Multi-piece cranio-maxillofacial implant

Abstract

A multi-piece implant is configured for implantation in a patient and includes a first component and a second component. The first component is made of a first material and includes an inner surface and an outer surface opposite the inner surface. The inner surface includes a recessed surface portion. The second component is made of a second material different from the first material and is sized such that a first portion of the second component is receivable in the recessed surface portion such that it is covered by the first component.

Description

SYKCMF-055MULTI-PIECE CRANIO-MAXILLOFACIAL IMPLANTCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of the filing date of United States Provisional Application No. 63 / 736,729, filed December 20, 2024, the disclosure of which is hereby incorporated by reference herein in its entirety.BACKGROUND

[0002] Cranio-maxillofacial bone deficiencies, whether the result of disease, trauma or other conditions, often call for complex solutions involving multiple implant components. In some instances, such solutions may require multiple surgeries. One challenge has been accounting for the various planned implants together, particularly where an optimal reconstruction involves elongate plates and volume-filling onlay implant components and / or volume-filling bone replacement implant components. To date, cranio-maxillofacial reconstructions that incorporate different implant types have been limited in terms of options for combining the different implant types as part of a single reconstruction. Additionally, such reconstructions have also been cumbersome to implement.

[0003] Accordingly, there is a need for improved implant designs to repair cranio- maxillofacial deficiencies.BRIEF SUMMARY

[0004] In a first aspect, the present disclosure relates to an implant configured for placement on a bone of a patient. The bone may be one or more bones in a cranio-maxillofacial region of a skull of the patient.

[0005] In a first embodiment of the first aspect, an implant configured for placement onto a bone includes a first component, a second component and a third component. In a first example of the first embodiment, the first component is made of a first material and includes a first inner surface and a first outer surface opposite the first inner surface. The first outer surface of the first component is contoured to emulate a cortical bone surface, and at least one of the first inner surface and the first outer surface includes a first recessed surface portion. The second component is made of the first material and includes a second inner surface and a second outer surface opposite the second inner surface. The second outer surface of the second component is contoured to emulate a cortical bone surface. When the first inner surface includes the first recessed surface portion, the second inner surface includes a second recessed surface portion and when the first outer surface includes the first recessed surface portion, theSYKCMF-055 second outer surface includes the second recessed surface portion. The third component is made of a second material different from the first material and includes a first portion and a second portion, at least one of the first portion and the second portion including a fastener opening therethrough. The first portion of the third component is received on the first recessed surface portion and the second portion of the third component is received on the second recessed surface portion.

[0006] In a second example of the first embodiment, the implant of the first example may be configured such that the first material is polyether ether ketone or poly(methyl methacrylate). The first component may include the first material continuously through a thickness dimension of the component from the first inner surface to the first outer surface. In a subset of these examples, the first and second components may be contoured components as described throughout the present disclosure. In a third example, the implant of the first or second examples may be configured such that the second material is a metallic material. In a subset of these examples, the third component may be a plate as described throughout the present disclosure. In a fourth example, the implant of the third example may be configured such that the third component includes a plurality of fastener openings spaced apart along a length of the third component, the fastener opening being one of the plurality of fastener openings. In a fifth example, the implant of the fourth example may be configured such that the first component has a variable thickness over an entire surface area of the first component and the third component has a first maximum thickness in a ring-shaped portion surrounding each fastener opening of the plurality of fastener openings.

[0007] In a sixth example of the first embodiment, the implant of any one of the first through fifth examples may be configured such that the first component includes a first curved outer edge shaped to complement a second curved outer edge of the second component such that the first component and the second component are flush with each other in an implanted configuration. In a seventh example, the implant of any one of the first through sixth examples may be configured such that the first component includes a third recessed surface portion spaced apart from the first recessed portion, the third recessed surface portion being configured to receive a fourth component made of the second material. In an eighth example, the implant of any one of the first through seventh examples may be configured such that a first end of the third component overlies the first component and a second end of the third component opposite the first end overlies the second component. In a ninth example, the implant of the eighthSYKCMF-055 example may be configured such that when the first, second and third components are implanted in a patient, the first end of the third component is covered by the first component and the second end of the third component is covered by the second component. In a tenth example, the implant of the ninth example may be configured such that the first component includes a third recessed surface portion on the first outer surface of the first component.

[0008] In an eleventh example of the first embodiment, the implant of any one of the first through tenth examples may be configured such that the first component includes a first interfacing surface and the second component includes a second interfacing surface that complements the first interfacing surface such that the first and second components fit together. In a twelfth example, the implant of the eleventh example may be configured such that when the first and second components are joined at the respective first and second interfacing surfaces, the first recessed surface portion is continuous with the second recessed surface portion. In a thirteenth example, the implant of any one of the first through sixth examples may include a fourth component made of the first material. The fourth component may include a third inner surface and a third outer surface opposite the third inner surface, the third outer surface of the fourth component being contoured to emulate a cortical bone surface. The fourth component may also include a third recessed surface portion on the third outer surface. The third component is configured to be received on the first, second and third recessed surface portions. In a fourteenth example, the implant of the thirteenth example may be configured such that the third component includes a closed loop bar. The closed loop bar may include a plurality of fastener openings spaced apart along its length such that at least one fastener opening from among the plurality of fastener openings is positioned over each of the first, second and third recessed surface portions.

[0009] In a second embodiment of the first aspect, an implant of a first example is configured for placement on bone and includes a first component and a second component. The first component is made of a first material and includes an inner surface and an outer surface opposite the inner surface, the inner surface including a recessed surface portion. The second component is made of a second material different from the first material and is sized such that a first portion of the second component is receivable in the recessed surface portion. The first portion of the second component is received in the recessed surface portion and is covered by the first component. Coverage of the first portion of the second component by theSYKCMF-055 first component may occur when the first component is anchored to bone and the second component is at least partially overlaid on the first component.

[0010] In a second example of the second embodiment, the implant of the first example may be configured such that the second component includes a fastener opening configured to receive a fastener to fix the second component to a bone. In a third example, the implant of the second example may be configured such that the second component includes a plurality of fastener openings spaced apart along a length of the second component, the fastener opening being one of the plurality of fastener openings. In a fourth example, the implant of the third example may be configured such that the first component has a variable thickness over an entire surface area of the first component and the second component has a first maximum thickness in a ring-shaped portion surrounding each fastener opening of the plurality of fastener openings. In a fifth example, the implant of the second example may be configured such that when the first component and the second component are implanted in the patient, the fastener opening of the second component is covered by the first component. In a sixth example, the implant of any one of the first through fifth examples may be configured such that when the first component and the second component are implanted in the patient, a second portion of the second component is outside of a periphery of the first component. In a seventh example, the implant of any one of the first through sixth examples may be configured such that the first material is poly ether ether ketone or poly (methyl methacrylate). In an eighth example, the implant of any one of the first through seventh examples may be configured such that the second material is a metallic material.

[0011] In a third embodiment, an implant of a first example is configured for placement onto a bone and includes first, second third and fourth components. The first component is made of a first material and includes a first inner surface and a first outer surface opposite the first inner surface, the first outer surface of the first component being contoured to emulate a cortical bone surface and including a first recessed surface portion. The second component is made of the first material and includes a second inner surface and a second outer surface opposite the second inner surface, the second outer surface of the second component being contoured to emulate a cortical bone surface and including a second recessed surface portion. The third component is made of the first material and includes a third inner surface and a third outer surface opposite the third inner surface, the third outer surface of the third component being contoured to emulate a cortical bone surface and including a third recessed surfaceSYKCMF-055 portion. And, the fourth component is made of a second material different from the first material. The fourth component includes a first portion, a second portion and a third portion, each of the first, second and third portions including a fastener opening therethrough. As assembled, the first portion is received on the first recessed surface portion, the second portion is received on the second recessed surface portion, and the third portion is received on the third recessed portion.

[0012] In a second example of the third embodiment, the implant of the first example may be configured such that the fourth component includes a closed loop bar with a plurality of fastener openings spaced apart along its length such that at least one fastener opening from among the plurality of fastener openings is positioned over each of the first, second and third recessed surface portions. In a third example, the implant of the first or second examples may be configured such that each of the first, second and third components includes a side surface shaped to complement a respective side surface on at least one of the other components from among the first, second and third components.

[0013] In a fourth embodiment, an implant is a cranio-maxillofacial implant, and, in a first example, includes a first component and a second component. The first component is configured to reconstruct at least part of one or more of a maxillary bone, a zygomatic bone and a frontal bone of a patient and is made of a first material. The first component includes a first recessed surface portion thereon. The second component is configured to reconstruct an orbital cavity of the patient. A portion of the second component is received on the first recessed surface portion when the respective components are implanted in a patient.

[0014] In a second example of the fourth embodiment, the implant of the first example may be configured such that the second component includes a surface region with a plurality of openings defining a mesh. In a third example, the implant of the first or second example may be configured such that the first component includes a second recessed surface portion entirely spaced apart from the first recessed surface portion, the second recessed surface portion being shaped to receive an elongate bone plate. In a fourth example, the implant of any one of the first through third examples may be configured such that the first material is a polymeric material and an outer surface of the first component is shaped to emulate a bone surface of the patient. In a fifth example, the implant of any one of the first through fourth examples may be configured such that the first component has a variable thickness over an entire surface area of the first component and the second component has a constant thickness over an entire surfaceSYKCMF-055 area of the second component. In a sixth example, the implant of any one of the first through fourth examples may be configured such that the second component has a variable thickness. Specifically, a thickness of the second component may be different at different locations on an outer surface of the second component. In a seventh example, the implant of any one of the first through sixth examples may be configured such that the second component is made of a second material different from the first material. In an eighth example, the implant of the seventh example may be configured such that the second material is a metallic material. In a ninth example, the implant of any one of the first through sixth examples may be configured such that the second component is made of the first material.

