Alveolar bone graft (ABG) simulator and method of use.

Description

1 / 43 Alveolar bone graft (ABG) simulator and method of use.

[001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 455,354, filed March 29, 2023. Field of Invention

[002] This invention relates generally to the field of surgical simulation tools and methods for their manufacture and use, and more particularly to surgical simulation tools for procedures involving alveolar bone grafting (ABG). Background of the Invention

[003] The use of physical simulators is known in the field of surgical education and training to allow surgeons and students to practice techniques involved in successful surgical outcomes, not only to improve subsequent performance in the operating room, but also to allow for enhanced competency-based assessment of surgical students.

[004] Surgical simulators are particularly important for training in relation to technically challenging surgical procedures. Alveolar bone grafting surgery is required to repair the alveolar cleft, and the procedure is technically challenging to perform as it requires careful dissection of the soft tissue to create a watertight shell to enclose the harvested bone graft. The procedure is necessary to close the alveolar cleft, allowing the teeth to move to properly form the upper maxillary arch. In addition, closing the alveolar cleft closes the communication between the mouth and nose. The procedure requires an understanding of the three-dimensional shape of the cleft, as well as the numerous soft tissue mucosal flaps that need to be created to close the cleft. Petition 870250087554, dated 09 / 26 / 2025, pp. 171 / 246 2 / 43 These factors make the alveolar bone grafting procedure challenging to conceptualize. Simulators are therefore essential to provide a resource for the surgeon to practice this procedure.

[005] State-of-the-art physical simulator models are commonly overly simplistic and suffer from a lack of useful reflection of the actual anatomical details that would be encountered during surgical procedures conducted on patients, resulting in reliance on computational models and cadaver-based training. Computational models have obvious limitations as surgical training tools, and cadavers with the necessary physical conditions can be difficult to obtain.

[006] This deficiency in the availability of useful physical simulator models is evident in the context of alveolar bone grafting (ABG) procedures.

[007] U.S. Patent Application Publication No. 2014 / 0057236, owned by Simquest International LLC and filed August 21, 2013 (Simquest), describes a physical surrogate surgical interface that represents an interface between a user and a simulated patient in a simulated surgical scenario involving the manipulation of both simulated hard and soft tissues. More specifically, the disclosed invention involves the surgical simulation generator that renders the simulation state data in real time into a real-time computer-generated video representation of the surgical simulation and provides the real-time video representation to a monitor for real-time viewing by the user. As the user utilizes the simulator, the sensor(s) detect(s) the user's manipulation of the surrogate surgical interface. The simulator generator generates a real-time 3D surgical simulation of the scenario. Petition 870250087554, dated 09 / 26 / 2025, pp. 172 / 246 3 / 43 surgical based on manipulation detected by the sensor. Thus, the simulator described involves computer-generated video representation components to function.

[008] Other previous works focus on surgical simulators for specific types of procedures, such as the Endoscopic Endonasal Skull Base Trainer, described in Publication of PCT application WO / 2023 / 170598, filed by the All India Institute of Medical Sciences on September 14, 2023; and the Advanced Training System Mannequin Simulator with alveolar bone graft, described in Publication of US Patent Application No. 2023 / 0368701, filed by Teresa de Jesus Pannaci Padron on March 18, 2023.

[009] Although some initial efforts have been made in the area to create more useful and detailed physical models for practice and training, there is a deficiency in the specific context of alveolar bone grafting (ABG) surgical procedures.What is needed is a simulator for alveolar bone grafting (ABG) surgical procedures that: reflects the anatomical complexity involved in such biological conditions; is specifically configured as a simulation tool specific to such a biological condition; in which the elements have an interaction and overlap that reflect the condition and create a simulated interaction, overlap, and sensation similar to that of the condition and as found in surgical procedures performed related to such a condition, as a modality devoid of solid mandibular components; and in which the surgical simulator comprises a human face model in which a cartridge configured as an oral cavity incorporating an alveolar cleft can be removablely attached, and said model is removablely attachable to a base. What is additionally needed is a surgical simulator that allows... Petition 870250087554, dated 09 / 26 / 2025, pp. 173 / 246 4 / 43 Performing alveolar bone grafting surgical procedures in a realistic simulated environment, thus allowing residents to practice the procedure to gain experience before operating on human patients. Summary of the Invention

[010] In one aspect, the present disclosure relates to an alveolar bone graft surgery simulator comprising: a cartridge configured to incorporate an oral cavity having an alveolar cleft formed therein; a model resembling a human face, to which the cartridge is removablely attached, and a base configured to be removablely attached to the model and the cartridge.

[011] In another aspect, the present description refers to the alveolar bone graft surgery simulator, in which the cartridge incorporates bone components and soft tissue components configured to form a maxilla having a gap in the alveolus.

[012] In another aspect, the present description refers to the alveolar bone graft surgery simulator, in which the connection between the model and the base is operable to: maintain the model in an orientation that is the orientation of a face during an alveolar bone graft surgical procedure; and stabilize the model during a simulation of alveolar bone graft surgery performed on the alveolar bone graft surgery simulator.

[013] In another aspect, the present description refers to the alveolar bone graft surgery simulator, in which the model is devoid of solid mandibular components.

[014] In another aspect, the present description refers to the alveolar bone graft surgery simulator, in which a retraction assistance device is removablely attached to the base and functions to provide retraction of the cartridge and model elements during use of the simulator. Petition 870250087554, dated 09 / 26 / 2025, pp. 174 / 246 5 / 43 Alveolar bone graft surgery.

[015] In another aspect, the present description refers to the alveolar bone graft surgery simulator, in which a clamp is attached in a removable manner to the base and said clamp is operable to maintain the alveolar bone graft simulator in a stable and stationary position.

[016] In another aspect, the present description refers to a method for forming an alveolar bone graft surgery simulator consisting of: forming a cartridge by superimposing simulated physiological tissues over a simulated maxillary bone to form an alveolar cleft, said maxillary bone having a base connector component formed thereon; forming a facial component simulating human facial skin and incorporating facial connector elements into the posterior part of said facial component; attaching the facial component to the cartridge to produce a simulated human head or a portion thereof having an alveolar cleft formed thereon; and attaching the combined cartridge and facial component to a base by connecting the facial connector elements to the corresponding base pins, connecting the base connector on the maxillary bone to the corresponding grooves in the base.

[017] In another aspect, the present description refers to a method for performing alveolar bone grafting surgery on an alveolar bone grafting surgery simulator, consisting of: assembling the alveolar bone grafting surgery simulator by connecting a cartridge configured to incorporate an oral cavity having an alveolar cleft formed therein to a base configured to attach in a removable manner to the model; and performing alveolar bone grafting surgery on the alveolar bone grafting surgery simulator.

[018] In this regard, before explaining at least one modality of Petition 870250087554, dated 09 / 26 / 2025, pp. 175 / 246 6 / 43 invention in detail, it should be understood that the invention is not limited in its application to the construction details and component arrangements set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and executed in various ways. Furthermore, it should be understood that the phraseology and terminology used herein are for descriptive purposes only and should not be considered limiting. Brief Description of the Drawings

[019] The invention will be better understood and its objectives will become evident when the following detailed description is considered. This description refers to the accompanying drawings, in which:

[020] FIG. 1 is a front perspective view of a base component of an embodiment of the present invention.

[021] FIG. 2 is a side perspective view of a maxillary component of an embodiment of the present invention, showing extensions for holding the maxilla.

[022] FIG. 3 is a top perspective view of a maxillary component of an embodiment of the present invention, showing extrusions for attaching teeth thereto.

[023] FIG. 4 is a bottom perspective view of a maxillary component of an embodiment of the present invention, showing a defect in the palate formed therein.

