Formable mesh for correction of bone defects

Abstract

A formable mesh implant suitable for corrective bone implants is disclosed. The formable mesh may include a plurality of node plates defining a mesh, wherein a connecting arm extends from each node plate. Each connecting arm associated with a given node plate is connected to a plurality of adjacent connecting arms at respective intermediate connecting regions, such that each connecting arm associated with a given node plate is connected to a different intermediate connecting region, and such that adjacent node plates are indirectly connected via the plurality of connecting arms. At least a subset of the node plates may each include a screw receiving hole, and the intermediate connecting regions may be free of screw receiving holes. In another exemplary embodiment, a formable mesh is disclosed wherein each connecting arm of a given node plate is connected to an adjacent node plate, wherein the adjacent node plates are directly connected via at least two connecting arms.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 653,745, filed on April 6, 2018, and entitled “FORMABLE MESH FOR CORRECTING BONE DEFECTS,” the entire contents of which are incorporated herein by reference. Background Art

[0003] The present disclosure relates to implants for correcting bone defects.

[0004] Surgical repair of skull or facial bone defects may be a technically difficult, laborious and time-consuming process. The precise repositioning of missing anatomical structures is particularly challenging. It is known that the computer-aided design and rapid prototyping techniques recently adopted have significantly improved efficiency and improved results. If the defect is stable, obvious and intuitive before surgery, computer modeling can be used to generate a virtual 3D model of the patient-specific implant.

[0005] Titanium mesh has been shown to be clinically effective in the reconstruction of non-load-bearing defects of the skull and facial bones (Kuttenberger and Hardt, J. Cranio Maxfac. Surg., 2001; Schipper et al., Eur. Arch. Otorhinolaryngol., 2004). The mesh provides a stable, permanent, biocompatible reconstruction that is well tolerated even when in direct contact with the paranasal sinuses. Titanium is the most biocompatible metal and is known to produce minimal inflammatory reactions upon implantation. Titanium undergoes osseointegration after implantation and is well tolerated even in contaminated areas. Due to its non-ferromagnetic properties, titanium is compatible with magnetic resonance imaging and produces minimal artifacts in magnetic resonance imaging (MRI) images. CT (computed tomography) artifacts associated with titanium mesh are also negligible, and postoperative visualization of structures adjacent to the titanium mesh is also unimpeded. Titanium mesh is very versatile in a variety of clinical situations and can be easily adapted to almost any non-load-bearing craniofacial defect. The mesh pattern is porous, allowing free drainage of body fluids and minimizing complications associated with retention of fluids in closed spaces (hematomas, seromas, etc.). The mesh is partially transparent, facilitating observation of the underlying structures through the mesh during surgery. Most importantly, titanium meshes are easily deformed. They are specifically designed to allow molding into three-dimensional structures, which can be done manually or using a mold system. They can be further trimmed to any desired size for implantation. Conventional mesh designs also provide multiple locations for screw fixation.

[0006] Despite the above benefits of titanium mesh, conventional mesh designs have many associated disadvantages. Some of them are technical, presenting challenges to surgeons during the intraoperative preparation of implants, while some can adversely affect the patient's prognosis and are very significant. For example, it may be challenging to manually shape conventional titanium sheets into three-dimensional shapes. The difficulty increases with the complexity of the surface topology and the underlying anatomical structure. Contouring on more limited areas with sharp angles results in a loss of surface fidelity and buckling of the titanium mesh connecting arms. In addition, the finishing of conventional meshes inevitably results in a corrugated implant edge with irregular sharp barbs. These may scratch or impact adjacent soft tissues, and potentially limit the activity of specific soft tissues (such as the activity of extraocular muscles in the orbit). For patients with thin skin, the implant edge is usually accessible and visible.

[0007] In addition, in order to be ductile, conventional mesh designs require large open space voids between the connecting arms, resulting in a very low "filling factor (surface area ratio between solid mesh and void space)". These voids cause three problems. First, the presence of large voids prevents the mesh from being used in areas where soft tissue prolapses through the mesh voids causing functional impairment. This is particularly important in orbital cavity reconstruction, where prolapse of the intra-orbital septum or extraocular muscles through the mesh can potentially lead to extraocular motor disorders. Secondly, adhesions between soft tissues on either side of the mesh unnecessarily complicate implant removal. Large voids allow the soft tissues on either side of the mesh to "fuse" during healing. If the implant needs to be removed for certain indications, the surgery requires extensive resection and separation of adhesions. The risk of accidental injury to surrounding structures, bleeding, etc. is significant. Finally, open mesh patterns with large voids are also prone to late erosion of the overlying soft tissues in the event of implant exposure. Titanium mesh exposure is a recognized complication and has been documented in 16% of patients undergoing titanium cranioplasty. It has also been documented in alveolar reconstruction and maxillary reconstruction. This complication has particularly significant consequences because it requires additional reconstructive surgery to remove the titanium implant and provide a replacement complex reconstruction. In a recent CT examination of titanium mesh cranioplasty, thinning of the overlying soft tissue (atrophy of the skin, fat, and muscle above the mesh) was demonstrated in 44% of patients. This phenomenon was not observed with smooth, solid implants.

[0008] Conventional mesh designs are also known to exhibit low impact resistance when compared to skull bone or other materials such as PEEK.

[0009] Figures 1A to 1G , FIG. 2A to FIG. 2D , FIG. 3A to FIG. 3D , FIG. 4A to FIG. 4C , FIG. 5A to FIG. 5D Various conventional mesh designs are shown. Figures 1A to 1GA net developed by Stryker (hereafter referred to as the Stryker net) is shown. Figure 1A and Figure 1B Two different views of the Stryker mesh formed on the skull mold are shown. Figure 1C As can be seen in FIG. 1 , the basic structure of the Stryker mesh includes a node plate 100 having a set of four radiating connecting arms 105, wherein the node plate 100 has a central screw receiving hole 110. Figure 1A and Figure 1B As can be seen in FIG. 1 , screw receiving holes 110 are formed in each gusset plate of the mesh. Figure 1D A detailed view of the Stryker net is shown, showing unit cell 115. Figure 1D The geometry of the basic node and linker configuration shown in Figure 2 is used to create the overall mesh pattern.

[0010] from Figure 1D As is apparent from the mesh design shown in FIG, each gusset plate 100 is connected to its adjacent gusset plate via a single curved connecting arm. For example, gusset plate 100A and gusset plate 100B are connected via a single connecting arm 105AB. A geometric representation of the relationship between the nodes and the connecting arms is shown in FIG. Figure 1E middle.

