WO2025096413A1 - Methods and apparatuses for simulating anatomical characteristics associated with medical conditions - Google Patents

Abstract

Methods and apparatuses for simulating anatomical characteristics associated with medical conditions are described. An apparatus may include an artificial abdomen formed of a deformable material; and an artificial uterus disposed within the artificial abdomen, wherein the artificial uterus is configurable between a contracted state and an expanded state. According to some embodiments, the techniques described herein relate to an apparatus, further including: a pump; a fluid conduit; and a fluid reservoir, wherein the pump pumps fluid between the fluid reservoir and the artificial uterus to change the artificial uterus between the contracted state and the expanded state. In some aspects, the techniques described herein relate to an apparatus, further including a power source, wherein the power source powers the pump to pump the fluid.

Description

METHODS AND APPARATUSES FOR SIMULATING ANATOMICAL

CHARACTERISTICS ASSOCIATED WITH MEDICAL CONDITIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/595,564, filed on November 2, 2023, the contents of which are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

[0002] Example embodiments of the present disclosure generally relate to the field of healthcare. More specifically, the present disclosure relates to methods and apparatuses for simulating anatomical characteristics associated with medical conditions.

BACKGROUND

[0003] Various medical conditions maybe detected through examinations involving palpation, which is a physical examination technique that involves feeling the body with the hands or fingers to assess the size, texture, consistency, location, and tenderness of organs or body parts. Such detection may require extensive medical training and experience to accurately and repeatably detect specific medical conditions.

[0004] Clinical shadowing can expose a medical student to many different conditions; however, such shadowing is limited to conditions experienced by patients that the medical student is working with. Thus, the range of conditions and range of symptoms will be limited. Further experience in the medical field after becoming a doctor exposes the medical professional to additional conditions and symptoms. However, it is desirable to improve the variety of conditions and symptoms that a physician is exposed to as early in a career as possible to improve patient diagnoses and outcomes.

BRIEF SUMMARY

[0005] Methods and devices for simulating anatomical characteristics associated with medical conditions are described. For example, a device may be utilized to train healthcare professionals to detect uterine atony more accurately and thereby reduce maternal mortality. [0006] In some aspects, the techniques described herein relate to an apparatus including: an artificial abdomen formed of a deformable material; and an artificial uterus disposed within the artificial abdomen, wherein the artificial uterus is configurable between a contracted state and an expanded state. According to some embodiments, the techniques described herein relate to an apparatus, further including: a pump; a fluid conduit; and a fluid reservoir, wherein the pump pumps fluid between the fluid reservoir and the artificial uterus to change the artificial uterus between the contracted state and the expanded state. In some aspects, the techniques described herein relate to an apparatus, further including a power source, wherein the power source powers the pump to pump the fluid.

[0007] According to certain embodiments, the techniques described herein relate to an apparatus, further including a controller, wherein the controller is configured to receive user input and to command the pump to pump fluid to and from the artificial uterus in response to the user input. In some aspects, the techniques described herein relate to an apparatus, wherein the artificial uterus is removable from the artificial abdomen through an access panel. In some aspects, the techniques described herein relate to an apparatus, wherein the artificial uterus is connected to the conduit by a quick disconnect fitting.

[0008] According to some embodiments, the techniques described herein relate to an apparatus, wherein the artificial uterus is replaceable. In some aspects, the techniques described herein relate to an apparatus, wherein the artificial abdomen is covered, at least in part, by silicone rubber. In some aspects, the techniques described herein relate to an apparatus, wherein the artificial abdomen further includes a silicone gel fill between the silicone rubber and the artificial uterus. In some aspects, the techniques described herein relate to an apparatus, wherein the artificial uterus is palpable through the silicone rubber and silicone gel fill.

[0009] In some aspects, the embodiments described herein relate to a method including: forming an artificial abdomen of a deformable material; receiving within the artificial abdomen an artificial uterus; and controlling the artificial uterus between a contracted state and an expanded state. In some aspects, the techniques described herein relate to a method, further including: pumping fluid between a fluid reservoir and the artificial uterus using a pump to change the artificial uterus between the contracted state and the expanded state.

[0010] According to some embodiments, the techniques described herein relate to a method, further including: providing power to the pump from a power source to pump the fluid. In some aspects, the techniques described herein relate to a method, wherein controlling the artificial uterus between a contracted state and an expanded state includes: receiving user input; and commanding the pump to pump fluid to and from the artificial uterus in response to the user input. In some aspects, the techniques described herein relate to a method, further including: accessing the artificial uterus through an access panel in the artificial abdomen for removal.

