Abstract:
An apparatus comprises a controller for remotely controlling an implantable device that is used to adjust a gastric band, and the controller transmits a telemetric signal to the implantable device. The apparatus further comprises a table that provides support for the controller. A rail is oriented in a first direction with respect to the table, and a tray is slidably coupled to the rail. The tray receives the controller, and the rail moves the tray and the controller in the first direction with respect to the table. The apparatus further comprises a roller coupled to the rail. The roller aids in moving the rail, the tray, and the controller in a second direction with respect to the table. The apparatus further comprises an attachment mechanism for securing the controller to the tray. The apparatus locates the controller in a desired location with respect to a patient.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 12/731,416, filed Mar. 25, 2010, the contents of which is incorporated herein by reference. 
     
    
     FIELD 
       [0002]    The present description generally relates to medical systems and apparatus and uses thereof for treating obesity and/or obesity-related diseases, and more specifically, relates to support apparatus used for remotely adjustable gastric band controllers. 
       BACKGROUND 
       [0003]    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 AP® (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 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 provides 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. 
         [0004]    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 connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction. 
         [0005]    Some remotely adjustable gastric banding systems have been proposed that utilize a controller to non-invasively fill and drain the gastric band. For example, internal pumps may be utilized to fill and drain the gastric band, and these internal pumps may be controlled telemetrically by an external controller. The controller may be used to send radio frequency waves for powering and communicating with the implanted device. The implanted device can fill or drain the gastric band as requested by the healthcare worker via the handheld controller. Such remotely adjustable gastric bands have been described in Birk et al., U.S. patent application Ser. No. 12/705,245, and Stroumpoulis, U.S. patent application Ser. No. 12/705,343, the entire disclosures of which are incorporated herein by this specific reference. 
         [0006]    Controllers for remotely adjustable gastric banding systems may be of a size and weight that cause manipulation of these controllers to be difficult. For example, the controller can weigh more than a couple of pounds and adjustments by hand can take several minutes. Holding the controller in the desired position for the desired time may also be difficult. Further, the accurate positioning of the controller is important in order to facilitate appropriate communication with the gastric banding system. 
         [0007]    Some devices exist that facilitate manipulation of objects. For example, Aikman, U.S. Patent Application Pub. No. 2008/0222813, is directed toward a system for positioning a patient on a bed to encourage side sleeping. The system comprises a rigid, but flexible pillow that is fixed with respect to the patient. This publication does not address a method or system for positioning an object with respect to a patient; rather, it discloses positioning a patient with respect to an object. Furthermore, the positioning required in Aikman may not be conducive to utilizing a remotely adjustable gastric banding system controller. 
         [0008]    Otsuka, et al., U.S. Pat. No. 7,189,249, generally discloses a medical instrument holding device that allows manipulation of a medical instrument. One end of an arm of the holding device is attached to a rail which allows for movement of the base of the device in one dimension. Thus it is desirable to develop a support system for a controller that is capable of more mobile and less-restrained positioning of the controller. 
         [0009]    Schommer, et al., U.S. Pat. No. 7,286,881, discloses an external power source, and system and method using such external power source, for an implantable medical device having therapeutic componentry and a secondary coil operatively coupled to the therapeutic componentry. A belt is used to position the external power source near the patient, and devices of only limited weight may be positioned with this belt. Thus, it is desirable to develop a positioning and support system that can provide support for heavier devices and that may facilitate easier, more flexible positioning of a gastric banding system controller. 
         [0010]    Brown, et al., U.S. Patent Application Pub. No. 2008/0272251, discloses a holding device for medical purposes having a carrier arm on whose distal end a medical instrument can be secured and having at least one joint for positioning the carrier arm and/or the medical instrument. But Brown&#39;s device is utilized for devices of limited size and weight, and Brown is limited to certain types of movement. 
         [0011]    As noted, these devices suffer from certain disadvantages. For example, the devices are not designed for the size and weight of a controller for a remotely adjustable gastric banding system. Further, these devices do not provide for desired flexibility in positioning such controllers. Moreover, these devices do not allow for adequate positioning and maintenance of the controller in a desired location. 
         [0012]    Thus, a need exists for a support apparatus for a remotely adjustable gastric banding system controller that allows a physician to more easily and accurately position the controller with respect to the patient and maintain the controller in that position during an adjustment of the gastric band. 
       SUMMARY 
       [0013]    Generally described herein are support apparatus for controllers used in remotely adjustable gastric banding systems. The apparatus and methods described herein aid in facilitating obesity control and/or treating obesity-related diseases. 
