orbital implants

Abstract

A system (201) includes a first implant (210) and a second implant (240), both configured to be placed within an orbit of a mammal. The first implant includes a first alignment edge (216) forming a portion of an outer perimeter of the first implant, having a length extending from a first portion of the first implant configured to be placed on an inner portion of the orbit to a second portion of the first implant configured to be placed on an outer portion of the orbit. The second implant includes a second alignment edge (246) forming a portion of an outer perimeter of the second implant, having a length extending from a first portion of the second implant configured to be placed on an inner portion of the orbit to a second portion of the second implant configured to be placed on an outer portion of the orbit. Further, the first alignment edge and the second alignment edge are aligned along a majority of the length of the respective alignment edges.

Description

Cross-reference to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 545,064, filed October 20, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0002] Trauma can damage the bone within the orbit of mammals, necessitating reconstruction. Specially designed, custom-made implants have been developed to provide this reconstruction. However, many existing implants are supplied as flat plates that must be shaped using instruments before placement in the patient. In such cases, reconstructing the desired reconstructed surface (i.e., the pre-illness surface) can be extremely difficult. Furthermore, while some existing implant designs are pre-formed to have three-dimensional features, users must frequently cut or adjust the plates to restore the pre-illness anatomy.

[0003] Another challenge is that achieving the desired therapeutic outcome is difficult when the area requiring reconstruction includes more than one wall and a baseplate within the orbit. One reason is the difficulty in providing implants suitable for this purpose. Yet another challenge is the limited effectiveness of the implant shape achieved through intraoperative bending of the implant plate, a shape necessary for proper implant fit. Typically, intraoperative bending involves evaluating intraoperative scans of the orbit to assess the shape and position of relevant anatomical structures, followed by adjusting the plate shape based on a visual review of the scans. This is ultimately an iterative process, as the user checks the fit after the first adjustment, but if the initial fit is not optimal, the scan is reviewed again for further adjustments. Furthermore, even when the plate is shaped to fit the patient, difficulties may arise in achieving accurate placement of the implant on the bone according to the surgical plan. Additionally, the limited availability of techniques for assessing the existing bone structure and providing planning for simulated reconstruction further restricts the potential for developing designs that optimally meet specific reconstructive needs.

[0004] Accordingly, there is a need to develop improved implant designs for reconstructing the bone within the orbital cavity. Summary of the Invention

[0005] This disclosure provides improved implant design for defective or damaged orbital cavities and improved methods for designing such implants. In some embodiments, intraorbital reconstruction in a patient may include providing two or more implants to repair all defective surfaces. Implants used for such reconstruction may include various physical indicators to improve the accuracy of implant placement on the patient's bone surfaces and the accuracy of positioning of each implant relative to one or more other implants also implanted in the same orbital cavity. Physical indicators may aid in 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 structures in the orbit to guide the proposed reconstruction structure, and the method further envisions user customization of the reconstruction plan after it has been generated using representative data.

[0006] In one aspect, this disclosure relates to methods for designing facial implants. In these methods, a virtual three-dimensional model of a patient's facial bones can be used. In one embodiment, in a first example, a method includes: defining a defect region within a bone surface at least partially located within the orbit of the facial bones; generating a reconstructed bone surface within the bone surface based on the definition of the defect region, distinguishing the reconstructed bone surface from an unmodified bone surface located outside the defect region; marking a plurality of points having three-dimensional coordinates on a display of the bone surface, wherein the boundaries of the reconstructed bone surface are distinguished from the unmodified bone surface, the plurality of points collectively defining an outer periphery of the facial implant, and the outer periphery of the facial implant encompassing at least a majority of the reconstructed bone surface; and generating a virtual facial implant model based on the outer periphery of the facial implant, wherein, when generating the virtual facial implant model, the position of the virtual facial implant model on the facial bones is verified based on visualization of the position of the virtual facial implant model on the reconstructed bone surface and visualization of the position of the virtual facial implant model on a two-dimensional image of the facial bones.

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

[0008] In a fourth example of the first embodiment, the method of any of the first to third examples may include: marking a plurality of guide points on a bone surface such that a line connecting the plurality of guide points defines the position of a guide line on a virtual facial implant model. In a fifth example, the method of the fourth example may include: marking a plurality of guide points to define the position of a guide line such that, when the virtual facial implant model is generated, the virtual facial implant model includes an elongated protrusion consistent with the position of the guide line. In a sixth example, the method of the fourth example may include: marking a plurality of guide points to define the position of a guide line such that, when the virtual facial implant model is generated, the virtual facial implant model includes a plurality of openings arranged sequentially in a line.

[0009] In a seventh example of the first embodiment, the method of any of the first to sixth examples may include: visualizing bone thickness in a region of the bone surface, including at least a defect area, using a preoperative scan of the patient, and defining the 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 in the range of 0.3 mm to 0.9 mm. Furthermore, for example, the thickness of the virtual facial implant may be 0.3 mm, 0.6 mm, or 0.9 mm. In a ninth example, the method of the seventh example may include: determining the fastener length of a fastener based on the bone thickness, the fastener being configured for use with a physical facial implant produced based on the virtual facial implant model. In a tenth example, the method of any of the first to ninth examples may include: marking an inner position label and an outer position label at corresponding inner and outer positions on the upward-facing surface of the virtual facial implant model. In an eleventh example, the method of any of the first to tenth examples may include: designating the 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 the twelfth example, the method of any of the first to eleventh examples may include: generating a reconstructed bone surface based on a mirror or statistical shape model of a second orbit opposite to the first orbit. In the thirteenth example, the method of any of the first to twelfth examples may include: defining the defect region by: observing the facial bones 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 of the first and second plurality of planes, marking lines on the facial bones representing the two-dimensional extent of the defect region in the corresponding plane. In the fourteenth example, the method of any of the first to thirteenth examples may include: using preoperative images as two-dimensional images.

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

[0011] In a second embodiment, a first example of a method for designing a facial implant for a defective orbit includes: defining a bone defect region in the orbit of a patient's virtual facial skeleton by: observing the virtual facial skeleton in multiple coronal views and marking a corresponding contour of the defect in the orbit in each of the multiple coronal views; observing the virtual facial skeleton in multiple sagittal views and marking a corresponding shape of the defect in the orbit in each of the multiple sagittal views; generating a virtual reconstruction of the bone on the virtual facial skeleton based on the shape marked in the multiple coronal and multiple sagittal views; marking a plurality of adjustable points on the facial skeleton to define a closed boundary that largely overlaps with the region representing the virtual reconstruction of the bone; and generating a virtual facial implant model with an outer periphery based on the closed boundary and a bone-facing surface having a contour complementary to the virtual reconstruction of the bone.

[0012] In a second example of the second embodiment, the method of the first example may include: moving the first adjustable point after marking a first adjustable point among a plurality of adjustable points to refine the closed boundary. In a third example, the method of either the first or second example may include: generating a virtual reconstruction of bone by: generating a virtual reconstruction of bone based on a shape marked in a plurality of coronal views and a plurality of sagittal views using statistical shape modeling. In a fourth example, the method of the third example may include: observing the virtual reconstruction of bone in at least one of a plurality of coronal views and a plurality of sagittal views, and manipulating the shape of the virtual reconstruction of bone in at least one of the plurality of coronal views and the plurality of sagittal views to change the virtual reconstruction of bone into a modified virtual reconstruction of bone.

[0013] In a second aspect, this disclosure relates to an orbital implant system. In a first example of a first embodiment, the orbital implant includes a first implant and a second implant. The first implant is shaped to fit onto a first bone surface within a patient's orbital cavity. The first implant has a first upper surface, a first bone-facing surface opposite to 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 defining the first line in the first upper surface, and the first line portion extends 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 has a second upper surface, a second bone-facing surface opposite to 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 defining the second line in the second upper surface, and the second line portion extends toward a second edge location of the second implant. The bone surfaces (i.e., the first bone surface and the second bone surface) on which the implants are designed are separated from each other. Furthermore, when the first implant and the second implant are adapted to the corresponding bone surfaces in the orbital cavity, the first line portion and the second line portion are aligned along a single path such that the shape of the first line portion near the first edge position and the shape of the second line portion extending away from the second edge position are part of a single path, while taking into account the space between the first edge position and the second edge position.