[0011] According to certain embodiments, the techniques described herein relate to a method, further including: connecting the artificial uterus to the conduit by a quick disconnect fitting. In some aspects, the techniques described herein relate to a method, further including: replacing the artificial uterus with another artificial uterus of a different size. In some aspects, the techniques described herein relate to a method, further including: covering the artificial abdomen, at least in part, with silicone rubber. In some aspects, the techniques described herein relate to a method, further including: filling a space between the silicone rubber and the artificial uterus with a silicone gel fill. In some aspects, the techniques described herein relate to a method, further including: palpating the artificial uterus through the silicone rubber and silicone gel fill.

BRIEF SUMMARY OF THE FIGURE

[0012] Having thus described the invention in general terms, reference will now be made to the accompanying drawing, which are not necessarily drawn to scale, and wherein:

[0013] Figure 1 illustrates an artificial abdomen incorporating an artificial uterus according to an example embodiment of the present disclosure; and

[0014] Figure 2 is a flowchart of a method for using an artificial abdomen incorporating an artificial uterus according to an example embodiment of the present disclosure.

DETAILED DESCRIPTION

[0015] Example embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

[0016] Methods and devices for simulating anatomical characteristics associated with medical conditions are described. Medical students are often trained in a healthcare setting with actual patients having real conditions. In this way, experienced healthcare professionals mentor students to identify, diagnose, and treat various medical conditions. While this shadowing type of training works well, medical students cannot all be exposed to all types of conditions that they will encounter during their careers. Further, medical conditions vary by patient, where a medical condition in one patient may exhibit different symptoms and characteristics from another patient. Thus, shadow training by mentors while important is also imperfect.

[0017] Medical dummies or medical simulators, referred to generally herein as simulators can be used in medical training to simulate medical conditions. Medical conditions that exhibit physical symptoms can be mimicked by medical simulators to manifest symptoms for a wide variety of medical conditions. Medical simulators are testbeds for medical training that can produce repeatable and consistent physical conditions that reflect human physical conditions in a manner that clinical shadowing cannot achieve. The variety of physical conditions or symptoms that can be achieved with simulators and the range of degree of conditions or symptoms is important for medical professionals to encounter in order to be well-versed in diagnosing medical conditions in their practice.

[0018] While medical simulators have existed in some form or another for years, medical simulators to simulate certain conditions have been elusive. Embodiments described herein address this need with regard to simulation of conditions that reflect postpartum hemorrhage (PPH). PPH is the leading cause of maternal mortality with uterine atony as the leading risk factor and origin for most cases of PPH. Uterine atony is the inadequate contraction of the smooth muscle cells that make up the middle layer of the uterine wall, also known as corpus uteri myometrial cells or myometrium. These cells function to induce uterine contractions during childbirth. Postpartum hemorrhage can occur when spiral arteries, devoid of musculature, are dependent on uterine contractions to mechanically squeeze them into hemostasis which is the natural process that stops bleeding and allows the body to repair an injury. When the process that controls hemostasis fails or malfunctions, excessive bleeding or hemorrhaging can occur.

[0019] PPH can go undiagnosed if the patient does not manifest the anticipated symptoms. Blood loss is one example of a symptom, where excessive blood loss postpartum can be an indicator of PPH. However, visible or observed blood loss is not always present during PPH. Current diagnostics and education relies heavily on the mechanics of bleeding which can lead to undiagnosed PPH in certain situations. Vital signs are another indicator of PPH, such as if heart rate significantly increases and blood pressure is falling, or where peripheral oxygen saturation is less than 95%. However, these symptoms may not always present themselves in a reliable and timely manner sufficient to stem the hemorrhage. Delay in recognition and treatment of PPH directly correlates with increased blood loss which leads to increased maternal complications, morbidity, and mortality. While less critical than the health complications and risks, delay in recognition and treatment of PPH also leads to increased organizational costs.

[0020] Embodiments described herein provide a medical simulator that simulates physical conditions of PPH in a manner not previously available and improves the ability of medical staff to properly diagnose PPH in a reliable and timely manner. Embodiments described herein provide a stand-alone uterine simulator to assist healthcare professionals in realistically distinguishing between a boggy and a firm uterus when assessing the post-partum patient. A boggy uterus refers to a uterus that is enlarged and more soft or flaccid than would be expected. This occurs when the uterus does not contract sufficiently during or after childbirth. A firm uterus, on the other hand, is a normal characteristic of a healthy uterus postpartum.

