WO2025083466A1

WO2025083466A1 - Orbital implant

Info

Publication number: WO2025083466A1
Application number: PCT/IB2024/000571
Authority: WO
Inventors: Andrea Mayer; Arden MCDONOUGH
Original assignee: Stryker European Operations Ltd
Current assignee: Stryker European Operations Ltd
Priority date: 2023-10-20
Filing date: 2024-10-15
Publication date: 2025-04-24
Anticipated expiration: 2026-04-20

Abstract

A system (201) includes a first implant (210) and a second implant (240), both configured for placement within a mammalian orbit. The first implant includes a first alignment edge (216) forming part of an outer perimeter of the first implant with a length extending from a first portion of the first implant configured for placement in an interior of the orbit to a second portion of the first implant configured for placement outside of the orbit. The second implant includes a second alignment edge (246) forming part of an outer perimeter of the second implant with a length extending from a first portion of the second implant configured for placement in an interior of the orbit to a second portion of the second implant configured for placement outside of the orbit. Further, the first alignment edge and the second alignment edge are aligned along a majority of the lengths of the respective alignment edges.

Description

ORBITAL IMPLANT

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Pat. App. No. 63/545,064 filed October 20, 2023, the disclosure of which is hereby incorporated by reference herein in its entirety.

BACKGROUND

[0002] As a result of trauma, bone within a mammalian orbit may be damaged and require reconstruction. Implant designs have been developed in the past that are specifically tailored to provide such reconstruction. However, many existing implants are supplied as flat plates that must be shaped using instrumentation prior to placement in a patient. In such cases, it may be very difficult to recreate a desired reconstruction surface, i.e., premorbid surface. Further, while some existing implant designs are preformed with three-dimensional characteristics, a user must often cut or adjust the plate to restore a premorbid anatomy.

[0003] Another challenge is that it has been difficult to obtain desirable patient outcomes in cases where an area in need of reconstruction includes more than one wall and one floor in an orbit. One reason for this is the difficulty in providing an implant that may serve such purpose. Yet another challenge has been the limited outcomes in terms of an implant shape obtained through intraoperative bending of the implant plate where such shape is necessary to properly fit the implant. Typically, intraoperative bending involves assessment of an intraoperative scan of the orbit to evaluate a shape and position of the relevant anatomy followed by adjustment of a shape of the plate based on a visual review of the scan. This ultimately is an iterative process, as the user checks the fit after the first adjustment, but will then review the scan again to make further adjustments if the initial fit is suboptimal. Moreover, even when a plate is shaped to fit in a patient, difficulties may arise in achieving accurate placement of the implant onto the bone in accordance with a surgical plan. Moreover, planning techniques to evaluate an existing condition of a bone structure and provide simulated reconstructions have been limited and thus have limited the potential for establishing a design that best satisfies specific reconstruction needs.

[0004] Accordingly, a need exists to develop improved implant designs for use in reconstructing bone within an orbital cavity. BRIEF SUMMARY

[0005] The present disclosure provides improved implant designs for use in a defective or damaged orbital cavity, and provides improved methods for designing such implants. In some embodiments, a reconstruction within an orbit of a patient may include the provision of two or more implants to repair all deficient surfaces. The implants used for such a reconstruction may include various physical indicators to improve the accuracy of implant placement on the bone surface of the patient and the positioning of each implant relative to one or more other implants also being implanted in the same orbital cavity. Physical indicators may aid with positioning, the use of navigation tools, or both. In methods of designing such implants, data aggregation techniques may be used to generate representative healthy bone structure in an orbit to guide a proposed reconstructed structure, and the method further contemplates user customization of a reconstruction plan further to that generated using representative data.

[0006] In one aspect, the present disclosure relates to methods of designing a facial implant. In these methods, a virtual three-dimensional model of a facial skeleton of a patient may be used. In one embodiment, a method includes, in a first example: defining a defect area within a bone surface at least partially within an eye orbit of the facial skeleton; generating a reconstructed bone surface within the bone surface based on the definition of the defect area, the reconstructed bone surface being distinguishable from an unmodified bone surface of the bone surface that is outside of the defect area; marking a plurality of points having three- dimensional coordinates on a display of the bone surface where a boundary of the reconstructed bone surface is distinguishable from the unmodified bone surface, the plurality of points collectively defining a facial implant outer perimeter and the facial implant outer perimeter encompassing at least a majority of the reconstructed bone surface; and generating a virtual facial implant model based on the facial implant outer perimeter, wherein upon generating the virtual facial implant model, a position of the virtual facial implant model on the facial skeleton is verifiable based on a visualization of a position of the virtual facial implant model on the reconstructed bone surface and based on a visualization of the position of the virtual facial implant model on a two-dimensional image of the facial skeleton.

[0007] In a second example of the first embodiment, the method may include defining surface contours of the virtual facial implant model based on a surface contour of the reconstructed bone surface. In a third example, the method of any one of the first and second examples may include marking one or more fastener opening locations on the display of the bone surface such that the generated virtual facial implant model includes fastener openings at the one or more fastener opening locations.

[0008] In a fourth example of the first embodiment, the method of any one of the first through third examples may include marking a plurality of guidance points on the bone surface such that a line connected by the plurality of guidance points defines a location of a guidance line on the virtual facial implant model. In a fifth example, the method of the fourth example may include marking the plurality of guidance points defines the location of the guidance line such that when the virtual facial implant model is generated, the virtual facial implant model includes an elongate protrusion coincident with the location of the guidance line. In a sixth example, the method of the fourth example may include marking the plurality of guidance points defines the location of the guidance line such that when the virtual facial implant model is generated, the virtual facial implant model includes a plurality of openings arranged in sequence in a line.

[0009] In a seventh example of the first embodiment, the method of any one of the first through sixth examples may include utilizing pre-operative scans of the patient to visualize a bone thickness in a region of the bone surface including at least the defect area and defining a thickness of the virtual facial implant model based on the bone thickness. In an eighth example, the method of the seventh example may include defining the thickness of the virtual facial implant model within a range from 0.3mm to 0.9mm. Thus, for instance, the thickness of the virtual facial implant may be 0.3mm, 0.6mm or 0.9mm. In a ninth example, the method of seventh example, the method may include determining a fastener length of a fastener based on the bone thickness, the fastener being configured for use with a physical facial implant fabricated based on the virtual facial implant model. In a tenth example, the method of any one of the first through ninth examples may include marking medial and lateral location labels on respective medial and lateral locations of an upward facing surface of the virtual facial implant model. In an eleventh example, the method of any one of the first through tenth examples may include designating a body of the virtual facial implant model as having a mesh surface, the mesh surface including an array of through holes that collectively define a pattern on the body. In a twelfth example, the method of any one of the first through eleventh examples may include generating the reconstructed bone surface is based on mirroring of a second eye orbit opposite the eye orbit or statistical shape modelling. In a thirteenth example, the method of any one of the first through twelfth examples may include defining the defect area includes viewing the facial skeleton in a first plurality of planes parallel to the coronal plane and in a second plurality of planes parallel to the sagittal plane, and, for each plane of the first and second plurality of planes, marking a line on the facial skeleton representing a two-dimensional extent of the defect area in the respective plane. In a fourteenth example, the method of any one of the first through thirteenth examples may include use of a pre-operative image as the two-dimensional image.

[0010] In yet another example, the method of design of the first embodiment may be part of a method of manufacturing a facial implant that includes: designing the virtual facial implant model according to the first embodiment and fabricating a physical facial implant based on the virtual facial implant model.

[0011] In a second embodiment, a first example of a method of designing a facial implant for an eye orbit with a defect includes: defining a bone defect area in an orbit of a virtual facial skeleton of a patient by: viewing the virtual facial skeleton in a plurality of coronal views, and in each view of the plurality of coronal views, marking a respective profile of the defect in the orbit; and viewing the virtual facial skeleton in a plurality of sagittal views, and in each view of the plurality of sagittal views, marking a respective profile of the defect in the orbit, generating a virtual reconstruction of bone on the virtual facial skeleton based on the profiles marked in the plurality of coronal views and in the plurality of sagittal views; marking a plurality of adjustable points on the facial skeleton to define an enclosed boundary, the enclosed boundary overlapping with a majority of an area representative of the virtual reconstruction of bone; and generating a virtual facial implant model with an outer perimeter based on the enclosed boundary and a bone facing surface with a contour complementary to the virtual reconstruction of bone.