[0015] In a fifth embodiment, an implant is a cranio-maxillofacial implant, and, in a first example, includes a first component and a second component. The first component is configured to reconstruct at least part of one or more of a maxilla bone, a zygomatic bone and a cranial bone and is made of a first material. The first component includes a first outer surface contoured to emulate a first cortical bone surface and a first inner surface opposite the first outer surface, at least one of the first outer surface and the first inner surface including a first recessed surface portion thereon. The second component is configured to reconstruct an orbital cavity or a cranial bone and is made of a second material different from the first material. The second component includes a second outer surface contoured to emulate a second cortical bone surface. A portion of the second component is received on the first recessed surface portion when the respective components are implanted in a patient.

[0016] In a second example of the fifth embodiment, the implant of the first example may be configured such that the first recessed surface portion and the portion of the second component emulate a single cortical bone surface area. In a third example, the implant of the first or second example may be configured such that the second component includes an outer peripheral shape with a contour that corresponds to a surface area for bone reconstruction. In a fourth example, the implant of the third example may be configured such that the second component has a varying width along an elongate dimension of the second component. In a fifth example, the implant of any one of the first through fourth examples may be configured such that the second component defines a plurality of first openings and a second opening, the plurality of first openings forming a pattern and being sized to promote bone ingrowth, the second opening being configured to receive a fastener.SYKCMF-055

[0017] In a second aspect, the present disclosure relates to a method of reconstructing a cranio-maxillofacial bone structure of a patient. In a first example of a first embodiment of the method, the method includes: processing an image of a pre- surgical cranio-maxillofacial bone structure of the patient to generate a virtual anatomical model of the cranio-maxillofacial bone structure; virtually generating a shape of a first implant component based on the virtual anatomical model, the first implant component defined as being made of a first material; and virtually generating a shape of a second implant component, the second implant component defined as being made of a second material different from the first material and including a portion configured to be received on a recessed surface portion of the first implant component, wherein the first implant component is configured to be positioned over the second implant component when implanted in the patient.

[0018] In a second example of the first embodiment of the method, the method of the first example may include: virtually generating a post-surgical cranio-maxillofacial bone structure of the patient including at least a removal or a repositioning of a bone fragment of the patient based on the image; and modifying the pre-surgical cranio-maxillofacial bone structure to arrive at a post-surgical cranio-maxillofacial bone structure based on the removal or repositioning of the bone fragment. In a third example, the method of the second example may be performed such that the modification of the pre-surgical cranio-maxillofacial bone structure to arrive at the post-surgical cranio-maxillofacial bone structure and the implantation of the first and second implant components are performed in a single surgical procedure. In a fourth example, the method of any one of the first through third examples may include fabricating the first implant component and the second implant component prior to accessing the patient to implant the first and second implants. In a fifth example, the method of the fourth example may include implanting the second implant component on a bone surface of the patient; and implanting the first component at least partially over the second component. In a sixth example, the method of the fifth example may be performed such that implanting the first component includes positioning the recessed surface portion directly over the portion of the second component.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present disclosure will become more fully understood from the detailed description and accompanying drawings, wherein:SYKCMF-055

[0020] FIG. 1 is a perspective view of a multi-piece cranial implant according to one embodiment of the present disclosure;

[0021] FIG. 2 is a first close-up view of a first edge portion of the multi-piece cranial implant of FIG. 1 ;

[0022] FIG. 3 is a second close-up view of a second edge portion of the multi-piece cranial implant of FIG. 1 ;

[0023] FIG. 4 is a perspective view of an implant system according to one embodiment of the present disclosure;

[0024] FIG. 5 is a perspective view of portions of the implant system shown in FIG. 4;

[0025] FIGs. 6-7 are perspective views of components of a multi-piece implant of the implant system of FIG. 4;

[0026] FIG. 8 is a side cross-sectional view of interacting portions of the multi-piece implant of FIGs. 6-7;

[0027] FIGs. 9-11 are perspective views of a component of the implant system of FIG. 4;

[0028] FIG. 12 is a front view of an implant system according to one embodiment of the present disclosure;

[0029] FIGs. 13-20 are close-up views of components of the implant system of FIG. 12;

[0030] FIG. 21 is a front view of an implant system according to one embodiment of the present disclosure;

[0031] FIGs. 22-24 are close-up views of components of the implant system of FIG. 21;

[0032] FIGs. 25A-B, 26A-B and 27A-B are sets of respective front and sectional views of components of the implant system of FIG. 21;

[0033] FIG. 28.1-28.51 are top views of plates according to various embodiments of the present disclosure;

[0034] FIG. 29 is a flow chart of a method of assembling and fabricating a multi-piece implant or implant system; and

[0035] FIG. 30 is a flow chart of a method of implanting a multi-piece implant or implant system.SYKCMF-055DETAILED DESCRIPTION

[0036] As used herein in reference to an implant or implant component, e.g., contoured component sized for placement on a maxillary bone, the term “superior” refers to a portion of the implant nearer a patient’s head while the term “inferior” refers to a portion of the implant nearer the patient’s feet when the implant is implanted in an intended position and orientation in the body of the patient. As with the terms “superior” and “inferior,” the term “anterior” refers to a portion of the implant nearer the front of the patient, the term “posterior” refers to a portion of the implant nearer the rear of the patient, the term “medial” refers to a portion of the implant nearer the mid- line of the patient, and the term “lateral” refers to a portion of the implant farther away from the mid-line of the patient. Additionally, as used herein, the terms “about,” “approximately,” “generally,” and “substantially” are intended to mean that slight deviations from absolute are included within the scope of the term so modified.

[0037] In one aspect, the present disclosure relates to a multi-piece implant. Such multi-piece implants may be configured to be used on various parts of the human skull, particularly in cranial and maxillo-facial regions of the skull. In one embodiment, a multipiece implant 5 is shown on skull 3 in FIG. 1. Multi-piece implant 5 includes a first contoured component 11, a second contoured component 31, a third contoured component 51, a first plate 81, a second plate 85, a third plate 91 and a fourth plate 95. Each contoured component is shaped to emulate a bone surface, e.g., a cortical bone surface through augmentation, replacement or both, and includes outer bounds intended to abut another contoured component or an edge of the implant recipient’ s bone that will remain after resection in preparation for receipt of the implant. Each plate may be used either to join contoured components or to join a contoured component with existing bone of the implant recipient, i.e. patient. In some variations, a plate may join two or more contoured components and existing bone.

[0038] Each of the first, second and third contoured components 11, 31, 51 includes a respective outer surface 13, 33, 53 that is shaped to emulate an outer cranial surface. Further, as noted above, an outer periphery of each contoured component is shaped to be complementary to an adjacent contoured component or a bone surface that is resected in preparation for receipt of the contoured component. Such resected bone surfaces define a periphery for receipt of the implant and are part of the cranium 3 A (e.g., frontal bone, parietal bone, occipital bone and / or temporal bone) of patient skull 3. Further, each contoured component 11, 31, 51 includes one or more recessed surface portions. A footprint of eachSYKCMF-055 recessed surface portion may have a generally rectangular shape, although variations may have other shapes. As visible in FIGs. 1 and 2, first contoured component 11 includes first, second and third recessed surface portions 16, 17, 18, second contoured component 31 includes fourth and fifth recessed surface portions 36, 37 and third contoured component 51 includes sixth and seventh recessed surface portions 56, 57. Side surfaces of the contoured components (not shown) may include an interfacing surface such as the stepped- surface shown in FIG. 8 for interlocking with a complementary interfacing surface on an adjacent contoured component. In some examples, an interfacing surface may be as described in U.S. Pat. No. 9,968,455 (hereinafter the “’455 Patent”), the disclosure of which is hereby incorporated by reference herein in its entirety. In further examples, other interconnection features are also contemplated. Each contoured component may have a thickness suitable for use as a cranial bone replacement. As to materials, in some examples, the contoured components may be made of polymeric materials, such as polyether-ether keytone (“PEEK”) or poly(methyl methacrylate) (“PMMA”). Optionally, and as shown in FIG. 1, one or more of the contoured components may include a plurality of pores (e.g., pore 61 A in FIG. 2) therethrough. Pores, where included, may be distributed partially or fully over a contoured component surface up to and including all contoured components of a given implant. In some examples, pores may be arranged in a pattern. In a subset of these examples, pores may be included in pairs distributed at specific locations on a contoured component. Pores may be used to secure, e.g., sew the dura firmly in place on the patient. And, pores may also be configured to facilitate the receipt of allograft onto or through the implant as part of the implantation process. Pores may similarly be configured to facilitate the receipt of fluid through the implant.

[0039] As to the plates, each plate 81, 85, 91, 95 has a generally square or rectangular outer shape with a central opening, as shown in FIG. 1. Further, the plates include openings at the respective comers configured for receiving fasteners. In other examples, the plates may have other shapes, such as an oblong or ovular shape. First plate 81 is positioned on first recessed surface portion 16 and on a portion of the cranial bone. Second plate 85 is positioned on second and fourth recessed surface portions 17, 36 to bridge first and second contoured components 11, 31. Third plate 91 is positioned in third, fifth and sixth recessed surface portions 18, 37, 56 to bridge first, second and third contoured components 11, 31, 51. Fourth plate 95 is positioned on seventh recessed surface portion 57 and on a portion of the cranialSYKCMF-055 bone. In variations, any one of the plates may be positioned on any one of the recessed surface portions. Each plate may be made of metallic materials such as stainless steel or titanium.

[0040] Multi-piece implant 5 may also be configured to receive fasteners, such as fastener 61 shown in FIG. 3. In some examples, Contoured components 11, 31, 51 of multipiece implant 5 may include pre-formed openings to receive fasteners. Thus, for instance, contoured component 51 may include a preformed opening where fastener 61 is received. In other examples, a material of contoured components allows for fasteners to be driven directly through the material of such contoured components.

[0041] Multi-piece implant 5 may be varied in many ways. With continued reference to cranial applications, the contoured components of the multi-piece implant may have shapes different from that shown in FIG. 1. In some examples, recessed surface portions may be located at different positions on the contoured components from those shown. In some examples, a size and / or depth of one or more of the recessed surface portions may vary from that shown. For instance, the recessed surface portions may have a square, partially circular or ovular footprint. In some examples, the total number of recessed surface portions may vary from that shown. And, in some examples, the multi-piece implant may include four or more contoured components. Further, in a variation, a cranial implant may include a single contoured component. And, in some examples of such variation, the single contoured component may include one or more recessed surface portions such as that shown in FIG. 2. Additionally, the features described above and applied to cranial implant applications may also be utilized for other facial applications, such as those on the maxillary bone, mandibular bone, zygomatic bone, and so on.

