper torso bracket <NUM> to actuate the arm actuation line, which arm actuation line is routed through tubing (not shown) from the arm motor 80a, through the hub <NUM> of the spindle <NUM> and guide tube fittings <NUM> of the forearm <NUM>, and to the actuation plate <NUM> of the hand <NUM>. The retrieval of the arm actuation line by the arm motor 80a produces a first moment between the forearm <NUM> and the hand <NUM> at the pivotable connection between the respective pivot brackets <NUM> and <NUM> thereof. The first moment causes the hand <NUM> to pivot about the pivotable connection between the pivot brackets <NUM> and <NUM>, and relative to the forearm <NUM>. The retrieval of the arm actuation line by the arm motor 80a also produces a second moment between the upper arm <NUM> and the forearm <NUM> at the pivotable connection between the respective pivot brackets <NUM> and <NUM> thereof. The second moment causes the forearm <NUM> to pivot about the pivotable connection between the pivot brackets <NUM> and <NUM>, and relative to the upper arm <NUM>. In several exemplary embodiments, during the retrieval of the arm actuation line by the arm motor 80a, the first moment pivots the hand <NUM> relative to the forearm <NUM> before the second moment pivots the forearm <NUM> relative to the upper arm <NUM>. The subsequent payout of the arm actuation line by the arm motor 80a permits relaxation of the simulated arm 18a according to gravity and the elastic properties of the simulated skin <NUM>.

In an exemplary embodiment, as illustrated in <FIG> and <FIG>, the simulated legs 20a and 20b are operably coupled to a lower torso bracket <NUM>. Also connected to the lower torso bracket <NUM> are a pair of leg motors 152a and 152b for actuating the simulated legs 20a and 20b, respectively, as will be discussed in further detail below. The lower torso bracket <NUM> includes a back plate <NUM>, a top plate <NUM>, support plates 158a and 158b, and side plates 160a and 160b. The side plates 160a and 160b support the leg motors 152a and 152b, respectively, and extend transversely from opposing sides of the back plate <NUM>. The support plates 158a and 158b extend upwardly from the back plate <NUM>, and the top plate <NUM> is connected to the support plates 158a and 158b. As a result, an empty space <NUM> is defined between the back plate <NUM>, the top plate <NUM>, and the support plates 158a and 158b.

A ball <NUM> is connected to the top plate <NUM>. The ball <NUM> is substantially identical to the ball <NUM> and forms part of an articulation joint that is substantially identical to the articulation joint 92a. The articulation joint of which the ball <NUM> is a part also includes the clamp <NUM> connected to the back plate <NUM> of the upper torso bracket <NUM>. As a result, the upper torso bracket <NUM> is operably coupled to the lower torso bracket <NUM> via the articulation joint (including the ball <NUM> and the clamp <NUM>) in a manner substantially identical to the manner in which the simulated arm 18a is operably coupled to the mounting plate 88a via the articulation joint 92a.

Clamps 164a and 164b are connected to the back plate <NUM>, adjacent the side plates 160a and 160b. The clamps 164a and 164b are substantially identical to the clamp <NUM> and each form part of an articulation joint that is substantially identical to the articulation joint 92a. The articulation joints of which the clamps 164a and 164b are a part also include balls 166a and 166b connected to the simulated legs 20a and 20b, respectively. As a result, the lower torso bracket <NUM> is operably coupled to the simulated legs 20a and 20b via the respective articulation joints (including the clamps 164a and 164b and the balls 166a and 166b) in a manner similar to the manner in which the simulated arm 18a is operably coupled to the mounting plate 88a via the articulation joint 92a.

In several exemplary embodiments, the simulated legs 20a and 20b are substantially identical to one another, and, therefore, in connection with <FIG>, only the simulated leg 20b will be described in detail below; however, the description below applies to both of the simulated legs 20a and 20b. Turning to <FIG>, the simulated leg 20b includes a leg insert <NUM> defining an upper leg <NUM>, a lower leg <NUM>, and a foot <NUM>, each providing mounting structure for various other components of the simulated leg 20b. The size and shape of the leg insert <NUM> are configured to simulate a patient's leg movement when the simulated leg 20b is actuated. The actuation of the simulated leg 20b is facilitated by one or more guide tube fittings <NUM> embedded in the upper leg <NUM> and the lower leg <NUM>, as will be discussed in further detail below.

The upper leg <NUM> engages an external support plate <NUM> that includes a mounting plate <NUM> extending transversely therefrom. The ball 166b of the simulated joint (connecting the simulated leg 20b to the lower torso bracket <NUM>) is connected to the mounting plate <NUM>. Embedded in the upper leg <NUM> is a sandwich plate <NUM> that is connected to the support plate <NUM> so that a portion of the upper leg <NUM> is sandwiched between the support plate <NUM> and the sandwich plate <NUM>. As a result, the sandwich plate <NUM>, the support plate <NUM>, and the ball 166b together support the upper leg <NUM> and facilitate articulation of the leg insert <NUM> about the simulated joint connecting the simulated leg 20b to the lower torso bracket <NUM>. A leg expansion bag <NUM> and a pulse module <NUM> (to which the simulated circulatory system provides the pneumatic or hydraulic pulse) are embedded in the upper leg <NUM>.

