Patent Publication Number: US-2023137797-A1

Title: Additively manufactured implant with ceramic coating

Description:
CLAIM OF PRIORITY 
     This patent application claims the benefit of priority, under 35 U.S.C. Section 119(e), to James D. Wernle, U.S. Patent Application Ser. No. 63/273,653, entitled “ADDITIVElY MANUFACTURED IMPLANT WITH CERAMIC COATING,” filed on Oct. 29, 2021, which is hereby incorporated by reference herein in its entirety. 
    
    
     BACKGROUND 
     This application relates generally, though not by way of limitation to three dimensional (3D) printing or additive manufacturing. 3D printing is a process whereby liquid, powder, or another base materials is used to form, often layer-by-layer, a three-dimensional structure using various machines (often referred to as 3D printers). To print a 3D object using a 3D printer, a CAD (computer-aided design) file is often converted to printing information that is transferred to a 3D printer, which uses the printing information to create the 3D object. In some examples of 3D printing, metals can be used to print complex shapes. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes (or prefixes) may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. 
         FIG.  1    illustrates an isometric view of an implant. 
         FIG.  2 A  illustrates an enlarged cross-sectional view of an implant. 
         FIG.  2 B  illustrates an enlarged cross-sectional view of an implant. 
         FIG.  3    illustrates an enlarged cross-sectional view of an implant. 
         FIG.  4    illustrates an enlarged cross-sectional view of an implant. 
         FIG.  5    illustrates an enlarged cross-sectional view of an implant. 
         FIG.  6    illustrates an enlarged cross-sectional view of an implant. 
         FIG.  7    illustrates an enlarged cross-sectional view of an implant. 
       FIG. S illustrates a schematic view of a method. 
         FIG.  9    illustrates an isometric view of an implant. 
         FIG.  10    illustrates an enlarged isometric view of an implant. 
     
    
    
     DETAILED DESCRIPTION 
     Ceramic coatings are desirable for use in implants because they can provide a very smooth surface that can create a relatively low friction interface that can help improve component life. However, ceramics by themselves may be incapable of withstanding typical forces experienced by joint implants. Ceramic-metallic composite coatings can help to address this issue; however, such coatings may require a substrate to have a rough surface to ensure adhesion of the coating to the substrate. Also, 3D printing of implant substrates can be relatively time-consuming and therefore expensive. 
     This disclosure helps to address these issues by using a binder jet 3D printing method that can produce a naturally rough surface for receipt of a ceramic plasma spray coating. The binder jet substrate can also be relatively fast and. therefore cost effective. Further, because the binder jet can use relatively small metallic particles during printing, the substrate can be printed to include interlocking components on the surface of the substrate. The interlocking components can receive the ceramic plasma spray coating and can help further adhere the ceramic layer to the substrate to help improve component strength and durability. 
     The above discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below is included to provide further information about the present patent application. 
       FIG.  1    illustrates an isometric view of an implant  100  that is implantable into a human body. The implant  100  can be a distal femoral implant, such as a condyle replacement. The implant  100  can optionally be other types of implants, such as a femoral head implant, a single femoral condyle implant, a tibial bearing implant, a humeral head implant, or a glenoid implant. 
     The implant  100  can include a substrate  102 . and an outer layer  104 . The substrate  102  can be a metallic substrate formed by additive manufacturing, such as a porous titanium substrate. The substrate  102  can include an inner surface  106  that can be engageable with a bone and an outer surface  108  that can be bonded to the outer layer  104 . The inner surface  106  can define a plurality of pores configured to promote bone ingrowth into the substrate  102 . As discussed in further detail below, the outer surface  108  can include one or more retention features. 
     The outer layer  104  can be a ceramic layer applied or adhered to the substrate  102 . For example, the outer layer  104  can be a plasma spray coating applied to the substrate  102 . The outer layer  104  can be formed around the retention features (as discussed in further detail below) to interlock (or secure or connect) the outer layer  104  with or to the substrate  102 . Following curing or drying of the outer layer  104 , the outer layer  104  can form a bearing surface  110  of the implant  100 . As shown in  FIG.  1   , the outer layer  104  can be applied to front (anterior) portions, side (medial or lateral) portions, rear (posterior) portions, upper (superior), or lower (inferior) portions of the substrate  102 . The outer layer  104  can be a composite of titanium dioxide and aluminum oxide, but can be other composite or non-composite ceramic materials. 
