Training station for surgical operations

Abstract

The invention relates to a training station for surgical procedures, comprising a model of an anatomical structure, a 3D digital model of the anatomical structure and a work base. The model of the anatomical structure is obtained using diagnostic images from a patient and corresponds to a replica of the anatomical structure, including bones, cartilage and skin. The 3D digital model allows a user of the training station to interact with a virtual representation of the model of the anatomical structure through an augmented reality and / or virtual reality system.

Description

Technical Field

[0001] This invention relates to models, anatomical models, and training models of human organs and tissues used in surgical procedures in the medical field. More specifically, the invention provides replicas of the anatomical structures of real patients for training in cosmetic or corrective surgeries. It also relates to three-dimensional digital models of physical models, which users can interact with via augmented reality and / or virtual reality before, during, or after training on the physical model. Background Technology

[0002] Surgeons typically require extensive training and practice to fully master the techniques of their medical specialty in order to achieve optimal results in the procedures in which they are performed. Generally, any type of surgical training is conducted on real patients with expert support for each intervention on cadavers, or at training stations designed to simulate soft tissue, cartilage, bone, and surgical-specific defects.

[0003] Generally, the most suitable training method is to conduct it on cadavers, as it allows for a comprehensive understanding of the actual effects of surgery on the patient, as well as the sensations required to adjust the forces applied to each tissue, the depth of incisions, and so on. However, due to the specific anatomical conditions required for each exercise, the difficulty in obtaining the consent needed for such surgeries, or the necessary logistical protection requirements, there are rarely enough cadavers available for such training courses.

[0004] The disadvantage of intervening in real patients with the assistance of experts is the potential danger to the patient, as a person with little or no training can severely affect sensitive structures and cause additional complications.

[0005] One of the most suitable, economical, and readily available methods for surgical training is through models that simulate the actual structures to be operated on. However, currently available models cannot fully and faithfully reproduce the specific structures, textures, consistency, and rigidity of real organs. One example might be the difficulty in replicating the anatomy of the human nasal cavity, which contains bone, cartilage, fat, and skin in specific areas, and has a thickness and structure that is difficult to replicate.

[0006] Similarly, it is well known that interventions in this area to correct nasal obstruction, cosmetic deformities, or trauma are highly complex because the surgery is performed in a narrowed area and requires delicate handling of the tissue; therefore, the movement must be efficient and smooth enough to avoid damage.

[0007] Therefore, there is a great need for models that accurately and anatomically simulate different biological structures to provide surgeons with adequate training before intervening in real patients. Summary of the Invention

[0008] This invention relates to human organ and tissue models, anatomical models, and training models used in the medical field for surgical procedures. In particular, the invention provides replicas of anatomically equivalent structures of anatomical regions from real patients, including bone, cartilage structures, and soft tissues such as muscle, skin, and fat. To obtain replicas that are as faithful as possible to real organs, the material of each replica structure must be carefully selected to provide the same texture, hardness, and flexibility as the real structure.

[0009] The model according to the invention uses information obtained from diagnostic images of real patients to segment and reconstruct each structure of interest in three dimensions in the most accurate way possible, so as to provide the thickness, density, size and specific location of each structure of interest.

[0010] In one embodiment of the invention, once a 3D reconstruction is obtained from diagnostic images, not only can a physical model be obtained for use in training, but also a 3D digital model that can be used to supplement training, as it allows users to interact with the virtual representation through augmented reality and / or virtual reality technologies.

[0011] According to one embodiment of the present invention, a training station for surgical procedures comprises a model of a patient's specific anatomy, a three-dimensional digital model of the anatomy, and a working base. Preferably, the model of the anatomy corresponds to the equivalent anatomy of a real patient and is composed of materials simulating bone, cartilage, and soft tissue.

[0012] In some embodiments, the bone structure attempts to faithfully replicate the compression, tensile strength, bending, elasticity, plasticity, rigidity, flexibility, and resistance properties of real bone. Such a bone structure can be obtained through appropriate 3D printing technology.