[0014] In a second example of the first embodiment, the implant of the first example may be structured such that: the first surface interruption is a first elongated ridge, and the second surface interruption is a second elongated ridge. In a third example of the first embodiment, the implant of the second example may be structured such that the first and second elongated ridges bend 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 sequentially arranged to define a first line, and the second surface interruption is a second plurality of positioning openings sequentially arranged to define a second line. In a fifth example of the first embodiment, the implant of any of the first to fourth examples may further include at least one annular protrusion extending from a first upper surface, the annular protrusion including a cavity adapted to receive a pointer tool. In a sixth example of the first embodiment, the implant of any of the first to fifth examples may be structured such that one or both of the first and second implants include a region having a mesh structure.

[0015] In the seventh example of the first embodiment, the implant of any of the first to sixth examples may include a first outer edge having a first outer edge portion, and the second implant may include a second outer edge having a second outer edge portion. In this arrangement, the first outer edge portion and the second outer edge portion define a gap therebetween, the gap having predetermined maximum and minimum width specifications along the length of the respective edge portions. In the eighth example, the implant of the seventh example may be configured 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 the ninth example, the implant of the eighth example may be configured such that the first contour has a zigzag shape or a jigsaw puzzle piece shape.

[0016] In the tenth example of the first embodiment, the implant of any of the first to ninth examples may include a plurality of supplementary implants, each of which may be disposed on a surface in the orbital cavity other than the first and second surfaces. In the eleventh example, the implant of any of the first to 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 defining the third line in the first upper surface. 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 defining the fourth line in the second upper surface. In this arrangement, the third and fourth surface interruptions may be part of a second single path, taking into account the space between a first end of the third surface interruption and a second end of the fourth surface interruption, the first end being the position on the third surface interruption closest to the fourth surface interruption. In the twelfth example, the implant of the eleventh example may be configured such that the first and second surface interruptions are corresponding first and second elongated ridges, and the third and fourth surface interruptions are a group of corresponding positioning openings arranged in a line in sequence.

[0017] In a first example of the second embodiment, the 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 the patient's orbit. Further, the first implant has a first alignment edge forming part of the outer periphery of the first implant, the first alignment edge having a length extending from a first portion of the first implant to a second portion of the first implant. The first portion of the first implant is configured to rest on a first bone surface remote from the edge of the orbit, and the second portion of the first implant is configured to rest on a second bone surface outside 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 the outer periphery of the second implant, the second alignment edge having a length extending from a first portion of the second implant to a second portion of the second implant. The first portion of the second implant is configured to rest on a third bone surface remote from the edge of the orbit, and the second portion of the second implant is configured to rest on a fourth bone surface outside the orbit. Furthermore, the first and second implants are designed to be arranged such that the first and second alignment edges are aligned along a significant portion of their respective lengths, such that where the first and second alignment edges are aligned, they are separated by a gap. The width of this gap is measured as the shortest distance between the edges of the implants at any location along either alignment edge. Because the edges are aligned along the gap, this distance is typically measured orthogonally to the direction of the respective alignment edges.

[0018] In a second example of the second embodiment, the implant system of the first example can be arranged such that the width of the gap separating the first implant and the second implant can be less than 5.0 mm. In a third example of the second embodiment, the implant system of either the first or second example can be arranged such that each of the first and second thicknesses is in the range of about 0.3 mm to about 0.9 mm. In a fourth example of the second embodiment, the implant system of any of the first to third examples can include a third implant having a third bone-facing surface shaped to complement a fifth bone surface within the patient's orbit, and the third implant having a third alignment edge forming part of the outer periphery of the third implant. The third alignment edge may have a length extending from a first portion of the third implant to a second portion of the third implant, the first portion of which is configured to rest on a fifth bone surface remote from the edge of the orbit, and the second portion of which is configured to rest on a sixth bone surface outside the orbit. The third alignment edge may be aligned with a fourth alignment edge forming part of the outer periphery of the first implant along a substantial length of the respective third and fourth alignment edges, such that where the third and fourth alignment edges are aligned, they are separated by a gap having a specification less than about 5.0 mm that separates the first and second implants. In a fifth example of the second embodiment, the implant system of any of the first to fourth examples may include a first line defined by an elongated ridge on an upper surface of the first implant opposite to the first bone-facing surface, or defined by a series of continuous 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 elongated ridge on an upper surface of the second implant opposite to the second bone-facing surface, or defined by a series of continuous openings through the second implant, the second line being aligned with the first line such that the first and second lines define a single continuous line other than the gap between the first and second implants.

[0019] In a seventh example of the second embodiment, the implant system of any of the first to sixth examples can be configured such that one of the first and second alignment edges includes a recessed edge, such that when the first and second alignment edges are aligned along a substantial length of the respective first and second alignment edges, the recessed edge defines a portion of the aperture region between the first and second implants. In an eighth example, the implant system of any of the first to seventh examples is configured such that the contours of the first and second bone-facing surfaces, as well as the shapes of the outer peripheries of the first and second implants, can be determined based on statistical shape modeling. In a ninth example, the implant system of any of the first to eighth examples can be configured such that a substantial length of the respective first and second alignment edges is shaped based on the contour of the patient's underlying bone surface. In a tenth example, the implant system of any of the first to ninth examples can be configured such that the mutually aligned portions of the first and second alignment edges have a serrated shape. Attached Figure Description

[0020] A more complete understanding of the subject matter and various advantages of this disclosure can be achieved by referring to the following detailed description (with reference to the accompanying drawings), wherein: Figure 1 This is a perspective view of an implant positioned in and around the bone surface of a patient’s eye socket, according to one embodiment of the present disclosure. Figure 2 This is a perspective view of an implant according to one embodiment of the present disclosure; Figure 3 This is a front view of an implant system positioned in and around the bone surface of a patient’s eye socket, according to an embodiment of the present disclosure. Figure 4 This is a front view of an implant system positioned in and around the bone surface of a patient’s eye socket, according to an embodiment of the present disclosure. Figure 5 This is a front view of an implant system positioned in and around the bone surface of a patient’s eye socket, according to an embodiment of the present disclosure. Figure 6 This is a front view of an implant system positioned in and around the bone surface of a patient’s eye socket, according to an embodiment of the present disclosure. Figure 7 This is a front view of an implant system positioned in and around the bone surface of a patient’s eye socket, according to an embodiment of the present disclosure. Figures 8 to 9This is a corresponding front view of an implant system positioned on the bone surface in and around the patient’s eye socket, according to one embodiment of the present disclosure; Figures 10 to 11 yes Figures 8 to 9 A close-up front view of the corresponding implant system; Figures 12 to 13 This is a corresponding front view of an implant system positioned on the bone surface in and around the patient’s eye socket, according to one embodiment of the present disclosure; Figure 14 This is a front view of an implant system according to an embodiment of the present disclosure; and Figures 15A to 19B The illustration shows corresponding steps in a method for designing an implant according to one embodiment of the present disclosure. Detailed Implementation

[0021] As used herein, unless otherwise stated, the term “anterior” refers to the front of the body or face, and the term “posterior” refers to the back of the body. The term “medial” refers to the area closer to or towards the midline of the body, and the term “lateral” refers to the area further away from or away from the midline of the body. The term “lower” refers to the area closer to or towards the feet, and the term “upper” refers to the area closer to or towards the top of the head. As used herein, the terms “approximately,” “about,” “generally,” and “substantially” are intended to indicate that slight deviations from absolute values ​​are also included within the scope of terms so modified.

[0022] In a first aspect, this disclosure relates to implants suitable for placement, at least partially, on a bone surface defining the orbit of a mammal. In one embodiment, implant 10 (in...) Figure 1 (As shown in the diagram, the implant 10 is partly located on the bone surface 9 within the patient's orbit 2, and partly extending from the orbit 2 to the peripheral edge 7, wherein the implant 10 is anchored in place by two fasteners 29.)

[0023] In another embodiment, the implant 110 is in Figure 2 As shown in the figure, implant 110 has a sheet-like structure having an upper surface 112 and a bone-facing surface (not shown) opposite the upper surface. Implant 110 can always have a generally constant thickness. In some non-limiting examples, the thickness of implant 110 can be 0.3 mm, 0.6 mm, or 0.9 mm, or other thicknesses in between. Implant 100 includes a plurality of holes 114 that collectively form a pattern and provide a mesh-like surface for implant 110. As shown, each of the plurality of holes 114 is hexagonal in shape, but the holes can also have other shapes. In other examples, with Figure 2Compared to the examples shown, multiple holes can occupy a smaller portion of the implant's surface area. In other examples, the implant can have a partially solid surface (e.g., the extended skirt 125 in implant 110). In variations of these examples, the implant can have an overall solid surface without any hole pattern. Such an implant can look similar to Figure 5 The implant 410, described in more detail elsewhere in this disclosure, can be formed with a customized shape such that the bone-facing surface of the implant has a profile that takes into account and complements the planned bone reconstruction surfaces within the patient's body. Thus, for an implant 110 that can be implanted into the orbit, the implant 110 can have a bone-facing surface whose profile conforms to the bone surface in the orbit and the bone surface in any surrounding bone surface region from which the implant will be received. (See above-referenced...) Figure 1 The implant 10 shown illustrates an example of how such an implant shape can be used to achieve a fit within a patient, wherein the implant 10 is positioned in the orbit 2 based on the planned reconstructed bone surface 9.

