Abstract:
Generally described herein are apparatus, systems and methods related to utilizing a guiding tip to connect two open ends of respective tubes of a gastric banding system. More particularly, one of these tubes may include a barbed element at or near the point of connection which makes it difficult to connect the two tubes as the barbed element may be larger than an opening to receive the barbed element. The guiding tip provides a solution to this problem by acting as an interface between the barbed element and the receiving tube. In this manner, the sealing functionality of the barbed element may be retained while improving the ease of inserting the barbed element into the receiving tube.

Description:
FIELD 
       [0001]    The present invention generally relates to medical systems, devices and uses thereof for treating obesity and/or obesity-related diseases. More specifically, the present invention relates to implementing a guiding tip to facilitate the connecting of tubes. 
       BACKGROUND 
       [0002]    Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND APO (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient&#39;s stomach forming a stoma that restricts the food&#39;s passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract. 
         [0003]    One example of a gastric banding system  105  is illustrated in  FIG. 1A . As shown, a body of a patient  100  having a stomach  120  is illustrated. The gastric banding system  105  may be positioned within the patient, forming a constriction about an upper portion of the stomach  120  via a gastric band  110 , and more particularly, via an inflatable portion  115  of the gastric band  110 . The gastric band  110  may be connected to an access port  130  by means of a connection tube  125 . A hypodermic needle  140  may penetrate the skin of the patient  100  and puncture a septum  135  of the access port  130  to add fluid to or remove fluid from the gastric band  110 . 
         [0004]    Another example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference. 
         [0005]    Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid access port (“access port”) connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction. 
         [0006]    Typically, the different components of the gastric banding system, e.g., the access port and the inflatable portion of the gastric band, are coupled or connected to each other via tubing or other fluid conduits. In some instances, it may be practical or desirable to join two pieces of flexible tubing instead of using one long piece of tubing. As shown in  FIG. 1B , the access port  130  coupled to a first tube  145  may need to be connected to a second tube  155  in order to establish a fluid path between the access port  130  and the inflatable portion  115  of the gastric band  110 . 
         [0007]    However, as the gastric banding system  105  is implanted inside a human body, leak prevention is important to reduce or eliminate the need to perform additional surgeries to fix the leaks. Currently, a tube connector  160  having barbed portions  170  and  175  for sealing purposes is being used to connect the two tubes  145  and  155 , as shown in  FIG. 1B . More particularly, the barbed portions  170  and  175  are utilized to provide a pressure seal and prevent leakage at the location  180  where the two tubes  145  and  155  are joined. 
         [0008]      FIG. 1C  illustrates a close up view of the tube connector  160  deployed within an inner diameter of the tubes  145  and  155 . The barbed portions  170  and  175  of the tube connector  160  may prevent and/or reduce leakage by pressing against the inner diameter of the tubes  145  and  155 . As such, necessarily, the barbed portions  170  and  175  have an exterior diameter that is larger than the inner diameter of the tubes  145  and  155 . 
         [0009]      FIG. 1D  illustrates a cross sectional view of  FIG. 1C , and more clearly shows the barbed portions  170  and  175  are larger than the inner diameters of the tubes  145  and  155 , thereby causing a bulge at locations  165  and  166 . Further shown is how the tube connector  160  defines a conduit  180  for coupling conduit  185  to conduit  190 . Conduits  180 ,  185  and  190  may be utilized to carry fluid and/or other substances (e.g., air, gel, etc.) to or removing fluid and/or other substances from the inflatable portion to control the effective size of the gastric band  110 . 
         [0010]    However, the drawback to having the barb portion larger than the inner diameter of the tube is that it makes it very difficult for the barb portion to be pressed into the tube.  FIG. 1E  illustrates the barb portion of the tube connector just prior to insertion into the tube. 
         [0011]    Furthermore, as with any implantation into the human body, sterility is of the utmost importance and physicians using gloves or other sterility-promoting products may have an even more difficult time when attempting to insert the barbed portion into the tube.  FIG. 1F  illustrates a cross sectional view of  FIG. 1E . Indeed, it may take the physician much time and effort to perform said insertion of the tube connector  160  into the flexible tube  155  considering that the physician has to align the tube connector with the mating end of tube  155 , while applying a significant force to cause the initial tube deformation and start the inserting process. In some situations where the tubes may be wet or slippery or very flexible, the inserting process to manipulate the tube connector into the flexible tube may be extremely frustrating. 
         [0012]    What is needed is a system that provides the sealing capabilities of the barbed portion while providing improved ease of connecting the tubes. 
