Modular simulator system for nursing care of a patient with a tracheotomy

Abstract

The present invention relates to a modular simulator system for teaching and training nursing care of people with a tracheotomy. The modular simulator system provides realistic anatomical structures with a range of simulated difficulty levels for the manipulation of a tracheotomy cannula and comprises a phantom and a set of replaceable modules that can be inserted in a receiving cavity located in the front portion of the neck of the phantom. The replaceable modules comprise a simulated stoma in direct communication with a simulated trachea with a soft front layer that simulates skin, the simulated trachea comprising an inlet opening with a perimeter contour that defines an access lumen in direct communication with the simulated stoma. Said perimeter contour comprises at least one protuberance that at least partially blocks the access lumen for access to the simulated stoma in order to simulate a defect in the skin that hinders the passage of the tracheotomy cannula.

Description

[0001] MODULAR SIMULATOR SYSTEM FOR NURSING CARE OF A PATIENT WITH TRACHEOSTOMY

[0002] DESCRIPTIVE MEMORY

[0003] The present invention is applicable in the medical field and in teaching or training; more specifically, it relates to a simulation system for teaching and training in nursing care for people with tracheostomies, such as cleaning, removing and replacing the tracheostomy tube, and sputum aspiration.

[0004] DESCRIPTION OF PRIOR ART

[0005] A tracheostomy is a surgical procedure performed to create an opening within the trachea through an incision below the cricoid cartilage, with the insertion of a tube or cannula to facilitate air passage into the lungs. The indications for tracheostomy are basically: upper airway obstruction, prolonged endotracheal intubation, facilitating aspiration of bronchial secretions, and the need for mechanical ventilation.

[0006] On the other hand, a tracheostomy refers to the artificial opening, commonly known as a stoma, created at the base of the neck to create a patent airway. It consists of a connection between the trachea and the outside, permanently and circumferentially sutured to the skin of the front of the patient's neck, with the stoma being the only airway.

[0007] The tracheostomy tube inserted into the stoma is a hollow tube made of various materials that connects the outside airway to the patient's lower airway, specifically the upper portion of the trachea. It also allows the tracheostomy opening to remain open, especially in the first few weeks when the tissue around the opening is still healing.

[0008] In the case of cannulas for adult use, they typically consist of two tubes fitted inside each other. The outer tube, or external cannula, makes contact with both the skin and the trachea; a strap is placed around it and secured to the patient's neck to prevent accidental dislodgement (due to detachment or displacement). The inner tube, called the internal cannula or endocannula, makes contact only with the lumen of the external cannula, and allows air and tracheobronchial secretions to pass through it. Cannulas can vary in thickness and length depending on the patient and the specific application.

[0009] In the case of pediatric tracheostomy tubes, these typically do not include an endocannula, but rather a single tube with different dimensions: internal diameter (ID), external diameter (OD), and length; the larger the ID, the longer and wider the tube.

[0010] For patient well-being, it is necessary to keep tracheostomy tubes clean to prevent infections and free of obstructions to avoid blockages and, consequently, respiratory problems.

[0011] After a patient has a tracheostomy, they will receive care from the healthcare team for the first few days. However, once discharged, the patient, their caregivers, or family members will need to learn the different care procedures, such as cleaning, removing, and replacing the tracheostomy tube.

[0012] The aforementioned implies that, both for the training of healthcare personnel and for the instruction of patient caregivers at home, it is necessary to perform each of the care procedures in a realistic manner, so that they can face possible scenarios, understand the tactile sensations to be expected when removing or inserting the cannula into the stoma, and what maneuvers should be avoided to reduce the risk of injury to stoma-related tissues. The problem is that the only way to practice in real-life scenarios or learn how to perform the procedure is to do it on a real patient.

[0013] In this sense, simulation plays a leading role as a learning method; being able to properly teach a patient or their caregiver how to perform care procedures, without having to do so on a real patient, is highly desirable to accelerate the patient's independence from hospital services or healthcare providers.

[0014] Perhaps one of the most basic simulation methods known is the use of a full-body doll with a perforation in the neck area, as exemplified in document CN201556335U published on August 18, 2010. The main disadvantages of these types of solutions are that they do not offer realistic stoma and tracheal structures, but rather only refer to a perforation with a life-size diameter, not a realistic shape.

[0015] The truth is that, in a real-life setting, stomas are not made in a single size, but can be made in different sizes depending on the patient's age and in accordance with the existing cannula sizes for each age group. Therefore, solutions with a single stoma size would require the purchase of several phantoms of different sizes, at least some for training cannula care procedures in children and others for adults, which would increase the cost of implementing a simulation unit to teach healthcare personnel, patients, or patient caregivers.