[0013] In one embodiment of the invention, the desired cartilage structure can also be obtained by 3D printing using information obtained from diagnostic images, and then attached to a bone structure to form an osteochondral skeleton. As mentioned above, the choice of materials is crucial to obtaining accurate simulations of the replicated area.

[0014] According to some embodiments of the invention, additional layers on the osteochondral skeleton, such as muscle, skin, and fat, can be included by means of a mold designed to give a specific shape and thickness to each of the layers, which can be directly adhered or fused together to obtain full coupling of all components of the model of the anatomical structure. Attached Figure Description

[0015] Figure 1 This corresponds to a training station for surgical procedures according to a preferred embodiment of the present invention.

[0016] Figure 2These are illustrative images of a three-dimensional digital model of the nasal cavity structure included in a training station according to an embodiment of the present invention.

[0017] Figure 3 The maxilla and nasal turbinates are generated in two parts of the model of the anatomical structure of the training station according to an embodiment of the present invention.

[0018] Figure 4 Details of the cartilage structure of an anatomical model of a training station according to an embodiment of the present invention are shown.

[0019] Figure 5 Corresponding to a mold, which allows the reproduction of the air volume inside the nose in a model of the anatomical structure of a training station according to an embodiment of the invention.

[0020] Figure 6a , 6b Figures 6c show an osteochondral skeleton model of the anatomical structure of a training station according to an embodiment of the present invention.

[0021] Figure 7a and 7b The anatomical model of the training station according to an embodiment of the present invention shows the soft tissue layer inside the nose covering the osteochondral bone and nasal mucosa.

[0022] Figure 8a and 8b The skin layer and the reinforcing mesh on the inner surface of the training station according to an embodiment of the present invention are shown.

[0023] Figure 9a , 9b 9c corresponds to the working base of the training station according to an embodiment of the present invention. Detailed Implementation

[0024] Some embodiments of the training station of the present invention are described below, with reference to the accompanying drawings. The training station for surgical procedures according to the present invention may include a model of the desired anatomical structure modeled based on the specific anatomical structure of a real patient. There are no particular limitations on the anatomical structures used in the training station, and they may correspond to any region of the desired anatomical structure. In particular, regions of the head and neck, such as the auricle, temporal bone, maxilla, mandible, or nasal cavity structures, are preferably selected.

[0025] Taking a nasal structure model as an example, the specific features of the surgical training station according to the present invention are described in detail.

[0026] like Figure 1 and Figure 2As shown, the present invention provides a training station (100) for surgical procedures, comprising: a model of an anatomical structure (101), a three-dimensional digital model (200) of the anatomical structure model (101), and a working base (900). Preferably, the anatomical structure model (101) corresponds to the equivalent anatomy of a patient and is composed of materials simulating bones, cartilage, and skin. The three-dimensional digital model (200) allows the training station user to interact with the representation of the anatomical structure model (101) via augmented reality and / or virtual reality systems. Similarly, the working base (900) has means for securing it to a surface for training and also has means for changing the angle of the model during training.

[0027] According to some embodiments of the invention, a training station (100) for surgical procedures includes a model (101) of an anatomical structure, which may correspond to, for example, the nasal structure, consisting of faithful replicas of the parts of a real patient possessing the functional and aesthetic features of interest for practicing nasal surgery, such as septoplasty, turbinate reconstruction, nasal dorsum surgery, nasal tip surgery, nasal base surgery, nasal flap surgery, and / or non-surgical nasal surgery. Features of interest are selected from septal deviation, nasal protrusion, nasal tip deformities, etc.

[0028] The anatomical model (101) is obtained using information from diagnostic images acquired through techniques such as computed tomography, in which volumetric spiral acquisition is performed in a multi-detector device, and high-resolution slices in the axial, sagittal, and coronal planes are obtained from the skull base using bone and soft tissue reconstruction algorithms. In certain cases, the diagnostic images can be supplemented by images obtained through additional techniques such as magnetic resonance imaging.