[0024] Continue to refer to Figure 2 The periphery of the implant 110 includes an extension skirt 125 and an extension arm 126. The extension skirt 126 extends from the central region 115 of the implant 110 to a free end 125A. Near the free end 125A are spaced-apart holes 127A and 127B. The holes 127A and 127B are sized to receive fasteners (e.g., bone screws). In this way, fasteners anchored through the holes 127A and 127B can be used to secure the implant 110 to the appropriate location on the bone surface. On the inner side of the extension skirt 125 opposite to the free end 125A is a set of positioning openings 122, which will be described in more detail below. Similar to the extension skirt 125, the extension arm 126 also extends from the central region 115 of the implant 110 to the free end 126A. The extension arm is narrower than the skirt and can have a minimized width sufficient to allow fasteners to be anchored through the openings 127C, 127D in the extension arm, while also minimizing the surface area facing the bone. Like the holes 127A, 127B, the holes 127C, 127D can also receive fasteners to anchor the implant 110 to the bone surface. In variations of the implant, it should be understood that holes sized to receive fasteners may additionally or alternatively be located in the central region of the implant.

[0025] Implant 110 includes a series of additional surface features that improve and simplify implant placement. These features include the aforementioned group of positioning openings 122, elongated ridges 132, and annular protrusions 137A to 137C. It should be understood that, although Figure 2The implant 110 shown includes each of these surface features, but these features are optional and can be customized by the user, as described in more detail elsewhere in this disclosure. Thus, for example, the user can choose to design an implant without any features or with one or more features. Additionally, the shape, position, and alignment of these features can be customized by the user during the design process. The group of positioning openings 122 includes three adjacent openings that extend sequentially across the width of the extending skirt 126 at the location of the openings. Each opening is separated by a structural connector 121 to define the size and spacing of these openings. In general, the group of positioning openings 122 can be advantageously used as a guide to confirm that the implant 110 is correctly positioned in the intended location on the patient's bone. For example, lines on the bone surface are visible through the openings, and this helps the user visualize the implant's position on the bone surface, thereby locating the implant. More generally, other advantages of the group of positioning openings include that, when the implant has a solid structure without mesh, such openings can be used to allow drainage through the implant. Furthermore, in variations of the design where the implant is part of a system having two or more implants, sets of positioning openings can be used to position the implants relative to each other. This is described in more detail elsewhere in this disclosure.

[0026] In some variations, the positioning openings can be located on the implant to define the boundary between what will ultimately be two separate implants. In this way, the implant can be designed and manufactured with a set of positioning openings extending from one edge to the other, and then, preoperatively or intraoperatively, the implant can be cut into two parts along the lines of the positioning openings. In a particular example, the design with a set of positioning openings for this purpose helps to accurately position the implant within the patient's body. Specifically, the entire implant with complete positioning openings can be placed in the patient's orbit, and holes can be pre-drilled in the patient's body at this time to set positions for anchoring the corresponding portions of the implant on the opposite side of the set of positioning openings. Then, with the holes drilled, the implant can be removed, cut along the set of positioning openings, and then repositioned into the orbit as two separate implants. At this point, the pre-drilled holes can be used as references to correctly position the newly separated implant portions.

[0027] The slender ridge 132 extends from the first end 133 to the second end 134, as... Figure 2As shown, it is a single structure elevated relative to the rest of the upper surface 112. The elongated ridge 132 is sufficiently elevated relative to the upper surface 112 so that a stylus or pointer can move along the elongated ridge 132, and it is desired that such a stylus or pointer will be predictably held on the elongated ridge. The implant 110 also includes annular protrusions 137A, 137B, 137C, each annular protrusion spaced apart from each other and protruding relative to the upper surface 112 of the implant 110. Figure 2 As shown, each annular protrusion has a protruding ring with a cavity within it. In this way, a stylus or pointer can be moved into the cavity of one of the annular protrusions and held in place with the ring surrounding the tip of the stylus. Both the elongated ridge 132 and the annular protrusions 137A to 137C are particularly advantageous as navigation aids, as described in more detail elsewhere in this disclosure. The implant 110 may also include markings for identifying the orientation, surface, side, or other identifiers of the implant. For example, the implant 110 includes a raised surface 139 in the shape of the number "1" on the upper surface of the central region 115 adjacent to the extension arm 126. In other non-limiting examples, the upper surface of the implant may include raised surfaces shaped like "M" and "L" to indicate the inner and outer sides.

[0028] The aforementioned features (e.g., groups of continuous positioning openings, annular protrusions, and elongated ridges) are all optional features to be included on the implant, and when included, can have the shape and position on the implant surface as desired by the user. This is one aspect of patient-specific design options that can be used to define the characteristics of an implant configured to be received in the orbit. Further details regarding patient-specific methods of implant design are described elsewhere in this disclosure. Another option to be included in the implant is an information label 119, which can be formed or attached to the implant. The information label 119 can include various details about the implant and can facilitate storage and distribution.

[0029] Implant 110 can be made from a variety of suitable biocompatible materials, including metallic materials, polymeric materials, and composite materials. An example of a metallic material that can be used is titanium. An example of a polymeric material that can be used is polyetheretherketone (PEEK). Another material that can be used to manufacture implants is MEDPOR® from Stryker®. These materials can also be used in combination. For example, the implant can be formed from a metallic material (e.g., titanium) with a MEDPOR® coating. While these materials are mentioned for implant 110, it should be understood that any of the implants contemplated in this disclosure can be made from any of the contemplated materials.

[0030] In a second aspect, this disclosure relates to an implant system comprising two or more implants used together for repairing or reconstructing a patient's orbit and / or surrounding area. In this aspect, the two or more implants can adequately cover the surface area intended for such repair or reconstruction in the orbit by having a design shape that requires positioning the implants very close to each other while still maintaining minimal separation, allowing each implant to function independently. These arrangements are advantageous because, for surgery involving the implantation of two implants, the entry point into the patient can be smaller than the entry point required to perform the same surgery using a larger single implant, which provides the same amount of coverage as the two implants. Overall, using multiple, smaller, separate implants provides the user with greater flexibility in the execution of reconstructive surgery compared to using a single, larger implant.

[0031] exist Figure 3 In one embodiment shown, system 201 includes a first implant 210 and a second implant 240. Unless otherwise specified, the reference numerals indicated by the 200 series are... Figure 2 The same reference numerals are used in the 100 series shown. Implant 210 includes a central region 215, an extension skirt 225, and an extension arm 226. The central region 215 is contoured to fit onto a bone surface 209 within the patient's orbit, and the extension skirt 225 and extension arm 226 are contoured to fit along a portion of the peripheral edge 207 outside the orbit. In implant 210, the central region 215 is typically solid and does not include a plurality of holes defining a mesh pattern; however, in variations of the depicted embodiment, the central region may have such holes to form a mesh structure. The shape of the central region 215 may include a peripheral edge with various curves, such as... Figure 3 As shown, this shape is based on a user-customized design, as described elsewhere in this disclosure. Furthermore, in standard surgery, this customized design of the implant shape can be based on an area of ​​the bone surface within and around the orbit to be reconstructed. Figure 3In this diagram, the bone surface 209 has been shown as reconstructed via software used for planning and design purposes. Such an image can be generated and displayed to a user as part of the design process described elsewhere in this disclosure. An extension skirt 225 extends from the central region 215 and is shaped to fit along a portion of the peripheral edge 207. Similarly, an extension arm 226 extends from the central region 215 and is shaped to fit another portion of the peripheral edge 207, which is separate from the portion covered by the extension skirt 225. The extension arm 226 is spaced apart from the extension skirt 225. The extension arm 226 includes two holes 227A, 227B adapted to receive fasteners to secure the implant 210 to the patient's bone.

