Computationally designed implants with biomechanical properties for promoting bone growth, and systems, devices, and methods thereof

Abstract

Systems, devices, and methods described herein relate to implantable devices, including implantable devices having a lattice structure (42). In some embodiment, an apparatus can include a body (12) configured to be implanted near bone tissue at a target site in a subject, where the body can be configured to provide mechanical support at the target site while generating a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the body.

Description

Agent’s File Ref. OSNT-OOl / OIWO 361279-2001COMPUTATIONALLY DESIGNED IMPLANTS WITH BIOMECHANICAL PROPERTIES FOR PROMOTING BONE GROWTH, AND SYSTEMS, DEVICES,AND METHODS THEREOFCROSS REFERNCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 755,080, filed February 6, 2025, and entitled “Computationally Designed Patient Specific Orthopedic and Spine Implants with Optimized Biomechanical Properties,” the disclosure of which is hereby incorporated by reference herein in its entirety.FIELD OF INVENTION

[0002] The present disclosure relates generally to bone-repair implant devices, and more specifically, to patient specific, computationally optimized, osseointegrated lattice implants that promote biomechanical healing.BACKGROUND

[0003] Orthopedic and spine-related disorders are typically caused by a change in the structure of normal biological tissue, including bone, which is responsible for load support / distribution. In the case of damage to the bone (e.g., bone fractures, the removal of a tumor, concentrated trauma causing damage, etc.), a portion of the bone / joint may require dissection, subsequently followed by a bone-fixation device to promote the healing of the bone / joint. Specifically, the goal of such devices is to replace the damaged / removed portion of bone, wherein the implant can either act in place of the bone, or promote the healing of bone around the implant such that the bone can heal to operate in substantially the same manner as before the fracture, tumor removal, or trauma. Bone-fixation devices can be either standard fixation implants, or anatomically matched patient-specific devices (the latter of which often providing better results in terms of patient recovery).

[0004] To date, fixation implants are often made of metals such as titanium or reinforced engineered polymers (e.g., PEEK or PEKK). Such materials offer various benefits and have proved viable for use in implant-related devices. However, the use of such materials can lead to long-term implant issues. For example, while such metals or polymers can provide a strong mechanical support in fixation constructs, the rigidity and stiffness of the implant can lead to “stress shielding” at the bone-implant interface, wherein the abrupt change in material (and- 1 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001thus, material properties) can hinder the proper integration of the implant and impair the healing process of a patient. For example, the abrupt change in mechanical stiffness can lead to the unloading of tissue, lack of proper fusion, and tissue resorption over time. All of these effects can cause harm to the patient (both short-term and permanent), require additional follow-up procedures, and cost large sums of money to correct. Thus, designing and implanting a bonefixation device that can properly mend a patient’s damaged bone and promote proper and healthy healing remains a challenge.SUMMARY[00051 The present implant device and methods of designing, creating, generating, or manufacturing an implant device can provide improvements over the prior art. A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination thereof installed on the system, that in operation, can cause the system to perform one or more actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions or applications that, when executed by data processing apparatuses, cause the apparatus to perform the actions. Other embodiments of this aspect include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, each configured to perform one or more of the present actions or methods. |0006| One general aspect of an implantable device of the present invention is a computationally optimized lattice structure. The lattice structure can comprise a plurality of interconnected members that define a plurality of pores. Additionally, the lattice structure includes: a first region configured to interface between the lattice structure and a patient’s bone and a second region spaced from the first region. The second region can be configured such that it does not interface with the patient’s bone when the implant is inserted into the patient. The first and second regions are configured to generate microstrains, induced by physiological loads, throughout the implant that are greater than a growth threshold when the implantable device is implanted in the patient and subjected to biomechanical loads. Microstrains induced throughout the implant that reach the growth threshold can facilitate and promote the osseointegration of the implant with the patient’s bone.

[0007] Implementations of the present invention may include one or more of the following features. The first region of the implant has a first porosity; and the second region has a second porosity that is greater than the first porosity. The second porosity is 5, 10, 15, 20, 25, 30, 40, or 50% greater than the first porosity. The porosity can increase gradually or incrementally- 2 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001through modifications for the pore / lattice size and thickness. The growth threshold (ideal microstrain range to promote osseointegration) ranges between 200 ps to 1500 ps for bone maintenance, and 1500 ps to 3000 ps for bone growth when biomechanical loads are applied to the device. The device is configured to exhibit an elastic modulus ranging from 1 GPa to 200 GPa, and the device is configured to exhibit a factor of safety between 1.5 and 4. The lattice structure can be a Beam-Based Lattices including: Body-Centered Cubic (BCC), Face-Centered Cubic (FCC), Cuboct (Cuboctahedral), Octet, Dodecahedron and Voronoi Lattice (Randomized, biologically inspired)

[0008] The lattice is configured to have a porosity ranging between 50% and 80% of overall device volume. A pore size of the plurality of pores can range between 300 pm and 50,000 pm, and a thickness of the interconnected members ranges between 100 pm and 30,000 pm. The device can additionally include: Ti-Nb (Titanium-Niobium), Ti-Ta (Titanium-Tantalum), Ti-Mo (Titanium-Molybdenum), Ti-Zr-Nb (Titanium-Zirconium-Niobium), Ti-29Nb-13Ta-4.6Zr (TNTZ), Ti-6A1-4V, CoCr (cobalt chromium), Ta (tantalum), Magnesium, Copper, PLGA, PEEK, PEKK, Nitanol, biodegradable metals or plastics, or a combination thereof. The implantable device may include: a third region configured to interface between the lattice structure and the patient’s bone; a first protrusion coupled to the first region; and a second protrusion coupled to the third region. The first region may include: protrusions, external plate fixations, same-diameter implant interfaces, or a combination thereof. The lattice structure can define a cylindrical shape, such that it can resemble or mimic a patient’s bone structure.

[0009] Another general aspect of the present invention includes a system for designing a medical implant, wherein a computing system may comprise: at least one memory which may include instructions and at least one processing device configured to execute the instructions. The instructions can cause the at least one processing device to perform operations that may include: analyzing patient information, generating a model of an implant based on the patient information, selecting a lattice structure, determining one or more biomechanical loads based on the patient information, subjecting the model of the implant to the one or more biomechanical loads to determine a strain on the lattice structure, modifying the model of the implant to increase localized microstrain induced on the lattice structure when subjected to one or more biomechanical loads, and generating an implant design based on the model. The simulated mechanical loads can be used to optimize the localized mechanical stiffness or modulus of elasticity of the lattice. Other embodiments of this aspect include corresponding- 3 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform one or more actions of the present methods.

[0010] The system may additionally include a manufacturing device configured to manufacture the implant design, where the manufacturing device can comprise a three-dimensional printer or mold.

[0011] The method also includes analyzing patient specific information; generating a three-dimensional model based on the patient specific information, selecting a lattice structure type, generating a lattice structure of an implant based on the three-dimensional model, testing the implant based on one or more anatomical or biomechanical factors of the patient to determine one or more parameters, and modifying the lattice structure based on the parameters. These devices and methods for design can be utilized in both human and veterinary use.

[0012] In some embodiments, an apparatus includes: a body configured to be implanted near bone tissue at a target site in a subject, the body including an interface configured to be disposed near the bone tissue, the body, when implanted, being configured to provide mechanical support at the target site that can withstand biomechanical loads associated with a set of predefined loading conditions, such that the body can support mobility of the subject under the set of predefined loading conditions, the body, while providing mechanical support at the target site, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the body.

[0013] In some embodiments, an apparatus includes: a body including a lattice structure configured to be implanted near bone tissue at a target site in a subject, the lattice structure having a plurality of interconnected members that define one or more open spaces, the plurality of interconnected members being interlocked with one another without internal trusses, the lattice structure, when implanted and being subjected to one or more loads, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the lattice structure.

[0014] In some embodiments, a method includes: receiving information of an anatomical region of a subject, the anatomical region including bone tissue of the subject; generating a three-dimensional (3D) representation of an implantable device in the anatomical region using the information of the anatomical region and information of the implantable device, the implantable device configured to be positioned adjacent to the bone tissue; applying one or more boundary conditions to one or more bone structures within the anatomical region of the 3D representation; simulating, using the 3D representation, one or more external forces or dynamic and static loads associated with a predefined set of activities to identify one or more- 4 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001stress regions in the implantable device; and defining a mechanical structure of the implantable device based on the one or more stress regions.

[0015] In some embodiments, an apparatus includes: a body configured to be implanted near bone tissue at a target site in a subject including a lattice structure, the lattice structure having a plurality of interconnected members that define one or more open spaces, the plurality of interconnected members being interlocked with one another; an antimicrobial element disposed on or integrated into the body; and one or more fixation elements configured to secure a position of the body near the bone tissue and to apply compression or cause the bone tissue to apply compression to the lattice structure.

[0016] In some embodiments, an apparatus includes: a body configured to be implanted near bone tissue at a target site in a subject, the body including a structure that is formed using three-dimensional printing; and one or more fixation elements configured to secure a position of the body near the bone tissue and to apply compression or cause the bone tissue to apply compression to the lattice structure, the body, when implanted and being subjected to the compression, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the lattice structure.|00l7[ As used herein, the term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. Two items that are “coupled” may be unitary with each other or may be connected to one another via one or more intermediate components or elements.|0018] The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise.

[0019] The term “substantially” is defined as largely, but not necessarily wholly, what is specified (and includes what is specified, e.g., substantially 90 degrees includes 90 degrees, and substantially parallel includes parallel) as understood by a person of ordinary skill in the art. Additionally, “substantially parallel” means within 10 degrees of parallel to, and “substantially perpendicular” means within 10 degrees of perpendicular to. In any disclosed embodiment, the terms “substantially,” “approximately,” and “about” may be substituted with “within [a percentage] of’ what is specified, where the percentage is 1, 1, 5, or 10%.|0020] The phrase “and / or” means and or or. To illustrate, A, B, and / or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C. In other words, “and / or” operates as an inclusive or.331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001

[0021] The terms “comprise” (and any form thereof such as “comprises” and “comprising”), “have” (and any form thereof such as “has” and “having”), and “include” (and any form thereof such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, an apparatus or system that “comprises,” “has,” “includes”, or “contains” one or more elements possesses those one or more elements but is not limited to possessing only those elements. Likewise, a method that “comprises,” “has,” “includes”, or “contains” one or more steps possesses those one or more steps but is not limited to possessing only those one or more steps.

[0022] Any embodiment of any of the apparatuses, systems, and methods can consist of or consist essentially of — rather than comprise / have / include — any of the described steps, elements, and / or features. Thus, in any of the claims, the term “consisting of’ or “consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.

[0023] Further, an apparatus or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.10024 ] The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.

[0025] Some details associated with the embodiments described above and others are described below.BRIEF DESCRIPTION OF THE DRAWINGS10026] The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The figures are drawn to scale unless otherwise noted, meaning the sizes of the depicted elements in each are accurate relative to each other for at least the embodiment shown.

[0027] FIG. 1 depicts a method for designing, modifying, and manufacturing an implant device of the present disclosure.

[0028] FIGs. 2A and 2B depict front and right side views, respectively, of a first embodiment of the present implant device.- 6 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001

[0029] FIGs. 2C-2D depict perspective and front views, respectively, of the implant device of FIGs. 2 A and 2B implanted in a bone.

[0030] FIG. 2E depicts a magnified view of the implanted implant device of FIG. 2D.

[0031] FIG. 2F depicts the implant device of FIGs. 2A and 2B with a second fixation method.(0032] FIG. 3A depicts a generated lattice structure based upon a patient’s bone structure.

[0033] FIGs. 3B and 3C depict perspective and front views, respectively, of a second embodiment of the present implant device generated from the lattice structure of FIG. 3 A.

[0034] FIGs. 3D and 3E depict front views of the implant device of FIGs. 3B and 3C implanted in an opaque and a translucent bone, respectively.

[0035] FIG. 3F depicts a magnified perspective view of the implanted implant device of FIG. 2E.

[0036] FIGs. 4A-4D depict perspective, left, front, and top views, respectively, of a third embodiment of the present implant device.

[0037] FIG. 4E depicts a left side view of the implant device of FIGs. 4A-4D implanted between a spinal structure.

[0038] FIG. 5 is a graph depicting the relation between strain and bone growth.

[0039] FIG. 6 depicts a comparison between multiple implant designs and the respective micro strains that incurred as a result thereof.

[0040] FIGs. 7A-7E depict additional embodiments of the implant devices of the present disclosure for use in various applications for both humans and animals.