[0011] The Stryker mesh is sparsely populated with gusset plates and tie arms, leaving a large amount of void area 120. Figure 1F As shown in , when the mesh is trimmed by cutting a set of connecting arms, the large gaps result in a sharp and burred mesh perimeter. As described above, the presence of such sharp perimeter areas is a significant disadvantage of such conventional mesh designs because they result in wavy edges in the final structure that are perceptible and visible to patients with thin skin.

[0012] When compressive and / or expansion forces are applied to the web, the interstitial regions also tend to deform via deformation of the connecting arms 105 . Figure 1G The effect of deformation on the void region is shown, which indicates buckling of the web and significant expansion of the void region, as well as localized weakening of the web due to reduced filling factor, which can occur in areas of high curvature.

[0013] FIG. 2A to FIG. 2C Another conventional mesh design (developed by Synthes, hereinafter referred to as the Synthes mesh) is illustrated. Figure 2C and Figure 1E It can be seen that the mesh design is geometrically similar to the Stryker mesh design. Figure 2D shows the dramatic expansion of the void region when the Sindix mesh is deformed under stress.

[0014] FIG. 3A to FIG. 3CYet another conventional mesh design (developed by Bioplate, hereinafter referred to as Bioplate mesh) is illustrated. Figure 3C and Figure 1E It can be seen that the net design is a hexagonal grid variation of the Stryker net design. Figure 3D The dramatic expansion of the triangular void areas is shown when the Bioplate mesh is deformed under stress.

[0015] FIG. 4A to FIG. 4C Another conventional mesh design (developed by KLS, hereinafter referred to as KLS1 mesh) is illustrated. Figure 4C and Figure 1E It can be seen that the mesh design is a square grid variation of the Stryker mesh design.

[0016] FIG. 5A to FIG. 5C Another conventional mesh design (also developed by KLS, hereinafter referred to as KLS2 mesh) is illustrated. Figure 5B and Figure 4B It can be seen that this mesh design is a variation of the KLS1 square grid design, where the connecting arms have two bends. Figure 5D A significant expansion of the void region is shown when the KLS2 mesh is deformed under stress, wherein the deformation of the mesh is enhanced via the increased length of the connecting arms of the KLS2 mesh design relative to the KLS1 mesh design. Each of the mesh designs described above has different levels of formability and adaptability based on the specific mesh pattern. It should be noted that each of the representative mesh designs shown above has two common properties: (i) each gusset plate of each mesh has a screw receiving hole, and (ii) each gusset plate of each mesh is directly connected to the adjacent gusset plate via a single connecting arm.

[0017] The aforementioned exemplary conventional mesh designs all have the following problems and design limitations: (i) undesirable gaps (void areas), especially after deformation, (ii) undesirable buckling of mesh links, (iii) perceptible contour defects due to mesh thickness and / or opening pattern, (iii) skin erosion due to large gaps, (iv) low impact resistance, and (v) the connecting arms do not properly bend to the contour when the mesh is formed according to the patient's anatomy.

[0018] Figure 6 is a photograph of a solid titanium implant. Although the solid implant avoids some of the disadvantages associated with mesh implants, it prevents intraoperative visualization of the underlying tissue and is less pliable under pressure than mesh and is difficult to trim. Summary of the invention

[0019] A formable mesh implant suitable for corrective bone implants is disclosed. The formable mesh may include a plurality of node plates defining a mesh, wherein a connecting arm extends from each node plate. Each connecting arm associated with a given node plate is connected to a plurality of adjacent connecting arms at respective intermediate connecting regions, such that each connecting arm associated with a given node plate is connected to a different intermediate connecting region, and such that adjacent node plates are indirectly connected via the plurality of connecting arms. At least a subset of the node plates may each include a screw receiving hole, and the intermediate connecting regions may be free of screw receiving holes. In another exemplary embodiment, a formable mesh is disclosed wherein each connecting arm of a given node plate is connected to an adjacent node plate, wherein the adjacent node plates are directly connected via at least two connecting arms.

[0020] Thus, in one aspect, there is provided a formable implant for bone fixation or correction of bone defects, the formable implant comprising a formable mesh comprising:

[0021] a plurality of gusset plates defining a grid, wherein at least a subset of said gusset plates include respective screw receiving holes for receiving mounting screws therethrough;

[0022] Each gusset plate has a plurality of connecting arms extending therefrom;

[0023] each of the plurality of connection arms associated with a given gusset plate extends to connect with a plurality of adjacent connection arms at respective intermediate connection regions, each adjacent connection arm being associated with a different adjacent gusset plate, such that each of the plurality of connection arms associated with a given gusset plate is connected to a different intermediate connection region and such that adjacent gusset plates are indirectly connected via the plurality of connection arms; and

[0024] Each intermediate connection area is free of screw receiving holes.

[0025] In another aspect, a formable implant for bone fixation or correction of bone defects is provided, the formable implant comprising a formable mesh, the formable mesh comprising:

[0026] a plurality of gusset plates defining a grid, wherein at least a subset of said gusset plates include respective screw receiving holes for receiving mounting screws therethrough;

[0027] Each gusset plate has a plurality of connection arms extending therefrom, each connection arm of a given gusset plate being connected to an adjacent gusset plate;

[0028] Adjacent gusset plates are directly connected via at least two connecting arms.

[0029] A further understanding of the functional and advantageous aspects of the present disclosure may be realized by referring to the following detailed description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0031] Figure 1A and Figure 1B A photograph showing an example of a titanium mesh known in the art.

[0032] Figure 1C Illustrated Figure 1A The unit cell of the mesh shown in .

[0033] Figure 1D and Figure 1E Shows Figure 1A An example of a mesh is shown in , with each node and connecting arm of the design schematically shown.

[0034] Figure 1F and Figure 1G It is shown Figure 1A A photograph showing the deformation of the net is shown in FIG.

[0035] Figure 2A Other unit cells of meshes known in the art are exemplified.

[0036] Figure 2B and Figure 2C Shows the Figure 2A An example of a mesh of a unit cell in FIG. 1 , with the individual nodes and connecting arms of the design schematically shown.

[0037] Figure 2D It is shown Figure 2B A photograph showing the deformation of the net is shown in FIG.

[0038] Figure 3A Other unit cells of meshes known in the art are exemplified.

[0039] Figure 3B and Figure 3C Shows the Figure 3A An example of a mesh of a unit cell in FIG. 1 , with the individual nodes and connecting arms of the design schematically shown.

[0040] Figure 3D It is shown Figure 3B A photograph showing the deformation of the net is shown in FIG.

[0041] Figure 5A Other unit cells of meshes known in the art are exemplified.

[0042] Figure 5B and Figure 5C Shows the Figure 5AAn example of a mesh of a unit cell in FIG. 1 , with the individual nodes and connecting arms of the design schematically shown.

