WO2021113936A1

WO2021113936A1 - Simulator model for anesthesias

Info

Publication number: WO2021113936A1
Application number: PCT/BR2020/050520
Authority: WO
Inventors: Ogari De Castro Pacheco; Marcelo STURARO; Mauricio Fernando BELLO; Joyce Midori Yamasita Da Paz SILVA
Original assignee: Cristália Produtos Químicos Farmacêuticos Ltda
Priority date: 2019-12-10
Filing date: 2020-12-08
Publication date: 2021-06-17
Also published as: MX2022006997A; BR102019026105A2; BR102019026105B1

Abstract

This invention refers to a three-dimensional simulator model and use of such model to simulate the accomplishment of anesthetic procedures and facilitate the analysis of anesthetic drug behavior, such as its baricity, distribution patterns, etc.

Description

"SIMULATOR MODEL FOR ANESTHESIAS"

FIELD OF THE INVENTION

[001] The present invention refers to the field of research and teaching in anesthesia, specifically regarding the evaluation of the behavior of anesthetic drugs. Particularly, the present invention refers to a three-dimensional simulator model and the use of such model to simulate the application of anesthesia and to facilitate the analysis of the behavior of anesthetic drugs, such as their baricity, distribution patterns and other relevant clinical factors in anesthetic procedures.

STATE OF THE ART

[002] Methods to provide pain insensitivity for the most diverse purposes have been applied and researched for a long time, and records of rudimentary anesthesia technigues dating from 4,000 B.C. can be found, when the Sumerian people used opium seeds for this purpose.

[003] More precise technigues began to be validated only in 1846, when the American dentist William T. G. Morton, in partnership with the surgeon John Collins Warren, succeeded in establishing that the inhalation of ether vapor was adeguate for sedation of a patient and painless and safely operation.

[004] According to information from the European Society of Anesthesiology, around 230 million patients are submitted to anesthesia for large surgical procedures per year, and the safety of patients during such procedures is a growing concern.

[005] The first procedures adopted to optimize the safety of patients submitted to anesthesia were pulse oximetry and capnography, which were implemented at the end of the 1970s, which provided, in United States, a decrease of deaths caused by cardiac arrest associated to anesthesia from 2.1 per 10,000 anesthetic procedures to 1.0 per 10,000 anesthetic procedures during the period from 1970 to 1988 (Staender S. Patient safety in anesthesia. Minerva Anestesiol 2010 Jan; 76 (1):45-50).

[006] The concern with safety during anesthetic procedures is so significant that the European Society of Anesthesiology created, in 2010, a document named Declaration of Helsinki, in which several objectives are listed to ensure the safety of the patient, including properly check the drugs used, especially regarding their toxicity. Latin America, as a bloc, signed this agreement in 2012.

[007] In this context, it is pointed out that there are several types of anesthetic procedures available in medical practice today, such as general anesthesia, local anesthesia, regional anesthesia and sedation, the latter not reguiring the use of devices that help the patient's respiratory ventilation . [008] Regional anesthesia is that intended to anesthetize only a specific portion of the patient's body. They are useful in lower abdomen, lower limbs and upper limbs surgeries, and can be divided in 4 types: intrathecal anesthesia (spinal anesthesia), epidural anesthesia, intravenous regional anesthesia (Bier's Block) and peripheral nerve and plexus blocks .

[009] Spinal anesthesia is typically characterized by administration of a local anesthetic (such as opioids, alpha-2 adrenergic agonists, etc) associated or not with adjuvants in the cerebrospinal fluid (fluid that floods the spinal cord), generating reversible motor and sensory blockages in the lower limbs and/or lower abdominal area.

[010] One approach to optimize the safety of patients submitted to anesthesia and that has been increasingly used is the simulation of such procedures in devices specifically built for the purpose of teaching and training.

[Oil] In this context, it is considered that regional anesthesia procedures are significantly more difficult to learn when compared to general anesthesia procedures, because of the positioning of the needle in the spinal column, among other factors (Allen J, et.al. A teaching tool in spinal anesthesia. AANA J. 2003 Feb; 71(1) :29-36) .

