NON-PATIENT-SPECIFIC CRANIOFACIAL IMPLANTS FOR THE CORRECTION AND / OR PREVENTION OF TEMPORAL OR PTERION DEFORMITIES - Patent application

Abstract

A non-patient-specific implant for neuroplastic surgery is provided. The non-patient-specific implant includes a three-dimensional mesh. The three-dimensional mesh includes titanium. The three-dimensional mesh is pre-folded. The three-dimensional mesh is configured to replace a space for hard tissue and / or a space for soft tissue. The three-dimensional mesh has a three-dimensional triangular shape.

Description

Technical Field

[0001] The technology disclosed in this application relates to a non-patient-specific craniofacial implant for correcting and / or preventing deformations of the temporal or pterion region. (Claim of Priority) This application claims the priority and benefit of U.S. Provisional Patent Application No. 63 / 237,703, filed on August 27, 2021, the entire disclosure of which is incorporated herein by reference.

Summary of the Invention

Problems to be Solved by the Invention

[0002] Performing neurosurgery may require a craniotomy of a fairly large size. The majority (about 75%) of all craniotomies can be performed within the pterion region or the temporal region. Therefore, the anatomical structure of the temporal region can be distorted for the resection of blood vessels and innervation of important structures such as the temporalis muscle and the temporal adipose body (i.e., the associated soft tissues). Therefore, following the damage to this anatomical structure, facial symmetry can be permanently at risk and distorted. Furthermore, a significant number of neurosurgical patients may lose a bone flap (i.e., a segment of bone removed for access to the brain) due to any of infection, tumor lesion, brain swelling, and / or traumatic fracture. Therefore, there may be deformations associated with the loss of separated soft tissues, or deformations associated with a reduction in the combination of hard and soft tissues. In any case, a second surgery known as cranioplasty may be required to reconstruct the missing skull and / or the missing soft tissue bulk.

Means for Solving the Problems

[0003] Aspects of the present disclosure generally relate to the field of reconstructive surgery, particularly craniofacial surgery, neuroplasty, craniofacial surgery, and neurosurgery, and more specifically to the field of improving the form and function of uncustomized implants in anatomical replacement. In one example, an implant not specific to a patient for neuroplasty may be provided. The implant not specific to a patient can include a three-dimensional mesh. The three-dimensional mesh can include titanium. The three-dimensional mesh can Pre-folded be optional.

[0004] In some embodiments of the present disclosure that can be used in combination with any other example or combination of examples listed herein, the three-dimensional mesh can replace both the space for hard tissue and the space for soft tissue.

[0005] In some embodiments of the present disclosure that can be used in combination with any other example or combination of examples listed herein, the hard tissue may be the skull, and the soft tissue may be the muscle and / or fat covering the skull.

[0006] In some embodiments of the present disclosure that can be used in combination with any other example or combination of examples listed herein, the three-dimensional mesh can replace only the space for soft tissue.

[0007] In some embodiments of the present disclosure that can be used in combination with any other example or combination of examples listed herein, the soft tissue can be the muscle and / or fat covering the vertebrae.

[0008] In some embodiments of the present disclosure that can be used in combination with any other example or combination of examples listed herein, the three-dimensional mesh can have a three-dimensional triangular shape.

[0009] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the three-dimensional mesh may include a filled space having a predetermined volume. The filled space may be formed within three side edges and a curved central portion of the three-dimensional mesh.

[0010] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the filled space may be configured to fill the volume of the space for hard tissue and / or soft tissue to be replaced by the three-dimensional mesh.

[0011] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the size of the three-dimensional mesh ranges from about 5 cm to about 10 cm.

[0012] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the size of the three-dimensional mesh ranges from about 10 cm to about 15 cm.

[0013] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the size of the three-dimensional mesh ranges from about 15 cm to about 20 cm.

[0014] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the three-dimensional mesh may have a higher rigidity than porous polyethylene and silicone.

[0015] In some embodiments of the present disclosure that can be used in combination with any other embodiment or combination of embodiments recited herein, the three-dimensional mesh may be configured to be placed in the middle cranial fossa region.

[0016] In some embodiments of the disclosure, which may be used in combination with any other example or combination of examples recited herein, the three-dimensional mesh may include one or more holes configured to receive fasteners.