[0043] Figure 5D It is shown Figure 5B A photograph showing the deformation of the net is shown in FIG.

[0044] Figure 6 is a photograph of a solid metal implant and the mold system used to deform the implant.

[0045] Fig. 7A is an example of a mesh used to correct bone defects.

[0046] Figure 7B The crossing of connection arms associated with different gusset plates at the intermediate connection region is illustrated.

[0047] Figure 7C Illustrated Fig. 7A The unit cell of the mesh shown in .

[0048] Fig.7D and Fig. 7E The schematic diagram shows the Figure 7B and Figure 7C The mesh region illustrated in FIG. 1 shows a connection path between mesh gussets via connecting arms.

[0049] Figure 7F is a photograph of an exemplary mesh formed on a skull model of bilateral frontal bone defects including orbital roof anatomy, wherein the mesh pattern is based on Figure 7C The unit cell shown in .

[0050] Figure 7G yes Figure 7F Detail of the photograph shown in , which is annotated to show the rotation of the connecting arms around the middle connecting region during deformation.

[0051] Figure 7H and Fig.7I The rotation of the connecting arms about the intermediate connecting region upon deformation is illustrated.

[0052] Figure 7J yes Figure 7F A photograph of an exemplary mesh demonstrating the overlap of adjacent mesh elements as the mesh is deformed.

[0053] Figure 7K Shows Fig. 7A An exemplary unit cell of the mesh shown in FIG.

[0054] Figure 7L and Figure 7M Shows Figure 7K A cross-sectional view of a mesh unit cell shown in FIG. 1 , wherein the thickness of the mesh varies within the unit cell.

[0055] Figure 7N and Fig.7O The different axial orientations of the connecting arms extending from adjacent gusset plates are shown.

[0056] Figure 7P is similar to Fig. 7A , but including recessed holes for tapered screw heads (e.g., as Figure 7K , Figure 7L and Figure 7M It does not include any secondary holes.

[0057] Fig. 8A The crossing of connection arms at the intermediate connection region associated with different gusset plates for a mesh with hexagonal symmetry is illustrated.

[0058] Figure 8B Illustrated Fig. 8A The unit cell of the hexagonal mesh shown in .

[0059] Figure 8C and Fig.8D The schematic diagram shows the Fig. 8A and Figure 8B The mesh region illustrated in FIG. 1 shows a connection path between mesh gussets via connecting arms.

[0060] Fig. 9A is a photograph of an alternative exemplary embodiment of a mesh pattern.

[0061] Fig. 9B The crossing of connection arms associated with different gusset plates at the intermediate connection region is illustrated.

[0062] Fig. 9C Illustrated Fig. 9A The unit cell of the mesh shown in .

[0063] Fig.9D and Fig.9E The schematic diagram shows the Fig. 9B and Fig. 9C The mesh region illustrated in FIG. 1 shows a connection path between mesh gussets via connecting arms.

[0064] Fig.9F and Figure 9G An alternative mesh configuration is shown that includes screw receiving holes in the elongated mesh member, wherein Fig.9F shows the crossing of the connection arms associated with the different gusset plates at the mid-connection region, while Figure 9G The unit cell of the mesh is illustrated.

[0065] Fig. 10A The connection of different gusset plates via a plurality of connection arms is illustrated for an exemplary square mesh.

[0066] Fig. 10B Illustrated Fig. 10A The unit cell of the mesh shown in .

[0067] Fig. 10C and Fig. 10D The schematic diagram shows the Fig. 10A and Fig. 10B The mesh region illustrated in FIG. 1 shows a connection path between mesh gussets via connecting arms.

[0068] Fig.11A yes Fig. 7A An example of a portion of a mesh is shown in , illustrating unit cells of exemplary sizes.

[0069] FIG. 11B to FIG. 11H The mesh filling factors for various mesh designs are shown.

[0070] Fig.12 is an example showing how a computerized average skull model can be used to create a region-specific template for a skull defect, where the region can be flattened and used to define the boundaries of the proposed mesh pattern. The mesh template can be optimized to include regions that match anatomical features and enhance shaping and implant fixation.

[0071] Fig.13 A flattened template for bilateral skull defects is shown. Once folded and shaped, it will form a patient-specific defect reduction. It should be noted that holes can be deleted and added as needed to provide fixation points.

[0072] Fig.14A and Fig. 14B A template of an orbital floor defect using the exemplary pattern from FIG. 7 is shown, wherein Fig.14A Left and right patterns are shown for the orbital floor including both the lateral and medial walls, and Fig. 14B Left and right patterns for the orbital floor and middle wall only are shown.

[0073] Fig. 14C and Fig.14D Shows Fig. 14B Photograph of an exemplary mesh in after being formed into an anatomical mold and placed in an anatomical orbital defect model. The mesh reshapes the defect to its pre-injury shape and conforms to the existing anatomy.

[0074] Fig.15A Illustrate how the template can be further improved to include various combinations of separate links and filler regions. Such improvements further reduce surface porosity and allow template regions to adapt to the underlying anatomical structure as needed. This exemplary embodiment shown is used for a similar Fig.12 Bilateral frontal bone defects shown in .

[0075] Fig. 15B yes Fig.15A A photograph of an exemplary mesh pattern is shown in FIG.

[0076] Fig. 15C yes Fig. 15B Detailed photograph of an exemplary mesh shown in , illustrating implant curvature, solid to patterned transition, mesh interlacing, and overlap. DETAILED DESCRIPTION

[0077] Various embodiments and aspects of the present disclosure will be described with reference to the details discussed below. The following description and accompanying drawings are examples of the present disclosure and should not be construed as limiting the present disclosure. Many specific details are described to provide a comprehensive understanding of the various embodiments of the present disclosure. However, in some cases, in order to provide a brief discussion of the embodiments of the present disclosure, known or conventional details are not described.

[0078] As used herein, the terms "comprises" and "comprising" should be interpreted as inclusive and open-ended rather than exclusive. Specifically, when used in the specification and claims, the terms "comprises" and "comprising" and variations thereof mean including the specified features, steps, or components. These terms should not be interpreted to exclude the presence of other features, steps, or components.

[0079] As used herein, the term "exemplary" means "serving as an example, instance, or illustration," and should not be construed as preferred or advantageous over other configurations disclosed herein.

[0080] As used herein, the terms "about" and "approximately" are meant to cover variations that may exist in the upper and lower limits of the range of the numerical values, such as variations in properties, parameters and dimensions. Unless otherwise stated, the terms "about" and "approximately" mean plus or minus 25% or less.

