Patent Publication Number: US-2022211528-A1

Title: Constraining mechanisms for selective deployment and associated methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a national phase application of PCT Application No. PCT/US2019/031769, internationally filed on May 10, 2019, which is herein incorporated by reference in its entirety for all purposes. 
    
    
     FIELD 
     The present disclosure relates to apparatuses, systems, and methods that include constraints used in delivery of implantable medical devices. More specifically, the present disclosure relates to apparatuses, systems, and methods that include constraints for selective deployment of an expandable device during device delivery. 
     BACKGROUND 
     Stents and stent-grafts, or other implantable medical devices, may be utilized to radially support a variety of tubular passages in the body, including arteries, veins, airways, gastrointestinal tracts, and biliary tracts. The preferred method of placing these devices has been to use specialized delivery systems to precisely place and deploy a device at the site to be treated. These delivery systems allow the practitioner to minimize the trauma and technical difficulties associated with device placements. Attributes of delivery systems include: low profile; ability to pass through introducer sheaths; ability to negotiate tortuous vasculature, smoothly and atraumatically; protection of constrained devices; and ability to accurately position and deploy the device. 
     Stents or stent-grafts may be deployed and plastically deformed, such as by using an inflatable balloon, or to self-expand, such as through elastic recovery, from a collapsed or constrained delivery diameter to an expanded and deployed diameter. Some stents are designed to elastically recover by being manufactured at their functional diameter out of a material that has elastic recovery properties, and then radially compressed to be mounted on a delivery catheter. 
     These stent and stent-graft devices may be held, compressed, or constrained in the delivery configuration prior to and during delivery to a target location. 
     SUMMARY 
     According to one example (“Example 1”), a medical device deployment apparatus includes at least one first constraining fiber arranged as a series of multiple loops to form a warp knit surrounding the medical device in a constrained configuration, the warp knit being configured to separate and be removed to deploy the medical device; and at least one second constraining fiber arranged with the at least one first constraining fiber, the at least one second constraining fiber having at least one loop arranged in a non-warp knit pattern. 
     According to another example (“Example 2”), further to the apparatus of Example 1, the at least one first constraining fiber comprises multiple fibers knitted together. 
     According to another example (“Example 3”), further to the apparatus of any one of Examples 1-2, the first constraining fiber and the at least one second constraining fiber form a constraint, and the at least one loop arranged in the non-warp knit pattern is arranged at a distal end of the constraint. 
     According to another example (“Example 4”), further to the apparatus of Example 3, the at least one loop arranged in the non-warp knit pattern is arranged in a chain-link stich. 
     According to another example (“Example 5”), further to the apparatus of Example 4, the at least one first constraining fiber is interwoven with the at least one second constraining fiber to form the constraint with each of the at least one first constraining fiber and the at least one second constraining fiber forming a row of knots. 
     According to another example (“Example 6”), further to the apparatus of Example 5, a first row of the row of knots is formed by the at least one first constraining fiber in the warp knit pattern and a second row of the row of knots is formed by the at least one second constraining fiber in a non-warp knit pattern. 
     According to another example (“Example 7”), further to the apparatus of Example 6, the non-warp knit pattern of the second row includes chain-link stiches. 
     According to another example (“Example 8”), further to the apparatus of any one of Examples 1-6 the at least one first constraining fiber includes the first constraining fiber and a third constraining fiber, and the at least one second constraining fiber includes the second constraining fiber and a fourth constraining fiber with the first constraining fiber, second constraining fiber, the third constraining fiber, and the fourth constraining fiber being interwoven to form a constraint. 
     According to another example (“Example 9”), further to the apparatus of Example 8, the constraint includes multiple knot rows including a first row of knots formed by the first constraining fiber interwoven with the second constraining fiber, and a second row of knots formed by the second constraining fiber interwoven with the third constraining fiber, a third row of knots formed by the third constraining fiber interwoven with the fourth constraining fiber, and a fourth row of knots formed by the fourth constraining fiber interwoven with the first constraining fiber. 