       FIG.  2 A  illustrates an enlarged cross-sectional view of an implant  200 .  FIG.  2 B  illustrates a further enlarged cross-sectional view of the implant  200 .  FIGS.  2 A and  2 B  are discussed together below. The implant  200  can be similar to the implant  100  discussed above;  FIGS.  2 A and  2 B  show how the implant  200  can include retention features formed from additive manufacturing, such as binder jetting. Any of the implants discussed above or below can be modified to include retention features. 
     As shown in  FIG.  2 A , the implant  200  can include a substrate  202  and a coating or outer layer  204 . The coating  204  can be a ceramic composite (the same or similar to the coating  104 ) and the substrate  202  can be a binder jet printed substrate (the same or similar to the substrate  102 ). Only a portion of the substrate  202  is shown in  FIGS.  2 A and  2 B .  FIG.  2 A  shows that the substrate  202  can include retention features  2112   a - 212   n.  The retention features  212  can have various shapes or can be a similar, repeating shape. As shown in  FIG.  2 A , the shape of the retention features  212  can be triangles. The retention features  212  can form a relatively rough surface of the substrate  202  for the coating or outer layer  204  to bind or adhere to. 
     As shown in FIG,  213 , the retention features  212  can each be formed of many particles  214 , which can be assembled (such as through binder jetting) to form the retention features. The particles  214   a - 214   n  can be cured and densified following the binder jetting. The particles  214  can be printed in various other shapes as discussed in further detail below. 
       FIG.  3    illustrates an enlarged cross-sectional view of an implant  300 . The implant  300  can be similar to the implants  100  and  200 , in that the implant  300  can include a substrate  302  and an outer coating  304  that can be similar to the substrates and outer coatings, respectively, discussed above. The implant  300  can differ in that the shape of the retention features  312   a - 312   n  can be a trapezoid or a keystone, Optionally, the shape of the retention features  312   a - 312   n  can be a trapezoidal prism or a partial trapezoidal prism. Such a shape can help to interlock or secure the outer coating  304  to the substrate  302 , as discussed in further detail below with respect to  FIG.  5   . Optionally, the retention features  312   a - 312   n  can have other shapes such as a rectangular prism or a cuboid. 
       FIG.  4    illustrates an enlarged cross-sectional view of an implant  400 . The implant  400  can be similar to the implants  100 - 300 , in that the implant  400  can include a substrate  402  and an outer coating  404  that can be similar to the substrates and outer coatings, respectively, discussed above. The implant  400  can differ in that the shape of retention features  412   a - 412   n  can have a cross-sectional Z-shape. That is, the retention features  412   a - 412   n  can have a depth in addition to the shown height and width. 
       FIG.  5    illustrates an enlarged cross-sectional view of an implant  500 . The implant  500  can be similar to the implants  100 - 400 , in that the implant  500  can include a substrate  502  and an outer coating  504  that can be similar to the substrates and outer coatings, respectively, discussed above. The implant  500  can differ in shape of retention features  512   a - 512   n  can be a keystone shape including multiple projections. 
     For example, the retention feature  512   a  can include a proximal portion  516  connected to an outer surface  508  of the substrate  502 . The proximal portion  516  defining a proximal width w 1 . The retention feature  512   a  can also include a distal portion  518  connected to the proximal portion  516 . The distal portion  518  can define a distal width w 2  that is larger than the proximal width. Because the distal portion  518  of the retention feature  512   a  is relatively larger or wider, it increases a force required to separate the outer coating  504  from the substrate  502 . The retention features of the implants  100 - 400  discussed above and  600 - 700  discussed below can include such width variations to help reduce a chance of delamination or separation of the spray coated outer layer (e.g.,  504 ) from the substrate e.g.,  502 ). 
     Additionally, the retention features can include multiple width variations. For example, the retention feature  512   b  can include the widths w 1  and w 2  and can also include a medial portion  520  defining a width w 3  and can include an outer distal portion  522  defining a width w 4  where the width w 4  can be larger than the width w 3 . These width variations in the retention features  512  can further help to limit separation or delamination of the outer coating  504  from the substrate  502 , such as during use of the implant  500 . 
