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Description

1 / 60 METHOD FOR SETTING UP A FLEXURAL MOLD FOR AN IMPLANT TO CORRECT A BONE STRUCTURE DEFECT Divided from BR 11 2022 024148-8, dated 05 / 28 / 2021 Cross-reference to related request(s)

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application Serial Number 63 / 031,888, filed May 29, 2020, incorporated herein by reference in its entirety, as being fully set forth below and for all applicable purposes. BACKGROUND Field of Revelation

[0002] This Application relates to methods and apparatus for manufacturing and using implants with navigation fiducials. Description of the Related Technology

[0003] Trauma, tumor tissue resection, congenital anomalies, and other deformities can lead to bone loss or otherwise disrupt bone structures, such as the complex and relatively thin bony structures that surround and support the human eye. For example, such deformities in the orbital walls and particularly in the orbital floor can cause the eyeball to leave its natural position, potentially leading to blurred vision, an aesthetically unpleasant appearance, and in some cases, an inability to fully close the eyelids. Such deformities present difficulties in internal bone repair and fixation problems in reconstructive surgery and trauma surgery.

[0004] In some examples, implants can be Petition 870260056473, dated 10 / 06 / 2026, p. 7 / 172 2 / 60 are used for internal repair of deformities and fracture fixation. Typically, an implant can take the form of thin plates. Implants can be manufactured flat or pre-flexed into a specific shape and can be shaped intraoperatively to suit an individual patient's anatomy. In some examples, an implant may have a patient-specific shape, where the shape, circumference, and surface profile are designed to match the patient's individual anatomy. Patient-specific implants generally provide a better fit to the patient's anatomy and easier implantation due to reduced intraoperative shaping.

[0005] However, as is typical in orbital implant surgeries and many other surgeries, the shape and accessibility of the anatomy, such as the eye socket, is such that, upon implantation, certain regions of the implant may be located under soft tissue (e.g., and the eyeball), thus obscuring those regions from vision. In one example, if, during surgery, placement of the implant to restore the original position of the eyeball cannot be achieved initially, the surgeon may need to remove and reshape the implant, or possibly even fill certain areas of the eye socket with graft material, resulting in a potentially lengthy trial-and-error surgery.

[0006] It is important to restore the original position of the eyeball as close as possible, not only for aesthetic reasons, but also to avoid blurred vision. Therefore, it is important to increase the chance of an initial repositioning of the eyeballs close to the Petition 870260056473, dated 10 / 06 / 2026, page 8 / 172 3 / 60 natural. In view of these and other problems, devices and methods that improve the probability of successful implantation are described in this document. SUMMARY

[0007] Certain aspects are directed to an implant (e.g., orbital) to correct a deformity of a bony structure (e.g., orbital). The implant includes a first surface comprising a shape configured to interface with a surface of the bony structure (e.g., a floor and / or a rim of the orbital bony structure). The implant also includes a second surface opposite to the first surface and substantially conforming to the shape of the first surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise a first point feature, a second point feature, and a third point feature that form nodes of a triangle, wherein each of the three or more point features is recessed below the second surface.

[0008] Certain aspects are directed toward a method of correcting a deformity of a bone structure. The method includes positioning a first surface of an implant on the deformity of the bone structure, a first surface comprising a shape configured to interface with a surface of the bone structure (e.g., a floor and / or a rim of the orbital bone structure), and a second surface opposite the first surface and substantially conforming to the shape of the first. Petition 870260056473, dated 10 / 06 / 2026, page 9 / 172 4 / 60 surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise a first point feature, a second point feature, and a third point feature that form nodes of a triangle, wherein each of the three or more point features constitutes at least one of the following: (i) the implant shape relative to a planned implant shape, or (ii) an implant position in a patient relative to a planned implant position in the patient. The method also includes tracing with a stylus of a navigation system along the second surface until the stylus is individually received by the three or more point features to compare one or more of the following: (i) the implant shape relative to a planned implant shape, or (ii) an implant position in a patient relative to a planned implant position in the patient.

[0009] Certain aspects are directed to a method of generating an implant for correcting a deformity of a bone structure. The method includes receiving an implant design, the design indicating a shape, size, and position of the implant in relation to a construction area corresponding to an additive manufacturing device, the implant design defining: a first surface comprising a shape configured to interface with a surface of the bone structure (e.g., a floor and / or a border of the orbital bone structure); and a second surface opposite to the first surface and substantially conforming to the shape of the first surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise the first feature Petition 870260056473, dated 10 / 06 / 2026, page 10 / 172 The method consists of a 5 / 60 point, a second point feature, and a third point feature forming nodes of a triangle, wherein each of the three or more point features constitutes at least one raised above or lowered below the second surface. The method also includes fabricating the implant using additive manufacturing. BRIEF DESCRIPTION OF THE PROJECTS

[0010] Figure 1 is a diagram that illustrates an example of a computer environment suitable for implementing three-dimensional (3D) object design, construction simulation, and manufacturing.

[0011] Figure 2 illustrates a functional block diagram of an example computer from Figure 1.

[0012] Figure 3 is a diagram that illustrates a process for manufacturing a 3D object or device.

[0013] Figure 4A is a diagram illustrating an exemplary additive manufacturing apparatus for generating a 3D object.

[0014] Figure 4B is a diagram illustrating a covering mechanism (e.g., a leveling drum / roller) that can be used instead of the covering mechanism in Figure 4A.

[0015] Figures 5A-5E are diagrams illustrating an example of an orbital implant installed on the orbital floor of a patient's right eye socket.

[0016] Figures 6A and 6B are diagrams illustrating an example of an orbital implant ready for use and the same implant in a flexed form for implantation, according to aspects of the disclosure.

[0017] Figures 7-23 are diagrams that illustrate Petition 870260056473, dated 10 / 06 / 2026, page 11 / 172 6 / 60 patient-specific orbital implants according to aspects of this revelation.

[0018] Figure 24 is a diagram that illustrates several examples of elevated ridges according to aspects of this revelation.

[0019] Figure 25 is a flow diagram illustrating exemplary operations for using an optical implant.

[0020] Figure 26 is a schematic diagram illustrating a conceptual example of a navigation system. DETAILED DESCRIPTION

[0021] Apparatus and methods disclosed in this document include techniques for producing implants with navigation fiducials and use of the implants for enhanced surgical implantation and deformity resolution procedures. Aspects of the present invention are illustrated by means of orbital implants, but one skilled in the art will readily appreciate that they also apply to other types of implants, particularly implants that are partially or totally hidden during installation in the patient's body or implants that can be shaped to better suit the patient's anatomy. In certain aspects, orbital implants comprise thin (sometimes perforated) plates or meshes. Although the features of the present disclosure can be discussed in relation to certain embodiments and figures below, all embodiments of the present disclosure can include one or more of the advantageous features discussed in this document.In other words, while one or more modalities can be discussed as having certain advantageous characteristics, one or more of these characteristics can also be used. Petition 870260056473, dated 10 / 06 / 2026, page 12 / 172 7 / 60 in accordance with several other embodiments disclosed in this document. Similarly, although exemplary embodiments may be discussed below as device, instrument, or method embodiments, it should be understood that such exemplary embodiments may be implemented in various devices, instruments, and methods. Unless explicitly stated, all method steps disclosed in this document may be wholly performed by a computing device, partially or wholly performed by a skilled user, such as a medical professional or a non-medical professional, such as a technician or engineer. Consequently, the term skilled in the art refers to a skilled medical or non-medical user.For example, all the steps of the method described for the design and production of implants, including but not limited to image segmentation, deformity reconstruction, implant design, implant bending, and implant manufacturing, can be performed entirely by a computing device, partially performed by a computing device, or partially or entirely performed by a qualified user, such as a medical professional or a non-medical professional, such as a technician or engineer.

[0022] In this disclosure, the terms distal and proximal in the context of an implant refer to the positions relative to a person skilled in the art placing the implant when the implant is in its planned position relative to the patient's anatomy. For example, the distal edge of an implant is the edge furthest from the person skilled in the art when the implant is in its planned position. Petition 870260056473, dated 10 / 06 / 2026, page 13 / 172 8 / 60 implantation. In this disclosure, the terms anterior and posterior in the context of an implant refer to positions relative to the patient's anatomy, as the implant is in its planned position in relation to the patient's anatomy. For example, the anterior edge of an implant is the edge facing the patient's most anterior side when the implant is in its planned implantation position.

[0023] In certain respects, an orbital implant can be designed in a computer system using any suitable computer-aided design (CAD) software and / or any suitable system for designing, simulating, and / or manufacturing 3D objects. Referring back to Figure 1, an example of a suitable computer environment for implementing 3D object design, construction simulation, and manufacturing is shown. The environment includes a system 100. The system 100 includes one or more computers 102a-102d, which may be, for example, any workstation, server, or other computing device capable of processing information. In some embodiments, each of the computers 102a-102d can be connected, by any suitable communication technology (e.g., an internet protocol), to a network 105 (e.g., the Internet).Consequently, the 102a-102d computers can transmit and receive information (e.g., software, digital representations of three-dimensional (3D) objects, commands or instructions to operate an additive manufacturing device, etc.) among themselves via the 105 network.