[0016] On the other hand, some simulators with phantoms are known that have replaceable parts that simulate the neck and trachea area, as can be seen in documents US2022246062A1 published on 08 / 04 / 2022, referring to an Airway Operation Simulation Device for Emergency Surgical Operation; and in US9679501 ​​published on 06 / 13 / 2017 referring to a Device for Cricothyroidectomy Simulation.

[0017] The solution given in said documents, as in many others present in the prior art, have replaceable parts because they aim at the replacement of the entire simulated organ and the simulated skin, given that they are oriented to the teaching and practice of the tracheostomy surgical procedure, that is, they are configured to practice the surgery that forms the stoma to install the tracheostomy tube in a patient; therefore, it involves the simulation of incisions, openings of the different layers that simulate the neck area, intervention of the simulated cricoid cartilage and even suturing in the phantom materials; so the pieces that have been cut or intervened in order to carry out the simulation of the surgery are unusable and must be replaced by new material that allows a new tracheostomy to be performed.Simulated practice of caring for a patient with a tracheostomy requires the use of an existing simulated stoma. This allows trainees, laypeople, family members, or caregivers to practice removing and replacing a tracheostomy tube. This means that they do not need to form the stoma, as is the case with surgical simulators.

[0018] The simulators known in the state of the art, intended solely for the practice of stoma care tasks, have several shortcomings, one of which is that they do not solve the problem of simulating, in an economical manner, a variety of stoma sizes. Instead, to have at least two sizes, to practice the replacement of cannulae in children as well as in adults, two independent phantoms are required, because existing solutions provide a single stoma. An example of this is seen in US2007218438A1 published on 09 / 20 / 2007, which describes educational material to simulate the placement of tracheostomy cannulas and airway care, where the phantom includes a head and neck, and the provision of a single type and size of stoma in the neck area.

[0019] Another factor that is not addressed by state-of-the-art solutions for training medical staff or patient caregivers is that in reality, the shape of the stoma, specifically the shape and condition of the leading edge, does not always remain the same over time, but can vary due to fairly common complications that occur in the stomas of patients who have had a tracheostomy for some time, which is the formation of ulcers, keloids, hypertrophic scars or peristomal granulomas in the skin surrounding the stoma.

[0020] Granulomas are lesions composed of multiple bumps. They can form around the circumference of the stoma, encompassing part or all of its contour. They are painful, have irregular edges, can cause redness and frequently bleeding, and even skin loss. These granulomas can be caused by the persistence of suture material, persistent skin trauma resulting from frequent cannula changes, very abrasive cleaning, pulling out the tube, etc. Granulomas can also be caused by continued irritation of the stoma mucosa, in which case they are inflammatory pseudopolyps around the circumference of the stoma.

[0021] Keloids and hypertrophic scars are alterations in wound repair, characterized by excessive connective tissue synthesis in response to trauma, sciatica, burns, and inflammation. Keloids and hypertrophic scars are pathological stages of the same physiological process and correspond to fibrous tumors arising from excessive collagen and ground substance deposition. Keloids are distinguished from hypertrophic scars in that they extend beyond the original wound and rarely regress, while hypertrophic scars are limited to the wound site and tend to disappear over time.

[0022] Both granulomas, as well as keloids and hypertrophic scars, cause the skin to thicken and become elevated, making the stoma entry contour irregular. Therefore, their presence requires greater care when handling the cannula in the patient's stoma.

[0023] As can be seen, the contour of the stoma entry rarely remains intact over time. In fact, patients with irregular stomas have been seen; other cases of strictures with keloid scarring, in which recannulation is very difficult to achieve; and other cases where granulomas have become injured and begin to bleed, often requiring emergency care. These injuries, being so common, challenge the learning processes of healthcare personnel and caregivers of patients with tracheostomies. Therefore, it is necessary to have a versatile, economical, and easy-to-use solution that allows simulating various real-life scenarios that may be encountered in these types of patients. This allows both caregivers and healthcare personnel to acquire knowledge, skills, and improved response in emergency situations related to the nursing care of people with tracheostomies.

[0024] GENERAL DESCRIPTION OF THE INVENTION

[0025] The present invention relates to a simulation system for teaching and training in nursing care for patients with tracheostomies; specifically, for teaching and training in various care procedures, such as tracheostomy tube removal and replacement, and sputum aspiration in such patients.

