Abstract:
A guidewire for medical procedures can be maintained in a coiled configuration with a clamp. Multiple clamped and coiled guidewires may be stored in a fluid-filled, storage bowl concurrently. Different clamps may have different colors to differentiate the clamps and clamped guidewires. The clamps may be markable to provide additional differentiation. The clamps can further comprise a guidewire introduction funnel and/or a guidewire torquer.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application Nos. 62/140,138, filed Mar. 30, 2015, 62/121,695, filed Feb. 27, 2015 and 62/107,962, filed Jan. 26, 2015, the contents of which are fully incorporated herein by reference. 
    
    
     BACKGROUND 
     The present disclosure relates to medical devices and methods, particularly for the storage of guidewires suitable for use in various medical procedures and for the introduction of these guidewires into the proximal hubs of catheters. 
     The following references may be of interest: U.S. Publication Nos. 2014/0259821, 2014/0171833, 2013/0292365, and 2012/0227751 and U.S. Pat. Nos. 8,679,065, 8,480,597, 7,886,906, 7,144,402, 6,047,825, 5,830,183, 5,279,573, 4,707,906, and D329698. 
     SUMMARY 
     The present disclosure relates to medical devices and methods, particularly for the storage of guidewires suitable for use in various medical procedures. During a medical procedure, for example, guidewires may be coiled and temporarily stored in one or more fluid-filled bowls. In many medical procedures, a single guidewire is used or multiple guidewires may be used concurrently. In such procedures, one or multiple guidewires may be stored between re-use during the same procedure in a coiled configuration where the stiff end of the guidewire is looped under the coiled guidewire loops to secure the loops. However, this technique may often fail as the loops can uncoil spontaneously or can be uncoiled when a medical practitioner attempts to identify and retrieve a specific guidewire from the bowl. With one or more of the coiled wires becoming uncoiled, the guidewire(s) may unravel, straighten, and spontaneously spring out of the sterile fluid filled bowl, becoming potentially contaminated and contaminating the sterile environment. In at least some cases, particularly in a small and crowded fluid filled storage bowl, a medical practitioner may confuse one guidewire with another. Such confusion may be problematic where one guidewire suitable for one application becomes used in a different application. Disclosed herein are devices and methods to temporarily store guidewires in an improved manner so as to address some of these disadvantages. 
     Aspects of the present disclosure provide color-coded and markable clamps for maintaining a guidewire in a coiled configuration when placed in a storage bowl. Clamps with different coloring and/or different markings made thereon may be used with different guidewires of various diameters and/or design or performance characteristics. The different clamps can help a medical practitioner quickly and easily identify and differentiate between different guidewires in a multi-wire environment. 
     Aspects of the present disclosure may provide a method of storing one or more guidewires. A guidewire may be wrapped into a coiled configuration. In the coiled configuration, the guidewire may have a coiled portion and a free end portion. The free end portion may comprise a stiff end of the guidewire. The free end portion may be wrapped under the coiled portion. A color-coded, markable clamp may be placed over the free end portions and/or a part of the coiled portion. The clamp may maintain the guidewire in the coiled configuration. The guidewire and clamp placed thereover may be placed in a fluid-filled storage bowl. The method may be repeated for a second or further guidewire to be placed in the same or different storage bowl. To distinguish the guidewires, the second or further clamp may have a different color than the first guidewire or may be marked in a different manner. In some embodiments, the first and/or second portion or jaw of the clamp may comprise an introducer shaped as a funnel. The funnel may lead to a straight guidewire lumen which leads to a tip tapered on the outside. The tip may be coupled to the hub of a catheter for the introduction of shaped tipped or other guidewires into the inner lumen of the catheter. The first, second, or other guidewire may have a diameter matching the color coding, marking, or labelling of the clamp; and, the lumen of the funnel of the clamp may have a diameter matching that of the guidewire. In this manner, a guidewire of a preselected size can be stored and introduced to a catheter with the same clamp or clamp structure. Further, a grasping mechanism may be actuated to secure the first guidewire relative to the funnel structure of the first clamp to allow the entire structure to function as a guidewire torque device or torquer. 