[0024] System 100 also includes one or more additive manufacturing devices (e.g., 3D printers) 106a-106b. As shown, the manufacturing device Petition 870260056473, dated 10 / 06 / 2026, page 14 / 172 9 / 60 additive manufacturing device 106a is directly connected to a computer 102d (and through computer 102d is connected to computers 102a-102c via network 105), and additive manufacturing device 106b is connected to computers 102a-102d via network 105. Consequently, one skilled in the art will understand that an additive manufacturing device 106 can be directly connected to a computer 102, connected to a computer 102 via a network 105, and / or connected to a computer 102 via another computer 102 and network 105.

[0025] It should be noted that although system 100 is described in relation to a network and one or more computers, the techniques described in this document also apply to a single computer 102, which can be connected directly to an additive manufacturing device 106.

[0026] Figure 2 illustrates a functional block diagram of an example of a computer from Figure 1. The computer 102a includes a processor 210 in data communication with a memory 220, an input device 230, and an output device 240. In some embodiments, the processor is also in data communication with an optional network interface card 260. Although described separately, it should be appreciated that the functional blocks described in relation to the computer 102a need not be separate structural elements. For example, the processor 210 and the memory 220 may be incorporated into a single chip.

[0027] The 210 processor can be a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), an array Petition 870260056473, dated 10 / 06 / 2026, page 15 / 172 A 10 / 60 field-programmable gate (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any suitable combination thereof designed to perform the functions described in this document. A processor may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other configuration.

[0028] The 210 processor can be coupled, via one or more buses, to read information from or write information to memory 220. The processor may additionally or alternatively contain memory, such as processor registers. Memory 220 may include processor cache, including a multi-level hierarchical cache, where different levels have different capacities and access speeds. Memory 220 may also include random access memory (RAM), other volatile storage devices, or non-volatile storage devices. Storage may include hard disks, flash memory, etc.

[0029] The processor 210 can also be coupled to an input device 230 and an output device 240 to, respectively, receive input and provide output to a computer user 102a. Suitable input devices include, but are not limited to, a keyboard, buttons, keys, switches, a pointing device, a mouse, a joystick, a remote control, an infrared detector, a barcode reader, a scanner, Petition 870260056473, dated 10 / 06 / 2026, page 16 / 172 11 / 60 a video camera (possibly coupled with video processing software to detect, for example, hand gestures or facial gestures), a motion detector or a microphone (possibly coupled with audio processing software to detect, for example, voice commands). Suitable output devices include, but are not limited to, visual output devices, including monitors and printers, audio output devices, including speakers, headphones and alarms, additive manufacturing devices and tactile output devices.

[0030] The 210 processor can also be coupled to a 260 network interface card. The 260 network interface card prepares the data generated by the 210 processor for transmission over a network according to one or more data transmission protocols. The 260 network interface card also decodes the data received over a network according to one or more data transmission protocols. The 260 network interface card may include a transmitter, a receiver, or both. In other embodiments, the transmitter and receiver may be two separate components.The 260 network interface board may be incorporated as a general-purpose processor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic device, discrete gate or logic transistor, discrete hardware components, or any suitable combination thereof designed to perform the functions described herein. Petition 870260056473, dated 10 / 06 / 2026, page 17 / 172 12 / 60

[0031] Figure 3 illustrates a process 300 for manufacturing a 3D object or device. As shown, in a step 305, a digital representation of the object is designed using a computer, such as computer 102a. For example, two-dimensional (2D) or 3D data can be entered into computer 102a to assist in designing the digital representation of the 3D object. Continuing in a step 310, the information corresponding to the 3D object is sent from computer 102a to an additive manufacturing device, such as additive manufacturing device 106, and device 106 initiates a manufacturing process to generate the 3D object, according to the received information. In a step 315, additive manufacturing device 106 continues manufacturing the 3D object using suitable materials, such as a polymer or metal powder. Finally, in a step 320, the 3D object is generated.

[0032] Figure 4A illustrates an exemplary additive manufacturing apparatus 400 for generating a 3D object. In this example, the additive manufacturing apparatus 400 is a laser sintering device. The laser sintering device 400 can be used to generate one or more 3D objects layer by layer. The laser sintering device 400, for example, can use a powder (e.g., metal, polymer, etc.), such as powder 414, to build an object, one layer at a time, as part of a construction process.

[0033] Successive layers of powder are spread over each other using, for example, a 415A coating mechanism (e.g., a recoating blade). The 415A coating mechanism deposits powder. Petition 870260056473, dated 10 / 06 / 2026, page 18 / 172 13 / 60 for a layer as it moves through the construction area, for example, in the direction shown or in the opposite direction if the 415A coating mechanism is to start from the other side of the construction area, such as for another construction layer. After deposition, a computer-controlled carbon dioxide (CO2) laser beam scans the surface and selectively binds the powder particles of the corresponding cross-section of the product. In some embodiments, the 412 laser scanning device is a mobile infrared laser source on the X and Y axes. As such, the laser source can be moved along an X axis and along a Y axis to direct its beam to a specific location of the top powder layer.Alternatively, in some embodiments, the laser scanning device 412 may comprise a laser scanner that receives a laser beam from a stationary laser source and deflects it over movable mirrors to direct the beam to a specified location in the device's work area. During laser exposure, the powder temperature rises above the material transition point (e.g., glass, polymer, metal) after which adjacent particles flow together to create the 3D object. The device 400 may also optionally include a radiation heater (e.g., an infrared lamp) and / or an atmosphere control device 416. The radiation heater may be used to preheat the powder between coating a new layer of powder and scanning that layer. In some embodiments, the radiation heater may be omitted. The atmosphere control device may be used throughout the process to prevent scenarios. Petition 870260056473, dated 10 / 06 / 2026, page 19 / 172 14 / 60 undesirable, such as oxidation of the powder.

[0034] In some other embodiments, as shown in relation to Figure 4B, a covering mechanism 415B (for example, a leveling drum / roller) may be used instead of the covering mechanism 415A. Consequently, the powder can be distributed using one or more movable pistons 418(a) and 418(b) that push the powder from a powder container 428(a) and 428(b) to a reservoir 426 that retains the formed object 424. The depth of the reservoir, in turn, is also controlled by a movable piston 420, which increases the depth of the reservoir 426 through downward motion as additional powder is moved from the powder containers 428(a) and 428(b) to the reservoir 426. The coating mechanism 415B pushes or rolls the powder from the powder container 428(a) and 428(b) to the reservoir 426. Similar to the embodiment shown in Figure 4A, the embodiment in Figure 4B can use the radiation heater 416 alone to preheat the powder between coating and scanning a layer. EXAMPLE OF ORBITALIZED IMPLANTS

[0035] Figures 5A to 5E are diagrams illustrating various stages of implantation of an orbital implant in a patient.

[0036] Figure 5A illustrates an example of a computer-generated three-dimensional (3D) model of a deformity 508 in the orbital floor of the right eye socket of a patient 500. An experienced user can generate a model of the deformity 508 to better model an ideal placement and shape of an implant. For example, Figure 5B illustrates an example of the model from Figure 5A, where the anatomical surface Petition 870260056473, dated 10 / 06 / 2026, page 20 / 172 A healthy 15 / 60 bone surrounding the deformity 508 is matched to a reconstructed anatomical surface 510 (e.g., where the reconstructed anatomical surface 510 is a mirror image of the patient's orbital floor in the left eye socket). This model of a desired bone structure can be used to produce (e.g., by additive manufacturing) a physical model of the desired bone structure, which can serve as a bending mold to pre-flex an off-the-shelf implant or can be used to design and manufacture a patient-specific implant.

[0037] Figure 5C is a diagram illustrating an example of a ready-to-use orbital implant model 520 installed over the deformity 508 in the orbital floor of the patient's right eye socket 500. In the present document, the 3D model of Figures 5A and 5B provides a basis for determining the extent to which portions of the ready-to-use orbital implant 520 should be flexed or reshaped to better mimic the healthy anatomical surface 510 of Figure 5B. The ready-to-use orbital implant 520 includes three extensions 512 configured to be fixed to a rim 506 of the orbital bony structure by means of fixation elements such as screws. A 3D model of the flexed or reshaped ready-to-use implant can be used to design and produce a bending mold, such as the one shown in Figure 5E: Figure 5E is a diagram illustrating an example of a 550 bending mold for pre-operatively or intra-operatively bending a ready-to-use implant.

[0038] Figure 5D is a diagram illustrating an example of a patient-specific orbital implant model 502 installed on an orbital floor 504 of Petition 870260056473, dated 10 / 06 / 2026, page 21 / 172 16 / 60 right eye socket of a patient 500 and fixed to a rim 506 of the orbital bone structure. In the present document, the 3D model of Figures 5A and 5B provides a basis for designing a patient-specific orbital implant shape to better mimic the healthy anatomical surface 510 of Figure 5B.

[0039] As discussed, patient-specific orbital implants 502 can be designed based on information about the patient's orbital bone structure. This information can be found, for example, in computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, ultrasound images, or images from other suitable medical imaging modalities. Through a process called "segmentation," the information from these medical images can be used to develop a virtual 3D model of the patient's orbital bone structure (e.g., using Materialise Mimics software). Using CAD software, the orbital implant 502 can be specifically designed to match a portion of the patient's orbital bone structure to resolve a structural deformity.The 502 orbital implant can then be manufactured using the additive manufacturing technology discussed above, such as selective laser sintering or selective laser melting with any suitable material, such as titanium, titanium alloy, stainless steel, polyether ether ketone (PEEK), etc.