         [0014]    In one embodiment, an apparatus comprises a controller for remotely controlling an implantable device that is used to adjust a gastric band, and the controller transmits a telemetric signal to the implantable device. The apparatus further comprises a table that provides support for the controller. A rail is oriented in a first direction with respect to the table, and a tray is slidably coupled to the rail. The tray receives the controller, and the rail moves the tray and the controller in the first direction with respect to the table. 
         [0015]    The apparatus further comprises a roller coupled to the rail. The roller aids in moving the rail, the tray, and the controller in a second direction with respect to the table. In an embodiment, the apparatus further comprises an attachment mechanism for securing the controller to the tray. The attachment mechanism may be a strap, a cup, a cavity, a tray, a grasper, and combinations thereof. 
         [0016]    Additionally, the apparatus may comprise an adjustable leg that is movable with respect to the table. The adjustable leg may be used to adjust a height of the table to accommodate various patient sizes. The adjustable leg comprises a telescoping pole that helps move the adjustable leg with respect to the table. A knob may be used to lock the telescoping pole and the leg in place. 
         [0017]    In accordance with another embodiment of the present invention, an apparatus comprises a base and a fixed pole connected to the base. A manipulator is connected to the fixed pole at a first end of the manipulator arm. The manipulator arm is capable of moving while the fixed pole is stationary. 
         [0018]    The apparatus further comprises an attachment device, coupled to a second end of the manipulator arm. A controller is coupled to the manipulator arm via the attachment device, and the controller remotely controls an implantable device that is used to adjust a gastric band. The controller transmits a telemetric signal to the implantable device in order to adjust the gastric band. 
         [0019]    In an embodiment, the apparatus comprises a plurality of wheels attached to the base. The wheels allow an operator to move the fixed pole. At least one of the plurality of wheels comprises a brake or a lock so the operator may lock the apparatus in a desired location. 
         [0020]    Further, in accordance with an embodiment, the manipulator arm comprises a first movable segment and a second movable segment. A first friction stop swivel joint connects the first movable segment to the second movable segment, and the first friction stop swivel joint maintains a position of the controller when the controller weighs from approximately three pounds to approximately eight pounds. The first friction stop swivel joint may comprise a knob to lock the first friction stop swivel joint. 
         [0021]    Other embodiments of the present invention include a second friction stop swivel joint connecting the second movable segment to a third movable segment. The first friction stop swivel joint rotates about a first axis, and the second friction stop swivel joint rotates about a second axis different than the first axis. These different axes allow three-dimensional movement of the controller. 
         [0022]    In accordance with an embodiment, a method for positioning a controller of a remotely adjustable gastric banding system near a patient comprises positioning the controller proximate a support apparatus. The controller is attached to the support apparatus using an attachment mechanism. The attachment mechanism may be one or more of the following: a strap, a cup, a cavity, a tray, a grasper, and combinations thereof. The support apparatus is adjusted to move the controller to a position for remotely adjusting an implantable gastric band. The support apparatus may be adjusted without an operator holding the controller. 
         [0023]    In a further embodiment, the method also comprises adjusting a telescoping pole to increase or decrease a height of the support apparatus. The telescoping pole may then be locked in place. The controller may be positioned on a tray, and an operator may slide the tray and the controller in a first direction. The operator may also slide the tray and the controller in a second direction to appropriately position the controller with respect to the patient. 
         [0024]    In another embodiment, the method comprises moving a manipulator arm to appropriately position the controller with respect to the patient. A friction stop swivel joint coupled to the manipulator arm may be locked to prevent undesired movement of the controller. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]      FIG. 1  illustrates a perspective, cut-away view of a support apparatus for a gastric banding system controller according to an embodiment of the present invention. 
           [0026]      FIG. 2  illustrates a perspective view of a support apparatus positioned with respect to a patient according to an embodiment. 
           [0027]      FIG. 3  illustrates a perspective view of a support apparatus for a gastric banding system controller according to another embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    The present invention generally provides a support apparatus used for remotely adjustable gastric band controllers. 
         [0029]    In accordance with various embodiments, the support apparatus described herein provide flexible and stabilizing support for hand-held gastric banding system controllers. Such flexible and stabilizing support may be provided during adjustments to the gastric banding system to facilitate reducing errors related to drift and/or motion of the controller and to reduce errors due to fatigue of the operator and/or the patient. 