The lower leg <NUM> is pivotably coupled to the upper leg <NUM>. Operably coupled to the lower leg <NUM> are a simulated intraosseous (IO) bone <NUM>, an IO retaining clip <NUM>, and an IO assembly <NUM>. The simulated IO bone <NUM> simulates a patient's tibia and provides structural reinforcement of the leg insert <NUM> during actuation of the simulated leg 20b. The simulated IO bone <NUM> includes a protrusion <NUM> that simulates an anatomical landmark known as the tibial tuberosity. The IO retaining clip <NUM> is embedded in the lower leg <NUM> and receives the IO assembly <NUM> adjacent the simulated IO bone <NUM>. Turning to <FIG>, the IO assembly <NUM> includes a reservoir <NUM> and a skin pad <NUM> that inlays with the skin <NUM> of the lower leg <NUM>. A drainage tube <NUM> is connected to the reservoir <NUM> of the IO assembly <NUM> and routed through the back of the lower leg <NUM>. In several exemplary embodiments, the simulated IO bone <NUM> and the IO assembly <NUM> may be used to perform an IO infusion training procedure.

Referring back to <FIG>, the foot <NUM> is pivotably coupled to the lower leg <NUM>. Operably coupled to the foot <NUM> are a capillary press to refill (CPTR) assembly <NUM>, a foot cyanosis insert <NUM>, and a leg actuation line tie-off <NUM>. The CPTR assembly <NUM> includes a CPTR housing <NUM> and a CPTR lens <NUM>. The CPTR housing <NUM> is embedded in the foot <NUM> and houses the CPTR housing <NUM> along with a pressure sensor (not shown), an LED (not shown), and a CPTR circuit board (not shown). The CPTR lens <NUM> is a semi-transparent component that disperses light from the LED in the form of a thumb print, and includes a recess <NUM> for the CPTR circuit board on its lower surface. The combination of the CPTR lens <NUM>, the pressure sensor, the LED and the CPTR circuit board together simulate the effect of pressing a patient's skin to force blood out of the pressed area, and releasing the patient's skin to allow the return of blood to the pressed area. The CPTR assembly <NUM> further includes an integrated lever (not shown) used to depress the pressure sensor and activate the CPTR assembly <NUM>. The foot cyanosis insert <NUM> is a transparent (or semi-transparent) component embedded at the tip of the foot <NUM> that disperses blue light to simulate a cyanotic state. The leg actuation line tie-off <NUM> is embedded in the foot <NUM> and provides an anchor point for a leg actuation line (not shown) of the simulated leg 20b.

Referring back to <FIG>, the leg motor 152b is connected to the side plate 160b of the lower torso bracket <NUM> to actuate the leg actuation line, which leg actuation line is routed through tubing (not shown) from the leg motor 152b, through the guide tube fittings <NUM> of the leg insert <NUM>, and to the leg actuation line tie-off <NUM> of the foot <NUM>. The retrieval of the leg actuation line by the leg motor 152b produces a third moment between the lower leg <NUM> and the foot <NUM> at the pivotable connection therebetween. The third moment causes the foot <NUM> to pivot about said pivotable connection and relative to the lower leg <NUM>. The retrieval of the leg actuation line by the leg motor 152b also produces a fourth moment between the upper leg <NUM> and the lower leg <NUM> at the pivotable connection therebetween. The fourth moment causes the lower leg <NUM> to pivot about said pivotable connection and relative to the upper leg <NUM>. In several exemplary embodiments, during the retrieval of the leg actuation line by the leg motor 152b, the third moment pivots the foot <NUM> relative to the lower leg <NUM> before the fourth moment pivots lower leg <NUM> relative to the upper leg <NUM>. The subsequent payout of the leg actuation line by the leg motor 152b permits relaxation of the simulated leg 20b according to gravity and the elastic properties of the leg insert <NUM> and the simulated skin <NUM>.

In an exemplary embodiment, as illustrated in <FIG>, the patient simulator system <NUM> includes a simulated respiratory system <NUM> including a breathing pump <NUM>, a lung valve <NUM>, simulated left and right lungs <NUM> and <NUM>, and an airway valve <NUM>. The breathing pump <NUM> includes a cylinder <NUM> and a piston <NUM> dividing the cylinder <NUM> into chambers <NUM> and <NUM>. During the upward stroke of the piston <NUM> (from right to left as viewed in <FIG>), the breathing pump <NUM> generates positive pressure in the chamber <NUM> and negative (vacuum) pressure in the chamber <NUM>. Conversely, during the downward stroke of the piston <NUM> (from left to right as viewed in <FIG>), the breathing pump <NUM> generates negative (vacuum) pressure in the chamber <NUM> and positive pressure in the chamber <NUM>.

The lung valve <NUM> includes breathing ports A, B, C, and D. The breathing port A of the lung valve <NUM> communicates, via a line L1, with both the airway valve <NUM> and the chamber <NUM> of the breathing pump <NUM>. The breathing port B of the lung valve <NUM> communicates with the simulated right lung <NUM>. The breathing port C of the lung valve <NUM> communicates with the simulated left lung <NUM>. The breathing port D of the lung valve <NUM> communicates with the chamber <NUM> of the breathing pump <NUM> via a line L2, which is larger in diameter than the line L1. Further, the airway valve <NUM> includes airway ports C, T, and A. The airway port C of the airway valve <NUM> communicates, via the line L1, with both the chamber <NUM> of the breathing pump <NUM> and the breathing port A of the lung valve <NUM>. The airway port T of the airway valve <NUM> communicates with an abdominal expansion bag <NUM>. The airway port A of the airway valve <NUM> communicates with both an airway system <NUM> and the leg expansion bag(s) <NUM> of the simulated legs 20a and 20b.

The lung valve <NUM> is configurable between a spontaneous breathing configuration in which the breathing port D is in communication with one or both of the breathing ports B and C, and an assisted breathing configuration in which both of the breathing ports A and D are in communication with one or both of the breathing ports B and C. Similarly, the airway valve <NUM> is configurable between an airway configuration in which the airway port A is in communication with the airway port C, and an abdominal configuration in which the airway port C is in communication with the airway port T. Accordingly, the simulated respiratory system <NUM> is operated by precisely controlling the respective configurations of the lung valve <NUM> and the airway valve <NUM>, along with the breathing amplitude and frequency generated by the piston <NUM>.