[0041] FIG. 8 depicts various spinal fusion implants, according to embodiments.

[0042] FIGs. 9A-9D depict various spinal fusion implants implanted into a subject, according to embodiments.

[0043] FIGs. 10A-10D depict an implant device configured to attach a prosthetic component (e.g., a limb) to a subject, according to embodiments.

[0044] FIG. 11 depicts a medullary nail-fixation implant.

[0045] FIG. 12 depicts a plate-fixation implant.

[0046] FIG. 13 depicts an external skeleton fixation-implant.

[0047] FIG. 14 depicts an implant including fixation elements, according to some embodiments.

[0048] FIGs. 15A-15B depict an implant that is implanted with an intramedullary nail, according to embodiments.- 7 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001DETAILED DESCRIPTION

[0049] Referring now to the drawings, FIG. 1 depicts a method or process 100 by which an implantable device (e.g., an implant 10 or device 10) can be designed, customized to fit a specific patient’s biomechanical and anatomical needs, and / or subsequently manufactured. The implant 10 can be utilized for both humans and animals (e.g., dog, horse, other mammal, or any other animal), in medical, coronary, or veterinary applications; or in any other application in which implants are utilized. Method 100 can comprise a plurality of steps, each integrated to facilitate the proper design and modification of implant 100 for a respective patient. To begin design, patient-specific information can be gathered or received through step 104. For example, at step 104, information of an anatomical region of a subject including bone tissue of the subject can be received. Step 104 can comprise a plurality of patient-information data gathering steps or procedures, including computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray scans, dual-energy X-ray absorptiometry (DEXA or DXA) scans, bone mineral density (BMD) scans, ultrasound scans and collecting additional patient medical history. To further illustrate, a CT scan, MRI scan, or other suitable scan (or a combination thereof) can be taken of a patient’s tentative implant site to receive information of the anatomical region and / or generate a patient-specific bone geometry for accurate implant design. In some operations, a DXA or BMD scan can additionally be performed to accurately map bone mineral density, which can greatly influence load-bearing capacity and location (and thus, effect the structure of implant 10). Segmentation and three-dimensional (3D) reconstruction can additionally be performed based off of gathered data to further define cortical and trabecular bone structure regions (e.g., 38 and 34, respectively). The cortical bone region (e.g., 38) of a bone can substantially comprise the outer, more rigid region of a bone. The trabecular bone region (e.g., 34) can substantially comprise the inner, less rigid region of a bone. Properly defining these regions in a patient bone model can facilitate the design of implant 10 that can integrate properly with the surrounding bone.[0050| Some methods 100 can include step 108, in which a three-dimensional model is generated based upon some or all data gathered or received in step 104. For example, a 3D representation or model of the anatomical region can be generated using the information of the anatomical region. In some embodiments, generating the 3D representation can include meshing the 3D model of the anatomical region. The 3D representation can identify one or more anatomical parts or regions of the anatomical region (e.g., cortical and trabecular bone structure regions) and / or include one or more characteristics of the anatomical parts (e.g., composition, properties, bone density, etc.). The 3D representation can be generated based on- 8 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001a plurality of patient-specific information, including at least one of a bone geometry, a bone morphology, a bone density, a patient height, a patient weight, a patient age, and a patient history. For example, as previously discussed, data can include not only CT scans and MRI scans, but additionally, BMD scans and segmentation boundaries. Scans of the patient’s bone can be segmented into a model, e.g., a stereolithography (STL) or standard for the exchange of product data (STEP) model. Thus, an extremely accurate model of the patient’s bone can be generated, not only depicting the size and shape of the bone, but additionally, the composition thereof. For example, one or more bone structures (e.g., the varying bone regions) within the anatomical region of the 3D representation can be assigned one or more material properties. The varying bone regions can be assigned heterogeneous properties based on BMD (bone material density) derived modulus values, allowing for accurate analysis of load displacements through the bone. In this way and others an accurate model of the patient’s bone can be generated.[00511 Some methods 100 can include step 112, in which a lattice type is chosen for the design of a lattice structure (e.g., 42) for use in implant 10. For example, Voronoi-based lattices can be used for the present implant 10. However, in other configurations, the lattice structure (e.g., 42) could comprise a gyroid lattice, diamond lattice (Schwarz D-Structure), octet-truss lattice, cubic lattice (body-centered cubic (BCC) or face-centered cubic (FCC)), Weaire-Phelan Lattice, dodecahedral lattice, a hexagonal honeycomb, or a combination thereof. The selection of lattice type for use in the lattice structure (e.g., 42) can impact the mechanical properties of implant 10. As will be described in further detail (e.g., FIG. 5), a specific range of microstresses induced throughout implant 10 can prove extremely desirable as such stresses can promote osteogenesis, or more simply, the growth of bone. Thus, selecting an appropriate lattice type for the lattice structure (e.g., 42) can help optimize recovery and healing.

[0052] Some methods 100 can include step 116, in which a model of implant 10 is generated. For example, a 3D representation of an implant or implantable device can be generated using information of the implantable device. In some processes, generation of the model can be performed, for example, by nTopology software. The model generated in step 116 can comprise a portion of the previously generated patient bone model. For example, a 3D representation of an implant or implantable device in an anatomical region can be generated (e.g., using the information of the anatomical region and the information of the implantable device), where the implantable device is configured to be positioned adjacent to the bone tissue. In this method, the implant can replace a portion of the bone that is removed. In other configurations, a lattice structure can be generated to form a plate, which could then be affixed- 9 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001to the outer portion of bone. In addition to generating the lattice structure (e.g., 42) of implant 10, fixation method must also be taken into account. In some configurations, an implant can be constructed with protrusions (e.g., 30) designed to fit into the intramedullary cavity (e.g., 26) of a bone (e.g., 22), thereby interfacing with the trabecular bone region (e.g., 34). In other configurations, an implant can be constructed for external plate fixation (e.g., affixed directly to the outer, cortical bone region 38). In yet other configurations, an implant can be constructed with protrusions (e.g., 30) and a same-diameter endplate (e.g., 62) such that the implant can connect to the bone both through the trabecular and cortical bone regions (e.g., 34 and 38, respectively). In some embodiments, implant 10 can comprise a combination of fixation methods depending on the patient’s needs. Fixation methods can be included in the generated model of step 116 to assist with further calculations that can be performed in later steps of method 100. Embodiments can also include integration with or features that work with external fixation devices (FIG. 13).

[0053] Some methods 100 can include step 120, in which testing and calculations are performed to ensure optimal functioning of the implant. For example, the three-dimensional implant model can be imported into FEA (finite-element analysis) software to analyze the mechanical properties of the implant. To illustrate, loading conditions can be applied, wherein one or more boundary conditions (e.g., constraints based upon surgical fixation type and intended mobility) can be applied to the one or more bone structures within the anatomical region of the 3D representation. Additionally, or alternatively, one or more external forces (e.g., body weight, muscles forces, and joint reaction forces) and / or dynamic or static loads associated with a predefined set of activities (e.g., simulated walking, lifting, or standing forces) can be simulated to determine the mechanical response of the implant 10. In particular, as a result of the above-mentioned simulations and calculations, one or more stress regions (e.g., high-stress areas) can be identified in the implantable device and strain distribution values can be assigned to guide construction of the lattice structure (e.g., 42), thereby altering mechanical properties to facilitate mechanotransduction. In some embodiments, at least one of a muscle activity, a j oint force, or a j oint torque can be determined to refine the external force(s) or dynamic and static loads to further refine the stress region(s) and / or adjust the mechanical structure of the implantable device. For example, additional variables can be utilized for design, including gait & motion analysis, a load bearing analysis, a joint kinematics analysis, or an inverse dynamics modeling. A mechanical structure of the implantable device can be defined based on the one or more stress regions. For example, simulated mechanical loads can be used to optimize the localized mechanical stiffness or modulus of elasticity of the lattice structure- 10 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001(e.g. 42). In some processes, software such as OpenSim, AnyBody, and nTopology can assist with the calculations, modeling, and FEA integration. Furthermore, material selection can be modified to impact the mechanical properties of implant 10. For example, implant 10 could include titanium, Ti-Nb (Titanium-Niobium), Ti-Ta (Titanium-Tantalum), Ti-Mo (Titanium-Molybdenum), Ti-Zr-Nb (Titanium-Zirconium-Niobium), Ti-29Nb-13Ta-4.6Zr (TNTZ), Ti-6A1-4V, CoCr (cobalt chromium), Ta (tantalum), Nitanol, Magnesium, Copper, Ti-34NB-13Ta-5Zr-0.30 (TNTZO), [3-Ti (beta titanium) Alloys containing Nb, Ta, Zr, Mo, Nb, Sn, Nitinol, PLGA (polylactic-co-glycolic acid), PEEK (polyetheretherketone), PEKK (polyetherketoneketone), steel, biodegradable polymers, biodegradable metals, biodegradable plastics, biologic materials or a combination thereof. Each material can have varying material properties, and thus, different materials (or a combination thereof) can yield drastically different mechanical properties for implant 10.

[0054] Some methods 100 can include step 124, in which post-processing optimization can be performed to further facilitate patient-implant integration. For example, in identified high-load regions, a denser, stronger lattice structure (e.g., 42) can be utilized to improve stability. In opposing low-load regions, porosity can be increased to better facilitate vascularization and osseointegration. Gradient-based transitions can be constructed through lattice structure 42 (e.g., at different regions within lattice structure) to prevent abrupt stiffness changes which can lead to stress shielding. Lattice thickness and cell size can be modified to promote osseointegration. Implant 10 can be further modified to, especially at the interfaces (e.g., 14 and 18), match the modulus of the surrounding bone, thus reducing the risk of bone resorption around interface sites. The material used to create the lattice can be modified to promote osseointegration, as different materials have different properties such as elastic modulus and stiffness. The material properties can also additionally effect the biologic interactions with cells. Surface roughness can additionally impact bone growth. For example, the design of the lattice structure (e.g., 42) and the entire device (e.g., 10) can include surface roughness characteristics (e.g., an exterior surface with rough features) configured to enhance cellular adhesion between the lattice structure and the bone tissue. The contact area can additionally be modified to reduce micromotion, thereby enhancing fixation between the bone-implant interface. In at least these ways, the design of an implantable device can be modified and optimized to facilitate enhanced healing and integration of an implant within a patient. Postprocessing analyses may also be performed in order to ensure manufacturability of implant 10. Certain embodiments of implant 10 can have smooth surface features to accommodate articulating surfaces (e.g., joints) in combination with the bone through-growth features- 11 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001facilitated by the lattice structure (e.g., 42). For example, operations such as a total knee replacement (as described below with reference to FIG. 7 A) can utilized an implant 10 with a lattice structure (e.g., 42) provided a structure for the bone to grow through, while the smooth surface features can facilitate joint movement (e.g., by providing a smooth surface for joint articulation).

[0055] Finally, step 128 can be performed in which implant 10 is manufactured based on the defined mechanical structure. In some cases, implant 10 can be manufactured via a process of manufacturing including at least one of powder bed fusion (e.g., electron beam melting (EBM), selective laser melting (SLM), direct metal laser sintering (DMLS), selective laser sintering (SLS), multi jet fusion (MJF)), binder and sintering (e.g., binder jetting, bound metal deposition (BMD), metal lithography), directed energy (e.g., directed energy deposition (DED) including powder-based DED and / or laser wire DED, wire-arc additive manufacturing (WAAM)), solid-state (e.g., cold spray, ultrasonic additive manufacturing), material jetting (e.g., PolyJet), vat photopolymerization (e.g., stereolithography (SLA), digital light processing (DLP), continuous liquid interface production (CLIP)), material extrusion (e.g., direct ink writing (DIW), fiber-reinforced extrusion, fused deposition modeling (FDM)), or hybrid manufacturing. The process of manufacturing can be used to manufacture implant 10 using at least one of polymers, metals, ceramics, or composites. In certain cases, a mold could be used to at least partially construct implant 10. In some processes or for certain implant designs, other methods of manufacture could be utilized. However, additive manufacturing methods can prove useful when constructing the complex design of the lattice structure (e.g., 42).