[0040] In some examples, a deformity in an orbital bone structure may prevent a person skilled in the art from developing a 3D model that accurately models the desired bone structure. In this case, the person skilled in the art may model an orbital bone structure from one side. Petition 870260056473, dated 10 / 06 / 2026, page 22 / 172 17 / 60 contralateral, if that side is intact. Thus, a mirror image of at least part of the virtual 3D model containing the contralateral eye socket can be recorded with the healthy tissue surrounding the deformity and used as a model for the design of the 502 orbital implant. Alternatively, a statistical shape model (SSM) of the orbital bone structure can be used to model the orbital bone structure based on the healthy or intact tissue and / or bone surrounding the deformity. For example, an SSM can be constructed based on segmenting or partitioning a digital image or stack of digital images into multiple segments (e.g., sets of pixels or voxels). Then, the segmentation transforms the image representation into something relatively easier to analyze, such as a three-dimensional model like a wireframe model or a surface model, involving one or more of these sets of pixels or voxels.In some examples, digital images are analyzed to locate objects and / or boundaries, such as anatomical areas of interest. In this case, the anatomical area of ​​interest might include the orbital bone structure. Based on a statistical analysis of a training set (e.g., several of these three-dimensional specimen models from a population), a SSM can be created, which is a three-dimensional deformable representation that encodes the correlations between shape variations among the members of the training set, which is considered representative of the entire population. An SSM is characterized by a vector of limited length. By assigning values ​​to the coordinates of this vector, the SSM can be deformed in a way that is consistent with the shape variations observed in the set. Petition 870260056473, dated 10 / 06 / 2026, page 23 / 172 18 / 60 training. Once an SSM is created based on a training set of intact orbital bones, the SSM can be fitted to the healthy or intact tissue and / or bone surrounding the deformity. The instance of the SSM thus obtained can then comprise a section encompassing the deformity and exhibiting a representative form of non-defective tissue. Therefore, it can be used to model a desired bone structure (i.e., reconstruct the deformity). The desired bone structure can be used as a model to design the orbital implant 502. The benefit of such a process is that it increases the likelihood of the eyeball being pushed back into its original position, which is one of the main benefits of patient-specific orbital implants 502. In some respects, the present disclosure relates to a method as described above for designing and / or manufacturing any of the patient-specific implants described below.

[0041] Preoperative planning can transfer many advantages of patient-specific orbital implants 502 to ready-to-use implants (e.g., see the ready-to-use orbital implant 600 described in more detail in Figures 6A and 6B below). For example, information about the patient's bone anatomy can be obtained (step 1) from medical images and used to develop (step 2) a 3D model (e.g., see Figure 5A) as described above (e.g., orbital bone structure model). A target shape for an eyeball-facing surface of the orbital implant can then be designed (step 3) using the 3D model, a mirror image of the contralateral side, and / or an SSM to model a desired bone structure as described. Petition 870260056473, dated 10 / 06 / 2026, page 24 / 172 19 / 60 above. The target shape can then be displaced toward the bone by a distance equal to the implant thickness. The resulting target shape or displacement target surface can then be matched to the 3D model of the patient's bone structure around the deformity to obtain (step 4) a 3D model of a desired bone structure (e.g., see Figure 5B) to serve as a bending mold. This bending mold, i.e., a physical model of the desired bone structure, can be manufactured (step 5) from the 3D model using additive manufacturing technology in any suitable material, such as polyamide. An experienced user, such as a surgeon, or a non-medical professional, such as a technician or engineer, can then use this mold to select the most appropriate off-the-shelf implant type and size (e.g., see Figure 6A) and bends (step 6 - see Figure 5C) the selected implant structure to fit the patient's anatomy and target shape.In some aspects, the present disclosure relates to a kit of such a bending mold and a ready-to-use implant. In some aspects, the present disclosure relates to a method as described above for designing and / or manufacturing a physical model of the desired bone structure to serve as a bending mold, as described above, and / or for selecting and / or bending a ready-to-use implant.

[0042] In some examples, the bending of the selected ready-to-use orbital implant can first be simulated using a 3D model of the selected ready-to-use implant and a 3D model of the patient's bone structure. The bending can be simulated so that the eyeball-facing surface of the orbital implant closely follows the shape Petition 870260056473, dated 10 / 06 / 2026, page 25 / 172 20 / 60 of the target, and so that the bone-facing surface of the implant is well seated in the bone structure surrounding or adjacent to the deformity (e.g., see Figure 5C). Simulated bending can allow a person skilled in the art, such as a medical professional or a non-medical professional, such as a technician or engineer, to choose an appropriate position for the implant. This can ensure that the fixation points (e.g., fixation points where the orbital implant is attached to the bone structure) are in locations with good bone stock and that the implant is not in a position where it could disturb or impair delicate anatomical features such as nerves. Simulated bending can allow said person skilled in the art to ensure that the deformity is well covered and that there is little excess implant material.In some examples, an orbital implant bending simulation may include selecting the most appropriate implant type, shape, and / or size from a library.

[0043] In some examples, the resulting shape of a virtually flexed orbital implant can be used to generate a set of instructions for a sheet metal bending machine configured to bend the implant according to the instructions. Alternatively, the resulting shape can be used to design a bending mold (e.g., see Figure 5E) that fits with the eyeball-facing surface or the bone-facing surface of the simulated implant bend. For example, the bending mold can have any shape suitable for easy manipulation, such as a prismatic shape with a flat bottom surface, and can have a top surface configured to match the eyeball-facing surface. Petition 870260056473, dated 10 / 06 / 2026, page 26 / 172 21 / 60 eyeball or facing the bone of the virtually flexed implant. The bending mold may include markings to outline the contour of the flexed implant or protrusions 552 to be received in one or more implant perforations or notches along the edge of the implant, such as mesh openings or any openings to receive fixation elements. The bending mold can be manufactured from the design using the additive manufacturing described above using any suitable material, such as polyamide. An experienced user can then flex the implant until it fits into the bending mold (see Figure 5E), using any markings and protrusions as aids. The flexed implant can then be sent to the hospital, optionally along with the mold. Alternatively, the mold can be sent to the hospital along with the unflexed implant.The surgeon or technician can then flex the implant until it fits into the bending mold, using any markings and protrusions as aids. In some aspects, the present disclosure relates to a kit of such a bending mold and a ready-to-use implant, either in its original state or in a pre-flexed state. In some aspects, the present disclosure relates to the methods as described above for selecting and / or virtually flexing a ready-to-use implant, for providing a bending mold, and / or for flexing a ready-to-use implant.

[0044] Whether an orbital implant is manufactured directly to a patient-specific shape or flexed according to a pre-operative planning procedure using an off-the-shelf implant, correct positioning Petition 870260056473, dated 10 / 06 / 2026, page 27 / 172 The 22 / 60 implant placement in the patient is important for restoring the natural position of the eyeball. The shape and accessibility of the eye socket are such that it is often only possible to fix the orbital implant to the bone on one side of the implant, usually along a proximal edge of the implant. A small deviation from the planned position along this edge can lead to a large deviation along the eyeball-facing surface and the distal edge of the implant. Thus, in some cases, navigation systems may be used during a surgical procedure to verify the position of the orbital implant relative to the patient's anatomy and compare this position with one or more planned positions or with a planned target implant shape.

[0045] Surgical navigation systems (e.g., see Figure 26) can provide functionality including: (i) loading (e.g., on the electronic processing device 2606) and displaying (e.g., on the display unit 2602) images or image feeds from intraoperative imaging equipment (e.g., digital camera / film, radiography, magnetic resonance imaging (MRI), computed tomography (CT), fluoroscopy, ultrasound, echocardiography, nuclear medicine such as positron emission tomography (PET), etc.); (ii) loading (e.g., on the electronic processing device 2606) and displaying (e.g., on the display unit 2602) preoperative virtual 3D models of the patient's anatomy; (iii) loading (e.g., on the electronic processing device 2606) and displaying (e.g., on the display unit 2602) preoperatively manufactured virtual 3D models of any hardware, such as Petition 870260056473, dated 10 / 06 / 2026, page 28 / 172 23 / 60 as implants; (iv) track (e.g., using the infrared sensor 2610) the location and orientation of instruments (e.g., pen 2608) to determine their position in the coordinate system of the navigation system; (v) scan anatomical surfaces or indicate certain anatomical landmarks with a tracked instrument, such as a probe or a pen (e.g., pen). 2608) to determine its position in the navigation system coordinate system; (vi) scan surfaces of any hardware, such as implants, or indicate identifiable features (e.g., navigation fiducials) of such hardware, such as points, lines, bends, contours, with a tracked instrument, such as a probe or a pen (e.g., 2608 pen) to determine its position in the navigation system coordinate system; and (vii) establish a relationship between loaded virtual 3D models and (a) images or image feeds from intraoperative imaging equipment, and / or (b) data collected with tracked instruments to correctly position the virtual 3D models in the navigation system coordinate system.For example, the information collected in (v) can be used to locate the patient in the navigation system's coordinate system and / or to bring the patient and the pre-operative virtual 3D models of the patient's anatomy into a common coordinate system. For example, a relationship can be established between a “real” coordinate system and a “virtual” coordinate system, and one way to achieve this is to scan the surfaces of the patient's anatomy to establish a match between the patient's anatomy and a pre-operatively loaded virtual 3D model. Petition 870260056473, dated 10 / 06 / 2026, page 29 / 172 24 / 60 patient anatomy.

[0046] As discussed, the 3D model can be generated from medical images using topological and geometric information obtained from the images. In some examples, the relationship between the 3D model's coordinate system and the real coordinate system is established by matching the corresponding anatomical reference points on the patient and the virtual 3D model. In other examples, the relationship between the 3D model's coordinate system and the real coordinate system is established by generating a trajectory along an axis of the geometric model that corresponds to the same trajectory along an axis of the patient's anatomy and driving the mobile trihedral conformation along the trajectory.