     Aspects of the present disclosure may also provide a clamp for facilitating guidewire storage. The clamp may comprise a first portion, a second portion, and a pivotable portion therebetween. The first and second portions may be folded or pivoted relative to one another about the pivotable portion to open or close the clamp. The first and second portions may comprise upper surfaces which may approximate or come into contact with one another when the clamp is closed. The upper surface of one or more of the first or second portions may comprise surface features to facilitate the capture of the guidewire. For example, the upper surfaces may comprise teeth or be ridged. Alternatively or in combination, the upper surfaces may comprise a high friction material or coating such as rubber, latex, teflon, silicone, or other polymer. The material or coating may be compliant to minimize any damage that may occur to the guidewire as it is clamped. The material and/or coating may be colored and/or may be markable such as with a pen or marker. Where a coating is used, the clamp upper or lower portions may comprise a core made of a harder material such as hardened rubber, silicone, or other polymer. Alternatively, the clamp may be in a single, integral piece made of the high friction and/or compliant material. 
     The clamp may further comprise a first end coupled to the first portion and a second end opposite the first end and coupled to the second portion. The first and second ends may be removably coupled to one another. For example, the first and second ends may form a latch mechanism. The first end may comprise one or more teeth to capture the second end when the first and second portions are folded or pivoted relative to one another to close the clamp. These teeth may be de-coupled from the second end so that the first and second portions can be folded or pivoted relative to one another to open the clamp. Alternatively or in combination, the first end may have a series of apertures or openings to capture the second end. 
     The clamp may further comprise a guidewire introducer coupled to one or more of the first or second portions. The guidewire introducer may be removably coupled to a main body of the clamp. The guidewire introducer may have a guidewire lumen, an open proximal funnel end to receive a guidewire and direct it into the guidewire lumen, and a distal tapered tip to couple with a proximal hub of a catheter. The guidewire introducer may further comprise a grasping mechanism to secure the guidewire received in the guidewire lumen. 
     Aspects of the present disclosure may also provide a kit for facilitating guidewire storage. The kit may include a first clamp and a second clamp. The clamps may be as described as above. The first clamp may have a first color and the second clamp may have a second color different from the first color. One or more of the first or second clamps may be markable. The kit may further include a storage bowl for the guidewires and a set of instructions. One or more of the first or second clamps may comprise a funnel structure integral with its first or second portion or jaw. The funnel structure may have a tip configured to be coupled to a hub of a catheter of the same internal diameter as marked or indicated by the respective clamp. The funnel structure may further comprise a grasper mechanism to secure a guidewire received in the funnel structure. Alternatively or in combination, the funnel structure may be a separate device to be removably coupled to the main body of the one or more clamps. 
     INCORPORATION BY REFERENCE 
     All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The novel features of the present disclosure are set forth with particularity in the appended claims. It should be noted that the drawings are not to scale and are intended only as an aid in conjunction with the explanations in the following detailed description. In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which: 
         FIG. 1A  shows a perspective view of a guidewire clamp according to many embodiments. 
         FIG. 1B  shows a side view of the guidewire clamp of  FIG. 1A . 
         FIG. 1C  shows a side view toothed extension of an end of the guidewire clamp of  FIG. 1A . 
         FIG. 1D  shows a magnified side view of an embodiment of the toothed jaws of the guidewire clamp of  FIG. 1A . 
         FIG. 1E  shows a magnified side view of an embodiment of the toothed jaws of the guidewire clamp of  FIG. 1A . 
         FIG. 1F  shows a side view of the guidewire clamp of  FIG. 1A  closed to grasp multiple loops of a guidewire. 
         FIGS. 2A and 2B  show perspective views of guidewires maintained in a coiled configuration by a guidewire clamp, according to many embodiments. 
         FIG. 3A  shows a side section view of a guidewire clamp with a built-in guidewire introducer funnel, according to many embodiments. 
         FIG. 3B  shows a top section view of the guidewire clamp of  FIG. 3A . 
         FIG. 3C  shows a perspective section view of the guidewire clamp of  FIG. 3A . 
         FIG. 3D  shows a back view of the guidewire clamp of  FIG. 3A . 