[012] Several factors must be considered when applying regional anesthesia, such as place of needle insertion, correct selection of dose and baricity of anesthetic drugs, correct positioning of the patient during the anesthesia application and soon after such application and also the administration speed and the volume of anesthetic drug administered (Praxedes H, et.al. Failure of subarachnoid blocks. Rev. Bras. Anestesiol. 2010 Jan. /Feb.; 60(l):90-7).

[013] The simulation of procedures in medical curriculum is understood as recreating or imitating part of a clinical scenario for the purpose of training and orientation for new procedures, exposing students to critical clinical scenarios, focusing on accelerating the acguisition and retention of new skills .

[014] Several types of models have been used in the field of anesthesiology for simulation as a teaching technigue, among them physical and mechanical models, highly-f idelity models to human anatomy and computational and digital models (software) .

[015] Currently there are more than 80 simulators commercially available in United States, most of them related to high-fidelity anatomical and sensory models, being set as high technology models that can simulate the vital signs of patients, however these models have a high cost of manufacturing and commercialization (Green M. Improving Patient Safety through Simulation Training in Anesthesiology: Where Are We? Anesthesiol Res and Pract 2016; 2016:

4237523) .

[016] In this context, there are several documents that describe the most diverse types of models to simulate the application of regional anesthesia, models oriented either to reproduce the human tissue resistance to the anesthetic injection needle penetration, or to reproduce the human bone anatomy or the presence of cerebrospinal fluid.

[017] Rigler (1991) describes a model that simulates the intrathecal space with the specific aim of studying the anesthetic drug behavior. The model was built from a rigid acrylic tube with internal diameter of 1.8 cm and external diameter of 2.5 cm. The dimensions and mold of the model are based on magnetic resonance imaging of the adult men spine, focusing on correctly reproduce the spine curvature. Small holes were arranged every 2 cm of the model, in order to simulate the intervertebral space and the tube was filled with a liguid that simulates the cerebrospinal fluid, composed of sodium (140 to 150 mEq/L) , chloride (120 to 130 mEq/L), albumin (25 mg %) and glucose (50 mg %). For the study of anesthetic behavior, 20:1 mixtures of lidocaine chloride (5%), with glucose (7.5%) and methylene blue solution (1%) were used, resulting in a hyperbaric solution with effective lidocaine concentration of 4.76% and specific density of 1.047 (Rigler ML et . al. Distribution of catheter-in ected local anesthetic in a model of the subarachnoid space. Anesthesiology 1991 Oct; 75(4): 684-692) .

[018] Wachter (1997) developed spinal cords models as faithful as possible to the human cord from computed tomography images from three patients with different spinal geometries. The models were built from PVC tubes with internal diameter of 19 mm and total length of 500 mm. The PVC tubes are attached to a base in such a way that it is possible to rotate it transversally and horizontally, simulating the position of the patient in supine, lateral decubitus, Trendelenburg or standing position. The models developed by Wachter aim to study the causes of the eguine tail syndrome (Wachter D. et . al. Distribution of Marcaine in an in vitro model of the subarachnoid space conforming to actual spinal column geometries. Technol and Health Care 1997 Dec; 5(6): 43747) .

[019] The document GB2369714 describes a model for simulating the application of epidural anesthesia consisting of a high-density polyethylene foam to simulate the interspinous ligaments of the lumbar spine and allows a needle to be introduced into the foam through the holes cut in the frame corresponding to the S1/L5 to L1/L2 lumbar interspace.

[020] The document US7403883 describes a model that allows the study and analysis of how substances are distributed through the human spinal canal. This model contains a first portion that includes a curved passage that mimics the size, shape and structure of an adult human spinal canal. This first portion can be attached to a second portion, which simulates the anatomical shape of the vertebra presented in the human spine. The first portion can be filled with a fluid that simulates the cerebrospinal fluid and other substances in solution can be applied in this portion in order to simulate the administration of anesthetic drugs.

[021] Chavez (2010) conducts a study about the behavior of anesthetics using a model that simulates the behavior of the cerebrospinal fluid. The objective of the study is to evaluate the influence of the Trendelenburg position and variations in the spinal canal configuration on the "spread" of hyperbaric anesthetic drugs. Two models are presented, one of them with a straight shape, and not presenting possible lumbar deviations resulting from lordosis, for example, and the other model includes simulations of spine curvatures for a more specific analysis of the spread of hyperbaric bupivacaine in positions contemplating simulations of patient inclination at 0°, 5°, 10° and 15° (Chavez VC et al. Spread of hyperbaric local anesthetics in a spinal canal model. The influence of Trendelenburg position and spinal configuration Anaesthesist . 2010 Jan;

59(1) :23-9 ).