[0012] In a second example of the second embodiment, the method of the first example may include moving a first adjustable point of the plurality of adjustable points after marking the first adjustable point to refine the enclosed boundary. In a third example, the method of any one of the first or second example may include generating the virtual reconstruction of bone includes utilization of statistical shape modeling to generate the virtual reconstruction of bone based on the profiles marked in the plurality of coronal views and in the plurality of sagittal views. In a fourth example, the method of the third example may include viewing the virtual reconstruction of bone in at least one of a second plurality of coronal views and a second plurality of sagittal views and manipulating a profile of the virtual reconstruction of bone in the at least one of the second plurality of coronal views and the second plurality of sagittal views to alter the virtual reconstruction of bone to a modified virtual reconstruction of bone. [0013] In a second aspect, the present disclosure relates to an orbital implant system. In a first example of a first embodiment, an orbital implant includes a first implant and a second implant. The first implant is shaped to fit onto a first bone surface within an orbital cavity of a patient, the first implant having a first upper surface, a first bone facing surface opposite the first upper surface and a first line portion having a length along the first upper surface. The first line portion includes a first surface interruption in the first upper surface that defines a first line, the first line portion extending toward a first edge location of the first implant. The second implant is shaped to fit onto a second bone surface within the orbital cavity, the second implant having a second upper surface, a second bone facing surface opposite the second upper surface and a second line portion having a length along the second upper surface. The second line portion includes a second surface interruption in the second upper surface that defines a second line, the second line portion extending toward a second edge location of the second implant. The bone surfaces upon which the implants are designed, namely, the first bone surface and the second bone surface, are separate from each other. And, when the first implant and the second implant are fitted within the respective bone surfaces in the orbital cavity, the first line portion and the second line portion are aligned along a single path such that a shape of the first line portion approaching the first edge location and a shape of the second line portion extending away from the second edge location are part of a single path while accounting for a space between the first and second edge locations.

[0014] In a second example of the first embodiment, the implant of the first example may have a structure such that the first surface interruption is a first elongate ridge and the second surface interruption is a second elongate ridge. In a third example of the first embodiment, the implant of the second example may be structured such that the first and second elongate ridges are curved over at least a portion of their respective lengths. In a fourth example of the first embodiment, the implant of the first example may be structured such that the first surface interruption is a first plurality of positioning openings arranged in sequence to define the first line and the second surface interruption is a second plurality of positioning openings arranged in sequence to define the second line. In a fifth example of the first embodiment, the implant of any one of the first through fourth examples may also include at least one ring- shaped protrusion extending from the first upper surface, the ring-shaped protrusion including a cavity therein adapted to receive a pointer tool. In a sixth example of the first embodiment, the implant of any one of the first through fifth examples may be structured such that one or both of the first implant and the second implant include a region having a mesh structure.

[0015] In a seventh example of the first embodiment, the implant of any one of the first through sixth examples may include a first outer edge with a first outer edge portion and the second implant may include a second outer edge with a second outer edge portion. In this arrangement, the first and second outer edge portions define a gap therebetween, the gap having a predetermined maximum and minimum width dimension along a length of the respective edge portions. In an eighth example, the implant of the seventh example may be structured such that the first edge portion has a first contour and the second edge portion has a second contour generally aligned with the first contour. In a ninth example, the implant of the eighth example may be structured such that the first contour has a zig-zag shape or a puzzle-piece shape.

[0016] In a tenth example of the first embodiment, the implant of any one of the first through ninth examples may include a plurality of supplemental implants, each of the plurality of supplemental implants being disposable in the orbital cavity on surfaces other than the first and second surfaces. In an eleventh example, the implant of any one of the first through tenth examples may include a third line portion having a length along the first upper surface, the third line portion including a third surface interruption in the first upper surface that defines a third line. The implant may also include a fourth line portion having a length along the second upper surface, the fourth line portion including a fourth surface interruption in the second upper surface that defines a fourth line. In this arrangement, the third surface interruption and the fourth surface interruption may be part of a second single path while accounting for a space between a first end of the third surface interruption and a second end of the fourth surface interruption, the first end being the closest location on the third surface interruption to the fourth surface interruption. In a twelfth example, the implant of the eleventh example may be structured such that the first and second surface interruptions are respective first and second elongate ridges and the third and fourth surface interruptions are respective sets of positioning openings arranged in sequence in a line.

[0017] In a first example of a second embodiment, a facial implant system includes a first implant and a second implant. The first implant has a first thickness and includes a first bone-facing surface shaped to complement a first bone surface within an orbit of a patient. Further, the first implant has a first alignment edge forming part of an outer perimeter of the first implant, the first alignment edge having a length extending from a first portion of the first implant configured for placement on the first bone surface remote from a rim of the orbit to a second portion of the first implant configured for placement on a second bone surface outside of the orbit. The second implant has a second thickness and includes a second bone-facing surface shaped to complement a third bone surface within the orbit. Further, the second implant has a second alignment edge forming part of an outer perimeter of the second implant, the second alignment edge having a length extending from a first portion of the second implant configured for placement on the third bone surface remote from the rim of the orbit to a second portion of the second implant configured for placement on a fourth bone surface outside of the orbit. Moreover, the first and second implants are designed to be arranged such that the first alignment edge and the second alignment edge are aligned along a majority of the lengths of the respective first and second alignment edges such that where the first and second alignment edges are aligned, the first and second alignment edges are separated by a gap. A width dimension of the gap is measured as the shortest distance between the implant edges at any location along either alignment edge. Because the edges are aligned along the gap, such distance is typically measured orthogonally relative to a direction of the respective alignment edges.

[0018] In a second example of the second embodiment, the implant system of the first example may be arranged such that the width dimension of the gap separating the first and second implants may be less than 5.0mm. In a third example of the second embodiment, the implant system of any one of the first and second examples may be arranged such that the first thickness and the second thickness are each in a range from about 0.3mm to about 0.9mm. In a fourth example of the second embodiment, the implant system of any one of the first through third examples may include a third implant with a third bone-facing surface shaped to complement a fifth bone surface within an orbit of a patient, the third implant having a third alignment edge forming part of an outer perimeter of the third implant. The third alignment edge may have a length extending from a first portion of the third implant configured for placement on the fifth bone surface remote from the rim of the orbit to a second portion of the third implant configured for placement on a sixth bone surface outside of the orbit. The third alignment edge may be aligned with a fourth alignment edge forming part of the outer perimeter of the first implant along a majority of the lengths of the respective third and fourth alignment edges such that where the third and fourth alignment edges are aligned, the third and fourth alignment edges are separated by a gap with a dimension separating the first and third implants that may be less than about 5.0mm. In a fifth example of the second embodiment, the implant system of any one of the first through fourth examples may include a first line defined by an elongate ridge on an upper surface of the first implant opposite the first bone-facing surface or a series of consecutive openings through the first implant. In a sixth example, the second implant in the implant system of the fifth example may include a second line defined by an elongate ridge on an upper surface of the second implant opposite the second bone-facing surface or a series of consecutive openings through the second implant, the second line and the first line being aligned such that the first and second lines define a single continuous line but for the gap between the first and second implants.

[0019] In a seventh example of the second embodiment, the implant system of any one of the first through sixth examples may be configured such that one of the first alignment edge and the second alignment edge includes a recessed edge such that when the first alignment and the second alignment edge are aligned along the majority of the lengths of the respective first and second alignment edges, the recessed edge defines part of a hole-shaped region between the first and second implants. In an eighth example, the implant system of any one of the first through seventh examples is structured such that a contour of the first bone-facing surface and the second bone-facing surface, and a shape of the outer perimeter of the first implant and the second implant, may be determined based on statistical shape modeling. In a ninth example, the implant system of any one of the first through eighth examples may be configured such that the majority of the of the lengths of the respective first and second alignment edges are shaped based on contours of an underlying bone surface of the patient. In a tenth example, the implant system of any one of the first through ninth examples may be configured such that portions of the first alignment edge and the second alignment edge that are aligned with each other have a zig-zag shape.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] A more complete appreciation of the subject matter of the present disclosure and of the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which: [0021] FIG. 1 is a perspective view of an implant positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0022] FIG. 2 is a perspective view of an implant according to one embodiment of the present disclosure;

[0023] FIG. 3 is a front view of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0024] FIG. 4 is a front view of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0025] FIG. 5 is a front view of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0026] FIG. 6 is a front view of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0027] FIG. 7 is a front view of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0028] FIGs. 8-9 are respective front views of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0029] FIGs. 10-11 are respective close up front views of the implant system of FIGs. 8-9;

[0030] FIGs. 12-13 are respective front views of an implant system positioned on bone surfaces in and around an orbit of a patient according to one embodiment of the present disclosure;

[0031] FIG. 14 is a front view of an implant system according to one embodiment of the present disclosure; and

[0032] FIGs. 15A-19B show respective steps in a method of designing an implant according to one embodiment of the present disclosure.