[0032] The implant 210 also includes three separate sets of positioning openings extending across different portions of the implant. The first set of positioning openings 222A extends across the width of the extended skirt 225 such that when the implant 210 is in its intended position on the patient's bone surface, the first set of positioning openings 222A is aligned along the ridge of the peripheral edge 207. The second set of openings 222B extends across the entire central region 215, and at the medial end of the implant 215, the third set of positioning openings 222C also extends across a narrower portion of the central region 215. Each set of positioning openings 222A to 222C and their corresponding alignment are... Figure 3 As shown in the figure. In some variations, the group of locating openings can be shaped to have a length different from that shown, such that the total number of locating openings in a particular group is less than or greater than the number shown. In a specific example, the locating openings in a group can be sized such that there are no more than six openings in any group. Therefore, Figure 3 The variant of the implant may have a middle group of positioning openings, which has a total of six openings instead of the eight openings in the second group 222B.

[0033] Turning to the second implant 240, the second implant 240 includes a central region 245 and an extension arm 256. Like the first implant 210, the central region 245 of the second implant 240 is solid; however, in various variations, the central region may include multiple holes to define a mesh structure. The extension arm 256 includes holes 257A, 257B adapted to receive fasteners. The implant 240 also includes a set of positioning openings 252 extending across the central body 215.

[0034] An additional defining feature of the first implant 210 and the second implant 240 is that each of them is shaped to be complementary to the other. Generally, the combination of the first implant 210 and the second implant 240 provides support for a single reconstruction or repair, such as... Figure 3As shown. To provide this support, each implant is shaped such that they can be positioned close to each other without contacting each other. In this way, the first implant 210 has an alignment edge 216 located on the side of the first implant 210 closest to the second implant 240. Similarly, the second implant 240 has an alignment edge 246 located on the side of the second implant 240 closest to the first implant 210. These respective alignment edges 216, 246 have the same or similar alignment at least a portion of the distance between the respective implants facing each other. For example, in Figure 3 In this configuration, the implant is designed such that the alignment edges 216, 246 from the extension arms 226, 256 to the openings 222B, 252 are generally parallel to each other and aligned with each other. In this way, as... Figure 3 The aligned edges 216 and 246 shown are aligned over most of the length of the gap 208.

[0035] Turning to the relevant position of the implants when implanted in a patient, the first implant 210 and the second implant 240 define a gap 208 therebetween. Although shown as a final design, implants 210 and 240 can be generated during a design process that can be programmed to ensure a minimum separation between implants 210 and 240, i.e., gap 208. Thus, while the entire periphery of each implant can be provided as input to design software that generates the proposed implant structure and its placement in the patient, as described elsewhere in this disclosure, such software can include settings that can be modified to ensure that a minimum gap exists between the implants in the proposed placement position in the patient if the proposed design does not already provide a minimum required gap. In some examples, the minimum gap between two implants can range from about 0.5 mm to about 2.0 mm. Additionally, and in a similar manner, the software can be programmed such that a maximum gap exists between the implants. In some examples, this can range from 1.0 mm to 5.0 mm. While the above explanation and accompanying examples relating to the gaps between the implants have been provided with respect to implant system 201, it should be understood that similar principles can be applied to other implant systems contemplated in this disclosure.

[0036] It should also be understood that the first implant 210 and the second implant 240 are designed such that the second set of positioning openings 222B on the implant 210 is aligned with the set of positioning openings 252 on the second implant 240. In other words, the set of positioning openings 222A and the set of positioning openings 252 are aligned such that the alignment extends across the corresponding alignment edges 216, 246. This alignment facilitates the use of the set of positioning openings in a continuous manner, as if they were a single set of positioning openings. In a surgical application, when the implants are positioned on the bone surface, this allows the first and second implants to be properly positioned relative to each other by checking the alignment of the corresponding sets of positioning openings. Furthermore, each set of positioning openings can also be used independently to help verify the position of the individual implants relative to the underlying bone.

[0037] Although implant system 201 is depicted as having a group of positioning openings, it does not include elongated ridges or annular protrusions. It should be understood that in various variations, one or both of the first implant 210 and the second implant 240 may include one or more elongated ridges, one or more annular protrusions, or both. Similarly, the group of positioning openings may be related to... Figure 3 The variations shown are arranged differently. These variations can be developed during the design of the implant to suit the needs of a specific surgical procedure and the anatomy of the patient receiving the implant. These variations can be similarly applied to any implant system contemplated in this disclosure.

[0038] In another embodiment, such as Figure 4 As shown, the implant system 301 includes a first implant 310, a second implant 340, and a third implant 370. Unless otherwise specified, the reference numerals indicated by the 300 series are consistent with... Figure 3 The same reference numerals are used in the 200 series shown. The first implant 310 has a central region 315 and an extended skirt 325. The central region 315 is solid and includes a set of positioning openings 322 extending across its width, as shown. Figure 4As shown. When positioned in a patient, the extension skirt 325 extends from the eye socket and extends onto the frontal bone 304. The extension skirt 325 also includes through-holes 327A to 327B, which are adapted to receive fasteners. The second implant 340 includes a central region 345, an extension skirt 355 extending from the central region 345, and an extension arm 356 extending from the extension skirt 355. The central region 345 includes a plurality of holes 344 to define a mesh structure in the central region. Both the extension skirt 355 and the extension arm 356 are shaped and designed such that when they are implanted in a patient, they can be positioned on a peripheral edge 307, some portions of which extend onto the zygomatic bone 306 and the maxilla. The extension skirt 355 includes a hole 357C, and the extension arm 356 includes holes 357A to 357B. The third implant 370 includes a central region 375 and an extension skirt extending therefrom. The central region 375 includes a plurality of holes 374 to define a mesh structure within the central region. The extended skirt includes a first portion 385A and a second portion 385B, both of which extend onto the peripheral edge 307 when implanted into a patient, wherein the first portion 385A of the extended skirt further extends over one or both of the zygomatic bone 306 and the maxilla. The extended skirts 385A to 385B include five holes 387A to 387E adapted for receiving fasteners in the design shown.

[0039] Similar to implant system 201, the implants of implant system 301 are shaped such that, when implanted into a patient, each implant 310, 340, 370 has at least one complementary outer edge to the other implants, allowing the implants to fit adjacent to each other, such that... Figure 4 As shown. Specifically, the first implant 310 has an alignment edge 316 located on the side of the first implant 310 closest to the second implant 340. To complement the alignment edge 316, the second implant 340 has a first alignment edge 346 located on the side of the second implant 340 closest to the first implant 310. These corresponding edges 316, 346 have the same or similar alignment over at least a portion of the distance between the respective implants facing each other. A similar relationship exists between the alignment edges of the second implant 340 and the third implant 370, wherein the second alignment edge 347 located on the side of the implant 340 closest to the third implant 370 and the alignment edge 376 of the third implant 370 have the same or similar alignment over at least a portion of the distance between the respective implants facing each other. Figure 4As shown, the alignment edge 376 is located on the side of the third implant 370 closest to the second implant 340. In the region where the second implant 340 and the third implant 370 are configured for implantation into the outer part of the orbit, the corresponding alignment edges 347, 376 move away from each other to form a larger aperture region along the second gap 308B over a limited distance along the gap 308B. This aperture region between the implants allows avoidance of the infraorbital aperture when the implants are implanted into their intended positions on the anatomical structure. In various variations, this principle can be applied to other surface areas by designing open areas to avoid specific locations on the bone surface. Additionally, including the aperture region can aid implantation by increasing the visualization of the bone surface beneath the implant.

[0040] Furthermore, and similarly to implant system 201, implant system 301 includes a group of positioning openings, wherein the first implant 310 includes a first group of positioning openings 322, the second implant 340 includes a second group of positioning openings 352, and the third implant 370 includes a third group of positioning openings 382. Figure 4 As shown, each group of positioning openings 322, 352, 382 extends across the width of the corresponding implant within the corresponding central regions 315, 345, 375. These groups of positioning openings 322, 352, 382 collectively define a single positioning line that curves and extends across the three implants 310, 340, 370. In this way, even when there is a first gap 308A between the first and second implants and a second gap 308B between the second and third implants, the groups of positioning openings are aligned as if they were a single, continuous line. Figure 4 As shown. As mentioned elsewhere in this disclosure, the group including such positioning openings provides additional means of confirming the position of each implant on the patient and the position of each implant relative to other implants when inserted during surgery.