[024] FIG. 5 is a rear perspective view of a jaw component of an embodiment of the present invention.

[025] FIG. 6 is a front perspective view of a jaw component of an embodiment of the present invention having a screen attached to it.

[026] FIG. 7 is a front view of a facial layer of a Petition 870250087554, dated 09 / 26 / 2025, pp. 176 / 246 7 / 43 embodiment of the present invention.

[027] FIG. 8 is a rear view of a facial layer of an embodiment of the present invention.

[028] FIG. Figure 9 is a front view of a component of the upper face mold for covering the facial component of an embodiment of the present invention.

[029] Figure 10 is a rear view of a component of the upper face mold for casting the facial component of an embodiment of the present invention, showing the recesses formed therein.

[030] Figure 11 is a base of the mold for casting the facial component of an embodiment of the present invention, showing the extrusions formed on it.

[031] Figure 12 is a component of the face mold for casting the face component of an embodiment of the present invention, showing the recesses formed therein.

[032] Figure 13 is an assembled mold for casting the facial component of an embodiment of the present invention.

[033] Figure 14 is a front view of a layer of the molded face of an embodiment of the present invention.

[034] Figure 15 is a rear view of a layer of the molded face of an embodiment of the present invention.

[035] Figure 16 is a bottom view of tooth components of an embodiment of the present invention.

[036] Figure 17 is a top view of tooth components of an embodiment of the present invention.

[037] Figure 18 is a perspective view of tooth components of an embodiment of the present invention, showing the interlocking features formed therein. Petition 870250087554, dated 09 / 26 / 2025, pp. 177 / 246 8 / 43

[038] Figure 19 is a perspective view of a maxillary component of an embodiment of the present invention, mounted on a rod for rotation of the maxilla.

[039] Figure 20 is a side perspective view of a jaw component of an embodiment of the present invention, showing a shellac coating applied to it.

[040] Figure 21 is a top perspective view of a jaw component of an embodiment of the present invention, showing a shellac coating applied thereto.

[041] Figure 22 is a bottom perspective view of a maxillary component of an embodiment of the present invention, showing a shellac coating applied thereto.

[042] Figure 23 is a rear perspective view of a maxillary component of an embodiment of the present invention, showing a shellac coating applied thereto.

[043] Figure 24 is a side perspective view of a maxillary component of an embodiment of the present invention, showing a silicone coating applied thereto.

[044] Figure 25 is a top perspective view of a maxillary component of an embodiment of the present invention, showing a silicone coating applied thereto.

[045] Figure 26 is a perspective view of a maxillary component of an embodiment of the present invention, showing a silicone coating applied thereto.

[046] Figure 27 is a rear perspective view of a maxillary component of an embodiment of the present invention, showing a silicone coating applied thereto. Petition 870250087554, dated 09 / 26 / 2025, pp. 178 / 246 9 / 43

[047] Figure 28 is a side perspective view of a jaw component of an embodiment of the present invention, showing a screen piece attached to it, coated with silicone.

[048] Figure 29 is a top perspective view of a jaw component of an embodiment of the present invention, showing a screen piece attached to it, coated with silicone.

[049] Figure 30 is a bottom perspective view of a maxilla component of an embodiment of the present invention, showing a screen piece attached to it, coated with silicone.

[050] Figure 31 is a rear perspective view of a jaw component of an embodiment of the present invention, showing a mesh piece attached to it, coated with silicone.

[051] Figure 32 is a side perspective view of a maxillary component of an embodiment of the present invention, showing a first mucosal layer coating applied thereto.

[052] Figure 33 is a top perspective view of a maxillary component of an embodiment of the present invention, showing a first mucosal layer coating applied thereto.

[053] Figure 34 is a bottom perspective view of a maxillary component of an embodiment of the present invention, showing a first mucosal layer coating applied thereto.

[054] Figure 35 is a rear perspective view of a maxillary component of an embodiment of the present invention, showing a first mucosal layer coating applied thereto.

[055] Figure 36 is a side perspective view of a maxillary component of an embodiment of the present invention, showing multiple layers of fat coatings applied thereto. Petition 870250087554, dated 09 / 26 / 2025, pp. 179 / 246 10 / 43

[056] Figure 37 is a top perspective view of a maxillary component of an embodiment of the present invention, showing multiple layers of fat coatings applied thereto.

[057] Figure 38 is a bottom perspective view of a maxillary component of an embodiment of the present invention, showing multiple layers of fat coatings applied thereto.

[058] Figure 39 is a rear perspective view of a maxillary component of an embodiment of the present invention, showing multiple layers of fat coatings applied thereto.

[059] Figure 40 is a rear view of the facial layer component of an embodiment of the present invention, showing an adhesive applied thereto.

[060] Figure 41 is a top perspective view of a jaw component of an embodiment of the present invention, showing an adhesive applied thereto.

[061] Figure 42 is a side view of a facial layer component attached to a maxilla of an embodiment of the present invention.

[062] Figure 43 is a front view of a facial layer component attached to a maxilla of an embodiment of the present invention.

[063] Figure 44 is a bottom view of a facial layer component attached to a maxilla of an embodiment of the present invention.

[064] Figure 45 is a top view of a facial layer component attached to a maxilla of an embodiment of the present invention.

[065] Figure 46 is a rear view of a facial layer component attached to a maxilla of an embodiment of the present invention.

[066] Figure 47 is a posterior view of the exposed palate of a facial layer component attached to a maxilla of an embodiment of Petition 870250087554, dated 09 / 26 / 2025, pp. 180 / 246 11 / 43 present invention.

[067] Figure 48 is a rear view of a facial layer component attached to a maxilla of an embodiment of the present invention, showing the second and third mucosal layers applied thereto.

[068] Figure 49 is a posterior view of the exposed palate of a facial layer component attached to a maxilla of an embodiment of the present invention, showing the second and third mucosal layers applied thereto.

[069] Figure 50 is an underview of the exposed palate of a facial layer component attached to a maxilla of an embodiment of the present invention, showing the teeth attached thereto.

[070] Figure 51 is an inferior perspective view of the exposed palate of a facial layer component attached to a maxilla of an embodiment of the present invention, showing the teeth attached thereto.

[071] Figure 52 is a side perspective view of the exposed palate of a facial layer component attached to a maxilla of an embodiment of the present invention, showing the teeth attached thereto.

[072] Figure 53 is a side perspective view of the exposed palate of a facial layer component attached to a maxilla of an embodiment of the present invention, showing the teeth attached thereto.

[073] Figure 54 is a top perspective view of a component of the base of the surgical simulator of an embodiment of the present invention.

[074] Figure 55 is a top perspective view of a component of the stabilizing plate of an embodiment of the present invention.

[075] Figure 56 is a top perspective view of a surgical simulator support of an embodiment of the present invention, formed by a stabilizing plate component fixed to a base component of the Petition 870250087554, dated 09 / 26 / 2025, pp. 181 / 246 12 / 43 surgical simulator.

[076] Figure 57 is a top view of a surgical simulator support of an embodiment of the present invention, showing the fittings formed therein.

[077] Figure 58 is a front perspective view of a surgical simulator support of an embodiment of the present invention, showing the extrusions formed in it.

[078] Figure 59 is a side perspective view of a surgical simulator support of an embodiment of the present invention, showing depressions formed in it.

[079] Figure 60 is a side perspective view of a pin of an embodiment of the present invention.

[080] Figure 61 is a front view of a clamp of an embodiment of the present invention.

[081] Figure 62 is a side view of a clamp of an embodiment of the present invention.

[082] Figure 63a is a front view of a clamp attachment component of an embodiment of the present invention, showing the extrusion formed therein.