[0021] Healthcare professionals may be trained to detect uterine atony by manually evaluating firmness of the uterus following childbirth. Such procedures may provide a valuable tool for the prevention of PPH. Embodiments described herein include a uterine simulator for training healthcare professionals to diagnose uterine atony. As a result, instances of uterine atony that may go undetected or detected after a delay can be more readily identified by medical professionals trained on the simulator described herein.

[0022] Embodiments described herein provide an apparatus that may be utilized to train healthcare professionals to detect uterine atony more accurately and thereby reduce maternal mortality. The apparatus may include an artificial abdomen (e.g., a simulated abdomen, a first component) and an artificial uterus (e.g., a simulated uterus, a second component). The artificial abdomen may be formed of one or more deformable materials, such as silicone rubber, silicone gel, or the like. For example, a first material may be utilized as artificial skin for the artificial abdomen and a second material may be utilized as a filler material or a structural material for the artificial abdomen. The artificial abdomen may include a cavity where the artificial uterus may be placed. In one example, the artificial uterus may be formed of latex. The artificial uterus may also include a cavity, which may be filled with a fluid to cause the expansion of the artificial uterus. The expansion of the artificial uterus may compress the artificial abdomen, which may increase a stiffness of the artificial abdomen or a stiffness of a portion of the artificial abdomen.

[0023] Figure 1 illustrates an example embodiment of a simulator 100 that may be used to diagnose PPH through uterine atony. As shown, the simulator 100 includes an artificial abdomen 110. The artificial abdomen may be shaped and sized to mimic an adult human. Disposed within the artificial abdomen 110 or torso may be covered with a simulated skin and have a texture of an actual abdomen. Disposed within the abdomen 110 is an artificial uterus 120, which may be approximately three to six inches in diameter. The artificial uterus 120 is shown in both an expanded state 122 which reflects a boggy uterus, and a contracted state 124 which reflects a more firm uterus. The expansion and contraction are facilitated by a pump 130 which pumps fluid into and out of the artificial uterus 120 to change the state of the artificial uterus between the expanded state 122 and the contracted state 124. The pump 130 is powered by power supply 140 and the fluid is pumped via conduit 135 between a fluid reservoir 150 and the artificial uterus 120 to change the state according to a desired setting.

[0024] A controller 160 is illustrated for controlling the pump 130, whereby a firmness setting or state is set by a user using the controller 160 to adjust the firmness. The controller may be in the form of buttons, a dial, or the like for adjusting the firmness. Optionally, the controller may be embodied by a remote control or use of a wireless device such as a mobile phone using an app to control the pump 130 and hence the state of the artificial uterus 120. While the pump 130, power supply 140, fluid reservoir 150, and controller 160 are shown outside of the abdomen 110, embodiments can incorporate these elements within the abdomen as a complete functional unit.

[0025] The power supply 140 can include a battery (e.g., a rechargeable battery) or a wired plug for insertion in an outlet. The power supply 140 in the form of a rechargeable battery may be charged, such as by USB (Universal Serial Bus) cable, a standard power cord, or optionally wirelessly charged.

[0026] While the illustrated embodiment includes a fluid-filled artificial uterus, embodiments can employ an air-filled artificial uterus, where the fluid reservoir 150 may not be necessary, and where the pump 130 may draw ambient air in to inflate the artificial uterus 120 and draw air out of the artificial uterus to deflate or contract the artificial uterus. This would simplify the apparatus and potentially reduce cost. However, as human organs have a texture generally more consistent with a fluid-filled object, the use of fluid in the artificial uterus 120 is generally preferred. [0027] The simulator described herein may optionally be modular, with the components removable and replaceable via posterior opening or other access panel. The artificial uterus 120 can be a fall used can be interchangeable with artificial uterus of different sizes to mimic real world variations in uterus size. To facilitate this, the conduit 135 may be attached to the artificial uterus via a quick disconnect fitting or the like. The abdomen can be made of or covered with a silicone material, and may include a fill that simulates flesh, such as using silicone gel as a filler.