In operation, when the lung valve <NUM> is in the spontaneous breathing configuration and the airway valve <NUM> is in the airway configuration: each upward stroke of the piston <NUM> forces air from the chamber <NUM> into one or both of the simulated left and right lungs <NUM> and <NUM> via the line L2 and produces a negative (vacuum) pressure in the airway system <NUM>; and each downward stroke of the piston <NUM> draws air out of one or both of the simulated left and right lungs <NUM> and <NUM> into the chamber <NUM> via the line L2 and produces a positive pressure in the airway system <NUM>. As a result, the upward and downward strokes of the piston <NUM> (when the lung valve <NUM> is in the spontaneous breathing configuration and the airway valve <NUM> is in the airway configuration): simulate the rise and fall of a patient's chest cavity; and cause the airway system <NUM> to inhale and exhale in a manner that simulates a patient's breathing pattern.

Further, when the lung valve <NUM> is in the spontaneous breathing configuration and the airway valve <NUM> is in the abdominal configuration: each upward stroke of the piston <NUM> produces a negative (vacuum) pressure in the abdominal expansion bag <NUM> and forces air from the chamber <NUM> into one or both of the simulated left and right lungs <NUM> and <NUM> via the line L2; and each downward stroke of the piston <NUM> produces a positive pressure in the abdominal expansion bag <NUM> and draws air out of one or both of the simulated left and right lungs <NUM> and <NUM> into the chamber <NUM> via the line L2. As a result, the upward and downward strokes of the piston <NUM> (when the lung valve <NUM> is in the spontaneous breathing configuration and the airway valve <NUM> is in the abdominal configuration): simulate the rise and fall of a patient's chest cavity; and cause the abdominal expansion bag <NUM> to deflate and inflate, respectively, in a manner that simulates respiratory distress in a patient (i.e., tummy retractions).

Finally, when the lung valve <NUM> is in the assisted breathing configuration and the airway valve <NUM> is in the airway configuration: each upward stroke of the piston <NUM> produces a negative (vacuum) pressure in the airway system <NUM> while permitting the escape of air from the lung valve <NUM> to the airway system <NUM> via the line L1; and each downward stroke of the piston <NUM> produces a positive pressure in the airway system <NUM> while permitting the escape of air from the airway system <NUM> to the lung valve <NUM> via the line L1. As a result, the upward and downward strokes of the piston <NUM> (when the lung valve <NUM> is in the assisted breathing configuration and the airway valve <NUM> is in the airway configuration) produce a pressure fluctuation in the airway system <NUM> that simulates a patient gasping for breath. This pressure fluctuation is sensed by a ventilator (not shown) operably coupled to the airway system <NUM>, which ventilator is then activated to assist (i.e., ventilate) the simulated respiratory system <NUM>. Once the ventilator has been activated, it communicates with both the airway valve <NUM> and the leg expansion bag(s) <NUM> (via, for example, a valve V1). Thus, the leg expansion bag(s) <NUM> accommodate any excess air forced into the simulated respiratory system <NUM> by the activated ventilator. Alternatively, the valve V1 may be used to prevent, or at least reduce, communication between the ventilator and the leg expansion bag(s) <NUM>, thereby simulating a patient with reduced lung compliance.

In an exemplary embodiment, as illustrated in <FIG>, the lung valve <NUM> includes a valve body <NUM>, a distributor <NUM>, and a valve lid <NUM>. The valve body <NUM> houses the distributor <NUM>. A valve motor <NUM> is operably coupled to the distributor <NUM> via a motor coupling <NUM>. The breathing ports A, B, C, and D are formed through the valve lid <NUM>. In an exemplary embodiment, the breathing ports A, B, C, and D are spaced apart along a circumference of the valve lid <NUM> at about <NUM>-degree intervals. In several exemplary embodiments, the breathing ports A, B, C, and D are spaced apart along a circumference of the valve lid <NUM> at intervals ranging from about <NUM>-degrees to about <NUM>-degrees. The valve lid <NUM> includes an end face <NUM> defining a fluid relief <NUM> that extends from the breathing port D. The distributor <NUM> includes an end face <NUM> defining a fluid relief <NUM>. The valve lid <NUM> is connected to the valve body <NUM> to encase the distributor <NUM> so that the end face <NUM> of the valve lid <NUM> sealingly engages the end face <NUM> of the distributor <NUM>. The circumferential position of the distributor <NUM> relative to the valve lid <NUM> is determined using an encoder shaft operably coupled to the distributor <NUM> and a potentiometer operably coupled to the valve lid <NUM>. The fluid relief <NUM> in the end face <NUM> of the valve lid <NUM> is shaped so that, regardless of the circumferential orientation of the distributor <NUM>, the breathing port D is in fluid communication with the fluid relief <NUM> on the end face <NUM> of the distributor <NUM>. Moreover, the fluid relief <NUM> on the end face <NUM> of the distributor <NUM> is shaped so that the lung valve <NUM> is actuable, via rotation of the distributor <NUM>, between the spontaneous breathing configuration and the assisted breathing configuration.

