WO2024200897A1 - Uterine atony simulator - Google Patents

Abstract

The invention relates to a uterine atony simulator formed by a rigid body inserted into a cavity of a flexible body with a configuration that simulates bleeding by introducing tubes into the rigid body and which, by mean of the inclusion of a tensioner inserted into the flexible body secured to a frame, enables the flexible body and the rigid body to be suspended. The invention provides an effective, reusable and economical means to reproduce anatomy and real bleeding and allows training, with active flow, on up to three gynaecology techniques: intrauterine balloon insertion; haemostatic suturing; and ligaturing of the uterine vessels. When the techniques are performed correctly, bleeding is stopped autonomously by the collapse of the tubes. In addition, the parts that may be damaged during the simulation can be easily replaced at low cost.

Description

Uterine atony simulator

OBJECT OF THE INVENTION

The present invention relates to a uterine atony simulator that provides a device for use in healthcare training, and which stands out for its reusable and economical nature, which provides an effective means for active flow training of up to three different gynecological techniques, namely: the placement of an intrauterine balloon, the placement of hemostatic sutures in the uterine thickness and the possibility of performing ligatures on blood vessels.

Advantageously, the uterine atony simulator allows, due to the arrangement and composition of its elements, to reproduce bleeding through the introduction of ducts, mimicking a real anatomical and functional model of uterine atony, being effective for repetitive training of the techniques previously described, and allowing the replacement of its components in case of damage, in a simple and low-cost manner.

BACKGROUND OF THE INVENTION

In recent years, the use of simulation as a learning tool in the field of medicine is increasingly taking on a prominent place. Simulation thus enables training in techniques in a safe and real-life environment, thereby improving the skills of professionals and the results in clinical practice.

In the field of obstetrics, there are several emergency situations that, although rare, require optimal and diligent management for their correct resolution. In this sense, postpartum hemorrhage (also known by its acronym PPH) is an obstetric emergency in which excessive bleeding occurs after delivery. It is a rare situation, but according to the World Health Organization (WHO), it represents one of the main causes of maternal mortality worldwide. Therefore, it is essential to have simulation models that allow training in techniques for the resolution of postpartum uterine bleeding. This training, based on repetition in a safe environment, allows the learning of technical skills to be able to perform them with the greatest possible success in an emergency situation. In addition, due to the low incidence of postpartum haemorrhages, it is even more necessary for obstetricians to carry out periodic practices as a form of ongoing training, as well as for doctors in training to learn them in simulators to be prepared to face a real situation. In this sense, the Spanish Society of Gynecology and Obstetrics (SEGO) recommends the periodic simulation of obstetric situations that are rare but have a great impact on maternal-fetal morbidity and mortality, such as postpartum haemorrhage.

That said, uterine atony is the most common cause of postpartum hemorrhage, and it is possible to resolve hemorrhage secondary to uterine atony using techniques such as insertion of a tamponade or intrauterine balloon, using capitonnage sutures or ligation of the pelvic blood vessels.

There are currently high-fidelity, high-cost advanced simulators on the market that allow training in the management of postpartum haemorrhage. These are complex modules that are marketed and require the purchase of modules from the company itself, made from materials that are susceptible to breakage, that require replacements and meticulous maintenance, and that usually only allow them to be used as modules of a specific simulator. All of this means that their availability is not viable for all audiences, and if purchased, they are usually installed in a simulation laboratory, and due to their high cost, only a small number of units can be purchased, so they must be shared among several students.

On the other hand, the applicant of the present invention is not aware of the existence on the market of simple simulators that allow, with active flow, training and confirming the proper performance of the hemostatic technique (compression sutures and insertion of intrauterine hemostatic balloons) in the management of postpartum hemorrhage secondary to uterine atony.

For all the above, the need is detected to develop a simulator for individual and repeated practice of postpartum hemorrhage situations with uterine atony, which is configured with low-cost, easy-to-acquire and reusable elements, and which simultaneously offers the possibility of practicing the insertion and placement of an intrauterine hemostatic balloon as well as training the performance of uterine compression sutures, even maintaining an active intracavitary flow that responds to the performance of the techniques and that ceases after their correct execution. DESCRIPTION OF THE INVENTION

The present invention allows to solve the problem described above, since it offers a simple, useful and economically accessible simulator, structurally and functionally similar to a real scenario, which allows the training of techniques for resolving postpartum hemorrhage in a specific clinical scenario: active hemorrhage secondary to uterine atony.