[0041] In another embodiment, such as Figure 5 As shown, the implant system 401 includes a first implant 410 and a second implant 440. Unless otherwise specified, the reference numerals indicated by the 400 series are consistent with... Figure 3The same reference numerals are used in the 200 series shown. The first implant 410 includes a central region 415, and a first extension arm 426 and a second extension arm 428. The second implant 440 includes a central region 445, and an extension skirt having a first portion 455A and a second portion 455B. Both the central region 445 and the extension skirts 455A to 455B have a mesh pattern structure based on a plurality of holes 444 distributed over a large portion of the second implant 440. A gap 408 between the implants 410, 440 is defined based on the expected placement of the respective implants when positioned in a patient. The first implant 410 has an alignment edge 416 located on the side of the first implant 410 closest to the second implant 440. Similarly, the second implant 440 has an alignment edge 446 located on the side of the second implant 440 closest to the first implant 410. These respective edges 416, 446 have the same or similar alignment on a portion of the distance between the respective implants facing each other. However, one misaligned sub-region of edges 416 and 446 is a sub-region of the second implant 440 including the recessed edge 446A, such as Figure 5 As shown. When implanted in a patient, the recessed edge 446A defines a perforated area of ​​exposed anatomical surface region located between the first implant 410 and the second implant 440. This exposed surface region can be used to provide greater visibility over existing anatomical structures to avoid obscuring certain anatomical structures, or for both purposes, and can be determined by the user at their discretion as part of the design process.

[0042] In another embodiment, such as Figure 6 As shown, the implant system 501 includes a first implant 510 and a second implant 540. Unless otherwise specified, the reference numerals indicated by the 500 series are consistent with... Figure 3The same reference numerals are used in the 200 series shown. In system 501, the first implant 510 and the second implant 540 are shaped to be positioned side-by-side, as in other embodiments described in this disclosure, but the implants 510, 540 have corresponding alignment edges 516, 546 that curve along the length of the implants 510, 540 to provide a puzzle piece-type relationship between the implants. Specifically, the alignment edge 516 of the first implant 510 has alternating protrusions and recesses along one direction of the edge, having a sequence of a first edge protrusion 516A, a first edge recess 516B, a second edge protrusion 516C, and a final second edge recess 516D. The alignment edge 516 is an example of a zigzag edge or contour. Similarly, the alignment edge 546 has alternating depressions and protrusions to complement the depressions and protrusions of the first implant, and the alignment edge 546 has a sequence of a first edge depression 546A, a first edge protrusion 546B, a second edge depression 546C, and a final second edge protrusion 546D. In this way, when placed in the patient's orbit, the first edge protrusion 516A is positioned adjacent to the first edge depression 546A, the first edge depression 516B is positioned adjacent to the first edge protrusion 546B, and so on. Figure 6 As shown. This arrangement creates a gap 508 between the first implant 510 and the second implant 540, which has an generally constant width along its length between the aligned edges 516, 546.

[0043] In another embodiment, such as Figure 7 As shown, the implant system 601 includes a first implant 610 and a second implant 640. Unless otherwise specified, the reference numerals indicated by the 600 series are consistent with... Figure 3 The 200 series numbers shown are the same as the reference numerals in the accompanying drawings. Implant system 601 is described above and... Figure 6 This is another variation of the jigsaw puzzle-type configuration of the implant system 501 shown. The first alignment edge 616 of the first implant 610 includes a first edge recess 616A, a first edge protrusion 616B, and a second edge recess 616C, each sequentially positioned along the length of edge 616. The second alignment edge 646 of the second implant 640 includes a first edge protrusion 646A, a first edge recess 646B, and a second edge protrusion 646C, each also sequentially positioned along the length of edge 646. In this way, when placed in place within a patient, the first edge recess 616A is positioned adjacent to the first edge protrusion 646A, the first edge protrusion 616B is positioned adjacent to the first edge recess 646B, and the second edge recess 616C is positioned adjacent to the second edge protrusion 646C, as shown. Figure 7As shown. This arrangement creates a gap 608 between the first implant 610 and the second implant 640, the gap 608 having a generally constant width along its length between the aligned edges 616, 646.

[0044] In another embodiment, such as Figures 8 to 11 As shown, the implant system 701 includes a first implant 710, a second implant 740, and a third implant 770. Unless otherwise specified, the reference numerals indicated by the 700 series are consistent with... Figure 4 The same reference numerals are used for the 300 series numbers shown. Each implant includes an elongated ridge, and when all three implants are implanted into the patient as intended, the multiple elongated ridges collectively serve as a single elongated ridge. Specifically, implant 710 includes a first elongated ridge 732 having a length from a first end 733 to a second end 734, extending across the width of a central region 715, as shown. Figure 8 As shown. The implant 740 includes a second elongated ridge 762 having a length from a first end 763 to a second end 764, extending across the width of a central region 745, as shown. Figure 8 and 9 As shown. The implant 770 includes a third elongated ridge 792, which has a length from a first end 793 to a second end (not shown), extending across the width of the central region 775, as shown. Figure 9 As shown. Each elongated ridge has curvature along its length, but their common alignment is evident because the alignment of the elongated ridges continuously spans gaps 708A and 708B between the individual implants. The continuity between the first elongated ridge 732 and the second elongated ridge 762 is shown in Figure 10 As shown in the figure, the continuity between the second elongated ridge 762 and the third elongated ridge 792 is... Figure 11 As shown in the image.

[0045] In another embodiment, such as Figures 12 to 13 As shown, the implant system 801 includes a first implant 810, a second implant 840, and a third implant 870. Unless otherwise specified, the reference numerals indicated by the 800 series are consistent with... Figure 4The same reference numerals are used in the 300 series shown. Except for the exact shape of the implants and the degree of alignment of the relative edges between the implants, implant system 801 is similar to implant system 301. The first implant 810 includes a first set of positioning openings 822 extending from a first end 823 to a second end 824, spanning the width of the central region 815. The second implant 840 includes a second set of positioning openings 852 extending from a first end 853 to a second end 854, spanning the width of the central region 845. And, the third implant 870 includes a third set of positioning openings 882 extending from a first end 883 to a second end 884, spanning the width of the central region 875. These sets of positioning openings 822, 852, and 882 collectively define a single positioning line that curves and extends across the three implants 810, 840, and 870. In this way, even when there is a first gap 808A between the first and second implants and a second gap 808B between the second and third implants, the groups of positioning openings are aligned as if they were a single continuous line, such as... Figures 12 to 13 As shown.

[0046] In another embodiment, such as Figure 14 As shown, the implant system 901 includes a first implant 910, a second implant 940, and a third implant 970. The second implant 940 and the third implant 970 are designed to be placed entirely outside the orbital bone plate and can be positioned around the edge of the orbit, such as... Figure 14 As shown. These additional implants can be implants configured for implantation in the skull, maxilla, or mandible, as well as other anatomical bone structures on the facial bones. It is conceivable that systems could be provided that include different types of implants, such as... Figure 14 The combination shown is illustrated. Similarly, the design methods described in this disclosure also envision methods that can incorporate different types of implants to provide, for example... Figure 14 The combination shown is applicable. Where advantageous, additional software configured for facial implant design can 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 of the facial bones.

[0047] Implants or implant systems can vary in many ways. For example, while the described embodiments of implant systems include systems with two and three implants, it is conceivable that up to six separate implants can be included in a single orbit as part of a single reconstruction, wherein each implant is designed to complement other implants within and around the patient's orbit. It should also be understood that... Figures 1 to 14The embodiments shown are merely illustrative of design features that can be incorporated into one or more implants, and the implants may have patient-specific shapes and other features. Furthermore, the specific size of the patient's orbit, the properties required for reconstruction, and determining which navigation features might be optimal for a particular surgery (e.g., elongated ridges, and / or positioning lines) can all be determined on a patient-by-patient basis.

[0048] On the other hand, this disclosure relates to a kit comprising one or more implants for implantation in a patient. In some embodiments, the kit comprises two or more implants. These implants may be the same as or different from each other. In some examples, one or more implants are patient-specific. In some examples, the implants are different but complementary to each other for use as implants in a single patient. In some examples, the kit may comprise different types of implants, such as implants that can be positioned on the surface of the skull inside or outside the orbit of a mammal.

[0049] In any of the above-conceptual kit embodiments, the kit may further include one or more fasteners for securing the implant to the bone. Furthermore, any of the above-conceptual embodiments may include instruments used in surgical procedures involving the implantation of an implant. Additionally, in any of the above embodiments, the kit or individual items and combinations thereof may be housed within one or more packages. For example, all items of the kit may be housed in a single package. In another example, all implants may be in one package, and all fasteners in another. Items included in the kit may also be packaged individually. For example, each implant may be in its own package. Packaging each item in the kit separately or in different combinations can improve the aseptic preservation of the items for use with implantable materials or in the operating room. In any of the above embodiments, the kit may further include an instruction manual containing a detailed explanation of the contents of the kit, including instructions for use of the contents.