         FIG. 3E  shows a top section view of the guidewire clamp of  FIG. 3A , highlighting the proximal end of the introducer funnel, according to many embodiments. 
         FIG. 3F  shows a back section view of the guidewire clamp of  FIG. 3A , highlighting the proximal end of the introducer funnel. 
         FIG. 4A  shows a top section view of a single piece guidewire clamp with an integrated introducer funnel and torquer, according to many embodiments. 
         FIG. 4B  shows a back section view of the single piece guidewire clamp of  FIG. 4A . 
         FIG. 5A  shows a top section view of a two piece guidewire clamp with a detachable introducer funnel and torquer, according to many embodiments. 
         FIG. 5B  shows a back section view of the two piece guidewire clamp of  FIG. 5A . 
         FIG. 6A  shows a top section view of another two piece guidewire clamp with a detachable introducer funnel and torquer, according to many embodiments. 
         FIG. 6B  shows a back section view of the two piece guidewire clamp of  FIG. 6A . 
         FIG. 7A  shows a top section view of another guidewire introducer funnel and torquer in an open configuration, according to many embodiments. 
         FIG. 7B  shows a cross-sectional view of the guidewire introducer funnel and torquer of  FIG. 7A  in the open configuration. 
         FIG. 7C  shows a top section view of the guidewire introducer funnel and torquer of  FIG. 7A  in a closed configuration, according to many embodiments. 
         FIG. 7D  shows a cross-sectional view of the guidewire introducer funnel and torquer of  FIG. 7A  in the closed configuration. 
         FIG. 8A  shows a top section view of another guidewire introducer funnel and torquer in an open configuration, according to many embodiments. 
         FIG. 8B  shows a cross-sectional view of the guidewire introducer funnel and torquer of  FIG. 8A  in  8 A in the open configuration. 
         FIG. 8C  shows a top section view of the guidewire introducer funnel and torquer of  FIG. 8A  in a closed configuration. 
         FIG. 8D  shows a cross-sectional view of the guidewire introducer fund and torquer of  FIG. 8A  in the closed configuration. 
         FIG. 9A  shows a top section view of another guidewire introducer funnel and torquer in an open configuration, according to many embodiments. 
         FIG. 9B  shows a top section view of the guidewire introducer funnel and torquer of  FIG. 9A  in a closed configuration. 
         FIG. 10A  shows a top section view of another guidewire introducer funnel and torquer in an open configuration, according to many embodiments. 
         FIG. 10B  shows a top section view of the guidewire introducer funnel and torquer of  FIG. 10A  in a closed configuration. 
         FIG. 11A  shows a top section view of another guidewire introducer funnel and torquer in an open configuration, according to many embodiments. 
         FIG. 11B  shows a top section view of the guidewire introducer funnel and torquer of  FIG. 11A  in a closed configuration. 
         FIG. 12A  shows a top section view of another guidewire introducer funnel and torquer in an open configuration, according to many embodiments. 
         FIG. 12B  shows a top section view of the guidewire introducer funnel and torquer of  FIG. 12A  in a closed configuration. 
         FIG. 13A  shows a side view of another guidewire clamp in a closed configuration, according to many embodiments. 
         FIG. 13B  shows a side view of the guidewire clamp of  FIG. 13A  in an open configuration. 
         FIG. 14  shows a cross-sectional view of teeth configurations for a guidewire clamp, according to many embodiments. 
         FIG. 15A  shows a perspective view of another guidewire clamp capturing multiple loops of a guidewire, according to many embodiments. 
         FIG. 15B  shows a top view of the guidewire clamp of  FIG. 15A  in an open configuration. 
         FIG. 15C  shows a top view of the guidewire clamp of  FIG. 15B  in a closed configuration. 
         FIG. 16A  shows a bottom view of the jaw of a guidewire clamp comprising a crushable, “thin” membrane, according to many embodiments. 