[0047] Once the patient has been located in the navigation system's coordinate system, any further movement of the patient relative to the navigation system can be tracked by means of a rigidly fixed tracker 2612 attached to the patient's anatomy 2616 and, optionally, another tracker 2614 attached to the pen 2608, and the spatial correspondence between the actual patient and the virtual 3D model of the anatomy can be maintained. For example, the information collected in (vi) can be used to locate any hardware in the navigation system's coordinate system and / or to bring the pre-operatively manufactured hardware and virtual 3D models of the hardware into a common coordinate system. For example, the same scanning procedure discussed above can be performed to establish a relationship between a 3D model of an orbital implant (and a coordinate system). Petition 870260056473, dated 10 / 06 / 2026, page 30 / 172 25 / 60 corresponding) with the actual physical orbital implant.

[0048] Thus, surgical navigation systems can be used to verify the position of an orbital implant during a procedure to install the implant in the patient (e.g., a virtual 3D model of the patient's anatomy and a virtual 3D model of the orbital implant (e.g., either in the patient's specific form or in the ready-to-use form with or without a planned simulated bend) in its planned position relative to the virtual 3D model of the patient's anatomy). The virtual 3D model of the patient's anatomy can be used to correctly position the 3D model of the orbital implant in the coordinate system of the navigation system.

[0049] In some examples, a person skilled in the art may use a tracked instrument from a navigation system, such as a probe or a pen, to track particular features of the orbital implant. By tracking the implant features, the position of those features can be collected, and the location of the features in the navigation system's coordinate system can be determined and displayed on the navigation system. By locating the actual implant features in a coordinate system, the implant position can be compared to a planned position (e.g., a position of the 3D model of the orbital implant relative to the 3D model of the patient's anatomy). The navigation system can measure any deviation between the actual physical position of the implant and the planned implant position and report the deviation to the person skilled in the art, optionally with instructions on how to modify the implant position to match the planned position. Petition 870260056473, dated 10 / 06 / 2026, page 31 / 172 26 / 60

[0050] Consequently, a surgical navigation system can determine an extent to which the planned bending of an optical implant has been achieved and / or an extent to which the location of the optical implant corresponds to the planned position, by employing identifiable features positioned at specific locations on the implant to establish the implant's position in space. Exemplary Techniques for Manufacturing and Using Orbital Implants with Navigation Fiducials

[0051] Figure 6A is a diagram illustrating an example of a ready-to-use 600 orbital implant according to disclosure aspects. The desired shape of a ready-to-use 600 implant can be determined both preoperatively and intraoperatively, and the implant can be flexed preoperatively or intraoperatively to fit the patient's anatomy. Any of the bending molds as described above can be used when flexing the implant.

[0052] As shown, the ready-to-use orbital implant 600 includes bending sites in the form of linear slots 602 that pierce the implant or narrowed connections 604. Such bending sites locally reduce the resistance of the implant 600 to deformation, while also subdividing the implant into several main sections 606 (e.g., a first main section 606a, a second main section 606b, and a third main section 606c). In the present document, the narrowed connections 604 connect several holes 608 through which the implant 600 can be fixed to a patient's bone structure. Petition 870260056473, dated 10 / 06 / 2026, page 32 / 172 27 / 60

[0053] The orbital implant 600 also includes a plurality of point features 610 that one skilled in the art can use to assess a location of the implant 600 in a coordinate system. For example, the point features 610 can be configured to receive a pen, so that the pen can feed back location information to the navigation system. In some examples, the point features 610 may be positioned on the surface of a section and / or along its edges, such as the edges it shares with adjacent sections. In certain aspects, the point features 610 may include a hole at the end of a linear groove 602. This may allow one skilled in the art using the pen to trace the linear groove 602 to the point feature 610. In some examples, the linear groove 602 may be a path feature that provides the pen's location information in addition to the point feature 610.Figure 6B illustrates an example bending of the 600 orbital implant from Figure 6A, where the 600 implant is bent to mimic a healthy anatomical orbital floor of a patient.

[0054] By locating aspects of the actual implant in a coordinate system common with the patient's anatomy, the implant position can be compared to a planned position (e.g., a position of the 3D model of the orbital implant relative to the 3D model of the patient's anatomy). The navigation system can measure any deviation between the actual physical position (an aspect or part) of the implant and the planned position (referred to aspect or part) of the implant and report the deviation to the person skilled in the art, optionally with Petition 870260056473, dated 10 / 06 / 2026, page 33 / 172 28 / 60 instructions on how to modify the implant position to match the planned position and / or to perform additional implant flexions to match the planned implant shape. Alternatively, a desired anatomical shape can be reconstructed preoperatively as described above (e.g., using a mirror image of the intact contralateral orbital cavity or an SSM of intact orbital cavities). By locating the implant features as preliminarily placed in the patient intraoperatively, the navigation system can compare the position of these features with the desired anatomical shape of the orbital cavity and report the deviation to the technician skilled in the art, optionally with instructions on how to modify the implant position and / or perform additional implant flexions to better match the desired anatomical shape of the orbital cavity.

[0055] Typically, patient-specific implants are designed specifically for individual patients and are manufactured according to a design developed prior to the operation. While any number of point features may be used, patient-specific implants may require fewer point features compared to off-the-shelf orbital implants because less or no implant shape adjustment may be necessary for a patient-specific implant.

[0056] Figure 7 is a diagram illustrating a patient-specific orbital implant 700 according to aspects of this disclosure. As illustrated, the superior surface of the implant 700 is a surface facing the eyeball 704, with a surface facing the bone 710 on the opposite side of the implant 700. The surface facing the Petition 870260056473, dated 10 / 06 / 2026, page 34 / 172 The 29 / 60 bone 710 is configured to interface with a portion of the patient's anatomy (e.g., a portion of the floor and / or anterior rim of the orbital cavity). To this end, the bone-facing surface 710 may be partially or fully shaped to match a surface of the patient's anatomy. Holes (e.g., a first hole 706a and a second hole 706b) are provided on a proximal edge of the implant 700 to accommodate screws or other fixation elements configured to secure the implant 700 to the bony structure of an eye socket. The implant 700 includes a raised ridge 708 along a distal edge of the implant 700. The implant 700 also includes three point features (e.g., first point feature 702a, second point feature 702b, and third point feature 702c), in this example in a non-isosceles triangle formation.In some examples, and to increase the robustness of implant position determination, point features can be spread as widely as possible.

[0057] In this example, the second point feature 702b and the third point feature 702c take the form of undulations, or recesses, on the surface facing the eyeball. These two point features are close to the proximal edge of the 700 implant and are therefore easier to reach with the tracked pen, compared to the first point feature 702a which is closer to the distal edge of the 700 implant. In the present document, when using a navigation system to determine a location of the 700 implant, a person skilled in the art can insert a distal tip of a pen from Petition 870260056473, dated 10 / 06 / 2026, page 35 / 172 30 / 60 navigation system with 702 point features for mapping implant location.

[0058] As noted, the first point feature 702a is located closer to the distal edge of implant 700 and therefore farther from the surgeon performing the implant 700. During implantation, the distal edge of implant 700 may lie beneath the soft tissue and eyeball, which may obscure the surgeon's first point feature. Thus, in order to guide the pen, the raised ridge 708 is configured to direct the pen to the first point feature 702a. In this example, the raised ridge 708 has at least one side wall that sits at an angle 2402 from the surface facing the eyeball. In some examples, the angle may be greater than 45° (e.g., an angle between 60° and 90°, see the first cross-section 2400a of Figure 24).The height of the raised ridge 708 can be high enough to prevent the pen tip from slipping over the ridge, yet low enough not to cause irritation of the soft tissue covering the implant 700 while in an implanted state (e.g., a height between 0.5 mm and 1.5 mm). As discussed below, the raised ridge 708 can include one or more other shapes and sizes.

[0059] In order to verify the implant position intraoperatively, the surgeon can place the pen tip on the second point feature 702b and the third point feature 702c to indicate the proximal point features. The surgeon can also trace the pen tip over the surface facing the eyeball in a Petition 870260056473, dated 10 / 06 / 2026, page 36 / 172 31 / 60 distal direction until reaching the raised ridge 708. Then, by sliding the pen in a lateral direction along the raised ridge 708, the surgeon can guide the pen tip to the first point feature 702a. Thus, no visual access to the distal region of the implant is necessary.

[0060] The pen may include an angled tip or, alternatively, a straight tip. However, a pen with a straight tip may have difficulty entering a dimple or orifice due to the narrow access between the implant and the soft tissue and due to its consequently sharp angulation relative to the surface facing the eyeball. Consequently, the pen may need to be held in a near-tangential position relative to the surface (e.g., at an angle between the pen axis and the surface of 30 degrees or less). Thus, as illustrated in Figure 7, the first point feature 702a is a wedge-shaped depression that opens towards the proximal side of the implant 700 to accommodate the pen. By pushing the pen tip along the raised ridge 708, the surgeon can feel the pen fall into the depression.Thus, once in the depression, the surgeon may continue to push the pen in a distal direction to keep the pen tip at the apex of the depression, until the pen encounters the elevated ridge 708. It should be noted that any of the point features described in this document may include one or more of a dimple, a depression, a hole, or any other suitable physical marking on the eyeball-facing surface, so as to indicate that the pen has reached a specific point or implant location. In certain embodiments, at least three. Petition 870260056473, dated 10 / 06 / 2026, page 37 / 172 32 / 60 point characteristics can be used, as three points may be sufficient to accurately locate the implant in a coordinate system. In certain aspects, the three points form a triangle (like a non-isosceles triangle), so that each edge length between the points is different, allowing each edge to be differentiated to better determine the implant's position and orientation in a coordinate system.