         [0030]    The controllers disclosed herein communicate telemetrically with and provide access to gastric banding system data and functions and are external, handheld, reusable battery-powered devices that are generally cylindrical in shape. The controller has a user interface including at least one display and at least one user input. The controller permits a clinician or a patient to navigate through menu driven screens used for data entry, data collection, and control of the gastric banding system. The controllers disclosed herein may weigh between approximately three pounds and approximately eight pounds. 
         [0031]    The controller is capable of communicating with the gastric banding system. “Capable of communicating” as used herein refers to the remote transmitter&#39;s ability to establish communications with the gastric banding system, yet still have the ability to break communication and the systems described herein still function. For example, the controller may communicate using radio frequency or other frequency wavelengths or telemetric signals. 
         [0032]    To establish communication, in one example embodiment, once the controller is initialized, a display shows a searching query for a nearby gastric banding system. As the controller is brought within a range of the gastric banding system, the display shows the strength of the communication link. Once stable communications have been acquired, the display shows the serial number of the system so a clinician can verify they have the appropriate patient records in hand. If the patient requires a tightening of the gastric band, the clinician can enter the amount of the desired volume increase for the gastric band. The controller can also display the current volume within the gastric band and indicate the new volume as the gastric band fills. The controller can also indicate desired and actual volumes during draining of the gastric band. As such, various embodiments of the present invention provide apparatus for maintaining the controller in a desired position for a period of time to accomplish the above and other tasks. 
         [0033]    Turning now to  FIG. 1 , in an embodiment of the present invention, a support apparatus  100  comprises a table  110  having a tray  120  that provides support and positioning for a controller  115 , such as a controller for a gastric banding system. The controller  115  may be referred to as a “hand-held” controller because the controller  115  may typically be held in a patient&#39;s or physician&#39;s hand where the support apparatus  100  is not being used. 
         [0034]    In an embodiment, the tray  120  is specifically designed for the controller  115  that is used in connection with a remotely-adjustable gastric banding system. The form, fit and function of the tray  120  are advantageously designed to provide support to and manipulation of the controller  115 . For example, the tray  120  is a similar shape as the controller  115 , and the tray  120  may have precisely aligned securing features, as discussed further below. 
         [0035]    The tray  120  may be slidably connected to a rail  125  or set of rails  125  to facilitate moving the tray  120  in a first direction  155  with respect to a surface of the table  110 . Moving the tray  120  in the first direction  155  facilitates positioning the controller  115  in a location with respect to the patient that allows the controller  115  to communicate with the gastric banding system. 
         [0036]    The rail  125  may interface with the tray  120  in any manner known in the art that allows the tray  120  to slide with respect to the rail  125 . The tray  120  and/or the rail  125  may comprise roller bearings or other bearing types to allow the tray  120  to slide with respect to the rail  125 . In an embodiment, the tray  120  and the rail  125  may comprise bearing and/or contact surfaces with a coefficient of friction sufficient to allow movement of the tray  120  and to keep the tray  120  in a given position determined by the physician, operator, and/or the patient. In an embodiment, the degree of friction between the tray  120  and the rail  125  is sufficient to restrict movement of the tray  120  unless the tray  120  is purposely repositioned by an operator. 
         [0037]    In various embodiments, the support apparatus  100  is designed to securely fit and/or maintain the controller  115  in place while allowing it to have motion within a plane when moved by an operator. For example, an attachment mechanism such as a strap, a cup, a cavity, a tray, a grasper, and combinations thereof may be used to secure the controller  115  to the tray  120 . The tray  120  may be advantageously designed to secure the controller  115  in place using the attachment mechanism. Furthermore, the controller  115  may comprise attachment locations for receiving the attachment mechanism, such as loops or grooves for a strap. 
         [0038]    The tray  120  can move side-to-side in the first direction  155  by sliding on the rail  125  as discussed above. The tray  120  may move in a second direction  160  with a motion substantially perpendicular to the motion of the rail  125  in the first direction  155 . 
         [0039]    In an embodiment, a second set of rails and/or guides  130  may be located on each side of the table  110 . The guides  130  may allow the rails  125  themselves to move in the second direction  160  with respect to the table  110 . In an embodiment, rollers  135  at the end of the rails  125  may include a bearing or other device that interacts with the guides  130  to guide the motion of the rails  125 . In further embodiments, any device may be employed that allows movement of the tray  120  in the second direction  160 . A sufficient amount of friction may exist between the rollers  135  and the guides  130  such that the tray  120  may remain in place if the controller  115  is not being purposely moved by an operator. 