Thus, the simulator that is recommended is made up of

A frame preferably with an opening at the top and on its front face.

A flexible body with an interior cavity and at least two holes that allow communication with the interior cavity. Preferably, the flexible body has walls surrounding the interior cavity, which have a preferred thickness of between 2 cm and 4 cm, and a density of between 20 kg/m ³ and 30 kg/m ³ , the flexible body preferably being made of foam rubber, ethylene vinyl acetate (EVA rubber) or a material with similar characteristics.

- A rigid body, which is housed in the inner cavity of the flexible body, which has at least three openings, where one opening - the largest one - is connected to a tube arranged through one of the holes in the flexible body. Said tube hermetically connects said opening of the rigid body with the outside and is fixed to the frame.

A tensioner inserted into the flexible body, such that the ends of the tensioner are anchored in at least two points of the frame at a height above the point at which the opening of the rigid body is fixed to the frame, the opening being located in a lower plane with respect to the rest of the rigid body, and the flexible body and the rigid body remaining suspended.

- At least two flexible-walled conduits that can be collapsed under external pressure, for the entry of liquid into the simulator, such that the end of the conduits is located inside the rigid body. Optionally, one of the conduits directly accesses the rigid body, preferably laterally, and the other conduit runs through the space delimited between the flexible body and the rigid body, accessing the interior of the rigid body through its upper part. The advantage of the developed simulator is that it allows the technical skills to be trained to be performed in the presence of an active flow. This is achieved thanks to the ducts that direct the liquid into the simulator, since from a container of liquid placed on the simulator, the flow descends due to hydrostatic pressure and circulates inside the rigid body, passes through the tube and exits through the front opening of the frame. It should be understood that the aforementioned liquid may be colored serum that simulates bleeding.

Thus, when the techniques to be trained are performed correctly, through compression, this flow will yield autonomously due to a pressure system when the ducts collapse, with the simulator itself confirming that they have been performed correctly.

This is why the rigid body that forms the simulator has at least three openings, two of which allow the ducts with liquid to enter through, simulating bleeding, while the third opening, which is larger, is connected to the tube arranged by one of the holes in the flexible body, through which the insertion of an intrauterine hemostatic balloon is allowed.

On the other hand, the flexible body simulates the atonic uterus and allows a compressive or capitonnage suture to be performed on it, compressing the ducts from the outside when performing it.

Additionally, the frame is preferably integrated by a container with a complete opening on the upper face - that is, the face opposite to the face on which the frame rests on the work surface - and has a recess on its front face where the tube that screws onto the rigid body is fixed, so that, despite the flexible body and the rigid body remaining suspended, the assembly has a stability that even makes it possible during suturing techniques to turn the flexible body over to perform sutures on the rear surface.

The flexible body preferably has dimensions between 20 and 25 cm in length, a width of between 16 and 18 cm and a total thickness of between 6 and 8 cm, so that it has the dimensions of a real postpartum uterus. The body is flexible in the sense that it is composed of a material that returns to its original shape when a deforming force applied to it ceases, a definition that also applies to elastic or elastically deformable bodies; this material also allows plication sutures to be made on it and can be reused for multiple purposes.

Thus, the end of the flexible body is positioned coincidentally with the opening of the body rigid in a lower plane is narrower to simulate the isthmus and the uterine cervix, while the opposite end of the flexible body is wider simulating the uterine fundus.

The tube connects the rigid body to the outside, with a preferred angle of inclination of 30 ^e and represents the vagina with great similarity to a real situation for the insertion of the intrauterine balloon.

On the other hand, the tensioners hold the flexible body to the frame. Each one fixes it from the anterosuperior edge of the flexible body simulating the round ligaments of the real anatomy, which allows the flexible body to be mobilized as occurs in clinical practice. From the posterosuperior faces of the flexible body, two appendages or structures preferably made of ethylene vinyl acetate (EVA rubber) extend like fallopian tubes, to give greater realism to the structure and also to make it more difficult to perform the sutures as in a real situation.

The detailed configuration of the developed simulator allows training the following technical skills:

Insertion and placement of an intrauterine tamponade or balloon (Foley catheter, Sengstaken-Blakemore® catheter or Bakri® balloon).

Performing hemostatic or capitonnage sutures (plication techniques of the B-Lynch or Hayman types).