     The width w 4  can also be larger than the width w 1  and can also be larger than the width w 2 . The widths w 1  and w 3  can be the same as can the widths w 2  and w 4 . Alternatively, the widths w 1 -w 4  can be different. Also, optionally, the retention features  512  can all have widths that are consistent between retention features. Alternatively, the retention features  512  can have widths that vary between retention features. Optionally, the retention features  512 . can be located (or can be located in higher density) on a rounded portion of the substrate  502 , such as to help secure the outer coating  504  to the substrate  502  where separation may normally occur, 
       FIG.  6    illustrates an enlarged cross-sectional view of an implant  600 . The implant  600  can be similar to the implants  100 - 500 , in that the implant  600  can include a substrate  602 . and an outer coating  604  that can be similar to the substrates and outer coatings, respectively, discussed above. The implant  600  can differ in that the shape of retention features  612   a - 612   n  can have a cross-sectional circular shape or a partial circle shape. Optionally, the retention features  612   a - 612   n  can have a spherical shape or a partial spherical shape. In either case, the retention features  612  can include proximal portion  616  defining a width w 1  and can include a distal portion  618  defining a width w 2  that is larger or wider than the width w 1  to help limit separation of the outer coating  604  from the substrate  602 , such as during use of the implant  600 . The proximal portion  616  can be connected to an outer surface  608  of the substrate  602 . 
       FIG.  7    illustrates an enlarged cross-sectional view of an implant  700 . The implant  700  can be similar to the implants  100 - 600 , in that the implant  700  can include a substrate  702  and an outer coating  704  that can be similar to the substrates and outer coatings, respectively, discussed above. The implant  700  can differ in shape of retention features  712   a - 712   n  can have a cross-sectional oval shape or a partial oval shape. Optionally, the retention features  712   a - 712   n  can have a ovoid shape or a partial ovoid shape. in either case, the retention features  712  can include proximal portion  716  defining a width  16  and can include a distal portion  718  defining a width w 2  that is larger or wider than the width w 1  to help limit separation of the outer coating  704  from the substrate  702 , such as during use of the implant  700 . 
       FIG.  7    also shows that the outer coating  704  can define or have a thickness t 1 . The thickness t 1  can optionally vary to match a contour of the outer surface  708 . The thickness t 1  can be between 100 and 300 micrometers (micron). The thickness t 1  can optionally be about 200 micrometers. 
       FIG.  7    also shows that the retention features  712  can define or have a height h 1 . The height h 1  can be between  10  micrometers and 100 micrometers, which means that the retention features  712  can extend from an outer surface  708  by 10 micrometers to 100 micrometers. The height h 1  can optionally be between 20 micrometers and 50 micrometers. In some examples, the thickness ti can be increased to accommodate the height h 1  of the retention feature  712 . Also, the thickness t 1  can be varied around other portions of the implant  700 . For example, edges of the implant  700  can have a reduced thickness and bearing surfaces (e.g., condyle replacement surfaces) can have a relatively larger thickness. 
     Because the binder jetting process can use relatively small particulates, as discussed above with respect to  FIGS.  2 A and  2 B , the retention features (such as the retention features  212  or  712 ) can be made at a relatively small scale, such as between  20  micrometers and  50  micrometers. This can allow the ceramic coating (e.g., outer layer  704 ) to be applied in a relatively thin layer (having a relatively small thickness) on top of the substrate (e.g., the substrate  702 ), while allowing for the use of interlocking features and still minimizing the impact to the outer layer or coating by the interlocking features. That is, the interlocking features can be large enough to increase interlocking between the substrate and the outer layer, but small enough to minimize impact on the profile (e.g., smoothness) of the outer layer. 
       FIG.  8    illustrates a schematic view of the method  800 , in accordance with at least one example of this disclosure. The method  800  can be a method of manufacturing an implant using additive manufacturing and plasma spray coating. More specific examples of the method  800  are discussed below. The steps or operations of the method  800  are illustrated in a particular order for convenience and clarity; any of the discussed operations can be performed in a different sequence, simultaneously, in series, or in parallel without materially impacting other operations. The method  800  as discussed includes operations performed by multiple different actors, devices, and/or systems. It is understood that subsets of the operations discussed in the method  800  can be attributable to a single actor, device, or system could be considered a separate standalone process or method. 
     The method  800  can begin at step  802  where a binder and metallic powder can be mixed. Optionally, other components can be added to the mix either before or after mixing the binder and the metallic powder. The binder can be a temperature activated adhesive and the metallic powder can be titanium. At step  804 , the metallic powder and binder mixture can be printed into a preliminary metallic substrate, such as using a binder jetting process. An outer surface of the preliminary metallic substrate can include a plurality of retention features on an outer surface of the preliminary metallic substrate. For example, the outer surface  508  of the implant  500  can include retention features  512 . 
     At step  806 , the preliminary metallic substrate can be cured, such as through a heating process to cross link the substrate. At step  808 , the preliminary metallic substrate can be de-powdered such that excess powder can be removed from the preliminary metallic substrate. At step  810 , the preliminary metallic substrate cab be de-binded such that the binder can be released from the preliminary metallic substrate. At step  812 , the preliminary metallic substrate can be densified, such as by sintering the preliminary metallic substrate to form a hardened metallic substrate. The preliminary metallic substrate can be densified in other ways. Sintering can be performed using one or more of heat or pressure applied to the preliminary metallic substrate. Optionally steps  810  and  812  can be performed together or at the same time. 