         FIG. 16B  shows a side view of the jaw of the guidewire clamp of  FIG. 16A . 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1A-1F  shows various views of a guidewire clamp  100  according to many embodiments. The guidewire clamp  100  may comprise two jaws—an upper jaw  110  and a lower jaw  120 —that may be closed against one another to trap a coiled guidewire GW between the teeth of the jaws  110 ,  120  ( FIG. 1F ). As shown in  FIG. 1B , the guidewire clamp  100  may be about 1.0 to about 1.5 cm in length, about 1.0 to about 1.5 cm in height, and about 2.5 cm in total width when closed. The teeth  130  of the jaws  110 ,  120  may fit with one another when closed ( FIG. 1D ) or may oppose one another ( FIG. 1E ). The jaws  110 ,  120  may pivot relative to one another about a pivot region  135 , which may be relatively thin, toothless, and flexible ( FIGS. 1A, 1B, 1F ). The lower jaw  120  may comprise an extension  120   a  which may comprise one or more teeth  123  and which may be curved toward the end  110   a  of the upper jaw  110  when the jaws  110 ,  120  are moved toward one another such as in the direction of arrow  103  ( FIG. 1A ). A tooth pair of the extension  120   a  may lock onto the extension  110   a  and the tooth pair may be selected to determine how tightly the jaws  110 ,  120  are locked with one another. The extension  120   a  may be peeled away from the end  110   a  such as in a direction  106  ( FIG. 1B ) to de-couple the ends of the jaws  110 ,  120  from one another. Alternatively or in combination, the upper jaw  110  may have an extension with teeth to lock onto the end of the lower jaw  120 . 
     In some embodiments, the guidewire clamp  100  may lack teeth for the top and/or bottom jaw. The guidewire clamp  100  may be made of various materials, such as a soft rubber, teflon, or other polymers. The entire guidewire clamp  100  may be made of a single material or of a combination of various materials. The guidewire clamp  100  may be color coded and/or comprise a markable surface for identification. A plurality of the guidewire clamps  100  may be provided in a kit, where different guidewire clamps of the kit for different diameter guidewires may have different colors. In some embodiments, the clamp  100  may further comprise an integral guidewire introducer lumen or funnel with a diameter matching that of the guidewire the clamp  100  is color coded or marked to identify. In some embodiments, the clamp  100  may further comprise an integral guidewire torque device or torquer as a part of the guidewire introducer lumen or funnel. 
       FIGS. 2A and 2B  show guidewires GW maintained in a coiled configuration by the guidewire clamp  100 , according to many embodiments. The guidewire GW may be formed into a configuration with multiple, circular loops with opposite first and second ends that are straight. The guidewire clamp  100  may grasp the guidewire GW at the circular loops. 
       FIG. 3A  shows a side section view of an embodiment of the guidewire clamp  100  with a built-in guidewire introducer funnel or funnel structure  300 , according to many embodiments;  FIG. 3B  shows the top section view of the same;  FIG. 3C  shows the perspective section view of the same;  FIG. 3D  shows the back view of the same;  FIG. 3E  shows a top section view of the same; and  FIG. 3F  shows a back view of the same. At the proximal end near the flexible region  140 , the funnel structure  300  may have a raised funnel ridge or rim  310  to facilitate introduction of the guidewire GW into a straight, central lumen  330  of the funnel structure  300 . The diameter of the straight, central lumen may match the diameter of the guidewire the clamp is color-coded, marked, or otherwise labeled for. At the distal end, the funnel structure  300  may comprise a tapered tip  320  which may couple to a proximal hub of a catheter and its inner lumen. A guidewire GW can be advanced through the lumen of the funnel structure  300  to introduce the guidewire GW to the hub and inner lumen of the catheter. As shown in  FIGS. 3C and 3D , the funnel structure  300  may be located on a side of the bottom or top jaws  110 ,  120 , respectively. As shown in  FIGS. 3E and 3F , the proximal end of the funnel structure  300  may include a raised funnel ridge or rim  310  to direct the guidewire GW, the leading tip of which is often curved, into the straight, central lumen. 
     The guidewire clamp  100  as in  FIGS. 3A-3F  may be suitable for a guidewire GW of a pre-selected size. The guidewire clamp  100  may be color coded, marked, or otherwise labelled to indicate its suitability for the guidewire GW of the pre-selected size. The funnel structure  300  of the guidewire clamp  100 , including its central lumen  330  and distal tip  320 , may have a size suitable for the guidewire GW to be advanced therethrough to be introduced into a catheter hub and lumen. 