[083] Figure 64 is a threaded screw of an embodiment of the present invention.

[084] Figure 65 is a clamp body of an embodiment of the present invention.

[085] Figure 66 is a clamp-type pressure cap of an embodiment of the present invention.

[086] Figure 67 is a lower arm component of an embodiment of the present invention. Petition 870250087554, dated 09 / 26 / 2025, pp. 182 / 246 13 / 43

[087] Figure 68 is a component of a spherical arm support connector of an embodiment of the present invention.

[088] Figure 69 is a component of the base of the arm of an embodiment of the present invention.

[089] Figure 70 is a component of the spherical support connector of the lower arm of an embodiment of the present invention.

[090] Figure 71 are components of the upper arm of an embodiment of the present invention.

[091] Figures 72 and 73 are assembled retraction arms of an embodiment of the present invention.

[092] Figure 74 is an assembled retraction assist device of an embodiment of the present invention.

[093] Figure 75 is an exploded view of the surgical simulator of an embodiment of the present invention.

[094] Figure 76 is a lower front view of the surgical simulator of the present invention, showing the assembled facial component, positioned for attachment to the surgical simulator support.

[095] Figure 77 is a bottom front view of the assembled surgical simulator of the present invention.

[096] Figure 78 is a side view of the surgical simulator of the present invention, showing the assembled facial component, positioned for attachment to the surgical simulator support.

[097] FIG. 79 is a side view of the assembled surgical simulator of the present invention showing the safety pin attaching the components of the surgical simulator.

[098] Figure 80 is an exploded view of the surgical simulator of an embodiment of the present invention, showing the alignment of the depressions. Petition 870250087554, dated 09 / 26 / 2025, pp. 183 / 246 14 / 43 formed in the facial component with the extrusions formed in the surgical simulator support.

[099] Figures 81 to 83 are lower front views of the assembled surgical simulator of an embodiment of the present invention, showing the facial component supported on pins and varying the positions of the connection between the depressions in the facial component and the pins.

[100] Figure 84 is a bottom view of the surgical simulator of an embodiment of the present invention, showing the adhesion parts attached thereto.

[101] Figure 85 is a top view of an assembled surgical simulator having a clamp attached to it, of an embodiment of the present invention.

[102] Figure 86 is a bottom front view of an assembled surgical simulator with a clamp attached to it, of an embodiment of the present invention.

[103] Figures 87 and 88 are top views of a retraction assist device coupled to retract a portion of the facial component of the surgical simulator of an embodiment of the present invention.

[104] Figure 89 is a lower front view of a surgical simulator positioned for use in an alveolar bone grafting (ABG) procedure.

[105] Figure 90 is a rear view of a surgical simulator positioned for use in an alveolar bone grafting (ABG) procedure.

[106] Figures 91 to 118 are top views of a surgical simulator having an alveolar bone graft (ABG) procedure performed in an embodiment of the present invention.

[107] In the drawings, embodiments of the invention are illustrated by way of example. It should be expressly understood that the description and drawings are for illustrative purposes only and to aid understanding, and are not intended to define Petition 870250087554, dated 09 / 26 / 2025, pp. 184 / 246 15 / 43 the limits of the invention. Detailed Description of Preferred Modality

[108] A simulator for the practice of alveolar bone grafting (ABG) surgery, comprising: a cartridge configured to incorporate an oral cavity having an alveolar cleft formed therein; a model resembling a human face, to which the cartridge can be attached in a removable manner, and a base configured for removable attachment to the model. Such a simulator is specifically configured to reflect the physical elements of an oral cleft that can be repaired by an ABG and comprising elements that are formed from materials with characteristics similar to the corresponding elements of such a human cleft. The elements are individually formed and connected in such a way as to form: layers of elements; and positioning and interactions between the elements to aid in the training of ABG surgical skills.Surgical procedures for ABG can be performed on the simulator, using the same instruments and surgical steps, and providing the same sensation as performing surgery on a human individual.

[109] The present invention is a simulator for the practice of alveolar bone grafting surgery, comprising: a simulated premaxilla bone; and a simulated prolabium tissue, attached in a separable manner to the simulated premaxilla bone. Such a simulator is configured to comprise elements in an assembly that is similar in characteristic to the corresponding elements of an oral cleft in which an ABG surgical procedure can be performed. The configuration of the surgical simulator promotes the learning and training of skills related to the oral cleft and its correction by an ABG surgical procedure. Surgical procedures that can be performed on a human oral cleft can be performed on the simulator. The similarities in Petition 870250087554, dated 09 / 26 / 2025, pp. 185 / 246 16 / 43 appearance and feel with a human oral cleft enhance the learning of surgical skills by users of the simulator invention.

[110] Throughout the following description, specific details are set forth in order to provide a more complete understanding of the invention, particularly for those skilled in the art. Notably, well-known elements, which would be known to those skilled in the art, may not have been shown or described in detail to avoid unnecessarily obscuring the description. The following description of examples of the invention is not intended to be exhaustive or to limit the invention to the precise form of any exemplary embodiment. Thus, the description and drawings should be considered in an illustrative, and not restrictive, sense.

[111] The present invention is directed to a simulator for the practice of alveolar bone grafting surgery, comprising a cartridge incorporating simulated human elements existing in an oral cleft, including a maxillary bone. The present invention further incorporates simulated tissue attached in a separable manner to the simulated maxillary bone. A simulated oronasal fistula is formed in the maxillary bone to simulate an oral cleft in the maxillary bone. Simulated periosteal, mucosal, and fat layers are attached to the maxillary bone. The maxillary portion forms the cartridge component of the invention.

[112] The simulator of the present invention further comprises a multilayered simulated facial skin, comprising the lower portion of a human face, extending from the nasal skin to the chin of a human face, and incorporating a portion of complete lips that can be opened and retracted, like the lips of a human mouth area.

[113] All references to elements of an oral cleft herein are references to simulated elements, created in accordance with the present invention, Petition 870250087554, dated 09 / 26 / 2025, pp. 186 / 246 17 / 43 as described here. The word "simulated" does not appear before references to all of these elements, but it should be interpreted in each reference to such elements, since all elements of the simulator are simulated elements.

[114] There are several processes that can be applied to the formation of the elements of the present invention. Some of these processes are described here. Each element is created individually and then assembled with the other elements to form the simulator, as described herein.

[115] Generally, elements are added to the simulator assembly individually, according to steps that result in the positioning of some elements in layers (where elements are positioned above or below other elements). Connections between elements are additionally formed in order to create interactions between elements, for example, movement relative to other elements, processes required to highlight elements from one another. The present invention may be anatomically accurate, or nearly so, when compared to a human oral cleft and the portions of a human head that will be accessed during an alveolar bone grafting surgical procedure. However, the simulator is additionally created to reflect connections, element positioning, and interactions between elements that are similar to an oral cleft and the portions of a human head that will be accessed during an alveolar bone grafting surgical procedure.

[116] Furthermore, since the simulator elements are created individually and assembled by positioning and connecting the elements, the positions and connections of such elements can be modified in different versions of the simulator. Such variations will further affect the interactions of the elements with each other and the experience of a user performing a surgical or other procedure. Petition 870250087554, dated 09 / 26 / 2025, pp. 187 / 246 18 / 43 learning in the simulator. An experienced reader will recognize that these features and the modifiability of the present invention allow versions of the present invention to be used for a variety of purposes related to learning, skills training, and other purposes related to alveolar bone grafting surgeries and other activities.

[117] Many methods and processes can be applied to the creation of the simulator elements and their assembly. For example, the elements can be generated by 3D printing, molds, and other processes. Below are provided some examples or processes for creating and assembling the elements of the present invention to form embodiments of the present invention. Other processes or variations of the processes described below are possible for creating and assembling the simulator of the present invention; furthermore, other elements besides those described below can be formed and assembled in the present invention.