[0017] In some embodiments of the disclosure, the non-patient-specific implant may include a three-dimensional titanium mesh. The three-dimensional titanium mesh Pre-folded may be, and the three-dimensional titanium mesh may have a three-dimensional triangular shape.

[0018] Additional features and advantages of the disclosed apparatus or system will be described in and will be apparent from the following detailed description and figures.

Brief Description of the Drawings

[0019]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Modes for Carrying Out the Invention

[0020] Aspects of the present disclosure are disclosed in the following description and the related drawings. Those skilled in the art will recognize that alternative embodiments may be devised without departing from the spirit or scope of the claims. Additionally, well-known elements of exemplary embodiments of the present disclosure may not be described in detail or may be omitted so as not to obscure the relevant details of the present disclosure.

[0021] As used herein, the term "exemplary" means "serving as an example, instance, or illustration." The embodiments described herein are not limiting but merely exemplary. It should be understood that the described embodiments should not be construed as necessarily more preferred or advantageous than other embodiments. Further, the terms "embodiments of the present invention," "embodiments," or "the present invention" do not require that all embodiments of the present invention include the described features, advantages, or modes of operation.

[0022] The present disclosure may refer to techniques developed by the inventor for utilizing craniofacial implants for correcting and / or preventing temporal and pterional cavitation deformities commonly occurring in neurosurgical patients, the disclosure of which is incorporated herein by reference in its entirety.

[0023] Artificial implants can be designed for anatomical replacement of bone (e.g., hard tissue) defects that they replace. They may be pre-designed using computer-aided design / manufacturing (CAD / CAM) as customized patient-specific implants, or may be pre-designed using anatomical averaging as "off-the-shelf" free-size implants. In either case, both implant manufacturing processes are equivalent to pre-fabricated implants made from safe and biocompatible alloplastic materials that retain their shape and form over time. Examples of alloplastic materials used for such implants include porous polyethylene or silicone.

[0024] In some embodiments, customized solutions for correcting and / or preventing temporal hollowing deformities may be provided. Some such solutions can replace both the missing bone and soft tissue in the craniofacial region and are disclosed in U.S. Patent No. 10,639,158, entitled "PATIENT-SPECIFIC CRANIOFACIAL IMPLANTS," filed on April 8, 2019, the disclosure of which is hereby incorporated by reference in its entirety. However, in some cases, considering the preoperative time, effort, and cost required to design a "one-of-a-kind" shape solution customized for each patient in need, non-patient-specific craniofacial implants may be required to correct and / or prevent deformities in the temporal or pterion region.

[0025] Alloplastic implants that are commonly sold as "universal" solutions for correcting or preventing temporal deformities, such as off-the-shelf non-customized pterion implants made of porous polyethylene (i.e., MedPor) or silicone, may not be optimal considering the much higher tendency for postoperative infection risk and lower surgeon preference or comfort.

[0026] The anatomical structure of the bones that make up a particular aspect of the human body can maintain a certain form and, thus, is suitable for the field of implantable implants in that their shape and form can always remain constant. Conversely, soft tissue regions found on the bone, such as muscle and fat, may constantly change shape in response to the movement of a person's body throughout the day and, thus, have inconsistent boundaries that make the task of implant design difficult. Therefore, solutions that take these factors into account are desirable.

[0027] For example, during neurosurgery, by using craniofacial implants to replace the atrophied temporal adipose bulk, temporal muscle bulk, and / or temporal bone, the affected or damaged part of the head (defects after craniotomy or craniectomy) can be safely reconstructed and replaced, all of which are generally affected by standard pterional craniotomy. After temporary removal or permanent resection of the skull in this pterion region for the purposes of neurosurgery or craniofacial plastic surgery, such defects are often reconstructed using either a custom craniofacial implant (CCI) or, most commonly, a "ready-made" non-patient-specific implant made from porous polyethylene.

[0028] A recent modification by the present inventor has revolutionized the field of soft tissue replacement surgery, called "temporal cavitation or temporal deformity correction," which allows clinicians such as neuroform surgeons or neurosurgeons to manually install / remold / size either a pre-ordered custom implant or a "ready-made" plastic implant and fit it perfectly into the temporal fossa defect as a true anatomical replacement. In either method, these methods, including craniofacial reconstruction by cranioplasty for predefined temporal or pterion defects, have been provided to surgeons with fully formed implants designed and manufactured based in part on preoperative computed tomography (CT) scans and three-dimensional reconstructions (+ / - stereolithographic models) by the advent of computer-aided design / manufacturing (CAD / CAM). However, the current challenge is that the most common "ready-made" solutions used for non-patient-specific reconstructions are made from sub-optimal alloplastics known as porous polyethylene (i.e., MedPor) or silicone, which are used in a common design method to eliminate the associated costs, preoperative time allocation, and labor required to fabricate and design alternative options that are "patient-specific" implants due to human anatomical averaging.