[0026] One of the objectives of the invention is to provide a realistic simulation system that allows training in different types of care and allows the acquisition of skills prior to performing procedures on real patients.

[0027] Another objective of the invention is to provide a versatile yet cost-effective simulator system that allows simulating different levels of difficulty that a user may encounter in the actual practice of tracheostomy patient care procedures, without having to purchase a complete simulator for each situation.

[0028] Another objective of the invention is to provide a simulator system that allows easy handling, assembly and disassembly, to be used by all types of users, whether trained medical personnel who teach nursing care related to the tracheostomy cannula, as well as medical personnel in training, caregivers or relatives of patients who assist them at home.

[0029] The present invention essentially relates to a modular system comprising a phantom that simulates real upper structures of a patient's head, neck, and upper thorax; and a set of replaceable modules that simulate real stoma structures with different morphological characteristics.

[0030] The phantom can simulate body parts according to different types of patients, such as newborns, infants, or adults; and preferably comprises an upper portion of the thorax, attached to a neck, and at least the lower portion of the head and face. Said phantom also comprises a receiving cavity in the front of the neck, where the various modules that make up the aforementioned set of replaceable modules can be inserted.

[0031] The present invention addresses the problem of simulating the different levels of difficulty that a user may face in the actual practice of tracheostomy patient care procedures, by providing the set of replaceable modules that simulate different abnormal anatomical characteristics in the stoma, which complicate the manipulation of the cannula, in order to generate different levels of difficulty in training in the care of a tracheostomy patient. The replaceable modules comprise a simulated trachea having an upper end and a lower end, and a simulated stoma with an outer end and an inner end that is in internal communication with said simulated trachea.Both elements, the simulated trachea and stoma, are inserted into an internal block, made of solid material, but with a soft texture, which simulates the cartilaginous tissue that normally surrounds the trachea and stoma, so that the user perceives the texture and resistance of tissues similar to real ones while training.

[0032] This internal block simulating cartilage tissue is contained within a rigid outer casing to allow manipulation of the modules and, specifically, to allow easy insertion into the receiving cavity present in the phantom.

[0033] Furthermore, this rigid casing is made up of perimeter walls that create an internal cavity containing the aforementioned internal block. The casing comprises a front face provided with a soft front layer that simulates skin and is in direct contact with the internal block made of soft material. This soft front layer, which simulates skin, has a shape and texture that imitates the anatomy of the front of the user's neck and comprises an entrance opening that simulates the entrance to a real stoma. The opening comprises a contour that defines an access lumen in direct communication with the outer end of the simulated stoma of the internal block.

[0034] During nursing care training, a tracheostomy tube is inserted through the lumen of the inlet opening to pass through the stoma and reach the simulated trachea. Both the simulated stoma and the simulated trachea have a realistic shape, imitated from a CT scan of a real patient.

[0035] Thus, in order to provide a versatile simulation system, which allows the user to train in different scenarios with different degrees of difficulty, the present invention proposes that the different replaceable modules comprise a particular difficulty, so that using a single phantom, for example simulating the anatomy of a child, said modules can be exchanged to offer different possible scenarios that the user could encounter in the actual practice of nursing care of a patient with a tracheotomy.

[0036] These particular difficulties present in the various replaceable modules are preferably located in the contour of the inlet opening present in the soft front layer that simulates skin; the contour of the inlet opening may comprise different sizes and / or shapes that simulate a deformation that makes it difficult to insert the tracheostomy cannula through the access lumen, which is in direct communication with the outer end of said simulated stoma of the internal block.

[0037] The inlet opening may comprise an irregular contour with at least one protrusion that interferes with the lumen of access to the stoma, simulating, for example, stomas of real patients who develop granulomas or keloids at the inlet opening.

[0038] The simulated protrusions are made of the same material as the soft, skin-like front layer, so that the user in training can perceive the real sensation of manipulating the cannula on a patient. The simulated protrusions can be solid, yet soft in texture, for example, to simulate keloids, so that the opening can change from having a flat, circular contour to an irregular, bulging contour.

[0039] The simulated bumps can be bumps with a hollow body made of the same material that makes up the soft front layer that simulates skin, but with a thin thickness, so that it is vulnerable and breaks with excessive friction, and that contain a spillable fluid inside, to simulate the exudation of a wounded or damaged bump during practice, as happens in reality with granulomas that frequently break due to friction with the cannula and bleed.