Performing ligatures on the uterine vessels.

As previously indicated, if the techniques are performed properly, the discharge of fluid stops, simulating the stopping of uterine bleeding.

For all the above, the configuration of this simulator offers the following advantages:

Low cost of the components that comprise it.

- Accessible material, with replacement parts for the components that make up the simulator being affordable and economical.

It allows you to train up to three different technical skills on the same device.

- Reusable nature, so that the simulator allows multiple uses, both repeatedly by the same student and to be used in different training workshops. - It does not require any special maintenance, electricity for its operation or complex assembly.

It allows training with an active flow of artificial blood, the volume of which can be easily controlled, and it is even possible to select the location where the active flow is desired to be present depending on the technical skills to be practiced.

It allows estimating the lost flow from the amount of serum that is loaded for entry to the simulator.

It allows for objective and independent verification that the technique for managing hemorrhage has been performed correctly, since bleeding stops at that moment if the uterine suture is performed correctly, if the intrauterine balloon has been inserted correctly or if the blood vessels have been correctly ligated.

Given its ease of manufacture and low cost, it allows for individual training with a device for each student.

In short, the advantageous configuration, composition, low cost and easy access of the simulator of the invention allows each student to have his or her own simulator, enabling individual training, and it is even possible to remove the suture after practice, allowing the flexible body to recover its initial shape and consistency for reuse. Likewise, after the use of the intrauterine balloon, its removal does not affect the shape of the simulator and it will be ready for reuse.

BRIEF DESCRIPTION OF THE DRAWINGS

To complement the description that will be made below and in order to help better understand the characteristics of the invention, in accordance with a preferred example of its practical implementation, a number of figures are included as an integral part of said description, in which the following have been represented for illustrative and non-limiting purposes:

Figure 1 shows a top perspective view of part of the elements that form the uterine atony simulator according to a first preferred embodiment of the present invention, without the ducts being represented therein.

Figure 2 shows a side view of part of the elements that form the simulator of the invention according to the preferred embodiment represented in the previous figure, Specifically, the following can be seen: the frame, the flexible body, one of the tensioners and a portion of the tube that connects the rigid body to the outside.

Figure 3 shows a top view of the simulator represented in accordance with the preferred embodiment of the present invention, where the following have also been represented: the circulation of the flow through the ducts and the intrauterine balloon arranged to show the practice of placing said technique.

Figure 4 shows a top view of the simulator represented in accordance with the preferred embodiment of the present invention, where the following have also been represented: the circulation of the flow through the ducts and the quilting suture, similar to how it would be performed during the practice of said technique.

Figure 5 shows a top view of the simulator represented in accordance with the preferred embodiment of the present invention, where the following have also been represented: the circulation of the flow through the ducts and the ligatures of the uterine vessels.

PREFERRED EMBODIMENT OF THE INVENTION

The figures shown illustrate a preferred embodiment of the invention in which the uterine atony simulator is formed by the following elements:

A flexible body (1), preferably made of foam rubber, with an interior cavity and at least two holes (2) and (2') that allow communication with the interior cavity.

A rigid body (3), which is housed in the inner cavity of the flexible body (1), which has three openings, where the opening (3') is connected to a tube (10) and arranged in a passing manner through one of the holes (2') of the flexible body (1), so that the tube (10) opens into the front recess (10') of the frame (5) on which the tube (10) is fixed.

A tensioner (4) inserted on each side of the flexible body (1), such that the ends of the tensioner (4) are anchored at two opposite points of the frame (5), at a height above the point at which the opening (3') of the rigid body (3) is fixed to the frame (5), the opening (3') being located on a lower plane with respect to the rest of the rigid body (3), and the flexible body (1) and the rigid body (3) remaining suspended.

A frame (5) that is integrated by a container with a complete opening on the upper face and emptied (1 O') on its front face (5'), the container being defined by four side walls, such that in the emptied (10') the tube (10) that comes from the rigid body (3) is fixed, while in the two side walls adjacent to the front face (5') the ends of the tensioner (4) are anchored, remaining fixed in two opposite points of the container.

A set of four conduits (6), (7), (8) and (9) with flexible walls that are easily collapsible under external pressure, preferably between 3 and 5 mm in diameter, which optionally includes independent valves (13) that control the entry of liquid into the simulator.