DETAILED DESCRIPTION

[0033] As used herein unless stated otherwise, the term “anterior” means toward the front part of the body or the face and the term “posterior” means toward the back of the body. The term “medial” means closer to or toward the midline of the body, and the term “lateral” means further from or away from the midline of the body. The term “inferior” means close to or toward the feet, and the term “superior” means closer to or toward the crown of the head. 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.

[0034] In a first aspect, the present disclosure relates to an implant adapted for placement at least partially on a bone surface that defines a mammalian orbit. In one embodiment, implant 10, shown in FIG. 1 as implanted within a patient, includes a portion on a bone surface 9 within an orbit 2 of the patient and a portion that extends out of orbit 2 onto peripheral rim 7, where implant 10 is anchored in place with two fasteners 29.

[0035] In another embodiment, implant 110 is shown in FIG. 2. Implant 110 has a sheet-type structure with an upper surface 112 and a bone-facing surface opposite the upper surface (not shown). Implant 110 may have a generally constant thickness throughout. In some non-limiting examples, a thickness of implant 110 may be 0.3mm, 0.6mm or 0.9mm, or other another thickness in between. Implant 100 includes a plurality of holes 114 that collectively form a pattern and provide implant 110 with a mesh-type surface. As shown, each hole of the plurality of holes 114 is hexagonal in shape, although the holes may also have other shapes. In other examples, the plurality of holes may occupy a lesser portion of a surface area of the implant than that shown in FIG. 2. In still further examples, the implant may have a partially solid surface, such as extension apron 125 in implant 110. In variations of these examples, the implant may have a generally solid surface overall without any hole patterns. Such an implant may appear similar to implant 410 in FIG. 5, described in greater detail elsewhere in the present disclosure. Implant 110 may be formed to have a shape customized so that a bone-facing surface of the implant has contours to take into account and complement a planned bone reconstruction surface in a patient. Thus, for implant 110 implantable into an orbit, implant 110 may have a bone-facing surface with contours that conform to a bone surface in the orbit and in any surrounding bone surface region that will receive the implant. One example of how such implant shape is leveraged to achieve a fit within a patient is shown via implant 10 shown in FIG. 1 referenced above, where implant 10 is positioned in orbit 2 based on a planned reconstructed bone surface 9.

[0036] With continued reference to FIG. 2, a periphery of implant 110 includes an extension apron 125 and an extension arm 126. Extension apron 126 extends from a central region 115 of implant 110 to a free end 125A. Proximate free end 125A are spaced apart holes 127A, 127B. Holes 127 A-B are sized to receive a fastener, such as a bone screw. In such manner, anchorage of fastener through holes 127 A-B may be used to secure implant 110 in place on a bone surface. On an inner side of extension apron 125 opposite free end 125A is a set of positioning openings 122, described in greater detail below. Similar to extension apron 125, extension arm 126 also extends from central region 115 of implant 1110 to a free end 126A. Extension arm is narrower than apron and may have a width minimized to be sufficient to allow for anchorage of fasteners through openings 127C, 127D in the extension arm while also minimizing bone-facing surface area. As with holes 127 A-B, holes 127C-D may also receive fasteners to anchor implant 110 onto a bone surface. In variations of the implant, it should be appreciated that holes sized for receipt of fasteners may additionally or alternatively be located in the central region of the implant.

[0037] Implant 110 includes a series of additional surface features that improve and simplify implantation of the implant. These include the previously mentioned set of positioning openings 122, elongate ridge 132, and ring protrusions 137A-C. It should be appreciated that while implant 110 shown in FIG. 2 includes each of these surface features, these feature are all optional and may be custom designed by a user, as described in greater detail elsewhere in the present disclosure. Thus, for example, a user may choose to design an implant with none of the features or one or more of the features. Additionally, the shape, location and alignment of the features may be customized by a user in the design process. The set of positioning openings 122 includes three adjacent openings in sequence extending across a width of extension apron 126 at the location of the openings. Each opening is separated by a structural connector 121 to define a size and a spacing of the openings. Collectively, set of positioning openings 122 may function advantageously as a guide to confirm whether implant 110 is properly positioned in an intended location on the bone of a patient. For example, a line of bone surface is visible through the openings, and this aids the user in visualizing the implant position on a bone surface and thus position the implant. More generally, other advantages of the sets of positioning openings include that such openings may be used to allow drainage through the implant when the implant has a solid structure without a mesh. Further, in variations of the design where the implant is part of a system with two or more implants, the sets of positioning openings may be used to position the implants with respect to each other. This is described in greater detail elsewhere in the present disclosure.

[0038] In some variations, positioning openings may be located on the implant to define a boundary between what would ultimately be two separate implants. In this manner, the implant may be designed and fabricated with a set of positioning openings extending from one edge to another, then, either pre-operatively or intraoperatively, the implant may be cut into two parts along the line of the positioning openings. In a specific example, a design with a set of positioning openings to serve this purpose may aid in positioning the implant accurately in a patient. Specifically, an overall implant with the positioning openings intact may be disposed in the orbit of the patient and holes may be pre-drilled into the patient at such time to set a position for anchoring respective parts of the implant on opposite sides of the set of positioning openings. Then, with holes drilled, the implant may be removed, cut along the set of positioning openings, and then placed into the orbit again as two separate implants. At such time, the pre-drilled holes may be used as a reference to properly position the newly separate implant parts.

[0039] Elongate ridge 132 extends from a first end 133 to a second end 134 as shown in FIG. 2, and is a singular structure raised relative to a remainder of upper surface 112. Elongate ridge 132 is sufficiently raised relative to upper surface 112 so that a stylus or pointer may be moved along elongate ridge 132 with an expectation that such stylus or pointer will remain predictably on the elongate ridge. Implant 110 also includes ring protrusions 137A, 137B, 137C, each spaced apart from the others and protruding relative to upper surface 112 of implant 110. Each ring protrusion has a protruding ring with a cavity therein, as shown in FIG. 2. In this way, a stylus or pointer may be moved into the cavity of one of the ring protrusions and stay in place with the ring surrounding the tip of the stylus. Both elongate ridge 132 and ring protrusions 137A-C are particularly advantageous as navigation aids, as is described in greater detail elsewhere in the present disclosure. Implant 110 may also include markings to identify an orientation, surface, side or other identifier of the implant. For example, implant 110 includes a raised surface 139 in the shape of the number “1” on the upper surface of central region 115 adjacent to extension arm 126. In other non-limiting examples, the upper surface of the implant may include raised surfaces shaped as “M” and “L” to denote medial and lateral. [0040] The above described features, such as the sets of consecutive positioning openings, the ring protrusions and the elongate ridge, are all optional features to include on an implant and when included may have a shape and a location on the implant surface as desired by a user. This is one aspect of the patient-specific design options available for defining the characteristics of an implant configured to be received in an orbit. Greater detail regarding patient specific approaches to implant design are described elsewhere in the present disclosure. Another option for inclusion with the implant is an informational tag 119 that may be formed or attached onto the implant. Informational tag 119 may include various details about the implant and may be advantageous for storage and distribution.

[0041] Implant 110 may be made of a variety of suitable biocompatible materials including metallic materials, polymeric materials and composites. One example of a metallic material that may be used is titanium. One example of a polymeric material that may be used is poly ether ether ketone (PEEK). Another material that may be used to form the implant is MEDPOR® by Stryker®. These materials may also be used in combination. For example, an implant may be formed of a metallic material, such as titanium, with a coating of MEDPOR®. While reference is made to implant 110 for these materials, it should be appreciated that any one of the implants contemplated by the present disclosure may be made from any one of the contemplated materials.