[0042] In other embodiments, a multi-piece implant may be multi-piece implant 105 or multi-piece implant 106, as shown in FIG. 4. As depicted in FIG. 4, each multi-piece implant 105, 106 is part of a larger implant system 101, described in greater detail elsewhere in the present disclosure. It should be appreciated that each of multi-piece implant 105 and multipiece implant 106 may be a standalone implant or may be utilized together on a single patient as part of an implant system.

[0043] With reference to multi-piece implant 105, certain components of multi-piece implant 105, shown assembled in FIG. 4, are also shown in FIGs. 5 and 9-11. Multi-piece implant 105 includes contoured component 111, and first, second and third plates 175, 177, 181. As shown in FIG. 4, first and second plates 175, 177 are configured to be received on aSYKCMF-055 bone-facing surface of contoured component 111 when implanted in a patient, while third plate 181 is configured to be received on an outer surface of contoured component 111. Contoured component 111 is shaped to fit outside of an orbit, here, a left orbit, on portions of the maxillary bone 103C and the left zygomatic bone 103B of the patient skull 103. Outer edges of contoured component 111 are curved, are shaped to follow contours of the bone, and are sized based on the nature of the bone reconstruction. Contoured component 111 as depicted is intended for use as an overlay on the patient bone, but may also partially or fully replace portions of bone. For example, if the zygomatic bone of the patient is fractured into many small pieces such that full removal of such pieces is required, then the contoured component may function as a partial bone replacement. In other examples, if some fractured bone is salvageable, then such bone may be reconstructed, fixed with one or more plates, and then contoured components may be used to cover gaps in the reconstructed bone structure or otherwise augment the bone surface.

[0044] In the depicted embodiment, and with reference to FIGs. 9-11, an outer surface 113 of first contoured component 111 is shaped to emulate a natural bone surface at least to some degree. Determination of a surface contour of outer surface 113 may be through mirroring of an opposite side of the face of the patient where the relevant bone on such opposite side is healthy. In other examples, including circumstances where both sides require reconstruction, contoured components may be used on both sides of the face to achieve symmetry. In a subset of these examples, specific contours may be based on a desired aesthetic, e.g., masculine or feminine, or based on reproducing an original surface contour of the patient. Additional techniques on arriving at an implant shape and surface contour are described elsewhere in the present disclosure.

[0045] Outer surface 113, shown in FIG. 10, includes a recessed surface portion 118 on lateral side of the component. An outer perimeter of the recessed surface portion 118 may complement a shape of a plate to be positioned onto outer surface 113 of first contoured component 111. In the depicted embodiment, the perimeter of recessed surface portion 118 includes a series of repeating curves to define overlapping circles, as shown in FIG. 10. In other examples, recessed surface portion 118 may have an elongate shape with a constant width or any other shape. A depth of recessed surface portion 118 may be shallow relative to an overall depth of contoured component 111 where an expected plate to be applied, e.g., third plate 181, is sufficiently shallow in depth such that when third plate 181 is applied to recessedSYKCMF-055 surface portion 118, third plate 181 does not stand proud of outer surface 113 or an extent to which third plate 181 stands proud of outer surface 113 is minimized.

[0046] Opposite outer surface 113 is bone-facing surface 114, shown in FIG. 11. On bone-facing surface 114 are first inner recessed surface portion 116A, 116B and second inner recessed surface portion 117. First inner recessed surface portion includes a first subportion 116A and a second subportion 116B. In the depicted embodiment, each subportion 116A, 116B follows the same alignment path, and an outer edge of the respective subportions 116A, 116B defines a portion of an arc. Due to the position of first inner recessed surface portion 116 A, 116B on a periphery of bone-facing surface 114, a width of first inner recessed surface portion 116A, 116B varies along its length. Second inner recessed surface portion 117 is spaced apart from first inner recessed surface portion 116A, 116B and has a generally constant width along most of its length, while its respective edges define an arc. Similar to recessed surface portion 118, a depth of first and second inner recessed surface portions 116A, 116B, 117 may be suited to receive plates so that such plates do not lift contoured component 111 off an implantation surface, i.e., bone surface of the patient. In the depicted embodiment, first inner recessed surface portion 116A, 116B are shaped and sized to receive second plate 177 and second inner recessed surface portion 117 is shaped and sized to receive first plate 175.

[0047] Additionally, contoured component 111 includes openings 122A, 122B. These openings may be sized and configured to receive fasteners to anchor, or aid in anchoring, contoured component 111 to underlying bone. In some examples, contoured component 111 may also include three or more openings, as described in greater detail elsewhere in the present disclosure.

[0048] For multi-piece implant 105, first, second and third plates 175, 177, 181 shown in FIG. 4 may all have a similarly patterned structure. In the embodiment as depicted, each plate includes a single row of spaced apart fastener openings along its length. Outer edges of the plates are defined by a series of repeating convex curves that may be characterized as being ring-shaped, each following a perimeter of a respective fastener opening. In some examples, the plates may have a maximum thickness within the ring-shaped portions of the plate. To accommodate a planned reconstruction of the applicable facial bone, each plate may have a different length. Further, each plate may be curved in multiple directions, e.g., in three dimensions to follow a surface shape of the bone and an intended anatomical placement. Further variations on the plates that may be included are described elsewhere in the presentSYKCMF-055 disclosure. For purposes of implantation, first and second plates 175, 177 are positionable onto a bone surface first, followed by contoured component 111, then third plate 181 over contoured component 111. Specifically, placement of contoured component 111 onto the bone is not interrupted by first and second plates 175, 177 as inner recessed surface portion 117 fits over first plate 175 and subportions 116A, 116B of first inner recessed surface portion fit over second plate 177. One advantage of having recessed surface portions 116A-B, 117 on bonefacing surface 114 of contoured component 111 is that contoured component 111 may easily fit over a plate or plates already affixed to the bone, in this instance, plates 175, 177. Such arrangement allows for the use of the plates to reconstruct and otherwise fix the patient’s bone structure, while at the same time providing a smooth outer contour rather than sharper steps defined by the plates. In the depicted arrangement, third plate 181 includes a first end portion 182A that is positioned on contoured component 111 and a second end portion 182B that is positioned on a bone surface. Inclusion of third plate 181 on outer surface 113 of contoured component provides fixation of contoured component 111 to the bone of the patient, and with placement of third plate 181 on a recessed surface portion of contoured component 111, protrusion of third plate 181 relative to outer surface 113 may be eliminated or greatly reduced, thereby improving the smoothness of the finished surface. Additional features of first, second and third plates 175, 177, 181 may be as described in U.S. Pat. No. 10,610,299 (the ‘“299 Patent”), the disclosure of which is hereby incorporated by reference herein in its entirety.

[0049] Turning now to multi-piece implant 106, such implant is shown assembled in FIG. 4. Certain components of multi-piece implant 106 are also shown in FIGs. 5-8. Multipiece implant 106 includes first contoured component 131, second contoured component 151, and first, second, third and fourth plates 185, 191, 195, 199. One advantage of multi-piece implant 106 having two separate contoured components is that such configuration reduces the space necessary to access a target site within the patient compared to a procedure where the two contoured components are formed as a single contoured component, thereby allowing for a more minimally invasive procedure. As shown in FIG. 4, each of the four plates of multipiece implant 106 is configured to be positioned on an outer surface of one or both of first contoured component 131 and second contoured component 151. Put another way, each of the four plates may be overlaid on at least part of a contoured component. As described throughout the present disclosure, implants may be configured so that plates may be overlaid on an outerSYKCMF-055 surface of a contoured component and in other cases may be overlaid on a bone-facing side of a contoured component.

[0050] First contoured component 131 is shown in isolation in FIG. 6 and includes an outer surface 133 opposite a bone-facing surface (not shown) and an interfacing surface 135 shaped to fit against a complementary interfacing surface on second contoured component 151. First contoured component 131 is shaped to be positioned outside of a right orbit of a patient and to cover portions of the right zygomatic bone 103D and maxillary bone 103C. Outer surface 133 includes a series of recessed surface portions, specifically, first recessed surface portion 136, second recessed surface portion 137 and third recessed surface portion 138. Each recessed surface portion 136, 137, 138 is sized to complement a plate. Recessed surface portions and plates configured to be received on such recessed surface portions may be the same as those for multi-piece implant 105 and may vary in the same ways as described for multi-piece implant 105. As shown in FIG. 6, each recessed surface portion 136, 137, 138 is spaced apart from the others, with first recessed surface portion 136 extending from interfacing surface 135 to an interior location on outer surface 133, and second and third recessed surface portions 137, 138 extending from an outer periphery of contoured component 131 toward an interior location on outer surface 133.

[0051] Second contoured component 151 is shown in isolation in FIG. 7 and includes an outer surface 153 opposite a bone-facing surface (not shown), and an interfacing surface 155 shaped to fit against complementary interfacing surface 135 on first contoured component 131. Second contoured component 151 is shaped to be positioned outside of a right orbit of a patient and to cover portions of at least one of a right zygomatic bone and a maxillary bone. Outer surface 153 includes a series of recessed surface portions, specifically, fourth recessed surface portion 156 and fifth recessed surface portion 158. Each recessed surface portion 156, 158 is sized to complement a plate. Recessed surface portions and plates configured to be received on such recessed surface portions may be the same as those for multi-piece implant 105 and may vary in the same ways as described for multi-piece implant 105. As shown in FIG. 7, fourth and fifth recessed surface portions 156, 158 are spaced apart from each other, with fourth recessed surface portion 156 extending from interfacing surface 155 to an interior location on outer surface 153, and fifth recessed surface portion 158 extending from an outer periphery of second contoured component 151 toward an interior location on outer surface 153. In some variations, one or both of first and second contoured components 131 and 151 maySYKCMF-055 replace part or all of a bone. In other variations, and as referenced above, first and second contoured components 131, 151 may augment the bone and function as an overlay. In some examples, a thickness of first and second contoured components 131, 151 may be variable.