[0056] Method 100 can include one or more of the steps described herein and it should be understood that certain steps may be omitted or combined with other steps or that additional steps may be performed. One or more steps (e.g., 104, 108, 112, 116, 120, 124, or 128) may be performed fully or in part by various computer systems or software. For example, a computer system can comprise at least one memory and at least one processing device, wherein the processing device can be configured to execute the instructions held within the memory to perform the various operations described herein. The processing device can perform one or more of the previously described steps, thereby (in part or fully) facilitating the generation, modification, or manufacture of an implant 10. In embodiments, the processing device can be, for example, a hardware based integrated circuit (IC), or any other suitable processing device configured to run and / or execute a set of instructions or code. For example, the processing device can be a general-purpose processor, a central processing unit (CPU), an accelerated processing unit (APU), an application specific integrated circuit (ASIC), a field programmable- 12 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001gate array (FPGA), a programmable logic array (PLA), a complex programmable logic device (CPLD), a programmable logic controller (PLC) and / or the like. The processing device can be operatively coupled to the memory and / or other devices (e.g., an I / O device and / or a communications interface), e.g., through a system bus (for example, address bus, data bus and / or control bus). The memory can be, for example, a random-access memory (RAM), a memory buffer, a hard drive, a flash memory, a read-only memory (ROM), an erasable programmable read-only memory (EPROM), and / or the like. In some instances, the memory can store, for example, one or more software programs and / or code that can include instructions to cause the processing device to perform one or more processes, functions, and / or the like. In some implementations, the memory can be a portable memory (for example, a flash drive, a portable hard disk, and / or the like) that can be operatively coupled to the processing device. In some instances, the memory can be operatively coupled to another compute device. For example, in some embodiments, the memory can be coupled to a remote server or database, e.g., for sending and / or receiving information therefrom. In some embodiments, the memory and processing device may be implemented on a single chip. In other embodiments, the memory and processing device may be implemented on separate chips.100571 Referring now to the drawings, FIGs. 2A through 2E depict a first embodiment of the present implant device, which can also be referred to as implant 10a or device 10a. The implant 10a can include a body 12 that can be configured to be implanted near bone tissue at a target site in a subject or subject. In some embodiments, the body 12 can include or be formed of a lattice structure 42. The body 12, when implanted, can be configured to provide mechanical support at the target site that can withstand biomechanical loads associated with a set of predefined loading conditions (e.g., external forces, boundary conditions, and dynamic or static loading of the bone tissue), such that the body 12 can support mobility of the subject under the set of predefined loading conditions. The predefined loading conditions can be set, for example, based on at least one of a geometry of the bone tissue, a density of the bone tissue, or expected postoperative loading or activity level of the subject. In addition, the implant 10a, while providing mechanical support at the target site and being subjected to one or more loads, can be configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the implant 10a. In some embodiments, the implant 10a can define a cylindrical shape or other 3D shape, e.g., such that it can resemble or mimic a patient’s bone structure.

[0058] As depicted, the implant 10a can include an interface, e.g., a first interface 14 and a second interface 18. Each interface 14 and 18 can be configured to interface with and connect- 13 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001to portions of a patient’s bone or bone tissue 22 (as shown in FIGs. 2C-2E). In some embodiments, one or more of the interfaces can be configured to be attached to portions of a patient’s bone, while in other embodiments, one or more of the interfaces can be configured to be disposed near and / or be in contact with bone tissue. For example, the first interface 14 and / or the second interface 18 can include one or more regions that conform to one or more surfaces of the bone. The one or more regions can include at least one of a flat shape, a concave shape, or a convex shape. In some embodiments, the implant 10a and / or the first interface 14 and the second interface 18 can include a first and second endplate 62 and one or more fixation elements, including at least one of a peg, a plate, a nail, or a screw. For example, the fixation element(s) can include a first and second peg (e.g., a protrusion 30) attached to the first and second endplates 62, respectively. The protrusion(s) 30 can be configured to extend beyond the endplate(s) 62 into the bone tissue. For example, in the configurations shown in FIGs. 2C-2E, the interfaces 14 and 18 comprise intramedullary (IM) cavity 26 disposed protrusions 30, wherein each protrusion can be inserted into the intramedullary cavity 26 and can connect with the trabecular bone region 34 of a patient (e.g., the inner, less dense portion of bone). In other configurations, the interfaces 14 and 18 can comprise external plate fixations, or alternatively, same-diameter interfaces. In such instances, each interface could connect directly to the cortical bone region 38 of a patient (e.g., the outer, denser portion of bone). Additionally, the implant 10a can comprise features to interface or interact with an external fixator (e.g., as depicted in FIG. 13).

[0059] The lattice structure 42 can extend from and connect the interface 14 with the interface 18. In the depicted configuration, the lattice structure 42 can comprise a Voronoi-based lattice structure. Preferably, and as will be described in further detail, Voronoi-based lattices can be used for the present implants 10. However, in other configurations, the lattice structure 42 could comprise a Triply periodic minimal surface (TPMS), gyroid lattice, diamond lattice (Schwarz D-Structure), Body-Centered Cubic (BCC), Face-Centered Cubic (FCC), Cuboct (Cuboctahedral), Octet, Dodecahedron, Weaire-Phelan Lattice, dodecahedral lattice, a hexagonal honeycomb, or a combination thereof.

[0060] A Voronoi lattice can be non-uniform and can create the unique lattice structure 42 depicted in FIGs. 2A-2E. Lattice structure 42 can comprise a plurality of interconnected members 46 that can define a plurality of pores 50 (e.g., one or more open spaces). In some embodiments, the plurality of interconnected members can include curved structures that can interlock with one another without internal trusses (e.g., without straight members or connections). In some embodiments, the plurality of interconnected members can include a- 14 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001plurality of curved members without sharp edges or transitions. Portions of lattice structure 42 can mimic the natural structure of trabecular bone 34, which consists of irregular, interconnected members that vary in size and orientation. The spatial heterogeneity created thus mimics natural bone, which can enhance cell adhesion and promote bone ingrowth (the growth of bone around, in, and through lattice structure 42). Contrary to currently-used implants, the non-uniform strut distribution of lattice structure 42 can induce localized variations in stress (e.g., varying stress concentrations throughout the lattice structure 42), which can stimulate osteogenesis, thereby facilitating bone growth. Additionally, lattice structure 42 can distribute loads more heterogeneously than uniform lattices, reducing stress shielding and promoting enhanced bone remodeling. Yet another benefit of lattice structure 42 comes in the form of patient-specific customization. For example, properties of lattice structure 42 can be modified (e.g., a gradient porosity can be constructed), creating smooth transitions from dense, cortical-like areas to highly porous, trabecular-like regions, thereby optimizing implant integration. In at least these ways, the implementation of lattice structure 42 can greatly improve the healing process for a patient and reduce the long-term risks associated with traditional bone-fixation devices.|0061| Device 10a can greatly improve the likelihood of implant acceptance with a host and the subsequent growth of bone, thereby integrating the device with the patient’s existing skeletal structure. In some embodiments, to fully integrate the device, each embodiment can be customized to each respective patient, e.g., according to the method described in FIG. 1. In addition to ensuring the size of the device is appropriate for a given patient, multiple other parameters pertaining to the device can be modified, thus improving the likelihood of acceptance, integration, and facilitated bone growth. For example, pore or void 50 size and pore or void 50 distribution of lattice structure 42 can be modified to better promote osteogenesis (e.g., the formation / development of bones). For example, the pores or voids 50 of lattice structure 42 can have variable sizes that range from the micrometer ranges (e.g., 10 pm) to the mm range, such as 50 mm (50,000 pm). For example, in some implementations the size (e.g., diameter, spherical diameter, width, length, height) of the pores or voids 50 can be equal to, or between any two of: 300 pm, 350 pm, 400 pm, 500 pm, 600 pm, 1,000 pm, 2,000 pm, 5,000 pm, 10,000 pm, 20,000 pm, or 50,000 pm (e.g., 12,700 pm). In some configurations, the size of the pores or voids can be altered throughout implant 10a (e.g., gradient changes in pore size) such that different regions of the implant can have varying pore or void sizes. For example, the pore or void 50 size in the center (e.g., an inner region) of lattice structure 42 can be greater than the pore or void size on the outer portion (e.g., an outer- 15 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001region) of the lattice structure 42, thereby mimicking natural bone structure (e.g., trabecular bone region 34 vs cortical bone region 38). Additionally, the total porosity or percentage of volume attributed to voids / spaces (e.g., negative volume percentage, void percentage, or volume of voids per unit volume of the lattice structure 42) can be equal to, or between any two of: 25%, 50%, 65%, 70%, 75%, 90%, or 95%. (e.g., 75%). In some embodiments, the lattice structure 42 can include a first region having a lower porosity or percentage of voids than a second region. For example, the first region of the lattice structure 42 can be configured to withstand higher biomechanical loads than the second region. In particular, the first region (e.g., the outer region) having lower porosity or percentage of voids can be configured to provide greater mechanical support than the second region, while the second region (e.g., the inner region) having a higher porosity or percentage of voids can be configured to enhance vascularization of the growth site and / or promote greater ingrowth of the bone tissue than the first region. In some embodiments, the second region can be at or near the interface (e.g., the first interface 14 and the second interface 18) and configured to enhance integration between the implant 10a and the bone tissue. In other words, the aforementioned gradients in porosity or percentage of voids can guide bone growth inwards from the cortical bone to the implant core, thus facilitating better integration of the implant into the bone. In some embodiments, the interconnected members can have variation in at least one of thickness or length, for example, such that the lattice structure can resemble the structure of natural bone tissue. For example, the thickness of the interconnected members 46 of lattice structure 42 can be equal to, or between any two of: 100 pm, 150 pm, 200 pm, 250 pm, 300 pm, 400 pm, 500 pm, 1,000 pm, 2,000 pm, 5,000 pm, 10,000 pm, 20,000 pm, or 30,000 pm (e.g., 1,250 pm). In some embodiments, the first region of the lattice structure 42 can have a set of interconnected members with greater thickness than a set of interconnected members of the second region.

[0062] As described herein, open spaces or voids within lattice structures are three-dimensional features (e.g., volumetric pores, interconnected void networks, and passageways), and their effective size may be described by characteristic dimensions such as a minimum dimension, maximum dimension, equivalent spherical diameter, or inscribed sphere diameter. Additionally, the open spaces are not required to have a uniform or regular geometry and may comprise irregular, anisotropic, and interconnected three-dimensional voids formed between curved or non-planar lattice members. As such, the open spaces are not limited to circular, cylindrical, or prismatic shapes, and the referenced dimensional ranges correspond to characteristic linear dimensions of volumetric voids, rather than a two-dimensional pore diameter. Further, an implant may include multiple regions with different three-dimensional- 16 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001open-space dimensions, such as smaller voids in high-load or subsidence-sensitive regions and larger voids in regions optimized for bone ingrowth, graft containment, or mechanotransductive response. The characteristic dimensions of open spaces may therefore vary continuously or discretely across the lattice structure.

[0063] By way of non-limiting examples, different open-space ranges may be used depending on application and bone quality:|0064] Subsidence resistance / poor bone quality (e.g., osteoporotic bone): Open spaces having characteristic dimensions of approximately 0.3 mm to 1.0 mm, enabling increased surface area, load sharing, and resistance to implant subsidence.

[0065] Standard bone quality (e.g., long bone metaphyseal / diaphyseal applications): Open spaces of approximately 0.6 mm to 2.0 mm, balancing mechanical stability with bone ingrowth and vascularization.

[0066] High-stability or graft-containing structures (e.g., spine cages, segmental defect implants, graft cages): Open spaces of approximately 1.0 mm to 5.0 mm, configured to contain bone graft material while providing structural stability and mechanotransductive load transfer.

[0067] Upper extremity or oral / maxillofacial applications: Open spaces of approximately 0.3 mm to 1.5 mm, where finer lattice features are desirable due to smaller anatomy and different loading environments.

[0068] Lattice structures primarily used for graft containment and mechanotransduction rather than load bearing: Larger open spaces (e.g., 1.5 mm to 5.0 mm or greater) may be used, with structural members configured to transmit controlled microstrain while retaining graft material.

[0069] As described herein, lattice structures can have variable porosity or void percentages. For example, a void percentage of approximately 50% to 80% can be a clinically and mechanically core operating range for lattice-based orthopedic implants. More specifically, many lattice implants that can be used across long bone, lower extremity, upper extremity, spine, and craniomaxillofacial applications may operate toward the upper portion of the 50% to 80% range (e.g., -70-80% porosity or void percentage), for example, to promote bone ingrowth, vascularization, and load sharing while maintaining sufficient structural integrity. Subsidence resistance and load sharing can be achieved by reducing effective stiffness and promoting distributed deformation, which in lattice structures may be accomplished through higher porosity or void percentage, compliant architectures, graded porosity or void percentage, or combinations thereof, rather than minimizing porosity. Additionally, a lattice structure may include regionally varying or graded porosity or void percentages, such that- 17 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001compliant, higher-porosity regions promote load sharing and subsidence resistance while lower-porosity regions provide localized structural support.

