Abstract:
A brace comprises a belt and removably attachable vertical strut(s). Each vertical strut can comprise one or more of a strut(s), thoracic pad(s), hip pad(s), lumbar support pad(s), chest support pad(s), de-rotation pad(s), or any other component suitable to assist or restrict movement of a wearer&#39;s body, reduce or apply a force to a wearer&#39;s body, correct the shape of a wearer&#39;s body, reduce pain, or provide support to a wearer&#39;s body. It is contemplated that each component can be removable or adjustable from a vertical strut or belt.

Description:
FIELD OF THE INVENTION 
       [0001]    The field of the invention is orthotics. 
       BACKGROUND 
       [0002]    The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art. 
         [0003]    Scoliosis is a medical condition associated with an abnormally curved spine, often thought to be a progressive disease, at least until adulthood. Scoliosis can have severe adverse affects on a patient&#39;s life, both physically and physiologically. One possible method of treating or managing scoliosis is surgery. Unfortunately, scoliosis surgery can be very risky. Less invasive methods of treating or managing scoliosis has traditionally included physical therapy, chiropractic therapy, or bracing, among other things. 
         [0004]    Some previous efforts have been made to provide improved comfort, support, or customizability to individual wearers. For example, U.S. Pat. No. 4,230,101 to Gold, U.S. Pat. No. 5,012,798 to Graf et al., International Patent Application Publication No. WO 2010/044796 to Ogilvie et al., International Patent Application Publication No. WO 2006.068459 to Van Loon et al., U.S. Pat. No. 5,405,313 to Albin, and UK Patent Application GB 2467974 to Mills teach various scoliosis management devices. 
         [0005]    All publications or other extrinsic evidence herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. 
         [0006]    Unfortunately, none of the above references teach a brace that provides both the desired level of comfort, support and modularity to a wearer. Thus, there is still a need for improved scoliosis braces. 
       SUMMARY OF THE INVENTION 
       [0007]    The inventive subject matter provides apparatus, systems and methods in which a scoliosis brace is configured to provide adjustable support to a wearer. The brace preferably comprises a flexible belt configured to wrap around a mid-portion of a wearer, along with various components (e.g., struts, pads, adjustment mechanisms, etc.) configured to removably couple with the flexible belt and thereby provide customizable support to different portions of a wearer&#39;s body. A brace of the inventive subject matter can advantageously be configured to add a force or restrict a motion in the sagittal, transverse and coronal planes. 
         [0008]    In one aspect of the inventive subject matter, a scoliosis brace comprises one or more vertical struts having an anchor pad (or base pad) coupled to a first strut, which is configured to removably attach to the interior side of the belt. It is contemplated that the anchor pad or the strut can removably attach to the belt in any commercially suitable manner, including for example, via a hook and loop fastener, snaps, buttons, magnets, and threading. 
         [0009]    As used herein, a “vertical strut” is defined broadly to include a plurality of components (pads, struts, angle or height adjustment mechanisms, etc.) that are coupled with one another to create a single piece. As used herein, a “strut” is a single rod or bar forming a part of a framework. It can generally be preferred that a strut is made from either (1) a rigid material (e.g., a metal, a hard plastic, etc.) that requires more than an average person&#39;s force to bend, or (2) a material (e.g., aluminum, etc.) that is sized and dimensioned to be pliable when a strong force is applied, but sturdy when an ordinary force is applied. 
         [0010]    A second strut can be coupled to the first strut and also be coupled with a thoracic pad configured to provide a pressure to a first side of the wearer below the underarm. It is contemplated that the first strut and the second strut can be movably coupled to one another such that one can rotate or pivot relative to the other. 
         [0011]    It is also contemplated that the height of the thoracic pad relative to the central point of the anchor pad can be adjusted via any commercially suitable height adjustment mechanism, including for example, a rack and pinion mechanism, a biasing mechanism, a slidably coupled telescoped component, or any other commercially suitable component. Similar mechanisms can also be provided to adjust a horizontal position of the thoracic pad relative to the central point of the anchor pad. 