[0061] Figure 8 is a diagram illustrating a patient-specific orbital implant 800 according to aspects of this disclosure. Implant 800 includes several features similar to those shown in Figure 7, including first point feature 802a located near a distal edge of implant 800 and second point feature 802b and third point feature 802c near a proximal edge. However, in this example, a raised ridge 808 at the distal end of implant 800 includes a notch 804 partially enclosing first point feature 802a. The notch 804 can be configured to indicate to the surgeon manipulating the pen when the pen tip has reached first point feature 802a beyond the depression of first point feature 802a. In some examples, the notch 804 can be used as an alternative to the depression feature.As an alternative to the 804 notch, a raised rib interruption 808 may be used. For example, the raised rib 808 may include a gap or a notch configured to act as a first-point feature, wherein the gap is smaller than the diameter of the pen tip so that it grips the pen. Petition 870260056473, dated 10 / 06 / 2026, page 38 / 172 33 / 60

[0062] Figure 9 is a diagram illustrating a patient-specific orbital implant 900 according to aspects of this disclosure. Implant 900 includes several features that are similar to those shown in Figures 7 and 8, including first point feature 902a located near a distal edge of implant 900 and second point feature 902b and third point feature 902c near a proximal edge. In this example, implant 900 includes a raised ridge 904 that does not follow the distal edge of implant 900 but follows a V-shaped trajectory. In the present document, when a surgeon pushes the pen against the raised ridge 904, this will cause the pen to be guided toward the apex of the V-shape, where first point feature 902a is located. The surgeon can feel the change in direction of the raised ridge 904 and understand that first point feature 902a has been reached.If more than one point feature is arranged along the raised ridge 904, the path of the raised ridge may be shaped as a concave and / or polyline, with segments (e.g., straight raised ridges) between the point features. The first point feature 902a may optionally include a depression region to aid in pen grip. As in the examples above, the raised ridge may include a notch that at least partially encircles the first point feature 902a or a break in the first point feature 902a.

[0063] Figure 10 is a diagram illustrating a specific patient orbital implant 1000 according to aspects of this disclosure. Implant 1000 includes several Petition 870260056473, dated 10 / 06 / 2026, p. 39 / 172 34 / 60 features that are similar to those shown in Figures 7-9 which cannot be further discussed for the sake of brevity. In this example, a raised ridge 1004 does not run close to the distal edge of implant 1000 as in the previous examples, but from the third point feature 1002c to the first point feature 1002a. After indicating the third point feature 1002c (e.g., a point feature that is visible to the surgeon) with the pen, the surgeon can slide the pen tip along the raised ridge 1004 until it reaches the first point feature 1002a. The raised ridge 1004 has a hook shape or hockey stick shape that flexes around the first point feature 1002a to lock the pen onto the first point feature 1002a and signal to the surgeon when the pen reaches that point feature.

[0064] Figure 11 is a diagram illustrating a patient-specific orbital implant 1100 according to aspects of this disclosure. The implant 1100 includes several features that are similar to those shown in Figures 7-10 which cannot be discussed further for the sake of brevity. In the present document, the implant 1100 includes a raised ridge 1104 that follows a path between the third point feature 1102c and the first point feature 1102a. The raised ridge 1104 also has a second leg that continues from the first point feature 1102a to a second point feature 1102b. Because the raised ridge 1104 is continuous, the pen can be guided through the entire sequence of point features.

[0065] Figure 12 is a diagram that illustrates a Petition 870260056473, dated 10 / 06 / 2026, p. 40 / 172 35 / 60 Patient-Specific Orbital Implant 1200 according to aspects of this disclosure. The 1200 implant includes several features that are similar to those shown in Figures 7-11 which cannot be discussed further for the sake of brevity. In this document, the 1200 implant includes a raised ridge 1204 to guide the pen to one or more point features. However, since the point features are arranged on one side of the raised ridge 1204, the raised ridge 1204 includes a series of alternating recesses and protrusions 1206 configured to notify the surgeon when the pen is along the wrong side of the raised ridge 1204, preventing the pen from moving and / or making pen progression more difficult along that side of the ridge 1204. Such warning features can be combined with the raised ridges of any of the other examples.

[0066] Figure 13 is a diagram illustrating a patient-specific orbital implant 1300 according to aspects of this disclosure. The implant 1300 includes several features that are similar to those shown in Figures 7-12 which cannot be further discussed for the sake of brevity. In the present document, a first point feature 1302a is a depression at the apex of a raised ridge 1304. The depression has an elongated shape so as to receive the tip of the pen held in a position close to tangent to the surface facing the eyeball. The raised ridge 1304 includes a side that makes a smooth or gradual transition 1306 from the top of the raised ridge 1304 to the surface of the implant 1300. The smooth transition 1306 prevents the pen from being guided along the wrong side of the ridge. Petition 870260056473, dated 10 / 06 / 2026, page 41 / 172 36 / 60 elevated and, instead, allows the pen to be guided back to the correct side without having to lift the pen from the 1300 implant surface. This smooth transition can be combined with the elevated ridges of any of the other examples.

[0067] Figure 14 is a diagram illustrating a patient-specific orbital implant 1400 according to aspects of this disclosure. The implant 1400 includes several features that are similar to those shown in Figures 7-13 which cannot be discussed further for the sake of brevity. In the present document, the implant has a raised ridge 1406 configured to guide a pen toward point features 1402. In contrast to previous examples, the raised ridge 1406 is positioned within a triangle formed by point features 1402. In this example, the raised ridge 1406 forms a plateau 1406 in the shape of a triangle. However, in some examples, the center of the triangle may include an elevation that is equal to the implant surface 1300 outside the triangle. The implant 1400 also includes a plurality of perforations 1404 that pass through the eyeball-facing surface to the opposite side.The size of the 1404 perforations may be relatively smaller than the 1402 point features and / or the pen to prevent the surgeon from incorrectly indicating the point features. Note that in this example there are no 1404 perforations along the paths between the 1402 point features. This prevents the pen from being caught by a perforation or falsely indicating a 1402 point feature. Such 1404 perforations may be combined with any of the other examples. The crest. Petition 870260056473, dated 10 / 06 / 2026, p. 42 / 172 37 / 60 raised in plateau style 1406 can also be used without drilling 1404.

[0068] The following examples demonstrate how the aspects described above can be freely combined. They do not limit the scope of this disclosure.

[0069] Figure 15 is a diagram illustrating a patient-specific orbital implant 1500 according to aspects of this disclosure. The implant 1500 includes several features that are similar to those shown in Figures 7-14 which cannot be discussed further for the sake of brevity. In the present document, the implant 1500 includes perforations 1504 and a raised ridge 1506 configured to guide a pen between point features 1502.

[0070] Figure 16 is a diagram illustrating a patient-specific orbital implant 1600 according to aspects of this disclosure. The implant 1600 includes several features similar to those shown in Figures 7-15 which cannot be discussed further for the sake of brevity. In the present document, the implant 1600 includes perforations 1604 and a raised ridge 1606, configured to guide a pen between point features 1602. In this example, the first point feature 1602a is a depression, while the second point feature 1602b and third point feature 1602c are holes or recesses.

[0071] Figure 17 is a diagram illustrating a patient-specific orbital implant 1700, according to the aspects of this disclosure. The 1700 implant includes several features similar to those shown in Figures 7-16 which cannot be discussed further for reasons of Petition 870260056473, dated 10 / 06 / 2026, page 43 / 172 38 / 60 brevity. In the present document, the implant 1700 includes perforations 1704 and a raised ridge 1706 configured to guide a pen between the point features 1702. Because the point features are arranged on one side of the raised ridge 1706, the raised ridge 1706 includes a series of alternating notches and protrusions 1708 configured to notify the surgeon that the pen is along the wrong side of the raised ridge 1706, preventing the tip from moving and / or making pen progression more difficult along that side of the ridge 1706. In this example, the first point feature 1702a, the second point feature 1702b, and the third point feature are holes or recesses.

[0072] Figure 18 is a diagram illustrating a patient-specific orbital implant 1800 according to aspects of this disclosure. The implant 1800 includes several features that are similar to those shown in Figures 7-17 which cannot be discussed further for the sake of brevity. In the present document, the first point feature 1802a is a depression at the apex of a raised ridge 1806. The raised ridge 1806 includes a side that makes a smooth transition 1808 from the top of the raised ridge 1806 to the surface of the implant 1800. The smooth transition 1808 allows the tip to be guided back to a correct position without having to lift the tip off the surface of the implant 1800 if the tip is guided too far from the point features.

[0073] Figure 19 is a diagram illustrating a specific patient orbital implant 1900 according to aspects of this disclosure. The 1900 implant includes several Petition 870260056473, dated 10 / 06 / 2026, p. 44 / 172 39 / 60 features that are similar to those shown in Figures 7-18 which cannot be discussed further for the sake of brevity. In the present document, the implant includes a plurality of perforations 1904 and a raised ridge 1906 connecting three point features 1902.

