Abstract:
The embodiments of the present disclosure may provide an apparatus used in ureteroscopy, a widespread method of treating kidney stones by enclosing the stone in a sheath before breaking it into a plurality of fragments with a fragmenting device. The configuration of the disclosed mesh top to a sheath may improve the practice of ureteroscopy by facilitating the removal of kidney stone fragments. The apparatus may comprise a sheath; a mesh top comprising: a first end having an opening into the interior of the mesh top, and a second end being attached to the sheath; and an enclosing means, wherein the mesh top is configured to: receive an object within an interior of the mesh top, enclose, via the enclosing means, the object within the mesh top, receive a fragmenting device through a second end, and retain fragments of the object caused by an operation of the fragmenting device.

Description:
RELATED APPLICATION 
       [0001]    Under provisions of 35 U.S.C. §119(e), the Applicants claim the benefit of U.S. provisional application No. 61/984979, filed Apr. 28, 2014 by the same inventors, which is incorporated herein by reference. 
         [0002]    It is intended that each of the referenced applications may be applicable to the concepts and embodiments disclosed herein, even if such concepts and embodiments are disclosed in the referenced applications with different limitations and configurations and described using different examples and terminology. 
     
    
     FIELD OF DISCLOSURE 
       [0003]    The present disclosure generally relates to removal of calculi and foreign bodies. 
       BACKGROUND 
       [0004]    Kidney stones may be removed in a plurality of ways. Common methods of treatment include Extracorporeal Shock Wave Lithotripsy (ESWL), Percutaneous Nephrolithotomy (PN) and Ureteroscopy. ESWL may often lead to kidney damage, postoperative complications, and a high recurrence rate. PN is an invasive procedure that involves an incision through the skin through which a device is guided into the kidney, necessitating extended recovery time. 
         [0005]    Compared to patients treated using ESWL or PN, ureteroscopy patients recover more quickly and suffer fewer post-operative complications. However, ureteroscopy procedures create stone fragments that may take hours to remove. Fragments are an issue with all treatment methods because fragments greater than 1 mm are clinically significant and, if left in the system, can re-aggregate and form additional stones. Consequently, up to fifty percent of all stone-formers have another stone after their first treatment. 
         [0006]    Physicians performing ureteroscopy procedures emphasize that the duration of the procedure is the most important aspect of the surgery that needs improving. Current methods of ureteroscopy take the physician only 15-20 minutes to break up the stone, but potentially another hour or more removing all of the stone fragments resulting from the lithotripsy. The physician must search through the urinary system and into the calyces of the kidney to locate these fragments, as their movement is completely sporadic. 
       BRIEF OVERVIEW 
       [0007]    This brief overview is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This brief overview is not intended to identify key features or essential features of the claimed subject matter. Nor is this brief overview intended to be used to limit the claimed subject matter&#39;s scope. 
         [0008]    The embodiments of the present disclosure may provide an apparatus used in ureteroscopy, a widespread method of treating kidney stones by enclosing the stone in a sheath before breaking it into a plurality of fragments with a fragmenting device. The configuration of the disclosed mesh top to a sheath may improve the practice of ureteroscopy by facilitating the removal of kidney stone fragments. The apparatus may comprise a sheath; a mesh top comprising: a first end having an opening into the interior of the mesh top, and a second end being attached to the sheath; and an enclosing means, wherein the mesh top is configured to: receive an object within an interior of the mesh top, enclose, via the enclosing means, the object within the mesh top, receive a fragmenting device through a second end, and retain fragments of the object caused by an operation of the fragmenting device. 
         [0009]    Both the foregoing brief overview and the following detailed description provide examples and are explanatory only. Accordingly, the foregoing brief overview and the following detailed description should not be considered to be restrictive. Further, features or variations may be provided in addition to those set forth herein. For example, embodiments may be directed to various feature combinations and sub-combinations described in the detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate various embodiments of the present disclosure. The drawings contain representations of various trademarks and copyrights owned by the Applicant. In addition, the drawings may contain other marks owned by third parties and are being used for illustrative purposes only. All rights to various trademarks and copyrights represented herein, except those belonging to their respective owners, are vested in and the property of the Applicant. The Applicant retains and reserves all rights in their trademarks and copyrights included herein, and grant permission to reproduce the material only in connection with reproduction of the granted patent and for no other purpose. 