       SUMMARY 
       [0013]    Generally described herein are apparatus, systems and methods related to utilizing a guiding tip to connect two open ends of respective tubes of a gastric banding system. More particularly, one of these tubes may include a barbed element at or near the point of connection which makes it difficult to connect the two tubes as the barbed element may be larger than an opening to receive the barbed element. The guiding tip provides a solution to this problem by acting as an interface between the barbed element and the receiving tube. In this manner, the sealing functionality of the barbed element may be retained while improving the ease of inserting the barbed element into the receiving tube. 
         [0014]    In one embodiment, provided is a gastric banding system for the treatment of obesity comprising a gastric band having an inflatable portion, an access port having a septum for removing or inserting fluid into the inflatable portion of the gastric band, the access port further having an access port connector. The gastric banding system may also comprise a first tube including a first end connected to the inflatable portion of the gastric band and a second end, the first tube having a first inner diameter, a second tube including a first end connected to the access port connector of the access port and a second end connected to the second end of the first tube, the second tube having a second inner diameter, and a tube connector for connecting the second end of the first tube and the second end of the second tube, the tube connector for fluidly coupling the first tube and the second tube. The tube connector may further include a first barb portion located at a first end of the tube connector, having a diameter larger than the first inner diameter of the first tube, the first barb configured to be pressed into the first inner diameter of the first tube in a factory or other convenient environment using assembly tools and without the typical hindrances of a surgery room, a stem portion located adjacent to the first barb portion, a second barb portion located adjacent to the stem portion, the second barb portion having a diameter larger than the second inner diameter of the second tube, the second barb configured to be pressed into the second inner diameter of second tube, and a guiding tip portion located at a second end of the tube connector, and having an outer diameter not larger than the first inner diameter of the first tube configured to be inserted into the first inner diameter of the first tube. 
         [0015]    In one embodiment, provide is a tube connector for connecting a first tube and a second tube comprising a first barb and having a diameter larger than the first inner diameter of the first tube, the first barb configured to be pressed into the first inner diameter of the first tube, a stem portion located adjacent to the first barb, a second barb portion located adjacent to the stem portion, the second barb portion having a diameter larger than the second inner diameter of the second tube, the second barb configured to be pressed into the second inner diameter of second tube, a guiding stem portion adjacent to the second barb, and a guiding tip portion adjacent to the guiding stem portion having an outer diameter not larger than a first inner diameter of the first tube configured to be inserted into the first inner diameter of the first tube. 
         [0016]    In one embodiment, provided is a gastric banding system for the treatment of obesity comprising a gastric band having an inflatable portion, an access port having a septum for removing or inserting fluid into the inflatable portion of the gastric band, the access port further having an access port connector, a first tube including a first end connected to the inflatable portion of the gastric band and a second end, the first tube having a first inner diameter, a second tube including a first end connected to the access port connector of the access port and a second end connected to the second end of the first tube, the second tube having a second inner diameter, a female tube connector for connecting the second end of the first tube and the second end of the second tube, and a male connector configured to be inserted into the female connector for connecting the second end of the first tube and the second end of the second tube. The female tube connector may further include a first barb portion located at a first end of the female tube connector, having a diameter larger than the first inner diameter of the first tube, the first barb configured to be pressed into the first inner diameter of the first tube, a stem portion located adjacent to the first barb portion, and a second barb portion located adjacent to the stem portion, the second barb portion having a diameter larger than the second inner diameter of the second tube, the second barb portion configured to be pressed into the second inner diameter of second tube. The male tube may further include an enlarged stem portion located at a first end of the male tube connector, having a diameter larger than the first inner diameter of the second tube, a non-exposed stem portion adjacent to the enlarged stem portion located within the second tube, and an exposed stem portion adjacent to the enlarged stem portion located outside the second tube, the exposed stem portion configured to be inserted into the female connector to establish a fluid connection between the first tube and the second tube. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    The features, obstacles, and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, wherein: 
           [0018]      FIG. 1A  illustrates a gastric banding system implanted within a patient&#39;s body. 
           [0019]      FIG. 1B  illustrates the gastric banding system of  FIG. 1A  having a tube connector. 
           [0020]      FIG. 1C  illustrates a close up view of the tube connector of  FIG. 1B . 
           [0021]      FIG. 1D  illustrates a cross-sectional view of the tube connector of  FIG. 1B . 
           [0022]      FIG. 1E  illustrates a perspective view of a portion of the tube connector of  FIG. 1B  prior to insertion into the tube. 
           [0023]      FIG. 1F  illustrates a cross sectional view of a portion of the tube connector of  FIG. 1E  prior to insertion into the tube. 