[118] The simulator of the present invention incorporates three main elements: a cartridge, a face layer attachable to the cartridge, and a cartridge base (or otherwise referred to as the simulator support). These elements, their sub-elements, and the assembly and function of each to form the simulator of the present invention are described below. The description is an example of one embodiment of the present invention, and variations are possible to form other embodiments of the present invention.

[119] The elements of the oral cleft that can be corrected by an alveolar bone grafting surgical procedure can be configured in a cartridge. The cartridge can be removablely connected to a facial model to form a lower head component. The cartridge and the lower head component are attachable to the simulator base element (being a simulator support) to form the fully assembled simulator. Petition 870250087554, dated 09 / 26 / 2025, pp. 188 / 246 19 / 43 When connected to the base element of the simulator, a surgical procedure can be performed on the cartridge element, including when the cartridge element is combined with the facial model. The base element of the simulator provides stability for the elements in the cartridge during an alveolar bone graft surgical procedure or during any other surgical procedure or oral cleft training for which the simulator may be used.

[120] One embodiment of the present invention incorporates a cartridge that includes the main components of the simulator, said cartridge being removable and attachable to a base component (being a support for the simulator). Said cartridge comprises an oral cavity that can be retracted during a simulated intraoral procedure. Said oral cavity incorporates a bony component and a soft tissue component of the maxilla with a cleft in the alveolus. Said cleft in the alveolus being either a unilateral cleft involving a larger and a smaller segment, or a bilateral cleft involving two smaller segments and a midline premaxilla. All references to the oral cleft herein further refer to any of the clefts described above in the alveolus. Said bony component includes a nasal cavity and a palate. Maxillary teeth are attachable to the bony component.

[121] The soft tissue is layered over the bony component, which may be a bony component of the maxilla. Said soft tissue comprises synthetic periosteum, mucosa, and gingiva. The skin of the facial component additionally comprises soft tissue. The periosteum, mucosa, and gingiva are positioned to be layered over the bony component and in relation to each other in a manner that simulates the positioning of this soft tissue within a human head. The periosteum is attached to the bony component with a dissection plane between them, which allows for realistic separation during the Petition 870250087554, dated 09 / 26 / 2025, pp. 189 / 246 20 / 43 simulated surgery. A mucosal layer lies in layers over the periosteum. This mucosal layer may comprise multiple layers, making it separable with a dissecting instrument. A gingival layer also lies in layers over the periosteum. This gingival layer tapers towards the maxillary teeth.

[122] The oral cavity of the similar may include a superior buccal sulcus. It may additionally incorporate an oronasal fistula. The size of the cleft formed in the cartridge may vary according to the type of cartridge incorporated into the simulator. Furthermore, the cleft segments may exhibit variable separation in the coronal, sagittal, and axial planes.

[123] The aforementioned embodiment of the present invention further incorporates a facial component having a mouth formed within it, through which the oral cavity is accessible when the facial component is attached to the cartridge. The attachment between said facial component and the cartridge may be a removable attachment or a fixed attachment.

[124] When assembled, the simulator comprises larger and smaller segment mucoperiosteal flaps that can be dissected from the simulated bone. In addition, mucoperiosteal flaps with the nasal side facing upwards can be created, and mucoperiosteal flaps with the palatal side facing downwards can be created.

[125] One embodiment of the present invention can be understood as being used in any of the following ways:

[126] i. The nasal and palatal flaps can be separated.

[127] ii. The mucosa, gingiva and periosteum can be cut.

[128] iii. Synthetic soft tissue can be sutured.

[129] iv. A complete alveolar bone graft surgery can be performed, involving cutting, dissection, separation of layers and suturing of Petition 870250087554, dated 09 / 26 / 2025, pp. 190 / 246 21 / 43 soft tissues joints.

[130] v. A simulated tissue can be inserted into the site of the cleft to simulate the bone graft itself.

[131] The materials used to form the elements of the present invention may vary. Hard tissue, such as the bone component, may be formed from any material with firm quality.

[132] Soft tissue elements can be formed from any material with a soft quality. In embodiments of the present invention, a variety of materials can be used. Some materials are expressly identified herein; however, other materials having similar characteristics and properties can also be used to form the elements of the present invention. As examples: elements that are simulations of soft tissues can be formed from any polymer, for example, silicone or urethane. Soft tissue elements can be formed from such material by casting (for example, in a mold), 3D printing, or any other process. Examples of silicones that can be used to form simulated soft tissue elements include DragonSkin™ (Smooth-On), EcoFlex™ (Smooth-On), and platinum-cured silicones.Simulated bone elements can be formed from materials such as polylactic acid, acrylonitrile butadiene styrene (ABS), or other polymers. Bone elements can be formed from these materials by casting using ABS molds or other polymers, or by 3D printing with polylactic acid or other materials usable for 3D printing. 3D-printed simulated bone elements can be formed using a fused deposition type 3D printer or a stereolithographic or light-curing type 3D printer. The descriptions of the use of specific materials set forth herein are examples of materials used in some embodiments of the present invention, and other materials. Petition 870250087554, dated 09 / 26 / 2025, pp. 191 / 246 22 / 43 could be used in other embodiments of the present invention.

[133] Embodiments of the present invention may incorporate some elements. The following are examples:

[134] a. Any intervening interface can be incorporated between different layers and components within the soft tissue.

[135] b. Any intervening interface may be incorporated between the hard and soft tissue components.

[136] c. A material can be incorporated to fill the alveolar gap.

[137] d. The cartridge may incorporate either a unilateral or bilateral alveolar cleft comprising a premaxilla and two adjacent alveolar clefts on each side, as well as two smaller adjacent segments on each side of the cleft.

[138] As discussed herein, surgical instruments used in an alveolar bone grafting surgical procedure performed on a human being can be used with the simulator. Embodiments of the present invention may further comprise a self-retracting system that is removablely attachable to the base of the simulator (the simulator support). Such uses of self-retracting systems may incorporate right-angle retractors, positionable to retract the oral cavity. Such a self-retracting system may be used, for example, to allow a single person to perform procedures on the simulator that require retraction, without the assistance of others to hold the retractor during the procedure.

[139] The present invention offers several benefits over the known state of the art. One of these benefits is that the present invention is specifically configured to reflect the main physical elements of an oral cleft in which an alveolar bone grafting surgical procedure can Petition 870250087554, dated 09 / 26 / 2025, pp. 192 / 246 23 / 43 to be performed, including the interactions between these physical elements that simulate the interactions in human physiology.

[140] Another benefit of the present invention in relation to the known prior art is that the elements of the simulator (e.g., bone, tissue, and other elements) are formed from materials that have physical characteristics similar to those of the physical elements they represent. For example, bone elements are formed from materials that reflect the density, hardness, and other characteristics of human facial bones, tissue elements are formed from materials that have the flexibility, elasticity, and other characteristics of human facial tissue, and other elements in the simulator are also formed from materials that have characteristics similar to the physical human facial elements they represent.

[141] Yet another benefit of the present invention in relation to the known state of the art is that the configuration of the simulator elements reflects the anatomical complexities of a human face incorporating an oral cleft that is correctable by an alveolar bone graft.