In the spontaneous breathing configuration, the distributor <NUM> is positionable between: a left lung disabled position (<FIG>) in which the breathing port D is in communication with the breathing port B but not the breathing port C; a normal breathing position (<FIG>) in which the breathing port D is in communication with both of the breathing ports B and C; and a right lung disabled position (<FIG>) in which the breathing port D is in communication with the breathing port C but not the breathing port B. Similarly, in the assisted breathing configuration, the distributor <NUM> is positionable between: a left lung disabled position (<FIG>) in which both of the breathing ports A and D are in communication with the breathing port B but not the breathing port C; a restricted flow position (<FIG>) in which both of the breathing ports A and D are in communication with the breathing ports B and C at a restricted flow rate; a normal breathing position (<FIG>) in which both of the breathing ports A and D are in communication with the breathing ports B and C at a normal flow rate; and a right lung disabled position (<FIG>) in which both of the breathing ports A and D are in communication with the breathing port C but not the breathing port B.

In an exemplary embodiment, as illustrated in <FIG>, the breathing pump <NUM> includes a motor <NUM>, an eccentric crank (not shown) housed within a crank case <NUM>, a rod <NUM>, the cylinder <NUM>, and the piston <NUM>. The breathing pump <NUM> may include features to increase efficiency and to prevent, or at least reduce, noise generation. For example, in several exemplary embodiments, the motor <NUM> is a brushless motor. Further, in several exemplary embodiments, the piston <NUM> is made of a light self-lubricating material such as, for example, graphite. Further still, in several exemplary embodiments, the cylinder <NUM> is made of precision-machined glass. The breathing pump <NUM> further includes a control board <NUM> operably coupled to the motor <NUM> to precisely control the breathing amplitude and frequency generated by the piston <NUM> (via the eccentric crank and the rod <NUM>).

In an exemplary embodiment, as illustrated in <FIG> and <FIG>, the simulated left and right lungs <NUM> and <NUM> form part of a lung compliance assembly <NUM>. The lung compliance assembly <NUM> includes a backing plate <NUM>, a pressure plate <NUM>, and a compliance motor <NUM>. The simulated left and right lungs <NUM> and <NUM> are trapped between the backing plate <NUM> and the pressure plate <NUM>. The compliance motor <NUM> is connected to the backing plate <NUM> to actuate a compliance actuation line (not shown), which compliance actuation line is routed through the backing plate <NUM> and connected to the pressure plate <NUM>. This actuation of the compliance actuation line adjusts the clamping force exerted by the pressure plate <NUM> on the simulated left and right lungs <NUM> and <NUM> to simulate the anatomical and physiological phenomena associated with the clinical presentation of lung compliance and its related complications. The lung compliance assembly <NUM> also includes simulated ribs <NUM> operably coupled to the pressure plate <NUM> to simulate the look and feel of a patient's ribs. In addition, connected to the backing plate <NUM> of the lung compliance assembly <NUM> is a chest deflection assembly <NUM> including a pair of leaf springs 266a and 266b. The leaf springs 266a and 266b include flex sensors 268a and 268b, respectively, contoured and affixed thereto. The leaf springs 266a and 266b are also connected to the back plate <NUM> of the upper torso bracket <NUM>. In operation, the leaf springs 266a and 266b enable deflection of the lung compliance assembly <NUM> relative to the back plate <NUM> of the upper torso bracket <NUM>, which deflection is measured by the flex sensors 268a and 268b. In this manner, the leaf springs 266a and 266b simulates the chest deflection of a patient without occupying the area behind the backing plate <NUM>.

In an exemplary embodiment, as illustrated in <FIG>, the airway valve <NUM> includes a valve body <NUM>, a valve lid <NUM>, and a valve rotor <NUM>. The valve rotor <NUM> is generally cylindrical and includes an end face <NUM> and a curved side surface <NUM> having intersecting passageways 280a and 280b, respectively, formed therethrough. The valve body <NUM> is generally cylindrical and includes an end face <NUM> having the airway port C formed therethrough, and a curved side surface <NUM> having the airway ports T and A formed therethrough. The airway ports C, T, and A each include a fitting <NUM>. The valve lid <NUM> is connected to the valve body <NUM>, opposite the end face <NUM>, to encase the valve rotor <NUM>. A valve motor <NUM> is incorporated into the valve lid <NUM> and operably coupled to the valve rotor <NUM> via a motor coupling (not shown). The circumferential position of the valve rotor <NUM> relative to the valve body <NUM> is controlled by the valve motor <NUM>. The passageways 280a and 280b of the valve rotor <NUM> and the airway ports C, T, and A of the valve body <NUM> are positioned so that the airway valve <NUM> is actuable, via rotation of the valve rotor <NUM>, between the airway configuration in which the airway port A is in communication with the airway port C, and an abdominal configuration in which the airway port C is in communication with the airway port T. More particularly, in the airway configuration, the airway port A is in communication with the airway port C via the intersecting passageways 280a and 280b of the valve rotor <NUM>. Similarly, in the abdominal configuration, the airway port C is in communication with the airway port T via the intersecting passageways 280a and 280b of the valve rotor <NUM>.

In an exemplary embodiment, as illustrated in <FIG> and <FIG>, the abdominal expansion bag <NUM> simulates the retraction and distention of the abdominal cavity. When used in combination, the abdominal expansion bag <NUM> and the breathing pump <NUM> enable precise control of breathing amplitude and frequency, along with all of the essential medical and physiological phenomena associated with a patient's abdomen. The position of the abdominal expansion bag <NUM> the patient simulator system <NUM> is shown most clearly in <FIG>. In several exemplary embodiments, at least a portion of the abdominal expansion bag <NUM> extends within the empty space <NUM> defined by the lower torso bracket <NUM>.