[0040] The objective of the simulated protuberances is that, during training, they at least partially obstruct the access lumen to the simulated stoma, according to different degrees of complexity that are possible to occur in reality; for example, a low difficulty could be given by an inlet opening with a flat, non-circular, but oval contour; a medium difficulty could be given by an inlet opening with an irregular contour comprising at least one solid protuberance partially obstructing the access lumen; a high difficulty could be given by an inlet opening with an irregular contour with one or several protuberances of different sizes, where at least one of them is a hollow body with a fluid inside, so that during practice it breaks due to rough handling and the fluid spills out, evidencing its breakage; so that it demands greater care and skill from the practitioner in handling the cannula.

[0041] In one embodiment of the invention, the contour of the inlet opening may have a shape that can be selected from a circular, elliptical, oval, or a combination thereof. In another embodiment of the invention, the contour of the inlet opening may have an irregular shape, that can be selected from a quasi-circular, quasi-elliptical, quasi-oval, or a combination thereof. In yet another embodiment of the invention, the contour of the inlet opening may have a combination of solid protrusions and hollow protrusions filled with a fluid.

[0042] The simulated stoma, both in its initial stages and throughout its internal development, like the simulated trachea, can have different shapes and dimensions to simulate users of different ages, such as newborns, infants, or adults; this configuration can be combined with the different shapes that can be given to the inlet opening.

[0043] Said soft, skin-simulating front layer can be made of a soft, elastic, and smooth textured material; it can be thermoplastic materials, such as polymers or elastomers of varying densities to provide an appearance and feel anatomically similar to the actual skin tissue of a newborn, infant, or adult patient. Preferably, said soft, skin-simulating front layer is made of a room-temperature vulcanizing silicone, such as a silicone known commercially as RTV silicone.

[0044] The inner block is made of a solid but soft material to the touch to simulate the cartilaginous tissue surrounding the trachea and stoma. It can be designed with thermoplastic materials, such as polymers or elastomers of different densities to provide a texture anatomically similar to the solid but soft structure of that real tissue. Preferably, said inner block can be manufactured from high-performance, platinum-based hardening liquid silicone compounds, such as the "Smooth-on" brand silicone, which is widely used in simulating human tissue for special makeup effects and skin effects, known as "Dragon Skin". In turn, said inner block can be made through direct pour molding within the rigid casing.

[0045] In order to facilitate handling and coupling between the replaceable modules and the phantom, the internal block of soft material that has inserts to the simulated stoma and the simulated trachea, is contained in the rigid outer casing, which comprises a front face provided with the soft front layer that simulates skin, so that when the module is inserted into the receiving cavity of the phantom, said soft front layer is level with the surface that forms the neck of the phantom.

[0046] The rigid housing of the module comprises an internal cavity to contain the internal block of soft material; said rigid housing is formed by rigid perimeter walls and a rigid rear wall, where said perimeter walls and the rear wall comprise a smooth and soft exterior surface to favor the sliding of the module inside the receiving cavity in the phantom. The perimeter walls of the rigid housing are flat plates that are arranged orthogonally to each other, and the rear wall is arranged perpendicular to said perimeter walls and in turn, opposite to the front face that is provided with the soft front layer that simulates skin, to form a cubic volume whose shape and dimensions (length, width and height) coincide with the receiving cavity in the phantom.

[0047] The rear edge joining the rigid perimeter walls with the rigid rear wall may be beveled or rounded to facilitate the insertion of the replaceable module into the phantom's receiving cavity; similarly, this cubic shape provides a simple shape that is easy to handle and fit into the phantom cavity.

[0048] In one embodiment of the invention, said simulated trachea forms an integral part of the rigid casing, located within its internal cavity and extending between two of the mutually opposite perimeter walls; where the intersection between the lower end and the upper end of said simulated trachea with said mutually opposite perimeter walls gives rise to lateral openings in the rigid casing.

[0049] The rigid casing contains in its internal cavity the inner block of soft material that simulates cartilaginous tissue and surrounds said simulated trachea; meanwhile, the simulated stoma is a channel formed in the soft material of said inner block, where the inner end of the simulated stoma is in direct communication with the simulated trachea, and its outer end is in direct communication with the entrance opening of the soft front layer that simulates the skin; where this soft front layer is located on the open front face of the casing, remaining in direct contact with the inner block.

[0050] The rigid shell may comprise a pouring opening, optionally available on the rear wall, which is useful in the process of forming the inner block, for pouring the soft material simulating cartilage tissue into the rigid shell.