     At step  814 , the hardened or densified metallic substrate can be heat treated, such as one or more of annealing, normalizing, hardening, tempering, aging, quenching, or the like. Optionally, the hardened or densified metallic substrate can be further densified such as through hot isostatic pressing (HIP). At step  816 , a ceramic coating can be plasma sprayed on the outer surface and the retention features of the hardened metallic substrate to interlock the ceramic coating to the hardened metallic substrate. 
     At step  818 , the outer surface can be polished of the ceramic coating to form a bearing surface of the implant. Optionally, a spray angle of a plasma sprayer can be varied during plasma spraying the ceramic coating on the hardened metallic substrate. At step  820 , a spray thickness of the ceramic coating can be varied on the hardened metallic substrate. 
       FIG.  9    illustrates an isometric view of an implant  900  that is implantable into a human body. The implant  900  can be similar to the implants  100 - 700  discussed above; the implant  900  can differ in that the implant  900  can be a humeral head implant. The implant  900  can optionally be other types of implants, such as a femoral oral head implant. 
     The implant  900  can include a substrate  902  and an outer layer  904 . The substrate  902  can be formed by additive manufacturing, such as binder jetting. The substrate  902  can be a metallic substrate porous titanium substrate. The substrate  902  can include an inner surface  906  that can be engageable with a bone and can be porous to help promote bone ingrowth. The inner surface  906  can define a plurality of pores configured to promote bone ingrowth into the substrate  902 . The outer surface  908  can be a relative rough surface configured to be bonded to the outer layer  904 . The outer surface  908  can include one or more retention features, such as those discussed above, Once bonded to the outer surface, the outer layer  904  can form a bearing surface  910  of the implant  900 , engageable with a glenoid or glenoid implant, for example. 
       FIG.  10    illustrates an enlarged cross-sectional view of an implant  1000 . The implant  100  can be similar to the implants discussed above, in that the implant  1000  can include a substrate  1002  and an outer coating  1004  that can be similar to the substrates and outer coatings, respectively, discussed above. The implant  1000  can differ in that the shape of retention features  1012   a - 1012   n  can be a complex or irregular shape. 
     For example, the retention feature  1012   c  can include a proximal portion  1016  connected to an outer surface  1008  of the substrate  1002 . The proximal portion  1016  can define a proximal width w 1 . The retention feature  1012   c  can also include a distal portion  1018  connected to the proximal portion  1016 . The distal portion  1018  can define a distal width w 2  that is larger than the proximal width w 1 . Because the distal portion  1018  of the retention feature  1012   a  is relatively larger or wider, it can increase a force required to separate the outer coating  1004  from the substrate  1002 . The retention features of the implants discussed above and below can include such width variations to help reduce a chance of delamination or separation of the spray coated outer layer (e.g.,  1004 ) from the substrate (e.g.,  1002 ). 
     Additionally, the retention features  1012  can include multiple shape variations. For example, the proximal portion  1016  can form a tapered or curved rectangular pyramid shape or square pyramid shape connected to the distal portion  1018 , such that the smallest width (w 1 ) of the proximal portion  1016  is located near the largest width (w 2 ) of the distal portion  1018 . These shape variations in the retention features  1012  can further help to limit separation or delamination of the outer coating  1004  from the substrate  1002 , such as during use of the implant  1000 . 
     Also, the distal portion  1018  can have a relatively square or rectangular shape (or rectangular prism shape with a relatively small height), which can help to increase a surface area of the distal portion  1018  and can add multiple edges and vertices to the retention features  1012 . These geometric features of the retention features  1012  can help to further increase a force required to separate or delaminate the outer coating  1004  from the substrate  1002 , such as during use of the implant  1000  following implantation. 
     Optionally, the retention features  1012  can be located (or can be located in higher density) on a rounded portion of the substrate  1002 , such as to help secure the outer coating  1004  to the substrate  1002  where separation may be more likely to occur. 
     Notes and Examples 
     The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others. 
     Example 1 is an implant implantable into a human body, the implant comprising: a metallic substrate formed by additive manufacturing, the metallic substrate engageable with a bone, the metallic substrate including: an inner surface defining a plurality of pores configured to promote bone ingrowth into the metallic substrate; an outer surface; and a plurality of retention features, each including: a proximal portion connected to the outer surface, the proximal portion defining a proximal width; and a distal portion connected to the proximal portion, the distal portion defining a distal width larger than the proximal width; and a ceramic layer spray coated to the metallic substrate and formed around the retention features to interlock the ceramic layer with the metallic substrate, the ceramic layer forming a bearing surface of the implant. 