     According to another example (“Example 10”), further to the apparatus of Example 9, at least one of the multiple knot forms a warp knit surrounding the medical device in the constrained configuration and another one of the multiple knot forms a non-warp knit surrounding the medical device in the constrained configuration. 
     According to another example (“Example 11”), further to the apparatus of any one of Examples 1-10, the at least one first constraining fiber and the at least one second constraining fiber combine to form a deployment line. 
     According to another example (“Example 12”), further to the apparatus of any one of Examples 1-11, the warp knit is configured to separate and be removed to deploy the medical device and the warp knit is arranged with the non-warp knit pattern interrupting the warp knit. 
     According to one example (“Example 13”), a method of deploying constrained medical device includes arranging the medical device in a constraint, the constraint including at least one first constraining fiber arranged as a series of multiple loops to form a warp knit surrounding the medical device in a constrained configuration, the warp knit being configured to separate and be removed to deploy the medical device and at least one second constraining fiber arranged with the at least one first constraining fiber, the at least one second constraining fiber having at least one loop arranged in a non-warp knit pattern; and unravelling the constraint by applying tension to an end of the at least one second constraining fiber. 
     According to another example (“Example 14”), further to the method of Example 13, the at least one loop arranged in the non-warp knit pattern is arranged in a chain-link stich. 
     According to another example (“Example 15”), further to the method of Example 13, a first row of the row of knots is formed by the at least one first constraining fiber in the warp knit pattern and a second row of the row of knots is formed by the at least one second constraining fiber in a non-warp knit pattern. 
     According to one example (“Example 16”), a medical device deployment apparatus includes an implantable medical device; a constraint configured to releasably constrain the implantable medical device in a constrained configuration, the constraint including: a first row of knots formed by a first constraining fiber interwoven with a second constraining fiber to form a warp knit surrounding the medical device in the constrained configuration, and a second row of knots formed by the second constraining fiber interwoven with a third constraining fiber to form a non-warp knit surrounding the medical device in the constrained configuration; and a deployment line coupled to constraint and configured to unknit the constraint and deploy the implantable medical device from the constrained configuration. 
     According to another example (“Example 17”), further to the apparatus of Example 16, the apparatus also includes a third constraining fiber and a fourth constraining fiber, and wherein a third a third row of knots formed by the third constraining fiber interwoven with the fourth constraining fiber, and a fourth row of knots formed by the fourth constraining fiber interwoven with the first constraining fiber. 
     According to another example (“Example 18”), further to the apparatus of Example 17, at least one of the third row and the fourth row forms a warp knit surrounding the medical device in the constrained configuration and another of the third row and the fourth row forms a non-warp knit surrounding the medical device in the constrained configuration. 
     According to another example (“Example 19”), further to the apparatus of Example 16, an end of the first constraining fiber is joined with an end of the second constraining fiber to form the deployment line. 
     According to another example (“Example 20”), further to the apparatus of Example 16, the constraint is circumferential arranged about the implantable medical device and the deployment line is configured to axially interrupt the constraint to unknit the second constraining fiber. 
     The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure. 
         FIG. 1  is a top plan view of a delivery system including a catheter with a constraint, in accordance with an embodiment; 
         FIG. 2  is a side view of an implantable medical device including a constraint, in accordance with an embodiment; 
         FIG. 3  is an illustration of a first constraining fiber and a second constraining fiber, in accordance with an embodiment; 
         FIG. 4A  is an illustration of a constraint in a first arrangement, in accordance with an embodiment; 
         FIG. 4B  is an illustration of the constraint, shown in  FIG. 4A , in a second arrangement, in accordance with an embodiment; 
         FIG. 4C  is an illustration of the constraint, shown in  FIGS. 4A-B , in a third arrangement, in accordance with an embodiment; 
         FIG. 4D  is an illustration of the constraint, shown in  FIGS. 4A-C , in a fourth arrangement, in accordance with an embodiment; 
         FIG. 5A  is an image of a delivery system in a delivery configuration, in accordance with an embodiment; and 
         FIG. 5B  is an image of the delivery system, shown in  FIG. 5A , in a semi-deployed configuration, in accordance with an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Definitions and Terminology 
     As the terms are used herein with respect to ranges of measurements “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement, but that may differ by a reasonably small amount such as will be understood, and readily ascertained, by individuals having ordinary skill in the relevant arts to be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like. 