[0051] The rigid shell can be manufactured using any technique that allows the formation of a hollow laminar body; preferably, the rigid shell is designed using three-dimensional (3D) printing technology from a thermoplastic material, preferably polylactic acid (PLA). The phantom comprises a realistic structure that preferably simulates body parts related to the respiratory tract; it may comprise a partial or total portion of a patient's head, attached to a neck, and this neck attached to a partial or total portion of the upper chest. The phantom can simulate patients of different ages, such as newborns, infants, and adults.

[0052] The phantom is made up of a preferably rigid and hollow structure to lighten its weight and save material, it comprises at least one flat wall to provide stability to the phantom while training is carried out; in a preferred embodiment, the phantom comprises a flat lower wall for support, arranged perpendicular to the craniocaudal axis of the phantom, that is, perpendicular to the vertical axis that runs in the direction of the spine; where this flat lower wall allows the phantom to be positioned on a horizontal surface simulating the position of a patient in an upright or seated state (sitting). The phantom may also comprise a flat rear support wall, parallel to the same craniocaudal axis, which allows the phantom to be supported on a horizontal surface simulating the position of the patient in a supine state (face up).

[0053] In a preferred embodiment of the invention, the phantom comprises, together, the two flat walls, that is, the flat lower wall and the flat rear wall, such that the system allows training to be carried out with the simulated patient in a supine position or in a sitting position with the same phantom, increasing the versatility of the simulator system.

[0054] As mentioned above, the phantom that forms part of the simulator system of the present invention comprises a receiving cavity in the front of the neck for inserting the replaceable modules; said receiving cavity is oriented along the anteroposterior axis of the phantom, and comprises a shape and dimensions (length, width and height) coinciding with the shape and dimensions of the rigid housing of the replaceable modules; preferably, it comprises a cubic shape with an open front face, with a contour matching the contour of the soft front layer that simulates the skin.

[0055] This cubic shape of the receiving cavity is formed by perimeter walls, arranged orthogonally to each other, and by a back wall perpendicular to said perimeter walls and opposite the open front face. At least said perimeter walls of the receiving cavity have a smooth surface to facilitate the sliding of the replaceable modules.

[0056] The bottom wall of the receiving cavity forms part of the flat rear wall of the phantom and comprises a decoupling opening sized to insert at least one finger of the user to push the replaceable module forward and remove it from said receiving cavity to replace it with another module, facilitating the manipulation of the system.

[0057] A lower wall of the receiving cavity comprises a perforation from which extends an inner channel having a lower end, where said perforation engages tightly with the lower end of the simulated trachea of ​​the replaceable modules, to allow the passage of a suction probe introduceable from the stoma and along said trachea.

[0058] The modular simulator system also includes a flexible, fluid-liquefiable inner reservoir, designed to simulate the presence of sputum. This allows the trainee to practice the sputum aspiration procedure often required in patients with tracheostomies, allowing them to insert a tube from the outside through the stoma and simulated trachea to reach the inner reservoir.

[0059] In order to provide realistic anatomical structures, the different components of the present modular simulator system, i.e. the phantom and the replaceable modules, as well as the soft frontal layer, the opening with the protuberances, the stoma and the simulated trachea, can be manufactured based on the reproduction of real anatomical structures from CT scans of real patients, with the creation of a three-dimensional solid digital model and three-dimensional printing of the model using imitation materials close to the real anatomical structures, which allow to have a tactile sensation very similar to reality.

[0060] BRIEF DESCRIPTION OF THE FIGURES

[0061] A detailed description of the invention will be carried out in conjunction with the figures that form an integral part of this presentation, where:

[0062] Figure 1 shows an isometric view of the components of the modular simulator system.

[0063] Figure 2 shows a longitudinal sectional view of a replaceable module that is part of the modular simulator system.

[0064] Figure 3 shows an isometric view of a replaceable module that is part of the modular simulator system.

[0065] Figure 4 shows an enlarged sectional view of a replaceable module, according to one embodiment of the protrusions.

[0066] Figure 5 shows an enlarged sectional view of a replaceable module, according to an alternative embodiment of the protrusions.

[0067] Figure 6 shows a longitudinal sectional view of the rigid housing of a replaceable module that is part of the modular simulator system.

[0068] Figure 7 shows a longitudinal sectional view of the rigid housing with the inner block and the soft front layer, of a replaceable module that is part of the modular simulator system.

[0069] Figure 8 shows an isometric view of a phantom that is part of the modular simulator system, according to one usage mode.

[0070] Figure 9 shows an isometric view of a phantom that is part of the modular simulator system, according to a second mode of use.