           [0011]    Furthermore, the drawings may contain text or captions that may explain certain embodiments of the present disclosure. This text is included for illustrative, non-limiting, explanatory purposes of certain embodiments detailed in the present disclosure. In the drawings: 
           [0012]      FIG. 1  illustrates an embodiment of an apparatus consistent with embodiments of the present disclosure; 
           [0013]      FIGS. 2A-2B  illustrate an embodiment of a handle consistent with embodiments of the present disclosure; 
           [0014]      FIG. 3  is a flow chart of a method for providing an apparatus implementing a sheath for enclosure and removal of foreign bodies; 
           [0015]      FIG. 4  illustrates the insertion of a guidewire in the direction of a kidney stone; 
           [0016]      FIG. 5  illustrates the insertion of the apparatus over the guidewire; 
           [0017]      FIG. 6  illustrates an inserted ureteroscope; 
           [0018]      FIG. 7  illustrates a basket capturing a kidney stone; 
           [0019]      FIG. 8  illustrates a kidney stone being pulled into the apparatus; 
           [0020]      FIG. 9  further illustrates a kidney stone being pulled into the apparatus; 
           [0021]      FIG. 10  illustrates a mesh top being closed around the stone; 
           [0022]      FIG. 11A  illustrates a captured kidney stone; 
           [0023]      FIG. 11B  illustrates a captured kidney stone being pulled into a mesh top; 
           [0024]      FIG. 11C  further illustrates a captured kidney stone being pulled into a mesh top; 
           [0025]      FIG. 11D  illustrates a mesh top being closed around the stone; 
           [0026]      FIG. 12  illustrates stone fragmenting within a closed mesh top; and 
           [0027]      FIG. 13  illustrates the removal of the smaller, more manageable pieces of kidney stone. 
       
    
    
     DETAILED DESCRIPTION 
       [0028]    As a preliminary matter, it will readily be understood by one having ordinary skill in the relevant art that the present disclosure has broad utility and application. As should be understood, any embodiment may incorporate only one or a plurality of the above-disclosed aspects of the disclosure and may further incorporate only one or a plurality of the above-disclosed features. Furthermore, any embodiment discussed and identified as being “preferred” is considered to be part of a best mode contemplated for carrying out the embodiments of the present disclosure. Other embodiments also may be discussed for additional illustrative purposes in providing a full and enabling disclosure. As should be understood, any embodiment may incorporate only one or a plurality of the above-disclosed aspects of the display and may further incorporate only one or a plurality of the above-disclosed features. Moreover, many embodiments, such as adaptations, variations, modifications, and equivalent arrangements, will be implicitly disclosed by the embodiments described herein and fall within the scope of the present disclosure. 
         [0029]    Accordingly, while embodiments are described herein in detail in relation to one or more embodiments, it is to be understood that this disclosure is illustrative and exemplary of the present disclosure, and are made merely for the purposes of providing a full and enabling disclosure. The detailed disclosure herein of one or more embodiments is not intended, nor is to be construed, to limit the scope of patent protection afforded in any claim of a patent issuing here from, which scope is to be defined by the claims and the equivalents thereof. It is not intended that the scope of patent protection be defined by reading into any claim a limitation found herein that does not explicitly appear in the claim itself. 
         [0030]    Thus, for example, any sequence(s) and/or temporal order of steps of various processes or methods that are described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal order, the steps of any such processes or methods are not limited to being carried out in any particular sequence or order, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and orders while still falling within the scope of the present invention. Accordingly, it is intended that the scope of patent protection is to be defined by the issued claim(s) rather than the description set forth herein. 
         [0031]    Additionally, it is important to note that each term used herein refers to that which an ordinary artisan would understand such term to mean based on the contextual use of such term herein. To the extent that the meaning of a term used herein—as understood by the ordinary artisan based on the contextual use of such term—differs in any way from any particular dictionary definition of such term, it is intended that the meaning of the term as understood by the ordinary artisan should prevail. 
         [0032]    Regarding applicability of 35 U.S.C. §112, ¶6, no claim element is intended to be read in accordance with this statutory provision unless the explicit phrase “means for” or “step for” is actually used in such claim element, whereupon this statutory provision is intended to apply in the interpretation of such claim element. 