[142] Another benefit of the present invention in relation to the known state of the art is that it is configured through an overlapping of elements to compose the simulator. The elements are formed individually and then configured in such a way that the elements are attached to other elements in a manner similar to the configuration and connections of a human oral cleft correctable by an alveolar bone grafting surgical procedure. The effect of the overlapping is to create elements that are not only positioned in a manner similar to human physiology, but that have similar connections and interactions with each other, in a manner similar to the elements of applicable human physiology. In particular, the ability to move certain elements within the simulator, and to move them in relation to others. Petition 870250087554, dated 09 / 26 / 2025, pp. 193 / 246 24 / 43 elements, during a surgical procedure performed on the simulator, will be similar to the experience of performing an alveolar bone grafting procedure on a human being. The layers of elements that must be addressed in an alveolar bone grafting procedure on a human being are reflected in the simulator. Furthermore, the action of separating elements from other elements within the simulator during a surgical procedure performed on the simulator will be similar to the experience of performing an alveolar bone grafting procedure on a human.

[143] An additional benefit of the present invention in relation to the prior art is that it allows the simulator to be used not only to simulate the manipulation of elements in an alveolar bone grafting surgical procedure, but also for the user to experience a sensation similar to the elements involved in such a surgical procedure. This facilitates learning, which better reflects the reality of performing an alveolar bone grafting surgical procedure on a human being, which can reduce the likelihood of errors on the part of a surgeon who has trained their surgical skills with the simulator. The formation of the simulator elements further promotes other forms of learning related to the oral cleft condition requiring alveolar bone grafting, such as visual identification and positioning of the elements, interactions between the elements, and other types of related learning. Simulator Components and Assembly Cartridge Components

[144] One embodiment of the present invention can be formed according to the following process, comprising the elements and components described below. Component 1: Maxilla Petition 870250087554, dated 09 / 26 / 2025, pp. 194 / 246 25 / 43

[145] The maxilla component 10, as shown in FIG. 1, is a bone component of the cartridge of the present invention. In embodiments of the present invention, the maxilla component can be 3D printed with Elegoo Mars3 Pro using water-washable white resin (2.5 s exposure, 35 s bottom layer exposure, 0.05 mm layer height). The maxilla component can also be formed in other ways from materials that simulate the feel of a human maxilla bone. As shown in FIG. 2, the maxilla component can incorporate a maxilla connector element 12, whereby the maxilla is removable and connectable to a base construction element 14.Such a connection can be made by inserting the connector element into a groove or recess in the base construction element, or the base construction element can incorporate an extrusion extending from it, which can be aligned with the connector element, and the extrusion and the connector element can be connected by an adhesive or other accessory. FIGS. 4 to 5 further show the jaw component 10 attached to a base construction element 14. The base construction element can be used to stabilize the jaw element during the cartridge forming process.

[146] As shown in FIG. 3, the maxillary component may incorporate extrusions that are formed as tooth connections 16. Through which the teeth are attachable to the maxillary component. As shown in FIG. 4, the maxillary component is formed to incorporate a palatal defection 18 that forms a portion of the oral cleft incorporated into the cartridge and is the base portion of that oral cleft. Component 2: Mesh

[147] Mesh components 20 and 22 can be attached to the jaw component. As shown in FIG. 6, the mesh components Petition 870250087554, dated 09 / 26 / 2025, pp. 195 / 246 26 / 43 may have different shapes to accommodate a 22 mesh element for the cleft side and a mesh element for the non-cleft side. The mesh element for the cleft side will be positioned on the side of the maxilla where the oral cleft will be formed, and the mesh component for the non-cleft side will be positioned on the other side of the maxilla. The mesh components may be in the form of high-power mesh. Other materials may also be used for the mesh components. The shape of each mesh component may be traced from the maxillary component, as traced along the nasal cavity and gingiva formed in the maxilla. Component 3: Face

[148] The facial component 24, as shown in FIG. 7, is molded to simulate human facial skin. As shown in FIG. 8, the back of the facial component may additionally comprise one or more facial connectors 26, by means of which the facial component is attachable to the cartridge.

[149] The facial component can be created using a mold. The mold can be a printed mold. Such a mold can consist of multiple subcomponents. For example, as shown in Figures 9 to 12, a mold can consist of a back mold component 28, a front mold component 30, and a base mold component 32. Each subcomponent can be printed with Ultimaker 3 using PLA (10% infill; 0.15 mm layer height; supports only for subcomponent 4,2). Other methods for creating the mold and any of its components and other materials can also be used.

[150] A mold used to form the facial component is assembled by fitting the upper extrusions of the mold base 36 formed on the mold base (as shown in Figure 11) into the corresponding indentations of the Petition 870250087554, dated 09 / 26 / 2025, pp. 196 / 246 27 / 43 rear mold 34 formed in the rear mold component (as shown in Figure 10); and fitting of the lower extrusions 38 of the mold base formed in the mold base (as shown in FIG. 11) into the corresponding front indentations 40 formed in the front mold component (as shown in FIG. 12).

[151] The mold can be held together with clamps, C-clamps, or another mechanism that keeps the assembled parts in a static position while the silicone is poured into the mold. The mold will form the facial components after the curing of the material used to form the facial component (for example, 2 to 4 hours may be required for the silicone to cure). In one embodiment of the present invention, Ecoflex20 silicone (dark flesh color; 150 mL) can be used to form a facial component using a printed mold. Component 4: Teeth

[152] One or more tooth components 42 may be incorporated in the present invention. For example, one embodiment of the present invention may incorporate ten tooth components, as shown in FIG. 16. The teeth may be batch 3D printed with the Elegoo Mars3 Pro using water-washable white resin (2.5 s exposure; 35 s bottom layer exposure; 0.05 mm layer height). Other materials and methods may be applied to form the tooth components. As shown in FIG. 17, each tooth component may be molded to incorporate a recess 44 therein, which is configured to attach to a tooth connection 16. Cartridge Manufacturing Process

[153] Several steps are involved in the manufacture of the cartridge. Below is an example of the steps performed in one embodiment of the present Petition 870250087554, dated 09 / 26 / 2025, pp. 197 / 246 28 / 43 invention. Alternative manufacturing steps and processes may be applied in other embodiments of the present invention. Step 1: Jaw coating component

[154] One or more layers of a coating 48 may be applied to the outer surface of the jaw component 10. For example, a shellac coating may be applied to the outer surface of the jaw component. Other materials may be used for the coating. The coating mediates the adhesion between the jaw component and materials, such as silicone, used to form other layers incorporated into the cartridge.

[155] In one embodiment of the present invention, as shown in FIG. 19, the jaw component 10 can be mounted on a rotating skewer 46 and the rotating skewer can function to rotate and thus rotate the jaw component. A brush can be used to apply a shellac coating to all exposed surfaces of the jaw component. After the shellac coating has dried (e.g., approximately 30 minutes), the procedure can be repeated to apply more than one layer (e.g., at least 4 layers of shellac coating). Step 2: Painting the first periosteal layer

[156] A first periosteal layer 50 can be formed over the maxillary component and thus incorporated as a layer of the cartridge. For example, a silicone can be used to create the first periosteal layer. Other materials can be used for the first periosteal layer.

[157] In one embodiment of the present invention, a first periosteal layer can be formed using a brush to paint a thin layer of Dragonskin-fx pro silicone (white color; 3 mL) onto the maxillary areas of the maxillary component (as shown in Figures 24 to 27). The silicone must cure (in approximately 30 minutes) before the start of the next step. Petition 870250087554, dated 09 / 26 / 2025, pp. 198 / 246 29 / 43 Step 3: Application of the mesh and painting of the second periosteal layer.

[158] A second periosteal layer 52 can be formed over the maxillary component and thus incorporated as a cartridge layer. For example, a combination of one or more mesh elements overlaid on the first periosteal layer and a silicone layer applied to these mesh elements can be used to create the second periosteal layer. Other materials can be used for the first and second layers.