[0074] Figure 20 is a diagram illustrating a patient-specific orbital implant 2000 according to aspects of this disclosure. Implant 2000 includes several features that are similar to those shown in Figures 7-19 which cannot be discussed further for reasons of brevity. In the present document, implant 2000 includes a raised ridge 2004 with a smooth transition 2006 connecting three point features 2002 that exhibit undulations.

[0075] Figure 21 is a diagram illustrating a patient-specific orbital implant 2100 according to aspects of this disclosure. The implant 2100 includes several features that are similar to those shown in Figures 7-20 which cannot be discussed further for reasons of brevity. In the present document, the implant 2100 includes a raised ridge 2104 with a smooth transition 2106 connecting three point features 2102 that are qualified by orifices.

[0076] Figure 22 is a diagram illustrating a patient-specific orbital implant 2200 according to aspects of this disclosure. The implant 2200 includes several features that are similar to those shown in Figures 7-21 which cannot be discussed further for reasons of brevity. In the present document, the implant 2200 includes a raised ridge 2204 connecting features of three Petition 870260056473, dated 10 / 06 / 2026, p. 45 / 172 40 / 60 points 2202. The first feature of point 2202a is a depression, while the second feature of point 2202b and the third feature of point 2202c are dimples.

[0077] Figure 23 is a diagram illustrating a patient-specific orbital implant 2300 according to aspects of this disclosure. The implant 2300 includes several features that are similar to those shown in Figures 7-22 which cannot be discussed further for reasons of brevity. In the present document, the implant 2300 includes a raised ridge 2304 connecting three point features 2302, wherein each point feature is a hole.

[0078] Figure 24 is a diagram illustrating six different example forms of raised ridges that can be used in an optical implant. A first raised ridge 2400a is a top surface ridge, meaning that the raised ridge runs along the edge of the implant (e.g., see raised ridge 708 / 808 in Figures 7 and 8). A second raised ridge 2400b is wave-shaped, having a concave portion of the ridge more capable of accepting the tip of a pen. A third raised ridge 2400c is a raised ridge that is formed at a distance from the edge of the implant (e.g., see the raised ridge in Figures 10-13 and 15-23). ​​A fourth raised ridge 2400d is wave-shaped, having a concave portion of the ridge more capable of accepting the tip of a pen and being formed at a distance from the edge of the implant. A fifth elevated ridge 2400e is a plateau-type ridge, as discussed above in Figure 14.A sixth elevated ridge 2400f is an elevated ridge with a smooth transition from the top of the ridge to the surface. Petition 870260056473, dated 10 / 06 / 2026, page 46 / 172 41 / 60 implant (for example, see the raised ridge having a smooth transition from the ridge to the eyeball-facing surface of the implant in Figures 18, 20 and 21).

[0079] In certain aspects, raised ridges can be replaced by grooves (e.g., grooves or recesses). Therefore, an implant according to the aspects of this document may have non-planar orientation features, which refer to raised grooves and / or channels. However, raised ridges offer the benefit of not locally weakening the implant. In other words, they do not reduce the implant's mechanical strength or resistance to deformation. Furthermore, as described above, in the distal areas of the implant, where tip orientation is most necessary, the tip may be inclined almost tangentially to the implant surface facing the eyeball, which may increase the risk of the pen tip leaving the groove or may completely prevent the pen tip from remaining in a groove. For this reason, raised ridges may be preferred.

[0080] It is also possible to combine two raised protrusions spaced apart to establish a channel to guide the pen tip. However, as with grooves, in the distal areas of the implant, the angulation of the pen relative to the implant surface may increase the risk of the pen tip exiting the channel or may completely prevent the pen tip from remaining in the channel. For this reason, it may be preferable to provide the implant with a raised protrusion or a series of raised protrusions only on one side of a pen path – for example, the path or range of Petition 870260056473, dated 10 / 06 / 2026, page 47 / 172 42 / 60 trajectories that the tip can follow on its way to a point feature, or the trajectory that establishes a path feature - such as the distal side.

[0081] Figure 25 is a flowchart illustrating the 2500 operations for using an orbital implant according to aspects disclosed in this document. The 2500 operations can be implemented as software components that are executed and operated on one or more processors (e.g., electronic processing device 2606 of Figure 26) in conjunction with one or more medical instruments (e.g., pen 2608 of Figure 26).

[0082] In a first block 2501, operations 2500 include loading a virtual model comprising a planned design or shape of an orbital implant into a navigation system and bringing it into a common coordinate system with the actual patient. For example, a virtual 3D model of a portion of the patient's anatomy can be loaded, wherein the virtual model of the implant and the virtual model of the anatomy are such that the implant is in its planned position relative to the patient's anatomy. The actual patient and the virtual model of the anatomy can then be registered (e.g., brought into a common coordinate system). For example, a pen from the navigation system can be used to indicate anatomical landmarks of the patient.The locations of these anatomical landmarks can then be recorded with the locations of the corresponding anatomical landmarks in the virtual anatomy model, maintaining the relative position of the virtual implant model in relation to the virtual anatomy model. Petition 870260056473, dated 10 / 06 / 2026, page 48 / 172 43 / 60

[0083] In a second block 2502, the operations 2500 include positioning a first surface of an orbital implant in the deformity of the orbital bone structure, a first surface comprising a shape configured to interface with a floor and / or rim of the orbital bone structure, and a second surface opposite to the first surface and substantially conforming to the shape of the first surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise a first point feature, a second point feature, and a third point feature that form nodes of a triangle, wherein each of the three or more point features constitutes at least one of those raised above or lowered below the second surface.

[0084] For example, as discussed in relation to Figures 5A-5D, the shape of the first surface may approximately mimic the shape of a floor and / or edge surface of the orbital bone structure, so as to allow for more or less stable positioning of the implant over the bone structure. Alternatively, as described above for patient-specific implants, part or all of the shape of the first surface may be designed to closely follow the shape of the bone structure so as to match it.

[0085] For example, as illustrated in Figures 6 and 7, the 600 / 700 orbital implant may include a plurality of 610 / 702 point features. Specifically, in Figure 6, the 610 point features may be recessed to the extent that they are perforations in the 600 implant. Petition 870260056473, dated 10 / 06 / 2026, page 49 / 172 44 / 60 In Figure 7, the first point feature 702a is a wedge-shaped depression or recess below the second surface, while the second point feature 702b and the third point feature 702c are recessed undulations below the second surface.

[0086] In a third block 2504, operations 2500 include tracing the navigation system pen along the second surface until the pen is received by each of three or more point features to compare one or more of: (i) the shape of the orbital implant, relative to a planned shape of the orbital implant, or (ii) a position of the orbital implant in a patient, relative to a planned position of the orbital implant in the patient. For example, a surgeon might trace the pen along the second surface (e.g., the surface facing the eyeball) of the implant, making contact between the pen and each of three or more point features. In this way, the physical act of scanning, or making contact between the pen and the point features, provides the navigation system with a position of those features in the navigation system's coordinate system.In some examples, making contact between the pen and a point feature, particularly a point feature near the distal edge of the implant, may involve sliding the pen along the second surface in a distal direction until one tip of the pen reaches a raised ridge of the implant, and then sliding the tip of the pen along the raised ridge until it is received at the point feature.

[0087] In a fourth block 2506, operations 2500 may optionally include receiving an indication of a Petition 870260056473, dated 10 / 06 / 2026, page 50 / 172 45 / 60 difference between one or more of: (i) the shape of the orbital implant relative to the planned shape of the orbital implant, or (ii) the position of the orbital implant in the patient relative to a planned position of the orbital implant in the patient. For example, once the position of the point features in the navigation system's coordinate system is determined, the navigation system can compare the position of the point features determined by touching the implant with the pen, with a position of the point features of the virtual 3D model of the planned implant shape, which was brought into the navigation system's coordinate system in the first block 2501. The navigation system can then determine any differences, such as differences between the constellation of point features on the actual implant and the constellation of point features in the virtual 3D model of the planned implant shape, or - derived from such differences - differences between the actual implant shape and the planned implant shape, and report the differences to the user. In another example, the navigation system can compare the position of point features determined by touching the implant with the pen, with a position of point features on the virtual 3D model of the implant, relative to the virtual model of the patient's anatomy (e.g., orbital bone structure). In this way, the navigation system can determine a difference between an actual placement of the physical implant, relative to the patient's anatomy, and a planned placement of a model of the implant relative to a model of the patient's anatomy.

[0088] In a fifth block 2508, operations 2500 may optionally include intrasurgical adjustment of a Petition 870260056473, dated 10 / 06 / 2026, page 51 / 172 46 / 60 or more of the orbital implant shape or the orbital implant position according to the corresponding difference indication. For example, based on the information provided in block 2506, the user can adjust the implant to more closely match the planned implant model and / or the implant position to more closely match the planned position (e.g., virtual positioning) of the implant.

[0089] Figure 26 is a schematic diagram illustrating a conceptual example of a navigation system. The 2600 system with a pen 2608 can be used in conjunction with preoperative images from an imaging process (e.g., computed tomography (CT), 3D and / or 2D fluoroscopy, ultrasound (US) imaging, magnetic resonance imaging (MRI)) and / or similar to perform an image-guided surgical procedure. The 2600 system includes at least one electronic processing device 2606, a display unit 2602, at least one tracked instrument 2608, such as a pen, and an infrared sensor 2610. The 2600 system further includes one or more trackers (e.g., a tracker 2612 rigidly fixed to the patient's anatomy 2616 and, optionally, another tracker 2614 fixed to the pen 2608). Instruments 2608 and trackers 2612 / 2614 may include markers, which can be easily detected by the infrared sensor 2610, allowing the navigation system to locate instruments 2608 and trackers 2612 / 2614 in space.