[022] Mashari (2018) describes a spine model from 3D printing of a spine model faithful to human anatomy whose information was obtained from computed tomography stored in specific software. The model developed by this researcher aims to simulate the tactile sensation and resistance when applying an injection (Mashari A. et al; Low-cost three- dimensional printed phantom for neuraxial anesthesia training: Development and comparison to a commercial model PLoS One. 2018; 13(6) : e0191664) .

[023] Although there are several models to simulate the anesthesia application in order to investigate the behavior of anesthetic drugs and/or to serve as a teaching tool, the simulator models presented in the state of the art have some disadvantages, such as high cost, human anatomy reproduction is not faithful and/or not all possible patient position are available .

[024] In addition, the models described in the state of the art aim to provide proper simulation of only one or two clinical scenarios related to the anesthesia application (for example, simulating the patient position or the human spine curvature), so that a model that allows the simulation of several clinical scenarios simultaneously and that is practical to transport to several locations was not described in the art.

[025] In this context, the present invention describes a simulator model for anesthesia suitable to simulate anesthetic procedures, being possible to simulate the cerebrospinal space and that still is a faithful reproduction of the human vertebral bone anatomy .

[026] The simulator model of th present invention allows the simulation of several clinical scenarios simultaneously, such as simulating any patient position for injection application and any existing spine curvature, besides being a light model, easy to handle, and presenting low production cost. In addition, the simulator model of the present invention is easy to assemble and clean and can be readily reused.

[027] These and other advantages of the invention, as well as the additional inventive features attached to the same inventive concept, will be evident in the description of the invention provided in this document .

SUMMARY OF THE INVENTION

[028] The present invention refers to a three- dimensional simulator model for regional anesthesia that allows the study and analysis of the anesthesia application, allowing the proper simulation of several clinical scenarios that occur during anesthetic procedures. In a specific objective, this model can be used to characterize and study drug distribution patterns through the cerebrospinal fluid, allowing a better understanding of its characteristics, such as baricity. [029] More specifically, the present model (1) is characterized by comprising a first portion (A) and a second portion (B) , the said first portion (A) consisting of a transparent tube (Al), optionally flexible, which contains an upper cover (A2) and a lower cover (A3), the said second portion (B) consisting of parts that faithfully simulate the human vertebra (LI to L5) and the intervertebral disc (D) and an optionally flexible bar (B4) that, when inserted inside the hole (01), fixes the above- mentioned parts (LI to L5) and the disc (D) through a lock (Bl). In an alternative configuration, the model (1) optionally has a support tube (B2), optionally flexible, and a support base (B3).

[030] This portion (A) fits perfectly in portion (B), in order to simulate the internal environment of the vertebral canal, which contains the cerebrospinal fluid and the spinal cord and the holes. The said portion (B) faithfully simulates the bone anatomy of the vertebra and intervertebral disc of the human spine, so that the set configures a three-dimensional simulator model that allows a proper evaluation of the anesthetic drug behavior when administered in the cerebrospinal space and the simulation of several clinical scenarios related to the anesthesia application .

[031] In another aspect, the present invention describes the use of the model described here for the simulation of anesthetic procedures and, more specifically, the simulation of the spinal anesthesia .

[032] This simulation additionally aims to be a good teaching and evaluation technigue of the anesthetic drug behavior and simulation of several clinical scenarios for the training of the correct application of anesthesia, regarding the position of needle insertion, drug application speed, possible challenges, such as spine curvature, patient position, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

[033] The following is a description of the figures that are in this descriptive report, for better understanding and illustration of the present invention .

[034] Figure 1. Schematic representation of the simulator model (1) in perspective view, comprising a first portion (A) and a second portion (B), the said first portion (A) consisting of a transparent tube (Al), optionally flexible, which contains an upper cover (A2) and a lower cover (A3), the said second portion (B) consisting of parts that faithfully simulate the human vertebra (LI to L5) and the intervertebral disc (D). In this representation, the model (1) presents a support tube (B2), optionally flexible, and a support base (B3). [035] Figure 2: Schematic representation of simulator model (1), highlighting the holes (A4) that are in the transparent tube (Al) and that simulate the intervertebral sites for the insertion of the anesthetic injection needle.