     In Example 2, the subject matter of Example 1 optionally includes wherein the metallic substrate is a porous titanium substrate formed from binder jet additive manufacturing. 
     In Example 3, the subject matter of Example 2 optionally includes wherein the ceramic layer is spray coated to the porous titanium substrate using plasma spray coating. 
     In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein the ceramic layer is made of a composite of titanium dioxide and aluminum oxide. 
     In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the retention feature has a cross sectional shape of a keystone, a trapezoid, a partial circle, or a partial oval. 
     In Example 6, the subject matter of any one or more of Examples 1-5 optionally include wherein the ceramic layer has a thickness between 100 and 300 micrometers. 
     In Example 7, the subject matter of Example 6 optionally includes wherein the retention feature extends from the outer surface between 10 micrometers and 100 micrometers. 
     In Example 8, the subject matter of any one or more of Examples 6-7 optionally include wherein the retention feature extends from the outer surface between 20 micrometers and 50 micrometers. 
     In Example 9, the subject matter of any one or more of Examples 1-8 optionally include wherein the retention featured is located on a rounded portion of the metallic substrate. 
     In Example 10, the subject matter of any one or more of Examples 1-9 optionally include wherein the implant is a femoral head implant, a femoral condyle implant, a tibial bearing implant, a humeral head implant, or a glenoid implant. 
     Example 11 is a method of manufacturing an implant, the method comprising: printing a metallic powder and binder mixture into a preliminary metallic substrate, an outer surface of the preliminary metallic substrate including a plurality of retention features on an outer surface of the preliminary metallic substrate; curing the preliminary metallic substrate through a heating process; de-powdering the preliminary metallic substrate; densifying the preliminary metallic substrate by sintering the preliminary metallic substrate to form a hardened metallic substrate; heat, treating the hardened metallic substrate; plasma spraying a ceramic coating on the outer surface and the retention features of the hardened metallic substrate to interlock the ceramic coating to the hardened metallic substrate. 
     In Example 12, the subject matter of Example 11 optionally includes polishing an outer surface of the ceramic coating to form a bearing surface of the implant. 
     In Example 13, the subject matter of any one or more of Examples 11-12 optionally include varying a spray angle of a plasma sprayer during plasma spraying the ceramic coating on the hardened metallic substrate. 
     In Example 14, the subject matter of any one or more of Examples 11-13 optionally include varying a spray thickness of the ceramic coating on the hardened metallic substrate. 
     In Example 15, the subject matter of any one or more of Examples 11-14 optionally include wherein the ceramic coating has a thickness between 100 and 300 micrometers. 
     In Example 16, the subject matter of any one or more of Examples 11-15 optionally include wherein the retention feature extends from the outer surface between 20 micrometers and 50 micrometers. 
     In Example 17, the subject matter of any one or more of Examples 11-16 optionally include wherein the metallic substrate is a porous titanium substrate formed from binder jet additive manufacturing. 
     In Example 18, the subject matter of Example 17 optionally includes wherein the ceramic coating comprises a composite of titanium dioxide and aluminum oxide. 
     Example 19 is an implant implantable into a human body, the implant comprising: a metallic substrate formed by additive manufacturing, the metallic substrate engageable with a bone, the metallic substrate including: an inner surface defining a plurality of pores configured to promote bone ingrowth into the metallic substrate; an outer surface; and a plurality of retention features; and a ceramic layer spray coated to the metallic substrate and formed around the retention features to interlock the ceramic layer with the metallic substrate, the ceramic layer forming a bearing surface of the implant. 
     In Example 20, the subject matter of Example 19 optionally includes wherein the metallic substrate is a porous titanium substrate formed from binder jet additive manufacturing, wherein the ceramic layer is spray coated to the porous titanium substrate using plasma spray coating, and wherein the ceramic layer is made of a composite of titanium dioxide and aluminum oxide. 
     In Example 21, the subject matter of Example 1 optionally includes wherein the proximal portion has a shape of a curved pyramid. 
     In Example 22, the subject matter of Example 1 optionally includes wherein the distal portion has a shape of a rectangular prism. 
     In Example 23, the apparatuses or method of any one or any combination of Examples s1-22 can optionally be configured such that all elements or options recited are available to use or select from. 
     The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein. 
     In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the tennis “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. 
     In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. 
     The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should he determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.