     This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology. 
     With respect terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error or minor adjustments made to optimize performance, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value. 
     Certain terminology is used herein for convenience only. For example, words such as “top”, “bottom”, “upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,” and “downward” merely describe the configuration shown in the figures or the orientation of a part in the installed position. Indeed, the referenced components may be oriented in any direction. Similarly, throughout this disclosure, where a process or method is shown or described, the method may be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain actions being performed first. 
     A coordinate system is presented in the Figures and referenced in the description in which the “Y” axis corresponds to a vertical direction, the “X” axis corresponds to a horizontal or lateral direction, and the “Z” axis corresponds to the interior/exterior direction. 
     Description of Various Embodiments 
     Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. 
     Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include forming or manufacturing a constraint. The constraining mechanisms are configured to hold, compress, or constraint an implantable medical device (e.g., a stent, stent-graft, balloon, filter, or other expandable medical device) in a delivery configuration prior to and during delivery to a target location. In certain instances, constraints may include one or more fibers that are arranged together. The fibers may be interwoven, stitched, or otherwise interlocked together circumferentially about the device. To remove the constraint, one or more of the fibers may be unknitted or disrupted from the other fibers in the constraint. 
     Constrained devices may store energy as a result of being constrained in a diameter smaller than a natural or deployed diameter. Thus, the devices may exhibit a radial displacement force against the zipper. During deployment of constrained devices, the radial force may force unknitting of the constraint without user involvement such that the constraint self un-knits. The aspects of the present disclosure, however, eliminate this accelerated deployment. As discussed in further detail below, the constraint may include a pattern or knot structure that lessens accelerated deployment. 
       FIG. 1  is a top plan view of a catheter  100  with a constraint  102 , according to some embodiments. As shown in  FIG. 1 , the constraint  102  is configured to constraint an implantable medical device  104  to a delivery configuration. The constraint  102  may include one or more fibers  106  arranged about the implantable medical device  104  to maintain the constraint  102  in a constrained configuration. 
     The constraint  102  is arranged along a length of the implantable medical device  104 . The constraint  102  is also circumferentially arranged about the implantable medical device  104  and may substantially cover the implantable medical device  104  for delivery. The one or more fibers  106  may be arranged within a lumen (not shown) of the catheter  100  and extend toward a proximal end of the catheter  100  that is arranged external to a patient during delivery of the implantable medical device  104 . The one or more fibers  106  include a proximal end  108  that a user may apply tension to in order to release the constraint  102  and deploy the implantable medical device  104 . 
     In certain instances, the one or more fibers  106  release similar to a rip cord such that interlocking portions (e.g., overlapping fibers or knots) sequentially release along the length of the implantable medical device  104 . As is explained in greater detail below, the constraint  102  is formed by interlocking together the one or more fibers  106  directly on the implantable medical device  104 . As compared to prior multiple fiber constraints which are knitted together and then subsequently arranged about a constrained device, the constraint  102  is formed directly on the implantable medical device  104 . The expandable medical device  104  may be a stent, stent-graft, a balloon, or a similar device. 