[0070] By way of non-limiting examples, porosity or void percentage of the lattice structure may include:

[0071] Core porosity or void percentage: Porosity or void percentage of approximately 50% to 80%, including some embodiments near approximately 70% to 80%, e.g., suitable for long bone, lower extremity, upper extremity, spine, and / or craniomaxillofacial implants.

[0072] Higher porosity or void percentage (e.g., subsidence, resistance, compliant load sharing, poor bone quality, graft-containing regions): Porosity or void percentage of approximately 70% to 95% which can enable, e.g., reduced effective stiffness, improved load distribution, enhanced mechanotransduction, and graft or biologic integration.10073] Lower porosity or void percentage and / or locally reinforced regions (e.g., structural interfaces, fixation-adjacent regions): Porosity or void percentage of approximately 30% to 60%, which can be selectively used in regions where increased local strength, fixation support, or fatigue resistance is required.

[0074] As described herein, thickness of interconnected members (e.g., member thickness) can be varied to tune stiffness, fatigue resistance, load sharing, and / or microstrain generation. In some embodiments, the thickness of the interconnected members can be selected based on at least one of anatomy, loading environment, or implant function. For example, for loadbearing lattice-based implants, a member thickness can range between approximately about 0.2 mm to about 5.0 mm, or about 0.75 mm to about 1.5 mm (e.g., long bone, lower extremity, upper extremity, spine, and craniomaxillofacial), or any other ranges or values therebetween. In some embodiments, thinner and / or thicker interconnected members can be used. Additionally, a lattice structure may include regional variation and / or graded member thickness, such that members having a higher thickness can be used in higher-load regions and members having a lower thickness (e.g., thinner members) can be used in regions optimized for at least one of compliance, ingrowth, graft containment, or microstrain generation.(0075] By way of non-limiting examples, thickness of interconnected members can include:

[0076] Long bone or lower extremity load-bearing (e.g., tibia, femur, segmental defects, limb salvage): Member thickness can range between approximately 0.75mm to 2.0mm, including in some embodiments, the member thickness can range between approximately 0.75mm to 1.5mm.- 18 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001

[0077] Upper extremity (e.g., humerus, radius, ulna reconstructions) or smaller long-bone constructs: Member thickness can range between approximately 0.5mm to 1.5mm, including in some embodiments, the member thickness can range between approximately 0.75mm to 1.5mm.

[0078] Spine, interbody, or structural support applications: Member thickness can range between approximately 0.75mm to 2.5mm, including in some embodiments, the member thickness can range between approximately 0.75mm to 1.5mm, and / or thicker members for higher stress or fatigue performance.

[0079] Craniomaxillofacial (CMF) or oral and maxillofacial reconstructions: Member thickness can range between approximately 0.5mm to 1 ,5mm, including in some embodiments, the member thickness can range between approximately 0.75mm to 1.5mm where mechanical integrity and / or manufacturability are prioritized.

[0080] Smaller-feature or higher-compliance lattices, including regions intended to increase deformability or surface area: Member thickness can range between approximately 0.2mm to 1.0mm, including in some embodiments, the member thickness can range between approximately 0.5mm to 1.0mm.

[0081] High-stability, graft containing, or bridging constructs including regions intended for increased stiffness or structural containment: Member thickness can range between approximately 1.5mm to 5.0mm.

[0082] Lattice structure 42 can be modified to further facilitate osteogenesis via mechanotransduction. Specifically, mechanotransduction refers to the phenomenon wherein mechanical stimulus can be converted to electrochemical activity. In the case of bone-fixation implants, mechanotransduction can be utilized to promote osteogenesis and increase the rate of bone growth around, into, and through an implant (e.g., device 10a) by inducing microstrains throughout the implant. As previously mentioned, existing implants are often made of titanium or an engineered substitute that is often too rigid or stiff to allow for such induced microstrains, thus preventing consistent integration of the implant. The implementation of a patient-specific and / or nonuniform lattice structure 42 can greatly reduce the stiffness and rigidity of implant 10a (while still allowing for a structurally-sound implant), thereby not only improving the integration between interfaces 14 and 18 with surrounding bone 22, but also prompting osteogenesis via mechanotransduction. To illustrate, lattice structure 42 can be designed such that normal loads distributed through bone 22 (and thus, implant 10a) can induce microstrains (e.g., generate a microstrain environment) throughout the lattice structure. Such microstrains, when calibrated between an ideal range, can greatly facilitate osteogenesis and promote the- 19 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001growth of bone on, into, and through implant 10a. In some configurations, the induced microstrains throughout the implant 10a can be equal to, or between any two of: 200 ps 200 ps, 300 ps, 500 ps, 1000 ps, 2000 ps, or 3000 ps (e.g., 1750 ps). Certain embodiments can additionally utilize a microstrain gradient, wherein the degree of microstrain is varied throughout regions of the implant (e.g., 10a). As a result of microstrain modification, device 10a can have (e.g., exhibit) an elastic modulus equal to, or between any two of: 0.5 GPa, 1 GPa. 2 GPa, 3 GPa, 5 GPa, 10 GPa, 15 GPa, 20 GPa, 30 GPa, 40 GPa, 50 GPa, 60 GPa, 80 GPa, 100 GPa, 150 GPa, or 200 GPa (e.g., 14 GPa). In some embodiments, the lattice structure 42 can include a plurality of regions that are configured to deform differently from one another.

[0083] As described herein, lattice-based implants can be designed to generate variable microstrain ranges, for example, depending on at least one of anatomy, loading environment, healing phase, or implant function. For example, microstrain ranges can vary across regions of the implant and / or across different applications, including early postoperative loading, graft containment, subsidence resistance, or long-term structural support. Additionally, implants can be configured to generate different microstrain ranges in different regions of the body and / or lattice structure, such as lower microstrain in load-bearing regions and higher microstrain in regions optimized for ingrowth or graft interaction.

[0084] By way of non-limiting examples, in some embodiments, microstrain ranges can include:

[0085] Core osteogenic or bone ingrowth: Microstrains can range between approximately 200 ps to 3000 ps, for example, for bone formation, remodeling, and / or osseointegration.

[0086] Lower microstrain (e.g., stability or early post-operative conditions): Microstrains can range between approximately 50 ps to 500 ps, where mechanical stasbility, load sharing, and / or maintenance of bone mass may be prioritized over bone formation.|0087] Moderate-to-high microstrain (e.g., enhanced mechanotransduction or adaptive remodeling): Microstrains can range between approximately 500 ps to 5000 ps, including higher strain levels that may promote adaptive remodeling when appropriately distributed.

[0088] High microstrain or localized strain (e.g., controlled deformation regions, graft interfaces): Microstrains can range between approximately 3000 ps to 10,000 ps, where localized and / or transient strain can be used in specific regions of the implant without inducing global structural failure in the implant.

[0089] In some embodiments, microstrain ranges can be measured and / or determined based on one or more compression tests, mechanical tests, and / or simulation conditions representative of in-vivo loading. For example, an implant can be positioned between opposing- 20 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001platens and / or fixtures configured to simulate bone-implant interfaces. The applied load may be distributed across the implant (e.g., across the body or lattice structure) in a manner that can be similar to and / or representative of in-vivo contact conditions. In some embodiments, different testing conditions can be used for different parts of the body. In some embodiments, dynamic compression and / or torsion can also be used. Microstrain may be determined and / or reported as local strain within lattice structure interconnected members, average strain within a defined lattice region, peak strain values within the lattice structure, or any combination thereof. The foregoing compression test conditions are provided as non-limiting examples, and microstrain ranges as described herein are not restricted to microstrain values generated under a single load magnitude, test configuration, or measurement technique. The microstrain ranges can be determined and / or satisfied under any one or more physiologically relevant loading scenarios, including static, cyclic, or dynamic loading.

[0090] By way of non-limiting examples, microstrain values may be measured, calculated, and / or validated using one or more of the following approaches:(0091[ Static mechanical loading tests, e.g., uniaxial or multiaxial compression, tension, bending, or torsion applied to the implant and / or the lattice structure at physiologically relevant load levels, for example, representative of postoperative or functional loading.

[0092] Representative compressive loading conditions, including compressive loads ranging between approximately 100N to 3000N, depending on anatomical location (e.g., upper extremity, lower extremity, spine), applied across the implant and / or the lattice structure.10093] Quasi-static compression testing can be performed using a mechanical test frame (e.g., ASTM International (American Society for Testing and Materials)-type compression setup), wherein microstrain can be measured within interconnected members or adjacent regions of the lattice structure using strain gauges, digital image correlation (DIC), computational strain mapping, or any combination thereof.

[0094] Computational modeling and simulation, such as FEA, in which boundary conditions and / or loads representative of physiological activity can be applied to estimate microstrain distributions within the lattice structure.

[0095] Worst-case or bounding load conditions, e.g., to represent at least one of maximum expected in-vivo loafing, early postoperative loading, or safety-factor-adjusted loads.

[0096] Static or quasi-static compression test in which the implant and / or the lattice structure can be subjected to a compressive load applied along a primary load-bearing axis of the implant.- 21 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001

[0097] Upper extremity or craniomaxillofacial applications: a compressive load between approximately 5 ON to 500N.

[0098] Lower extremity or long bone applications: a compressive load between approximately 300N to 3000N.

[0099] Spine, segmental defect, or structural load-bearing implants: a compressive load between approximately 500N to 5000N.

[0100] Implant 10a can reduce the chance of infection among patients, both through direct methods and through secondary effects. For example, lattice structure 42 can promote vascularization (angiogenesis) around and within implant 10a. By promoting vascularization (e.g., the growth of vessels and tissue through the implant site), the region can experience higher oxygen levels, improved immune cell supply, and efficient waste removal, thereby reducing the opportunity for bacteria to grow around or within the implant site. The enhanced mechanical stimulation (e.g., mechanotransduction facilitated by lattice structure 42) can additionally promote deep-bone integration, reducing the space for bacteria to grow while simultaneously reducing the chance for bacterial biofilm to anchor on or within the implant site. Additionally, in some embodiments, material postprocessing of implant 10a can occur after manufacturing, e.g., wherein specialized coatings are layered onto the surface 54 of the implant 10a and / or the lattice structure 42, antimicrobial elements (e.g., surface features, fillings, reservoirs, etc.) can be added or integrated into the implant 10a, etc. For example, the implant 10a can include non-eluting, contact-active antimicrobial component and / or at least one eluting antimicrobial component, the eluting antimicrobial being released from within, through, or adjacent to the lattice structure. Such can help prevent the growth of bacteria. In some configurations, coatings on surface 54 can comprise: silver or copper nanoparticles (which can disrupt bacterial membranes), antibiotic-loaded porous coatings (which can slowly release antibiotics for localized infection control), hydrophilic coatings (which can prevent bacterial adhesion to the device), bioactive coatings, hydroxyapatite, titanium oxide, or a combination thereof. Alternatively, or additionally, the implant 10a and / or the lattice structure 42 can be manufactured using one or more treatments, including at least one of plasma oxidation, anodization, hydrothermal treatment, ion implantation, laser peening, heat treatment, or hot isostatic pressing. In some embodiments, the lattice structure and antimicrobial elements are compatible with sterilization by at least one of gamma irradiation, electron beam irradiation, ethylene oxide, or low-temperature plasma.

[0101] Similar to lattice structure 42, interfaces 14 and 18 are improved over existing systems to further facilitate healthy integration of implant 10a within a patient. As previously- 22 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001described, common bone-fixation devices often prove too rigid or stiff to facilitate long term integration with the patient. The prior methodology prioritizes a strong and rigid implant such that the likelihood of structural collapse is extremely minimal. However, when interfacing with bone 22, the much greater rigidity of an implant can cause damage over time to the surrounding bone. This damage, known in the art as “subsidence”, occurs when an implant gradually “sinks” into bone due to excessive localized stress, inadequate load distribution, material mismatch between the implant and the bone, or a combination thereof. While most commonly seen in intramedullary (IM) implants (e.g., “nails” extend into the IM cavity 26 and possibly contact the trabecular portion 34 of bone 22), subsidence can even occur with plate interfaces or other fixation devices that connect to the cortical portion 38 of bone. Implant 10a can mitigate the risk of subsidence through a variety of structural features, including porosity or void percentage grading (to better match anatomical bone stiffness), closer press-fit fixation (to prevent micromotion), increased bone-implant contact area, or a combination thereof. In other configurations (e.g., when external plates or same-diameter implants are used for interfaces 14 and 18), methods of mitigating subsidence can include: using porous lattice plates to improve load-sharing, improved plate contouring to facilitate an even stress distribution, utilizing graded stiffness materials (e.g., functional porosity), ensuring optimal cortical engagement to better anchor the implant to the bone, or a combination thereof.