[159] In one embodiment of the present invention, the second periosteal layer can be formed by matching the edges of the mesh elements with the corresponding edges of the nasal cavity and gingiva to identify where the second periosteal layer should be positioned relative to the maxillary component. A brush can be used to apply a layer of Dragonskin-fx pro silicone (white color; 3 mL) over the previous periosteal layer. The silicone should cure (in approximately 30 minutes) before the start of the next step, and care should be taken to ensure that the mesh elements are fixed throughout the curing process.

[160] Together, the first periosteal layer and the second periosteal layer form the periosteum within the sheath. Step 4: Application of the first mucosal layer

[161] A first mucosal layer 54 can be formed as a layer over the maxillary component and thus be incorporated as a layer of the cartridge. For example, a silicone can be used to create the first mucosal layer. Other materials can be used for the first mucosal layer.

[162] In one embodiment of the present invention, the first mucosal layer can be formed using a syringe to dispense Dragonskin-fxpro silicone (light red color; 7 mL) onto the maxillary component. The Petition 870250087554, dated 09 / 26 / 2025, pp. 199 / 246 The 30 / 43 jaw component can be attached to a rotating skewer that functions to rotate and thus spins the jaw component. The rotating motion applied by the rotating skewer will distribute the silicone evenly, resulting in the formation of a thin layer. The silicone must cure (in approximately 30 minutes) before the next step begins. Step 5: Applying the layers of fat

[163] One or more layers of fat 56 can be formed as a layer over the jaw component and thus be incorporated as a layer of the cartridge. For example, a silicone can be used to create one or more layers of fat. Other materials can be used for one or more layers of fat.

[164] In one embodiment of the present invention, the first layers of fat can be formed by positioning the maxillary component so that the lower part of the maxillary component faces upwards. A brush can be used to paint two layers of Dragonskin-fx pro silicone (dark red color; 3 mL) onto the maxillary areas of the anterior mucosal layer. The silicone must cure (in approximately 30 minutes) before the application of another layer of fat and, once all layers of fat have been added, before the start of the next step.

[165] The positioning, thickness and exact characteristics of each layer formed in the cartridge will be in accordance with the requirements of the corresponding physical element in a human being being formed. Step 6: Attaching the facial component to the cartridge.

[166] Once the layers discussed here are in place, the cartridge is superimposed on the maxilla, and the cartridge can be attached to the facial component. The cartridge can be attached by means of an adhesive or by other means by which the cartridge and the facial component are firmly attached in a manner Petition 870250087554, dated 09 / 26 / 2025, pages 200 / 246 31 / 43 that the accessory does not slip or come loose. The accessory may be a fixed or removable fixed attachment. Various attachment methods may be used in the embodiment of the present invention.

[167] In one embodiment of the present invention, the facial component can be attached to the cartridge after the maxillary component is disassembled from the rotating grid. Loctite SF7701 primer and Loctite 4851 adhesive can be used to bond the facial component to the maxillary component. Such adhesive can be applied to areas of the facial component and to areas of the cartridge (for example, along the dotted lines 58 shown in FIGS. 40 and 41).

[168] Examples of the facial component 24 attached to the cartridge 60 are shown in FIGS. 42 to 47. When the facial component is attached to the cartridge, the result incorporates all of the following physiological elements, as shown in FIG. 91: Mucosa, Sulcus, Gingiva, Papilla, Teeth, Lower lip, Larger segment, Smaller segment, Upper lip, Oronasal fistula and Alveolar cleft. Step 7: Application of two more layers of mucosa

[169] One or more additional mucosal layers 62 may be formed as a layer over the cartridge 60 after the facial component is attached to the cartridge. For example, a silicone may be used to create one or more additional mucosal layers. The facial component 24 should be positioned to expose the palatal section 64 of the cartridge (as shown in FIG. 49). Other materials may be used for one or more additional mucosal layers.

[170] In one embodiment of the present invention, additional mucosal layers can be formed by reassembling the maxilla onto the rotating grid and initiating rotation of the rotating grid. The facial component can be flipped to expose the palatal section of the cartridge. A syringe can be used to dispense two Petition 870250087554, dated 09 / 26 / 2025, pp. 201 / 246 Apply 32 / 43 layers of Dragonskin-fxpro silicone (light red color; 7 mL) to the maxillary component. The silicone must cure (in approximately 30 minutes) before applying another mucosal layer and, once all mucosal layers have been added, before starting the next step. Step 8: Attaching the dental component to the model.

[171] Dental components 42 can be attached to the cartridge (as shown in FIGS. 51 to 53). Such attachment can occur by aligning a toothed connection formed in the cartridge with a toothed recess formed in a dental component. The tooth areas can be cleaned with a knife as needed (e.g., to remove silicone or other materials). Dental components can be attached to the cartridge by various means and materials, including by means of a sustained attachment by force pressures between the dental connection and the toothed recess, or by means of an adhesive, or by other means or materials.

[172] In one embodiment of the present invention, dental components can be attached to the cartridge using Loctite SF7701 primer and Loctite 4851 adhesive. Such adhesives can be applied to the tooth indentations or to the corresponding dental connections. Simulator support components Component 5: Base component (the surgical simulator support)

[173] As shown in FIGS. 54 to 56, the base component (which is the support for the surgical simulator) is formed by a base element 66 having an edge support 68 attached to it. The attachment can be made by various means, including pins, adhesives or other means of fixation. Such edge support is formed to incorporate a base edge 72 and one or more base pins 74. Embodiments of the present invention may additionally incorporate one or more base attachment holes 70. The component of Petition 870250087554, dated 09 / 26 / 2025, pp. 202 / 246 33 / 43 base can be formed from various materials and by various methods. One embodiment of the present invention may also incorporate a base component in which the edge support is formed into the base element as a single element.

[174] The base component further incorporates one or more base connectors 76, by means of which the cartridge, with the face component attached to it, can be attached to the base component. For example, as shown in FIGS. 57 to 59, one or more base connectors are formed by base extrusions extending from the base element, with grooves or other indentations formed therein.

[175] In one embodiment of the present invention, the base component and the elements that form the base component can be printed with Ultimaker 3 using PLA (settings: 10% infill; 0.15 mm layer height, no supports). The printed base element and the edge support subcomponents can be bonded, for example, using Loctite SF7701 primer and Loctite 4851 adhesive. Component 6: Fastening pins

[176] As shown in Figure 75, one or more attachment pins 78 can be used to attach the cartridge to the base component, for example, by inserting an attachment pin into the holes 80 formed in a base connector (as shown in FIG. 59). One embodiment of the attachment pins consists of two identical subcomponents (model in Figure 31), printed with Ultimaker 3 using PLA (10% infill; 0.15 mm layer height; supports) (photos in Figure 32).

[177] When a maxillary connector element 12 in the maxillary component is inserted into a corresponding base connector 76 in the base component, if said maxillary connector element and the corresponding base connector Petition 870250087554, dated 09 / 26 / 2025, pp. 203 / 246 34 / 43 have aligned holes when the jaw connector element is inserted into the corresponding base connector, an attachment pin can be inserted into these holes to stabilize the attachment (as shown in FIG. 75). Component 7: Clamp

[178] A clamp component may be used to hold the base component in a specific position on a table or other surface. The use of the clamp component is optional. The purpose of the clamp component is to increase the adhesion of the base to slippery surfaces, particularly when the surgical simulator is used with external retraction.