[0052] As stated above, interface surfaces on respective first and second contoured components 131, 151 are shaped to have complementary shapes so that a close fit is obtained when the two contoured components are combined (i.e., joined), as shown in FIG. 5. In some examples, and as shown in FIG. 5, adjacent outer surfaces of the first and second contoured components are flush with each other in an implanted configuration. In one example, the respective interfacing surfaces may have features as shown in FIG. 8. Specifically, interfacing surface 135 may include a lip portion 135 A that protrudes relative to a base portion 135B, while interfacing surface 155 may include a recessed portion 155 A that is recessed relative to a base portion 155B. As shown in FIG. 8, the respective surfaces on each contoured component 131, 151 may be sized to complement each other for a close fit. In some examples, including multipiece implant 106, the interfacing surfaces may be curved along part or all of their respective lengths. Such curvature may be in two or three dimensions. Variations on the interfacing surfaces shown in FIG. 8 are also contemplated. For example, interfacing surfaces of the contoured components may be as described in the ‘455 Patent. When interfacing surfaces 135,155 are combined as shown in FIG. 5, for example, respective recessed surface portions 136,156 form a continuous recessed surface portion that may receive a single plate. For example, as shown in FIG. 4, second plate 191 may be received in such combined recessed surface portion. Inclusion of a plate such as second plate 191 to bridge together two contoured components configured to abut each other, such as first and second contoured components 131, 151, provides additional fixation to eliminate relative movement or shifting between such contoured components post-implantation.

[0053] In any of the contemplated variations, a depth of contoured components 111, 131, 151 may vary at different locations along their respective outer surfaces. Such depth may generally be dictated by the condition of the existing bone and plan for reconstruction.

[0054] In other embodiments, a multi-piece implant may be multi-piece implant 205 or multi-piece implant 206, as shown in FIG. 12. Unless otherwise indicated, details of the recessed surface portions in the contoured components and details of the plates for multi-piece implants 205, 206 may be the same as described for multi-piece implants 105, 106. As depicted in FIG. 12, each multi-piece implant 205, 206 is part of a larger implant system 201, describedSYKCMF-055 in greater detail elsewhere in the present disclosure. It should be appreciated that each of multipiece implant 205 and multi-piece implant 206 may be a standalone implant or may be utilized together on a single patient as part of an implant system.

[0055] With reference to multi-piece implant 205, certain components of multi-piece implant 205, shown assembled in FIG. 12, are also shown in FIGs. 13-14 and 17-18. Multipiece implant 205 includes first contoured component 211 (positioned in part on left zygomatic bone 203B in FIG. 12), second contoured component 231 (positioned in part on right zygomatic bone 203D in FIG. 12) and plate 281. In FIG. 12, first and second contoured components 211, 231 are shown as transparent so that a position of plate 281 underneath is visible. As shown in FIG. 12, portions of plate 281 are configured to be positioned on bone of the patient so that first and second contoured components 211, 231 are received on top of plate 281.

[0056] First contoured component 211 is shown in isolation in FIGs. 13 and 17 and includes an outer surface 213 and a bone facing surface opposite the outer surface. First contoured component is shaped for positioning generally over the maxillary bone 203C of the patient skull 203 between the nasal bone and the ramus of the mandible. With specific reference to FIG. 13, which shows first contoured component 211 as transparent, the bonefacing surface includes a first inner recessed surface portion 216 and a second inner recessed surface portion 217 separate from the first inner recessed surface. In an implanted configuration, the respective inner recessed surfaces extend in a superior direction from an inferior edge 226 of first contoured component but terminate at a location inferior to superior edge 227. Each inner recessed surface portion 216, 217 may be accompanied by a respective notch 224A, 224B along inferior edge 226. The inclusion of such notches may render it easier to position contoured component 211 over plate 281 during use. First contoured component 211 may also include openings to receive fasteners. As depicted, first contoured component 211 includes openings 222A, 222B for such purpose, though it is envisioned that such openings may vary in location, size and quantity to suit a specific surgical procedure.

[0057] Second contoured component 231 of multi-piece implant 205, shown in isolation in FIGs. 14 and 18, generally mirrors first contoured component 211, with first contoured component 211 being shaped for placement on a left side of the maxilla and second contoured component 231 being shaped for placement on a right side of the maxilla. In FIG. 14, second contoured component 231 is shown as transparent with third inner recessed surface portion 236 and fourth inner recessed surface portion 237 visible. As with first contouredSYKCMF-055 component 211, each of third and fourth inner recessed surface portions 236, 237 extend from inferior edge 246 toward superior edge 247, but terminate inferior to the superior edge 247. Second contoured component 231 may include notches 244A, 244B and openings 242A, 242B in a similar manner to first contoured component 211.

[0058] For both first and second contoured components 211, 231, a shape and depth of the inner recessed surface portions 216, 217, 236, 237 may be as described for multi-piece implants 105, 106, and contemplated variants thereof.

[0059] Plate 281 includes a base bar 282 that is sized to extend across a significant portion of a width of multi-piece implant 205, along with first through fourth arms 283, 284, 285, 286 that extend on one side of base bar 282. In an implanted configuration, each arm 283, 284, 285, 286 extends in a superior direction from base bar 282, as shown in FIG. 12. Each part of plate 281, including base bar 282 and arms 283-286 is defined by a bar with spaced apart fastener openings. A width of the bar may vary along its length such that proximate fastener openings, the plate is wider. In the depicted embodiment, arms 283-286 of plate 281 are positioned on the maxillary bone 203C so that first contoured component 211 is receivable over first arm 283 and second arm 284 and second contoured component 231 is receivable over third arm 285 and fourth arm 286. In each case, an inner recessed surface portion of a contoured component is received over a respective arm, and as such, the arms of plate 281 do not interfere with the placement of first and second contoured components 211, 231 onto the bone surface. Specifically, first inner recessed surface portion 216 is received over second arm 284, second inner recessed surface portion 217 is received over first arm 283, third inner recessed surface portion 236 is received over fourth arm 286 and fourth inner recessed surface portion 237 is received over third arm 285. Similar to multi-piece implants 105, 106, inner recessed surface portions of first and second contoured components 211, 231 may have a depth to negate or greatly minimize a gap between bone-facing surface of contoured components and bone when contoured components are placed over plate 281.

[0060] Turning now to multi-piece implant 206, such implant is shown in FIG. 12 with subcomponents shown in isolation in FIGs. 16 and 20. Multi-piece implant 206 includes contoured component 271 and plate 291. Contoured component 271 is shaped for and configured to be placed on a chin of the patient. Contoured component 271 includes openings 272 A, 272B for receipt of fasteners and, in a central region of a bone-facing surface of contoured component 271, includes an inner recessed surface portion 276, as shown in FIG.SYKCMF-05512. Contoured component 271 also includes notches 274A, 274B adjacent to inner recessed surface portion 276. Plate 291 is an enclosed bar with a generally rectangular shape, as shown in FIG. 12 and may also be referred to as a closed loop bar. A single row of openings is included on respective elongate sides 292A, 292B of plate 291. Inner recessed surface portion 276 is shaped and has a depth so that it may be received on plate 291 when plate 291 is attached to mandibular bone 203E. In the depicted arrangement, contoured component 271 may entirely overlap with a long dimension of elongate side 292B when placed thereon.

[0061] In any of the contemplated variations, a depth of contoured components 211, 231, 251, 271 may vary at different locations along their respective outer surfaces 213, 233, 253, 273. Such depth may generally be dictated by the condition of the existing bone and plan for reconstruction.

[0062] In another embodiment, a multi-piece implant may be multi-piece implant 305 shown in FIG. 21. Certain components of multi-piece implant 305 are also shown in FIGs. 22- 24 and 25A-27B. Unless otherwise indicated, details of the recessed surface portions in the contoured components and details of the plates for multi-piece implant 305 may be the same as described for multi-piece implants 105, 106. Multi-piece implant 305 includes contoured component 311, first plate 361, second plate 371 and orbital plate 381. Contoured component 311 is shaped to augment (i.e., as an overlay), replace and / or fill a volume around a left orbit of the patient skull 303 including portions of the left zygomatic bone 303B and maxillary bone 303C, as shown in FIGs. 21-22, for example. First and second plates 361, 371 and orbital plate 381 are configured to be positioned over contoured component 311 in an implanted configuration.

[0063] Contoured component 311, shown with orbital plate 381 in FIGs. 22-24 and 25A-27B, includes an outer surface 313 shaped to emulate portions of the maxillary bone 303C and left zygomatic bone 303B that is augments or replaces. Contoured component 311 is also shaped to extend into an orbital cavity surface 303G within the left orbital cavity as shown in FIGs. 22 and 24. In the depicted configuration, outer surface 313 includes a first recessed surface portion 316, a second recessed surface portion 317 and a third recessed surface portion 318. Each of first and second recessed surface portions 316, 317 have a peripheral shape and depth to receive a portion of an elongate plate, while third recessed surface portion 318 has a shape to accommodate receipt of orbital plate 381. Each recessed surface portion is spaced apart from the others, with third recessed surface portion 318 being in between and spacedSYKCMF-055 apart from first and second recessed surface portions 316, 317. A depth of contoured component 311 may vary at different locations along its outer surface 313, and its magnitude generally may be dictated by the condition of the existing bone and plan for reconstruction, as described in greater detail elsewhere in the present disclosure.