[0071] Figure 10 shows a rear isometric view of a phantom and a replaceable module, which are part of the modular simulator system.

[0072] Figure 11 shows a front isometric view of a phantom that is part of the modular simulator system.

[0073] Figure 12 shows a sagittal sectional view of a phantom and a replaceable module fitted into the phantom.

[0074] Figure 13 shows a sagittal sectional view of a phantom and a replaceable module fitted into the phantom, along with a fluid reservoir. Figure 14 shows a longitudinal sectional view of a replaceable module in use, with a tracheostomy tube attached to the stoma and the simulated trachea.

[0075] DETAILED DESCRIPTION OF THE INVENTION

[0076] The invention will now be described in greater detail with reference to the accompanying figures, along with an exemplary embodiment of the sterile container used to hold a penile prosthesis. This embodiment is provided by way of explanation of the invention; however, the implementation of the invention is not limited to this application alone.

[0077] Those of ordinary skill in the art will appreciate upon reading this specification and viewing these drawings that various modifications and variations may be made thereto while maintaining the same inventive concept.

[0078] In a preferred embodiment of the invention, as shown in FIG.l, the present invention relates to a modular simulator system (1) for teaching and training in nursing care of people with tracheostomy, which allows providing realistic anatomical structures with varied levels of simulated difficulty, to practice tasks related to the insertion of a tracheostomy cannula (A) into the stoma of a patient with tracheostomy.It comprises a phantom (20) and a set of different replaceable modules (10) that can be inserted into a receiving cavity (21) present in the phantom (20); said replaceable modules (10) comprise a simulated stoma (11) for introducing a tracheostomy cannula (A), where each of the replaceable modules (10) comprises a simulated stoma (11) of a different configuration to simulate various deformations that may make it difficult to introduce the tracheostomy cannula and thus, provide different levels of complexity that can be addressed through training with the present modular simulator system (1).

[0079] Specifically, as can be best seen in FIG. 2, the replaceable modules (10) comprise the simulated stoma (11), which has an outer end (111) and an inner end (112) in communication with a simulated trachea (12), which in turn comprises a lower end (121) and an upper end (122). The simulated stoma (11) and the simulated trachea (12) are inserted into an inner block (13) of soft material simulating cartilaginous tissue, which in turn is contained in a rigid outer casing (14) comprising an open front face (141) provided with a soft front layer (15) simulating the patient's skin and which is in direct contact with the inner block (13); This soft front layer (15) that simulates skin, comprises an entrance opening (151) with a perimeter contour (152) that defines an access lumen (153) in direct communication with the outer end (111) of said simulated stoma (11).

[0080] As illustrated in FIG. 3, the perimeter contour (152) of the inlet opening (151) located in the soft front layer (15) that simulates the skin, comprises at least one protuberance (154) to at least partially obstruct the access lumen (153), to simulate a defect in the skin that makes it difficult to pass a tracheostomy cannula.

[0081] In a preferred embodiment of the invention, shown in FIG. 4, said protuberances (154) consist of a hollow body (155) formed from the same material that makes up the soft front layer (15) that simulates the skin, but having a thickness less than the thickness of said soft front layer (15), such that said lesser thickness is vulnerable to breakage; where this hollow body (155) comprises inside it a fluid (156), which can be spilled, to simulate the exudation of a wounded protuberance (154).

[0082] In another embodiment of the invention, shown in FIG. 5, said protuberances (154) consist of a solid body (156) formed of the same material that forms the soft front layer (15) that simulates skin.

[0083] In relation to the configuration of the rigid housing (14) of the replaceable modules (10), as illustrated in FIG. 6, it comprises an internal cavity (142) formed by rigid perimeter walls (143) and a rigid rear wall (144); said perimeter walls (143) are rigid flat plates that are arranged orthogonally to each other to form a cubic volume; meanwhile, the rear wall (144) is arranged perpendicular to the perimeter walls (143) and, at the same time, opposite the open front face (141) where the soft front layer (15) that simulates skin is arranged (not illustrated). The rigid housing (14) comprises a smooth and soft outer surface (147) to favor the sliding of the replaceable module (10) inside the receiving cavity (21) of the phantom (20) (not illustrated in figure 6).

[0084] In the present embodiment of the invention, the aforementioned simulated trachea (12) forms an integral part of the rigid casing (14), being located in its internal cavity (142) and extending between two of the perimeter walls (143) opposite each other; where the intersection between the lower end (121) and the upper end (122) of said simulated trachea (12) with the aforementioned perimeter walls (143) opposite each other, gives rise to lateral openings (145) of the rigid casing (14).