[179] In one embodiment of the present invention, the clamp component may consist of four elements: a clamp body 84 (formed to incorporate a flat side having a 45-degree curve or virtually 45 degrees at each end thereof), a clamp screw plate 86, and a clamp base connector 88. The clamp component may be printed with Ultimaker 3 using PLA (20% infill; 0.15 mm layer height; support only on subcomponent 7.1). The attachment component may be assembled, as shown in FIGS. 61 and 62, by threading the attachment screw 82 into the corresponding threads formed in the attachment body 84 and then press-fitting the attachment screw plate onto the end of the attachment screw. The attachment body may be coupled to the attachment base connector by pressing it into a correspondingly shaped cavity formed in the attachment base connector.The attachment to the base element of the simulator support is done by inserting the 90 pins of the base connector into the corresponding holes on the underside of the base element. Component 8: Retraction Assist Device Petition 870250087554, dated 09 / 26 / 2025, pp. 204 / 246 35 / 43

[180] A retraction assistance device can be used to retract parts of the facial component, as needed, so that the oral cavity is visible for the alveolar bone grafting surgical procedure and to maintain the retracted position. The use of the retraction assistance device can assist a single user in performing a surgical procedure on the simulator without the need for a second person to be present to hold a retractor. The retraction assistance device can be formed in various configurations and from various materials.

[181] In one embodiment of the present invention, the retraction assist device 104 (as shown in FIG. 74) can be 3D printed and is formed from components that include an arm base component 96 (as shown in FIG. 69) and the following components for each of the two assembled retraction arms 102a and 102b (shown in FIGS. 72 and 73): a lower arm component 92 (as shown in FIG. 67), an arm ball support connector component 94 (as shown in FIG. 68), a lower arm ball support connector 98 (as shown in FIG. 70) and an upper arm component 100a or 100b, as shown in FIG. 71.

[182] The retraction assist device and its components can be 3D printed with Ultimaker 3 using PLA (20% infill; 0.15 mm layer height; supports on all components). Each assembled retraction arm can be snap-fit ​​mounted: a lower arm component onto a lower arm ball support connector; an arm ball support connector component onto a lower arm component; and an upper arm component onto an arm ball support connector component at the ball joints. Each assembled retraction arm can be attached to the arm base component. Petition 870250087554, dated 09 / 26 / 2025, pages 205 / 246 36 / 43 screwing the ball bearing connector of the lower arm of each arm onto the corresponding threads of the arm base component, to form the retraction assist device.

[183] ​​The retraction assistance device is attached in a removable manner to the base element by inserting the buckle 106 formed on the arm base component into a corresponding groove on the top of the base element. The ends of the upper arm components on each arm can be fitted with different retractors appropriate for the functions that occur during the alveolar bone grafting surgical procedure performed on the simulator.

[184] The use of a retraction assistance device when using the simulator is optional. However, the use of the retraction assistance device allows for the self-sufficient performance of a surgical procedure on the simulator and thus alleviates the need for stronger adhesion to the base. Simulator features Modular design

[185] The surgical simulator is assembled by attaching the cartridge to the base component. The base component is reusable. The base component assists in immobilizing and stabilizing the cartridge while the surgeon operates, as well as positioning the cartridge in an authentic orientation. The cartridge can be attached to the base component with the facial component attached to the cartridge or without the facial component attached to the cartridge.

[186] As shown in FIGS. 75 to 79, to attach the cartridge to the base component, the cartridge is positioned above the base component and the cartridge is lowered, so that the connecting elements of the jaw 12 (formed on both sides of the jaw) are inserted into the corresponding base connectors 76 formed on the base until there is alignment between the Petition 870250087554, dated 09 / 26 / 2025, pages 206 / 246 37 / 43 holes are formed in the jaw connector elements and the holes of the base connectors 106 (formed in the corresponding base connectors). The attachment pins 78 can be inserted through the aligned holes to stabilize the connection between the base component and the cartridge.

[187] The cartridge does not include any solid mandibular component. To limit movement of the lower jaw during a surgical procedure performed on the simulator, the cartridge has a second fastening mechanism that connects it to the base component.

[188] As shown in FIGS. 80 to 83, the facial component can be pulled over the protrusion 72 of the base component. The facial connector(s) 26 formed on the back of the facial component can be positioned so that each facial connector corresponds to one or more of the base pins 74, and one or more of the base pins fits inside a facial connector (which is formed as a hole on the back of the facial component and is configured to form a snap-fit ​​connection when the base pin is fitted inside a facial connector).

[189] As shown in FIG. 75, the cartridge can be lowered towards the base component along the dotted lines extending from the base connectors in the direction indicated by the arrows shown aligned with such dotted lines. Once the holes in the jaw and the holes in the base connector 106 are aligned, the arms of the fastening pins 78 can be pinched and the attachment pin can then be slid through the holes aligned along the dotted lines shown extending from the hole in the base connector 106 in the direction of the arrows near the attachment pin. A gentle force can be applied while lowering the cartridge towards the base component until the holes in the jaw extensions align with the holes in the base connector. Petition 870250087554, dated 09 / 26 / 2025, pp. 207 / 246 38 / 43 Base Component Adhesion

[190] An adhesive can be attached to the base component, allowing it to be removablely attached to the surface on which it is placed. Such an adhesive can cause the base component to adhere sufficiently to the support surface, so that the base component resists movement caused by external retraction or other forces exerted on the simulator during its use, including during any surgical procedure.

[191] In one embodiment of the present invention, this adhesion can be created by attaching one or more adhesive pieces 108 to the underside of the base component. For example, four Scotch self-adhesive mounting squares can be attached to the underside of the base component, so that one is positioned at each corner of the base component. The adhesives can be used to removablely adhere the base component to the support surface on which it is placed, pressing it firmly against the support surface.

[192] On more slippery support surfaces, the basic adhesion may be insufficient to withstand the application of intense forces on the simulator, such as those that occur during external retraction. In this case, the cartridge may tip over. In this case, the base component can be attached to a support surface with a protruding edge (e.g., table or desk) using clamp component 110, as shown in Figures 85 and 86. Clamp base connector 88 can be attached to base component 66 when the clamp is used to attach the simulator. Self-contained retraction option (allows the simulator to be used by a single person)

[193] For self-sufficient performance of a surgical procedure on the simulator, the user can use the retraction assistance device. Each Petition 870250087554, dated 09 / 26 / 2025, pp. 208 / 246 39 / 43 One of the retraction arms 102a and 102b mounted on the retraction assist device can be fitted with retraction tools and positioned to retract parts of the facial component 24, allowing access to and visualization of cartridge elements, such as the dental components 42 and other cartridge elements. Such use of the retraction assist device allows a single user to complete a surgical procedure in simulation, such as an alveolar bone graft. In some embodiments of the present invention, the mounted retraction arms have three adjustable joints, providing a wide range of envelope positioning. In some embodiments of the present invention, the lower joint of the mounted retraction arms may be lockable, so as to reinforce the retractor against reactionary bending forces exerted by the facial component when retracted.

[194] Furthermore, due to the fact that the retraction assist device is attached to the base component, there are no forces exerted on the base component resulting from any external retraction. Thus, the use of the retraction assist device can alleviate the need to use any adhesive on the underside of the base component. The use of the retraction assist device with the simulator allows surgical procedures to be performed on the simulator when the simulator is positioned on a support surface, without the need to use a clamp, and therefore there is no need for such a support surface to incorporate a suitable protruding edge for locking.

[195] The retraction assistance device and the clamp component can both be used simultaneously to stabilize the simulator, to create a significantly enhanced stability experience during a surgical procedure performed on the simulator. METHOD Petition 870250087554, dated 09 / 26 / 2025, pp. 209 / 246 40 / 43

[196] The simulator can be used for training purposes on surgical procedures related to oral cleft conditions correctable by an alveolar bone grafting surgical procedure, and other training related to such a condition and surgical procedure. For example, the present invention can be used to perform an alveolar bone grafting surgical procedure from start to finish, using real surgical instruments. The following steps of the procedure can be performed on the simulator when it is fully assembled.