[0029] Once the images are obtained, reconstructions of bones, cartilage, and soft tissues (such as skin, mucous membranes, adipose tissue, etc.) can be generated by segmenting each structure of the analyzed anatomy. Accurately determining each of these structures, as well as their thickness and shape, is crucial for achieving realistic and functional replicas for training purposes. Using information from the diagnostic images and the segmentation process, a complete three-dimensional digital model (200) of each structure of interest can be generated, which can be used during practice in a virtual simulator, as well as as input for generating a model (101) of the anatomy that will be used during training.

[0030] In some embodiments of the invention, the model (101) of the anatomical structure can be generated by modeling or using 3D printing technology. The 3D printing technology used for this process can be selected from fused deposition modeling (FDM), Polyjet, electron beam freeform fabrication (EBF3), electron beam melting (EBM), selective thermal sintering (SHS), selective laser sintering (SLS), projection bonding (DSPC), laminated object fabrication (LOM), stereolithography (SLA), ultraviolet photopolymerization (SGC), or a suitable combination of these technologies.

[0031] like Figure 3 As shown, in a preferred embodiment, the anatomical model (101) includes a bone structure (300) consisting of the maxilla (301) and nasal turbinates (302). The bone structure (300) can be obtained by selective laser sintering (SLS) using nylon or polystyrene, preferably nylon 11 or nylon 12. Modeling the bone structure (300) in this way allows for osteotomy using actual surgical instruments that provide a sensation similar to that of the real maxilla, as they can mimic the characteristics of real bone, such as compression, tensile strength, bending, elasticity, plasticity, stiffness, flexibility, resistance, etc. In a particular embodiment of the invention, the modeling material of the bone structure (300) can be combined with, for example, salt, which can impart specific properties to the material in the printed product, such as piezoelectric properties, thereby enabling the use of a piezoelectric scalpel. Similarly, the bone structure (300) of the anatomical model (101) according to the invention preserves the anatomical features of the maxilla, such as the lacrimal duct (303), maxillary sinus (304), frontal sinus (305), etc.

[0032] In one embodiment of the invention, the bone structure (300) may be a single piece or a combination of segments added later to obtain a complete maxilla (301). Segmentation of the maxilla (301) allows for the development of interchangeable modules that facilitate the introduction of different features, such as additional alterations to intranasal or external nasal anatomy. In particular, for the latter, a segment of the nasal bone may be fabricated using a specific combination of materials, which would allow for the use of techniques such as piezoelectric scalpels.

[0033] Furthermore, in a preferred embodiment of the invention, the maxilla (301) includes a channel (306) surrounding the posterior edge of the maxilla (301), which allows the model to be fixed to the working base (900) and positioned in the most suitable direction according to the working conditions.

[0034] according to Figure 4In the illustrated embodiment of the invention, the cartilage structure (400) of the anatomical model (101) corresponds to a faithful replica of the patient's anatomy, including desired defects such as deformities and deviations, while maintaining its length, thickness, height, and width. All these specific features are determined and reproduced based on the segmentation results and the three-dimensional digital model (200) as described above. The replicated cartilage structure (400) can be obtained by 3D printing using any of the techniques already mentioned, preferably FDM or Polyjet in this case. In embodiments of the invention, thermoplastic filaments are used for FDM technology, while pure thermoplastic filaments or composite materials are used for Polyjet technology. The aim of combining these materials is to obtain a Shore hardness between 50 and 90, thereby achieving a sensation comparable to real cartilage.

[0035] To manufacture a model (101) of the anatomical structure of soft tissues, such as skin, adipose tissue, muscle tissue, and nasal mucosa, according to the present invention, it is necessary to manufacture corresponding molds, into which the appropriate material for each tissue will be injected. The molds can be manufactured using any of the aforementioned 3D printing technologies, with FDM being preferred, using PLA, ABS, ASA, PET, PETG, PC, PVA, TPU, or TPE filaments, with PLA filaments (polylactic acid) being the most preferred.