[0102] In some configurations the present implants can have one or more articulating surfaces that are coupled to the lattice structure (e.g., 42) depending on the treatment area of the implant. The articulating surfaces can be in addition to or in place of protrusions (e.g., 30) described herein. For example, FIG. 7 A shows an articulating surface for a knee replacement. However other implants having differing articulating surfaces should be understood. Further, at least some of the implants described herein can include (1) surface roughness features, which can be programed (and improve bone growth and healing); (2) lattice designs for mechanobiologic effects for improved bone growth; (3) anatomical matching for proper fit and bone endplate coverage; (4) ability to have smooth articulated surfaces for total joint replacements, or other anatomical needs for smooth surfaces; or combination thereof.

[0103] As can be seen in FIGs. 2D and 2E, implant 10a, when implanted within bone 22 of the patient, can comprise protrusions 30 disposed into IM cavity 26 and contacting trabecular region 34 to ensure a proper fit within the patient. In some configurations, protrusions 30 can define one or more cavities 58 to facilitate the insertion and securement of a screw within and through bone 22 and implant 10a. As depicted, implant 10a comprises one cavity 58 on each protrusion 30. However, in other configurations, protrusions 30 may define a plurality of- 23 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001cavities 58 to provide additional reinforcement as needed. Dimensions of the various components of implant 10a may be altered to suit a patient’s specific needs. For example, protrusions 30 may vary in length, such that longer protrusions can be fit within a patient’s IM cavity 26. As is depicted, interfaces 14 and 18 each additionally comprise endplate 62 which can contact the cortical region 38 of bone 22 to provide additional support for the bone-implant interfaces 14 and 18. Lattice structure 42 can then facilitate an ideal microstrain distribution to prompt osteogenesis, thereby speeding up recovery time for a patient and mitigating the risk of future complications. While protrusions 30 are depicted with respect to implant 10a, it can be appreciated that implant 10a may not include integrated protrusions. For example, implant 10a may be fixed to bone tissue and / or other neighboring anatomical structures via one or more fixation elements (e.g., screws, nails, plates, etc.). Further details of this embodiment is described with reference to FIG. 2F below.

[0104] In some configurations, implant 10a can include a surgical guide (not depicted) removably coupled to the implant. The surgical guide, in some embodiments, can be connected to lattice structure 42 such that when implant 10a is placed as desired (e.g., protrusions 30 are disposed within the patient’s IM cavity 26), the surgical guide can denote drilling sites to align with cavities 58. In this manner, a surgeon can place implant 10a as desired within a bone 22 and drill holes using the surgical guide, rather than utilize traditional methods to ensure alignment. The surgical guide can thus provide an easier, more cost effective, and more foolproof method of determining the orientation of cavities 58. After drilling the required holes through bone 22, the surgical guide can be removed from the implant, allowing for enhanced healing as more space is available for bone / tissue growth around the implant.

[0105] Referring now to FIG. 2F, implant 10a is depicted with a secondary fixation method. Rather than employ protrusions (e.g., 30) to fit within a patient’s IM cavity (e.g., 26), or in addition to employing protrusions, plate 66 can be utilized for a less-invasive procedure. Plate 66 can define one or more cavities 58 to facilitate the insertion and securement of a screw within and through bone 22. Implant 10a, when outfitted with an external plate 66 fixation method, can function in substantially the same manner as when outfitted with protrusions 30. Lattice structure 42 can occupy the implant site in the same manner, but rather than dispose protrusions (e.g., 30) through the patient’s IM cavity (e.g., 26), plate 66 can be disposed onto cortical portion 38 of bone 22 such that the plate can provide a means to affix implant 10a to the bone. In some embodiments, plate 66 can comprise a lattice similar to that of lattice structure 42, thus allowing for similar benefits as to those described for the lattice structure. Screws can be deposited through cavities 58 defined by plate 66 and into the bone (e.g., 22) to- 24 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001ensure a stable bone-implant interface. In some embodiments, the screws can comprise a lattice similar to that of lattice structure 42, thus allowing for similar benefits as to those described for the lattice structure. While plate 66 can be partially load-bearing, much of the induced microstresses can be induced on lattice structure 42, thus functioning in substantially the same manner as implant 10a. While a plate and screws are described herein, it can be appreciated that other types of fixation elements can be used in addition to and / or in lieu of plates and / or screws. For example, nails, cages, cables, pins, rods, straps, wires, clamps, or other types of fixation devices can be used instead of or in addition to a plate and / or a screw.[0106| In use, the fixation elements can be configured to promote a microstrain environment. For example, the fixation elements can provide compression on the implant, e.g., from surrounding bone tissue. An external fixation element can be configured to provide some form of load transfer, and an integrated fixation (e.g., FIGS. 2A-2E) can enable implant to take on load. In the embodiment of a nail being used as the fixation element, the nail can be used to force two pieces of bone together around an implant as described herein. Compression can also be provided, for example, using screws, plates, rods, etc. In some embodiments, the implant can include one or more openings for screws to couple and / or go through it, e.g., to provide load transfer and / or compression.[0107| As described above, the implant 10a can be formed as a patient-specific lattice implant, which can enhance stability and provide more uniform load distribution. This can increase resistance to subsidence, lower the risk of implant migration, and / or provide surface microstrains through the implants which interact mechanobiologically in the fusion process. The implant 10a can be formed to be patient-specific, e.g., using methods as described with respect to FIG. 1. For example, such methods can include finite element modeling using patient specific anatomical information. In some embodiments, multiple sizes and / or configurations of the implant 10a can be produced. A physician can determine, based on a specific patient and / or application, which implant 10a to use for the patient. The physician can then select among the different implants 10a to determine which one would most closely meet the requirements for the specific patient and / or application. In such cases, the implant 10a may not be patient-specific but can be more tailored to the patient and / or application given loading conditions, patient characteristics (e.g., weight, breed, etc.), application, and / or other parameters. In some embodiments, finite element analysis or other computational methods (e.g., performed by a processor) can be used to select an implant having a suitable size and / or configuration for use with a particular patient or subject.- 25 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001

[0108] While FIGs. 2A-2F depict the implant as having the shape of a portion of bone (e.g., a cylindrical or substantially cylindrical shape), it can be appreciated that in other embodiments, the implant can be shaped as a fixation device (e.g., a screw, plate, nail, cage, etc.). In such embodiments, the implant can be used with other devices (e.g., bone fusion devices, cages, plates, or even other fixation devices).

[0109] Referring now to FIGs. 3A-3F, a second embodiment of the present device, hereafter referred to as implant 10b, is described. FIG. 3 A depicts lattice structure 342 generated for a large section of the patient’s bone 322. As was described with reference to FIG. 1, a three-dimensional model of the patient’s bone can be generated, wherein a portion thereof can be used to model and create the implant device (e.g., implant 10b). FIGs. 3B-3F then show device 10b, standalone and integrated into bone 322 of a patient. Implant 10b can be substantially similar to implant 10a and functions in much the same manner. For example, implant 10b can include a body 312, which can be structurally and / or functionally similar to body 12. For example, the body 312 can have a lattice structure including a plurality of interconnected members 346 (e.g., structurally and / or functionally similar to the interconnected members 46) defining one or more pores or voids 350 (e.g., the pore(s) 50). The implant 10b can include one or more interfaces configured to be coupled to the bone 322 of the patient, including a first interface 314 and a second interface 318, which can be structurally and / or functionally similar to the interfaces 14 and 18. In particular, the interfaces 314 and 318 can include an endplate 362 (e.g., structurally and / or functionally similar to the endplate(s) 62) and a protrusion 330 (e.g., structurally and / or functionally similar to the protrusion(s) 30). However, one notable difference for implant 10b is the inclusion of porous protrusions 330 (as opposed to implant lOa’s solid protrusions 30) and porous endplates 362. As previously discussed, the porosity or void percentage of protrusions 330 and endplates 362 can be modified to suit the needs of a given patient. In this case, implant 10b can provide a better interface to promote bone ingrowth through the pores defined by protrusions 330 and endplates 362.

[0110] Implant 10b thus utilizes a lattice structure 342, not only in between interfaces 314 and 318 (as was depicted between interfaces 14 and 18 in implant 10a), but additionally in protrusions 330 and endplates 362. In some embodiments, implant 10b includes a body 312 that is formed of a first lattice structure and protrusions 330 that are formed of a second lattice structure. In some embodiments, the first and second lattice structures can have the same characteristics as the lattice structure 342 depicted in FIG. 3A. In some embodiments, the first and second lattice structures can be different from one another. For example, the first lattice- 26 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001structure can have a first void volume to total volume (e.g., void percentage), and the second lattice structure can have a second void volume to total volume that is less than or greater than the first void volume to total volume. In some embodiments, the first and second lattice structures can be formed of the same material. In some embodiments, the first and second lattice structures can be formed of different material. In some embodiments, the first and second lattice structures can be formed of different types of lattice structures. In some embodiments, the first and second lattice structures can include interconnected members that have different sizes (e.g., different lateral dimensions).[0111 FIGs. 3D-3F depict the implant 10b implanted or integrated into bone 322. Bone 322 can include a cortical region 338 of the bone 322 (e.g., similar to the cortical region 38 in FIGs. 2C-2E), an IM cavity 326 (e.g., similar to the IM cavity 26 in FIGs. 2C-2E), and a trabecular region 334 (e.g., similar to the trabecular region 34 in FIGS. 2C-2E). The cortical region 338 of bone 322 can include an outer, more rigid region of the bone 322, while the trabecular region 334 can include an inner, less rigid region of the bone 322.

[0112] Referring now to FIGs. 4A-4E, a third embodiment of the present device, hereafter referred to as implant 10c, is described. FIGs. 4A-4D depict implant 10c standalone while FIG.4E depicts the device implanted between vertebral bodies 470, thus acting as a replacement for an intervertebral disc. In particular, FIG. 4A shows a perspective view of implant 10c, FIG. 4B shows a side (e.g., lateral) view of implant 10c, FIG. 4C shows a front view of implant 10c, and FIG. 4D shows a top (e.g., superior) view of implant 10c. Implant 10c can function in substantially the same manner as implants 10a or 10b; however, implant 10c can be designed for different applications (e.g., spinal fusion) and / or involve a different fixation method. For example, implant 10c can include a body 412 having a lattice structure, including a plurality of interconnected members 446 defining one or more pores 450. Additionally, implant 10c can include an interface 414 including an endplate 462. The previously discussed implants (e.g., 10a or 10b) can facilitate a connection between the respective implant and bone 422 of a patient through the use of protrusions (e.g., the protrusions 30, the protrusions 330), an external plate (e.g., the external plate 66), or an external fixation device (e.g., FIG. 13). Implant 10c uses a secondary version of external plate fixation, wherein the endplate 462 and / or interface 414 of the implant 10c can be coupled (e.g., affixed) directly to the cortical region 438 of a bone 422 (e.g., vertebral body 470). As can be seen best by FIGs. 4A-4D, implant 10c includes a body 412 having the lattice structure 442, extending between each endplate 462. As such, when prompting osteogenesis, bone 422 can be permitted to grow into and through endplates 462 and lattice structure 442, such that the bone can eventually fully connect through implant 10c.- 27 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001In some configurations, implant 10c can additionally comprise rods (not depicted) that can be inserted through the vertebral bodies 470 and / or through the implant to further anchor the implant to the surrounding bone.

[0113] Referring now to FIG. 5, a chart depicting the states of bone growth (or lack thereof) is depicted, plotted against applied strain. The phenomenon is described by Wolffs law, wherein osteogenesis can be prompted or halted by applied strains. As can be seen, applied strain, up to a certain point (e.g., 3000 pm) can facilitate an adapted state or a growth state for bones. Strains past 3000 pm can cause overload, which can negatively impact the growth of bone structures. On the other hand, strains lower than 200 pm can lead to bone loss. This lower bound can fluctuate and is patient-specific, which is why the specific range for current implant devices is between 100 pm and 3000 pm. The state of “bone loss” wherein too little strain is applied throughout the bone interface (and additionally, implant 10a, 10b, 10c, or other implants described below, and any bone connected therethrough), is a common occurrence with implants taught in the art. Thus, lattice structure (e.g., lattice structure 42), patient specific modification, and enhanced material selection can greatly mitigate this issue and allow for enhanced microstrain distribution, thus prompting more rapid osteogenesis.