[0064] For multi-piece implant 305, first and second plates 361, 371 shown in FIG. 21 may both have a similarly patterned structure, i.e., elongate in shape with a single row of fastener openings along its length. As with the plates depicted in FIGs. 4 and 12, outer edges of first and second plates 361, 371 are defined by a series of repeating convex curves, each following a perimeter of a respective fastener opening. To accommodate a planned reconstruction of the applicable facial bone, each plate may have a different length. Further, each plate may be curved in multiple directions, i.e. three-dimensionally to follow a surface shape of the bone and an intended anatomical placement. In the depicted embodiment, first plate 361 is shaped to be positioned around a periphery of the left orbit of the patient along an upper portion of left zygomatic bone 303B and onto part of cranium 303A, while second plate 371 is shaped to be positioned around the periphery of the left orbit from the left zygomatic bone 303B, into the maxillary bone 303C and toward the nasal bone.

[0065] Orbital plate 381 is shaped to cover a portion of a surface area on orbital cavity surface 303G, as shown in FIGs. 22-24. As depicted, a portion of orbital plate 381 has a plurality of openings to define a mesh, though the inclusion of such plurality of openings is optional. In different examples, a proportion of orbital plate 381 with the mesh may be greater or less than that shown in FIGs. 22-24. Thus, the orbital plate may include no mesh over its surface area, a mesh throughout its surface area, or a mesh over a portion of its surface area. A thickness of orbital plate 381 may be constant throughout, or may have some variation to accommodate placement. Similar to contoured component 311, orbital plate 381 may be designed to be produced with a shape having a desired surface contour for the region in and around the orbit onto which it is to be implanted. Such shape may be realized through fabrication or through manual adjustment of a fabricated plate. Orbital plate 381 may also be designed to include additional features, such as predefined fastener openings for anchorage of orbital plate 381 into bone.

[0066] In the depicted embodiment of multi-piece implant 305, contoured component 311 is configured to be positionable onto bone surfaces proximate the left orbit of the patient, first plate 361 is positionable so that part of first plate 361 is received on second recessedSYKCMF-055 surface portion 317, second plate 371 is positionable so that part of second plate 371 is received on first recessed surface portion 316, and orbital plate 381 is positionable on third recessed surface portion 318.

[0067] Another multi-piece implant is shown in FIG. 21 in the form of multi-piece implant 307. Multi-piece implant includes first contoured component 331 and second contoured component 351, with first contoured component 331 shaped to fit onto a ramus 303F of mandible 303E and second contoured component 351 extending toward a chin region of mandible 303E. The first and second contoured components 331, 351 abut one another as shown in FIG. 21 and may include openings sized and configured to receive fasteners to secure the respective contoured components to the mandible. Optionally, the respective contoured components 331, 351 may include complementary interfacing surfaces for fitting the components against each other.

[0068] In any of the described embodiments of the multi-piece implant, contoured components may be formed with one or more fastener openings configured for the receipt of fasteners. In some examples, each contoured component of a multi-piece implant includes at least three fastener openings configured for the receipt of fasteners. Such fastener openings may be located in positions best suited for bone anchorage and to otherwise stabilize the contoured component post-surgery. One or more of such fastener openings may include a countersink. In any of the described embodiments, a multi-piece implant may also optionally include one or more fasteners sized and otherwise configured to anchor the implant to the patient. Examples of fasteners that may be part of a multi-piece implant include self-tapping screws, self-drilling screws and emergency screws, among others. Further, contoured components may include a surplus of fastener openings such that during implantation, a surgeon may utilize a desirable subset of the fastener openings for securement of the contoured component to the bone of the patient.

[0069] Contoured components of multi-piece implants 5, 105, 106, 205, 206, 305, 307, including contoured components 11, 31, 51, 111, 131, 151, 211, 231, 271, 311, 331, 351, may be made of polymeric materials, such as PEEK or PMMA. In some examples, one or more of the contoured components may be made entirely of polymeric materials throughout its volume. In some of these examples, such contoured components may be formed monolithically. In other examples, the contoured components may be made of polymers along with other additives. Further, the polymeric materials utilized to form contoured components may haveSYKCMF-055 characteristics as described in U.S. Pat. No. 7,655,047, the disclosure of which is hereby incorporated by reference herein in its entirety. For instance, a contoured component may be made of biocompatible porous high-density polyethylene (“HDPE”). Moreover, a bone facing surface of a contoured component made of any of the contemplated materials may have greater porosity than other regions of the component to enhance and promote bone ingrowth. In still further examples, a multi-piece implant may include one or more contoured components made of titanium. In a specific example, a contoured component configured for placement in a cranial region of a skull may be made of titanium. As to the plate components, plate components of multi-piece implants 5, 105, 106, 205, 206, 305, 307, including plates 175, 177, 181, 185, 191, 195, 199, 281, 291, 361, 371, 381, may be made of metallic materials such as stainless steel, titanium or a titanium alloy, e.g., Ti6A14V alloy. In some examples, orbital plate 381 may be made of polymeric materials, such as PEEK or PMMA. Individual plate components may be formed monolithically.

[0070] Multi-piece implant 105, 106, 205, 206, 305, 307 may include contoured components that vary from the depicted embodiments for at least the reason that each patient may require different implant components or implant component characteristics as part of a treatment. For instance, contoured components of the multi-piece implant 105, 106, 205, 206, 305, 307 may have shapes different from that shown in FIGs. 4, 12 and 21. In some examples, recessed surface portions may be located at different positions on the contoured components from those shown. In some examples, a size and / or depth of one or more of the recessed surface portions may vary from that shown. For instance, the recessed surface portions may have a square, partially circular, ovular or an irregular footprint. In some examples, the total number of recessed surface portions may vary from that shown. For example, a contoured component may include one, two, three, four or more recessed surface portions, and such recessed surface portions may be arranged in any combination between the bone-facing surface and the outer surface of the contoured component. Further, a contoured component may have no recessed surface portions, i.e., no recessed surface portions on its bone-facing surface and no recessed surface portions on its outer surface. And, in some examples, the multi-piece implant 105, 106, 205, 206, 305, 307 may include three or more contoured components.

[0071] The examples of the multi-piece implant described above may be varied in many ways. In some examples, a multi-piece implant includes a contoured component with a recessed surface portion and a plate. In a subset of these examples, the recessed surface portionSYKCMF-055 is on a bone-facing surface of the contoured component. In another subset, the recessed surface portion is on an upper or outer surface of the contoured component opposite the bone-facing surface. In yet another subset, the contoured component includes a recessed surface portion on both the bone-facing surface and the outer surface of the contoured component. In each of the aforementioned examples, the contoured component may include two or more recessed surface portions on surfaces of the contoured component that include a recessed surface portion. In some examples, the contoured component of the multi-piece implant may be formed of two separate contoured components that are shaped to abut against each other in an implanted configuration. In still further variations, the contoured component may be formed from three or more contoured components that are respectively shaped to be combined together when implanted in a patient. In each of these examples, the plate may be configured to be received in one or more of the recessed surface portions. Further, in other examples, the multi-piece implant may include two or more plates. Plates included in a multi-piece implant may have any length or shape suitable for a planned repair or reconstruction. In any one of the contemplated examples, the multi-piece implant may also optionally include one or more fasteners.

[0072] In any one of the contemplated embodiments of the multi-piece implant, the contoured component may have an overall shape and volume that varies to suit a specific repair to be undertaken. Similarly, while plates shown in the depicted embodiments include a single row of fastener openings defined by a series of ring-shaped plate structure, other plate shapes are also contemplated, such as curved plates, Y plates and T plates. Examples of additional plates that may be included as part of a multi-piece (e.g., including a single contoured component and a plate, two contoured components and a plate, etc.) or multi-part implant are shown in FIGs. 28.1-28.51. Such plates may be used with cranial implants such as multi-piece implant 5 or other cranio-maxillofacial implants, such as multi-piece implants 105, 106, 205, 206, 305, 307. In embodiments that include one or more of the plates shown in FIGs. 28.1- 28.51, or embodiments that include a combination of such plates, complementary contoured components may have recessed surface portions shaped to receive to such plates.

[0073] In another aspect, the present disclosure relates to an implant system for repair or reconstruction of bone in cranio-maxillofacial regions of the skull of a patient. Contemplated implant systems may include two or more implants at spaced apart locations on the skull. One or more of the implants of the system may be a multi-piece implant.SYKCMF-055

[0074] In one embodiment, implant system 101 is shown in FIG. 4, with components thereof shown in FIGs. 5-11. Several separate implants are included as part of the system to address the nature of the deficiencies in the patient bone structure, and this applies in a similar way for implant systems 201 and 301 described below. These systems may also be referred to as “multi-part” systems. Implant system 101 includes multi-piece implant 105, multi-piece implant 106 and contoured component 171. Details of multi-piece implants 105, 106 are described elsewhere in the present disclosure. Contoured component 171 is an implant shaped to augment a chin region of mandible 103E. In implant system 101, each implant is shaped to augment and / or replace portions of one or more of a zygomatic bone, maxillary bone and mandibular bone.

[0075] In one embodiment, implant system 201 is shown in FIG. 12, with components thereof shown in FIGs. 13-20. Implant system 201 includes multi-piece implant 205, multipiece implant 206, contoured component 251 and plate 295. An additional plate similar to plate 295 may also be included under contoured component 251. Details of multi-piece implants 205, 206 are described elsewhere in the present disclosure. Contoured component 251 is an implant shaped to augment a right side of mandibular bone 203E. In the specific repair plan shown in FIG. 12, contoured component 251 bridges a gap between portions of mandibular bone 203E. Contoured component 251 may include openings to receive fasteners, and as depicted in FIG. 19, includes openings 262A, 262B for such purpose, though it is envisioned that such openings may vary in location, size and quantity to suit a specific surgical procedure. Plate 295 includes a single row of spaced apart openings along its length such that the plate material defines a plurality of rings. Plate 295 is configured to be positioned on a left side of mandibular bone 203E. In implant system 201, each implant is shaped to augment and / or replace portions of one or more of a maxillary bone and mandibular bone.

[0076] In one embodiment, implant system 301 is shown in FIG. 21, with components thereof shown in FIGs. 22-24 and in FIGs. 25A-27B. Implant system 301 includes multi-piece implant 305 and multi-piece implant 307. Details of multi-piece implants 305 and 307 are described elsewhere in the present disclosure. In implant system 301, each implant is shaped to augment and / or replace portions of one or more of a zygomatic bone, maxillary bone and mandibular bone.SYKCMF-055

[0077] Materials and other characteristics for contoured components and plates in implant systems 101, 201, 301 may be the same as those described elsewhere in the present disclosure for multi-piece implants.