In an exemplary embodiment, as illustrated in <FIG>, the airway system <NUM> includes an airway unit <NUM>, a skin layer <NUM>, nose tubes 294a and 294b, an esophagus tube <NUM>, and a trachea tube <NUM>. The skin layer <NUM> is formed to simulate a patient's face (including simulated eyelids, nostrils, cheeks, and lips) and is operably coupled to the airway unit <NUM> and the nose tubes 294a and 294b. The nose tubes 294a and 294b are connected to the simulated nostrils of the skin layer <NUM> via a pair of nose tube bushings 299a and 299b. In several exemplary embodiments, the skin layer <NUM> is, includes, or is part of the simulated skin <NUM> of the patient simulator system <NUM>. The airway unit <NUM> includes a mouth cavity <NUM> and an internal airway <NUM>. The mouth cavity <NUM> and the internal airway <NUM> include anatomically correct simulated features, such as, for example, a simulated tongue <NUM>, a simulated epiglottis <NUM>, and simulated vocal cords (not shown). Additionally, a speaker <NUM> is operably coupled to the airway unit <NUM> and communicates audibly into the mouth cavity <NUM> to simulate a patient's vocal sounds. Operably coupled to the exterior of the airway unit <NUM> adjacent the mouth cavity <NUM> are light-emitting diodes (LEDs) <NUM> and a transparent (or semi-transparent) overmold <NUM> positioned between the LEDs <NUM> and the skin layer <NUM>. The transparent overmold <NUM> diffuses light beneath the skin layer <NUM> (e.g., the simulated lips and cheeks) from the LEDs <NUM> to simulate the various states of a patient's face, including, for example, cyanosis, jaundice, paleness, and redness.

The esophagus tube <NUM> is operably coupled to the airway unit <NUM> and communicates with the internal airway <NUM>. Similarly, the trachea tube <NUM> is operably coupled to the airway unit <NUM>, adjacent the esophagus tube <NUM>, and communicates with the internal airway <NUM>. Moreover, the trachea tube <NUM> is operably coupled to the simulated respiratory system <NUM>, and communicates with the airway valve <NUM> and the leg expansion bag(s) <NUM>. An O-ring <NUM> is sealingly engaged between the trachea tube <NUM> and the airway unit <NUM> to facilitate an airtight seal with various tracheal intubation devices. A trachea tubing depth sensor <NUM> is operably coupled to the trachea tube <NUM> to ensure proper execution of various intratracheal training procedures. In addition, the nose tubes 294a and 294b are operably coupled to the airway unit <NUM> and communicate with the internal airway <NUM>, opposite the esophagus tube <NUM> and the trachea tube <NUM>.

In several exemplary embodiments, the mouth cavity <NUM> and the internal airway <NUM> are shaped to facilitate a training procedure for the insertion and placement of a laryngeal mask airway adjacent the trachea tube <NUM> and the esophagus tube <NUM>. In several exemplary embodiments, the nose tubes 294a and 294b and the internal airway <NUM> are shaped to facilitate a training procedure for nasotracheal intubation. In several exemplary embodiments, the nose tubes 294a and 294b and the internal airway <NUM> are shaped to facilitate a training procedure for the insertion and placement of a nasogastric feeding tube. In several exemplary embodiments, the simulated respiratory system <NUM> and the airway system <NUM>, in combination, enable realistic pulmonary feedback during various training procedures, such as, for example, a training procedure for endotracheal intubation, a training procedure for a valve bag mask ventilation, or another training procedure discussed herein.

In an exemplary embodiment, as illustrated in <FIG>, the simulated head <NUM> of the patient simulator system <NUM> includes a mandible assembly <NUM> operably coupled to the skin layer <NUM> and configured to open and close the simulated lips. The mandible assembly <NUM> includes a cheek bracket <NUM>, a jaw bracket <NUM>, a sliding mandible <NUM>, a drive motor <NUM>, and a double-lobed drive cam <NUM>. The cheek bracket <NUM> includes a base plate <NUM>, cheek plates 328a and 328b, a hook plate <NUM>, and a back plate <NUM>. The cheek plate 328b and the hook plate <NUM> extend transversely from opposing ends of the base plate <NUM> and define mounts 334a and 334b, respectively, to which the drive motor <NUM> is operably coupled. The back plate <NUM> extends transversely from the hook plate <NUM> in a direction opposite the base plate <NUM>, and the cheek plate 328a extends transversely from the back plate <NUM>. In combination, the hook plate <NUM>, the back plate <NUM>, and the cheek plate 328a define a space in which the double-lobed drive cam <NUM> extends. The hook plate <NUM> and the cheek plates 328a and 328b extend in parallel-spaced planes, and the back plate <NUM> and the base plate <NUM> extend in perpendicular-spaced planes.

The jaw bracket <NUM> includes a base plate <NUM> and side plates 338a and 338b extending transversely from opposing ends of the base plate <NUM>. The side plates 338a and 338b are pivotably coupled to the cheek plates 328a and 328b of the cheek bracket <NUM>. Moreover, the side plate 338a includes an integrated lever <NUM> operably coupled to the double-lobed drive cam <NUM>. As a result, the rotation of the double-lobed drive cam <NUM> by the drive motor <NUM> pivots the jaw bracket <NUM> about the pivotable connection between the side plates 338a and 338b and the cheek plates 328a and 328b. The double-lobed drive cam <NUM> is shaped to enable uninhibited manipulation of the jaw bracket <NUM> when in the center (or neutral) position.