[036] Figure 3: A transparent tube configuration (Al), with the codes indicating the dimensions (3a, 3b) .

[037] Figure 4: 4a, 4b - An upper cover configuration (A2); 4c, 4d - a lower cover configuration (A3) .

[038] Figure 5: 5a, 5b - A support tube configuration (B2), optionally flexible, with emphasis on the hole (02) for bar fitting (B4);

[039] Figure 6: 6a, 6b, 6c - A configuration of the parts that faithfully simulate the human vertebra (LI to L5), with emphasis on the hole (01); and 6d - optionally flexible bar representation (B4).

[040] Figure 7: 7a, 7b, 7c - A configuration of the parts that faithfully simulate the intervertebral disc, with emphasis on the hole (01).

[041] The objects of the present invention will be better understood from the detailed description of the invention and the attached claims .

DETAILED DESCRIPTION OF THE INVENTION

[042] The present invention concerns a three- dimensional simulator model for simulation of anesthetic procedures, particularly regional anesthesia and even more particularly, spinal anesthesia, which allows the study and analysis of the application of anesthetic solutions, particularly regarding the drug distribution through the cerebrospinal fluid, and the simulation of several clinical scenarios related to the anesthesia application .

[043] The present invention refers to a three- dimensional simulator model for anesthesia (1) characterized by comprising a first portion (A) and a second portion (B) , the said first portion (A) consisting of a transparent tube (Al), optionally flexible, which contains an upper cover (A2) and a lower cover (A3), the said second portion (B) consisting of parts that faithfully simulate the human vertebra (LI to L5) and the intervertebral disc (D) and an optionally flexible bar (B4) that, when inserted inside the hole (01), fixes the above- mentioned parts (LI to L5) and the disc (D) through a lock (Bl). In an alternative configuration, the model (1) optionally presents a support tube (B2), which contains a hole (02) to fit the bar (B4), and a support base (B3) .

[044] In a specific modality, the present invention consists of a three-dimensional simulator model for anesthesia characterized by the fact that it comprises a first portion (A) and a second portion (B), the said first portion (A) consisting of a transparent tube (Al), optionally flexible, which contains an upper cover (A2) and a lower cover (A3), the said second portion (B) consisting of parts that faithfully simulate the human vertebra (LI to L5) and the intervertebral disc (D) and a optionally flexible bar (B4) that, when inserted inside the hole (01), fixes the above-mentioned parts (LI to L5) and the disc (D) through a lock (Bl), and the said set (B) being fixed to a support tube (B2) which contains a hole (02) to fit the bar (B4) and which is attached to a support base (B3) and fixed to this base through a lock (Bl).

[045] In one modality of the present invention, the said first portion (A) presents small holes (A4) that simulate the possible sites for the injection of anesthetic compound. These holes are optionally coated with rubberized material or any other suitable material, in order to establish mechanical resistance to needle insertion.

[046] The said first portion (A) can be easily filled with liguid that simulates the cerebrospinal fluid through the opening of the above-mentioned upper cover (A2 ) and filling the tube (Al) with this liguid. This portion (A) perfectly fits in the second portion (B), in order to simulate the internal environment of the vertebral canal, which contains the cerebrospinal fluid and the spinal cord, and the holes (A4) simulate the intervertebral sites for the insertion of the anesthetic injection needle. [047] In one modality, the said portion (B) is composed of parts (LI to L5) that faithfully simulate the bone anatomy of the human spine and other parts (D) that faithfully simulate the intervertebral disc anatomy. These parts are assembled in an optionally flexible bar (B4), which is inserted inside the hole (01) existing in these parts (LI to L5) and in the discs (D), fixing the parts through the lock (Bl). This portion presents, in an alternative configuration, a support tube (B2) that contains a hole (02) to fit the bar (B4) and is optionally attached to a support base (B3) and fixed to this base .