[0050] On the other hand, this disclosure relates to methods for designing implants or implant systems, wherein one or more implants are used to repair or reconstruct the orbit and surrounding region in a patient's skull. The design method may be part of a preoperative surgical planning process, and software may be used to evaluate options for the surgical procedure in question and determine one or more optimal implants for final design, for production and use in surgery. It should be understood that the software referenced in the various methods described herein may be installed on a computer system capable of running the software. The computer system may include a processor, memory, a display, and other components to optimize the intended functionality of the software. Furthermore, it should be understood that providing a computer system and / or software for performing the methods may be an optional step in the methods contemplated by this disclosure.

[0051] In one embodiment, a method for designing an implant for use in a patient's orbit involves using software to design the implant based on existing information about the patient's facial anatomy. (See reference...) Figures 15A to 19B This embodiment is described below. The method begins with uploading images (e.g., CT scans) of the skull of a patient requiring orbital reconstruction. The image data acquired and used in this method will provide sufficient information about the patient's skull structure to enable three-dimensional analysis. The image data with three-dimensional features is then sliced ​​from a series of horizontal, coronal, and sagittal planes passing through the skull. Specifically, multiple horizontal plane images taken at intervals along a bottom-to-top direction at the height of the patient's skull, multiple coronal plane images taken at intervals along a front-to-back direction at the depth of the patient's skull, and multiple sagittal plane images taken at intervals along a side-to-lateral axis at the width of the patient's skull are extracted. As will be described in more detail below, these slices enhance the options available to the user for planning the reconstruction of the bone structures in the orbit and the implants accompanying the reconstruction. Furthermore, regarding the terminology of reference planes, it should be understood that throughout the disclosure, references to the coronal plane and the sagittal plane can refer to a cross-sectional cut of any plane parallel to the respective central coronal plane and central sagittal plane, and therefore such reference planes are not limited to the central bifurcation planes typically associated with such terms.

[0052] Once the image data is uploaded for software processing, the user can view the current condition of the skull to begin planning for reconstructing the damaged bone surface. In this embodiment, as... Figures 15A to 19B As shown, what needs to be reconstructed is the left orbit 1012 of the patient's skull 1001. However, it should be understood that the repair of the left orbit described with respect to this embodiment is merely illustrative, and numerous other repairs within and around one or both orbits of the skull can be envisioned. Figure 15AAs shown, the user interface can display four different views of the patient's skull 1001. This display is presented through a user interface that communicates with a computer system running the software. The four views that can be displayed simultaneously include the lower horizontal plane 1051 (viewed from below), the anterior coronal plane 1052 (viewed from the front), the left sagittal plane 1053 (viewed from the left), and a stereoscopic view 1054. Although Figure 15A A set of horizontal, coronal, and sagittal planes is shown, but the software can be manipulated to change the center (not shown) of each intersection of the horizontal, coronal, and sagittal planes, so that any particular portion of the skull anatomy can be displayed in each viewing plane. This can be done by shifting the center along a single axis, i.e., changing the section cut, i.e., the slice, only in one view, or by shifting the center along two or three axes, and can be fully customized as a function of the number of slices available in each view. Thus, for example, different locations around the left orbit 1012 to be reconstructed can be viewed by shifting the center as needed. Additionally, the user interface may optionally include additional indicators associated with each view to indicate which slice from the group is displayed for a particular view. In the depicted embodiment, for this purpose, bars 1061, 1062, and 1063 are displayed at the bottom of the respective views 1051, 1052, and 1053. Lines 1061A, 1062A, and 1062B that cross these corresponding bars 1061, 1062, and 1063 can indicate the current position (i.e., slice) along the range of dimensions of the skull in the accompanying view, which is represented by the range of dimensions of the total number of slices in that view. Thus, for example, line 1063A, slightly to the right of the center of bar 1063, indicates that the slice displayed in the sagittal view 1053 is slightly off-center from the center of skull 1001. It should be understood that while, ideally, a patient's CT scan is taken directly along or parallel to the midline plane (e.g., the sagittal plane), in some cases, CT data may be captured from an angled perspective. In this case, the initial image slice may be angled relative to the desired plane of observation, including one or more of the coronal, sagittal, and horizontal planes. When this occurs, software can be used to recapture the image slice along a plane at the desired angle (i.e., in the coronal, sagittal, and horizontal planes).

[0053] By manipulating the cross-sectional incisions displayed in different views of the bone to be reconstructed (here, the bone surface in and around the left orbit 1012), the cross-sectional planes displayed to the user can be adjusted to identify areas of the preoperative bone surface 1018 within the left orbit where the reconstructed bone surface should be located. This is referred to as defect definition 1101A to 1101B. The software includes a marking tool 1102 for marking such defect areas at any of the displayed slices on a series of visual slices, i.e., across the dimensions of the skull measured on an axis orthogonal to the view under consideration, at the cross-sectional incision displayed in one of the multiple planar views. For example, in Figures 15A to 15B In the anterior coronal view 1052 shown, marking tool 1102 moves across the defect portion of bone surface 1018 to mark the defect region 1104 used for reconstruction as part of defect definition step 1101A. When observing the same central location, marking tool 1102 can also be used in coronal view 1053 to define the defect region 1106, as shown. Figure 15C As shown, this is indicated as defect definition step 1101B. The centers of the three viewing planes can be moved, for example, by switching the positions of lines 1061A to 1063A on the corresponding bars 1061 to 1063, and, if applicable (not shown), additional defect areas can be marked on other slices. This process can continue until sufficient marking is completed to correctly identify the volume (including surface area) of the bone to be reconstructed. For example, the coronal view 1052 can be adjusted along a front-to-back direction to different cross-sectional planes (i.e., image slices) so that additional defect areas can be marked. Similarly, the cross-sections displayed in the sagittal and horizontal views can also be changed to mark additional defect areas.

[0054] Continuing with the defect definition steps, in some examples, the software may include an algorithm that automatically interprets the provided defect definitions, allowing automatic interpolation of defect definitions for any spaces left between the labeled slices based on actual information input by the user. Thus, where only a limited number of slices in each view are marked with defect definitions, the physical space between the planes of such slices can be automatically interpolated to complete the defect definition. The number of labeled defective regions required to fully identify the reconstructed area (e.g., the necessary number of different cross-sectional views with labeled defective regions) is the number of degrees to which the deteriorated bone structure is adequately captured, such that the resulting reconstructed surface adequately represents the reconstruction required for a properly designed implant. In implementations where the software for carrying out this method includes automatic interpolation between labeled slices, fewer defect definition markers may be needed to achieve sufficient results. Therefore, there is no specific minimum number of labeled slices as a condition for generating a reconstructed bone surface, and the amount of marking may vary due to the numerous possibilities of the reconstructive surgery.

[0055] When the preoperative bone surface 1018 (if applicable) within and around the left orbit 1012 includes sufficient markings of the defect area to complete defect definition, the software can process this defect definition to generate a defect reconstruction in defect reconstruction step 1111, such as... Figures 16A to 16E As shown. In this method, the software can generate a reconstructed bone surface based on defect constraints using either mirroring 1113 or statistical shape modeling (SSM) 1112, such as... Figure 16B An example of a user interface with such options is shown. Mirroring involves capturing images of healthy or otherwise undamaged and undeteriorated bone structures in the orbit opposite the orbit to be reconstructed, and using the shape of the healthy orbit to reconstruct the area of ​​the problematic orbit highlighted by the defect. SSM involves processing a database of images, where the images are healthy or otherwise undamaged and undeteriorated bone structures, and aggregating the images to compute representative structures. This representative structure is then used to determine the bone surfaces to be reconstructed for the patient based on the defect definition. More specifically, SSM data is adapted to healthy portions of the patient's anatomy and then used to extrapolate missing or abnormal anatomical structures in an anatomically plausible manner. SSM then creates new surfaces to reconstruct the defect and then merges them into the anatomical structures outside the defect-defined area (i.e., healthy bone). In some examples, the use of SSM can be customized to use a subset of images from the database, where the subset is selected based on images that can be grouped together from image data within a larger database.