[0081] It should be understood that, unless otherwise indicated, any designated range or group is a shorthand way of referring individually to each and every member of the range or group, and each and every possible subrange or subgroup subsumed therein, and similarly with respect to any subrange or subgroup therein. Unless otherwise indicated, the present disclosure is directed to and specifically incorporates each and every specific member and combination of subranges or subgroups.

[0082] As used herein, the term "in the order of magnitude of" when used in connection with an amount or parameter refers to a range spanning about one-tenth to ten times greater than the stated amount or parameter.

[0083] As described above, conventional bone fixation mesh designs have many disadvantages, including undesirable gaps (void areas), especially after deformation; undesirable buckling of mesh links; perceptible contour defects due to mesh thickness and / or opening pattern; skin erosion due to large gaps; low impact resistance; and when the mesh is formed to the patient's anatomy, the connecting arms do not bend properly to the contour. The inventors sought to design new mesh patterns that would overcome these limitations.

[0084] Fig. 7A An example of an exemplary mesh that addresses deficiencies of conventional mesh designs is shown. Figure 7C A detailed view of an exemplary mesh is shown, which illustrates the unit cells of the mesh by lines 200. The mesh includes a plurality of gusset plates defining a grid (a square grid in this non-limiting example) wherein Figure 7C Gusset plates 200A to 200I are shown. At least a portion of the gusset plates include respective screw receiving holes for receiving mounting screws therethrough. In the exemplary embodiment, gusset plate 200E includes screw receiving holes.

[0085] from Fig. 7A and Figure 7C As can be seen in the Figures 1 and 2, the present mesh has several distinguishing features that differentiate the present mesh from the conventional mesh designs described above and solve the problems associated with the conventional mesh designs described above. For example, as described in further detail below, the exemplary mesh has a higher fill factor (the two-dimensional density of the mesh material area relative to the total area when viewed from above) than conventional mesh designs, resulting in a more rigid mesh that provides an improved balance between mesh rigidity and mesh transparency, resulting in improved strength and impact resistance, while still allowing observation of the tissue beneath the mesh when it is implanted.

[0086] The exemplary mesh also exhibits an altered geometric configuration that avoids limitations associated with conventional mesh designs that use a single connecting arm between adjacent nodes. A distinguishing feature of the exemplary mesh is that there is no direct connection between adjacent node plates. For example, Figure 7CA central node plate 200E is shown surrounded by four adjacent nearest node plates 200A to 200B in a square grid. A set of connecting arms 205E1 to 205E4 extend from the central node plate 200E. However, unlike the conventional mesh design described above, instead of being directly connected to other node plates, each of these connecting arms (205E1 to 205E4) extends to a respective intermediate connection region, wherein each intermediate connection region does not have a screw receiving hole. Specifically, connecting arm 205E1 extends to intermediate connection region 225A, connecting arm 205E2 extends to intermediate connection region 225B, connecting arm 205E3 extends to intermediate connection region 225C, and connecting arm 205E4 extends to intermediate connection region 225D. In some exemplary embodiments, the area of ​​each intermediate connection region is less than the area of ​​each node plate. In some exemplary embodiments, the area of ​​any given intermediate connection region within the mesh is less than the area of ​​the node plate adjacent to the given intermediate connection region.

[0087] like Figure 7C As can be seen in the figure, a plurality of connection arms meet and connect at each intermediate connection region, wherein, in the exemplary embodiment, each connection arm connected at a given intermediate connection region extends from a different adjacent gusset plate, such that adjacent nearest gusset plates are indirectly connected through a plurality of connection arms. For example, connection arms 205F3, 205B4, 205E1, and 205A2 associated with gusset plates 200F, 200B, 200E, and 200A, respectively, are connected at intermediate connection region 225A. As described above, each intermediate connection region is free of screw receiving holes.

[0088] In the present exemplary mesh embodiment, each pair of adjacent nearest node plates (e.g., node plates 200E and 200A, 200E and 200B, 200E and 200C, and 200E and 200D) is connected by two connection paths, rather than a single connection path. For example, it is apparent that the connection between the center node plate 200E and the node plate 200B is facilitated by two connection paths including two pairs of connection arms, wherein each pair of connection arms includes a connection through a different intermediate connection region. The first connection path includes a pair of connection arms 205E1 and 205B4, which are themselves connected through an intermediate connection region 225A. The second connection path includes a pair of connection arms 205E2 and 205B3, which are themselves connected through an intermediate connection region 225B. This dual connection path aspect of the present exemplary mesh can be contrasted with each of the above-described conventional mesh designs that have only a single connection path extending between any two adjacent node plates.

[0089] Furthermore, unlike the conventional mesh design described above where non-adjacent nearest gusset plates are connected only by additional gusset plates, in the present exemplary mesh, diagonally adjacent gusset plates are connected. For example, the connection between the central gusset plate 200E and the diagonally adjacent gusset plate 200F is achieved by connecting arms 205E1 and 205F3 connected via intermediate connection regions 225A.

[0090] Fig.7D and Fig. 7E The schematic diagram shows the Figure 7B and Figure 7C The mesh area shown in Figure 2 shows the connection paths between the mesh gusset plates via the connecting arms.

[0091] Reference now Figure 7B and Fig.7D , which respectively show a detailed view of the connecting arms intersecting at a given intermediate connection region and a schematic diagram of the connection path, it is apparent that in the exemplary embodiment shown, the connecting arms extend from the given intermediate connection region in a non-linear configuration, wherein the connecting arms bend or bend between their connection to a given gusset plate and their connection to a given intermediate connection region. Figure 7B and Fig.7D In the exemplary embodiment shown in , the connecting arms extend from a given intermediate connection area in the windmill structure.

[0092] This configuration allows for the conversion of compressive or expansion forces applied to the mesh into rotational (e.g., torsional) forces within the mesh. This aspect of the mesh's behavior is Figure 7F and Figure 7G It is obvious that Figure 7F Shows Fig. 7A A photograph of a mesh-based mesh shown in FIG. 1 , wherein an exemplary mesh in the photograph is formed on a skull model, Figure 7G Shows Figure 7F and shows the direction of rotation of the windmill structure when compressive forces are applied to the mesh. Figure 7F It is demonstrated how application of forces to the web causes the connection arms to rotate about their respective mid-connection regions, whereas the gusset plates may experience little or no rotational motion and instead primarily translational motion (and are therefore labeled rotationally static in the figure).