[0114] Referring now to FIG. 6, a comparison of microstrains for three implants having protrusions 530, 630, or 730 (e.g., similar to implants 10a or 10b) is shown. Implant 500 is based on traditional IM-implants, wherein a protrusion 530 is disposed through the IM cavity (e.g., the IM cavity 26) of a bone (e.g., the bone 22). Protrusion 530 comprises a single body, which can extend through and connect both portions of a patient’s bone. Lattice structure 542 is disposed outside of (and connected to) protrusion 530 to showcase the difference in microstrain (as compared to the following implant devices). Protrusion 530, disposed through and connecting both interfaces 514 and 518, is load-bearing (whereas the connected lattice structure 542 is not). Implant 600 uses protrusions 630 only at the interfaces 614 and 618 and includes lattice structure 642. Lattice structure 642, dissimilar to lattice structure 542, is loadbearing and can induce microstrains throughout implant 600. Implant 700 is substantially similar to implant 600, wherein lattice structure 742 is load-bearing and is utilized to induce microstrains throughout the implant. However, implant 700 employs lattice structure 742 with a higher porosity and smaller interconnected member (e.g., 46) thickness, thereby increasing the microstrains induced through the implant. Based on the previously discussed phenomena of Wolff s Law and the use of mechanotransduction to promote osteogenesis, implant 700 can function in a more effective manner than implant 600, and a substantially more effective manner than implant 500. Microstrains can be calculated through FEA analysis prior to- 28 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001manufacturing and use patient-specific data to ensure that optimal microstrain levels can be reached without compromising the safety of device 10. For example, factors of safety for such implants can be equal to, or between any two of: 1.5, 2, 2.5, 3, or 4 (e.g., 3), to ensure that an appropriate balance between structural rigidity and applied microstrain is reached.

[0115] Referring now to FIGs. 7A-10D, various implants are shown for a variety of applications for human and animal use. Each implant can be created or generated utilizing one or more steps of the methods described herein and have a lattice structure that can include features that are described above. Accordingly, the implants of the present disclosure can provide a lattice structure that will be specifically tailored to the area and mammal in which the implant will be used. Each lattice structure can be configured to create sufficient macrostrains to facilitate bone growth as described herein.10116] FIG. 7 A shows an implant 1000 configured to be implanted during a total knee replacement procedure, according to some embodiments. Arrow 1002 shows the anterior direction of the implant 1000 (e.g., the front of the knee). The implant 1000 can be structurally and / or functionally similar to other implants described herein (e.g., the implants 10a, 10b, 10c); however, the implant 1000 can be adapted for total knee replacement (e.g., be adapted to withstand loads associated with the specific anatomy and / or generate microstrains that promote bone growth under the predefined loading conditions associated with the specific anatomy and / or procedure). The implant 1000 can include a first component 1010 that can be configured to be coupled to a femur and a second component 1020 configured to be coupled to a tibia. The implant can include one or more regions having smooth surface features to facilitate joint movement (e.g., by providing a smooth surface for joint articulation). Additionally, the implant 1000 can include one or more regions having a lattice structure that can be structurally and / or functionally similar to the lattice structure 42 as described with reference to FIG. 2A-2E. For example, the second component 1020 can include a protrusion 1022 configured to be implanted and / or secured within a bone (e.g., the tibia). The protrusion 1022 can have a lattice structure to facilitate bone growth and integration between the bone and the implant 1000, similar to that described with reference to FIGs. 2A-4E.

[0117] FIG. 7B shows an implant 1100 configured to be implanted during a corpectomy procedure, according to some embodiments. The implant 1100 can be configured to be coupled to and / or disposed between one or more vertebral bodies 1002. The implant 1100 can be structurally and / or functionally similar to the implants described herein (e.g., the implants 10a, 10b, 10c); however, the implant 1100 can be adapted for a corpectomy procedure (e.g., be adapted to withstand loads associated with the specific anatomy and / or generate microstrains- 29 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001that promote bone growth under the predefined loading conditions associated with the specific anatomy and / or procedure). In an embodiment, the implant can be a corpectomy cage. The implant 1100 can include a body 1012 having a lattice structure that can be structurally and / or functionally similar to the lattice structures described herein, including the lattice structure 42. Additionally, the implant 1100 can include one or more interfaces having one or more endplates 1062 that can be structurally and / or functionally similar to the endplate(s) described herein, including the endplate(s) 462. For example, the endplate(s) 1062 can be configured to be coupled to the vertebral bodies 1002 and configured to distribute one or more loads, for example, to reduce subsidence.

[0118] FIG. 7C shows an implant 1200 configured to be implanted during an ankle fusion procedure, according to some embodiments. The implant 1200 can be configured to be coupled to one or more bones near or at the ankle (e.g., a tibia, a fibula, a talus). The implant 1200 can be structurally and / or functionally similar to the implants described herein (e.g., the implants 10a, 10b, 10c); however, the implant 1200 can be adapted for ankle fusion (e.g., be adapted to withstand loads associated with the specific anatomy and / or generate microstrains that promote bone growth under the predefined loading conditions associated with the specific anatomy). For example, the implant 1200 can include a lattice structure including a plurality of interconnected members 1246 (e.g., the interconnected member(s) 46) defining one or more pores 1250 (e.g., the pore(s) 50). The lattice structure can be structurally and / or functionally similar to the lattice structures described herein, including the lattice structure 42.

[0119] FIG. 7D-7E show implants configured to be coupled to and / or replace a mandible, according to some embodiments. In particular, FIG. 7D shows an implant 1300 configured to be implanted during a mandibular segmental defect procedure, while FIG. 7E shows an implant 1400 configured to be implanted during a mandibular defect reconstruction procedure (e.g., a total joint replacement). The implant 1300, as shown in FIG. 7D, can include a first region 1310 and a second region 1320. The first region can include one or more holes 1312 configured to receive one or more fixation elements (e.g., a screw). The one or more fixation elements can secure the implant 1300 to the mandible 1302. The second region 1320 can have a lattice structure that can be structurally and / or functionally similar to the lattice structures described herein, including the lattice structure 42. For example, the lattice structure of the second region 1320 can be configured to promote bone growth, for example, to integrate a bone graft with the mandible 1302. In some embodiments, the lattice structure can be configured to span a different region and / or a different area. For example, as shown in FIG. 7E, the implant 1400 can have a lattice structure having a larger area compared to the lattice structure of implant- 30 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-20011300. In particular, the lattice structure of implant 1400 can span a ramus of the mandible and / or a body of the mandible, for example, to replace the mandible. The lattice structure of implant 1400 can be structurally and / or functionally similar to the lattice structure of implant 1300.

[0120] FIG. 8 depicts various spinal fusion implants, according to embodiments. The spinal fusion implants can include an implant 1500 that is a transforaminal lumbar interbody fusion (TLIF) device, an implant 1600 that is an anterior lumbar interbody fusion (ALIF) device, and an implant 1700 that is a posterior lumbar interbody fusion (PLIF) device. Each of implants 1500, 1600, and 1700 can be structurally and / or functionally similar to other implants described herein (e.g., the implants 10a, 10b, 10c). For example, each of implants 1500, 1600, and 1700 can include a lattice structure, which can be structurally and / or functionally similar to the lattice structure 42 as described with reference to FIG. 2A-2E. The lattice structure of implants 1500, 1600, and 1700 can be configured to facilitate bone growth and integration between the bone and the implant 1000, similar to that described with reference to FIGs. 2A-4E. For example, the implants 1500, 1600, and 1700 can be configured to promote bone growth between adjacent vertebrae and therefore be used in interbody fusion applications. In some embodiments, the implants can include one or more openings or holes 1502, 1602, 1702, e.g., for facilitating implantation of the implants (e.g., coupling to a delivery device) and / or for receiving a fixation element (e.g., a screw, nail, rod, etc.). These openings 1502, 1602, 1702 can be configured to enable placement, manipulation, or fixation of the implants 1500, 1600, 1700.|O121] FIGs. 9A-9D depict various spinal fusion implants (e.g., implants 1500, 1600, 1700, and / or other implants described herein) implanted into a subject, according to embodiments. During an interbody fusion procedure, disc material is removed from between adjacent vertebrae of the spine. The implant 1500, 1600, 1700 can be positioned between the adjacent vertebrae in the removed disc space. FIG. 9B depicts the implant 1500 implanted in the space. FIG. 9C depicts the implant 1700 implanted in the space. FIG. 9D depicts the implant 1600 implanted in the space. In embodiments, the implant 1500, 1600, 1700 can be configured to provide mechanical support and withstand biomechanical loads associated with predefined loading conditions associated with the spinal region in which the implant is implanted. Additionally, or alternatively, one or more fixation elements (e.g., rods 1802, screws 1804) can be attached to the adjacent vertebrae or nearby bone structure to provide additional support. In embodiments, the implant 1500, 1600, 1700 can be configured to generate a microstrain environment that promotes ingrowth of bone tissue on, in, or through its lattice structure.- 31 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001

[0122] In embodiments, the implants 1500, 1600, 1700 can be formed as patient-specific lattice implants, which can enhance stability and provide more uniform load distribution. This can increase resistance to subsidence, lower the risk of implant migration, and / or provide surface microstrains through the implants which interact mechanobiologically in the fusion process. The implants 1500, 1600, and 1700 can be formed to be patient-specific, e.g., using methods as described with respect to FIG. 1. For example, such methods can include finite element modeling using patient specific anatomical information. In some embodiments, the implants 1500, 1600, 1700 may not be patient specific but can be selected from a plurality of implants having predefined sized and / or configurations, e.g., based on loading conditions, patient characteristics (e.g., weight, breed, etc.), application, and / or other parameters.

[0123] FIGs. 10A-10D depict an implant device configured to attach a prosthetic component (e.g., a limb) to a subject, according to embodiments. FIG. 10A shows an implant 2300 (e.g., an osseointegrated prosthetic implant) implanted within a bone 2302 of an amputated limb of the subject. In particular, the implant 2300 can include a first region 2310 configured to be anchored to and / or implanted within the bone 2302 (e.g., a femur). The first region 2310 can include a body having a lattice structure. The body and / or lattice structure of the implant 2300 can be structurally and / or functionally similar to the body and the lattice structures described herein, including the body 12 and the lattice structure 42. The first region 2310 can be coupled to a connector 2320 (e.g., an abutment) configured to extend through the skin 2304 of a stoma. The connector 2320 can be coupled to a second region 2330 (e.g., an external prosthetic component) such that the connector 2320 can provide a transcutaneous connection between the first region 2310 and the second region 2330 of the implant 2300. The second region 2330 can include and / or be coupled to a prosthetic component, as shown in FIG.10B. More specifically, in FIG. 10B, an implant 2400 is anchored to a femur 2402 via a first region 2410. As described with reference to FIG. 10A, the first region 2410 can include a lattice structure, for example, to improve integration of the implant 2400 with the femur 2402. The first region 2410 can be coupled to a prosthetic limb 2430 via a connector 2420 (e.g., the connector 2320). In some embodiments, as shown in FIG. 10C, a connector 2520 (e.g., the connector 2320, the connector 2420) can include a screw 2522. The screw 2522 can be configured to securely and / or removably couple to a prosthetic limb. In some embodiments, when the prosthetic limb is removed, a first region 2510 and the connector 2520 can remain anchored to a bone. FIG. 10D shows an implant 2600 (e.g., the implant 2300, 2400, 2500) coupled to a prosthetic limb 2630 (e.g., the prosthetic limb 2430) when not coupled (e.g., attached) to a subject.- 32 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001

[0124] Referring now to FIGs. 11-13, a variety of implants are shown depicting different fixation methods. Various injuries / procedures can require differing methods of treatment, and as such, it should be understood that no one method of fixation will prove suitable for the various injuries. FIGs. 11-13 depict 1) a medullary nail fixation method, 2) a plate fixation method, and 3) an external device fixation method, respectively. Each of these fixation methods can be used depending on patient needs, and each can benefit from the methods and technology described above. For example, the fixation devices used (e.g., IM nail, peg, screw, plate, rods, external fixation elements, etc.) can include a lattice structure (e.g., graded lattice structure) as described herein, e.g., to promote bone growth. The fixation devices can also be used with lattice structure, e.g., such as lattice structures 10a, 10b, 10c, and / or other lattice structures described herein. The fixation devices can also include antimicrobial elements (e.g., coating, reservoirs, etc.), which can reduce the risk of infection and avoid complications. For example, the fixation elements can include non-eluting, contact-active antimicrobial component and / or at least one eluting antimicrobial component, the eluting antimicrobial being released from within, through, or adjacent to the lattice region.