         [0012]    A brace of the inventive subject matter can also comprise a first hip pad coupled to the first strut via a third strut, and configured to provide support to a hip area of a wearer. It is contemplated that the first strut and third strut can couple with one another to act as a height adjustment mechanism (e.g., to adjust a vertical position of the hip pad on the wearer relative to the central point of the anchor pad or an angle adjustment mechanism (e.g., to adjust a horizontal or vertical position of the hip pad on the wearer relative to the central point of the anchor pad). 
         [0013]    In another aspect of the inventive subject matter, it is contemplated that the thoracic pad can be coupled to a curved arm configured to at least partially wrap around an upper chest portion of a wearer. The curved arm is preferably coupled to a de-rotation pad that is configured to put pressure on the upper chest wall on one side to cause a force intended to resist forward motion and rotation of that side of the chest when the brace is worn. 
         [0014]    One or more straps can be provided and configured to couple with two or more components of the brace. For example, a first strap can be coupled to the belt (e.g., via hook and loop fastener, snaps, buttons, threading, zipper, or other commercially suitable fastener(s) or combinations thereof) and the thoracic pad (e.g., via a carabiner, a buckle, a button, a snap, or other commercially suitable fastener(s) or combinations thereof). A second strap can be configured to couple to at least two of the following, among other components: the de-rotation pad, the rounded arm, the first, second or third strut, the anchor pad, or the hip pad. 
         [0015]    In some embodiments, a first vertical strut comprising the anchor pad, first strut, thoracic pad, de-rotation pad or hip pad can be coupled to the belt such that it provides support predominantly to a left or right side of the wearer. As used herein, the term “provides support predominantly to a left or right side” means that at least 80% of the components are located on a single side of the wearer. Thus, it is contemplated that a first vertical strut can be coupled to the belt such that it provides support predominantly to a left side of the wearer, even though 20% or less of the support is provided to the right side of the wearer. In some preferred embodiments, at least 90%, at least 95%, or even 100% of the support can be provided to a single side of the wearer via a first vertical strut. It is contemplated that additional components can be provided, if needed, via a second vertical strut to couple to the belt such that it provides support predominantly to the opposite side of the wearer. 
         [0016]    The additional components can include a second anchor pad having a fourth strut and coupled to the belt, a second thoracic pad movably coupled to the second anchor pad via a fifth strut, a second de-rotation pad coupled to the second thoracic pad via a second rounded arm, a second hip pad, or any other suitable component(s). 
         [0017]    Alternatively or additionally to being movably coupled to one another, each of the struts, straps, and pads can be removably coupled with, or attached to, another strut, pad, belt or other component of the inventive subject matter. Where a strut, pad or other component is moved from a first location to a second location, it is contemplated that the locations can be completely distinct or partially overlapping. For example, it is contemplated that a strut, pad or other component can be moved by as little as 5 cm, 2 cm, or even 1 cm or less, or can be moved by as much as 6 cm, 10 cm, or even 20 cm or even more. 
         [0018]    Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1  shows one embodiment of a vertical strut of the inventive subject matter. 
           [0020]      FIG. 2  shows one embodiment of a thoracic pad, rounded arm and de-rotation pad of the inventive subject matter. 
           [0021]      FIG. 3  shows one embodiment of another vertical strut of the inventive subject matter. 
           [0022]      FIG. 4  shows one embodiment of a first and second vertical strut coupled to a flexible belt. 
           [0023]      FIG. 5  shows one embodiment of a brace of the inventive subject matter as worn by a wearer. 
           [0024]      FIG. 6  shows one embodiment of a strap of the inventive subject matter having a buckle. 
           [0025]      FIG. 7  shows one embodiment of a rear portion of a brace of the inventive subject matter. 
           [0026]      FIG. 8  shows one embodiment of a side portion of a brace of the inventive subject matter. 
           [0027]      FIG. 9  shows a step by step flowchart of one method of fitting a wearer with a brace of the inventive subject matter. 