[0042] In a second aspect, the present disclosure relates to an implant system that includes two or more implants that are used together to repair or reconstruct an orbit and/or a surrounding region of a patient. In this aspect, the two or more implants may sufficiently cover a surface area in the orbit intended for such repair or reconstruction by having design shapes that call for the implants to be positioned very close to each other while still maintaining a minimum separation such that each implant performs independently. These arrangements are advantageous in that an access portal into a patient for a surgery that includes implantation of two implants may be smaller than an access portal needed to complete the same surgery where a larger single implant is used to provide the same amount of coverage as the two implants. Overall, the use of separate smaller implants provides a user with more flexibility in the performance of a reconstruction procedure than would otherwise be available when using a single larger implant.

[0043] In one embodiment shown in FIG. 3, a system 201 includes a first implant 210 and a second implant 240. Reference numerals indicated by the 200 series of numerals refer to like reference numerals in the 100 series of numerals shown in FIG. 2, unless otherwise indicated. Implant 210 includes a central region 215 contoured to fit on bone surface 209 within the orbit of the patient and an extension apron 225 and extension arm 226 contoured to fit along portions of peripheral rim 207 outside of the orbit. In implant 210, central region 215 is generally solid and does not include a plurality of holes to define a mesh pattern, although in variations of the depicted embodiment, the central region may have such holes to form a mesh. A shape of central region 215 may include a peripheral edge that has a variety of curves, as shown in FIG. 3, where such shape is based on a custom design by a user, as described elsewhere in the present disclosure. And, in a standard procedure, such custom design of an implant shape may be based on an area of bone surfaces in and around the orbit that are to be reconstructed. In FIG. 3, bone surface 209 is already shown as reconstructed via software for planning and design purposes. Such images may be generated and displayed to a user as part of a design process described elsewhere in the present disclosure. Extension apron 225 extends from central region 215 and is shaped to fit along a portion of peripheral rim 207. Similarly, extension arm 226 extends from central region 215 and is shaped to fit another portion of peripheral rim 207 separate from that covered by extension apron 225. Extension arm 226 is spaced apart from extension apron 225. Extension arm 226 includes two holes 227 A-B adapted for receipt of fasteners to secure implant 210 to the bone of the patient.

[0044] Implant 210 also includes three separate sets of positioning openings extending across different parts of the implant. A first set of positioning openings 222A extends across a width of extension apron 225 so that when implant 210 is in its intended position on a patient bone surface, first set of positioning openings 222A is aligned along a ridge of peripheral rim 207. A second set of openings 222B extends across an entirety of central region 215, and, at an inward end of implant 215, a third set of positioning openings 222C, also extends across a narrower portion of central region 215. Each set of positioning openings 222A-C and their respective alignments is shown in FIG. 3. In some variations, the sets of positioning openings may be shaped to have a different length than that shown such that the total number of positioning openings in a specific set is fewer or greater than that shown. In one specific example, the positioning openings in a set may be sized so that there are no more than six openings in any one set. Thus, a variation of the implant in FIG. 3 may have a middle set of positioning openings with six openings total in place of the eight openings in second set of openings 222B.

[0045] Turning to second implant 240, second implant 240 includes central region 245 and extension arm 256. As with first implant 210, central region 245 of second implant 240 is solid, although in variations, the central region may include a plurality of holes to define a mesh. Extension arm 256 includes holes 257A-B adapted for receipt of fasteners. Implant 240 also includes a set of positioning openings 252 extending across central body 215. [0046] An additional defining characteristic of first implant 210 and second implant 240 is that each is shaped to complement the other. As a general matter, it is the combination of first and second implants 210, 240 that provides the support for a single reconstruction or repair, as shown in FIG. 3. To provide such support, each implant is shaped so that the implants are positionable close to each other without being in contact with each other. In this manner, first implant 210 has an alignment edge 216 that is on a side of first implant 210 closest to second implant 240. Similarly, second implant 240 has an alignment edge 246 on a side of second implant 240 closest to first implant 210. These respective alignment edges 216, 246, have the same or similar alignment over at least part of a distance where the respective implants face each other. For example, in FIG. 3, the implants are designed so that alignment edges 216, 246 are generally parallel and aligned with each other from extension arms 226, 256 to the sets of openings 222B, 252. In this manner, alignment edges 216, 246 as depicted in FIG. 3 are aligned over a majority of a length of gap 208.

[0047] Turning to the relative position of the implants when implanted in the patient, first and second implants 210, 240 define a gap 208 therebetween. While shown as a final design, implants 210, 240 may be generated during a design process that may be programmed to ensure a minimum separation, i.e., gap 208, between implants 210, 240. Thus, while an entire perimeter of each implant may be provided as input into design software that generates proposed implant structures and their placement locations in the patient, as described elsewhere in the present disclosure, such software may include a setting that may modify the implants to ensure a minimum gap is present between the implants in a proposed placement location within a patient if the proposed design does not already provide a gap that meets the minimum requirement. In some examples, the minimum gap between two implants may be in a range from about 0.5mm to about 2.0mm. Additionally, and in a similar manner, the software may be programmed so that there is a maximum gap between the implants. In some examples, this may be in a range from 1.0mm to 5.0mm. While the above explanation and accompanying examples relating to the gap between implants is made with respect to implant system 201, it should be appreciated that similar principles may apply to the other implant systems contemplated by the present disclosure.

[0048] It should also be appreciated that first and second implants 210, 240 are designed so that second set of positioning openings 222B on implant 210 are aligned with the set of positioning openings 252 on second implant 240. Put another way, the sets of positioning openings 222A, 252 are aligned so that the alignment extends across the respective alignment edges 216, 246. Such alignment facilitates the use of the collective sets of positioning openings in a continuous manner as if they were a single set of positioning openings. In one surgical application, this allows the first implant and second implant to be properly positioned with respect to each other by checking the alignment of the respective sets of positioning openings when the implants are in position on a bone surface. Moreover, each set of positioning openings may also be used to independently aid in the verification of a position of the individual implants relative to underlying bone.

[0049] While implant system 201 is depicted with sets of positioning openings but does not include an elongate ridge or ring protrusion, it should be appreciated that in variations, one or both of first and second implants 210, 240 may include one or more elongate ridges, one or more ring protrusions, or both. Similarly, sets of positioning openings may be arranged differently from those shown in FIG. 3. These variations may be established during design of the implant to suit the needs of a particular surgery and the anatomy of the patient receiving the implants. These variations may similarly apply to any of the implant systems contemplated by the present disclosure.

[0050] In another embodiment, shown in FIG. 4, an implant system 301 includes first implant 310, second implant 340 and third implant 370. Reference numerals indicated by the 300 series of numerals refer to like reference numerals in the 200 series of numerals shown in FIG. 3, unless otherwise indicated. First implant 310 has a central region 315 and an extension apron 325. Central region 315 is solid and includes a set of positioning openings 322 extending across its width, as shown in FIG. 4. When positioned in a patient, extension apron 325 extends out of orbit and onto frontal bone 304. Extension apron 325 also includes holes 327 A-B therethrough adapted for receipt of fasteners. Second implant 340 includes central region 345, extension apron 355 extending from central region 345, and extension arm 356 extending from extension apron 355. Central region 345 includes a plurality of holes 344 to define a mesh in the central region. Both extension apron 355 and extension arm 356 are shaped and designed so that they are positionable onto peripheral rim 307 when implanted in a patient, with portions extending onto zygomatic bone 306 and the maxilla. Extension apron 355 includes hole 357C and extension arm 356 includes holes 357A-B. Third implant 370 includes central region 375 and an extension apron extending therefrom. Central region 375 includes a plurality of holes 374 to define a mesh in the central region. The extension apron includes a first part 385A and a second part 385B, both extending onto peripheral rim 307 when implanted on a patient, with first part 385A of extension apron extending further over one or both of zygomatic bone 306 and the maxilla. Extension apron 385A-B includes five holes 387A-E adapted for receipt of fasteners in the design as shown.

[0051] Similar to implant system 201, the implants of implant system 301 are shaped so that when implanted in a patient, each implant 310, 340, 370 has outside edges to complement at least one of the other implants so that the implants may be fitted adjacent to each other as shown in FIG. 4. Specifically, first implant 310 has alignment edge 316 that is on a side of first implant 310 closest to second implant 340. To complement alignment edge 316, second implant 340 has a first alignment edge 346 on a side of second implant 340 closest to first implant 310. These respective edges 316, 346, have the same or similar alignment over at least part of a distance where the respective implants face each other. A similar relationship between alignment edges exists between second implant 340 and third implant 370, where second alignment edge 347 on a side of implant 340 closest to third implant 370 has the same or similar alignment to alignment edge 376 of third implant 370 over at least part of a distance where the respective implants face each other. As shown in FIG. 4, alignment edge 376 is on a side of third implant 370 closest to second implant 340. In a region of second and third implant 340, 370 configured for implantation outside of the orbit, respective alignment edges 347, 376 move away from each other to create a larger hole-shaped region along second gap 308B over a limited distance along gap 308B. Such hole-shaped region between the implants allows for the avoidance of the infraorbital foramen when the implants are implanted in their intended locations on the anatomy. In variations, this principle may be applied to other surface regions by having a design with open regions to avoid specific locations on a bone surface. Additionally, inclusion of a hole-shaped region may aid in the implantation of the implant through increased visualization of the bone surface below the implants.