The sliding mandible <NUM> is a generally U-shaped component including a mandible body <NUM> and slides 344a and 344b connected to opposing ends of the mandible body <NUM>. The slides 344a and 344b include slots 346a and 346b, respectively. Moreover, domed bumpers 348a and 348b are connected to the slides 344a and 344b, respectively, opposite the mandible body <NUM>. The domed bumpers 348a and 348b serve as anatomical landmarks within the patient simulator system <NUM>'s simulated head <NUM>. The sliding mandible <NUM> is connected to the jaw bracket <NUM> via fasteners extending through the slots 346a and 346b. As a result, the sliding mandible <NUM> is moveable relative to the jaw bracket <NUM> between a retruded position in which the base plate <NUM> of the jaw bracket <NUM> complementarily engages the mandible body <NUM>, and a protruded position in which the domed bumpers 348a and 348b engage the opposing ends of the base plate <NUM>. In this manner, the jaw bracket <NUM> and the sliding mandible <NUM> are together operable to simulate the form and function of a patient's jaw. The sliding mandible <NUM> is also connected to the skin layer <NUM> to further enhance the skin layer <NUM>'s simulation of a patient's face.

In an exemplary embodiment, as illustrated in <FIG>, the simulated head <NUM> of the patient simulator system <NUM> further includes an endoskeleton skull <NUM> and a skin layer <NUM> into which a simulated fontanelle <NUM> is incorporated. In several exemplary embodiments, the simulated fontanelle <NUM> is integrally formed with the skin layer <NUM>. Moreover, in several exemplary embodiments, the skin layer <NUM> is, includes, or is part of the simulated skin <NUM> of the patient simulator system <NUM>. The endoskeleton skull <NUM> includes an indented fontanelle region <NUM> generally in the shape of a patient's fontanelle. Extending through the endoskeleton skull <NUM> adjacent the indented fontanelle region <NUM> are a fontanelle fitting <NUM> and a pulse fitting <NUM>. The simulated fontanelle <NUM> includes a pulse bladder <NUM> and a fontanelle bladder <NUM> formed in the skin layer <NUM>. The fontanelle bladder <NUM> extends within the indented fontanelle region <NUM> of the endoskeleton skull <NUM>, and the pulse bladder <NUM> extends adjacent the fontanelle bladder <NUM>. The pulse bladder <NUM> is operably coupled to the pulse fitting <NUM>, and communicates with the simulated circulatory system (not shown) to receive the pneumatic or hydraulic pulse. The fontanelle bladder <NUM> is operably coupled to the fontanelle fitting <NUM>, and communicates with the simulated respiratory system <NUM> to receive either positive or negative (vacuum) pressure. This positive or negative (vacuum) pressure produces either a swollen or sunken state in the simulated fontanelle <NUM>.

In several exemplary embodiments, the fontanelle fitting <NUM> and the pulse fitting <NUM> are substantially identical to one another, and, therefore, in connection with <FIG>, only the pulse fitting <NUM> will be described in detail below; however the description below applies to both the fontanelle fitting <NUM> and the pulse fitting <NUM>. Turning to <FIG>, the pulse fitting <NUM> includes a male coupling <NUM> connected to the skin layer <NUM> and a female coupling <NUM> connected to the endoskeleton skull <NUM>. An O-ring <NUM> extends within an annular groove on the male coupling <NUM>, opposite the skin layer <NUM>. The female coupling <NUM> receives the male coupling <NUM> and is sealingly engaged by the O-ring <NUM>. Operably coupled to the female coupling <NUM>, opposite the male coupling <NUM>, is a pulse air supply line <NUM> that communicates with the simulated circulatory system to receive the pneumatic or hydraulic pulse. In a similar manner, a fontanelle air supply line <NUM> is connected to the female coupling (not visible in <FIG>) of the fontanelle fitting <NUM>, and communicates with the simulated respiratory system <NUM> to receive either the positive or negative (vacuum) pressure.

The present disclosure introduces a patient simulator, including a simulated respiratory system and a simulated airway system, the simulated respiratory system including a lung valve; a first simulated lung in communication with the lung valve; and a breathing pump including a cylinder and a piston dividing the cylinder into first and second chambers, the first chamber being in communication with the lung valve via at least a first flow path, the second chamber being in communication with the lung valve via at least a second flow path, and the piston being adapted to reciprocate within the cylinder; and the simulated airway system being configured to be in communication with the second chamber of the breathing pump via at least a third flow path. In several exemplary embodiments, the patient simulator further includes an airway valve including first, second, and third ports, and being actuable between an airway configuration, in which the first port is in communication with the third port, but not the second port, and an abdominal configuration, in which the first port is in communication with the second port, but not the third port; wherein the first port is in communication with the second chamber of the breathing pump; wherein the third port is in communication with the simulated airway system; and wherein, when the airway valve is in the airway configuration, the first and third ports form part of the third flow path. In several exemplary embodiments, the second port of the airway valve is in communication with an abdominal expansion bag of the patient simulator so that when the airway valve is in the abdominal configuration: each stroke of the piston in a first direction produces a pressure decrease in the abdominal expansion bag and forces air from the first chamber of the breathing pump into the first simulated lung via at least the first flow path, and each stroke of the piston in a second direction, which is opposite the first direction, produces a pressure increase in the abdominal expansion bag and draws air out of the first simulated lung and into the first chamber of the breathing pump via at least the first flow path; and wherein the increase and decrease of pressure in the abdominal expansion bag simulates respiratory distress in a human patient. In several exemplary embodiments, the lung valve includes first, second, and third ports, and is actuable between a spontaneous breathing configuration, in which the first port is in communication with the second port, and an assisted breathing configuration, in which both of the first and third ports are in communication with the second port; wherein the first chamber of the breathing pump is in communication with the first port via at least the first flow path; wherein the first simulated lung is in communication with the second port; and wherein the second chamber of the breathing pump is in communication with the third port via at least the second flow path. In several exemplary embodiments, the lung valve further includes a fourth port arranged so that, in the spontaneous breathing configuration, the first port is in communication with one, or both, of the second port and the fourth port, and, in the assisted breathing configuration, both of the first and third ports are in communication with one, or both, of the second and fourth ports; and wherein the simulated respiratory system further includes a second simulated lung in communication with the fourth port. In several exemplary embodiments, at least respective portions of the second and third flow paths are in communication with each other and the second chamber of the breathing pump. In several exemplary embodiments, when the lung valve is in the spontaneous breathing configuration and the simulated airway system is in communication with the second chamber of the breathing pump via at least the third flow path: each stroke of the piston in a first direction forces air from the first chamber of the breathing pump into the first simulated lung via at least the first flow path, and produces a pressure decrease in the airway system to simulate inhalation of a human patient's breath; and each stroke of the piston in a second direction, which is opposite the first direction, draws air out of the first simulated lung into the first chamber of the breathing pump via at least the first flow path, and produces a pressure increase in the airway system to simulate exhalation of the human patient's breath. In several exemplary embodiments, when the lung valve is in the assisted breathing configuration and the simulated airway system is in communication with the second chamber of the breathing pump via at least the third flow path: each stroke of the piston in a first direction produces a pressure decrease in the airway system while permitting air to escape from the third port of the lung valve to the airway system via at least respective portions of the second and third flow paths; and each stroke of the piston in a second direction, which is opposite the first direction, produces a pressure increase in the airway system while permitting air to escape from the airway system to the third port of the lung valve via at least respective portions of the second and third flow paths; and the escape of air from the third port of the lung valve to the airway system, and vice versa, during the respective strokes of the piston in the first and second directions, produces a pressure fluctuation in the airway system that simulates a human patient gasping for breath. In several exemplary embodiments, at least a portion of the second flow path is smaller in diameter than the first flow path to facilitate said pressure fluctuation. In several exemplary embodiments, a mechanical ventilator is operably coupleable to the simulated airway system and configurable to sense said pressure fluctuation.