           [0028]      FIG. 10  shows another embodiment of a brace of the inventive subject matter having substantially similar left and right vertical struts with removable and adjustable components. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed. 
         [0030]    It is contemplated that a brace of the inventive subject matter can utilize one or more of the components discussed in co-owned U.S. Pat. Nos. 7,001,348 and 8,142,377, and U.S. Patent Application Publication Nos. 2012/0232450 and 2012/0245502. For example, it is contemplated that a brace can utilize a pulley system as disclosed in U.S. Pat. No. 7,001,348. 
         [0031]      FIG. 1  shows a vertical strut  100  of the inventive subject matter. Vertical strut  100  is configured to provide support to a right or left side of a wearer, and preferably comprises an anchor pad  170  coupled with strut  190 , a hip pad  180 , a thoracic pad  140 , rounded arm  130 , and de-rotation pad  120  having a buckle receiver  110 . 
         [0032]    Anchor pad  170  comprises a hook or loop fastener  171  that is configured to removably attach to a belt (not shown). Contemplated pads can comprise any commercially suitable material(s), including for example, foam, silicon, nylon, cotton, mesh, or any other suitable material. 
         [0033]    Strut  190  is coupled to angle/height adjustment mechanism  150  that allows a user to adjust a horizontal or vertical location of thoracic pad  140  relative to the anchor pad  170 . One embodiment of such an angle/height adjustment mechanism is a second strut  162  and screw  161  mechanism. The horizontal location of thoracic pad  140  relative to anchor pad  170  can be adjusted via adjustment mechanism  150  by simply rotating the second strut  162  relative to the first strut  190 . The vertical height of thoracic pad  140  relative to anchor pad  170  can be adjusted via adjustment mechanism  150  by unscrewing screw  161 , adjusting the alignment of perforations on first strut  190  and second strut  162 , and re-tightening screw  161 . 
         [0034]    In some other embodiments, it is contemplated that other angle or height adjustment mechanisms can be used, including for example, a series of snaps, a rack and pinion mechanism, a biasing mechanism, a slidably coupled telescoped component, or any other commercially suitable mechanisms. 
         [0035]    Thoracic pad  140  can be coupled to curved arm  130  via a similar angle/height adjustment mechanism  160 . Curved arm  130  is coupled with de-rotation pad  120 , which advantageously provides support to an upper chest region of a wearer, and is configured to at least partially prevent a rotation of a patient&#39;s torso when worn, for example, by preventing a rotation of one or more components of the brace with respect to another component. 
         [0036]      FIG. 2  is a close up view of a thoracic pad, rounded arm and de-rotation pad of a vertical strut  200  of the inventive subject matter. Strut  280  is coupled to an anchor pad (not shown) and thoracic pad  260  via a fastener that also acts as a height adjustment mechanism  270 . However, other types of fasteners could be used. Thoracic pad  260  is further coupled to curved arm  215 , which can also acts as a part of height and angle adjustment mechanism  240  in conjunction with one or more fasteners  216 . It is contemplated that a user can remove or loosen fasteners  216  and realign the perforations of curved arm  215  with a suitable perforation of thoracic pad  260  in order to adjust an angle or height of de-rotation pad  210  relative to thoracic pad  260 . 
         [0037]    De-rotation pad  210  can be coupled to curved arm  215  in any commercially suitable manner. However, it is currently preferred that de-rotation pad  210  and curved arm  215  are coupled together via a series of perforations and a snap configured to lock de-rotation pad  210  in a position aligned with one of the perforations. 
         [0038]    De-rotation pad  210 &#39;s fastener (height adjustment mechanism  220 ) is coupled to buckle receiver  250 , which is configured to receive a buckle of a strap (not shown). A strap can be advantageously used to block a rotation of a component of the brace with respect to another component of the brace or providing a tension or tautness between the components to which it is attached. For example, a strap that is coupled to buckle receiver  250  and the belt can advantageously be used to block a change in a vertical position of a de-rotation pad relative to the belt, and further block a rotation of the vertical strut  200  comprising the de-rotation pad relative to the belt (alternatively or additionally to the blocking provided by a fastening mechanism between the belt and vertical strut). 