Figures 1 and 2 represent a preferred embodiment of the simulator of the invention, without including the preferred arrangement of the ducts (6), (7), (8) and (9).

On the other hand, Figures 3, 4 and 5 represent the preferred embodiment of the invention in which the simulator is provided with a total of four conduits (6), (7), (8) and (9) for the entry of liquid, which simulate the right and left uterine artery and vein.

Thus, the termination of the ducts (6), (7), (8) and (9) with a flexible wall that can collapse under external pressure is located inside the rigid body (3), so that two of the ducts (7) and (9) penetrate directly and laterally - preferably through the lower-lateral region thereof - into the flexible body (1) and into the rigid body (3) and have their termination inside the rigid body (3); while the other two ducts (6) and (8) penetrate laterally into the interior of the flexible body (1) in the same way as the previous ones (through the lower-lateral region of the flexible body), run through the space delimited between the flexible body (1) and the rigid body (3) and run upwards through the space delimited between the interior of the flexible body (1) and the exterior of the rigid body (3), their termination being located inside the rigid body (3) which they enter through its upper end.

Likewise, the simulator includes appendages (14) arranged on the posterosuperior lateral faces of the flexible body (1) that represent the fallopian tubes and are preferably made of ethylene vinyl acetate (EVA rubber), giving the simulator of the present invention greater realism and closeness to the anatomy of the female reproductive system.

Preferably, the flexible body (1), which includes an inner cavity, is formed by a sheet of foam rubber folded over itself, with the edges completely joined together. except in the area of the holes (2) and (2'). In this way, from the aforementioned plate joined by its sides, for example, by means of an adhesive, the flexible enveloping body is generated that surrounds the rigid body (3), which enables a suitable foam surface for the performance of technical skills such as, for example, suturing.

As shown in Figure 2, the simulator includes a tensioner (4) inserted into the flexible body (1), its ends being anchored to the frame (5) at two points opposite each other. Preferably, the material that integrates the tensioner (4) is an elastic material. Thus, the flexible body (1) that simulates the uterus is positioned obliquely at the upper end, allowing the direction of the active flow to be defined to enable its exit through the lower-front part of the wall (5') of the container, as can be seen in Figure 2.

As seen in Figure 3, the uterine atony simulator of the present invention allows the presence of active bleeding from the liquid stored in a bag (15) which flows through the four ducts (6), (7), (8) and (9), and whose circulation is easily controlled by the opening-closing keys (13).

These ducts (6), (7), (8) and (9) form an infusion system that allows simulating active bleeding that occurs due to the difference in hydrostatic pressure (free fall) from the liquid, which can be a coloured serum to simulate bleeding, which is placed on the simulator in a bag (15), which is regulated by the keys (13) that allow the flow speed to be modified and/or stopped if desired.

Therefore, the fluid introduced through the ducts (6), (7), (8) and (9) allows simulating active bleeding from the uterine cavity.

On the other hand, the rigid body (3) has two openings, with one of the ducts of the first pair of ducts (7) and (9) inserted into each of them to inject liquid into the interior of the rigid body (3), simulating bleeding. On the other hand, the flexible body (1) simulates an atonic uterus with an orifice (2') that simulates the opening of the uterine cervix. In this way, during the practice of inserting and placing an intrauterine balloon, the student introduces said intrauterine balloon through the orifice (2') of the flexible body (1) through the orifice (10') of the tube (10) that allows access to the interior of the rigid body (3).

As shown in Figure 3, when the intrauterine balloon is correctly positioned, Once introduced through the cervical canal into the rigid body (3), the student proceeds to fill it and by compression the ducts (7) and (9) collapse (against the walls of the rigid body), stopping the bleeding at the moment that the student has correctly completed the technique.

The usual models of intrauterine balloon (11) consist of a drainage tube (12), such that the balloon (11) is placed in the internal cavity defined by the rigid body (3), and the drainage tube (12) is placed passing through the interior of the opening (3') or nozzle of the rigid body (3) and through the tube (10) that simulates the cervical canal, as seen in figure 3.

On the other hand, as observed in figure 4, the foam rubber material used for the flexible body (1) allows the training of compressive uterine sutures (16) using straight and/or curved needles and synthetic absorbable thread, training that is performed while an active flow (or bleeding) occurs, and said flow ceases if the sutures are performed with adequate compression and tension, and manage to coapt the ducts (6) and (8) against the external walls of the rigid body.