[048] After a simulation of the anesthetic drug application, the liguid is easily removed of this portion (A) by removing the lower cap (A3). The first portion (A) is easily sanitized by removing the upper (A2) and lower (A3) covers, proceeding with the proper sanitization and drying, if necessary, and another simulation can be performed in a guick and practical way.

[049] The optional flexibility feature of the tube (Al) and bar (B4) allows the simulation of several physiological and pathological deviations of the vertebral spine curvature, which can make the spinal anesthesia application more difficult, such as marked kyphosis and lordosis and scoliosis, so that these clinical scenarios are easily reproduced by the simulator model herein. [050] In addition, the tube (Al) is made of transparent material, which allows the perfect visualization of the application of anesthetic containing a dye and its behavior inside this tube, which was previously filled with liquid that simulates cerebrospinal fluid, in order to allow the proper simulation of the behavior of these drugs in the spinal environment.

[051] In a particular aspect, the mentioned tube (Al) has an external opening diameter (DA1E) of about 40 mm, preferably 36 mm, an internal opening diameter (DA1I) of about 30 mm, preferably 29,70 mm, total length (CA1) of about 350 mm, preferably 340 mm and an optional curvature angle (AA1) at the end of about 20°, preferably 19°53^'. This tube (Al) is made of optionally flexible materials, such as plastic materials, more specifically polyurethane and the covers (A2) and (A3) are made of thermoplastic polymeric materials, such as polycarbonate.

[052] The bar (B4), which is inserted in the hole (01) of the parts (LI to L5) e discs (D) , is optionally made of flexible materials, preferably polyurethane, or rigid materials, such as stainless steel. In a particular aspect, it has the total length (CB4) of about 340 mm, preferably 335 mm.

[053] The parts (LI to L5), which faithfully simulate the bone anatomy of the human vertebra and the intervertebral disc (D), are inserted around the bar (B4), intercalating a part that simulates the vertebra and a part that simulates the intervertebral disc, and the set is fixed through the lock (Bl). These parts are optionally fitted to the support tube (B2) through the hole (02), and are optionally fixed to the support base (B3), through this bar (B4) and the lock (Bl), the latter is configured as a nut of adeguate size, preferably M6.

[054] In a specific modality, the parts (LI to L5) simulating the human vertebra have a width (LL) of about 140 mm, preferably 139 mm, height (HL) of about 160 mm, preferably 159.1 mm and depth (PL) of about 85 mm, preferably 85.6 mm. The parts simulating the intervertebral disc (D) have width (LD) of about 100 mm, preferably 101.9 mm, height (HD) of about 80 mm, preferably 7 9.3 mm and depth (PD) of about 22 mm, preferably 22.7 mm.

[055] In a specific preferential modality, the parts simulating the human vertebra (LI to L5) and the parts simulating the intervertebral disc (D) are produced by 3D printing, and can be manufactured using any material suitable for this kind of printing, preferably polyethylene terephthalate glycol (PETG) and materials known as flex filaments, which can be made of different components, usually polymeric materials, such as acrylonitrile butadiene styrene and polylactic acid.

[056] In one modality, the parts (LI to L5; and D) are produced using the 3D printing technology based on a reliable model of the human anatomical structure to serve as a mold. The reliability of model adopted as a mold, associated with the production technigue via 3D printing ensures that the parts are highly faithful to human anatomy.

[057] Also in a particular aspect of the present invention, the mentioned support tube (B2) is made of materials such as stainless steel and has a total length (CB2) of about 100 mm, preferably 97 mm, a diameter (DB2) of about 50 mm, preferably 51 mm and an inclination (AB2) in its upper portion of about 7°, preferably 7°3^'.

[058] In a preferential aspect of the present invention, the simulator model (1) comprises a tube (Al), which has an external opening diameter (DA1E) of about 40 mm, preferably 36 mm, an internal opening diameter (DA1I) of about 30 mm, preferably 29.70 mm, total length (CA1) of about 350 mm, preferably 340 mm and an optional curvature angle (AA1) at the end of about 20°, preferably 19°53^'; a portion B, comprising parts (LI to L5), which has width (LL) of about 140 mm, preferably 139 mm, height (HL) of about 160 mm, preferably 159.1 mm and depth (PL) of about 85 mm, preferably 85.6 mm; and parts (D) that have width (LD) of about 100 mm, preferably 101.9 mm, height (HD) of about 80 mm, preferably 79.3 mm and depth (PD) of about 22 mm, preferably 22.7 mm, which are fixed through the insertion in its hole (0) of a bar (B4), which has the total length (CB4) of about 340 mm, preferably 335 mm and fixed with a lock through a lock (Bl) of appropriate size. Optionally, the mentioned portion B can be fixed, through the mentioned bar (B4), in a support tube (B2), which has a total length (CB2) of about 100 mm, preferably 97 mm, a diameter (DB2) of about 50 mm, preferably 51 mm and an inclination (AB2) in its upper portion of about 7°, preferably 1°3'. This tube (B2) is optionally fixed to a support base (B3).