[0052] Further, and also similar to implant system 201, the implants of implant system 301 include sets of positioning openings, with first implant 310 including a first set of positioning openings 322, second implant 340 including a second set of positioning openings 352 and third implant 370 including a third set of positioning openings 382. Each set of positioning openings 322, 352, 382 extends across a width of the respective implants in the respective central regions 315, 345, 375, as shown in FIG. 4. Collectively, the sets of positioning openings 322, 352, 382 define a single positioning line curving and extending across the three implants 310, 340, 370. In this manner, even though there is a first gap 308A between the first and second implants and a second gap 308B between the second and third implants, the sets of positioning openings are aligned as if they were a single continuous line, as shown in FIG. 4. As mentioned elsewhere in the present disclosure, the inclusion of such sets of positioning openings provides an additional means to confirm a position of each implant on the patient and a position of each implant with respect to the other implants when implanted during surgery.

[0053] In another embodiment, shown in FIG. 5, an implant system 401 includes first implant 410 and a second implant 440. Reference numerals indicated by the 400 series of numerals refer to like reference numerals in the 200 series of numerals shown in FIG. 3, unless otherwise indicated. First implant 410 includes central region 415 and first and second extension arms 426, 428. Second implant 440 includes a central region 445 and an extension apron with a first part 455A and a second part 455B. Both central region 445 and extension apron 455A-B have a mesh patterned structure based on a plurality of holes 444 distributed over a majority of second implant 440. A gap 408 between implants 410, 440 is defined based on an intended implanted position of the respective implants when positioned in a patient. First implant 410 has an alignment edge 416 that is on a side of first implant 410 closest to second implant 440. Similarly, second implant 440 has an alignment edge 446 on a side of second implant 440 closest to first implant 410. These respective edges 416, 446, have the same or similar alignment over part of a distance where the respective implants face each other. One subregion where edges 416, 446 are not aligned, however, is where second implant 440 includes a recessed edge 446A, as shown in FIG. 5. When implanted in a patient, recessed edge 446A defines a hole-shaped region of an exposed anatomical surface region between first implant 410 and second implant 440. Such exposed surface region may serve to provide greater visibility of the existing anatomy, to avoid coverage of certain anatomy, or both, and may be determined at user discretion as part of the design process.

[0054] In another embodiment, shown in FIG. 6, an implant system 501 includes first implant 510 and a second implant 540. Reference numerals indicated by the 500 series of numerals refer to like reference numerals in the 200 series of numerals shown in FIG. 3, unless otherwise indicated. In system 501, first and second implants 510, 540 are shaped to be positioned side-by-side, as with other embodiments described in the present disclosure, although implants 510, 540 have respective alignment edges 516, 546 that curve along their length to provide a puzzle-piece type relationship between the implants. Specifically, alignment edge 516 of first implant 510 has alternating projections and recesses along one direction of the edge with a sequence of a first edge projection 516A, a first edge recess 516B, a second edge projection 516C, and finally a second edge recess 516D. Alignment edge 516 is one example of a zig-zag shaped edge or contour. Similarly, alignment edge 546 has alternating recesses and projections to complement those of the first implant, with a sequence of a first edge recess 546A, a first edge projection 546B, a second edge recess 546C, and finally a second edge projection 546D. In this manner, when placed into position in an orbit of a patient, first edge projection 516A is positioned proximate first edge recess 546A, first edge recess 516B is positioned proximate first edge projection 546B, and so on, as shown in FIG. 6. Such an arrangement produces a gap 508 between first and second implants 510, 540 with a generally constant width along its length between alignment edges 516, 546.

[0055] In another embodiment, shown in FIG. 7, an implant system 601 includes a first implant 610 and a second implant 640. Reference numerals indicated by the 600 series of numerals refer to like reference numerals in the 200 series of numerals shown in FIG. 3, unless otherwise indicated. Implant system 601 is another variation of the puzzle-piece configuration of implant system 501 described above and shown in FIG. 6. First alignment edge 616 of first implant 610 includes first edge recess 616A, first edge projection 616B and second edge recess 616C, each located in sequence along a length of edge 616. Second alignment edge 646 of second implant 640 includes a first edge projection 646A, a first edge recess 646B and a second edge projection 646C, each also located in sequence along a length of edge 646. In this manner, when placed into position in a patient, first edge recess 616A is positioned proximate first edge projection 646A, first edge projection 616B is positioned proximate first edge recess 646B, and second edge recess 616C is positioned proximate second edge projection 646C, as shown in FIG. 7. Such an arrangement produces gap 608 between first and second implants 610, 640 with a generally constant width along its length between alignment edges 616, 646.

[0056] In another embodiment, shown in FIGs. 8-11, an implant system 701 includes a first implant 710, a second implant 740 and a third implant 770. Reference numerals indicated by the 700 series of numerals refer to like reference numerals in the 300 series of numerals shown in FIG. 4, unless otherwise indicated. Each implant includes an elongate ridge, and the elongate ridges collectively function as a single elongate ridge when all three implants are implanted as intended in a patient. Specifically, implant 710 includes a first elongate ridge 732 having a length from a first end 733 to a second end 734 that extends across a width of central region 715, as shown in FIG. 8. Implant 740 includes second elongate ridge 762 having a length from a first end 763 to a second end 764 that extends across a width of central region 745, as shown in FIGs. 8 and 9. Implant 770 includes third elongate ridge 792 having a length from a first end 793 to a second end (not shown) that extends across a width of central region 775, as shown in FIG. 9. Each elongate ridge has a curvature along its length, although their shared alignment is apparent in that the alignment of the elongate ridge is continuous across gaps 708A, 708B between the individual implants. Continuity between first elongate ridge 732 and second elongate ridge 762 is shown in FIG. 10 and continuity between second elongate ridge 762 and third elongate ridge 792 is shown in FIG. 11.

[0057] In another embodiment, shown in FIGs. 12-13, an implant system 801 includes a first implant 810, a second implant 840 and a third implant 870. Reference numerals indicated by the 800 series of numerals refer to like reference numerals in the 300 series of numerals shown in FIG. 4, unless otherwise indicated. Implant system 801 is similar to implant system 301, other than differences in the exact shape of the implants and the extent of alignment of opposing edges between the implants. First implant 810 includes a first set of positioning openings 822 extending from a first end 823 to a second end 824 across a width of central region 815. Second implant 840 includes a second set of positioning openings 852 extending from a first end 853 to a second end 854 across a width of central region 845. And, third implant 870 includes a third set of positioning openings 882 extending from a first end 883 to a second end 884 across a width of central region 875. Collectively, the sets of positioning openings 822, 852, 882 define a single positioning line curving and extending across the three implants 810, 840, 870. In this manner, even though there is a first gap 808 A between the first and second implants and a second gap 8O8B between the second and third implants, the sets of positioning openings are aligned as it they were a single continuous line, as shown in FIGs. 12 and 13.

[0058] In another embodiment, shown in FIG. 14, an implant system 901 includes a first implant 910, a second implant 940 and a third implant 970. Second and third implants 940, 970 are bone plates designed for placement entirely outside of an orbit and may be positioned around a rim of the orbit, as shown in FIG. 14. These additional implants may be implants configured for implantation on the cranium, maxilla or mandible, among other anatomical bone structures on the facial skeleton. It is contemplated that a system can be provided that includes different types of implants, such as the combination shown in FIG. 14. Similarly, methods of design described in the present disclosure also contemplate methods that may incorporate different types of implants in order to provide combinations such as that shown in FIG. 14. Where advantageous, additional software configured for facial implant designs may be used in conjunction with the software implemented in the embodiments described herein to generate a complete surgical plan including implants designed for different regions on a facial skeleton.