[0085] As previously mentioned, and as exemplified in FIG. 7, the rigid casing (14) is the one that contains in its internal cavity (142) the internal block (13) of soft material that simulates cartilaginous tissue, surrounding said simulated trachea (12); meanwhile, said simulated stoma (11) is a channel formed in the soft material of said internal block (13), where the inner end (112) of the simulated stoma (11) is in direct communication with the simulated trachea (12), and its outer end (111) is in direct communication with the inlet opening (151) of the soft front layer (15) that simulates the skin; where this soft front layer (15) is located on the open front face (141) of the casing (14), being in direct contact with the internal block (13).The rigid casing (14) may comprise a pouring opening (146) optionally available on the rear wall (144), which is useful in the process of forming the inner block (13), for pouring soft material simulating cartilage tissue into the rigid casing (14).

[0086] In the present embodiment of the invention, shown in FIG. 8, the phantom (20) simulates at least a portion of the head (25) attached to a neck (26) and this, attached to an upper portion of the thorax (27) of a simulated patient; meanwhile, the receiving cavity (21) of the phantom (20), intended to house the replaceable modules (10), is located in the front part of the neck (26). The phantom (20) comprises a flat lower wall (22) arranged perpendicular to a craniocaudal axis (y) of the phantom (20), which allows the phantom (20) to be positioned on a horizontal surface simulating the position of a patient in an upright or seated state (sitting).

[0087] As exemplified in FIG. 9, the phantom additionally comprises a flat posterior wall (23) arranged parallel to said craniocaudal axis (y) of the phantom (20), which allows the phantom (20) to be positioned on a horizontal surface simulating the position of a patient in a supine state (face up). With reference to FIG. 10, the receiving cavity (21) of the phantom (20) is oriented on the anteroposterior axis (x) of the phantom (20), and comprises a shape and dimensions matching the shape and dimensions of the rigid housing (14) of the replaceable modules (10), to allow said replaceable modules (10) to fit and enter the aforementioned receiving cavity (21).

[0088] As best seen in FIG. ll, said receiving cavity (21) comprises a cubic shape with an open front face (24), comprising perimeter walls (211) orthogonal to each other, and a back wall (212) that is perpendicular to said perimeter walls (211) and in turn, is opposite to the open front face (24). At least said perimeter walls (211) of the receiving cavity (21), contemplate a smooth and soft interior surface (218) to favor the sliding of a replaceable module (10) (not illustrated) inside the receiving cavity (21) of the phantom (20).

[0089] Referring to FIG. 12, the bottom wall (212) of the receiving cavity (21) forms part of the planar rear wall (23) of the phantom (20); said bottom wall (212) of the receiving cavity (21) comprises a decoupling opening (213) configured to insert at least one finger of the user to push the replaceable module (10) forward and remove it from said receiving cavity (21) to replace it with another module. On the other hand, a lower wall (214) of the receiving cavity (21) of the phantom (20) comprises a perforation (215) from which an inner channel (216) with a lower end (217) extends, where said perforation (215) tightly couples with the lower end (121) of the simulated trachea (12) of the replaceable modules (10).

[0090] In another embodiment of the invention, as exemplified in FIG. 13, the modular simulator system (1) further comprises a flexible inner reservoir (30) liquefiable with a fluid, to simulate the presence of aspiratable sputum, where said flexible inner reservoir (30) is releasably coupled to the lower end (217) of the inner channel (216) of the phantom (20).

[0091] In use, as shown in FIG. 14, the inlet opening (151) present in the soft front layer (15) that simulates skin, allows the introduction or removal of a tracheostomy cannula (A) through the simulated stoma (11) to reach the simulated trachea (12). The presence of various protuberances (154) in the perimeter contour (152) of the inlet opening (151), allows simulating different deformations that make the manipulation of said tracheostomy cannula (A) difficult.

Claims

CLAIMS 1. Modular simulator system (1) for teaching and training in nursing care of people with tracheostomy, comprising a phantom that simulates part of a head, neck and upper part of a thorax; where the modular simulator system allows providing realistic anatomical structures with varied levels of simulated difficulty in the manipulation of a tracheostomy cannula; CHARACTERIZED in that it comprises a set of replaceable modules (10) insertable into a receiving cavity (21) located in the front part of the neck of the phantom (20);the replaceable modules (10) comprise a simulated stoma (11), with an inner end (112) in direct communication with a simulated trachea (12), both inserted in an inner block (13) of soft material simulating cartilaginous tissue and contained in a rigid outer casing (14) comprising a front face (141) provided with a soft front layer (15) simulating skin, which is in direct contact with the inner block (13); where this skin-simulating layer (15) comprises an inlet opening (151) with a perimeter contour (152) defining an access lumen (153) in direct communication with an outer end (111) of said simulated stoma (11).