[0036] Preferably, in order to obtain a model of the anatomical structure (101) that is equivalent to the real structure, the air volume present in these regions must be accurately replicated. In particular, such as Figure 5 As shown, a component is used to replicate the accurate air volume present inside the nose (500) in the nasal structure used as an example. The purpose of this air volume is to fill the air space inside the nose, leaving only a thin layer of silicone to replicate the nasal mucosa, which surrounds the entire interior of the nose. Features of the air volume mold allow for the formation of areas of greater or lesser thickness within the mucosa of the model as needed, thereby promoting nasal patency. The mold for the air volume present inside the nose (500) can be obtained using any of the 3D printing techniques described above, in which case FDM using TPU or TPE thermoplastic filaments is preferred, with TPU (thermoplastic polyurethane) filaments being the most preferred.

[0037] In some embodiments of the invention, the materials selected for replicating skin, adipose tissue, and muscle are those that allow for faithful replication of specific characteristics of each of these tissues, such as elasticity, flexibility, texture, hardness, and consistency. Specifically, the aim is to achieve a Shore hardness between 20 and 90. Preferably, the selected material is a silicone rubber cured with peroxide or platinum, and more preferably a silicone resin cured with platinum, such as those known in the art, such as Equinox, SORTA-Clear, Smooth-Sil, Magikmold, Elkem, Bluestar, Mold Star, Dragon Skin, Rebound, Ecoflex, Body Double, Rubber Glass, and Encapso-K. In some embodiments, if the selected silicone resin requires, a vacuum degassing process is performed to prevent air bubbles and defects from forming in the silicone resin during pouring into the mold.

[0038] like Figure 6a As shown, according to some embodiments of the invention, the osteochondral skeleton (600) is composed of the maxilla (301) and the nasal cartilage dorsal side (601), the latter being composed of the nasal septum (602) and the superior lateral cartilage (603). The connection between the maxilla (301) and the cartilage can be achieved through a superimposed structure and fixed by a common adhesive, such as a polyaddition, polymerization, or condensation curing adhesive, preferably a polymerization curing adhesive, which fixes the cartilage to the vertical plate of the maxilla (309) and the vomer (307).

[0039] In some embodiments of the present invention, such as Figure 6b and 6c As shown, after the nasal septum (602) is set, a nylon mesh (605), referred to as the nasal mesh, can be incorporated into the tail and anterior portions of the cartilage using a suitable adhesive, preferably a polyaddition-curing adhesive. This mesh will later be integrated into the nasal mucosa that will cover the septal cartilage (602). In a preferred embodiment of the invention, the mesh is placed from side to side, covering the area corresponding to the anterior 30 mm to 5 mm of the anterior septum, as well as its tail edge (604) and nasal ridge (308). This mesh mimics the adhesion characteristics of the mucocartilaginous membrane and the so-called cross-fibers in a real nasal septum. Similarly, the mesh allows the user to be guided during septoplasty practice by serving as a reference point for verifying the correct anatomical plane.

[0040] To ensure precise positioning of the inferior lateral cartilage (606) of the nasal tip in the model (101) constituting the anatomical structure, a 3D-printed mold can be used to facilitate proper assembly of all components. In one embodiment of the invention, once all elements of the osteochondral skeleton (600) are in their final positions, a new nasal mesh nylon net (605) can be placed on the elements of the nasal structure to simulate the perichondrium (e.g., on the superior lateral cartilage (603) or inferior lateral cartilage (606)) and periosteum (608) (on the nasal bone and the ramus of the maxilla). Furthermore, the presence of the mesh allows the user to have clear reference points for the anatomical planes that must be followed during surgery on the model (101) of the anatomical structure, as well as measuring devices marking the limits of the dorsal anatomical planes at the cartilage level, which is typically above the cartilage (above the mesh) and below the periosteum at the nasal bone level (below the mesh).