[0028] During a training procedure, a medical professional may palpate the artificial abdomen 110, which may be configured to simulate various stiffnesses corresponding to various medical conditions. For example, inflating the artificial uterus 120 (e.g., using the pump 130) to a first size may be representative of a first health condition (e.g., no uterine atony) and inflating the artificial uterus 120 to a second size may be representative of a second health condition (e.g., uterine atony). In some examples, utilizing the device to simulate a plurality of health conditions may enable healthcare professionals to be trained more effectively and ultimately to more accurately assess whether a patient is experiencing uterine atony.

[0029] In some examples, the device may be modular, and may include one or more components which may be interchanged or reconfigured in specific combinations to replicate specific conditions. For example, the simulator 100 may include an artificial abdomen 110 and a plurality of artificial uteruses 120. Each artificial uterus may have a different size or a different stiffness, which may enable different medical conditions to be simulated. For example, a first artificial uterus having a first size may compress the artificial abdomen to a first degree, resulting in a first stiffness of the artificial abdomen. A second artificial uterus having a second size may compress the artificial abdomen to a second degree, resulting in a second stiffness of the artificial abdomen. Accordingly, the device may be utilized to simulate a variety of health conditions, which may enable healthcare professionals to be more effectively trained when compared to conventional techniques and devices.

[0030] Figure 2 illustrates a flowchart depicting a method according to an example embodiment of the present disclosure. It will be understood that each block of the flowcharts and combination of blocks in the flowcharts may be implemented by various means. Accordingly, blocks of the flowcharts support combinations of means for performing the specified functions and combinations of operations for performing the specified functions. [0031] Figure 2 is a flowchart of a method for use of an artificial abdomen in diagnosing medical conditions. As shown at 210, an artificial abdomen is formed of a deformable material. This allows the abdomen to be subject to palpation as is common for medical practitioners in diagnosing medical conditions. The artificial abdomen receives therein an artificial uterus as shown at 220. The artificial uterus is controlled between a contracted state and an expanded state at 230. This may be performed, for example, in response to user input.

[0032] Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. An apparatus comprising: an artificial abdomen formed of a deformable material; and an artificial uterus disposed within the artificial abdomen, wherein the artificial uterus is configurable between a contracted state and an expanded state.

2. The apparatus of claim 1, further comprising: a pump; a fluid conduit; and a fluid reservoir, wherein the pump pumps fluid between the fluid reservoir and the artificial uterus to change the artificial uterus between the contracted state and the expanded state.

3. The apparatus of claim 2, further comprising a power source, wherein the power source powers the pump to pump the fluid.

4. The apparatus of claim 3, further comprising a controller, wherein the controller is configured to receive user input and to command the pump to pump fluid to and from the artificial uterus in response to the user input.

5. The apparatus of claim 4, wherein the artificial uterus is removable from the artificial abdomen through an access panel.

6. The apparatus of claim 5, wherein the artificial uterus is connected to the fluid conduit by a quick disconnect fitting.

7. The apparatus of claim 6, wherein the artificial uterus is replaceable.

8. The apparatus of claim 1, wherein the artificial abdomen is covered, at least in part, by silicone rubber.

9. The apparatus of claim 8, wherein the artificial abdomen further includes a silicone gel fill between the silicone rubber and the artificial uterus.

10. The apparatus of claim 9, wherein the artificial uterus is palpable through the silicone rubber and silicone gel fill.

11. A method comprising: forming an artificial abdomen of a deformable material; receiving within the artificial abdomen an artificial uterus; and controlling the artificial uterus between a contracted state and an expanded state.

12. The method of claim 11, further comprising: pumping fluid between a fluid reservoir and the artificial uterus via a fluid conduit using a pump to change the artificial uterus between the contracted state and the expanded state.

13. The method of claim 12, further comprising: providing power to the pump from a power source to pump the fluid.

14. The method of claim 13, wherein controlling the artificial uterus between a contracted state and an expanded state comprises: receiving user input; and commanding the pump to pump fluid to and from the artificial uterus in response to the user input.

15. The method of claim 14, further comprising: accessing the artificial uterus through an access panel in the artificial abdomen for removal.

16. The method of claim 15, further comprising: connecting the artificial uterus to the fluid conduit by a quick disconnect fitting.

17. The method of claim 16, further comprising: replacing the artificial uterus with another artificial uterus of a different size.

18. The method of claim 11, further comprising: covering the artificial abdomen, at least in part, with silicone rubber.

19. The method of claim 18, further comprising: filling a space between the silicone rubber and the artificial uterus with a silicone gel fill.

20. The method of claim 19, further comprising: palpating the artificial uterus through the silicone rubber and silicone gel fill.