[059] In a particular aspect, the present invention consists of the mentioned tube (Al), which has an external opening diameter (DA1E) of about 40 mm, preferably 36 mm, an internal opening diameter (DA1I) of about 30 mm, preferably 29.70 mm, total length (CA1) of about 350 mm, preferably 340 mm and an optional curvature angle (AA1) at the end of about 20°, preferably 19°53^'; the mentioned portion B comprises parts (LI to L5), which has width (LL) of about 140 mm, preferably 139 mm, height (HL) of about 160 mm, preferably 159.1 mm and depth (PL) of about 85 mm, preferably 85.6 mm; and parts (D) that has width (LD) of about 100 mm, preferably 101.9 mm, height (HD) of about 80 mm, preferably 79.3 mm and depth (PD) of about 22 mm, preferably 22.7 mm, which are fixed through the insertion in its hole (01) of a bar (B4), which has the total length (CB4) of about 340 mm, preferably 335 mm and a lock (Bl) of proper size, with the mentioned portion B fixed, through the mentioned bar (B4), and a support tube (B2), which has a total length (CB2) of about 100 mm, preferably 97 mm, a diameter (DB2) of about 50 mm, preferably 51 mm and an inclination (AB2 ) in its upper portion of about 7°, preferably 7°3, such tube (B2) being fixed to a support base (B3).

[060] In order to simulate the clinical conditions that may be present when applying anesthesia, this model can be guickly assembled by stacking on the bar (B4), the parts simulating the human vertebra, intercalating with parts simulating the intervertebral disc. After this assembly, the parts are fixed using the lock (Bl) and it is optionally possible to fix this assembly in a support tube (B2) and in a support base (B3) . This support base can have different shapes and dimensions.

[061] In the assembled set, the portion (A) of this model is then fixed, which includes a transparent tube (Al), optionally flexible, which contains a upper cover (A2) and a lower cover (A3) . Then, the upper cover (A2) is opened, keeping the lower cover (A3) attached to the tube (Al) and the tube (Al) is filled with a proper liguid to simulate the cerebrospinal fluid. In particular, this liguid can be a sodium, glucose and albumin solution or saline solution .

[062] To simulate the anesthetic drug, a solution with different dyes and that have specific density in relation to the liquid used inside the tube (Al) can be used. Typically, solutions with higher, equal and/or lower density than the liquid used inside the tube (Al) are used, in order to be able to visualize the behavior of the substance injected inside the tube (Al), especially by simulating the characteristic of baricity, and the influences of factors such as the liquid injection speed, the needle position in the spine and the simulated position in which the patient could be.

[063] In this context, when injecting a solution with higher density than the liquid that is inside the tube (Al), it will be observed that the injected liquid will be concentrated in a region below the site of injection application. Similarly, if the injected liquid has lower density than the density of the liquid that is inside the tube (Al), this liquid will be concentrated in a region above the site of injection application.

[064] In an illustrative modality, solutions of PEG- 400, sodium chloride and methylene blue can be injected as solutions that simulate hyperbaric anesthetic drugs. As solutions that simulate hypobaric anesthetic drugs, sodium chloride solution in 70% alcohol and red dye can be used and, as solutions that simulate isobaric anesthetic drugs, 0.9% sodium chloride solution and yellow dye.

[065] The injection application speed will also affect the spreadability of the applied liquid, a factor that can be properly visualized durinq the simulation usinq the model described here.

[066] Under another aspect, since the simulator model of this invention enables the simulation of all possible positions that the patient can be, as well as several possible human spine inclination, the influence of these factors can also be readily visualized, so that their impact on a successful anesthetic procedure can be easily understood.