[0029] Aspects of the present disclosure can address problems of the prior art by providing a titanium mesh having a three-dimensional curved shape that conforms to triangular shapes of various sizes (miniature, small, medium, large, and extra-large) and capable of replacing one or both of hard tissues (e.g., bone) and soft tissues (e.g., overlying muscle and fat). The titanium mesh according to the present disclosure is a more reliable material in the fight against postoperative infection and can improve intraoperative handling to truly advance the field.

[0030] The titanium mesh according to the present disclosure may be more resistant to external forces associated with accidental head trauma than alloplastic materials. Aspects of the present disclosure Folded can advance the field by prefabricating soft tissue and / or hard tissue implants having a titanium mesh, which, unlike the prior art, can provide a final “off-the-shelf” non-custom solution. Thus, the field of soft tissue and hard tissue replacement for neurosurgical, cranioneurosurgical, and craniofacial surgeries is significantly improved by including a titanium mesh (with or without special coatings or polish) by varying both the material and the shape, providing surgeons with a much improved solution to the fight against preventing and / or correcting temporal and pterion deformities after cranioneurosurgery.

[0031] The use of CCI designed for dual purposes can potentially maintain the appearance after neurosurgery, prevent postoperative deformities with accompanying social stigma, shorten the total operation time, prevent scalp-related wound complications, and enhance patient satisfaction. This significant advancement can be achieved by utilizing the underutilized space of hard and soft tissues around the brain (thereby eliminating the old, outdated, generational dogma that cranial implants can be designed for anatomical bone spaces), using the novel design algorithm provided by the inventor, and using CAD / CAM design preoperatively. However, at that point, this solution requires the use of alloplastic materials such as porous polyethylene (MedPor), polymethyl methacrylate (PMMA), or PEEK that can be laser sintered and / or shaped into customized shapes. Previously, it was not known or understood that a two-dimensional piece of titanium mesh, very similar to origami techniques, could be pre-folded onto itself. Aspects of the present disclosure can eliminate all of the extra cost and labor required to "customize" each implant Pre-folded A titanium mesh can be provided.

[0032] FIG. 1 shows an example of a non-patient-specific implant 100 according to the present disclosure. In some embodiments, the non-patient-specific implant 100 can be made of titanium mesh. The non-patient-specific implant 100 can be prefabricated using anatomical averaging. The non-patient-specific implant 100 can have various sizes, such as extra-small, small, medium, large, and extra-large. The non-patient-specific implant 100 can be configured to accommodate various degrees of existing soft tissue atrophy Pre-folded For example, each of the non-patient-specific titanium mesh implants of various sizes can have various amounts of volume, for example, inside a triangular implant. In some embodiments, the side edges of the titanium mesh may be pre-folded.

[0033] In some embodiments, the non-patient-specific implant 100 may include various other features. For example, the non-patient-specific implant 100 may include one or more holes 110. The one or more holes 110 may be configured to receive fasteners. Examples of fasteners include screws, nails, bolts. The one or more holes 110 in the non-patient-specific titanium mesh implant 100 can facilitate the fixation of fasteners (e.g., which are easier to fix to the human craniofacial skeleton), which saves the surgeon's time and effort and provides more available options for the surgeon to place fasteners for the purpose of permanent fixation compared to less rigid porous polyethylene or silicone implants that may require more complex methods for skull fixation. Here too, care may need to be taken to minimize any micromotion of the anatomical implant after surgery, otherwise the infection rate of foreign bodies may increase and it may ultimately be removed. Thus, aspects of the present disclosure may provide significantly improved properties compared to non-patient-specific implants made of plastic (i.e., porous polyethylene).