           [0024]      FIG. 2A  illustrates the gastric banding system having a tube connector according to an embodiment of the present invention. 
           [0025]      FIG. 2B  illustrates a close up view of the tube connector of  FIG. 2A  having only guiding tip portion inserted into a tube according to an embodiment of the present invention. 
           [0026]      FIG. 2C  illustrates a close up view of the tube connector of  FIG. 2A  having the guiding tip portion and the barbed portion inserted into a tube according to an embodiment of the present invention. 
           [0027]      FIG. 2D  illustrates a cross sectional view of  FIG. 2C  according to an embodiment of the present invention. 
           [0028]      FIG. 2E  illustrates the tube connector of  FIG. 2A  apart from the tube according to an embodiment of the present invention. 
           [0029]      FIG. 2F  illustrates a cross sectional view of the tube connector of  FIG. 2A  apart from the tube according to an embodiment of the present invention. 
           [0030]      FIG. 3A  illustrates a tube connector of the tube according to an embodiment of the present invention. 
           [0031]      FIG. 3B  illustrates a cross sectional view of the tube connector of  FIG. 3A  according to an embodiment of the present invention. 
           [0032]      FIG. 4A  illustrates a tube connection system according to an embodiment of the present invention. 
           [0033]      FIG. 4B  illustrates a tube connection system of  FIG. 4A  according to an embodiment of the present invention. 
           [0034]      FIG. 4C  illustrates a cross sectional view of the tube connection system of  FIG. 4A  according to an embodiment of the present invention. 
           [0035]      FIG. 4D  illustrates the tube connector of  FIG. 4A  disposed within the tube according to an embodiment of the present invention. 
           [0036]      FIG. 4E  illustrates a cross sectional view of the tube connector of  FIG. 4D  disposed within the tube according to an embodiment of the present invention. 
           [0037]      FIG. 4F  illustrates a tube connector of the tube according to an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0038]    Apparatuses, systems and/or methods that implement the embodiments of the various features of the present invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate some embodiments of the present invention and not to limit the scope of the present invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements. 
         [0039]    Turning to  FIG. 2A , illustrated is a gastric banding system  200  include a tube connector  260  having a guiding tip portion  277 . The tube connector  260  may be made out of a biocompatible plastic or metal in the shape shown in  FIG. 2A . The gastric banding system  200  may include an access port  230  with a septum  235 . The access port  230  may include an access port connector  236  for interfacing with a first tube  245 . The first tube  245  may be connected to the second tube  255  which may be connected to an inflatable portion  215  of a gastric band  210 . 
         [0040]    More particularly, the first tube  245  may include a first end  246  and a second end  247 . Similarly, the second tube  255  may include a first end  256  and a second end  257 . The first end  246  of the first tube  245  may be connected to the access port connector  236  and the second end  247  of the first tube  245  may be connected to the second end  257  of the second tube  255 . The first end  256  of the second tube  255  may be connected to the inflatable portion  215  of the gastric band  210 . In this manner, a pathway may be established between the access port  230  and the gastric band  210 . 
         [0041]      FIGS. 2B and 2C  illustrate close-up views of how the guiding tip  277  improves the ease of attaching the second end  247  of the first tube  245  to the second end  257  of the second tube  255 . As shown, extending from the second barb portion  275  is a guiding stem portion  276  culminating in a rounded, ball-shaped guiding tip portion  277 . The guiding tip portion  277  may be designed to be rounded in order to ensure that the guiding tip portion  277  does not stab or damage the inner diameter of the second tube  255  when inserted. Notably, the outer diameter of the guiding tip portion  277  is no larger than the inner diameter of the second tube  255 , thereby making it much easier for the physician to insert the guiding tip portion  277  into the inner diameter of the second tube  255 . Once inserted, the physician can apply a force to press the second barb portion  275  into the inner diameter of the second tube  255  without having to align the second barb portion  275  with the opening  272  of the second tube  255  as the guiding tip portion  277  and the guiding stem portion  276  is already inserted and functions to align the second barb portion  275  with the opening  272 . Furthermore, as the physician is applying the force, the physician does not have to worry that the second barb portion  275  will slip away from position because by virtue of already being inserted the guiding tip portion  277 , in a sense, holds the second barb portion  275  from slipping away from the correct inserting position. As a result, the guiding tip portion  277  and the guiding stem portion  276  allows the physician to press the second barb portion  275  into the inner diameter of the second tube  255  in a much more efficient manner.  FIG. 2C  illustrates the second barb portion  275  as inserted into the second tube  255  creating the bulge  266  thereby providing a fluid seal at the location of the bulge  266 . 