The present disclosure also introduces a method, including simulating, using a patient simulator, a human patient's breathing pattern, the patient simulator including a simulated respiratory system and a simulated airway system, the simulated respiratory system including a lung valve, a first simulated lung in communication with the lung valve, and a breathing pump including a cylinder and a piston dividing the cylinder into first and second chambers, the first chamber being in communication with the lung valve via at least a first flow path, and the second chamber being in communication with the lung valve via at least a second flow path; and the simulated airway system being configured to be in communication with the second chamber of the breathing pump via at least a third flow path; wherein simulating, using the patient simulator, the human patient's breathing pattern includes reciprocating the piston within the cylinder. In several exemplary embodiments, the method further includes actuating an airway valve of the patient simulator to an airway configuration, the airway valve including a first port in communication with the second chamber of the breathing pump, a second port, and a third port in communication with the simulated airway system; wherein, when the airway valve is in the airway configuration, the first port is in communication with the third port, but not the second port, so that the first and third ports form part of the third flow path. In several exemplary embodiments, the method further includes simulating, using the patient simulator, respiratory distress within the human patient; wherein the second port of the airway valve is in communication with an abdominal expansion bag of the patient simulator; and wherein simulating, using the patient simulator, respiratory distress within the human patient includes: stroking, when the airway valve is in the abdominal configuration, the piston in a first direction to produce a pressure decrease in the abdominal expansion bag and force air from the first chamber of the breathing pump into the first simulated lung via at least the first flow path; and stroking, when the airway valve is in the abdominal configuration, the piston in a second direction, which is opposite the first direction, to produce a pressure increase in the abdominal expansion bag and draw air out of the first simulated lung and into the first chamber of the breathing pump via at least the first flow path. In several exemplary embodiments, the lung valve includes first, second, and third ports, the first chamber of the breathing pump being in communication with the first port via at least the first flow path, the first simulated lung being in communication with the second port, and the second chamber of the breathing pump being in communication with the third port via at least the second flow path; and the method further includes actuating the lung valve between a spontaneous breathing configuration, in which the first port is in communication with the second port, and an assisted breathing configuration, in which both of the first and third ports are in communication with the second port. In several exemplary embodiments, the lung valve further includes a fourth port arranged so that, in the spontaneous breathing configuration, the first port is in communication with one, or both, of the second port and the fourth port, and, in the assisted breathing configuration, both of the first and third ports are in communication with one, or both, of the second and fourth ports; and the simulated respiratory system further includes a second simulated lung in communication with the fourth port. In several exemplary embodiments, at least respective portions of the second and third flow paths are in communication with each other and the second chamber of the breathing pump. In several exemplary embodiments, simulating, using the patient simulator, the human patient's breathing pattern includes: stroking, when lung valve is in the spontaneous breathing configuration and the simulated airway system is in communication with the second chamber of the breathing pump via at least the third flow path, the piston in a first direction to force air from the first chamber of the breathing pump into the first simulated lung via at least the first flow path, and produce a pressure decrease in the airway system to simulate inhalation of the human patient's breath; and stroking, when lung valve is in the spontaneous breathing configuration and the simulated airway system is in communication with the second chamber of the breathing pump via at least the third flow path, the piston in a second direction, which is opposite the first direction, to draw air out of the first simulated lung into the first chamber of the breathing pump via at least the first flow path, and produces a pressure increase in the airway system to simulate exhalation of the human patient's breath. In several exemplary embodiments, the method further includes producing, using the patient simulator, a pressure fluctuation in the airway system to simulate the human patient gasping for breath; wherein producing, using the patient simulator, the pressure fluctuation in the airway system to simulate the human patient gasping for breath includes: stroking the piston in a first direction to produce a pressure decrease in the airway system while permitting air to escape from the third port of the lung valve to the airway system via at least respective portions of the second and third flow paths; and stroking the piston in a second direction, which is opposite the first direction, to produce a pressure increase in the airway system while permitting air to escape from the airway system to the third port of the lung valve via at least respective portions of the second and third flow paths. In several exemplary embodiments, at least a portion of the second flow path is smaller in diameter than the first flow path to facilitate said pressure fluctuation. In several exemplary embodiments, the method further includes operably coupling a mechanical ventilator to the simulated airway system, the mechanical ventilator being configurable to sense said pressure fluctuation.