[067] The understandinq of the influence of anesthetic injection speed, of patient position, the features of the anesthetic druq, such as its baricity, as well as the site of the injection application, is a key factor for a successful anesthetic procedure, since each one of these factors should be properly selected dependinq on the reqion of the body that is seekinq to desensitize.

[068] After simulatinq the anesthetic procedure and the clinical conditions that can be present when applyinq anesthesia, the model of the present invention can be easily sanitized by removinq the lower cover (A3) and discardinq the liquid inside the tube (Al) . The upper cover (A2) can also be removed, which makes the model very easy to be sanitized, and, as a consequence, a quick reuse is possible, if another simulation is desired.

[069] The model of this invention can also be quickly disassembled, by removing the lock (Bl) and the bar (B4) and detaching the parts (LI to L5 and D), so that this model can be easily transported from one place to another.

[070] Therefore, another object of the present invention is the use of the three-dimensional simulator model to simulate the application of anesthetic drugs and the clinical conditions that can be present when performing anesthetic procedures, in order to facilitate the analysis of the drug behavior, such as its baricity and distribution patterns .

[071] In view of what has been exposed here, it is clear that the simulator model described here allows the simultaneous visualization of several clinical aspects of relevant impact for the proper performance of an anesthetic procedure, thus allowing a simulation of anesthetic procedures closer to reality, which helps to optimize the safety in performing these procedures.

[072] In addition, the simulator model of the present invention presents low production cost, besides being easily assembled, disassembled, sanitized and transported, allowing that the anesthetic procedure simulation to be performed in very diverse environments, thus making the access to acguisition and retention of new skills in the field of anesthesia more democratic.

Claims

1. Three-dimensional simulator model for anesthesia characterized by the fact that it comprises a first portion (A) and a second portion (B), the said first portion (A) consisting of a transparent tube (Al), optionally flexible, which contains an upper cover (A2) and a lower cover (A3), the said second portion (B) consisting of parts that faithfully simulate the human vertebra (LI to L5) and the intervertebral disc (D) and an optionally flexible bar (B4) that, when inserted inside the hole (01), fixes these parts (LI to L5) and the disc (D) through a lock (Bl), and the said portion (B) is optionally fixed to a support tube (B2) that contains a hole (02) to fit the bar (B4) and that is optionally attached to a support base (B3) and fixed to this base through a lock (Bl) .

2. Simulator model according to the claim 1, characterized by the fact that the tube (Al) has an external opening diameter (DA1E) of about 40 mm, preferably 36 mm, an internal opening diameter (DA1I) of about 30 mm, preferably 29.70 mm, total length (CA1) of about 350 mm, preferably 340 mm and an optional curvature angle (AA1) at the end of about 20°, preferably 19°53^'.

3. Simulator model according to the claim 1, characterized by the fact that the first portion (A) has small holes (A4) that simulate the possible sites for the injection of anesthetic compound.

4 . Simulator model according to the claim 1, characterized by the fact that the bar (B4) has the total length (CB4) of about 340 mm, preferably 335 mm .

5. Simulator model according to the claim 1, characterized by the fact that the parts (LI to L5 ) have width (LL) of about 140 mm, preferably 139 mm, height (HL) of about 160 mm, preferably 159.1 mm and depth (PL) of about 85 mm, preferably 85.6 mm.

6. Simulator model according to the claim 1, characterized by the fact that the parts (D) have width (LD) of about 100 mm, preferably 101.9 mm, height (HD) of about 80 mm, preferably 79.3 mm and depth (PD) of about 22 mm, preferably 22.7.

7. Simulator model according to the claim 1, characterized by the fact that the optional support tube (B2) has a total length (CB2) of about 100 mm, preferably 97 mm, a diameter (DB2) of about 50 mm, preferably 51 mm and an inclination (AB2) in its upper portion of about 7°, preferably 7°3^'.