[0059] The implant or implant system may be varied in many ways. For example, while the depicted embodiments of the implant system include systems with two and three implants, it is contemplated that up to at least six separate implants may be included in single orbit as part of a single reconstruction, where each of the implants are designed to complement the others within and around an orbit of a patient. It should also be appreciated that the embodiments shown in FIGs. 1-14 are merely illustrative of design features that may be incorporated into the implant or implants, and that an implant may have a shape and other features that are customized for a patient and therefore patient specific. Thus, a specific size of a patient orbit, the nature of the reconstruction needed, and a determination of what navigation features may be optimal for a specific procedure, such as elongate ridges, and/or positioning lines, may all be determined on a patient-by-patient basis.

[0060] In another aspect, the present disclosure relates to a kit including one or more implants for implantation in a patient. In some embodiments, a kit includes two or more implants. These implants may be the same or different from each other. In some examples, one or more of the implants are patient specific. In some examples, the implants are different but complement each other for use as an implant in a single patient. In some examples, the kit may include different types of implants, such as implants positionable within a mammalian orbit or on a skull surface outside of the orbit.

[0061] In any of the above contemplated kit embodiments, the kit may further include one or more fasteners for use in securing an implant to a bone. Further, any of the above contemplated embodiments may include instrumentation used in surgical procedures that include implantation of the implants. Further, in any one of the above 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 implants may be in one package and all of the fasteners in another. The items included in the kit may also be individually packaged. For example, each implant may be in its own package. Packaging each item in the kit separately or in different combinations may improve the preservation of sterility of the items in preparation for use with implantable materials or 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.

[0062] In another aspect, the present disclosure relates to methods of designing an implant or an implant system where the implant or implants are used to repair or reconstruct an orbit and surrounding region in a skull of a patient. A method of design may be part of a pre-surgical planning process and may utilize software to evaluate options for the surgery at issue and to determine an optimal implant or implants for 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.

[0063] In one embodiment, a method of designing an implant for use in an orbit of a patient involves the use of software to design the implant based on an existing condition of a patient’s facial anatomy. This embodiment will be described with reference to FIGs. 15A-19B. The method begins with an upload of an image, such as a CT scan, of a skull of the patient in need of orbital reconstruction. 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. The image data, having three-dimensional characteristics, is then separated into slices of image data from a series of horizontal, 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 image 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 axis across a width of the patient’s skull may be extracted. As will be described in greater detail below, these slices provide an enhancement on the options available to a user for planning a reconstruction of bone structure in the orbit and the implant to accompany the reconstruction. Further, as to the terminology for the referenced planes, it should be appreciated that throughout the 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.

[0064] Once the image data is uploaded for processing by the software, a user may view the existing condition of the skull to commence development of a plan for reconstruction of deficient bone surfaces. In this embodiment, illustrated in FIGs. 15A-19B, it is a left orbit 1012 of a skull 1001 of the patient that is in need of reconstruction. It should be appreciated, however, that repair of the left orbit described for this embodiment is merely illustrative, and that innumerable other repairs in and around one or both orbits of a skull are also contemplated. As shown in FIG. 15A, a user-interface may display four different views of skull 1001 of the patient. This display may be through a user-interface that is in operative communication with the computer system that runs the software. The four views, which may be displayed simultaneously, include an inferior horizontal plane 1051 (view from below), an anterior coronal plane 1052 (view from the front), a left sagittal plane 1053 (view from the left side), and a perspective view 1054. While FIG. 15A shows 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 around left orbit 1012 to be reconstructed 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. In the depicted embodiment, bars 1061, 1062, 1063 are displayed for this purpose at the bottom of respective views 1051, 1052, 1053. A line 1061A, 1062A, 1062B across such respective bars 1061, 1062, 1063 may indicate the current location, i.e., slice, along an extent of a dimension of a skull in the accompanying view, the dimension being represented by the dimensional extent of the total number of slices for that view. Thus, for example, line 1063A, somewhat to the right of a center of bar 1063, indicates that the displayed slice in the sagittal view 1053 is a bit off of a center of skull 1001. It should be appreciated that while in an optimal scenario, a CT scan of a patient is taken directly along or parallel a midline plane, such as the sagittal plane, it is possible that in some instances CT 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.

[0065] With the ability to manipulate the section cut displayed in different views of the bone to be reconstructed, here, the bone surfaces in and around left orbit 1012, the sectional planes displayed to the user may be adjusted to identify areas of a pre-operative bone surface 1018 within the left orbit that should have a reconstructed bone surface. This is known as defect definition 1101A-B. The software includes a marking tool 1102 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, across a dimension of the skull measured in an axis orthogonal to the view under consideration. For example, in anterior coronal plane view 1052 shown in FIGs. 15A-B, marking tool 1102 is moved across deficient parts of bone surface 1018 to mark a defect area 1104 for reconstruction as part of defect definition step 1101A. While viewing the same center location, a defect area 1106 may also be defined using marking tool 1102 in coronal plane view 1053, as shown in FIG. 15C, indicated as defect definition step 1101B. A center of the three viewing planes may be moved, e.g., by toggling a position of one or more of lines 1061A-1063A on respective bars 1061-1063, 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 identify a volume of bone, including surface area, to be reconstructed. For example, the coronal view 1052 may be adjusted along 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.

[0066] With continued reference to the defect definition step, in some examples, the software may include an algorithm to automatically interpret the provided defect definition so that the defect definition for any space left between marked slices may be automatically interpolated based on the actual information input by the user. Thus, in instances where only a limited number of slices in each view are marked with a defect definition, a physical space between the planes of such slices may be automatically interpolated to complete the defect definition. The number of marked defect areas necessary to fully identify the reconstruction area, e.g., the necessary quantity of different sectional views with marked defect areas, is a number that sufficiently captures the extent of the deteriorated bone structure so that a generated reconstruction surface is sufficiently representative of the required reconstruction to properly design an implant. In implementations where software to implement the method includes automatic interpolation between marked slices, fewer defect definition markings may be necessary to arrive at an adequate result. Thus, there is no specific minimum quantity of marked slices as a condition for generating a reconstructed bone surface, and the amount of marking may vary among the innumerable possibilities for reconstruction procedures.

[0067] When pre-operative bone surface 1018 within left orbit 1012, and around left orbit, as applicable, includes sufficient marking of defect areas to complete a defect definition, the software may process such defect definition to generate a defect reconstruction in a defect reconstruction step 1111, shown in FIGs. 16A-16E. In this method, the software may use mirroring 1113 or statistical shape modeling (SSM) 1112 to generate a reconstructed bone surface based on the defect definition, as shown by one example of a user interface with such options in FIG. 16B. Mirroring involves capturing an image of a healthy or otherwise undamaged and not deteriorated bone structure in an orbit opposing the orbit to be reconstructed and using a shape of the healthy orbit to reconstruct areas of the orbit at issue that are highlighted by the defect definition. 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. In some examples, use of SSM may be tailored so that a subset of images from a database are used, where the subset is selected based on images that may be grouped together from among the image data within the larger database.

[0068] Returning to the details of the reconstruction step 1111, in FIG. 16A, a bone surface of skull 1001 of the patient is reconstructed with an initial reconstructed surface 1118, based on implementation of an adaptive facial model, i.e., SSM. In other examples, mirroring may be used. The software may be configured to default to one modelling process, i.e., one of mirroring or SSM, or may be configured so that a user may manually select a modelling process for each individual patient. As with earlier steps in the method, the user interface may be manipulated to display the bone structure in different slices of the coronal, sagittal and horizontal views. One slice of coronal plane 1052 is shown in FIG. 16C and one slice of sagittal plane 1053 is shown in FIG. 16D. In each of these views, an outline of the originally defined defect area 1104, 1106, is shown, along with a reconstructed bone surface 1114, 1116. Effectively, these sectional views 1052, 1053 provide an overlay of a tentative bone reconstruction over the pre-operative images, e.g., CT images. The reconstructed bone surface is an initial reconstructed bone surface in that it is the surface generated by the SSM alone. However, it should be appreciated that this surface may be further modified through manual adjustment, as is described in greater detail below. A diagram of a bone surface 1116 within orbit 1012 reconstructed with SSM is shown in FIG. 16E to illustrate a result of running the SSM for the defect definition.