[0034] Aspects of the present disclosure can provide the surgeon with an implant with significantly improved rigidity and structural integrity with respect to the missing bone and / or soft tissue, which is notably lacking with respect to plastic materials (i.e., porous polyethylene) that bend more easily with external trauma. In some embodiments, the non-patient-specific titanium mesh implant 100 according to the present disclosure can replace the missing volume of hard and soft tissue and correct and / or prevent visible contour deformations based on the volume maintained within the titanium mesh implant (e.g., within a triangular design).

[0035] In some embodiments, the off-the-shelf titanium mesh implant 100 according to the present disclosure can fill the adjacent spaces of hard and / or soft tissues. For example, the off-the-shelf titanium mesh implant according to the present disclosure can be used in the replacement of isolated soft tissues and / or in situations where both hard and soft tissues require replacement.

[0036] In some embodiments, the off-the-shelf titanium mesh implant 100 according to the present disclosure can be used with other types of implants. For example, the off-the-shelf titanium mesh implant 100 according to the present disclosure can be attached to the outside of a prefabricated customized implant made of an alloplastic material such as PEEK, porous polyethylene, and / or PMMA, which may not have (pre-expanded) soft tissue regions.

[0037] In some embodiments, the off-the-shelf implant 100 is like three-dimensional origami for improving form and function Folded A titanium mesh, newly utilizing an anatomically specific implant for reconstructive surgery, can be provided for the reconstruction combining hard and soft tissues. In some embodiments, the off-the-shelf implant 100 according to the present disclosure can go beyond the hard tissue replacement design that uses flat two-dimensional titanium mesh pieces for standard bone replacement. In some embodiments, the off-the-shelf implant 100 according to the present disclosure can be, for example, in a unique triangular pattern based on anatomical averaging for the reconstruction combining soft and hard tissues by prefabricating five different sizes for off-the-shelf availability such as extra-small, small, medium, large, and extra-large Pre-folded and can include flat pieces of titanium mesh. The varying space / footprint can Folded be related to the volume of the space incorporated within the center of the origami-like triangular titanium mesh implant.

[0038] In some embodiments, the off-the-shelf implant 100 according to the present disclosure may include a titanium mesh that can replace the skull and / or the soft tissue space above it. This can provide an improved alternative in the field of reconstruction over commonly used implants made of porous polyethylene or silicone that are less desirable.

[0039] In some embodiments, the off-the-shelf implant 100 according to the present disclosure can use the titanium mesh in a To be folded way similar to origami. This can replace the less desirable risk of infection commonly associated with alloplastic materials such as porous polyethylene. In some embodiments, the off-the-shelf implant according to the present disclosure may have a three-dimensional triangular shape as shown in FIGS. 1-5, and may represent an inner internal volume space that matches the atrophy of the missing soft tissue or the severity of the changes expected after neurosurgery, and may have a range spectrum (narrow >>> wide) of profile widths.

[0040] For example, the off-the-shelf implant 100 may have three side edges (a first side edge 122, a second side edge 124, a third side edge 126) connected to each other, and the three side edges 122, 124, 126 may define the boundary of the off-the-shelf implant 100. The central portion 130 of the off-the-shelf implant 100 may be curved. For example, the central portion 130 of the off-the-shelf implant 100 may have a convex curvature, and a filling space 140 having a predetermined volume can be formed within the three side edges 122, 124, 126 and the curved central portion 130. In some embodiments, the filling space 140 may correspond to the volume of the space for the hard and / or soft tissue to be replaced by the three-dimensional mesh.

[0041] Aspects of the present disclosure can be used for additional muscle and fat volumes covering important areas around the brain / skull. In some embodiments, aspects of the present disclosure Pre-foldedA rigid, patient-non-specific implant made of titanium mesh can be provided, which can safely replace various tissue types such as bone, muscle and / or fat. The soft tissue implant can include various functional embedded neurotechnologies, for example, in a triangular titanium mesh implant, there may be spaces not utilized, which can provide modalities for enhancing life, changing life, and / or saving life for the nearby brain. Folded The soft tissue implant components inside the titanium mesh may be replaceable with other soft tissue implant components in a plug-and-play fashion (if previous technologies are no longer necessary).