         [0039]      FIG. 3  shows a different vertical strut  300  of the inventive subject matter. Vertical strut  300  comprises an anchor pad  310 , thoracic pad  320  and an angular and height adjustment mechanism  325  comprising a first and second strut,  316  and  317 , respectively. It is contemplated that vertical strut  300  could also include additional components that are removable and adjustable with respect to the anchor pad  310  and thoracic pad  320 . For example, vertical strut  300  could also comprise a third strut coupled with a hip pad, a rounded arm coupled with a de-rotation pad, or any other suitable component. 
         [0040]    It is contemplated that vertical strut  100  or  200  could be worn on a right side of a wearer while vertical strut  300  is worn on a left side of a wearer, or vice versa. 
         [0041]      FIG. 4  shows a first vertical strut  440  and second vertical strut  460  each removably attached to a belt  410  of the inventive subject matter. Brace  400  comprises belt  410  having hook or loop fastener  420  on an inner side  422 , and a complementary hook or loop fastener  430  on an outer side  425 . Brace  400  also comprises a first vertical strut  440  removably attached to a left inner side of belt  400 , and a second vertical strut  460  removably attached to a right inner side of belt  400 . 
         [0042]    Belt  410  is preferably configured to wrap around a mid-portion of a wearer and securely fasten to itself via hook or loop fasteners  420  and  430 , although any commercially suitable fasteners could be used. First strap  470  is coupled with a first attachment point (on outer side  425 ) on the outer side of belt  400 , and is configured to couple with a thoracic pad of second vertical strut  460 , and de-rotation pad  450  of first vertical strut  440  via buckle receiver  455 . First strap  470  and de-rotation pad  450  can be advantageously used together to cause an increase in pressure on a portion of the patient to support them in a desired position. 
         [0043]    One having ordinary skill in the art should appreciate that references to a “fastener” are used broadly to refer to any commercially suitable fastener(s), including for example, a hook and loop fastener, a button, a snap, a belt type buckle, a side squeeze buckle, a magnet, a zipper, perforations and screws or snaps, or any other commercially suitable fastener(s). One having ordinary skill in the art should also appreciate that some fasteners can also serve as, or be coupled with, an adjustment mechanism such as a length, height, angle or other adjustment mechanism. 
         [0044]      FIG. 5  shows the brace  400  of  FIG. 4  as partially fastened to a wearer. As shown, belt  410  has been fastened to itself around a mid-portion of the wearer via hook and loop fasteners, and the brace  400  is being tightened via first cord system  475  and second cord system  476 . It is contemplated that the pull tabs of cord systems  475  and  476  (e.g.,  475 A and  476 A) can comprise a hook or loop fastener that can removably attach to a hook or loop fastener of the outer side of belt  400 . As discussed above, it is contemplated that a brace of the inventive subject matter can utilize one or more of the components discussed in co-owned U.S. Pat. Nos. 7,001,348 and 8,142,377, and U.S. Patent Application Publication Nos. 2012/0232450 and 2012/0245502. For example, it is contemplated that a brace can utilize a pulley system as disclosed in U.S. Pat. No. 7,001,348. 
         [0045]    Brace  400  comprises a second strap  478 , which is fastened to an outer side of belt  400  via any suitable fastener (e.g., hook or loop, snaps, buttons, etc.) and further coupled to a thoracic pad of first vertical strut  440 . 
         [0046]      FIG. 6  shows a front-left side view of the brace  400  of  FIGS. 4 and 5 . First strap  470  is attached to belt  410  and second vertical strut  460 , and is shown in being fastened to buckle receiver  455  of de-rotation pad  450  via buckle  471  of first strap  470 . Second strap  478  is removably fastened to belt  410  and removably fastened to the thoracic pad of first vertical strut  440  via a screw that also acts as part of an angle and height adjustment mechanism between the curved arm and thoracic pad of first vertical strut  440 . 