       FIG. 2  is a side view of the device  104  including the constraint  102 , in accordance with an embodiment. As shown, the device  104  includes a delivery diameter D 1  and a deployed diameter D 2  (not shown) that is larger than the delivery diameter D 1 . The removable constraint  102  is attached to the device  104  at its delivery diameter D 1 . As shown, the constraint  102  includes at least one constraining fiber in the form of a warp knit. For example, the constraint  102  may include a first constraining fiber  110  and a second constraining fiber  112 . The first and/or the second constraining fiber(s)  110 ,  112  may operate, for example, as a deployment line  120  configured to release the constraint  102  and transition the device  104  from the delivery diameter D 1  to the deployed diameter D 2  in response to a force applied to the deployment line  120  (which may be coupled to one or more of the knot rows  114  as discussed in further detail below). 
     The device  104  may have a desired deployed diameter D 2  from about 5 mm-15 mm, or 6 mm-9 mm, or 6 mm-12 mm, 10 mm-20 mm, 15 mm-30 mm, 25 mm-45 mm, for example, and a delivery diameter D 1  that is less than the deployed diameter D 2 . For example, in some instances, a ratio of the delivery diameter D 1  of the device  104  to the deployed diameter D 2  (not shown) of the device  104  is less than about 0.3, less than about 0.29, less than about 0.28, less than about 0.27, or less than about 0.26. For reference, the term “diameter” is not meant to require a circular cross-section, and is instead to be understood broadly to reference a maximum transverse cross-sectional dimension of a device  104 . 
       FIG. 3  is an illustration of a first constraining fiber  110  and a second constraining fiber  112 , in accordance with an embodiment. The first constraining fiber  110  and the second constraining fiber  112  each include a series of loops  220 ,  222 , respectively. A single one of the series of loops  220 ,  222  is shown highlighted in  FIG. 3  for ease of illustration. The first constraining fiber  110  and the second constraining fiber  112  may form a medical device deployment apparatus in certain instances. In certain instances, the first constraining fiber  110  and the second constraining fiber  112  are formed of a single constraining fiber that is looped upon itself to form two lines  110 ,  112 . 
     In addition, the loops  220  of the first constraining fiber  110  may form a warp knit that surrounds a medical device in a constrained configuration as shown in  FIG. 3 . As discussed in further detail below with reference to  FIGS. 4A-D , the first constraining fiber  110  forming a warp knit may be one of a group of fibers that form a warp knit in one or more rows of a constraint  102 . The loops  222  of the second constraining fiber  112  may be arranged with the first constraining fiber  110  with the second constraining fiber  112  having at least one loop  224  arranged in a non-warp knit pattern. As shown in  FIG. 3 , the at least one loop  224  is a distal most loop of the multiple loops  222 . In certain instances, each of the loops  22  of the second constraining fiber  112  may include the non-warp knit pattern. As noted above, the first constraining fiber  110  and the second constraining fiber  112  may form a constraint  102 . In certain instances, the loop  224  having the non-warp knit pattern is arranged at a distal end of the constraint  102 . In certain instances, the loop  224  may be arranged in a chain-link stich. The at least one loop  224  arranged in a non-warp knit pattern is arranged with the non-warp knit pattern and interrupts the warp knit 
     The first constraining fiber  110  may be interwoven with the second constraining fiber  112  to form the constraint  102  with each of the first constraining fiber  100  and the second constraining fiber  122  forming a row of knots. As shown in  FIG. 3 , the first constraining fiber  110  and the second constraining fiber  112  are interwoven to form a single knot row  226 . As discussed and shown in  FIGS. 4A-B , the constraint  102  may include additional knot rows  226 . 
     The constraint  102  may be deployed by interrupting the knot row  226  by applying tension to a deployment line. In certain instances, the first constraining fiber  110  and the second constraining fiber  112  may be combined to form a deployment line. 