[0093] like Figure 7G As can be seen in FIG. 1 , when a compressive force is applied to the web, the connecting arms rotate relative to the intermediate connecting region (marked with the letter "a" in the figure), torsionally absorbing the applied force and the rotational deformation of the web. Figure 7H and Fig.7I This phenomenon can be further understood. Figure 7HThe configuration of connecting arms 205B3, 205G3, 205C1 and 205E2 extending from the intermediate connecting region 225B without mesh deformation is shown. Fig.7I The effect of a compressive (lateral compression) force on the web is shown. Under compressive force, the windmill structure formed by the connecting arms and the intermediate connecting area rotates as the windmill structure is compressed laterally. The compression and rotation of the windmill structure is achieved by Fig.7I The box 245 in the Figure 7H The narrowing and angle change of the frame 240 is shown.

[0094] In addition, if Fig.7I 200B and 200C. As can be seen in the figure, the curved connecting arms that form the windmill structure together with the intermediate connecting region 225B are able to overlap the adjacent gusset plates during the application of the compressive force. In particular, it can be seen that the connecting arms 205G3 and 205E2 overlap the edges of the gusset plates 200B and 200C, respectively. This aspect of the present exemplary mesh and other related meshes disclosed herein is in contrast to the conventional mesh designs described above, which have uniform thickness and cannot overlap the nodes and connecting arms, and there is no variation in the cross-sectional geometry of the connecting arms.

[0095] When adjacent nodes and connecting arms are forced together, they meet in similar contact areas throughout the mesh pattern. This is more likely to occur at the perimeter during mesh formation, where areas of high curvature cause parts of the mesh to expand while other areas contract (e.g., Figure 7J ). To compensate for this deformation, one component of the mesh is able to drive the other component in this area by (i) design of the pattern, (ii) rounding the edges of the components, and (iii) varying the cross-section / material thickness. This creates an interlacing of the mesh, which reduces mesh deformation and strengthens the implant. The overlap of the connecting arms and adjacent gusset plates can be Figure 7J , where the compressive forces applied to the lower region of the mesh during its formation have caused a spatial overlap, thereby accommodating the compressive forces without causing buckling of the mesh structure.

[0096] In some exemplary embodiments, each gusset plate may include a respective screw receiving hole. However, in other exemplary embodiments, only a subset of the gusset plates may include respective screw receiving holes. Fig. 7A An example of such an embodiment is shown in , where half of the gusset plates include screw receiving holes. Reducing the number of screw receiving holes in this manner increases the mesh packing factor (density), strength, and impact resistance, while still maintaining a large number of potential locations for securing the mesh to the underlying bone.

[0097] In some exemplary embodiments, the mesh may be formed with node plates having holes of different sizes. For example, the node plates may include a first subset of node plates that include respective first holes having a first diameter, and the node plates may include a second subset of node plates that include second holes having a second diameter. The first holes and the second holes may have different diameters. For example, the node plates of the first subset may have respective first holes adapted to receive screws (e.g., bone screws), and the node plates of the second subset may have respective second holes having a diameter less than the first diameter. In this case, the second holes of the node plates of the second subset may have a second diameter adapted to insert surgical sutures. The number of node plates having the first holes may be different from the number of node plates having the second holes. The node plates may include, for example, a third subset of node plates that have no holes. Figure 7F The photograph shown in shows an example of such a mesh, wherein the mesh includes a first subset of gusset plates having respective first holes, the first holes having a first diameter suitable for receiving bone screws; a second subset of gusset plates having respective second holes, the second holes having a second diameter suitable for inserting surgical sutures therethrough; and a third subset of gusset plates without holes.

[0098] In some exemplary embodiments, the size of the node plate can vary in the mesh. In some exemplary embodiments, the node plate can be provided in at least two different sizes. Although many of the exemplary embodiments shown in the present disclosure use a circular node plate shape, it should be understood that the circular shape is only one example of a variety of possible node plate shapes. For example, in two non-limiting exemplary embodiments, the node plate shape can be elliptical or polygonal. In some exemplary embodiments, the node plates defining the mesh can be provided in at least two different shapes.

[0099] It should be understood that the aforementioned exemplary embodiments pertaining to different hole configurations and gusset plate shapes and sizes are not intended to be limited to the present exemplary mesh, but may be applied to any mesh. For example, the conventional mesh described above may be adapted according to the aforementioned exemplary embodiments.

[0100] Reference again Figure 7C , the connecting arms are shown to have varying widths over their longitudinal extent. Figure 7C An exemplary embodiment is shown in which all connecting arms have variable widths, but in some exemplary embodiments this may also be the case for one or more arms. In other exemplary embodiments, the width of one or more connecting arms may be constant along their longitudinal extent. In some exemplary embodiments, the width of at least one connecting arm may initially increase toward a maximum width as the connecting arm extends from its respective gusset plate and then decrease as the connecting arm extends further to its respective intermediate connecting region.

[0101] It should be understood that the aforementioned exemplary embodiments pertaining to connecting arms of varying widths are not intended to be limited to the present exemplary mesh, but may be applied to any mesh. For example, the conventional mesh described above may be adapted according to the aforementioned exemplary embodiments.

[0102] In some exemplary embodiments, the thickness of the mesh may be constant in a manner similar to conventional mesh designs having a constant thickness within each unit cell of the mesh and within the unit cells forming the mesh. However, in other exemplary embodiments, the thickness of the mesh may vary spatially within each unit cell of the mesh, and this spatial variation in thickness may be repeated within the unit cells forming the mesh. In other exemplary embodiments, the thickness of the mesh may vary spatially within two or more unit cells of the mesh.

[0103] Figures 7K to 7M Exemplary embodiments of meshes having thickness variations within a unit cell are illustrated. Figure 7L and Figure 7M Shows the Figure 7K Two different exemplary cross sections of the cross section shown in FIG. Figure 7L In , the web thickness varies within the center gusset plate 200E to form countersunk screw receiving holes. Figure 7M , an exemplary embodiment is illustrated in which the thickness of the center node plate 200E is different from the thickness of the other node plates 200A and 200C. In addition, the thickness of the connecting arm is different from the thickness of the node plate. It should be understood that Figure 7L and Figure 7M The exemplary embodiments shown in are merely illustrative and not restrictive, and other variations with different thickness variations may alternatively be implemented. For example, in some exemplary embodiments, the thickness of one or more connecting arms may additionally or alternatively vary. In some exemplary embodiments, the thickness variation within the unit cell may include a thickness variation between two or more node plates and / or between one or more connecting arms. In other exemplary embodiments, the thickness variation within the unit cell may include a variation between the thickness of the connecting arm and the thickness of one or more node plates.

[0104] It should be understood that the aforementioned exemplary embodiments pertaining to thickness variation are not intended to be limited to the present exemplary mesh, but may be applied to any mesh. For example, the conventional mesh described above may be adjusted according to the aforementioned exemplary embodiments.