[0125] By way of non-limiting example, antimicrobial implementations can include one or more of the following:

[0126] Antimicrobial coatings on lattice members and / or the surface of the fixation devices (e.g., the surface of a nail), including antibiotic-eluting coatings.

[0127] Drug-eluting reservoirs, pores, channels, microcapsules, or the like within the lattice structure.

[0128] Metallic antimicrobials (e.g., silver or copper) or antibiotic-loaded materials and / or porous coatings (e.g., bone graft, bone substitute, collagen, hydrogel, putty, cement, or carrier matrix) which can be positioned within or retained by the lattice structure, including open spaces or voids.

[0129] Contact-active antimicrobial polymers, quaternary amine surfaces, or surface chemistries (e.g., cationic polymeric antimicrobials, quaternary ammonium or quaternized amine functionality, covalently bound antimicrobial polymers, alkylated or quaternized polyamines ,e.g., polyethyleneimine-based systems, or other contact-killing microbial polymers that inhibit bacterial adhesion and biofilm formation).

[0130] Localized antibiotic delivery enabled by lattice structure voids, channels, and / or reservoirs configured to spatially confine biologic or antibiotic material while maintaining mechanical stability and microstrain generation.- 33 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001

[0131] It can be appreciated that the antimicrobial elements may be present on or within interconnected members, solid regions, fixation elements, or any combination thereof.101321 In some embodiments, the implantable devices described herein can include a fixation element integrated therein. In other words, the implantable device can include its own fixation elements or constructs. FIG. 14 depicts an implant 2700 including one or more fixation elements, according to some embodiments. The implant 2700 can be structurally and / or functionally similar to other implants described herein, including, for example, implants 10a, 10b, 10c. For example, the implant 2700 can include a lattice structure, e.g., to promote bone growth. The implant 2700 can also include fixation elements that are implemented as protrusions 2730 and endplates 2762, which can be configured to attach the implant 2700 to the bone tissue. As described with reference to implant 10b, in some embodiments, these fixation elements can include a lattice structure to also promote bone growth.

[0133] Alternatively, or additionally, the implantable devices described herein can be implanted with one or more accessory devices (e.g., external or separate fixation elements). For example, FIGs. 15A-15B depict an implant 2800 implanted with an intramedullary nail, according to embodiments. The implant 2800 can be structurally and / or functionally similar to other implants described herein, including, for example, implants 10a, 10b, 10c, but the implant 2800 relies on a separate intramedullary nail 2802 for fixation and support. The implant 2800, for example, can be disposed around a portion of the intramedullary nail 2802 that extends between two sections or portions of bone tissue. The intramedullary nail 2802 can include one or more openings through which screws 2804 can be inserted to affix the intramedullary nail (and therefore the implant 2800) in place. In other words, the intermedullary nail 2802 can be configured to extend through the body and be fixed to bone tissue using on or more dynamic or static screws. In other embodiments (as described above), other types of fixation devices (e.g., plate, rods, cages, etc.) can be used. In some embodiments, the intramedullary nail 2802 and / or screws 2804 can also be formed of a lattice structure, e.g., to promote bone growth. In some embodiments, the implant 2800, the intramedullary nail 2802 and / or screws 2804 can include one or more antimicrobial elements (e.g., a coating, reservoirs, etc.).

[0134] The present disclosure can be embodied in one or more embodiments, as described below.

[0135] Embodiment 1: The apparatus comprising: a body configured to be implanted near bone tissue at a target site in a subject, the body including an interface configured to be coupled to the bone tissue, the body, when implanted, being configured to provide mechanical support at the target site that can withstand biomechanical loads associated with a set of predefined- 34 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001loading conditions, such that the body can support mobility of the subject under the set of predefined loading conditions, the body, while providing mechanical support at the target site, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the body.

[0136] Embodiment 2: The embodiment of Embodiment 1, wherein the body comprises a fixation construct selected from the group consisting of intramedullary fixation members, plates, rods, screws, external fixation components, or combinations thereof, the fixation construct including at least one lattice region formed on, within, embedded in, or coupled to the fixation construct.

[0137] Embodiment 3: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open spaces, the lattice region is positioned at or adjacent to at least one infection-critical or load-critical region of the fixation construct, including but not limited to metaphyseal regions, diaphyseal regions, segmental defects, screw or fastener interfaces, junctions between fixation elements, or interfaces between the fixation construct and bone.

[0138] Embodiment 4: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open spaces, wherein antimicrobial functionality is associated with at least one of the lattice region or the fixation construct, and wherein the fixation construct and lattice region together form an antimicrobial fixation system.

[0139] Embodiment 5: The embodiment of Embodiment 4, wherein the antimicrobial functionality comprises at least one non-eluting, contact-active antimicrobial component and at least one eluting antimicrobial component, the eluting antimicrobial being released from within, through, or adjacent to the lattice region.

[0140] Embodiment 6: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open spaces, wherein the lattice structure is configured to generate a target microstrain environment under physiological loading.

[0141] Embodiment 7: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open spaces, wherein the lattice structure includes a first region configured to reduce subsidence and a second region configured to promote bone ingrowth.

[0142] Embodiment 8: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open- 35 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001spaces, wherein the lattice structure defines three-dimensional voids configured to retain bone graft, biologic material, or antibiotic-containing material.

[0143] Embodiment 9: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open spaces, wherein the lattice structure simultaneously retains a biologic material and provides antimicrobial activity.

[0144] Embodiment 10: In some embodiments, the implants described herein can be configured for use in at least one of cervical, thoracic, or lumbar spine applications.

[0145] Embodiment 11: In some embodiments, the implants described herein can be configured to promote spinal fusion and correct spinal deformity under compressive loading.

[0146] Embodiment 12: In some embodiments, the implants described herein can be configured as a vertebral body replacement or corpectomy cage.

[0147] Embodiment 13: The embodiment of Embodiment 1, wherein the body can include a lattice structure having a plurality of interconnected members that define one or more open spaces, wherein the lattice structure is configured to distribute load across an endplate to reduce subsidence.

[0148] Embodiment 14: The embodiment of Embodiment 1, further comprising one or more fixation elements, wherein the one or more fixation elements comprise a screw including a lattice region. Embodiment 15: The embodiment of Embodiment 1, further comprising one or more fixation elements, wherein the one or more fixation elements comprise a plate including lattice regions configured to promote bone ingrowth.

[0149] Embodiment 16: The embodiment of Embodiment 1, further comprising one or more fixation elements, wherein the one or more fixation elements include both solid regions and lattice regions.

[0150] Embodiment 17: The embodiment of Embodiment 4, wherein the lattice structure and antimicrobial functionality are compatible with sterilization by at least one of gamma irradiation, electron beam irradiation, ethylene oxide, or low-temperature plasma.

[0151] Embodiment 18: The embodiment of Embodiment 4, wherein the antimicrobial functionality is applied prior to sterilization.

[0152] Embodiment 19: The embodiment of Embodiment 4, wherein the lattice retains antimicrobial activity after sterilization.]0153[ Embodiment 20: A method of treating bone, comprising implanting a fixation construct comprising a lattice structure configured to promote bone ingrowth and provide antimicrobial protection.- 36 - 331320087Agent’s File Ref. OSNT-OOl / OIWO 361279-2001

[0154] Embodiment 21: A method of reducing infection while promoting bone fusion via a lattice configured to generate microstrain.

[0155] Embodiment 22: An implant comprising a lattice structure having spatially varying porosity, strut thickness, and / or unit cell geometry, wherein a first region is optimized for initial mechanical stability, and a second region is optimized for bone through-growth and long-term osseointegration.

[0156] Embodiment 23: An implant wherein the lattice geometry is configured to induce targeted microstrain ranges within adjacent bone tissue sufficient to promote osteogenesis while avoiding stress shielding.

[0157] Embodiment 24: A patient-specific or anatomy-specific implant generated from imaging data, wherein the implant geometry conforms to species-specific, breed-specific, or patient-specific spinal anatomy.

[0158] Embodiment 25 : An implant comprising a surface or bulk-treated lattice configured to reduce bacterial adhesion, biofilm formation, or infection risk while maintaining osseointegration.

[0159] Embodiment 26: An interbody implant having an interface geometry configured to resist migration and subsidence, and distribute loads across vertebral endplates in a controlled manner.

[0160] Embodiment 27: A joint replacement implant comprising a solid load-bearing core, and a lattice-based fixation region configured to promote osseointegration while reducing stress shielding.

[0161] Embodiment 28: An implant wherein a gradual transition zone exists between solid and lattice regions to reduce stress concentrations and fatigue failure.

[0162] Embodiment 29: A joint replacement implant configured for canine anatomy, wherein joint kinematics, load paths, and fixation geometry differ from human joint replacements.

[0163] Embodiment 30: A joint replacement implant comprising an antimicrobial surface or bulk-modified lattice that reduces infection risk without inhibiting osseointegration.

[0164] Embodiment 31 : An implant platform wherein a lattice architecture is configurable for use in both spinal fusion and joint replacement applications.

[0165] Embodiment 32: A hip stem revision implant comprising: a longitudinal stem body and a lattice structure integrated into at least a proximal and / or metaphyseal region of the stem, wherein the lattice structure is configured to promote osseointegration and mechanical fixation in deficient or compromised bone.- 37 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001

[0166] Embodiment 33: The implant wherein the lattice structure comprises spatially varying porosity, strut thickness, or unit cell geometry along the stem length, such that a first region provides structural support and load transfer, and a second region provides enhanced bone ingrowth in regions of bone loss.

[0167] Embodiment 34: The lattice structure is configured to induce microstrain within adjacent bone tissue in a range that promotes osteogenesis while reducing stress shielding.10168] Embodiment 35: The implant comprises a proximal lattice fixation region configured for metaphyseal fixation, and a distal stem region configured for diaphyseal stabilization.

[0169] Embodiment 36: The stem comprises a solid structural core and a surrounding lattice region configured to engage cortical bone while permitting bone ingrowth.

[0170] Embodiment 37: A patient-specific hip stem revision implant generated from imaging data, wherein the lattice geometry and stem dimensions are tailored to the patient’s femoral canal and bone quality.

[0171] Embodiment 38: The lattice structure spans a bone defect, cavitary defect, or segmental bone loss region and provides mechanical support while permitting bone regeneration through the lattice.

[0172] Embodiment 39: The hip stem revision implant comprises a lattice structure functionalized to reduce bacterial adhesion or biofilm formation while maintaining osseointegration.

[0173] Embodiment 40: The implant is configured for use in human and / or veterinary hip revision procedures.

[0174] Embodiment 41 : A hip stem revision implant comprising: a longitudinal stem body, a lattice structure forming at least a portion of the stem configured to promote osseointegration, and an antimicrobial functionality associated with the lattice structure, wherein the antimicrobial functionality reduces bacterial adhesion or biofilm formation without inhibiting bone ingrowth, the antimicrobial functionality is incorporated into the lattice structure by chemical modification, grafting, bulk incorporation, or covalent attachment, rather than by a removable or sacrificial coating, the lattice structure comprises spatially varying porosity and antimicrobial distribution, wherein regions of higher infection risk comprise increased antimicrobial activity while maintaining osseointegration, the lattice structure provides a three-dimensional architecture that increases surface area for antimicrobial functionality while permitting vascularized bone ingrowth.- 38 - 331320087Agenf s File Ref. OSNT-OOl / OIWO 361279-2001

[0175] Embodiment 41: A patient-specific hip stem revision implant wherein both lattice geometry and antimicrobial functionality are tailored based on patient anatomy, bone quality, or infection risk.

[0176] Embodiment 42: A method of treating a patient requiring revision hip arthroplasty comprising implanting a lattice-based hip stem revision implant having antimicrobial functionality integrated with the lattice structure.

[0177] The above specification and examples provide a complete description of the structure and use of illustrative embodiments. Although certain embodiments have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. As such, the various illustrative embodiments of the apparatuses, systems, and methods are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and embodiments other than the one shown may include some or all of the features of the depicted embodiment. For example, elements may be omitted or combined as a unitary structure, and / or connections may be substituted. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and / or functions, and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments.

[0178] Some non-limiting examples of the present methods and devices are described in the following appendices. It should be understood that the examples described herein are illustrative and are intended to provide specific examples and do not limit the scope of the disclosure. The methods and devices described herein could be altered, modified, combined, or omitted as would be understood by a person of skill in the art.