2. Modular simulator system (1), according to claim 1, CHARACTERIZED in that the perimeter contour (152) of the inlet opening (151) comprises at least one protuberance (154), formed of the same material that forms the soft front layer (15) that simulates skin, which at least partially obstructs the access lumen (153) to the simulated stoma (11), to simulate a defect in the skin that makes it difficult to pass a tracheostomy cannula.

3. Modular simulator system (1), according to claim 2, CHARACTERIZED in that said at least one protuberance (154) comprises a hollow body (155) formed of the same material that forms the soft front layer (15) that simulates skin, having a thickness less than the thickness of said soft front layer (15) that simulates skin, and where the hollow body (155) comprises a fluid (156) inside it, which can be spilled, to simulate the exudation of a wound.

4. Modular simulator system (1), according to claim 1, CHARACTERIZED in that the rigid housing (14) of the replaceable modules (10), comprises an internal cavity (142) formed by rigid perimeter walls (143) that are arranged orthogonally to each other, and a rigid rear wall (144) that is arranged perpendicular to said perimeter walls (143), where said rigid perimeter walls (143) and said rigid rear wall (144) comprise a smooth and soft outer surface (147) to favor the sliding of the replaceable module (10) inside the receiving cavity (21) of the phantom (20).

5. Modular simulator system (1), according to claim 1, CHARACTERIZED in that the phantom (20) comprises a flat lower wall (22) arranged perpendicular to a craniocaudal axis (y) of the phantom (20); and further comprises a flat posterior wall (23) arranged parallel to said craniocaudal axis (y) of the phantom (20).

6. Modular simulator system (1), according to claim 1, CHARACTERIZED in that the receiving cavity (21) present in the phantom (20), is oriented on an anteroposterior axis (x) of the phantom (20), and comprises a shape and dimensions coinciding with the shape and dimensions of the rigid casing (14) of the replaceable modules (10).

7. Modular simulator system (1), according to claim 1, CHARACTERIZED in that said receiving cavity (21) comprises a cubic shape with an open front face (24), perimeter walls (211) orthogonal to each other, and a back wall (212) that is perpendicular to said perimeter walls (211) and in turn, is opposite to the open front face (24).

8. Modular simulator system (1), according to claim 7, CHARACTERIZED in that at least said perimeter walls (211) of the receiving cavity (21), contemplate a smooth and soft interior surface (218) to favor the sliding of a replaceable module (10) inside the receiving cavity (21) of the phantom (20).

9. Modular simulator system (1), according to claims 5 and 7, CHARACTERIZED in that the back wall (212) of the receiving cavity (21) forms part of the flat rear wall (23) of the phantom (20).

10. Modular simulator system (1), according to claim 9, CHARACTERIZED in that said bottom wall (212) of the receiving cavity (21) comprises a decoupling opening (213) configured to insert at least one finger of the user to push the replaceable module (10) forward and remove it from said receiving cavity (21) to replace it with another module.

11. Modular simulator system (1), according to any of the preceding claims, CHARACTERIZED in that a lower wall (214) of the receiving cavity (21) of the phantom (20) comprises a perforation (215) from which an inner channel (216) extends with a lower end (217), where said perforation (215) couples aligned with a lower end (121) of the simulated trachea (12) of the replaceable modules (10).

12. Modular simulator system (1), according to claim 1, CHARACTERIZED in that it further comprises a flexible interior reservoir (30) fillable with fluid, to simulate the presence of aspiratable sputum, releasably coupled to the lower end (217) of said interior channel (216) of the phantom (20).

13. Modular simulator system (1), according to claim 1, CHARACTERIZED in that the phantom and the set of replaceable modules are manufactured based on the reproduction of real anatomical structures from tomography scans of real patients and the creation of three-dimensional solid digital models.

14. Modular simulation system (1), according to claim 1, CHARACTERIZED in that said soft front layer (15) that simulates skin is formed of a silicone that vulcanizes at room temperature; said inner block (13) is formed of a high-performance liquid silicone that hardens with a platinum base; and said rigid housing (14) is formed of thermoplastic material.

Images