     The knot row  226  may be one of a number of rows formed in the constraint  102 . In certain instances, the first constraining fiber  110  may include multiple fibers knitted together. The first constraining fiber  110  may be a group or type of fiber that forms a pattern. Similarly, the second constraining fiber  112  may be a group or type of fiber that forms a pattern. For example, the first constraining fiber  110  (group) may form a first row of the row of knots in a warp knit pattern and a second row of the row of knots is formed by the second constraining fiber  112  (group) in a non-warp knit pattern. In certain instances, the non-warp knit pattern of the second row comprises chain-link stiches. In these instances the at least one first constraining fiber  110  includes the first constraining fiber  110  and a third constraining fiber and the at least one second constraining fiber  112  includes the second constraining fiber  112  and a fourth constraining fiber with the first constraining fiber, second constraining fiber, the third constraining fiber, and the fourth constraining fiber being interwoven to form a constraint  102  as discussed with reference to  FIGS. 4A-D . 
     The non-warp knit pattern, knot or stitch, used in a constraint  102  , that includes one or more additional knot rows with these rows formed in a knit or warp knit lessens the opportunity for self-deployment of the constraint  102 . In certain instances, a chain stitch, formed by the one loop  224  in a row  226  or all loops in a row of a constraint  102 , that includes one or more additional knot rows with these rows formed in a knit or warp knit, facilitates controlled deployment of the constraint  102 . 
       FIG. 4A  is an illustration of a constraint  102  in a first arrangement, in accordance with an embodiment. The constraint  102  is shown as a sheet of interwoven fibers, however, the constraint  102  may be arranged circumferentially about an implantable medical device. The constraint  102  can include a first constraining fiber  110  and a second constraining fiber  112  as described above with reference to  FIG. 3  that form multiple knot rows. For example and as shown in  FIG. 4A , the constraint  102  includes a first constraining fiber  110 , a second constraining fiber  112 , a third constraining fiber  338 , and a fourth constraining fiber  340 . The constraining fibers  110 ,  112 ,  338 ,  340  may be arranged together to form multiple knot rows  342 ,  344 ,  346 ,  348 . In certain instances, the number of constraining fibers  110 ,  112 ,  338 ,  340  may be equal to the number of knot rows  342 ,  344 ,  346 ,  348 . In addition, the constraining fibers  110 ,  112 ,  338 ,  340  may be interwoven or interlocked with one another to form the knot rows  342 ,  344 ,  346 ,  348 . 
     In certain instances, the first row of knots  342  of the constraint  102  may be formed by the first constraining fiber  110  interwoven with the second constraining fiber  112 . As shown, the first constraining fiber  110  are interwoven with the second constraining fiber  112  to form the knot row  342  in a warp knit. The knot row  342  may be a warp knit when the constraint  102  is surrounding the medical device in the constrained configuration. 
     In addition, the second row of knots  344  may be formed by the second constraining fiber  112  interwoven with the third constraining fiber  338 . The second constraining fiber  112  may be interwoven with the third constraining fiber  338  to form a non-warp knit with the row of knots  344 . The knot row  344  may be a warp knit when the constraint  102  is surrounding the medical device in the constrained configuration. 
     As shown in  FIG. 4A , the constraint  102  includes the multiple knot rows  342 ,  344 ,  346 ,  348  with the first row of knots  342  being formed by the first constraining fiber  110  interwoven with the second constraining fiber  112 , the second row of knots  344  formed by the second constraining fiber  112  interwoven with the third constraining fiber  388 , the third row of knots  346  formed by the third constraining fiber  348  interwoven with the fourth constraining fiber  340 , and the fourth row of knots  348  formed by the fourth constraining fiber  340  interwoven with the first constraining fiber  110 . 