[0056] Returning to the details of rebuilding step 1111, in Figure 16A In this method, based on the implementation of an adaptive facial model (i.e., SSM), the bone surface of the patient's skull 1001 is reconstructed using an initial reconstruction surface 1118. In other examples, mirroring can be used. The software can be configured to default to a modeling process (i.e., either mirroring or SSM), or it can be configured to allow the user to manually select a modeling process for each individual patient. As in earlier steps of this method, the user interface can be manipulated to display bone structures in different slices of coronal, sagittal, and horizontal views. A slice of the coronal plane 1052 is shown in... Figure 16C As shown, a slice of the sagittal plane 1053 is in Figure 16DThe following views are shown. In each of these views, the initial defined defect regions 1104, 1106 are shown, along with the reconstructed bone surfaces 1114, 1116. These sectional views 1052, 1053 effectively provide a provisional overlay of the bone reconstruction on preoperative images (e.g., CT images). The reconstructed bone surface is the initially reconstructed bone surface because it is a surface generated solely by the SSM. However, it should be understood that this surface can be further modified manually, as described in more detail below. Figure 16E A simplified diagram of the bone surface 1116 within the orbit 1012 reconstructed using SSM is shown to illustrate the results of running SSM with the defect constrained.

[0057] When initial bone reconstruction is generated, such as Figures 16A to 16E As shown, the user can optionally manually adjust the reconstructed surface. This manual adjustment can be made to suit unique circumstances. For example, if a surgeon seeks to provide a correction that elevates the eye within its socket due to orbital shrinkage, the initial bone reconstruction can be modified by the surgeon. Similar to the preceding steps, in the refinement of reconstruction step 1121, the skull 1001 can be observed in coronal, sagittal, and horizontal plane views, and in multiple image slices within each of these views, to evaluate the existing reconstructed surface. The existing reconstructed surface can be observed to assess the feasibility of adjusting the planned reconstruction based on any one of the plane views. The user can then modify the reconstructed surface on one or more slices in each view according to their judgment. In this embodiment, some refinement is made to the defective reconstruction, and this is in Figures 17A to 17D This is shown as part of a refinement of reconstruction step 1121. Figures 17A to 17D In this context, all images are displayed in a way that is visible to the user. Figure 17A The image shows a three-dimensional view of the skull 1001 with reconstructed surface 1128, and... Figures 17B to 17D The image shows three different cross-sectional planar views of the skull with reconstructed surfaces: coronal planar view 1052, sagittal planar view 1053, and horizontal planar view 1051. These views can be displayed simultaneously. Figures 17A to 17D The view in [the context]. Figure 17C An example adjustment of the reconstructed bone surface is shown in sagittal view 1053, where tool 1122 can be used to manipulate the initial reconstructed surface 1116 established through processing using SSM. Lines can be moved and / or smoothed to modify the reconstructed surface as needed to obtain a more optimized reconstructed surface. Figure 17CIn this process, based on this manipulation, the reconstructed surface 1126 is modified from the initial reconstruction line. This form of adjustment can be performed across any number of slices in any of the three cross-sectional views of the skull until a satisfactory shape is obtained for the design of the implant. In some variations of this method, the software can be configured to allow manipulation and modification of the reconstructed bone surface in a stereoscopic view of the skull using three-dimensional refinement tools.

[0058] Once the reconstructed bone surface is finalized, the software can be used to generate a refined reconstructed bone surface 1138, which can also be generated on the monitor, such as... Figure 18A and Figure 18B As shown. At this point, implant design can begin. The specific steps in the implant design process are detailed below. Figure 18A and Figure 18B The steps are illustrated as 1131A and 1131B, respectively. In step 1131A, tool 1132 (e.g., a marker on a user interface) can be used to mark points 1134 on the bone surface to define the perimeter of the implant. Each marked point is associated with coordinates in three-dimensional space (e.g., three Cartesian coordinates) that reflect the point's location on the bone surface. As a guide to assist the marking process, the user can refer to the refined, reconstructed shape of the bone surface 1138, which differs from the rest of the bone surface, such as in... Figure 18A The three-dimensional view of skull 1001 is shown. When point 1134 is marked on the bone surface, the software can generate lines 1135 connecting the corresponding points along the bone surface. The alignment of such lines 1135 can be based on a curvature that gradually changes along their length and adapts to changes in the surface contour of the bone along the length of the line. During the process of marking the implant contour with points, these points can be dragged and moved, or deleted and replaced as needed by the user. Once a closed loop is established and indicated as the final determination for defining the perimeter of the implant, the user can continue to incorporate additional internal implant features, such as... Figure 18B Those shown in the image.

[0059] Specifically, in Figure 18B In the implant design step 1131B shown, two loops 1133 are added to the outer edge 1007 of the skull 1001 to indicate the location of openings for receiving fasteners in the implant. These loops can be defined based on indications made by the user regarding their location on the bone surface. Furthermore, points 1136 are marked along the proposed implant surface to define lines 1137 connecting these points along the implant surface. Specifically, as... Figure 18B As shown, such lines indicate the location of the elongated ridges on the implant (i.e., the elongated ridges used as navigation aids). Although Figure 18BThe illustration depicts a design for fastener openings and elongated ridges on the implant; however, it should be understood that other implant features can be designed in a similar manner. For example, groups of annular protrusions and positioning openings can also be marked on the proposed implant surface. Additionally, portions of the implant (i.e., the area inside the closed loop) can be marked to indicate whether the implant will have a mesh configuration (see, for example, multiple holes 114) or a solid structure. Furthermore, the thickness and material of the implant can also be specified.

[0060] In some optional variations of this method, the software used can be configured to have an option to modify the appearance of the skull 1001 on the display to show contours (not shown) indicating bone thickness. These contours can take the form of various colors indicating different bone thicknesses. This option can be used during the implant design process to evaluate the planned implant placement and size, as well as to assess internal implant features (e.g., fastener hole locations). Visible bone thickness can help the user determine the optimal implant shape, placement, and / or fastener hole locations, all based on the available bone structure in the planned design. In this way, for example, the locations of these holes can be modified to provide stronger anchorage via greater available bone depth.

[0061] Once the implant's shape has been established and its features have been added and confirmed, the software processes these inputs to generate a virtual implant model 1210 based on the planned design in implant generation step 1141, such as... Figure 19A As shown. This virtual implant model 1210 can be displayed on a user interface for the user to consider. In the depicted embodiment, implant design steps 1131A to 1131B generate a virtual implant model 1210 with an extension arm 1226 (wherein the extension arm 1226 has holes 1227A to 1227B) and an elongated ridge 1232 extending across the central region of the implant. At this time, the user can not only... Figure 19A The proposed final implant design is viewed in the three-dimensional view shown, and can be viewed in cross-sectional planes including the horizontal plane 1051, the coronal plane 1052, and the sagittal plane 1053, and throughout the method, can be viewed in different slices within each of these planar views. In each specific view (i.e., in a specific slice), the surface of the virtual implant model 1210 can be observed, for example... Figure 19BSurfaces 1144, 1146, and 1148 are shown in the diagram. Similarly, in each of these views, a reproduction of the original preoperative image (e.g., a CT scan) obtained from the patient can be observed, overlaid on the virtual implant model 1210. If the provisional final design is unsatisfactory in any way, the user can return to the implant design step and redesign the implant. Of course, if the problem is caused by the planned bone reconstruction surface, the user can return to an earlier step in the method to make changes. Otherwise, if the design is deemed satisfactory for its intended purpose as an implant in the patient's body, the design is stored and prepared for production. In some examples, the design may be sent to an external manufacturing site for fabrication.

[0062] In variations of the above embodiments, the design method can be extended to the design of additional implants to complement the first implant, such as those similar to... Figure 3 and Figure 4 The arrangements shown are illustrated. In this case, the method will be performed in the same manner for each additional implant. Furthermore, the user can design all the details of each implant to be placed in a single orbit, with the software providing guides (if applicable) over the gaps between the implants. In some examples, surgery may require bilateral orbital reconstruction, where both orbits are reconstructed. In this case, SSM can be used to generate the bone reconstruction, and the method can be performed separately for each orbit. The software can also be integrated with other design software, such as those used for designing craniofacial panels (e.g., Figure 14 Software integration of boards 940 and 970 shown in the figure.