         [0033]    Furthermore, it is important to note that, as used herein, “a” and “an” each generally denotes “at least one,” but does not exclude a plurality unless the contextual use dictates otherwise. When used herein to join a list of items, “or” denotes “at least one of the items,” but does not exclude a plurality of items of the list. Finally, when used herein to join a list of items, “and” denotes “all of the items of the list.” 
         [0034]    The following detailed description refers to the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the following description to refer to the same or similar elements. While many embodiments of the disclosure may be described, modifications, adaptations, and other implementations are possible. For example, substitutions, additions, or modifications may be made to the elements illustrated in the drawings, and the methods described herein may be modified by substituting, reordering, or adding stages to the disclosed methods. Accordingly, the following detailed description does not limit the disclosure. Instead, the proper scope of the disclosure is defined by the appended claims. The present disclosure contains headers. It should be understood that these headers are used as references and are not to be construed as limiting upon the subjected matter disclosed under the header. 
         [0035]    The present discloser includes many aspects and features. Moreover, while many aspects and features relate to, and are described in, the context of kidney stone removal, embodiments of the present disclosure are not limited to use only in this context. 
       I. Apparatus Overview 
       [0036]    Consistent with embodiments of the present disclosure, an apparatus for the removal of calculi and foreign bodies may be provided. This overview is provided to introduce a selection of concepts in a simplified form that are further described below. This overview is not intended to identify key features or essential features of the claimed subject matter. Nor is this overview intended to be used to limit the claimed subject matter&#39;s scope. The apparatus implementing a sheath for removal of foreign bodies may be used by individuals or companies to assist in the process of removing kidney stones. 
         [0037]    The embodiments of the present disclosure may provide a cylindrical mesh top configurable to a sheath used in ureteroscopy. Although the disclosed mode of implementation of the mesh top is illustrated with reference to the capture of kidney stones, it should be understood that the embodiments disclosed herein may be adapted to accommodate the capture of calculi and foreign bodies (e.g., renal calculi or kidney stone fragments). Furthermore, although the disclosed mode of implementation is illustrated within a kidney, it should be understood that the embodiments disclosed herein may be used within the body (i.e. throughout the ureter or renal pelvis). 
         [0038]      FIG. 1  illustrates an improved sheath and mesh top  100  of the present disclosure. The improved apparatus may comprise a mesh top  110  used in configurable conjunction with a sheath  105 . Mesh top  110  may be configured with an enclosing means  115  at approximately an open end  112  of mesh top  110 . In some embodiments, enclosing means  115  may comprise, for example, but not be limited to, a loop knot. Open end  112  may be employed to receive a foreign body into mesh top  110 , while enclosing means  115  may be employed to enclose the foreign body captured within mesh top  110 . Methods of receiving the foreign body into method top  105  will be detailed below. 
         [0039]    Enclosing means  115  may be regulated by, for example, but not limited to, a tension cord operated through a channel  120  by a tension switch. Such regulation would enable a closing of open end  112  of mesh top  110 . It should be understood that enclosing means  115 , tension cord channel  120 , and a tension switch may be replaced with any suitable contraction mechanism used to close open-end  112 . In some embodiments, tension cord channel  120  may be used as a “backbone” to mesh top  110 , providing structural stability throughout use in a ureteroscopy procedure. 
         [0040]    During the ureteroscopy procedure, sheath  105  may be employed to encompass and pass a plurality of devices into the kidney including, but not limited to, a lithotripter. Although the embodiments disclosed herein reference a lithotripter, any suitable fragmenting device may be employed throughout the various embodiments of the present disclosure. Mesh top  110  consistent with embodiments of the present disclosure may be designed to accommodate various lithotripters configured to pass through sheath  105 , including, for example, but not limited to, electrohydraulic, pneumatic, ultrasonic, or laser devices. Embodiments of the present disclosure may be employ such lithotripters to fragment a kidney stone once the kidney stone is received within mesh top  110  and open end  112  has been closed to secure the foreign body within mesh top  110 . 
         [0041]    Unlike conventional lithotripter applications, however, embodiments of the present disclosure may call upon the initiation of the fragmentation process once the stone is captured within enclosed mesh top  110 . In this way, once fragmented, the fragments of the stone may remain within the enclosed mesh top  110  without escaping back into the kidney, thereby eliminating the process of individual fragment collection. 