[0078] In another aspect, the present disclosure relates to a kit for use in a cranio- maxillofacial surgery. In some embodiments, the kit includes two or more implant components. For example, a kit may include two contoured components, two or more plates, or a contoured component and a plate. Contoured components and plates used in a kit may be any of those contemplated by the present disclosure. In further examples, additional implant components may be included in a kit. In any of the contemplated kits, one or more fasteners may be included as part of the kit. Such fasteners may be configured for use in anchoring one or more of the implant components to a bone. Additionally, in any of the contemplated embodiments, a kit may include instrumentation used for purposes of preparation and / or placement of such implant components into a patient.

[0079] Further, in any one of the contemplated kit embodiments, the kit or individual items and combinations thereof may be disposed within a package or a plurality of packages. For example, all of the items of the kit may be disposed within a single package. In another example, all of the implant components (e.g., contoured components, plates, and fasteners) may be in one package and all of the instrumentation in another. In some examples, each implant component type may be in separate packages. Further, the items included in the kit may also be individually packaged. For example, each implant component may be in its own package. In examples where a kit is provided in at least two packages, up to and including individual packaging, all packages may be further packaged into a larger container or box. Packaging each item in the kit separately or in different combinations may improve the sterility of the items in preparation for placement in the patient or more generally in preparation for use in the surgical theater. In any of the above embodiments, a kit may further include an instruction manual with an explanation of details relating to the contents of the kit including instructions for use of the contents.

[0080] In yet another aspect, the present disclosure relates to methods of designing and fabricating a multi-piece implant or an implant system where contoured components and / or plates are used to repair or reconstruct one or more regions in a cranio-maxillo-facial region of a patient. While the following method, also shown in FIG. 29, includes design and fabrication, it should be appreciated that in some examples, a singular method may be limited to a methodSYKCMF-055 of design only or a method of fabrication only. Further, it should be appreciated that while the method below is not described with reference to a specific embodiment of a multi-piece implant or an implant system shown in the figures of the present disclosure, the described method is performable for all multi-piece implants and implant systems contemplated by the present disclosure.

[0081] A method of designing a multi-piece implant or implant system may be part of a pre-surgical planning process and may utilize software to evaluate options for the surgery at issue and to determine optimal parameters for contoured components and / or plates for inclusion in a final design to fabricate and use in a procedure. It should be appreciated that software referenced in the various methods described herein may be installed on computer systems capable of running the software. A computer system may include a processor, storage, displays, and other components to optimize the intended functions of the software. Further, it should be appreciated that providing a computer system and / or software for use in performing the methods may be an optional step in the methods contemplated by the present disclosure.

[0082] In one embodiment, a method of designing a multi-piece implant or an implant system for repair or reconstruction of various cranio-maxillofacial regions of a patient involves the use of software to design the implant based on an existing condition of a patient’s anatomy. For the sake of brevity, references to “implant system” in this method are intended to encompass implant systems as contemplated elsewhere in the present disclosure along with multi-piece and / or multi-part implants. This method embodiment will be described with reference to FIG. 29. The method begins with a step 501 including the capture of images, such as CT scan images, of a skull of a patient to be treated. Once sufficient images have been captured, step 502 includes uploading of such images of the skull of the patient onto a storage location capable of being accessed and utilized by the software. The image data acquired and used in this method will provide sufficient information about the patient skull structure to be able to analyze it in three-dimensions. For purposes of processing the image data, the image data, having three-dimensional characteristics, is separated into slices of image data in a series of horizontal (i.e., transverse), coronal and sagittal planes through the skull. Specifically, a multitude of horizontal plane images taken at intervals along an inferior- superior direction over a height of the patient’s skull may be extracted, a multitude of coronal plane images taken at intervals along an anterior-posterior direction across a depth of the patient’s skull may be extracted, and a multitude of sagittal plane images taken at intervals along a medial-lateral axisSYKCMF-055 across a width of the patient’s skull may be extracted. These slices provide an enhancement on the options available to a user for planning a reconstruction of bone structure in an applicable region of the cranio-maxillofacial space and the implant component to accompany the reconstruction. Further, as to the terminology for the referenced planes, it should be appreciated that throughout the present disclosure, references to coronal and sagittal planes may refer to any planar section cut that is parallel to the respective central coronal and central sagittal planes, and thus such referenced planes are not limited to the central bifurcating planes often associated with such terms.

[0083] Once the necessary segmentation and processing is complete, step 503 includes generation of an anatomical model for use in analyzing the patient anatomy to plan a repair or reconstruction. Optionally, in step 503A, the software may process the input image data, via the segmented images or otherwise, to generate data on bone thickness throughout any portion of the skull up to and including the entirety of the skull. As described in greater detail below, such further processing renders it possible for a user to evaluate existing bone thickness when planning implant design and placement.

[0084] Once the anatomical model is generated and accessible for use, step 504 is performed where a user may view the existing condition of the skull to commence development of a plan for reconstruction of deficient bone surfaces. Areas to be treated may include one or more regions of the cranium or maxillofacial bone structure. As part of the design process, a user may evaluate the condition of the bone and initially determine whether any resections should be performed to prepare the skull for receipt of one or more implants, and to determine where, how many, and what type of implants to include as part of the repair or reconstruction. For example, a suitable repair may include a multi-piece implant with a contoured component and a plate.

[0085] In some examples, plates, such as the plates shown in FIGs. 1, 4, 12 and 21, may, in step 505, optionally be designed using interactive tools, e.g. a cursor controlled by a mouse, applied on a user interface displaying an external view of the patient skull, e.g., a simple perspective view of the skull such as that shown in FIG. 4. A method of designing the plate in such examples may be as described in the ‘299 Patent. In some of these and in other examples, contoured components may also be designed directly on a perspective or other external view of the patient skull. During the design process, a location, type, size, shape and other characteristics of each implant component may be established and finalized. Further, fastenerSYKCMF-055 opening locations for anchorage of contoured components and plates, e.g., via fasteners may also be established. And, as described in greater detail elsewhere in the present application, indications of bone thickness in the virtual anatomical model may also be used to aid in finalizing a design. Additionally, in some examples, a post-surgical cranio-maxillofacial bone structure of the patient that includes removed or repositioned bone fragments may be generated for use as a reference when designing the plate or other implant components.

[0086] During the process of determining a shape and position of contoured components and plates, various techniques may be used to aid in arriving at a suitable design. For example, mirroring techniques may be used where an anatomical region opposite the one to be reconstructed is in a healthy condition, and thus may provide a template for the applicable reconstruction. Such technique is particularly advantageous for design of contoured components. In other examples, average models of cranial and / or facial anatomy may be utilized as baseline data to guide design of implant components such as contoured components and plates. And in still further examples, statistical shape modeling (SSM) may be used. SSM involves the processing of a database of images, where the images are of healthy or otherwise undamaged and not deteriorated bone structures, and aggregating the images to calculate a representative structure. Such representative structure is then used to determine a reconstructed bone surface of the patient based on the defect definition. More specifically, SSM data is fitted to healthy parts of the patient anatomy and is then used to extrapolate missing or abnormal anatomy in an anatomically plausible way. SSM then creates a new surface to reconstruct the defect that is then blended into the anatomy outside of the defect definition area, i.e., healthy bone. Such reconstruction may then inform as to an appropriate implant design.

[0087] Further, in step 505A, external views of the skull may also optionally be used to identify resection lines and any planned adjustment in a position of bones post-operatively. Such information may then be used to optionally generate guide designs that may be used to carry out the surgical procedure. For example, the details of the skull anatomy may be used to generate cutting guide designs to complete any necessary resections. In other examples, the skull anatomy may be used to generate a marking guide for marking the bone or a positioning guide to guide a user to a desired position on the bone. A procedure may also incorporate any combination of the aforementioned guides. In some examples, procedures for planning bone cuts and designing guides may be in accordance with those described in the ‘299 Patent. In other examples, an established resection plan may be stored digitally without any guideSYKCMF-055 designs, and may be retrieved during surgery for reference via a navigation system to complete the planned cuts, as described elsewhere in the present disclosure. The above-described design process may be iterative, and preliminary implant designs and / or resection cuts may be viewed on the user interface of the computer system to evaluate and further refine implant component characteristics and the surgical plan more generally. The contents of such display may also be understood to be a virtually generated implant system or implant overlaid on a virtually generated anatomical model.