         [0040]    With reference to  FIG. 2 , according to an embodiment of the present invention, the support apparatus  100  is configured to accommodate a patient  170  on an examination table  175 . Because the support apparatus  100  may be utilized for patients of various sizes, embodiments of the present invention, with reference again to  FIG. 1 , comprise adjustable legs  140 . The legs  140  and/or table  110  may move in a height adjustment direction  165  to add flexibility to the support apparatus  100  and to accommodate various sizes of patients. 
         [0041]    Movement of the table  110  and/or the legs  140  may be accomplished with a telescoping pole  145  coupled to the legs  140 . In an embodiment, the legs  140  may slide within the table  110  to facilitate adjusting the height, and the telescoping pole  145  may be disposed within one or both of the legs  140 . In another embodiment, the telescoping pole  145  may extend out the bottom of the table  110  and may have feet that contact the floor and/or the examination table. 
         [0042]    An operator may move the table  110  and/or the legs  140  to increase or decrease the height of the support apparatus  100 . As the height of the support apparatus  100  increases, the telescoping pole  145  expands, and as the height of the support apparatus  100  decreases, the telescoping pole  145  contracts. The operator may secure the support apparatus  100  at the desired height by turning a knob  150  on each side of the support apparatus  100 . Turning the knob  150  applies friction to the telescoping pole  145  to maintain the desired height of the support apparatus  100 . Other mechanisms can be used to maintain the desired height such as a detent in leg mechanism or a peg and hole mechanism. 
         [0043]    In an embodiment, the various components of support apparatus  100  are constructed of non-metallic materials so as not to interfere with the radio frequency functionality of the controller  115  and inductive operations of the gastric banding system. 
         [0044]    With the support apparatus  100  at the desired height, the operator may slide the controller  115  and/or the tray  120  in the first direction and/or the second direction to a location appropriate for remotely adjusting the gastric banding system. Once the controller  115  is in the appropriate location, adjustments to and/or readings from the gastric banding system may be made while the support apparatus  100  prevents drift and/or motion of the controller and prevents fatigue of the operator and/or the patient who might otherwise hold the controller in his hand. 
         [0045]    Turning now to  FIG. 3 , in an embodiment, a support apparatus  300  for a controller  315  comprises a movable pole, such as a manipulator arm  320 . The manipulator arm  320  allows an operator to move the controller  315  to a desired position with respect to a patient. As noted above, the controller  315  may be used to make remote adjustments to a gastric banding system located within a patient&#39;s body. The support apparatus  300  facilitates maintaining controller  315  in a desired position for a certain time while reducing errors related to drift and/or motion of the controller and related to fatigue of the operator and/or the patient. 
         [0046]    The support apparatus  300  comprises a base  310 . The base  310  may be weighted to prevent the support apparatus  300  from toppling and/or moving when the controller  315  is secured to the support apparatus  300 . For example, the base  310  may be advantageously designed to counter-balance the weight of the controller  315 , where the controller  315  weighs between approximately three pounds and approximately eight pounds. 
         [0047]    The base  310  further comprises wheels  312  so that an operator may move the support apparatus  300  to a desired location close to a patient. The wheels  312  are configured to provide sufficient resistance to rolling such that the support apparatus  300  will not move unless moved by an operator. For example, the wheels  312  may have a small amount of friction, or the wheels  312  may comprise a wheel brake to prevent unwanted rolling of the support apparatus  300 . 
         [0048]    A fixed pole  305  is connected to and extends vertically from the base  310  to allow the controller  315  to be placed above a patient, either in a prone position or in any inclined position. The manipulator arm  320  has a first end  327  that is coupled to the fixed pole  305 , and the manipulator arm  320  may move independently of the fixed pole  305 . In other words, the manipulator arm  320  may move while the fixed pole  305  remains stationary. A second end  328  of the manipulator arm  320  is coupled to an attachment mechanism  340  that secures the controller  315  to the support apparatus  300 . 
         [0049]    The attachment mechanism  340  may comprise a support mechanism, such as a plate or a tray, and/or a holder including one or more of the following: a strap, a cup, a cavity, a tray, a grasper, and combinations thereof. In an embodiment, the attachment mechanism  340  comprises a strap that secures the controller  315  to the second end  328  of the manipulator arm  320 . In another embodiment, the attachment mechanism  340  may comprise a tray secured to the manipulator arm  320 , and the controller  315  may sit on the tray. A strap may then be configured to secure the controller  315  to the tray. The strap and/or other attachment mechanism may be advantageously sized for the controller  315 , and the controller  315  may have specific connection points for the strap. 