[0069] When an initial bone reconstruction is generated, as shown in FIGs. 16A-E, a user may optionally make manual adjustments to the reconstruction surface. Such manual adjustments may be made to accommodate unique circumstances. For example, if a surgeon seeks to provide a correction that will lift the eye in the socket because it has shrunk, the initial bone reconstruction may be modified by the surgeon. As with the previous steps, in a refinement of reconstruction step 1121, skull 1001 may be viewed in coronal, sagittal and horizontal planar views, and in a multitude of image slices in each of those views, to evaluate an existing reconstruction surface. The existing reconstruction surface may be viewed to evaluate the potential for adjustment of the planned reconstruction from any one of the planar views. The user may then modify the reconstruction surface on one or more slices in each view at the user’s discretion. In this embodiment, some refinement of the defect reconstruction is made and this is shown in FIGs. 17A-17D, as part of the refinement of reconstruction step 1121. Among FIGs. 17A-D, all images being displays visible to the user, a perspective view of skull 1001 is displayed with the reconstruction surface 1128 in FIG. 17A and three different sectional plane views of the skull, i.e., coronal 1052, sagittal 1053 and horizontal 1051, are displayed with the reconstruction surface in FIGs. 17B-D, respectively. The views in FIGs. 17A-D may be displayed simultaneously. One example adjustment of the reconstructed bone surface is shown in the sagittal view 1053 of FIG. 17C, where a tool 1122 may be used to manipulate an initial reconstruction surface 1116 established through the processing with the SSM. The line may be moved and/or smoothed out to modify the reconstruction surface as desired to obtain a more optimal reconstruction surface. In FIG. 17C, reconstruction surface 1126 is modified from an initial reconstruction line based on such manipulation. This form of adjustment may be made across any number of slices in any of the three sectional views of the skull until arriving at a shape deemed satisfactory for use in the design of an implant. In some variations of the method, the software may be configured so that the reconstructed bone surface may be manipulated and modified in the perspective view of the skull using a three-dimensional refinement tool.

[0070] Once a reconstructed bone surface is finalized, the software may be used to generate a refined reconstructed bone surface 1138, which may also be generated on a display, as shown in FIGs. 18A and 18B. At this juncture, implant design may commence. Specific steps in an implant design process are shown as steps 1131A and 1131B in FIGs. 18A and 18B, respectively. In step 1131 A, a tool 1132, e.g., marker on user interface, may be used to mark points 1134 on the bone surface to define a perimeter of an implant. Each point that is marked is associated with coordinates in three dimensional space, e.g., three cartesian coordinates, reflective of the point’s position on a surface of the bone. As a guide to aid in the marking process, a user may refer to an outline of refined reconstructed bone surface 1138 visible as distinct from a remainder of the bone surface in the perspective view of skull 1001 as shown in FIG. 18 A. As points 1134 are marked on the bone surface, the software may generate a line 1135 along the bone surface connecting the respective points. An alignment of such line 1135 may be based on having a gradual curvature along its length and to accommodate changes in a surface contour of the bone along a length of the line. During the process of marking an outline for the implant using points, such points may be dragged and moved, or deleted and replaced, as desired by a user. When a closed loop is established and indicated as finalized to define the implant perimeter, the user may continue with the incorporation of additional internal implant features, such as those shown in FIG. 18B.

[0071] In implant design step 1131B specifically, shown in FIG. 18B, two loops 1133 are added on a peripheral rim 1007 of skull 1001 to indicate locations of openings to receive fasteners in the implant. Such loops may be defined based on an indication of locations for such loops on the bone surface by a user. Also, points 1136 are marked along a proposed implant surface to define a line 1137 connecting such points along a surface of the implant. As shown in FIG. 18B in particular, such line indicates a location of an elongate ridge on the implant, i.e., an elongate ridge for use as an aid in navigation. While FIG. 18B illustrates the design of fastener openings and an elongate ridge on the implant, it should be appreciated that other implant features may be designed in a similar manner. For example, ring protrusions and sets of positioning openings may also be marked on the proposed implant surface. Additionally, portions of the implant, i.e., area inside the closed loop, may be marked to indicate parts of the implant that will have a mesh configuration (see e.g., plurality of holes 114) or that will have a solid structure. Further, an implant thickness and material may also be specified.

[0072] In some optional variations of the method, the software used may be configured to have an option of modifying the appearance of skull 1001 on the display to show contours indicative of bone thickness (not shown). These contours may take the form of various colors indicative of different bone thicknesses. This option may be utilized 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 hole locations. The visible bone thickness may aid the user in a determination of optimal implant shape, position and/or fastener hole locations, all on account of available bone structure based on the planned design. In this manner, for example, hole locations may be modified where doing so may provide a stronger anchorage via greater available bone depth.

[0073] When an implant outline is established and implant features are added and confirmed, the software processes these inputs to generate a virtual implant model 1210 based on the planned design in an implant generation step 1141, as shown in FIG. 19A. Such virtual implant model 1210 may be displayed on a user- interface for consideration by a user. In the depicted embodiment, implant design steps 1131A-B generate virtual implant model 1210 with extension arm 1226 having holes 1227A-B therein, and an elongate ridge 1232 extending across a central region of the implant. At this juncture, a user may view the tentative final implant design not only in the perspective view shown in FIG. 19A, but also in the sectional planes including horizontal plane 1051, coronal plane 1052 and sagittal plane 1053, and, as throughout this method, in different slices within each of those planar views. In each specific view, i.e., in a particular slice, a surface of virtual implant model 1210 may be viewed, such as surfaces 1144, 1146, 1148, shown in FIG. 19B. In each of these views, again, reproductions of the original pre-operative images, e.g. CT scans, retrieved from the patient, may be viewed with virtual implant model 1210 overlaid thereon. If the tentative final design is not satisfactory in any way, a user may return to the implant design step and redesign the implant. Of course, if the problem arises from the planned bone reconstruction surface, the user may go even further back in the method to make changes. Otherwise, if the design is deemed satisfactory for its intended purpose as an implant for implantation in the patient, the design is stored and readied for use in fabrication. In some examples, the design may be sent to an external fabrication site for manufacture.

[0074] In variations of the above described embodiment, the method of design may extend to the design of additional implants to complement the first implant, such as arrangements similar to those shown in FIGs. 3 and 4, for example. In such cases, the method would proceed in the same manner for each of the additional implants. And, a user may design all details of each implant to be implanted in a single orbit, with the software providing a guiderail on a gap between the implants, as applicable. In some examples, a surgery may call for a bi-orbital reconstruction where two orbits are reconstructed. In such cases, SSM may be used to generate a bone reconstruction and the method may proceed as otherwise described for each orbit, respectively. The software may also be integrated with other design software, such as that used to design cranio-maxillofacial plates, such as plates 940, 970 shown in FIG. 14.

[0075] The method of designing an implant or an implant system may be varied in many ways. In some embodiments, the method of design may be partially or fully automated. In one example, a fully automated method may involve the upload of an image to a computer for processing by the software, with the software automatically generating an implant design. In such an example, the software would be programmed to analyze the existing anatomy for defect definition based on a comparison with any baseline healthy bone data available to the software. It should be appreciated that automation of such step, or at least the quality of the defect definition that results from such automation, may be limited by the reference data available for processing by the software. Further, the software may be pre-programmed with a selection of mirroring or SSM for the automated bone reconstruction, and such automatically generated reconstruction would be used as a basis for the implant design. The software may also be programmed to generate sets of positioning openings or navigation ridges as desired. In other examples, a user may provide input for one or more steps in the method, while other steps may be automated. For instance, defect definition may be performed manually by a user as described in the present disclosure, while the remaining steps in the method may be automated and performed by the software.

[0076] In other variations of the above method of design, the method may be limited to a subset of the above described method steps. Thus, in one example, a method may commence with image data that already includes a reconstructed bone surface in the orbit, so that the method only involves design of the implant itself, such as is shown in FIGs. 18A-B and 19A- B. This method may optionally continue and include fabrication of the designed implant. In another example, the method may involve solely the planning of a bone reconstruction surface, such as is shown in FIGs. 15A to 16E. It may optionally also include reconstruction refinement, as shown in FIGs. 17A-D.

[0077] In another aspect, the present disclosure relates to methods of manufacturing one or more of the implants and implant systems contemplated by the present disclosure. In some embodiments, one or more of the implants and implant systems may be formed using one or more of injection molding, forging or investment casting and rough machining. In other embodiments, additive layer manufacturing may be used to form one or more of the implants and systems of the present disclosure. Examples of additive layer manufacturing techniques that may be utilized include Fused Deposition Modelling (“FDM”), Shape Deposition Manufacturing (“SDM”), Selective Laser Power Processing (“SLPP”), Direct Metal Laser Sintering (“DMLS”), Selective Laser Sintering (“SLS’), Selective Laser Melting (“SLM”), Selecting Heating Sintering (“SHS”), Electron Beam Melting (“EBM”), material jetting, binder jetting, or the like. Additional details of exemplary additive manufacturing methods are described in U.S. Pat. Nos. 7,537,664, 8,590,157, 8,728,387, 9.180,010 and 9,456,901, the disclosures of which are hereby incorporated by reference herein in their entireties.