       FIGS. 4A-12B  show further embodiments of the guidewire clamp  100 . The guidewire clamp  100  may comprise the guidewire introducer  300  which may also serve as a guidewire introducer/torquer component with the aid of slider compression assembly  400 . The guidewire clamp device  100  and/or the guidewire introducer and/or the guidewire introducer/torquer component  300  may have a rounded or rectangular cross sectional area. The funnel tips  310  of the guidewire introducer and/or the guidewire introducer/torquer  300  may have a smaller cross-sectional area than the main body of the guidewire clamp  100  and may be spaced apart from the main body. 
     The individual introducer and introducer/torquer components can be an integral part of the guidewire clamp device  100  ( FIGS. 4A, 4B ) or may be detachable through couplings  500  or clasps  600  and function independently ( FIGS. 5A-6B  and  FIGS. 6A-6B ). The individual introducer and introducer/torquer devices  300  may be made available/sold as an independent introducer device or an independent introducer/torque device  300  without the guidewire clamp  100  ( FIGS. 7A-12B ). A simple introducer  300  (for example, without a torquer function) may be an integral part of the guidewire clamp  100 , or be made detachable and function independently. 
     Also provided may be assemblies and components to grasp a guidewire GW in the introducer devices  300 , allowing them to also function as a torquer. Various assemblies and components in various combinations are described below. Such components may include: a screw assembly to compress the jaws, jaws compressible by a screw mechanism, a slider compression assembly which may press against a thin walled compressible elastic memory dilator or an elastic memory membrane (either or both of which may be a metal or a synthetic plastic) to grab the guidewire, by a slider compression assembly, or a thin walled compressible elastic memory dilator which may be pressed against the guidewire by a slider compression assembly. This dilator may be packaged already inserted into the funnel component of the guidewire clamp device, or packaged separately to be better protected until use, when it is slipped into the guidewire lumen of the guidewire clamp device. It may be held securely in place by a ridge that snaps into a corresponding grove in the introducer body. The introducer device  300  may have various cross-sectional shapes such as circular, ovoid, rectangular, square, or triangular, to name a few. 
       FIGS. 4A and 4B  illustrate a guidewire clamp device  100  which may be provided as a single piece device. 
       FIGS. 5A and 5B  illustrate a guidewire clamp device  100  which may be provided as a two piece device, with a detachable guidewire introducer and torquer component  300 . 
       FIGS. 6A and 6B  illustrate a guidewire clamp device  100  which is provided as a two piece device, with a detachable guidewire introducer and torquer component  300 . 
       FIGS. 7A-7D  illustrate a slider  400  and an elastic memory membrane assembly  700  to grab the guidewire GW to serve as the introducer/torque device  300 . The elastic memory membrane  700  can provide a continuous uninterrupted path for the guidewire GW (including curved tipped and other guidewires) free of obstruction. The slider compression assembly  400  may comprise a “click stop” so the button of the slider compression assembly  400  may be pressed to lock the membrane  700 . 
       FIGS. 8A-8D  illustrate a slider  400  and a thin walled compressible elastic memory dilator  800  to grab the guidewire to serve as the introducer/torque device  300 . The thin walled compressible elastic memory dilator  300  can provide a continuous uninterrupted path for the guidewire GW (including curved tipped and other guidewires) free of obstruction. 
       FIGS. 9A-9B  illustrate a screw/jaws assembly  900  in the introducer tip  320  and a thin walled compressible elastic memory dilator  910  to grab the guidewire GW to serve as the introducer/torque device  300 . The thin walled compressible elastic memory dilator  900  can provide a continuous uninterrupted path for the guidewire GW (including curved tipped and other guidewires) free of obstruction. The thin walled compressible elastic dilator  910  may be glued to the full length of the introducer/torque body guidewire lumen  330 . 