[0088] In some examples, and as shown in FIGs 25A-27B, a user-interface may optionally display different views of skull 303 of the patient with or without one or more components of an implant (multi-piece implant 305 is shown as an example in these figures). This display may be through a user-interface that is in operative communication with the computer system that runs the software. The views, which may be displayed simultaneously, include a left sagittal plane 401 (view from the left side of the patient) in FIG. 25B, an anterior coronal plane 402 (view from the front) in FIG. 26B, and an inferior transverse or horizontal plane 403 (view from below) in FIG. 27B. While FIGs. 25B, 26B and 27B show one set of horizontal, coronal, and sagittal planes, the software may be manipulated to change the center where each of the horizontal, coronal and sagittal planes meet (not shown), so that any specific part of the skull anatomy may be displayed in each of the viewing planes. This may be done by shifting the center along a single axis, i.e., changing the section cut, i.e., slice, in one view only, or by shifting the center along two or three axes, and is completely customizable as a function of the number of available slices in each view. Thus, for example, different locations of the region of bone anatomy to be repaired or reconstructed, e.g., the region around left orbit of patient skull 303, may be viewed by moving the center as desired. Additionally, the user interface may optionally include an extra indicator associated with each view to indicate which slice is displayed from among the set for a particular view. It should be appreciated that while in an optimal scenario, a CT scan of a patient is taken directly along or parallel to a midline plane, such as the sagittal plane, it is possible that in some instances CT scan image data may be captured from an oblique angle. In such cases, initial image slices may be angled relative to a desired viewing plane, including one or more of the coronal, sagittal, and horizontal planes. When this occurs, the software may be used to recapture image slices along planes that are at a desired angulation, i.e., on coronal, sagittal and horizonal planes.SYKCMF-055

[0089] With the ability to manipulate the section cut displayed in different views of the bone to be reconstructed, the sectional planes displayed to the user may be adjusted to identify areas of a pre-operative bone structure that should be augmented or, in cases where the bone is too deficient for augmentation, replaced. During this process, the bony anatomy may optionally be marked for any planned resections. Such digitally recorded markings may then be stored and later utilized in a reconstruction procedure. Specifically, during reconstruction, the prepared markings may be displayed with the anatomy on a user interface so that a user may align a tool linked to a navigation system to a location on a bone using the markings as displayed on the user interface. Such a step may also optionally be supplemented with other aids, such as haptic feedback. Through the aforementioned approach, resection of the bone may be completed without the need for any cutting guides. In other methods, resection data collected through marking or other means may be used for generation of an appropriate guide, e.g., cutting guide or marking guide to prepare the bone. The software may include a marking tool to mark such deficient areas at any displayed slice on the series of viewable slices, i.e., on a displayed section cut in one of the planar views. A center of the three viewing planes may be moved, e.g., by toggling an icon on the user interface, and further defect areas may be marked on other slices, as applicable (not shown). This process may continue until sufficient marking is completed to properly determine any resections (step 505A) and / or implant component designs, e.g., contoured components and plates (step 505). For example, the coronal view 402 may be adjusted along the anterior-posterior direction to different cross- sectional planes, i.e., image slices, so that additional defect areas can be marked. Similarly, the displayed cross-sectional planes in the sagittal and horizontal views may also be changed to mark additional defect areas. These marking techniques may similarly be used to set implant component parameters, such as size, shape and placement. In some examples, and where applicable, planning for resections may be performed separately from planning the implant design.

[0090] Further to the above, the software may be configured so that a tentative design of either contoured components or plates may be viewed from an external perspective and then further modified in the sectional views or vice versa.

[0091] Designs generated based on user selections of implant type, size, shape and placement may optionally incorporate generic implant design details. For example, plate designs may optionally include generic features such as one or more of a predetermined plateSYKCMF-055 thickness, ring shape and size, fastener opening size, and fastener opening spacing. Examples of generic features that may optionally be included for contoured components include a minimum thickness and / or a minimum number of fastener openings.

[0092] In some optional variations of the method, the software used may be configured to include an option for modifying the appearance of the skull or portions of the skull on the user interface display to show contours indicative of bone thickness, to the extent that the source images of the patient provide sufficient data to do so. In some examples, these contours may take the form of various colors indicative of different bone thicknesses. For example, see FIG. 9 for multi-piece implant 105, FIGs. 13-16 for multi-piece implant 205 and FIG. 24 for multi-piece implant 305. This option may be utilized in steps 504 and 505 during the implant design process to evaluate a planned implantation position and size of the implant and to evaluate internal implant features, such as fastener opening locations. The visible bone thickness may aid the user in a determination of optimal implant shape, position and / or fastener opening locations, all on account of available bone structure based on the planned design. In this manner, for example, fastener opening locations may be modified where doing so may provide a stronger anchorage via greater available bone thickness.

[0093] Once any optional resection plans are finalized and the implant and / or implant system details are finalized, the various components are fabricated in step 506, as shown in FIG. 29. Implant components may be fabricated through a variety of methods. In some embodiments, additive manufacturing techniques may be used to fabricate implant components such as contoured components and / or plates. For example, components may be formed via selective laser sintering (“SLS”), among other techniques. Detailed descriptions of the SES technology may be found in U.S. Pat. Nos. 4,863,538, 5,017,753, 5,076,869, and 4,944,817, the disclosures of which are hereby incorporated by reference herein in their entirety. In other examples, selective laser melting (SLM) may be used. A detailed description of the use of SLM technology may be found in U.S. Pat. No. 7,537,664, the disclosure of which is hereby incorporated by reference herein in its entirety. The SLM and SLS technologies have enabled the direct manufacture of solid or porous three-dimensional articles of high resolution and dimensional accuracy from a variety of materials including, among others, metal and metal alloys, metal powders with binders, polycarbonate, nylon, other plastics and composite materials, such as polymer-coated metals. Additionally, techniques such as but not limited to SLS, three-dimensional inkjet printing (3DP), stereolithography (SLA), and fused filamentSYKCMF-055 fabrication (FFF) may be used with polymer powders or strands to produce polymeric constructs. In other embodiments, milling may be used to fabricate implant components. For example, contoured components may be milled. In still further embodiments, molding techniques may be used to fabricate implant components. For example, contoured components may be molded via an injection molding technique. Further, regardless of method of manufacture, plates may be formed into a provisional shape such that a user may bend the plate into a final shape after fabrication. Such an approach may be more practical where an anatomical model of the patient’ s skull is first fabricated and then utilized to check the reshaped plate prior to implantation.

[0094] Optionally, steps 506A-506C, shown in FIG. 29, may also be performed to evaluate the suitability and fit of the implant components. In step 506A, a physical replica of the anatomical model used for the design is fabricated. In step 506B, the implant components, such as contoured components and plates, are fitted into the physical replica to assess suitability for implantation. In some examples, the fabricated implant components may be manipulated if doing so is possible and also renders them more suitable to fit within the patient. In step 506C, the suitability and fit of the implant components is evaluated to determine whether to proceed to surgery with such implant components. If it is determined that the implant components are inadequate, the method returns to step 504, where the user once again evaluates the computer-based anatomical model to design an implant or implant system. At the end of this process in step 507, whether via the first fabrication or a fabrication based on a later design iteration, the fabricated components of the implant or implant system are ready for implantation in the patient.

[0095] As stated above, the method shown in FIG. 29 may be performed for any of the implants or implant systems contemplated by the present disclosure. Thus, for example, the components of any one of multi-piece implant 5 and implant systems 101, 201, 301 may be designed and fabricated according to the above method. In variations of the described methods, a surgical plan including design of multi-piece implant(s) and or other implant(s) may be developed without any guides. In such cases, a repair or reconstruction of bone of a patient need not require any guides for completion of the procedure.

[0096] In another aspect, the present disclosure relates to a method of using a multipiece implant, a multi-part implant or an implant system to repair or reconstruct one or more parts of a cranio-maxillofacial region of a patient skull. This method is advantageous in that itSYKCMF-055 may be performed in a single procedure that includes accessing the patient anatomy and placing all implants, in contrast with procedures that involve bone preparation in a first procedure, and then later in a separate procedure, placement of an implant or implants. One embodiment of such method is shown in FIG. 30. The method begins with step 601 including retrieval of any guides, e.g., marking guides or cutting guides and implant components that will be used to complete the procedure. Such guides and implant components may be made available through performance of one or more of the steps 501-507 shown in FIG. 29.

[0097] At the commencement of the procedure, the patient anatomy may be registered so that navigation may be used to identify locations for implant placement, including fastener opening locations, and optional bone resection, including guide placement. Registration may be performed so that the skull anatomy may be viewable on a display and a coordinate system of the skull may be the same as a coordinate system of a stylus, probe or end-effector of a robotic system used to execute the design plan. One example of a navigation system that may be used to aid in the completion of this operation is described in U.S. Pat. No. 7,725,162, the disclosure of which is hereby incorporated by reference herein in its entirety. With the patient anatomy registered, a region of the patient to be operated on is accessed in step 602. If the surgical plan specifies any bone resection or bone resection and bone adjustment, then such steps are performed at this time. The navigation system may be used to ensure accurate cuts and bone adjustment.

[0098] When bone preparation is complete, implant components are delivered into the patient for implantation in step 603. Again, navigation may be used to ensure accurate placement and positioning of the implant components. Where a multi-piece implant is included and such implant includes both a plate and a contoured component, an order of placement of those components is followed to ensure the proper component is positioned underneath another component. When each implant component is properly positioned, fasteners may be used to secure the respective implant components to bone. Where a plate is positioned over a contoured component, fasteners through the plate may also be driven through the contoured component. Where a contoured component is positioned over a plate, fasteners through the plate at locations to be covered by the contoured component may be driven through the plate directly and the contoured component may be placed over the plate separately after fastening is complete. Once all implant component placements are confirmed, step 604 completes the procedure with the closure of the skull.SYKCMF-055

[0099] In some methods, the method of implantation may be performed with the aid of a robotic system. In this manner, an end effector of the robot may accurately cut bone and place the various implant components based on the registered coordinates of the anatomy. Examples of robotic systems that may be used include those described in U.S. Pat. Nos. 6,676,669; 7,892,243; 6,702,805; 6,723,106; 7,035,716; 6,757,582; 7,831,292; 8,010,180; 7,950,306; and 9,622,823; and U.S. Pat. App. Pub. Nos. 2010 / 0268249; 2010 / 0268250; 2010 / 0275718; and 2003 / 0005786, the disclosures of which are hereby incorporated by reference herein in their entirety.

[0100] The multi-piece implants, multi-part implants and implant systems of the present disclosure provide many advantages. Multi-piece implants include interface features so that plates and contoured components may be utilized together as part of a combined implant structure. This allows for leveraging of characteristics of both implant types (e.g., plates may be used to hold separate bone fragments together and to transfer loads / increase load bearing capacity, contoured components may be used to provide volume to recreate a healthy bone shape where bone is otherwise deficient or absent). Multi-piece and / or multi-part implants may be part of a repair or reconstruction, and such components, collectively, may be implanted in a single-stage surgical procedure. One Advantage of multi-piece implants that include two or more contoured components is that such a configuration reduces the space necessary to access a target site relative to a single contoured component and thus allows for a smaller incision and smaller access pathway. Further, the inclusion of recessed surface portions on contoured components facilitates the receipt of plates on the contoured components so that such plates do not protrude relative to an outer surface, or a bone-facing surface as applicable, of the contoured component. Further, by being able to plan plate sizing and placement ahead of time during a pre-operative planning phase, a surgical procedure may be performed more predictably with a reduced risk that changes may be necessary during the procedure itself, thereby reducing the risk that the procedure may require additional time.