[0041] In a preferred embodiment of the invention, considering that decoupling of certain parts typically occurs in the lower cartilage (606) of a model (101) of nasal anatomy, it is desirable to provide reinforcement for the foot of the lower leg (606a) in this area. Therefore, a nylon reinforcing mesh (607) may be included, which is inserted into the premaxilla (bone) and covers the lower part of the lower leg (606a) (cartilage), thereby surrounding the foot of the lower leg (606a). This mesh is bonded with a specific adhesive, increasing the strength and reliability of the model.

[0042] According to some embodiments of the invention, a model (101) of the nasal anatomy faithfully reproduces the complex features of the anatomical structure, such as the spaces inside and outside the nasal flaps, the thickness of the soft tissue covering the nasal tip, nasal dorsum, nasal septum (602), and nasal turbinates (302), the muscle tissue covering the external structures of the nose and maxilla (301), etc. All of the above are reproduced while maintaining the patency of the simulated nostrils. Therefore, including soft tissue on the osteochondral skeleton (600) may involve the fabrication and use of a 3D mold that allows for the accurate reproduction of these features.

[0043] Based on the above, such as Figure 7a and 7bAs shown, in an example of a model (101) of the nasal anatomy, the silicone layer (700) is firmly attached to the osteochondral bone (600), penetrating between the cartilage structures (400). This allows for a very detailed re-creation of the adhesions of the nasal ligaments (midline Pitangi, vortex ligaments, and intercartilaginous ligaments), thus allowing for a better understanding of the anatomical structure of the nasal tip and the back of the nasal cartilage (601). Using this method to connect soft tissues yields a precise anatomical structure, which also provides an anatomical feel comparable to real tissue in terms of consistency, texture, and flexibility. To achieve precise coupling of the muscle layer (700) to the osteochondral bone (600), the osteochondral bone (600) can be arranged within a 3D-printed mold, into which a selected degassed silicone resin is poured to form the mucosa (701) and the muscle (700). The gap between the mold and the osteochondral bone (600) is thus covered with silicone resin to achieve the desired shape and thickness of the structure.

[0044] Regarding the nasal mucosa (701) and muscle (700) according to exemplary embodiments of the present invention, Figure 8a The fabrication of the skin layer (800) and the subcutaneous adipose tissue of the nasal anatomy model (101) required the use of segmentation information and processing of images obtained from a reference patient to create a specially designed 3D mold. This 3D mold was designed to maintain the patency of the nostrils and facilitate adhesion of the alar cartilage to the osteochondral bone (600). The selected materials were intended to mimic the elasticity, firmness, and flexibility of human skin. In a preferred embodiment of the invention, once the skin layer (800) was obtained, adipose tissue was added to specific areas of the inner surface of the skin (800) using silicone resin having characteristics and color similar to human fat to replicate the adipose tissue.

[0045] In order to reinforce the skin (800) in the area with the greatest tensile strength, in Figure 8b In the preferred embodiment shown, the nylon mesh (801) is integrated into the skin along its back, tips, and post segments via a fusion process that includes securing the nylon mesh to the inner surface of the skin (800). Once the nylon mesh (801) is in place, a layer of silicone is applied, and the assembly of the skin (800) and the nylon mesh (801) is introduced into a specially designed 3D mold that fuses the nylon mesh openings (801) to the inner surface of the skin (800) through pressure from its components, thereby creating optimal adhesion between the two elements.

[0046] According to certain embodiments of the invention, the skin layer (800) and all its specific features can be coupled to the osteocartilaginous structure by methods known in the art, such as fusion, or by casting silicone resin onto the osteocartilaginous structure and muscle layer, together with the already completed muscle layer (700); fusion is the preferred method in this case. In a preferred embodiment, the process is mediated by using a specially designed mounting mold to adhere the skin (800) to the underlying structure using silicone resin. Once the silicone resin drying process is complete, the fusion of all layers and elements constituting the model is finished.