[0042] Several descriptions of patient-specific craniofacial implants are disclosed in U.S. Patent No. 10,639,158, entitled "PATIENT-SPECIFIC CRANIOFACIAL IMPLANTS," filed on April 8, 2019, the disclosure of which is hereby incorporated by reference in its entirety, and describes replacing missing soft tissue simultaneously with skull reconstruction by using computer-aided design algorithms that focus on the above soft tissue. Further technological innovations may include improved designs that include more defined anatomical vector lines (i.e., improved results) to improve consistency, prefabricated temporal windows to prevent soft tissue impingement during placement, and placing these craniofacial implants above rather than under the scarred temporal muscles. However, these "dual-purpose craniofacial implants" (e.g., the first purpose is to replace missing bone for brain protection, and the second purpose is to restore facial symmetry subsequent to soft tissue deformation) can be created and delivered using alloplastic materials (i.e., porous polyethylene, PMMA, and PEEK), as disclosed in Zhong et al.'s "Quantitative Analysis of Dual-Purpose, Patient-Specific Craniofacial Implants for Correction of Corporal Deformity," the disclosure of which is hereby incorporated by reference in its entirety. However, as described above, alloplastic materials can be inferior solutions in temporal and pterion-type deformities considering the risk of bacterial infection and poor surgeon ergonomics. Additionally, customized craniofacial implants may be accepted for surgery and sometimes lack the bulk-out first described by the inventor. In contrast, the non-patient-specific titanium mesh implants according to the present disclosure can have a much improved profile with respect to both surgeon familiarity and a more desirable user profile and a far more optimal infection resistance profile.Thus, it can be used alone and can be placed outside the craniofacial implant with a "bone-only" replacement that is insufficiently prepared to correct and / or prevent temporal hollowing.

[0043] As shown in the figures, aspects of the present disclosure can provide a unique origami-like three-dimensional Fold titanium mesh implant (see FIGS. 1 and 2). In some embodiments, the non-patient-specific titanium mesh implant according to the present disclosure may be attached outside a standard skull flap or replacement implant (see FIGS. 3-5). The implant can be formed in a very small, small, medium, large, or extra-large implant design, and the surgeon can determine its use during cranioplasty based on intraoperative evaluation and the degree of soft tissue resorption.

[0044] In some embodiments, the non-patient-specific implant 100 according to the present disclosure can be delivered as a "ready-made" implant after virtual shape creation by human anatomical averaging and CAD / CAM design, including, for example, a) a craniofacial implant designed to replace a missing skull (i.e., an existing skull defect), and b) soft tissue designed to replace missing temporal muscle / fat. This manufacturing process provides a sufficient internal volume (e.g., within the filling space 140). The internal space components (e.g., the filling space 140) may be delivered in very small, small, medium, large, or extra-large sizes to accommodate differences in neurosurgical procedures or the degree of expected soft tissue resorption after existing deformations. Thus, the pre-formed sizes can vary with respect to length, width, and height. An exemplary clinical scenario in such an embodiment may be a patient with an existing skull defect who requires an existing soft tissue defect after neuroplasty and / or neurosurgery.

[0045] In some embodiments, the improved implant can provide the surgeon with a "non-patient-specific craniofacial implant" for a neurosurgical patient. When the neurotechnology is sophisticated and the footprint is small, these functional devices seat within the temporal fossa as there is nothing inside the inner space. Pre-folded It can be pre-designed to fill the triangular area within the titanium mesh implant.

[0046] In some embodiments, the non-patient-specific implant 100 according to the present disclosure includes a non-patient-specific soft tissue implant designed to replace the missing temporal muscle / temporal fat body / subcutaneous tissue, according to human anatomical averaging and CAD / CAM design. Folded It may be delivered as a titanium mesh origami-like implant, and the manufacturing process provides a number of holes for fastening means (e.g., screws) connection to the surrounding healthy skull in the vicinity during implantation. The soft tissue component can be delivered in sizes of extra-small, small, medium, large, or extra-large to accommodate different degrees of expected soft tissue absorption. An exemplary clinical scenario for such an embodiment can be a patient having an existing soft tissue defect after a deficit due to a neurosurgical craniotomy that requires a neuroplasty procedure.

[0047] In some embodiments, a non-patient-specific soft tissue implant for a neurosurgical patient can be provided with a view to future deformations. Thus, extra-small, small, medium, large, and extra-large sized soft tissue implant components may be delivered to the surgeon in a pre-sterilized package, which can be determined based on the intraoperative assessment and the degree of soft tissue mobilization identified when the surgeon knows that postoperative irradiation is required for cancer control by the neurosurgeon at the time of craniotomy and soft tissue deformation of the temporal / pterion area is expected in the future.