         [0042]      FIG. 2D  illustrates a cross sectional view of  FIG. 2B  and better illustrates the differences in diameter sizes of the various components. In this embodiment, the outer diameter of the guiding stem portion  276  may have the smallest diameter. Next, the guiding tip portion  277  may have a diameter larger than or equal to the guiding stem portion  276 . The guiding stem portion  276  and the guiding tip portion  277  are configured to be smaller than the inner diameter  290  of the second tube  255  so that a physician may easily insert these portions into the second tube  255 . The second barbed portion  275  and/or the stem portion  271  may be larger than the inner diameter  290  of the second tube  255  to prevent leaking of fluid out of the connection location between the first tube  245  and the second tube  255 . 
         [0043]    The functionality and the inter-relationships of the different components having been described, attention will now be turned to the connector  260  itself.  FIG. 2E  illustrates the tube connector  260  apart from the tubes  245  and  255 . In this embodiment, the connector  260  appears similar to connector  160 , except with the connector  260  further includes the features of the guiding stem portion  267  and the guiding tip portion  277 . The ball-shaped guiding tip portion  277 , in addition to advantageously being shaped to avoid scraping the inner wall of the second tube  255  during insertion, may also be configured to be slightly larger than the guiding stem portion  276  in order to serve as a visual aid to the physician during the initial insertion process. 
         [0044]      FIG. 2F  illustrates a cross sectional view revealing an inner cavity  263  extending from a first end  261  of the connector  260  to a second end  262  of the connector  260 . As shown, the inner cavity  263  may be utilized to pass fluid or other substances from the first end  261  to the second end  262  and vice versa. When the connector  260  is inserted into a first tube and a second tube, the inner cavity  263  may be utilized to pass fluid between the first tube and the second tube. As illustrated, the connector  260  has a varying topology. Proximal to the first end  261 , the first barb  270  may define a first outer diameter  299  and a second outer diameter  298 . The first barb  270  gradually increases in diameter between the first outer diameter  299  and the second outer diameter  298 , while maintaining a constant sized inner cavity  263  (as marked by  296 ). The stem portion  271  also shares the constant sized inner cavity  263  while having an outer diameter smaller than the second outer diameter  298 . The stem portion  271  leads to the second barb  275  which includes a first outer diameter  297  sized to be greater than a second outer diameter  294 , gradually decreasing in diameter moving away from the stem portion  271 . However, at the second outer diameter  294 , an inner diameter  276  of the inner cavity  263  is reduced between the second outer diameter  294  and the guiding tip portion  276 . At this same portion, the outer diameter  274  of the guiding stem portion  276  is decreased as compared to the second outer diameter  294  and before increasing at the outer diameter  292  of the guiding tip portion  277 . Advantageously, the reduced inner diameter  276  of the inner cavity  263  allows for a minimum wall thickness while still providing sufficient rigidity. In other words, the outer diameter  292  of the guiding tip portion  277  and the outer diameter  247  of the guiding stem portion  276  are small enough to fit through the opening of a tube, while the wall defining the inner diameter  276  is still thick enough to provide sufficient rigidity to structurally support the guiding tip portion  277  and the guiding stem portion  276  of the connector  260 . 
         [0045]    The above descriptions corresponding to  FIG. 2A-2F  describe certain embodiments of a connector. However, many other embodiments are also possible. For example, a second guiding stem portion and a second guiding top portion may be integrated or attached to the connector  260  proximal to the first end  261  to achieve similar functionality at the first end  261  of the connector  260 . 
         [0046]      FIG. 3A  illustrates another embodiment of a connector  360  having a first barb portion  370  and a second barb portion  375  with a stem portion  361  therein between. Attached to the second barb portion  375  is a guiding stem portion  376 , which culminates in a guiding tip portion  377  defining an opening  378 . The functionality of the connector  360  is generally similar to the functionality of the connector  260 . However, as compared to the connector  260 , the connector  360  of  FIG. 3A  does not include the ball feature at the guiding tip portion  377 , and instead may include a thicker wall to increase rigidity. The embodiment of  FIG. 3A  may be advantageous in situations where a larger load is desirably carried by the connector  360 . 
         [0047]      FIG. 3B  illustrates a cross sectional view of the connector  360  of  FIG. 3A . The connector  360  may include a tapered inner diameter of cavity  363  at the location of second barb portion  375  to reduce turbulence and promote smooth fluid flow with less resistance. 