[0101] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present disclosure as defined by the appended claims.

Claims

SYKCMF-055CLAIMS1. An implant configured for placement on a bone of a patient comprising: a first component made of a first material and including a first inner surface and a first outer surface opposite the first inner surface, the first outer surface of the first component being contoured to emulate a first cortical bone surface, and at least one of the first inner surface and the first outer surface including a first recessed surface portion; a second component made of the first material and including a second inner surface and a second outer surface opposite the second inner surface, the second outer surface of the second component being contoured to emulate a second cortical bone surface, wherein when the first inner surface includes the first recessed surface portion, the second inner surface includes a second recessed surface portion and when the first outer surface includes the first recessed surface portion, the second outer surface includes the second recessed surface portion; and a third component made of a second material different from the first material, the third component including a first portion and a second portion, at least one of the first portion and the second portion including a fastener opening therethrough, wherein the first portion of the third component is received on the first recessed surface portion and the second portion of the third component is received on the second recessed surface portion.

2. The implant of claim 1, wherein the first material is polyether ether ketone or poly(methyl methacrylate) and the first component includes the first material continuously through a thickness dimension of the first component from the first inner surface to the first outer surface.

3. The implant of any one of claims 1-2, wherein the second material is a metallic material.

4. The implant of any one of claims 1-3, wherein the third component includes a plurality of fastener openings spaced apart along a length of the third component, the fastener opening being one of the plurality of fastener openings.

5. The implant of claim 4, wherein the first component has a variable thickness over an entire surface area of the first component and the third component has a first maximumSYKCMF-055 thickness in a ring-shaped portion surrounding each fastener opening of the plurality of fastener openings.

6. The implant of any one of claims 1-5, wherein the first component includes a first curved outer edge shaped to complement a second curved outer edge of the second component such that the first component and the second component are flush with each other in an implanted configuration.

7. The implant of any one of claims 1-6, wherein the first component further comprises a third recessed surface portion spaced apart from the first recessed surface portion, the third recessed surface portion being configured to receive a fourth component made of the second material.

8. The implant of any one of claims 1-7, wherein a first end of the third component overlies the first component and a second end of the third component opposite the first end overlies the second component.

9. The implant of claim 8, wherein when the first, second and third components are implanted in the patient, the first end of the third component is covered by the first component and the second end of the third component is covered by the second component.

10. The implant of claim 9, wherein the first component further comprises a third recessed surface portion on the first outer surface of the first component.

11. The implant of any one of claims 1-10, wherein the first component includes a first interfacing surface and the second component includes a second interfacing surface that complements the first interfacing surface such that the first and second components fit together.

12. The implant of claim 11, wherein when the first and second components are joined at the respective first and second interfacing surfaces, the first recessed surface portion is continuous with the second recessed surface portion.SYKCMF-05513. The implant of any one of claims 1-12, wherein the first inner surface of the first component includes the first recessed surface portion and the second inner surface of the second component includes the second recessed surface portion.

14. The implant of any one of claims 1-13, further comprising a fourth component made of the first material and including a third inner surface and a third outer surface opposite the third inner surface, the third outer surface of the fourth component being contoured to emulate a third cortical bone surface, the fourth component further comprising a third recessed surface portion on the third outer surface, wherein the third component is received on the first, second and third recessed surface portions.

15. The implant of claim 14, wherein the third component includes a closed loop bar with a plurality of fastener openings spaced apart along its length such that at least one fastener opening from among the plurality of fastener openings is positioned over each of the first, second and third recessed surface portions.

16. An implant configured for placement on a bone of a patient comprising: a first component made of a first material, the first component including an inner surface and an outer surface opposite the inner surface, the inner surface including a recessed surface portion; and a second component made of a second material different from the first material, the second component being sized such that a first portion of the second component is receivable in the recessed surface portion, wherein the first portion of the second component is received in the recessed surface portion and is covered by the first component.

17. The implant of claim 16, wherein the second component includes a fastener opening configured to receive a fastener to fix the second component to the bone.

18. The implant of claim 17, wherein the second component includes a plurality of fastener openings spaced apart along a length of the second component, the fastener opening being one of the plurality of fastener openings.SYKCMF-05519. The implant of claim 18, wherein the first component has a variable thickness over an entire surface area of the first component and the second component has a first maximum thickness in a ring-shaped portion surrounding each fastener opening of the plurality of fastener openings.

20. The implant of any one of claims 17-19, wherein when the first component and the second component are implanted in the patient, the fastener opening of the second component is covered by the first component.

21. The implant of any one of claims 16-20, wherein when the first component and the second component are implanted in the patient, a second portion of the second component is outside of a periphery of the first component.

22. The implant of any one of claims 16-21, wherein the first material is polyether ether ketone or poly(methyl methacrylate).

23. The implant of any one of claims 16-22, wherein the second material is a metallic material.

24. An implant configured for placement onto a bone comprising: a first component made of a first material and including a first inner surface and a first outer surface opposite the first inner surface, the first outer surface of the first component being contoured to emulate a first cortical bone surface and including a first recessed surface portion; a second component made of the first material and including a second inner surface and a second outer surface opposite the second inner surface, the second outer surface of the second component being contoured to emulate a second cortical bone surface and including a second recessed surface portion; a third component made of the first material and including a third inner surface and a third outer surface opposite the third inner surface, the third outer surface of the third component being contoured to emulate a third cortical bone surface and including a third recessed surface portion; andSYKCMF-055 a fourth component made of a second material different from the first material, the fourth component including a first portion, a second portion and a third portion, each of the first, second and third portions including a fastener opening therethrough, wherein the first portion is received on the first recessed surface portion, the second portion is received on the second recessed surface portion, and the third portion is received on the third recessed surface portion.

25. The implant of claim 24, wherein the fourth component includes a closed loop bar with a plurality of fastener openings spaced apart along its length such that at least one fastener opening from among the plurality of fastener openings is positioned over each of the first, second and third recessed surface portions.

26. The implant of any one of claims 24-25, wherein each of the first, second and third components includes a side surface shaped to complement a respective side surface on at least one other component from among the first, second and third components.

27. A cranio-maxillofacial implant comprising: a first component configured to reconstruct at least part of one or more of a maxillary bone, a zygomatic bone and a frontal bone of a patient, the first component being made of a first material and including a first recessed surface portion thereon; and a second component configured to reconstruct an orbital cavity of the patient, the second component being made of a second material different from the first material, wherein a portion of the second component is received on the first recessed surface portion.

28. The cranio-maxillofacial implant of claim 27, wherein the second component includes a surface region with a plurality of openings defining a mesh.

29. The cranio-maxillofacial implant of any one of claims 27-28, wherein the first component includes a second recessed surface portion entirely spaced apart from the first recessed surface portion, the second recessed surface portion being shaped to receive an elongate bone plate.SYKCMF-05530. The cranio-maxillofacial implant of any one of claims 27-29, wherein the first material is a polymeric material and the first component and an outer surface of the first component is shaped to emulate a bone surface of the patient.

31. The cranio-maxillofacial implant of any one of claims 27-30, wherein the first component has a variable thickness over an entire surface area of the first component and the second component has a constant thickness over an entire surface area of the second component.

32. A cranio-maxillofacial implant comprising: a first component configured to reconstruct at least part of one or more of a maxilla bone, a zygomatic bone and a cranial bone, the first component being made of a first material and including a first outer surface contoured to emulate a first cortical bone surface and a first inner surface opposite the first outer surface, at least one of the first outer surface and the first inner surface including a first recessed surface portion thereon; and a second component configured to reconstruct an orbital cavity or the cranial bone, the second component being made of a second material different from the first material and including a second outer surface contoured to emulate a second cortical bone surface, wherein a portion of the second component is received on the first recessed surface portion.

33. The cranio-maxillofacial implant of claim 32, wherein the first recessed surface portion and the portion of the second component emulate a single cortical bone surface area.

34. The cranio-maxillofacial implant of any one of claims 32-33, wherein the second component includes an outer peripheral shape with a contour that corresponds to a surface area for bone reconstruction.

35. The cranio-maxillofacial implant of any one of claims 32-34, wherein the second component has a varying width along an elongate dimension of the second component.SYKCMF-05536. The cranio-maxillofacial implant of any one of claims 32-35, wherein the second component defines a plurality of first openings and a second opening, the plurality of first openings forming a pattern and being sized to promote bone ingrowth, the second opening being configured to receive a fastener.

37. A method of reconstructing a cranio-maxillofacial bone structure of a patient comprising: processing an image of a pre-surgical cranio-maxillofacial bone structure of the patient to generate a virtual anatomical model of the cranio-maxillofacial bone structure; virtually generating a first shape of a first implant component based on the virtual anatomical model, the first implant component defined as being made of a first material; and virtually generating a second shape of a second implant component, the second implant component defined as being made of a second material different from the first material and including a portion configured to be received on a recessed surface portion of the first implant component, wherein the first implant component is configured to be positioned over the second implant component when implanted in the patient.

38. The method of claim 37, further comprising: virtually generating a post- surgical cranio-maxillofacial bone structure of the patient including at least a removal or a repositioning of a bone fragment of the patient based on the image; and modifying the pre-surgical cranio-maxillofacial bone structure to arrive at the post- surgical cranio-maxillofacial bone structure based on the removal or repositioning of the bone fragment.

39. The method of claim 38, wherein the modifying of the pre-surgical cranio-maxillofacial bone structure to arrive at the post-surgical cranio-maxillofacial bone structure and an implantation of the first and second implant components are performed in a single surgical procedure.SYKCMF-05540. The method of any one of claims 37-39, further comprising fabricating the first implant component and the second implant component prior to accessing the patient to implant the first and second implant components.

41. The method of claim 40, further comprising: implanting the second implant component on a bone surface of the patient; and implanting the first implant component at least partially over the second implant component.

42. The method of claim 41, wherein implanting the first implant component includes positioning the recessed surface portion directly over the portion of the second implant component.

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