[0078] In another aspect, the present disclosure relates to a method of performing a surgery to reconstruct facial bones in a patient, and in particular bones inclusive of those in an orbit or orbits of the patient. In one embodiment, a method begins with accessing a region of a patient’s bone surface requiring reconstruction and moving any anatomy that is an obstacle to accessing surfaces identified for reconstruction. An implant is then positioned in the orbit, and, in some cases on bone surfaces extending out of the orbit, as per a designed shape of the implant. Positioning lines on the implant, where included, may be used to aid in positioning the implant in the orbit. Similarly, navigation guides, such as ring protrusions and elongate ridges, where included, may be used in conjunction with navigation tools such as styluses and probes that are linked to navigation equipment to monitor a location of the implant as it is positioned in the patient by comparing its live location with a planned implantation location established during pre-operative planning. If the planned reconstruction includes two or more implants that are to be received in a single orbit of the patient, the same process may be followed for the second implant. Additionally, positioning lines and navigation lines, where they extend to define a single path between the implants, may also be used to position the first implant and the second implant with respect to each other. Once the implants are in position, they are secured in place on the bone, and where applicable, fasteners may be used to secure the implant or implants to the bone by placement of such fasteners through designated holes in the implant. When the implant or implants are confirmed as being properly fixed in the orbit, the method may conclude with removal of all tools and the replacement of all displaced anatomy back to its natural position, followed by the closure of any incisions.

[0079] While the methods of implanting an implant in and/or around an orbit of a patient as described in the present disclosure are described as being performed manually, other embodiments may employ robots to aid in the performance of the methods of implantation contemplated by the present disclosure. In one non-limiting example, a robot may be programmed for use in the method and operate to create surgical access to a facial region of a patient, and to position and anchor an implant on a bone surface in an orbit of the patient.

[0080] 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

1. An orbital implant system comprising: a first implant shaped to fit onto a first bone surface within an orbital cavity of a patient, the first implant having a first upper surface, a first bone facing surface opposite the first upper surface and a first line portion having a length along the first upper surface, the first line portion including a first surface interruption in the first upper surface that defines a first line, the first line portion extending toward a first edge location of the first implant; and a second implant shaped to fit onto a second bone surface within the orbital cavity, the second bone surface being separate from the first bone surface, the second implant having a second upper surface, a second bone facing surface opposite the second upper surface and a second line portion having a length along the second upper surface, the second line portion including a second surface interruption in the second upper surface that defines a second line, the second line portion extending toward a second edge location of the second implant, wherein when the first implant and the second implant are fitted within the respective bone surfaces in the orbital cavity, the first line portion and the second line portion are aligned along a single path such that a shape of the first line portion approaching the first edge location and a shape of the second line portion extending away from the second edge location are part of a single path while accounting for a space between the first and second edge locations.

2. The orbital implant system of claim 1, wherein the first surface interruption and the second surface interruption are first and second elongate ridges, respectively.

3. The orbital implant system of claim 2, wherein the first and second elongate ridges are curved over at least a portion of their respective lengths.

4. The orbital implant system of claim 1, wherein the first surface interruption is a first plurality of positioning openings arranged in sequence to define the first line and the second surface interruption is a second plurality of positioning openings arranged in sequence to define the second line.

5. The orbital implant system of any one of claims 1-4, wherein the first implant further comprises at least one ring-shaped protrusion extending from the first upper surface, the ring- shaped protrusion including a cavity therein adapted to receive a pointer tool.

6. The orbital implant system of any one of claims 1-5, wherein one or both of the first implant and the second implant include a region having a mesh structure.

7. The orbital implant system of any one of claims 1-6, wherein the first implant includes a first outer edge with a first outer edge portion and the second implant includes a second outer edge with a second outer edge portion, the first and second outer edge portions defining a gap therebetween, the gap having a predetermined maximum and minimum width dimension along a length of the respective edge portions.

8. The orbital implant system of claim 7, wherein the first edge portion has a first contour and the second edge portion has a second contour generally aligned with the first contour.

9. The orbital implant system of claim 8, wherein the first contour is a zig-zag shape.

10. The orbital implant system of any one of claims 1-9, further comprising a plurality of supplemental implants, each of the plurality of supplemental implants being disposable in the orbital cavity on surfaces other than the first and second surfaces.

11. The orbital implant system of any one of claims 1-10, further comprising a third line portion having a length along the first upper surface, the third line portion including a third surface interruption in the first upper surface that defines a third line, and a fourth line portion having a length along the second upper surface, the fourth line portion including a fourth surface interruption in the second upper surface that defines a fourth line, the third surface interruption and the fourth surface interruption being part of a second single path while accounting for a space between a first end of the third surface interruption and a second end of the fourth surface interruption, the first end being the closest location on the third surface interruption to the fourth surface interruption.

12. The orbital implant system of claim 11, wherein the first and second surface interruptions are respective first and second elongate ridges and the third and fourth surface interruptions are respective sets of positioning openings arranged in sequence in a line.

13. A facial implant system comprising: a first implant having a first bone-facing surface shaped to complement a first bone surface within an orbit of a patient, the first implant having a first alignment edge forming part of an outer perimeter of the first implant, the first alignment edge having a length extending from a first portion of the first implant configured for placement on the first bone surface remote from a rim of the orbit to a second portion of the first implant configured for placement on a second bone surface outside of the orbit; and a second implant having a second bone-facing surface shaped to complement a third bone surface within the orbit, the second implant having a second alignment edge forming part of an outer perimeter of the second implant, the second alignment edge having a length extending from a first portion of the second implant configured for placement on the third bone surface remote from the rim of the orbit to a second portion of the second implant configured for placement on a fourth bone surface outside of the orbit, wherein the first alignment edge and the second alignment edge are aligned along a majority of the lengths of the respective first and second alignment edges.

14. The facial implant system of claim 13, wherein when the first and second alignment edges are aligned, the first and second alignment edges are separated by a gap that is less than about 5.0mm.

15. The facial implant system of any one of claims 13-14, wherein the first implant has a first thickness and the second implant has a second thickness, the first thickness and the second thickness each being in a range from about 0.3mm to about 0.9mm.

16. The facial implant system of any one of claims 13-15, further comprising a third implant with a third bone-facing surface shaped to complement a fifth bone surface within an orbit of a patient, the third implant having a third alignment edge forming part of an outer perimeter of the third implant, the third alignment edge having a length extending from a first portion of the third implant configured for placement on the fifth bone surface remote from the rim of the orbit to a second portion of the third implant configured for placement on a sixth bone surface outside of the orbit, wherein the third alignment edge is aligned with a fourth alignment edge forming part of the outer perimeter of the first implant along a majority of the lengths of the respective third and fourth alignment edges such that where the third and fourth alignment edges are aligned, the third and fourth alignment edges are separated by a gap with a dimension separating the first and third implants that is less than about 5.0mm.

17. The facial implant system of any one of claims 13-16, wherein the first implant further comprises a first line defined by an elongate ridge on an upper surface of the first implant opposite the first bone-facing surface or a series of consecutive openings through the first implant and the second implant further comprises a second line defined by an elongate ridge on an upper surface of the second implant opposite the second bone-facing surface or a series of consecutive openings through the second implant, the second line and the first line being aligned such that the first and second lines define a single continuous line but for the gap between the first and second implants.

18. The facial implant system of any one of claims 13-17, wherein one of the first alignment edge and the second alignment edge includes a recessed edge such that when the first alignment and the second alignment edge are aligned along the majority of the lengths of the respective first and second alignment edges, the recessed edge defines part of a hole-shaped region between the first and second implants.

19. The facial implant system of any one of claims 13-18, wherein a contour of the first bone-facing surface and the second bone-facing surface, and a shape of the outer perimeter of the first implant and the second implant, are determined based on statistical shape modeling.

20. The facial implant system of any one of claims 13-19, wherein the majority of the of the lengths of the respective first and second alignment edges are shaped based on contours of an underlying bone surface of the patient.