         [0047]      FIG. 7  shows a back view of the brace  400  shown in  FIG. 4  as worn by a wearer. Brace  400  comprises a tightening mechanism  480  shown in having two cord systems  475  and  476 . It is contemplated that first cord system  475  can be configured to tighten a top portion of belt  410  (e.g., shorten a distance between the top portion of right cord guide cover  482  and left cord guide cover  484 ) when pulled in a first direction, while second cord system  476  can be configured to tighten a bottom portion of belt  410  (e.g., shorten a distance between the bottom portion of right cord guide cover  482  and left cord guide cover  484 ) when pulled in a second direction different from the first direction. Alternatively, each cord could be used to tighten a top and a bottom portion of belt  410 . 
         [0048]    Brace  400  further comprises a third strap  486  and fourth strap  488 . Third strap  486  is configured to attach to left cord guide cover  484  and first vertical strut  440  via any suitable fastening means, and fourth strap  488  is configured to attach to right cord guide cover  482  and second vertical strut  460  via any suitable fastening means. 
         [0049]    The combination of first, second, third and fourth straps ( 470 ,  478 ,  486 , and  488 ) can be used together to provide increased support to a wearer while ensuring that a proper amount of force is being applied to the areas intended. 
         [0050]      FIG. 8  is a left side view of the brace  400  of  FIGS. 4-7  showing first vertical strut  440  attached to an inner side of belt  410 . As shown, anchor pad  441  is substantially aligned with the height of belt  410 . Vertical strut  440  is configured to provide pressure to at least two portions of the wearer&#39;s body. The first area  440 A is the left side of the wearer between the underarm and mid-portion, which is supported by thoracic pad  442 . The second area  440 B is the left hip of the wearer, which is supported by hip pad  443 . 
         [0051]    Second strap  478  and third strap  486  are each fastened to belt  410  and thoracic pad  442 , and are configured to provide an adjustable amount of tension or tautness between the two components to which they are attached, or prevent a rotation of one component (e.g., the thoracic pad  442 ) relative to another component (e.g., the midline of the belt where the belt could be folded in half along its length) to thereby prevent a rotation of a patient&#39;s body, or adjust the patient&#39;s body back into a less rotated state. 
         [0052]      FIG. 9  provides a step by step flowchart of one method of fitting a wearer with a brace. 
         [0053]    As shown in step  1 , a healthcare professional or other person can obtain an x-ray of a wearer&#39;s spine to identify a curve apex and locations where force should be applied. For example, step  1  shows that force should be applied at points A, B and C. 
         [0054]    Step  2  shows how to locate an anchor point to which the anchor pad can be aligned. The left anchor point, for example, is located between the rib cage and iliac crest of the wearer. Depending on the curvature of the wearer&#39;s spine or other factors, it is contemplated that the anchor point(s) can alternatively be in a location other than between the rib cage and iliac crest. 
         [0055]    Step  3  shows a vertical strut being fit on a wearer based on the anchor pad&#39;s alignment with the left anchor point. Once the location of the anchor pad is determined, the remaining components of the vertical strut can be adjusted (e.g., bending of the strut, adjustment of the relative heights of each component, adjustment of an angle between components, etc.) to provided a force to the intended areas of a user (e.g., areas A and C of step  1 ) as shown in Steps  4  and  5 . 
         [0056]    Step  4  shows a possible arrangement of components of a vertical strut. Step  5  shows that the thoracic pad of the first vertical strut can align with force point A. In this embodiment, it is generally preferred that at least two inches separate the underarm of the wearer and the top portion of the thoracic pad. In this embodiment, a Phillips screw driver can be used to align the thoracic and hip pads with previously identified locations where force will be applied. 
         [0057]    Step  6  shows a second vertical strut being fit on the wearer based on a second anchor pad&#39;s alignment with the right anchor point. The thoracic pad of the second vertical strut is applied to force point B identified Step  1 , which represents a curve apex of the wearer&#39;s spine. 