[197] · Incision through the synthetic mucosa using a blade.

[198] · Incision around the alveolar fistula to create upward-facing nasal floor flaps.

[199] · Incision along the mucosa of the larger segment and gingiva using a surgical blade.

[200] · Incision along the mucosa of the smaller segment and gingiva to create an advancement flap to cover the anterior wall of the cleft.

[201] · Elevation of the mucoperiosteum from the underlying bone using an elevator.

[202] · Incision through the periosteum to allow the mucoperiosteal flap to advance into the cleft.

[203] • Dissection of the mucoperiosteum from the bony margins of the lesser and greater segments towards the posterior incisure of the alveolar cleft.

[204] • Suturing of upward-facing nasal floor flaps.

[205] · Suturing of downward-facing palatal floor flaps.

[206] • Placement of a simulated graft material at the site of the alveolar cleft.

[207] · Advancement of the mucoperiosteal flap from the smaller segment anteriorly and suturing of the flap to create the anterior wall of the cleft site. Petition 870250087554, dated 09 / 26 / 2025, pp. 210 / 246 41 / 43

[208] FIGS. 92 to 118 illustrate the use of the simulator to perform an alveolar bone grafting surgical procedure, including the following steps:

[209] 1. Use of a 112 retractor to expose the alveolar bone graft site in preparation for surgery (as shown in Figure 92).

[210] 2. Mark the planned incision around the oronasal cleft and fistula with a marker 114 (as shown in Figure 93).

[211] 3. Make an incision around the oronasal fistula using a scalpel. 116 (as shown in Figure 94).

[212] 4. Make an incision along the margin of the larger segment's cleft using a scalpel 116 (as shown in Figure 95).

[213] 5. Make an incision along the margin of the smaller segment's cleft using a scalpel 116 (as shown in FIG. 96).

[214] 6. Make an incision along the gingival margin of the cleft margin of the larger segment using a scalpel 116 (as shown in FIG. 97).

[215] 7. Perform mucosal dissection 62 of the deeper underlying tissue along the anterior / superior aspect of the oronasal fistula (as shown in FIG. 98).

[216] 8. Perform continuous mucosal dissection 62 of the deeper tissue along the oronasal fistula using scissors (as shown in FIG. 99).

[217] 9. Separate the gingival papilla from the dental component to elevate the mucosal flap of the smaller segment using a scalpel (as shown in FIG. 100).

[218] 10. Perform mucoperiosteal flap elevation using a 118 elevator (as shown in FIG. 101).

[219] 11. Perform a 120 posterior cut in the mucosa posteriorly Petition 870250087554, dated 09 / 26 / 2025, pp. 211 / 246 42 / 43 along the smaller segment. The posterior cut is made through the superiosteal plane (as shown in FIG. 102).

[220] 12. Perform additional elevation of the mucoperiosteal flap 122 using an elevator and forceps (as shown in FIG. 103).

[221] 13. Make an incision through the vertical component of the periosteum 124 on the edge of the crack in the smaller segment, using scissors (as shown in FIG. 104).

[222] 14. Incise the periosteum using scalpel 116 along the bone-periosteal interface of the mucoperiosteal flap of the smaller segment (as shown in FIG. 105).

[223] 15. Connect the incision around the upper component of the oronasal fistula 126 with the incision at the margin of the smaller segment cleavage (as shown in FIG. 106).

[224] 16. Perform mucoperiosteal flap elevation of the larger segment at the cleft margin using a 118 elevator (as shown in FIG. 107).

[225] 17. Elevate the flap of the smaller segment 128 within the cleft site using an elevator (as shown in FIG. 108).

[226] 18. Perform further elevation and connection of the mucosal flap between the alveolar cleft site and the anterosuperior component of the oronasal fistula using scissors along the larger segment 130 (as shown in FIG. 109).

[227] 19. Create the nasal side flap 132 and the palatal side flaps using scissors (as shown in FIG. 110).

[228] 20. Perform the nasal flap elevation on the side of the smaller segment 134 (as shown in FIG. 111).

[229] 21. Place a suture 136 at the component junction Petition 870250087554, dated 09 / 26 / 2025, pp. 212 / 246 43 / 43 anterior / superior of the oronasal fistula with the flaps on the nasal side (as shown in FIG. 112).

[230] 22. Close the flaps on the upward-facing nasal side with sutures 136 (as shown in FIG. 113).

[231] 23. Perform complete closure of the nasal side 138 of the oronasal fistula back to the apex of the cleft (as shown in FIG. 114).

[232] 24. Perform closure of the palatal flaps facing downwards 140 and closure of the nasal flaps facing upwards (as shown in FIG. 115).

[233] 25. Insert the bone graft material 142 into the alveolar cleft (as shown in FIG. 116).

[234] 26. Advance the mucoperiosteal flap from the smaller segment 144 toward the flap of the larger segment (as shown in FIG. 117).

[235] 27. Complete the closure of the tear site using sutures 136 (as shown in FIG. 118).

[236] Those skilled in the art will understand that other variations of the modalities described herein may also be practiced without departing from the scope of the invention. Other modifications are therefore possible. For example, the simulator may be used to perform other surgical procedures besides alveolar bone grafts, which may be performed in an oral cavity. Petition 870250087554, dated 09 / 26 / 2025, pp. 213 / 246

Claims

1 / 2 CLAIMS 1. Alveolar bone graft surgery simulator, characterized in that it comprises: a cartridge configured to incorporate an oral cavity having an alveolar cleft formed therein; a model resembling a human face, to which the cartridge is removablely attachable; and a base configured to be removablely attached to the model and the cartridge.

2. Alveolar bone graft surgery simulator, according to claim 1, characterized in that the cartridge incorporates bone components and soft tissue components configured to form a maxilla having an opening in the alveolus.

3. Alveolar bone graft surgery simulator, according to claim 1, characterized in that the connection between the model and the base is operable to: maintain the model in an orientation that is the orientation of a face during an alveolar bone graft surgical procedure; and to stabilize the model during a simulation of alveolar bone graft surgery performed on the alveolar bone graft surgery simulator.

4. Alveolar bone graft surgery simulator, according to claim 1, characterized in that the model is devoid of solid mandibular components.

5. Alveolar bone graft surgery simulator, according to claim 1, characterized in that a retraction assistance device is removablely attached to the base and functions to provide retraction of the cartridge and model elements during use of the alveolar bone graft surgery simulator.

6. Alveolar bone graft surgery simulator, according to claim 1, characterized in that a removable clamp is attached to the base and said clamp is operable to maintain the alveolar bone graft simulator in a stable and stationary position.

7. Method for forming an alveolar bone graft surgery simulator, characterized in that it consists of: a. forming a cartridge by superimposing simulated physiological tissues over a simulated maxillary bone to form an alveolar cleft, said maxillary bone having a base connector component formed thereon; b. forming a facial component that simulates human facial skin and incorporates facial connector elements on the posterior part of said facial component; c. attaching the facial component to the cartridge to produce a simulated human head or portion thereof having an alveolar cleft formed thereon; and d. attaching the combined cartridge and facial component to a base by connecting the facial connector elements to the corresponding base pins, connecting the base connector on the maxillary bone to the corresponding grooves on the base.

8. Method for performing an alveolar bone graft surgery on an alveolar bone graft surgery simulator, characterized in that it consists of: a. assembling the alveolar bone graft surgery simulator by connecting a cartridge configured to incorporate an oral cavity having an alveolar cleft formed therein to a base configured to be attached in a removable manner to the model; and b. performing an alveolar bone graft surgical procedure on the alveolar bone graft surgery simulator. Petition 870250087554, dated 09 / 26 / 2025, pp. 215 / 246

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