8. Simulator model according to the claim 1, characterized by the fact that the tube (Al) has an external opening diameter (DA1E) of about 40 mm, preferably 36 mm, an internal opening diameter (DA1I) of about 30 mm, preferably 29.70 mm, total length (CA1) of about 350 mm, preferably 340 mm and an optional curvature angle (AA1) at the end of about 20°, preferably 19°53^'; the said portion B comprises parts (LI to L5), that have width (LL) of about 140 mm, preferably 139 mm, height (HL) of about 160 mm, preferably 159.1 mm and depth (PL) of about 85 mm, preferably 85.6 mm; and parts (D) that have width (LD) of about 100 mm, preferably 101.9 mm, height (HD) of about 80 mm, preferably 79.3 mm and depth (PD) of about 22 mm, preferably 22.7 mm, which are fixed through the insertion in its hole (01) of a bar (B4), which has a total length (CB4) of about 340 mm, preferably 335 mm and a lock (Bl) of proper size, and the said portion B is optionally fixed, through the bar (B4), and a support tube (B2), which has a total length (CB2) of about 100 mm, preferably 97 mm, a diameter (DB2) of about 50 mm, preferably 51 mm and an inclination (AB2) in its upper portion of about 7°, preferably 7°3, and this tube (B2) is optionally fixed to a support base (B3).

9. Simulator model according to the claim 1 to 8, characterized by the fact that the tube (Al) is made of materials optionally flexible, such as plastic materials, preferably polyurethane and the bar (B4) is made of rigid materials such as stainless steel or optionally made of flexible materials, preferably polyurethane.

10. Simulator model according to the claim 8, characterized by the fact that the said first portion (A) has small holes (A4) that simulate the possible sites for the injection of the anesthetic compound .

11. Simulator model according to the claims 1 to 8, characterized by the fact that the parts that simulate the human vertebra (LI to L5) and the parts that simulate the intervertebral disc (D) are made through 3D printing.

12. Simulator model according to the claim

11, characterized by the fact that the parts that simulate the human vertebra (LI to L5) and the parts that simulate the intervertebral disc (D) are made of any proper material for this kind of printing, preferably polyethylene terephthalate glycol (PETG) and flex filaments.

13. Simulator model according to the claim

12, characterized by the fact that the flex filaments can be composed of polymeric materials, such as acrylonitrile butadiene styrene and polylactic acid.

14. Three-dimensional simulator model for anesthesia characterized by the fact that comprises a first portion (A) and a second portion (B), the said first portion (A) consisting of a transparent tube (Al), optionally flexible, which contains an upper cover (A2) and a lower cover (A3), the said second portion (B) consisting of parts that faithfully simulate the human vertebra (LI to L5) and the intervertebral disc (D) and an optionally flexible bar (B4) that, when inserted inside the hole (01), fixes the parts (LI to L5) and the disc (D) through a lock (Bl), and the portion (B) is fixed to a support tube (B2) that contains a hole (02) to fit the bar (B4), which is attached to a support base (B3) and fixed to this base through a lock (Bl).

15. Simulator model according to the claim 14, characterized by the fact that the tube (Al) has an external opening diameter (DA1E) of about 40 mm, preferably 36 mm, an internal opening diameter (DA1I) of about 30 mm, preferably 29.70 mm, total length (CA1) of about 350 mm, preferably 340 mm and an optional curvature angle (AA1) at the end of about 20°, preferably 19°53^'; the so-called portion B comprises parts (LI to L5), which has width (LL) of about 140 mm, preferably 139 mm, height (HL) of about 160 mm, preferably 159.1 mm and depth (PL) of about 85 mm, preferably 85.6 mm; and parts (D) that has width (LD) of about 100 mm, preferably 101.9 mm, height (HD) of about 80 mm, preferably 79.3 mm and depth (PD) of about 22 mm, preferably 22.7 mm, which are fixed through the insertion in its hole (01) of a bar (B4), which has the total length (CB4) of about 340 mm, preferably 335 mm and a lock (Bl) of proper size, and the portion B is fixed, through the mentioned bar (B4), in a support tube (B2), which has total length (CB2) of about 100 mm, preferably 97 mm, a diameter (DB2) of about 50 mm, preferably 51 mm and an inclination (AB2) in its upper portion of about 7°, preferably 7°3, and this tube (B2) is fixed to a support base (B3) .

16. Use of the three-dimensional simulator model, as defined in the previous claims, for simulation of anesthetic drug application and clinical conditions that can be present when performing anesthetic procedures, in order to facilitate the analysis of the drug behavior, such as its baricity and distribution patterns.