         [0058]    Step  7  shows how a de-rotation pad of the first vertical strut can be adjusted to fit the wearer. In this embodiment, the top edge of de-rotation pad is adjusted to be 1 inch below the clavicle of the wearer and directly above the nipple, as shown in Step  8 . The de-rotation pad can be coupled to a curved arm or strut, which in this embodiment comprises bendable aluminum. This curved arm or strut can serve as an additional angle adjustment mechanism. 
         [0059]    Once the first and second vertical struts have been adjusted to fit the wearer&#39;s body, a measurement can be taken between the wearer&#39;s left mid-line and the wearer&#39;s right mid-line as shown in Step  9 . 
         [0060]    Each of the first and second vertical struts can comprise a hook or loop fastener that is configured to removably fasten with a hook or loop fastener of either an inner or outer side of the belt (inner side shown here) as shown in Step  10 . The center line of the belt should first be identified, and either strut should be attached on opposing sides of the center line such that a distance between the midlines of each anchor pad equals the distance between the left mid-line and the right mid-line previously measured in accordance with Step  9 . 
         [0061]    Step  11  shows a wearer putting on the brace after the first and second vertical struts have been fit and attached to the belt in accordance with Steps  1 - 10 . The wearer aligns the anchor pads of each strut with the left or right anchor points and wraps the belt such that the ends of the belt overlap and fasten to one another. As shown in Step  12 , the first end of the first and second tension straps are then attached to the belt. A mid portion of the first tension strap is then attached to the second vertical struts thoracic pad, and a second end of the first tension strap is coupled with de-rotation pad via a buckle. The second end of the second tension strap is attached to the thoracic pad of the first vertical strut via a screw mechanism. 
         [0062]    Step  13  shows third and fourth tension straps each attached to the belt and a different component of the brace. Step  14  shows the wearer tightening the brace through first and second cord systems that are pulled in opposite directions and fastened to the belt via pull tabs. 
         [0063]    It is contemplated that a brace of the inventive subject matter can alternatively or additionally comprise other components, including for example, a lumbar pad, an underarm support, or a chest support pad. 
         [0064]      FIG. 10  shows another brace  500  of the inventive subject matter having substantially similar left and right vertical struts with removable and adjustable components. Brace  500  comprises a belt  510 , a first tension strap  520 , second tension strap  530 , third tension strap  540 , fourth tension strap  550 , a first vertical strut  555  comprising a first anchor pad  551  having a first strut (not shown), a first thoracic pad  552  having a second strut  553 , a first hip pad  554  having a third strut (not shown), and a second vertical strut  560  comprising a second anchor pad  561  having a fourth strut (not shown), a second thoracic pad  562  having a fifth strut  563 , and a second hip pad  564  having a sixth strut (not shown). 
         [0065]    The second strut (e.g.,  553 ) and third strut are removably and adjustably coupled with first strut such that an angle or vertical position of the first thoracic pad and first hip pad can be adjusted relative to the first anchor pad, or even removed. Similarly, the fifth strut (e.g.,  563 ) and sixth strut are removably and adjustably coupled with third strut such that an angle or vertical position of the second thoracic pad and second hip pad can be adjusted. 
         [0066]    Each of the first and second thoracic pads are coupled with a rounded arm,  570  and  575 , which are in turn coupled with de-rotation pads,  580  and  585 . The first and second straps are removably attached to the front portion of belt  510  and a thoracic pad, while the third and fourth straps are removably attached to the back portion of belt  510  and a thoracic pad. When the brace is worn, the tension straps can both block a rotation of a component of the brace relative to other components and provide increased tension or tautness between components of the brace. 
         [0067]    As used herein, and unless the context dictates otherwise, the term “coupled to” is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms “coupled to” and “coupled with” are used synonymously. 
         [0068]    In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. 
         [0069]    As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise. 
         [0070]    The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. 
         [0071]    Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
         [0072]    It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C . . . and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.