[0179] The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.- 39 - 331320087

Claims

Agenf s File Ref. OSNT-OOl / OIWO 361279-2001CLAIMS1. An apparatus, comprising:a body configured to be implanted near bone tissue at a target site in a subject, the body including an interface configured to be disposed near the bone tissue,the body, when implanted, being configured to provide mechanical support at the target site that can withstand biomechanical loads associated with a set of predefined loading conditions, such that the body can support mobility of the subject under the set of predefined loading conditions,the body, while providing mechanical support at the target site, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the body.

2. The apparatus of claim 1 , wherein the body includes a lattice structure having a plurality of interconnected members that define one or more open spaces.

3. The apparatus of claim 2, wherein the lattice structure is a Voronoi -based lattice structure.

4. The apparatus of claim 2, wherein one or more open spaces are 3D voids that have a 3D volume with dimensions that range between about 300 pm and about 10,000 pm.

5. The apparatus of claim 2, wherein the lattice structure has a variable void percentage that ranges between about 25% and about 90%.

6. The apparatus of claim 2, wherein the lattice structure includes a first region that is configured to withstand higher biomechanical loads than a second region.

7. The apparatus of claim 6, wherein the first region has a lower void percentage than the second region.

8. The apparatus of claim 6, wherein the first region has a set of interconnected members with greater thickness than a set of interconnected members of the second region.Agent’s File Ref. OSNT-OOl / OIWO 361279-20019. The apparatus of claim 2, wherein the lattice structure has a graded void percentage with a first region of the lattice structure having lower void percentage than a second region of the lattice structure,wherein the first region is configured to provide greater mechanical support than the second region,wherein the second region is configured to promote greater ingrowth of the bone tissue than the first region, the second region being at or near the interface and configured to enhance integration between the body and the bone tissue.

10. The apparatus of claim 2, wherein the plurality of interconnected members have a thickness of between 25 pm to 2000pm.

11. The apparatus of claim 2, wherein the plurality of interconnected members have variation in at least one of thickness and length.

12. The apparatus of claim 2, wherein the lattice structure includes a plurality of regions that are each configured to deform differently from one another.

13. The apparatus of claim 2, wherein the plurality of interconnected members includes curved structures that interlock with one another without internal trusses.

14. The apparatus of claim 2, wherein the plurality of interconnected members include irregular interconnected members that vary in thickness and length, such that the lattice structure resembles a structure of natural bone tissue.

15. The apparatus of claim 1, wherein the predefined loading conditions include external forces, boundary conditions, and dynamic or static loading of the bone tissue.

16. The apparatus of claim 15, wherein the predefined loading conditions are set based on at least one of a geometry of the bone tissue, a density of the bone tissue, or expected postoperative loading or activity level of the subject.

17. The apparatus of claim 1 , wherein the body includes an inner region and an outer region, wherein the outer region is configured to provide greater mechanical support than the inner region,Agenf s File Ref. OSNT-OOl / OIWO 361279-2001wherein the inner region is configured to promote greater ingrowth of the bone tissue than the outer region.

18. The apparatus of claim 1, wherein the body is configured to generate the microstrain environment by generating microstrains that range from about 300 ps to about 3000 ps.

19. The apparatus of claim 1, wherein the body includes at least one of pure titanium (CP-Ti), Ti-Nb (Titanium -Niobium), Ti-Ta (Titanium-Tantalum), Ti-Mo (Titanium -Molybdenum), Ti-Zr-Nb (Titanium-Zirconium-Niobium), Ti-29Nb-13Ta-4.6Zr (TNTZ), Ti-6A1-4V, CoCr (cobalt chromium), Ta (tantalum), Nitanol, Magnesium, Nitinol, Copper, Ti-34NB-13Ta-5Zr-0.30 (TNTZO), polyetherketoneketone (PEKK), polyetheretherketone (PEEK), polylactic-co-glycolic acid (PLGA), steel, beta titanium alloys containing Nb, Ta, Zr, Mo, Nb, Sn, biodegradable metals, biodegradable plastics, or biologic materials.

20. The apparatus of claim 1, further comprising one or more fixation elements, the one or more fixation elements including at least one of a peg, a plate, or a screw.

21. The apparatus of claim 20, wherein the body includes first and second endplates, and the one or more fixation elements include: a first peg attached to the first endplate and configured to extend beyond the first endplate into the bone tissue, and a second peg attached to the second endplate and configured to extend beyond the second endplate into the bone tissue.

22. The apparatus of claim 1, wherein the body is configured to have an elastic modulus that ranges from between about 1 GPa to about 200 GPa,23. The apparatus of claim 1, wherein the body defines a cylindrical shape.

24. The apparatus of claim 1, wherein the body includes one or more coatings, the one or more coatings including at least one of silver nanoparticles, copper nanoparticles, antibiotic-loaded porous coatings, hydrophilic coatings, hydrophobic coatings, antimicrobial elements, bone graft with antimicrobial beads, polymeric contact-active antimicrobials, bioactive coatings, hydroxyapatite, or titanium oxide.Agent’s File Ref. OSNT-OOl / OIWO 361279-200125. The apparatus of claim 1, wherein the body is manufactured using one or more treatments, the one or more treatments including at least one of plasma oxidation, anodization, hydrothermal treatment, ion implantation, laser peening, heat treatment, or hot isostatic pressing.

26. The apparatus of claim 1, wherein the interface includes one or more regions that conform to one or more surfaces of the bone, the one or more regions including at least one of a flat shape, a concave shape, or a convex shape.

27. An apparatus, comprising:a body including a lattice structure configured to be implanted near bone tissue at a target site in a subject,the lattice structure having a plurality of interconnected members that define one or more open spaces, the plurality of interconnected members being interlocked with one another without internal trusses,the lattice structure, when implanted and being subjected to one or more loads, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the lattice structure.

28. The apparatus of claim 27, wherein the lattice structure is a Voronoi-based lattice structure.

29. The apparatus of claim 27, wherein the one or more open spaces have variable sizes that range between about 300 pm and about 10,000 pm in diameter.

30. The apparatus of claim 27, wherein the lattice structure has a variable void percentage that ranges between about 50% and about 80%.

31. The apparatus of claim 27, wherein the lattice structure includes a first region that is configured to withstand higher biomechanical loads than a second region.

32. The apparatus of claim 31 wherein the first region has a lower void percentage than the second region.Agent’s File Ref. OSNT-OOl / OIWO 361279-200133. The apparatus of claim 31, wherein the first region has a set of interconnected members with greater thickness than a set of interconnected members of the second region.

34. The apparatus of claim 27, wherein the lattice structure has a graded void percentage with a first region of the lattice structure having lower void percentage than a second region of the lattice structure,wherein the first region is configured to provide greater mechanical support than the second region,wherein the second region is configured to promote greater ingrowth of the bone tissue than the first region, the second region being at or near an interface between the body and the bone tissue and configured to enhance integration between the body and the bone tissue.

35. The apparatus of claim 27, wherein the plurality of interconnected members have a thickness of between 100pm to 500pm.

36. The apparatus of claim 27, wherein the plurality of interconnected members have variation in at least one of thickness and length.

37. The apparatus of claim 27, wherein the lattice structure includes a plurality of regions that are each configured to deform differently from one another.

38. The apparatus of claim 27, wherein the plurality of interconnected members include irregular interconnected members that vary in thickness and length, such that the lattice structure resembles a structure of natural bone tissue.

39. The apparatus of claim 27, wherein the lattice structure is configured to generate the microstrain environment by generating microstrains that range from about 200 ps to about 3000 ps.

40. The apparatus of claim 27, wherein the lattice structure is formed of at least one of titanium, Ti-Nb (Titanium -Niobium), Ti-Ta (Titanium-Tantalum), Ti-Mo (Titanium -Molybdenum), Ti-Zr-Nb (Titanium-Zirconium-Niobium), Ti-29Nb-13Ta-4.6Zr (TNTZ), Ti-6A1-4V, CoCr (cobalt chromium), Ta (tantalum), Nitanol, Magnesium, Nitinol, Copper, Ti-34NB-13Ta-5Zr-0.30 (TNTZO), polyetherketoneketone (PEKK), polyetheretherketoneAgent’s File Ref. OSNT-OOl / OIWO 361279-2001(PEEK), polylactic-co-gly colic acid (PLGA), steel, beta titanium alloys containing Nb, Ta, Zr, Mo, Nb, Sn, biodegradable metals, biodegradable plastics, or biologic materials.

41. The apparatus of claim 27, wherein the lattice structure includes one or more coatings, the one or more coatings including at least one of silver nanoparticles, copper nanoparticles, antibiotic-loaded porous coatings, hydrophilic coatings, hydrophobic coatings, antimicrobial elements, bone graft with antimicrobial beads, polymeric contact-active antimicrobials, bioactive coatings, hydroxyapatite, or titanium oxide.

42. The apparatus of claim 27, wherein the lattice structure is manufactured using one or more treatments, the one or more treatments including at least one of plasma oxidation, anodization, hydrothermal treatment, ion implantation, laser peening, heat treatment, or hot isostatic pressing.

43. The apparatus of claim 27, wherein the plurality of interconnected members include a plurality of curved members without sharp edges.

44. The apparatus of claim 27, wherein the lattice structure includes an exterior surface with rough features configured to enhance adhesion between the lattice structure and the bone tissue.

45. A method, comprising:receiving information of an anatomical region of a subject, the anatomical region including bone tissue of the subject;generating a three-dimensional (3D) representation of an implantable device in the anatomical region using the information of the anatomical region and information of the implantable device, the implantable device configured to be positioned adjacent to the bone tissue;applying one or more boundary conditions to one or more bone structures within the anatomical region of the 3D representation;simulating, using the 3D representation, one or more external forces or dynamic and static loads associated with a predefined set of activities to identify one or more stress regions in the implantable device; andAgenf s File Ref. OSNT-OOl / OIWO 361279-2001defining a mechanical structure of the implantable device based on the one or more stress regions.

46. The method of claim 45, wherein the 3D representation is generated based on a plurality of patient-specific information, the patient-specific information including at least one of a bone geometry, a bone morphology, a bone density, a patient height, a patient weight, a patient age, and a patient history.

47. The method of claim 45, wherein the information of the anatomical region includes at least one of a computed tomography (CT) scan, a magnetic resonance imaging (MRI) scan, a dual-energy X-ray absorptiometry (DEXA) scan, a bone mineral density (BMD) scan, or an ultrasound scan.

48. The method of claim 45, wherein information of the anatomical region includes a 3D model of the anatomical region, andgenerating the 3D representation includes meshing the 3D model of the anatomical region.

49. The method of claim 45, further comprising assigning one or more material properties to the one or more bone structures within the anatomical region of the 3D representation.

50. The method of claim 45, further comprising:determining at least one of a muscle activity, a joint force, or a joint torque; refining the one or more external forces or dynamic and static loads associated with a predefined set of activities;refining the one or more stress regions in the implantable device of the 3D representation; andadjusting the mechanical structure of the implantable device based on the one or more refined stress regions.

51. The method of claim 50, wherein determining the muscle activity, the joint force, or the joint torque is based on at least one of a gait analysis, a load bearing analysis, a joint kinematics analysis, or an inverse dynamics modeling.Agent’s File Ref. OSNT-OOl / OIWO 361279-200152. The method of claim 45, further comprising manufacturing the implantable device based on the defined mechanical structure.

53. The method of claim 52, wherein manufacturing the implantable device is performed via at least one of powder bed fusion, binder and sintering, directed energy, solid-state, material jetting, vat photopolymerization, material extrusion, or hybrid manufacturing, electron beam melting (EBM), selective laser melting (SLM), a mold, or additive manufacturing.

54. An apparatus, comprising:a body configured to be implanted near bone tissue at a target site in a subject including a lattice structure, the lattice structure having a plurality of interconnected members that define one or more open spaces, the plurality of interconnected members being interlocked with one another;an antimicrobial element disposed on or integrated into the body; andone or more fixation elements configured to secure a position of the body near the bone tissue and to apply compression or cause the bone tissue to apply compression to the lattice structure.

55. The apparatus of claim 54, wherein the antimicrobial element includes at least one of a reservoir or a coating.

56. The apparatus of claim 54, wherein the body, when implanted and being subjected to the compression, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the lattice structure.

57. An apparatus, comprising:a body configured to be implanted near bone tissue at a target site in a subject, the body including a structure that is formed using three-dimensional printing; andone or more fixation elements configured to secure a position of the body near the bone tissue and to apply compression or cause the bone tissue to apply compression to the lattice structure,the body, when implanted and being subjected to the compression, being configured to generate a microstrain environment that promotes ingrowth of the bone tissue on, in, or through the lattice structure.

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