[0047] exist Figures 9a to 9c In the illustrated embodiment of the invention, the anatomical model (101) is further equipped with a working base (900) through which the anatomical model (101) can be connected and fixed to a stable surface, such as a table. For proper fit, a channel (306) of the maxilla (301) engages with a track connector (901), which in turn engages with the central portion of a mounting base (902). In some embodiments of the invention, the track connector (901) can be oriented in any direction, allowing the model to be adapted to right- or left-handed users, or depending on the conditions of the space where training is performed. Furthermore, in certain embodiments of the invention, the mounting base (902) has a millimeter ruler (903) attached to the side, allowing the user to measure different elements during training. In some embodiments of the invention, the track connector (901) also includes a multi-functional wedge (904) that allows the tilt to be adjusted around the anterior-posterior axis or lateral axis as needed by the user.

[0048] In some embodiments of the invention, the mounting base (902) further includes a fixing system comprising a series of anti-slip silicone strips (907) on the edge of the rear region of the mounting base (902) and a clamping system (908) that can be placed on one or both side rails of the mounting base (902) to securely fix the model to a table or lower surface.

[0049] Furthermore, in a particular embodiment of the invention, the working base (900) is also provided with a bridge (905) that includes a mounting system (906) for the instrument, which is capable of optimally exposing the anatomical structure of the model during most training phases and also allows the user to free their hands for most of the training.

[0050] There are no particular restrictions on the manufacturing method of the components of the working base (900), so they can be obtained by any of the 3D printing methods or by hand molding described above.

Claims

1. A training station (100) for surgical procedures, comprising: Anatomical model (101). A three-dimensional digital model (200) of the anatomical structure model (101), and Working base (900). The anatomical model (101) corresponds to the patient's equivalent anatomical structure and is composed of materials that simulate bones, cartilage, and skin; The three-dimensional digital model (200) of the anatomical structure model (101) allows training station users to interact with the representation of the anatomical structure model (101) through augmented reality and / or virtual reality systems; The working base (900) has a clamping system for securing the working base (900) to the surface for training, and also has an adjustable multi-functional wedge for changing the angle of the model during training; The anatomical model (101) mentioned above includes bone structure (300), cartilage structure (400) and soft tissue structure; The soft tissue structures mentioned above include nasal mucosa (701), muscle (700), fat and skin (800); The model of the anatomical structure (101) also includes a nylon mesh (605) located between the material of the simulated cartilage and the material of the simulated muscle (700). The nylon mesh is incorporated into the tail and anterior portions of the cartilage using a polyaddition-cured adhesive; and The nylon mesh is integrated into the nasal mucosa covering the septal cartilage.

2. The training station according to claim 1, wherein, The anatomical model (101) was obtained from diagnostic images from computed tomography scans.

3. The training station according to claim 1, wherein the soft tissue structure is composed of silicone rubber.

4. The training station according to claim 1, wherein, The model of the anatomical structure (101) is a head or neck structure selected from the group including the auricle, temporal bone, mandible or maxilla, or nasal structure.

5. The training station according to claim 1, wherein the anatomical model (101) is a nasal model.

6. The training station according to claim 1, wherein, The working base (900) includes a track connector (901), a mounting base (902), and a clamping system (908).

7. The training station according to claim 6, characterized in that, The track connector (901) includes a multi-functional wedge (904) that alters the tilt angle around the axis of the track connector (901).

8. The training station according to claim 6, wherein, The working base (900) also includes a bridge (905) which includes a mounting system for the instrument (906).

9. The training station according to claim 1, wherein, The nylon mesh (605) is arranged on one or more superior cartilages (603), inferior cartilages (606), nasal bones and / or the ascending ramus of the maxilla to simulate the perichondrium and / or periosteum during surgical training and to provide a reference for identifying anatomical planes.

Images