[0048] In some embodiments, another indication for the use of the novel dual-purpose implant described above is in the case of a planned craniectomy (i.e., the selective removal of the non-affected or normal skull). Many neurosurgical procedures are planned for brain diseases covered by normal and healthy bone (patient population that has not had surgery at the site of interest and has no damage to anatomical structures). However, as the field of neuroplastic surgery expands, the use of non-patient-specific implants will become more commonly adopted in all neurosurgical patients undergoing temporal and pterional craniotomies as a way to counter any risk in the social stigma of post-neurosurgical deformities and associated craniofacial deformities. In other words, neurosurgical patients will be able to desire their pre-operative appearance (in addition to a safe brain surgery), which is very similar to the parallel revolution that began in the 1950s where breast cancer patients desired reconstruction during cancer resection. Thus, aspects of the present disclosure provide the surgeon with a origami-like Pre-folded titanium mesh implant design with soft tissue implant components in very small, small, medium, large and extra-large sizes, which the surgeon can determine to use during craniotomy based on intraoperative evaluation and the degree of soft tissue absorption.

[0049] In some embodiments, in patients who require planned reconstruction by neuroplastic surgery, aspects of the present disclosure can provide an improved treatment strategy by neuroplastic surgery. These three-dimensional non-patient-specific craniofacial implants become more refined with an improved footprint, so that instead of needing to replace both the vertebra and the soft tissue of the spine for placement, the non-patient-specific implant according to the present disclosure can fill the soft tissue elements around the spinal cord Pre-fold as can be done.

[0050] Aspects of the present disclosure may provide a method for providing a non-patient-specific titanium mesh implant. In some embodiments, various sizes (e.g., 3 to 5 sizes) of the non-patient-specific titanium mesh implant may be selected to cover the most common sizes of bone defects of the voids so as to provide a desired nerve formation effect while minimizing the overlap on the bone surrounding the bone defect and / or void. In some embodiments, the non-patient-specific titanium mesh implant 100 according to the present disclosure may have a size (e.g., length / width) in the range of about 5 cm to about 10 cm, about 10 cm to about 15 cm, or about 15 cm to about 20 cm. In other embodiments, the non-patient-specific titanium mesh implant 100 according to the present disclosure may have any other suitable size. In some embodiments, the non-patient-specific titanium mesh implant according to the present disclosure can be formed and utilized in any of various ways. In some embodiments, the non-patient-specific titanium mesh implant according to the present disclosure may be 3D printed.

[0051] In some embodiments, the selected size of the non-patient-specific titanium mesh implant 100 may be processed, cut in a suitable manner, or formed in other ways. For example, the non-patient-specific titanium mesh implant can be molded, cut, and / or formed prior to surgery so that it can fill and solve existing skull defects and maintain any desired craniofacial symmetry with non-defective regions.

[0052] In some embodiments, once an appropriately sized implant is selected, any further modifications may be performed before the implant is surgically placed. In some embodiments, selecting an appropriately sized implant (within a given size) may obviate the need for further modification. In some embodiments, the non-patient-specific titanium mesh implant according to the present disclosure can be sterilized (and provided in a pre-sterilized package).

[0053] In some embodiments, before and after cutting, the off-the-shelf titanium mesh implant can be coated or polished. For example, an anti-friction coating process can be applied to the off-the-shelf titanium mesh implant according to the present disclosure to make it smoother and more suitable for the constantly moving scalp and soft tissues for long-term durability, and thus improve the current "sandpaper-like" titanium mesh products currently on the market. In some embodiments, this coating and / or manufacturing / finishing process that can reduce the abrasiveness of the titanium mesh allows for the generation of effective sliding, especially in the case of thin scalp from repeated surgeries or radiation therapies for tumor diseases, reducing the risk of final extrusion, infection, removal, and failure.

[0054] In some embodiments, the off-the-shelf titanium mesh implant according to the present disclosure may be polished to be smooth or at least not rough. Thus, the off-the-shelf titanium mesh implant according to the present disclosure can be implemented in a desired and effective manner to protect the overlying soft scalp and soft tissues (i.e., the temporalis muscle and the temporal fat body) from long-term damage, final atrophy, and / or erosion leading to breakage and removal after implantation.