         [0050]    Various components near the controller  315 , such as the attachment mechanism  340  and the manipulator arm  320  near the second end  328  of the manipulator arm  320 , may be made of a non-metallic material so as to not interfere with the operation of the controller  315 . 
         [0051]    Utilizing the attachment mechanism  340  in conjunction with the support apparatus  300  allows the controller  315  to become a “hands-free” controller. Typically, the controller  315  would be a “hand-held” controller because an operator, physician, and/or patient would need to hold the controller  315  by hand in order to perform adjustments to the gastric banding system. However, attachment mechanism  340  allows the controller  315  to more accurately be positioned without being held by an operator. 
         [0052]    In an embodiment, the manipulator arm  320  comprises movable segments  322 ,  323 ,  324 . These movable segments  322 ,  323 ,  324  allow for finer positioning of the controller  315 . The movable segments  322 ,  323 ,  324  may be connected to each other using friction stop swivel joints  330 . Friction stop swivel joints may also be used to connect the manipulator arm  320  to the fixed pole  305  and/or the attachment mechanism  340 . 
         [0053]    The swivel joints  330  are configured to have sufficient friction such that the movable segments  322 ,  323 ,  324  stay in place unless an operator desires them to move. In an embodiment, each swivel joint  330  may comprise a locking mechanism, such as a knob, that restricts movement of the swivel joint  330  if the locking mechanism is engaged. 
         [0054]    In an embodiment, the swivel joints  330  allow motion about one axis and/or in one plane. In another embodiment, the swivel joints  330  may move about multiple axes and/or in multiple planes. It should be understood that any combination of single/multiple axes/plane swivel joints  330  may be used without departing from the scope of the present invention. Various combinations of the swivel joints  330  allow for three dimensional movements and positioning of the controller  315 . Further, using various combinations of the swivel joints  330  allows a compromise between positioning flexibility and cost and complexity of the support apparatus  300 . 
         [0055]    In accordance with various embodiments, the support apparatus  100 ,  300  may include electromechanical devices to facilitate automated, hands-free operation of the support apparatus  100 ,  300 . Height and/or positional adjustments may then be made via motors, servos, gears, and the like to appropriately locate the controller  115 ,  315  to perform adjustments to the gastric banding system. Computers may be utilized for precise positioning control. 
         [0056]    According to an embodiment, a method for positioning a controller of a remotely adjustable gastric banding system comprises securing the controller to a support apparatus. The controller may be secured to the support apparatus using an attachment mechanism including one or more of the following: a strap, a cup, a cavity, a tray, a grasper, and combinations thereof. An operator may adjust the position of the controller with respect to the support apparatus without the operator holding the controller. 
         [0057]    In an embodiment, as illustrated in  FIG. 1 , the support apparatus  100  is adjusted to accommodate a patient. The adjustable legs  140  are adjusted by causing the telescoping pole  145  to expand or collapse. The adjustable legs  140  may be locked in place using the knob  150 . The adjustable legs  140  may be adjusted, and other adjustments to the support apparatus  100  may be made before and/or after securing the controller  115  to the support apparatus  100 . Similarly, the tray  120  may be moved in the first direction  155  and/or the second direction  160  before and/or after securing the controller  115  to the tray  120 . 
         [0058]    In an embodiment, as illustrated in  FIG. 3 , the support apparatus  300  may be rolled towards a patient before and/or after securing the controller  315  to the attachment mechanism  340 . The manipulator arm  320  is then moved with respect to the fixed pole  305  to position the controller  315  in a desired location for adjusting the gastric band. The support apparatus  300  may be positioned near the patient, and other adjustments to the support apparatus  300  may be made before and/or after securing the controller  315  to the support apparatus  300  and/or the attachment mechanism  340 . 
         [0059]    Embodiments of the present invention provide advantages over the prior art. Although many other advantages will be apparent, some are discussed here. For example, the support apparatus disclosed herein remove the requirement for an operator to hold the gastric banding system controller during adjustment of the gastric band. Because of the positioning requirements for successful operation of the controller and adjustment of the gastric band, this hands-free system is more user-friendly and accurate, and does not lead to operator fatigue. Further, the patient, physician, and/or operator may perform certain other tasks during adjustment of the gastric band because their hands are free to do so. 
         [0060]    Unless otherwise indicated, all numbers expressing weights, sizes 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. 
         [0061]    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. 
         [0062]    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. 
         [0063]    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. 
         [0064]    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. 
         [0065]    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. 
         [0066]    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.