The present disclosure also introduces a patient simulator system including a simulated respiratory system, the simulated respiratory system including simulated left and right lungs, a lung valve, a breathing pump, an airway pump, an abdominal expansion bag, a leg expansion bag, and an airway system. In an exemplary embodiment, the breathing pump includes cylinder and a piston dividing the cylinder into first and second chambers, the piston being adapted to reciprocate in the cylinder. In an exemplary embodiment, the lung valve includes first, second, third, and fourth breathing ports, the first breathing port being in communication with the second chamber of the breathing pump via a first line, the second breathing port being in communication with both the airway valve and the first chamber of the breathing pump via a second line, and the third and fourth breathing ports being in communication with the simulated left and right lungs, respectively, wherein the second line is relatively smaller in diameter than the first line. In an exemplary embodiment, the lung valve is actuable between: a first breathing configuration in which the first breathing port is in communication with one or both of the third and fourth breathing ports; and a second breathing configuration in which both the first and second breathing ports are in communication with one or both of the third and fourth breathing ports.

The present disclosure also introduces a patient simulator system including a simulated torso, simulated arms, and simulated legs, the simulated torso including an upper torso bracket interconnecting the simulated arms, and a lower torso bracket interconnecting the simulated legs. In an exemplary embodiment, the simulated arms and the simulated legs are connected to the upper torso bracket and the lower torso bracket, respectively, via articulation joints, the articulation joints each including a clamp, a ball, and a clamp screw.

The present disclosure also introduces a patient simulator system including a simulated head, the simulated head including an endoskeleton skull and in skin layer into which a simulated fontanelle is incorporated. In an exemplary embodiment, the simulated fontanelle includes a pulse bladder and a fontanelle bladder formed in the skin layer. In an exemplary embodiment, the simulated skull includes an indented fontanelle region, a fontanelle fitting, and a pulse fitting, the fontanelle fitting and the pulse fitting each extending through the endoskeleton skull adjacent the indented fontanelle region. In an exemplary embodiment, the fontanelle bladder extends within the indented fontanelle region of the endoskeleton skull, is operably coupled to the fontanelle fitting, and communicates with a simulated respiratory system of the patient simulator system to receive either positive or negative (vacuum) pressure. In an exemplary embodiment, the pulse bladder extends adjacent the fontanelle bladder, is operably coupled to the pulse fitting, and communicates with a simulated circulatory system of the patient simulator system to receive a pneumatic or hydraulic pulse.

The present disclosure also introduces a simulated respiratory system for a patient simulator system according to one or more aspects of the present disclosure.

The present disclosure also introduces a lung valve according to one or more aspects of the present disclosure.

The present disclosure also introduces a breathing pump according to one or more aspects of the present disclosure.

The present disclosure also introduces an airway valve according to one or more aspects of the present disclosure.

The present disclosure also introduces an airway system according to one or more aspects of the present disclosure.

The present disclosure also introduces a method according to one or more aspects of the present disclosure.

The present disclosure also introduces a system according to one or more aspects of the present disclosure.

The present disclosure also introduces an apparatus according to one or more aspects of the present disclosure.

The present disclosure also introduces a kit according to one or more aspects of the present disclosure.

It is understood that variations may be made in the foregoing without departing from the scope of the present disclosure.

In various embodiments, the elements and teachings of the various embodiments may be combined in whole or in part in some or all of the various embodiments. In addition, one or more of the elements and teachings of the various embodiments may be omitted, at least in part, and/or combined, at least in part, with one or more of the other elements and teachings of the various embodiments.

In various embodiments, while different steps, processes, and procedures are described as appearing as distinct acts, one or more of the steps, one or more of the processes, and/or one or more of the procedures may also be performed in different orders, simultaneously and/or sequentially. In various embodiments, the steps, processes and/or procedures may be merged into one or more steps, processes and/or procedures.

In various embodiments, one or more of the operational steps in each embodiment may be omitted. Moreover, in some instances, some features of the present disclosure may be employed without a corresponding use of the other features. Moreover, one or more of the above-described embodiments and/or variations may be combined in whole or in part with any one or more of the other above-described embodiments and/or variations.

In the foregoing description of certain embodiments, specific terminology has been resorted to for the sake of clarity. However, the disclosure is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes other technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "left" and right", "front" and "rear", "above" and "below" and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

Claim 1:
A patient simulator (<NUM>), comprising:
a simulated respiratory system, comprising:
a lung valve (<NUM>);
a first simulated lung (<NUM>) in communication with the lung valve (<NUM>); and
a breathing pump (<NUM>) including a cylinder (<NUM>) and a piston (<NUM>) dividing the cylinder (<NUM>) into first and second chambers (<NUM>, <NUM>), the first chamber (<NUM>) being in communication with the lung valve (<NUM>) via at least a first flow path, the second chamber being (<NUM>) in communication with the lung valve (<NUM>) via at least a second flow path, and the piston (<NUM>) being adapted to reciprocate within the cylinder (<NUM>);
and
a simulated airway system configured to be in communication with the second chamber (<NUM>) of the breathing pump (<NUM>) via at least a third flow path.