[0055] In some embodiments, the titanium mesh craniofacial implant according to the present disclosure may be pre-bent prior to implantation. This may be desirable considering the radius of curvature of the skull, as typically there are no flat-shaped skull defects in humans. Thus, having a titanium mesh implant supplied in a flat shape may only require additional effort and time in the operating room and is undesirable from the perspectives of safety, time, and cost. Thereby, by pre-bending the titanium mesh craniofacial implant during the manufacturing process, the effort of the surgeon before and during surgery can be reduced, the amount of associated technicians involved in the proper formation and modeling of the craniofacial implant can be reduced to achieve the desired repair of the defect, the surgical know-how regarding addressing the contour irregularities associated with reconstruction by cranioplasty can be used to maintain craniofacial symmetry, and ultimately, an improved implant can be provided that improves the functionality of the easily exposed area and also improves the postoperative appearance of the recipient of the implant.

[0056] In some embodiments, the off-the-shelf titanium mesh implant according to the present disclosure can include countersunk holes to allow for a much smaller or shallower fastener (e.g., screw) profile during insertion. In some embodiments, one or more holes of the off-the-shelf titanium mesh implant according to the present disclosure can function as countersunk holes. For a typical screw for a neuroforming implant having a length of 4 mm with 2 mm inserted into bone and 2 mm within the mesh or implant, the countersunk hole can provide a reduction of 1 mm or more. In other words, using the countersunk hole, 3 mm of the 4 mm screw can be inserted into bone such that only 1 mm remains within the mesh or implant. As a result, a flat implant profile can be provided. Thus, the countersunk holes along the mesh implant can provide a final thin structure by having flat head screws inside the countersunk hole regions, thereby improving the result with a smooth or smoother contour of the craniofacial implant. Particularly in smokers or irradiated patients, small screw edges under thin or atrophied scalp can be very problematic, potentially including symptoms such as chronic pain, visible deformities, and even leading to extrusion / infection requiring removal of the mesh implant, all of which can be reduced by the countersunk holes.

[0057] In some examples, the off-the-shelf titanium mesh implant according to the present disclosure can be symmetric. In other embodiments, the off-the-shelf titanium mesh implant according to the present disclosure can be asymmetric. The asymmetric structure can provide additional angles for bending and shaping the implant, resulting in an easier, less time-consuming, and more accurate implant structure.

[0058] In some embodiments, the patient-independent titanium mesh implant according to the present disclosure may be placed over the temporalis muscle to prevent angiogenesis disruption and unnecessary bleeding. Such placement of the titanium mesh craniofacial implant can provide the desired reconstruction of the temporal region as well as the missing bone in the skull defect, which is particularly relevant in the case of secondary craniofacial reconstruction after head trauma or tumor that requires craniotomy and subsequent staged surgeries.

[0059] As used herein, "about," "approximately," and "substantially" are understood to refer to a range of numbers, e.g., from -10% to +10% of the referenced number, preferably from -5% to +5% of the referenced number, more preferably from -1% to +1% of the referenced number, and most preferably from -0.1% to +0.1% of the referenced number. Further, such numerical ranges are to be construed as supporting claims directed to any number or sub-set of numbers within that range. For example, a disclosure of 1-10 is to be construed as supporting ranges such as 1-8, 3-7, 1-9, 3.6-4.6, 3.5-9.9, etc.

[0060] Throughout this specification, references to "various aspects," "some aspects," "some embodiments," "other embodiments," "some cases," or "one aspect" mean that the particular feature, structure, or characteristic described in connection with that aspect is included in at least one embodiment. Thus, the phrases "in various aspects," "in some aspects," "in certain embodiments," "in some embodiments," "in other embodiments," "in certain other embodiments," "in some cases," or "in one aspect" as seen throughout this specification do not necessarily all refer to the same aspect. Further, the particular features, structures, or characteristics illustrated or described in connection with one embodiment can be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments, but are not limited thereto.

[0061] When the positional relationship between two parts is described using terms such as "on", "above", "below", "under", and "next", one or more parts may be located between the two parts unless those terms are used with the terms "immediately" or "directly". Similarly, as used herein, the terms "attachable", "attached", "connectable", "connected" or any similar terms may include attachable directly or indirectly, attached directly or indirectly, connectable directly or indirectly, and connected directly or indirectly.