[0090] The 2606 electronic processing device may be, for example, a personal computer or Petition 870260056473, dated 10 / 06 / 2026, page 52 / 172 47 / 60 similar. The electronic processing device 2606 includes at least one processor and a memory (e.g., a non-transient computer-readable medium). The memory (not shown) may be, for example, a random access memory (RAM), a memory buffer, a hard disk, a read-only memory (ROM), an erasable programmable read-only memory (EPROM), and / or so forth. In some embodiments, the memory of the electronic processing device 2606 stores instructions to cause the processor to perform operations (e.g., operations 2500 of Figure 25) and / or functions associated with the use of a personal computer application, controlling one or more medical instruments such as a pen, displaying and updating an image on the display unit 2602 according to the movement of the pen, and / or the like.

[0091] The processor (not shown) of the 2606 electronic processing device may be any suitable processing device configured to operate and / or execute a set of instructions or code. For example, the processor may be a general-purpose processor, a central processing unit (CPU), an accelerated processing unit (APU), or similar. In some embodiments, the processor of the 2606 electronic processing device may be included, for example, in an application-specific integrated circuit (ASIC). The processor may be configured to operate and / or execute a set of instructions (e.g., the 2500 operations illustrated in Figure 25) or code stored in memory associated with the use of a personal computer application, a mobile application, an internet browser, communications Petition 870260056473, dated 10 / 06 / 2026, page 53 / 172 48 / 60 telephone or mobile phones and / or similar.

[0092] The display unit 2602 is configured to be in electronic communication with the electronic processing device 2606. The display unit 2602 can be any suitable display configured to provide a user interface to the electronic processing device 2606. For example, the display unit 2602 can be a cathode ray tube (CRT) monitor, a liquid crystal display (LCD) monitor, a light-emitting diode (LED) monitor, a head-mounted device, and / or the like. The display unit 2602 can be configured to provide the user interface to a personal computer application or similar. For example, the display unit 2602 can be configured to graphically represent a medical image of an anatomical structure.In some embodiments, the display unit 2602 can graphically represent the position of one or more medical instruments (e.g., the pen 2608 and / or any other suitable device) as the medical instrument is positioned relative to a target tissue (e.g., an organ and / or bone structure) of a patient and relative to a preoperative image or model of the target tissue. In some embodiments, the processing device 2606 can be configured to map the movement of the pen 2608 relative to a preoperative image of the target tissue, and the display unit 2602 can graphically represent a virtual position of the pen 2608 relative to the image of the target tissue. The processing device 2606 can determine the position of the pen 2608 relative to the target tissue.

[0093] The electronic processing device Petition 870260056473, dated 10 / 06 / 2026, page 54 / 172 49 / 60 The 2606 can be configured to be in electronic communication with the 2608 pen (e.g., via a wireless connection, an Ethernet cable, Universal Serial Bus (USB), SATA cable, eSATA cable, or similar). The 2608 pen can be any suitable instrument configured to be tracked by a tracking system (e.g., optical tracking or other modality). For example, an infrared emitting diode (IRED) can be used to map the position of the 2608 pen in physical space onto a virtual coordinate system and pre-operative image. EXEMPLARY ASPECTS

[0094] Implementation examples are described in the following numbered clauses. The numbered clauses refer to implants and methods involving implants. One skilled in the art will readily appreciate that they may refer to orbital implants or other types of implants.

[0095] 1. An implant for correcting a deformity of a bone structure, comprising: a first surface comprising a shape configured to interface with a surface of the bone structure; and a second surface opposite to the first surface and substantially conforming to the shape of the first surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise a first point feature, a second point feature, and a third point feature forming nodes of a triangle, wherein each of the three or more point features is recessed below the second surface. Petition 870260056473, dated 10 / 06 / 2026, page 55 / 172 50 / 60

[0096] 2. The implant of aspect 1, in which at least one or more of the three point features comprises a hole through the implant from the first surface to the second surface.

[0097] 3. Implant according to any one of claims 1 and 2, wherein at least one or more of the three point features comprises a depression configured to receive a pen tip angled tangentially close with respect to the second surface.

[0098] 4. Aspect 3 implant, in which the depression is a wedge-shaped or elongated depression.

[0099] 5. Implant according to any one of claims 1-4, further comprising a raised ridge on the second surface partially encompassing at least one of three or more point features.

[00100] 6. The implant of aspect 5, in which the elevated ridge surrounds referred to as at least one or more of the three point features on a distal side.

[00101] 7. Implant according to either claim 5 or 6, wherein the raised ridge follows a distal edge of the second surface.

[00102] 8. Implant according to any one of claims 5-7, wherein the raised ridge comprises at least one of a corner, a hook, a notch or a gap in at least one of three or more point features.

[00103] 9. The implant of aspect 8, in which the corner, hook, notch or gap is configured to receive a pen tip angled substantially tangentially to the second surface.

[00104] 10. Implant in accordance with any of the Petition 870260056473, dated 10 / 06 / 2026, p. 56 / 172 51 / 60 claims 5-9, where the raised ridge extends from the first point feature of the three or more point features to the second point feature of the three or more point features.

[00105] 11. Implant according to any of claims 5-10, further comprising another raised ridge on the second surface, the other raised ridge extending from the second point feature to the third point feature of the three or more point features.

[00106] 12. The implant of aspect 11, in which the raised ridge and the other raised ridge form a continuous ridge line on the second surface.

[00107] 13. Implant according to any one of claims 5-12, wherein the raised crest comprises a plurality of protrusions on one side of the raised crest.

[00108] 14. The implant aspect 13, where the side is a distal side of the elevated crest.

[00109] 15. Implant according to any of claims 5-14, further comprising a gradual transition on one side of the raised ridge from a raised ridge top to the second surface.

[00110] 16. The implant aspect 15, where the side is a distal side of the elevated crest.

[00111] 17. Implant according to any one of claims 5-16, wherein the raised ridge comprises a concave side to receive the tip of a pen.

[00112] 18. The implant with aspect ratio 17, where the concave side is a proximal side of the elevated ridge.

[00113] 19. Implant in accordance with any of the Petition 870260056473, dated 10 / 06 / 2026, p. 57 / 172 52 / 60 claims 1-4, further comprising one or more elevated ridges extending along a path between the first point feature of the three or more point features and the second point feature of the three or more point features, wherein each of the one or more elevated ridges is located on a first side of the path and not on a second side of the path.

[00114] 20. The implant of aspect 19, where the first side of the path is a distal side of the path.

[00115] 21. Implant according to any one of claims 1-20, further comprising a plurality of perforations through the implant from the first surface to the second surface.

[00116] 22. The implant of aspect 21, in which a path between the first point feature of three or more point features and the second point feature of three or more point features does not include plurality of perforations.

[00117] 23. A method for correcting a deformity of a patient's bone structure, the method comprising: positioning a first surface of an implant over the deformity of the bone structure, the first surface comprising a shape configured to interface with a surface of the bone structure, and a second surface opposite to the first surface and substantially conforming to the shape of the first surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise a first point feature, a second point feature and Petition 870260056473, dated 10 / 06 / 2026, page 58 / 172 53 / 60 third point feature forming nodes of a triangle, wherein each of the three or more point features is at least one of those raised above or lowered below the second surface; and tracing with a pen of a navigation system along the second surface until the pen is individually received by the three or more point features, to compare one or more of: (i) the shape of the implant in relation to a planned shape of the implant, or (ii) a position of the implant in the patient in relation to a planned position of the implant in the patient.

[00118] 24. The method of aspect 23, further comprising loading a virtual 3D implant model into the navigation system and bringing the virtual 3D implant model and the bone structure into a common coordinate system.

[00119] 25. The method of either of aspects 23 and 24, further comprising loading a virtual 3D anatomy model into the navigation system, wherein bringing the virtual 3D implant model and the bone structure into a common coordinate system comprises: registering anatomical features of the patient with anatomical features of the virtual 3D anatomy model and maintaining a relative position of the virtual 3D implant model and the virtual 3D anatomy model.

[00120] 26. The method of any of aspects 23-25, further comprising receiving an indication of a difference between one or more of: (i) the shape of the implant in relation to the virtual 3D implant model, or (ii) the position of the implant in the patient in relation to a position of the virtual 3D implant model in relation to the patient.

[00121] 27. The aspect method 26, comprising Petition 870260056473, dated 10 / 06 / 2026, page 59 / 172 54 / 60 still adjust, intrasurgically, one or more of the implant shape or implant position according to the indication of the difference.

[00122] 28. The method of any of aspects 23-27, in which at least one or more of the three point features is configured to receive a pen tip angled tangentially close to the second surface.

[00123] 29. The method of any of the aspects 23-28, in which at least one or more of the three point features comprise a wedge-shaped or elongated depression.

[00124] 30. The method of any of the aspects 23-29, in which at least one or more of the three point features are partially surrounded by a raised ridge.

[00125] 31. The aspect method 30, in which the elevated ridge surrounds at least partially the aforementioned at least one or more of the three point features on a distal side of at least one of the three or more point features.

[00126] 32. The method of either of aspects 30 and 31, wherein the raised crest comprises a corner, hook, notch or gap in at least one or more of the three point features, to receive a pen tip of the navigation system.