       FIGS. 10A and 10B  illustrate a screw/jaws assembly  1000  in the introducer tip  310  and a thin walled compressible elastic memory dilator  1010  to grab the guidewire GW to serve as the introducer/torque device  300 . The thin walled compressible elastic memory dilator  1010  can provide a continuous uninterrupted path for the guidewire GW (including curved tipped and other guidewires) free of obstruction. The screw/jaws assembly  1000  may comprise a knurled knob  1020  to turn the funnel body into the screw jaws assembly  1000  and thereby tighten the jaws to “grab” the guidewire GW. 
       FIGS. 11A and 11B  illustrate a screw/jaws assembly  1100  in the funnel to grab the guidewire GW to serve as an introducer/torquer device  300 . The screw/jaws assembly  1100  may comprise a thin walled compressible elastic memory dilator  1110 , a knurled knob  1120  to turn the screw-jaws assembly  1100  into the funnel body  300  and thereby tighten the jaws to “grab” the guidewire GW, sets of jaws  1130 , and a screw  1140  to interface with the jaws  1130 . 
       FIGS. 12A and 12B  illustrate a screw/jaws assembly  1200  in the funnel to grab the guidewire GW to serve as an introducer/torque device  300 . The screw/jaws assembly  1200  may comprise a knurled knob  1220  to turn the screw-jaws assembly  1200  into the funnel body  300  and thereby tighten the jaws to “grab” the guidewire GW, sets of jaws  1230 , and a screw  1240  to interface with the jaws  1230 . 
     Referring now to  FIGS. 13A and 13B , a guidewire clamp  1300  may define an opening  1310  through which a separate guidewire introducer/torquer  300  may be grasped. The guidewire clamp  1300  may comprise a first toothed jaw  1320  and a second toothed jaw  1330 , each with graspable ends  1320   a ,  1330   a , respectively, which may extend outward to be manipulated. The guidewire clamp  1300  may further comprise a flexible middle portion  1340  which the first and second toothed jaws  1320  and  1330  can pivot about. In many embodiments, the guidewire clamp  1300  is biased to be in the closed position shown by  FIG. 13A . 
     Referring to  FIG. 14 , the jaws  1410  of the guidewire clamps may interface with one another in many ways to graph a guidewire GW. For example, teeth  1400   a  may comprise semi-circular cut-outs which define a passageway sized and shaped to bundle of loops of the guidewire GW when the jaws are closed. Alternatively or in combination, teeth  1400   b  may comprise linear teeth with complimentary pairs of teeth defining a passageway for a single loop of the guidewire GW such that the loops of the guidewire GW are spread linearly side to side. 
       FIG. 15  shows a guidewire claim  1500 . The guidewire clamp  1500  may comprise a plurality of ribs  1510 . Loops of the guidewire GW may be held in-between the ribs  1510 . The guidewire clamp  1500  may comprise a gap  1520 . The guidewire clamp  1500  may further comprise end tabs  1530   a  and  1530   b , and the end tab  1530   a  may be advanced through the gap  1520  ( FIG. 15C .) One or more of the ribs  1510  may facilitate closure and locking of the end tab  1530   a  through the gap  1520  ( FIG. 15C .) The guidewire clamp  1500  may be flexible such that the end tab  1530   a  may be bent, pulled, or otherwise manipulated in the manner shown ( FIGS. 15B, 15C .) 
     Referring to  FIGS. 16A and 16B , the guidewire clamps described herein may be constructed of a crushable, “thin” membrane  1600 . The crushable “thin” membrane may cover the teeth  1400   a  and/or the teeth  1400   b  of the jaw  1410 . The crushable, “thin” membrane  1600  may be deformed by the coils of the guidewire and may a traumatically “mold” around the coils to secure them in the semi-circular openings of the teeth  1400   a  and/or the teeth  1400   b . The crushable, “thin” membrane  1600  may be molded as part of the entire clamp of the same material, may be present in the entire “semicircle” (teeth  1400   a  and/or teeth  1400   b ) of the jaw  1410 , may reach only part way from the trough of the teeth  1400   a  and/or the teeth  1400   b  to the edge of the jaw  1410 , and/or may be present in both the upper and lower jaws or in just one. 
     While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit of the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.