[0063] Methods for designing implants or implant systems can vary in a variety of ways. In some embodiments, the design method can be partially or fully automated. In one example, a fully automated method may involve uploading images to a computer for processing by software, where the software automatically generates an implant design. In such an example, the software would be programmed to analyze existing anatomy for defect definition based on a comparison with any baseline healthy bone data available to the software. It should be understood that the automation of this step (or at least the quality of defect definition produced by such automation) may be limited by the reference data available for processing by the software. Furthermore, the software may be pre-programmed to select mirror or SSM for automated bone reconstruction, and this automatically generated reconstruction will be used as the basis for the implant design. The software may also be programmed to generate groups of locating openings or navigating the spine as needed. In other examples, a user may provide input for one or more steps in the method, while other steps may be automated. For example, defect definition may be performed manually by the user, as described in this disclosure, while the remaining steps in the method may be automated and performed by the software.

[0064] In other variations of the above design method, the method may be limited to a subset of the steps described above. Thus, in one example, the method may begin with image data that already includes reconstructed bone surfaces within the orbit, allowing the method to focus solely on the design of the implant itself, for example, as... Figures 18A to 18B and Figures 19A to 19B As shown in the diagram. This method can optionally continue and include the production of the designed implant. In another example, the method may involve only the planning of the bone reconstruction surface, for example... Figures 15A to 16E As shown in the diagram. It may also optionally include reconstruction refinement, such as... Figures 17A to 17D As shown.

[0065] On the other hand, this disclosure relates to methods for manufacturing one or more of the implants and implant systems envisioned by this 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 this disclosure. Examples of additive layer manufacturing techniques that may be utilized include fused deposition modeling (“FDM”), shape deposition manufacturing (“SDM”), selective laser energy processing (“SLPP”), direct metal laser sintering (“DMLS”), selective laser sintering (“SLS”), selective laser melting (“SLM”), selective heat 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. Patents 7,537,664, 8,590,157, 8,728,387, 9,180,010, and 9,456,901, the disclosure of which is incorporated herein by reference in its entirety.

[0066] On the other hand, this disclosure relates to a method of performing surgery to reconstruct a patient's facial bones, particularly those in one or more of the patient's orbits. In one embodiment, a method begins by accessing the area of ​​the patient's bone surface that needs reconstruction and removing any anatomical structures that impede access to the surface identified for reconstruction. An implant is then positioned in the orbit and, in some cases, on a bone surface extending out of the orbit, depending on the design shape of the implant. Positioning lines on the implant, if included, can be used to aid in positioning the implant in the orbit. Similarly, navigation guides (e.g., annular protrusions and elongated ridges, if included) can be used in conjunction with navigation tools (e.g., styluses and probes) linked to a navigation device to monitor the implant's position in the patient by comparing the actual position of the implant with a planned implantation position established during preoperative planning. If the planned reconstruction involves two or more implants to be received in a single orbit of the patient, a second implant can be placed following the same procedure. Additionally, positioning lines and navigation lines (where they extend to define individual paths between the implants) can also be used to position the first and second implants relative to each other. Once the implants are in place, they are secured in their proper positions on the bone, and, where applicable, one or more implants can be secured to the bone using fasteners placed through designated holes in the implants. When one or more implants are confirmed to be properly secured in the orbit, the procedure can conclude with the removal of all instruments and the replacement of any displaced anatomy with its natural position, followed by closure of any incisions.

[0067] While the method of implanting an implant into and / or around a patient's orbit as described in this disclosure is described as being performed manually, other embodiments may employ a robot to assist in performing the implantation method envisioned in this disclosure. In a non-limiting example, the robot may be programmed to be used in the method and operated to create a surgical pathway to the patient's facial region and to position and anchor the implant onto the bone surface in the patient's orbit.

[0068] Although this disclosure has been described herein with reference to specific embodiments, it should be understood that these embodiments are for illustrative purposes only, illustrating the principles and applications of this disclosure. Therefore, it should be understood that various modifications can be made to the illustrative embodiments, and other arrangements can be designed without departing from the spirit and scope of this disclosure as defined in the appended claims.

Claims

1. An orbital implant system, comprising: A first implant, the first implant being shaped to fit onto a first bone surface within a patient's orbital cavity, 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 defining the first line in the first upper surface, the first line portion extending toward a first edge location of the first implant. as well as 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 defining the second line in the second upper surface, the second line portion extending toward a second edge location of the second implant. Wherein, when the first implant and the second implant are adapted within the corresponding bone surface in the orbital cavity, the first line portion and the second line portion are aligned along a single path such that the shape of the first line portion near the first edge position and the shape of the second line portion extending away from the second edge position are part of a single path, while taking into account the space between the first edge position and the second edge position.

2. The orbital implant system according to claim 1, wherein the first surface interruption portion and the second surface interruption portion are respectively a first elongated ridge and a second elongated ridge.

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

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

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

6. The orbital implant system according to any one of claims 1 to 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 according to any one of claims 1 to 6, wherein the first implant includes a first outer edge having a first outer edge portion, and the second implant includes a second outer edge having a second outer edge portion, the first outer edge portion and the second outer edge portion defining a gap between them, the gap having a predetermined maximum width specification and a minimum width specification along the 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 serrated shape.

10. The orbital implant system according to any one of claims 1 to 9, further comprising a plurality of supplementary implants, each of the plurality of supplementary implants being disposed on a surface in the orbital cavity other than the first surface and the second surface.

11. The orbital implant system according to any one of claims 1 to 10, further comprising a third line portion and a fourth line portion, the third line portion having a length along the first upper surface, the third line portion including a third surface interruption defining a third line in the first upper surface, the fourth line portion having a length along the second upper surface, the fourth line portion including a fourth surface interruption defining a fourth line in the second upper surface, the third surface interruption and the fourth surface interruption being part of a second single path, taking into account the space between a first end of the third surface interruption and a second end of the fourth surface interruption, the first end being the position on the third surface interruption closest to the fourth surface interruption.

12. The orbital implant system of claim 11, wherein the first surface interruption and the second surface interruption are corresponding first elongated ridges and second elongated ridges, and the third surface interruption and the fourth surface interruption are a group of corresponding positioning openings arranged 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 the patient's orbit, the first implant having a first alignment edge forming part of the outer periphery of the first implant, the first alignment edge having a length extending from a first portion of the first implant to a second portion of the first implant, the first portion of the first implant being configured to rest on the first bone surface remote from the edge of the orbit, and the second portion of the first implant being configured to rest on a second bone surface outside the orbit. as well as A second implant has a second bone-facing surface shaped to complement a third bone surface within the orbit. The second implant has a second alignment edge forming part of the outer periphery of the second implant. The second alignment edge has a length extending from a first portion of the second implant to a second portion of the second implant. The first portion of the second implant is configured to rest on a third bone surface remote from the edge of the orbit, and the second portion of the second implant is configured to rest on a fourth bone surface outside the orbit. The first alignment edge and the second alignment edge are aligned along most of the length of the respective first alignment edge and the second alignment edge.

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

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

16. The facial implant system of any one of claims 13 to 15, further comprising a third implant having a third bone-facing surface shaped to complement a fifth bone surface within the patient's orbit, the third implant having a third alignment edge forming part of the outer periphery of the third implant, the third alignment edge having a length extending from a first portion of the third implant to a second portion of the third implant, the first portion of the third implant being configured to rest on the fifth bone surface remote from the edge of the orbit, the second portion of the third implant being configured to rest on a sixth bone surface outside the orbit, wherein the third alignment edge is aligned with a fourth alignment edge forming part of the outer periphery of the first implant along a substantial length of the respective third alignment edge and the fourth alignment edge, such that where the third alignment edge and the fourth alignment edge are aligned, the third alignment edge and the fourth alignment edge are separated by a gap having a specification of less than about 5.0 mm separating the first implant and the third implant.

17. The facial implant system of any one of claims 13 to 16, wherein the first implant further comprises a first line defined by an elongated ridge on an upper surface of the first implant opposite to the first bone-facing surface, or defined by a series of successive openings through the first implant, and the second implant further comprises a second line defined by an elongated ridge on an upper surface of the second implant opposite to the second bone-facing surface, or defined by a series of successive openings through the second implant, the second line being aligned with the first line such that the first line and the second line define a single, continuous line other than the gap between the first implant and the second implant.

18. The facial implant system of any one of claims 13 to 17, wherein one of the first alignment edge and the second alignment edge includes a recessed edge such that when the first alignment edge and the second alignment edge are aligned along a substantial length of the respective first alignment edge and the second alignment edge, the recessed edge defines a portion of a perforated region between the first implant and the second implant.

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

20. The facial implant system of any one of claims 13 to 19, wherein the lengths of the respective first alignment edge and second alignment edge are shaped based on the contour of the patient's underlying bone surface.

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