[00127] 33. The method of any of the aspects 23-32, wherein the implant comprises a raised ridge and wherein the stroke of the navigation system pen along the second surface until the tip is received, individually, by the three point features, further comprising: sliding a pen tip along Petition 870260056473, dated 10 / 06 / 2026, page 60 / 172 55 / 60 of the second surface until reaching the raised ridge; and slide the pen tip along the raised ridge until the pen tip is received on at least one of the three point features.

[00128] 34. A method for generating an implant to correct a deformity of a bone structure, the method comprising: receiving a design of the implant, the design indicating a shape, size and position of the implant in relation to a construction area corresponding to an additive manufacturing device, the implant design defining: a first surface comprising a shape configured to interface with a surface of the bone structure;and a second surface opposite the first surface and substantially conforming to the shape of the first surface, the second surface comprising three or more point features on the second surface, wherein the three or more point features comprise a first point feature, a second point feature, and a third point feature forming nodes of a triangle, wherein each of the three or more point features constitutes at least one of a raised above or lowered below the second surface; and leading to the manufacture of the implant using additive manufacturing.

[00129] 35. The aspect 34 method, in which at least one or more of the three point features comprises a hole through the implant from the first surface to the second surface.

[00130] 36. The method of either of aspects 34 and 35, in which at least one or more of the three point features comprise a depression. Petition 870260056473, dated 10 / 06 / 2026, p. 61 / 172 56 / 60 configured to receive the tip of a pen angled tangentially with respect to the second surface.

[00131] 37. The aspect ratio 36, in which the depression is a wedge-shaped or elongated depression.

[00132] 38. The method of any of the aspects 34-37, in which the implant design further defines a raised ridge on the second surface partially involving at least one of the three or more point features.

[00133] 39. The aspect method 38, in which the elevated ridge partially surrounds the aforementioned at least one or more of the three point features on a distal side.

[00134] 40. The method of either of aspects 38 and 39, in which the elevated ridge follows a distal edge of the second surface.

[00135] 41. The method of any of aspects 38-40, wherein the raised crest comprises at least one of a corner, a hook, a notch or a gap in at least one of three or more point features.

[00136] 42. The aspect ratio method 41, in which the corner, hook, notch or gap is configured to receive the tip of a pen angled substantially tangentially to the second surface.

[00137] 43. The method of any of the aspects 38-42, in which the elevated ridge extends from the first point feature of the three or more point features to the second point feature of the three or more point features.

[00138] 44. The method of either of the aspects 38-43, in which the implant design defines yet another raised ridge on the second surface, the other raised ridge being Petition 870260056473, dated 10 / 06 / 2026, p. 62 / 172 57 / 60 extending from the second point characteristic to the third point characteristic of the three or more point characteristics.

[00139] 45. The aspect ratio method 44, in which the raised ridge and the other raised ridge form a continuous ridge line on the second surface.

[00140] 46. The method of any of the aspects 38-45, in which the implant design further defines a plurality of protrusions on one side of the elevated ridge.

[00141] 47. The aspect ratio 46, where the side is a distal side of the elevated ridge.

[00142] 48. The method of either of aspects 38-47, in which the implant design further defines a smooth transition on one side of the raised ridge from a top of the raised ridge to the second surface.

[00143] 49. The aspect ratio 48, where the side is a distal side of the elevated ridge.

[00144] 50. The method of any of aspects 34-37, in which the implant design defines one or more elevated ridges on one side of a path between the first point feature of the three or more point features and the second point feature of the three or more point features.

[00145] 51. The aspect method 50, in which one side of the path is a distal side of the path.

[00146] 52. The method of any of the aspects 34-37, in which the implant design further defines a raised ridge comprising a concave side to receive the tip of a pen.

[00147] 53. The aspect ratio method 52, in which the side Petition 870260056473, dated 10 / 06 / 2026, page 63 / 172 58 / 60 concave is a proximal side of the elevated ridge.

[00148] 54. The method of any of the aspects 34-37, in which the implant design further defines a plurality of perforations through the implant, from the first surface to the second surface.

[00149] 55. The aspect method 54, in which the implant design does not define any of the plurality of perforations along a path between the first point feature of three or more point features and the second point feature of three or more point features.

[00150] 56. The method of any of the aspects 34-37, further comprising: receiving a digital file comprising the implant design; and uploading the digital file into a navigation system.

[00151] 57. The aspect ratio method 56, in which the digital file also includes indicative data for the position of each of the three or more point characteristics.

[00152] 58. The aspect method 57, in which the indicative data of a position are indicative data of a planned implant position, in relation to a patient's anatomy.

[00153] 59. The aspect method 58, in which the indicative data of the planned implant position comprise a virtual 3D representation of at least part of the patient's anatomy and indicative data of a position of each of three or more implant point features with respect to the patient's anatomy. ADDITIONAL CONSIDERATIONS Petition 870260056473, dated 10 / 06 / 2026, page 64 / 172 59 / 60

[00154] Several embodiments disclosed in this document provide for the use of a computer control system. One skilled in the art will readily appreciate that these embodiments can be implemented using various different types of computing devices, including general-purpose and / or special-purpose computing system environments or configurations. Examples of well-known computing systems, environments, and / or configurations that may be suitable for use in connection with the embodiments set forth above may include, but are not limited to, personal computers, server computers, portable or laptop devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments (e.g., networks, cloud computing systems, etc.) that include any of the above systems or devices and the like.These devices may include stored instructions that, when executed by a microprocessor in the computing device, cause the computing device to perform specified actions to execute the instructions. As used in this document, instructions refer to computer-implemented steps for processing information in the system. Instructions may be implemented in software, firmware, or hardware and include any type of programmed step performed by system components.

[00155] A microprocessor can be any conventional single- or multi-chip microprocessor for use Petition 870260056473, dated 10 / 06 / 2026, page 65 / 172 A general 60 / 60 microprocessor can be a Pentium® processor, a Pentium® Pro processor, an 8051 processor, a MIPS® (interlocked pipelined stage) processorless microprocessor, a PowerPC® processor, or an Alpha® processor. Additionally, the microprocessor can be any conventional special-purpose microprocessor, such as a digital signal processor or a graphics processor. The microprocessor typically has conventional address lines, conventional data lines, and one or more conventional control lines.

[00156] Aspects and embodiments disclosed in this document may be implemented as a method, apparatus, or article of manufacture using standard programming or engineering techniques to produce software, firmware, hardware, or any combination thereof. The term article of manufacture, as used in this document, refers to code or logic implemented in hardware or computer-readable non-transient media, such as optical storage devices and volatile or non-volatile memory devices, or computer-readable transient media, such as signals, carrier waves, etc. Such hardware may include, but is not limited to, field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), complex programmable logic devices (CPLDs), programmable logic arrays (PLAs), microprocessors, or other similar processing devices. Petition 870260056473, dated 10 / 06 / 2026, page 66 / 172

Claims

1 / 3 CLAIMS 1. A method for configuring a bending mold for an implant to correct a defect in a bone structure, the method characterized by comprising: obtaining information about the bone structure from medical images; using a computer to generate a three-dimensional model of the bone structure; designing a target shape using the three-dimensional model of the bone structure, a mirror image of a contralateral side and / or a statistical shape model; matching the target shape with the three-dimensional model of the bone structure to obtain a three-dimensional model of a desired bone structure; manufacturing a bending mold based on the three-dimensional model of the desired bone structure; and using the bending mold by bending an implant structure.

2. A method according to claim 1, characterized by further comprising displacing the target shape towards the bone structure along the thickness of the implant before matching it to the three-dimensional model of the bone structure to obtain the desired three-dimensional model of the bone structure.

3. Method, according to claim 1 or 2, characterized in that the manufacture of the bending mold comprises manufacturing the bending mold using additive manufacturing.

4. Method, according to any one of claims 1 to 3, characterized in that the implant comprises one or more sections and one or more locations of reduced resistance to deformation bending separating the sections.

5. A method, according to any one of claims 1 to 4, characterized in that the implant comprises one or more point features.

6. A method, according to any one of claims 1 to 5, characterized by further comprising the steps of: performing a simulation of implant bending so that one surface of the implant facing the bone is seated on a part of the bone structure surrounding the defect and a second surface of the implant opposite the surface of the implant facing the bone follows the target shape.

7. Method, according to claim 6, characterized by further comprising generating a set of instructions for a sheet metal bending machine.

8. Method according to claim 6, characterized in that the manufacturing step of a bending mold based on the three-dimensional model of the desired bone structure comprises: designing the bending mold to coincide with the bone-facing surface of the implant, as simulated to be bent, or with the second surface of the implant, as simulated to be bent.

9. Method, according to claim 8, characterized in that the bending mold comprises marks to delineate a contour of the implant as simulated to be bent or protrusions to be received in one or more perforations of the implant or in notches along an edge of the implant.

10. A method, according to any one of claims 6 to 9, characterized by further comprising the steps of: using a navigation system to measure the deviation between the implant after bending and the simulation; and reporting said deviation.

11. Method according to claim 10, characterized by further comprising providing instructions for performing additional bending of the implant.

12. Method according to claim 10 or 11, characterized in that: the implant comprises one or more sections, one or more bending points with reduced resistance to deformation separating the sections, and one or more point features along the edges of the sections; wherein the one or more bending points and one or more point features comprise a linear slot and a hole at one end of the linear slot, respectively; and wherein the use of the navigation system to measure the deviation comprises the use of a probe to trace the linear slot to the hole. Petition 870260056473, dated 10 / 06 / 2026, pp. 129 / 172

Images