[0105] Reference now Figure 7N and Figure Fig.7O In the exemplary mesh, it can be seen that the connecting arms of each gusset plate extend spatially from their respective gusset plates at an acute angle relative to the respective alignment axis, with adjacent gusset plates having different associated alignment axes. Figure 7N, connecting arms 205B4 and 205B3 extend downwardly from gusset plate 200B in respective directions 250 and 255. These directions are at acute angles relative to a central alignment axis 260 located between the two directions. Figure 7N , connecting arms 205E1 and 205E4 extend from center gusset plate 200E in directions 270 and 275 that are at acute angles relative to center alignment axis 280. Figure 7N and Fig.7O It can be seen that the alignment axes 260 and 280 associated with adjacent gusset plates 200B and 200E, respectively, extend in different directions. In the exemplary embodiment shown, the two alignment axes 260 and 280 are perpendicular. It should be noted that this perpendicular relationship is not intended to be limiting, and for different mesh types, the alignment axes associated with adjacent gusset plates may extend in different directions.

[0106] Refer to Figure 7N , and considering the central node plate 200E, it can be seen that the connecting arms are arranged as pairs of adjacent connecting arms located on opposite sides of each node plate. For example, a first pair of connecting arms 205E1 and 205E4 are located on the left side of the central node plate 200E, and a second pair of connecting arms 205E2 and 205E3 are located on the right side of the central node plate 200E. As shown, an inter-arm slot is defined between each pair of connecting arms, wherein a first inter-arm slot 206L is defined between the connecting arms 205E1 and the connecting arms 205E4, and a second inter-arm slot 206R is defined between the connecting arms 205E2 and the connecting arms 205E3. These inter-arm slots 2061 and 206R can be used to define a deformation (e.g., pivot) axis, which is located on the aforementioned alignment axis 280 of the mesh. As can be seen in the figure, the inter-arm slots associated with adjacent node plates extend in different directions, providing different local deformation axes for the mesh.

[0107] It should also be noted that additional inter-arm slots are located between pairs of connecting arms associated with adjacent gusset plates. For example, additional inter-arm slots 206A are located in the region between connecting arm 205E1 associated with gusset plate 200E and connecting arm 205B4 associated with gusset plate 200B. These additional inter-arm slots help define additional deformation axes, such as axis 290, which are obliquely angled relative to the aforementioned alignment axes associated with the pairs of connecting arms extending from the respective gusset plates.

[0108] Reference now FIG. 8A to FIG. 8D , showing FIG. 7A to FIG. 7C Other embodiments of the embodiment illustrated in , wherein the mesh pattern forms a hexagonal grid as opposed to a square grid. FIG. 7A to FIG. 7C The four connecting arms in the network shown in FIG. 8A to FIG. 8CIn the embodiment shown in , each intermediate connection region has three connection arms extending therefrom. In the hexagonal net, each gusset plate has three connection arms extending therefrom, wherein the connection arms extend from each gusset plate in radially offset directions.

[0109] It should be understood that the mesh configuration of the exemplary meshes disclosed herein is not intended to be limiting, and the exemplary meshes can be adapted according to a variety of mesh types. Other non-limiting examples of mesh types include diamond, rectangular, and parallelogram-based meshes.

[0110] Reference now Fig. 9A , shows a photograph of an exemplary mesh with a square grid of gusset plates interconnected via elongated members. As can be seen in the figure, this exemplary mesh does not have a direct connection between adjacent gusset plates, similar to Fig. 7A The network shown in .

[0111] like Fig. 9C , a set of connecting arms extend from each gusset plate (e.g., gusset plates 400A to 400D). However, unlike the conventional mesh designs described above, rather than connecting directly to other gusset plates, each of these connecting arms extends to a respective elongated member, such as elongated member 410 (which provides an intermediate connection region for the mesh), wherein Fig. 9A and 9C In the embodiment shown in FIG. 4 , each elongated member has no screw receiving hole. Specifically, connecting arm 405A3, connecting arm 405B2, connecting arm 405C1, and connecting arm 405D4 extend to elongated member 410. Fig. 9A and Fig. 9C , adjacent elongated members are oriented at different angles, and in the present exemplary embodiment, adjacent elongated members are perpendicular, such as adjacent elongated member pairs 410A-410B and 410A-410C.

[0112] In the present exemplary mesh embodiment, each pair of adjacent nearest gusset plates (e.g., gusset plates 400A and 400B, 400A and 400D, 400B and 400C, and 400C and 400D) is connected by two connection paths, rather than a single connection path. For example, it is apparent that the connection between gusset plate 400A and gusset plate 400B is facilitated by two connection paths including two pairs of connection arms. The first connection path includes elongated member 410A, while the second connection path includes elongated member 410B. This dual connection path aspect of the present exemplary mesh can be contrasted with each of the above-described conventional mesh designs that have only a single connection path extending between any two adjacent gusset plates.

[0113] Furthermore, unlike the conventional mesh designs described above in which non-adjacent nearest gusset plates are connected only by additional gusset plates, in the present exemplary mesh, diagonally adjacent gusset plates are connected. For example, the connection between the central gusset plate 400A and the diagonally adjacent gusset plate 400C is achieved by connecting arms 405A3 and 405C13 connected via elongated members 410A.

[0114] Fig.9D and Fig.9E The schematic diagram shows the Fig. 9B and Fig. 9C The mesh area shown in Figure 2 shows the connection paths between the mesh gusset plates via the connecting arms.

[0115] Fig.9F and Figure 9G An alternative exemplary mesh design is shown in which the elongated members include screw receiving holes. It should be understood that in alternative exemplary embodiments based on this mesh design, a subset of the elongated members may include screw receiving holes.

[0116] In the present exemplary embodiment, each gusset plate includes a screw receiving hole, but it will be appreciated that other embodiments may be implemented in which a subset of gusset plates include respective holes.

[0117] In some exemplary embodiments, one or more elongated members of the mesh may include at least one pair of grooves defining a localized deformation axis. Fig. 9A and Fig. 9C In the exemplary embodiment shown in , each elongated member includes two pairs of perpendicular slots to allow deformation thereof (eg, during compression of the mesh), with each pair having a respective deformation axis.

[0118] FIG. 10A to FIG. 10D Illustrated with Fig. 7A , Fig. 8A and Fig. 9A Another exemplary network with a different network topology is shown in FIG. Fig. 10B , the exemplary mesh includes a plurality of gussets defining a mesh. The exemplary mesh shows a subset of gussets including screw receiving holes, but the configuration may vary as described above (e.g., using gussets with holes of different sizes or lacking a different subset of holes). In the present mesh design, a plurality of connecting arms extend from each gusset plate, but unlike Fig. 7A , Fig. 8A and Fig. 9A Unlike the mesh design shown in , each connecting arm of a given gusset plate is connected to the adjacent gusset plate without the need for an intermediate connecting region.