[0062] It should be understood that at least some of the figures and descriptions herein are simplified to show elements relevant to a clear understanding of the present disclosure and other elements are excluded for clarity. However, those skilled in the art will recognize that these and other elements may be desirable. However, such elements are well known in the art and do not facilitate a better understanding of the present disclosure, so descriptions of such elements are not provided herein.

[0063] The terms used herein are intended to describe only particular embodiments and are not intended to limit the present disclosure. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless specifically stated otherwise. As used herein, the term "comprises" and / or "comprising" identifies the presence of the described features, integers, steps, operations, elements, and / or components, but does not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the term "at least one of X or Y" or "at least one of X and Y" should be construed as X, or Y, or X and Y.

[0064] It should be understood that the embodiments disclosed in this specification can be further modified without departing from the spirit of the present invention. Further, in some examples, non-patient-specific implants according to the present disclosure may be constructed of any material that enables them to function as described herein, for example, various artificial biomaterials and / or 3D printed titanium, or any combination thereof. Further, in some examples, both bone implants and soft tissue implants can include cavities therein for implantable neural technology, similar to the embodiments described above.

[0065] The foregoing description and the accompanying drawings illustrate the principles, preferred embodiments, and modes of operation of the present invention. However, the present invention should not be construed as being limited to the specific embodiments described above. Further variations of the above-described embodiments will be understood by those skilled in the art.

[0066] Therefore, the above-described embodiments should be considered illustrative rather than restrictive. Thus, it should be understood that variations to those embodiments can be made by those skilled in the art without departing from the scope of the present invention as defined by the following claims.

Claims

1. An implant for nerve formation surgery, comprising a three-dimensional mesh, wherein the three-dimensional mesh contains titanium, the three-dimensional mesh is bent during pre-production based on anatomical averaging for the reconstruction combining soft tissue and hard tissue, an implant for nerve formation surgery.

2. The implant according to claim 1, wherein the hard tissue includes the skull, and the soft tissue includes muscles and / or fat covering the skull.

3. The implant according to claim 1, wherein the three-dimensional mesh is bent based on anatomical averaging so as to replace only the space for soft tissue.

4. The implant according to claim 3, wherein the soft tissue includes muscles and / or fat covering the vertebrae.

5. The implant according to claim 1, wherein the three-dimensional mesh has a three-dimensional triangular shape.

6. The three-dimensional mesh includes a filling space having a predetermined volume, the implant according to claim 5, wherein the filling space is formed inside three side edges and a curved central portion of the three-dimensional mesh.

7. The implant according to claim 6, wherein the filling space is configured to fill the volume of the space for the hard tissue and / or soft tissue to be replaced by the three-dimensional mesh.

8. The implant according to claim 1, wherein the size of the three-dimensional mesh ranges from about 5 cm to about 10 cm.

9. The implant according to claim 1, wherein the size of the three-dimensional mesh ranges from about 10 cm to about 15 cm.

10. The implant according to claim 1, wherein the size of the three-dimensional mesh ranges from about 15 cm to about 20 cm.

11. The implant according to claim 1, wherein the three-dimensional mesh has higher rigidity than porous polyethylene and silicone.

12. The implant according to claim 1, wherein the three-dimensional mesh is bent based on anatomical averaging so as to be placed in the middle cranial fossa region.

13. The implant according to claim 1, wherein the three-dimensional mesh includes one or more holes configured to receive fasteners.

14. An implant for nerve formation surgery, comprising a three-dimensional titanium mesh, wherein the three-dimensional titanium mesh has been bent during pre-production, The three-dimensional titanium mesh has a three-dimensional triangular shape based on anatomical averaging for reconstruction combining soft tissue and hard tissue, An implant for nerve formation surgery.

15. The implant according to claim 14, wherein the hard tissue includes a skull, and the soft tissue includes muscles and / or fat covering the skull.

16. The three-dimensional titanium mesh includes a filling space having a predetermined volume, The implant according to claim 14, wherein the filling space is formed inside three side edges and a curved central portion of the three-dimensional titanium mesh.

17. The implant according to claim 16, wherein the filling space is configured to fill a volume of a space for hard tissue and / or soft tissue to be replaced with the three-dimensional titanium mesh.

18. The implant according to claim 14, wherein the three-dimensional titanium mesh includes one or more holes configured to receive fasteners.

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