     In certain instances, one or more of the rows  342 ,  344 ,  346 ,  348  forms a knit or a warp knit pattern with loops of the constraining fibers  110 ,  112 ,  338 ,  340  and another of the one or more of the rows  342 ,  344 ,  346 ,  348  forms a non-knit or non-warp knit pattern with one or more of the loops (e.g., a distal loop as described with reference to  FIG. 3 ) of the constraining fibers  110 ,  112 ,  338 ,  340 . In certain instances, at least one of the third row  346  and the fourth row  348  forms a warp knit surrounding the medical device in the constrained configuration and another of the third row  346  and the fourth row  348  forms a non-warp knit surrounding the medical device in the constrained configuration. The constraint  102  may include three of the rows  342 ,  344 ,  346 ,  348  in the warp pattern and one of the rows  342 ,  344 ,  346 ,  348  in a non-warp pattern. The one or more rows  342 ,  344 ,  346 ,  348  being in the non-warp pattern includes a single knot being arranged in a non-warp stitch (e.g., a chain stitch), two or more of the knots of the one or more rows  342 ,  344 ,  346 ,  348  being a non-warp stitch, multiple knots of the one or more rows  342 ,  344 ,  346 ,  348  being a non-warp stitch, alternating knots of the one or more rows  342 ,  344 ,  346 ,  348  being a non-warp stitch, two or more or all of the knots of the one or more rows  342 ,  344 ,  346 ,  348  being in a non-warp stitch. 
     The non-warp pattern of one or more of the rows  342 ,  344 ,  346 ,  348  may lessen the opportunity for accelerated or unwanted deployment of the constraint  102 . The different non-warp pattern of one or more of the rows  342 ,  344 ,  346 ,  348  interrupts the pattern of the constraint  102 . 
     A deployment line  350  may be coupled to an end of the second constraining fiber  112  (e.g., the fiber having the non-warp knit knot or knots) to force deployment of the constraint  102 . An end of the first constraining fiber  110  is joined with an end of the second constraining fiber  112 , which may be combined to form the deployment line  350 . In other instances, the deployment line  350  is the second constraining fiber  112  or a separate line or wire. In certain instances, the deployment line  350  is configured to unknit the second constraining fiber  112  and deploy the implantable medical device from the constrained configuration. As noted above, the constraint  102  may be circumferential arranged about the implantable medical device and the deployment line  350  may be configured to axially interrupt the constraint  102  to unknit the second constraining fiber  112  as is shown in  FIGS. 4B-C . 
       FIGS. 4B-C  are illustrations of the constraint, shown in  FIG. 4A , in different steps of the constraint  102  unknitting. A-H, as shown in  FIGS. 4A-D , are location indicators of portions or sections of the second constraining fiber  112 . In comparing the arrangement of the second constraining fiber  112  in  FIG. 4A  and  FIG. 4B , the loop or chain stitch D has been pulled axially. Additional pulling of the A section of the second constraining fiber  112  removes the slack remnants from loop D section of the second constraining fiber  112  and shows that a warp knit rows  342 ,  346 ,  348  is holding the constraint  102  together (e.g., as shown in  FIGS. 4B-C ). 
     In certain instances, the second constraining fiber  112  may include a warp knit in the knot row  344  subsequent to loop or chain stitch D. Pulling the second constraining fiber  112  or the deployment line  350  would also untie the warp knit E section of the second constraining fiber  112 .  FIG. 4C  shows loop E of the second constraining line  112  pulled out of the row  344 . The next knot in row  344  may be chain stitch which requires an axial load applied to the second constraining fiber  112  or deployment line  350 . As sections of the second constraining fiber  112  are removed from the knot row  344 , the sections become a part of the deployment line  350 . Remaining sections of the second constraining fiber  112  may be warp knit or non-warp knit knots. 
       FIG. 5A  is an image of a delivery system  10  in a delivery configuration, in accordance with an embodiment.  FIG. 6B  is an image of a delivery system  10  in a semi-deployed configuration, in accordance with an embodiment. As shown, disrupting one of the constraining fibers (e.g., the second constraining fiber  112 , for example) of a knot row initiates unravelling of at least a portion of the constraint  102 , as shown in  FIG. 5B . 
     The inventive concepts of this application have been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of the inventive concepts provided they come within the scope of the appended claims and their equivalents.