Furthermore, as shown in Figure 5, if the above does not stop the bleeding, the simulator of the present invention allows training the third technique described and practicing the ligation (17) with suture of the ducts (6), (7), (8), and (9) preventing the passage of flow through them, and stopping the bleeding.

For all the above, the simulator of the invention does not require an external control that modifies the uterine tone, but the presence of a continuous flow simulates vascularization, and the flexible body (1) simulates an atonic uterus. Thus, bleeding is resolved autonomously and independently when the flexible body (1) and the corresponding ducts are compressed, after adequately performing the hemostatic techniques, as shown in figures 3, 4 and 5. This allows self-assessment in an objective way and strengthens learning.

Claims

R E I V I N D I C A T I O N E S 1 ^a .- Uterine atony simulator characterized by comprising the following elements: A frame (5) A flexible body (1) with an interior cavity and at least two holes (2) and (2') that allow communication with the interior cavity, - A rigid body (3), which is housed in the inner cavity of the flexible body (1 ), which has at least three openings, where one opening (3 ') is connected to a tube (10) arranged through one of the holes (2 ') of the flexible body (1 ), A tensioner (4) inserted in the flexible body (1 ), so that the ends of the tensioner (4) are anchored in at least two points of the frame (5) at a height above the point where the opening (3 ') of the rigid body (3) is fixed to the frame (5), the opening (3 ') being located in a lower plane with respect to the rest of the rigid body (3), and the flexible body (1 ) and the rigid body (3) being suspended, - At least two flexible wall conduits collapsible under external pressure, for the entry of liquid into the simulator, so that the end of the conduits is located inside the rigid body (3), where the conduits access through two of the openings of the rigid body (3) to inject liquid into the interior of the rigid body (3), simulating bleeding, while the flexible body (1) simulates an atonic uterus to carry out the haemostatic capitonnage sutures and the insertion of an intrauterine balloon through one of the holes (2'). 2 ^a .- Simulator, according to claim 1 ^a , characterized in that one of the conduits directly accesses the rigid body (3) and the other conduit runs through the space delimited between the flexible body (1) and the rigid body (3), the end of the conduits being located inside the rigid body (3). 3 ^a .- Simulator, according to claim 1 ^a or 2 ^a , characterized in that it has two additional ducts, such that two ducts (7) and (9) penetrate directly into the flexible body (1 ) and into the rigid body (3) accessing laterally, their terminations being arranged inside the rigid body (3), while two ducts (6) and (8) penetrate laterally into the flexible body (1 ), traveling through the space delimited between the flexible body (1 ) and the rigid body (3) before accessing the interior of the rigid body (3) through its upper end. 4 ^a.- Simulator, according to claim 1 ^a , characterized in that the flexible body (1) has walls surrounding the interior cavity, which have a thickness of between 2 cm and 4 cm, and a density of between 20 and 30 kg/m ³ . ^5.- Simulator, according to any of the preceding claims, characterized in that the flexible body (1) is made of foam rubber or ethylene vinyl acetate (EVA rubber). ^6th.- Simulator, according to any of the preceding claims, characterized in that the flexible body (1), which includes an interior cavity, is formed by a sheet of foam rubber folded over itself, the edges being joined in their entirety except in the region of the holes (2) and (2'). 7 ^a.- Simulator, according to claim 1 ^a , characterized in that the ends of the tensioner (4) inserted in the flexible body (1), are anchored to the frame (5) at two opposite points. 8 ^a.- Simulator, according to claim 1 ^a and 7 ^a , characterized in that the tensioner (4) is made up of an elastic material. 9 ^a.- Simulator, according to claim 1 ^a , characterized in that the frame (5) has a recess (10') on which the tube (10) is fixed, such that the tube (10) has a preferred angle of 30 ^e . 10 ^a .- Simulator, according to claim 1 ^a , characterized in that the frame (5) is integrated by a container with a complete opening on the upper face and an emptying (10') on its front face (5'), the container being defined by four side walls, such that the tube (10) is fixed in the emptying (10'), while the ends of the tensioner (4) are anchored in the two walls adjacent to the front face (5'), remaining fixed in two opposite points of the container. 1 1 ^a.- Simulator, according to claim 1 ^a , characterized in that the conduits with flexible walls that are collapsible under external pressure have a diameter of between 3 and 5 mm, each conduit being provided with a key (13) to control the entry of liquid into the simulator.