         [0048]    Generally, the connectors  260 ,  360  of  FIGS. 2A and 3A , respectively, may involve connecting two flexible tubes where one end of the connector may be pre-inserted into one of the flexible tubes. This situation may be typical of operations or surgeries where only one tube needs to be cut to a customized length at the time of the surgery and therefore, pre-inserting a fitting into the tube to be cut would not be useful since it has to be cut. However, in certain scenarios, there might not be a need to customize the length at the time of the surgery (e.g., in the field) and therefore, a dual-connector system may make the field assembly easier. 
         [0049]    Turning to  FIG. 4A , a tubing connecting system  400  is illustrated. The tubing connecting system  400  may include a first connector  410  having a first end  415  pre-attached or inserted in a first tubing  445  and exposing a second end  416 . The tubing system  400  may also include a second connector  460  having a first end  465  pre-attached or inserted in a second tubing  455  and exposing a second end  466 . In one embodiment, the second connector  460  may be very similar to the connector  160  as illustrated in  FIG. 1E . One significant difference between the tubing connecting system  400  and the prior art system illustrated in  FIG. 1A-1F  is the inclusion of the first connector  410 . The first connector  410  serves as a guiding rod for locating and aligning with the opening at the second end  466  of the second connector  460 . In this manner, the two tubes  445  and  455  may be connected by inserting the second end  416  of the first connector  410  into the second end  466  of the second connector  460  and pressing the two tubes  445  and  455  together.  FIG. 4B  illustrates how the tubing connecting system  400  may appear when the second end  416  of the first connector  410  is inserted into the second end  466  of the second connector  460  and the two tubes  445  and  455  are pressed together. In this manner, by designing the second end  416  of the first connector  410  to easily fit within the second end  466  of the second connector  460 , the physician is not required to spend much time and/or effort to perform joining the two tubes  445  and  455 . 
         [0050]      FIG. 4C  illustrates a cross sectional view of the tube connector system  400  of  FIG. 4B  showing how the first connector  410  (e.g., a male connector) is inserted and held in place by a second connector  471  (e.g., a female connector), thereby connecting and holding the two tubes  445  and  455  in place. The outer diameter  477  of the first connector  410  proximal to the guiding stem portion  476  may be the same or smaller than the inner diameter  472  of the second connector  471  to facilitate an easy insertion process. As the guiding stem portion  476  is inserted, the second end  466  (e.g., a second barbed portion  475 ) may penetrate and be positioned between the outer surface  418  of the first connector  410  and the inner surface  419  of the first tube  445 . More particularly, the second end  466  of the second connector may squeeze between said inner surface  491  of the first tube  445  and the outer surface  418  of the first connector  410 . Advantageously, the fit of the second end  466  within the first tube  445  may be tight to promote good sealing and leak prevention. Furthermore, the second barbed portion  475  at the second end  466  may serve to limit any leaking that may be present. 
         [0051]      FIGS. 4D and 4E  illustrates the first tube  445  and the first connector  410  with the other portions of the connector system  400  omitted for clarity. As shown here, the first connector  410  may include a large stem portion  411  at the first end  462 , which may be larger in diameter than the inner diameter of the first tube  445  thereby causing a bulge  462 . The large stem portion  411  may be attached to the non-exposed stem portion  412 , which is attached to the exposed stem portion  413  located at the second end  416  of the connector  410 . The non-exposed stem portion  412  and the exposed stem portion  413  may have a smaller diameter than the diameter of the large stem portion  411 . More particularly, in one embodiment, the non-exposed stem portion  412  and the exposed stem portion  413  may have the same or smaller diameter as the inner diameter of the first tube  445 . The outer surface of the non-exposed stem portion  412  and the exposed stem portion  413  are not adhered to the inner surface of the first tube  445  so that the second barb portion  475  may separate and be squeezed in between the outer surface of the non-exposed stem portion  412  and the inner surface of the first tube  445  during the insertion process (as shown in  FIG. 4C ). 
         [0052]      FIG. 4F  illustrates the first connector  410  without the first tube  445  for clarity. As shown here, structurally, the non-exposed stem portion  412  and the exposed stem portion  413  might not be delineated in any manner, and may be defined by which portions are inside the first tube  445  and which portions are outside the first tube  445 . However, the large stem portion  411  is shown to have a larger outer diameter than rest of the connector  410 . 
         [0053]    Unless otherwise indicated, all numbers expressing quantities of ingredients, volumes of fluids, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least 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 the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. 
         [0054]    The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. 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 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. 
         [0055]    Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may 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 deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims. 
         [0056]    Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context. 
         [0057]    Furthermore, certain references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety. 
         [0058]    Specific embodiments disclosed herein may be further limited in the claims using consisting of or and consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein. 
         [0059]    In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.