[0119] In contrast to the conventional mesh design described above, the adjacent closest gusset plates are directly connected via multiple connecting arms. For example, gusset plates 500A and 500B are directly connected via connecting arms 505AB1 and 505AB2. Fig. 10B The present exemplary embodiment illustrated in shows a configuration in which adjacent nearest gusset plates are connected by a pair of connecting arms, but it is understood that alternative embodiments in which adjacent nearest gusset plates are connected by three or more connecting arms may be implemented.

[0120] like Fig. 10B As can be seen in the illustrative embodiment, each pair of connecting arms extending between a pair of adjacent nearest gusset plates is separated by a pair of intersecting linear slots formed therebetween (e.g., slot 506AB1 and slot 506AB2 formed between connecting arm 505AB1 and connecting arm 505AB2). These intersecting linear slots (which may be perpendicular as shown, or intersecting at an oblique angle) provide local deformation axes to support deformation of the mesh during formation of the mesh.

[0121] It should be understood that the meshes disclosed herein can be formed according to the methods and apparatus disclosed in U.S. Pat. No. 8,974,535, entitled "METHODOF FORMING PATIENT-SPECIFIC IMPLANT," which is incorporated herein by reference in its entirety. For example, a mesh can be formed with a forming tool having features suitable for indexing to provide a custom-shaped implant in accordance with the teachings of U.S. Pat. No. 8,974,535. In addition, in accordance with the teachings of U.S. Pat. No. 8,974,535, anatomical features and / or artificial features provided in the mold system can be used to facilitate local deformation of the template / mesh, wherein the mesh pattern and template geometry are optimized and matched. It should also be noted that the mold geometry and indexing can be used as a reference guide for positioning and placing the implant once formed. As explained above, the exemplary mesh embodiments described herein and variations thereof can be used to achieve meshes with higher fill factors (densities), which can provide improved strength relative to conventional mesh designs. In FIG. 11A to FIG. 11H A comparison of the fill factors of various meshes is provided in . Fig.11A Illustrated Fig. 7A A portion of the mesh pattern shown in FIG. 1 shows a unit cell having an exemplary size of 13×13 mm. Fig.11H A solid implant with these dimensions would have a 169 mm 2 area. Fig. 11B and Fig. 11C The Stryker web is shown, which has a 57.59 mm 2 of mesh area and a fill factor (density) of only 34%. Fig.11D Shows the initial Fig. 7AThe net shown in FIG. 1 has a 108 mm 2 of mesh area and a fill factor of 64%, which is almost twice that of the Stryker mesh. In fact, as can be seen by comparing Fig.11D and FIG. 11E to FIG. 11F It can be seen that Fig.11D The filling factor of the net shown in almost exceeds that of the inverted Stryker net. Fig.11G and Fig. 11B , it can be seen that the reverse Fig.11D The net shown in has a filling factor close to that of the Stryker net.

[0122] It should be understood that the mesh designs of the present disclosure can be implemented with a wide range of fill factors (e.g., by varying the dimensions of mesh features, such as the dimensions of the gusset plates, the diameter of the holes formed in the gusset plates, and the length and width of the connecting arms). In some exemplary embodiments, a mesh can be formed according to having an area fill factor of at least 0.4, or at least 0.5, or at least 0.6. In some exemplary embodiments, a mesh can be formed according to having an area fill factor of 0.4 to 0.9, or 0.5 to 0.8, or 0.6 to 0.7.

[0123] In some exemplary embodiments, a mesh template specific to one or more anatomical regions may be provided. In other words, a mesh template may be provided in a flattened state having a peripheral shape and / or mesh pattern specifically adapted for a selected anatomical region. Such region-specific mesh templates may include additional features such as indexes and other markings that aid in positioning and / or orientation of the mesh once the appropriate shape is formed relative to the patient's anatomy.

[0124] Reference now Fig.12 , provides an example showing an exemplary embodiment of how to create an anatomical region-specific template for a skull defect. In one exemplary embodiment, a computerized average skull model can be used to design an anatomical region-specific template. The region can be flattened and used to define the boundaries of the mesh pattern. The mesh template can be optimized to include regions that match anatomical features and enhance molding and implant fixation. In Fig.12In the figure, the bilateral frontal bone defect shapes are shown at 600 on a computerized average skull model 605. The average skull is created using an averaging algorithm and 3D processing as described in a recent article by Teshima TL, Patel V, Mainprize JG, Edwards G, and Antonyshyn OM (A three-dimensional statistical average skull: Application of biometric morphing in generating missing anatomy, J Craniofac Surg. 2015 Jul; 26(5): 1634-8) and in a monograph chapter by Antonyshyn O, Mainprize J, Edwards G. (Computer Planning for Craniofacial Surgery. In: Alex M. Greenberg, editor(s). Digital Technologies in Craniomaxillofacial Surgery. (United States): Springer Verlag; 2015, currently in press). In this non-limiting method, a library of bone 3D surfaces extracted from a skull CT volume is landmarked by a semi-automatic method. These landmark groups are co-registered together by generalized Prucker analysis (non-rigid), and a consensus (average) landmark group is determined. An average skull surface can be created by deforming (warping) one or more skull surfaces to be consistent. The average skull of the entire library or a subset of the library can be used for implant development.

[0125] Skull defects include any full thickness defects of the frontal, parietal, temporal or occipital bones, which are known and clear or not known and clear before surgery, and involve or do not involve paranasal sinuses. The skull database can be used to identify and manage recurring defect types. The average skull model and skull database are used to define the defect size range of a given anatomical region, and are used to develop mesh sizes and shapes that adapt to defect geometry. A series of defect templates can then be made for any given region by unfolding and / or flattening the geometry of the planar mesh. This is achieved using software that can simulate unfolding or flattening with finite element analysis and adaptive meshing algorithms (Tri-D Technologies, Toronto, Canada) or with computer-aided design software that can calculate and approximate unfoldable surfaces. The final processing includes manually verifying the 2D template shape on a 3D physical model. The bilateral frontal defect areas derived from the average skull model and skull database are shown at 610. The mesh template in its flattened form is shown at 615. As shown at 620 and explained in further detail below, an anatomical region-specific mesh template may include optimized regions for molding, forming to anatomical features, and fixation. For example, 620 shows a region of a template that includes a large portion that may be patterned, e.g., Figure 7F or Fig.15A and Fig. 15B The density of the pattern can be adjusted as desired, including increasing the fill factor to 1.0. Element 620a represents a change in the mesh pattern to enhance mesh folding where the implant needs to be arched outward to match the desired shape from the apex of the skull to the brow. Fig. 15C 620b shows an example of such enhanced detail. Element 620c shows a change in mesh pattern and / or density to allow for local concavity, suture of the posterior side of the frontal zygomatic bone. This is consistent with the features shown in 620e to conform to the zygomatic prominence of the frontal bone. Another series of features are identified in 620d (upper orbital rim and orbital roof) and 620f (glabellar and nasal bone). As shown in element 620b, variable zones or bands can be added to modify and incrementally increase the size of the template around the perimeter. This area can also contain most of the fixation points for the implant.

[0126] Fig.13 An example of a flattened template for bilateral skull defects is shown. Once folded and formed, it will form a patient-specific defect reduction. It should be noted that holes can be deleted and added as needed to provide fixation points. As shown in the figure, the flattened anatomical region-specific mesh template includes a frontal wing above the sinus feature 640, an implant area 630 for large bilateral skull defects, and a temporal / parietal wing feature 635.

[0127] Fig.14A and Fig. 14BAn anatomical region specific mesh template for an orbital floor defect using the exemplary pattern from FIG. 7 is shown, wherein Fig.14A Left and right patterns are shown for the orbital floor including both the lateral and medial walls, and Fig. 14B Left and right patterns for the orbital floor and middle wall only are shown. Fig.14A The exemplary orbital floor template shown in includes side wall features 650, medial wall features 655, anatomical indexing tabs 660, mold indexing features 675, and identification features 680. It should be understood that the orbital floor template may include any or all of these features. Fig. 14B The exemplary orbital floor template shown in has no side wall features. Fig. 14C and Fig.14D Shows Fig. 14B Photograph of an exemplary mesh in after being formed into an anatomical mold and placed in an anatomical orbital defect model. The mesh reduces the defect to its pre-injury shape and conforms to the existing anatomy.

[0128] Fig.15A An example of an anatomical region specific bilateral frontal bone defect is illustrated which has been modified to include additional features such as separate links and / or filler areas, which may be included in various combinations. Fig.15A In the exemplary embodiment shown in , the anatomical region specific mesh template includes features such as a solid frontal panel feature 685 without mesh links and voids, a temporal feature 690, a nasal / glabellar feature 695, and a supraorbital feature 700. Such improvements further reduce surface porosity and allow template regions to adapt to the underlying anatomical structure as needed. The shaping of these regions can be enhanced by introducing slots 701, the absence of pattern 701, or changes in mesh density. Each panel can be freely bent, conforming to the patient's specific anatomical structure and allowing the surgeon to edit the template as needed.

[0129] Fig. 15B yes Fig.15A A photograph of an exemplary mesh pattern is shown in FIG. Fig. 15C yes Fig. 15B Detailed photograph of an exemplary mesh shown in , illustrating implant curvature, solid to patterned transition, mesh interlacing, and overlap.

[0130] The specific embodiments described above have been shown by way of example, and it should be understood that these embodiments can be easily modified and replaced in various forms. It should also be understood that the claims are not intended to be limited to the specific forms disclosed, but are intended to cover all modifications, equivalents and substitutions that fall within the spirit and scope of the present disclosure.

Claims

1. A formable implant for bone fixation or correction of bone defects, the formable implant comprising a formable mesh, the formable mesh comprising: A plurality of gusset plates arranged in space according to a two-dimensional grid; wherein each gusset plate is surrounded by a plurality of intermediate connection structures, the plurality of intermediate connection structures providing connection between the gusset plate and a set of adjacent nearest gusset plates; Each intermediate connection structure is connected to a plurality of gusset plates via a plurality of windmill connection arms, wherein the plurality of windmill connection arms are configured such that when a compressive force is applied to the formable mesh, the compressive force is converted into a torsional force, and the compressive force is mainly absorbed via a rotation of the intermediate connection structure relative to the gusset plates.

2. The formable implant of claim 1, wherein each gusset plate comprises an elongated member.

3. A formable implant according to claim 2, wherein adjacent slender members are oriented at different angles.

4. A formable implant according to claim 3, wherein adjacent slender members are perpendicular.

5. The formable implant of claim 2, wherein each elongated member includes at least one pair of slots defined therein to permit deformation thereof, wherein each pair of slots are aligned along a different respective axis.

6. A formable implant according to any one of claims 1 to 5, wherein adjacent nearest gusset plates are connected by two intermediate connection structures.

7. A formable implant according to any one of claims 1 to 5, wherein at least one connecting arm has a width that varies over its longitudinal extent.

8. A formable implant according to any one of claims 1 to 5, wherein the width of at least one connecting arm initially increases toward a maximum width as the connecting arm extends from its respective node plate, and then decreases as the connecting arm further extends to its respective intermediate connecting structure.

9. A formable implant according to any one of claims 1 to 5, wherein each gusset plate has a respective screw receiving hole.

10. The formable implant of any one of claims 1 to 5, wherein the gusset plates of the first subset have respective screw receiving holes, and wherein the gusset plates of the second subset are free of screw receiving holes.

11. A formable implant according to any one of claims 1 to 5, wherein the node plates of the first subset have respective screw receiving holes, and wherein the node plates of the second subset have respective additional holes defined therein, wherein the diameter of the additional holes is smaller than the diameter of the screw receiving holes.

12. The formable implant of claim 11, wherein the additional holes have a diameter suitable for inserting surgical sutures therethrough.

13. The formable implant of claim 11 wherein the plurality of gusset plates includes a third subset of gusset plates without holes.

14. A formable implant according to any one of claims 1 to 5, wherein the formable mesh has an area fill factor of at least 0.

4.

15. A formable implant according to any one of claims 1 to 5, wherein the formable mesh has an area fill factor of at least 0.

5.

16. A formable implant according to any one of claims 1 to 5, wherein the formable mesh has an area fill factor of at least 0.

6.

17. A formable implant according to any one of claims 1 to 5, wherein the thickness of the formable mesh varies spatially and repeatedly within each unit cell of the mesh.

18. A formable implant according to any one of claims 1 to 5, wherein the thickness of the formable mesh varies spatially within two or more units of the mesh.

19. The formable implant of any one of claims 1 to 5, further comprising one or more solid regions connected to and extending out of the formable mesh.

20. A formable implant according to any one of claims 1 to 5, wherein three connecting arms extend from each intermediate connecting structure.

21. A formable implant according to any one of claims 1 to 5, wherein four connecting arms extend from each intermediate connecting structure.

22. A formable implant according to any one of claims 1 to 5, wherein the gusset plates defining the lattice are provided in at least two different sizes.

23. A formable implant according to any one of claims 1 to 5, wherein the gusset plates defining the lattice are provided in at least two different shapes.

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