         [0042]    Still consistent with embodiments of the present disclosure, and as will be further detailed below, mesh top  110  may be comprised of a flexible, interwoven fabric (e.g., a braided closed-loop material) designed for expansion and contraction along an inner diameter of mesh top  110 . For example, as a stone is received through open end  112 , the force of the stone against mesh top  110  may cause a radial expansion of mesh top  110 . The compressive force, in turn, may cause open end  112  to dilate (e.g., an increase in the mesh top&#39;s inner diameter). The expansion may facilitate the entry of a stone into mesh top  110 . 
         [0043]    Further still, as the resultant stone fragments are pulled out of the kidney (by removal of the sheath), the friction between the walls of the passage and mesh top  110  may create a tension, causing mesh top  110  to stretch and elongate. In turn, the extension causes mesh top  110  to more tightly enclose the fragments (due to the decreased inner diameter), thereby ensuring that fragments remain securely within mesh top  110 . Consequently, the removal of a plurality of calculi fragments may be facilitated in one pass, reducing the time, discomfort, and risk of recurrence associated with treatment. 
         [0044]    By enclosing the stone in mesh top  110  before the fragmentation process, embodiments of the present disclosure may eliminate the need to locate and remove resultant fragments, thereby shortening total procedure time substantially. Moreover, since the resultant fragments are readily captured within the enclosed mesh top  110  and subsequently, are removed, re-aggregation will not occur, reducing readmissions for that reason. Accordingly, patients and their families, hospitals, physicians, and payers will benefit from the use of the embodiments disclosed herein. 
         [0045]    Both the foregoing overview and the following detailed description provide examples and are explanatory only. Accordingly, the foregoing overview and the following detailed description should not be considered to be restrictive. Further, features or variations may be provided in addition to those set forth herein. For example, embodiments may be directed to various feature combinations and sub-combinations described in the detailed description. 
       II. Apparatus Configuration 
       [0046]      FIG. 1  illustrates an improved sheath and mesh top  100 . It should be understood that a mesh top  110  and an improved sheath  105  comprising an integrated mesh top  110  may be individually, collectively, and interchangeably referred to as an “apparatus” throughout the embodiments of the present disclosure. Accordingly,  FIG. 1  may be said to disclose an apparatus  100 . 
         [0047]    Apparatus  100  may comprise, but not be limited to, for example, a sheath  105 , a mesh top  110 , an enclosing means  115 , and a tension cord channel  120 . The sheath  105  may be comprised of a hydrophilic coating material, such as, for example, but not limited to a Fluorinated ethylene propylene (FEP)-coated outer sheath. The sheath  105  may provide a working channel for the procedure. A dilator (not shown) may enable deployment of apparatus  100  through a urethra of a subject (e.g., a patient with kidney stones). The dilator may be coated in hydrophilic material, such as, for example, but not limited to Polytetrafluoroethylene (PTFE). 
         [0048]    A mesh top  110  may be implemented for capturing calculi or foreign body within the kidney of the subject (i.e., kidney stone). Mesh top  110  may be fabricated from a braided closed-loop material. The material may be comprised of for example, but not limited to, nitinol per ASTM F2063. An enclosing means  115 , such as, for example, but not limited to, a loop knot tying mechanism, may be implemented towards an open end  112  of mesh top  110 . In some embodiments, enclosing means  115  may be integrated within the fabric of mesh top  110  and positioned approximately towards open end  112 . The closing means  115  may be comprised of, but not limited to, for example, a monofilament prolene line. 
         [0049]    A channel for a monofilament prolene closure line  120  may run through sheath  105 . The line tension may be controlled by a tension switch implemented at an end of sheath  105 . In this way, increasing tension in the line may cause a tightening of the loop knot, thereby enclosing open end  112  of mesh top  110 . 
         [0050]      FIGS. 2A-2B  illustrate a handle  200  consistent with embodiments of the present disclosure. Handle  200  may be implemented at the base of apparatus  100 . The handle may be comprised of, but not limited to, plastic, such as, for example Acrylonitrile butadiene styrene (ABS). A tension switch, or ratcheting means  205  placed within handle may enable an operator to guide the apparatus as well as open and close the mesh top. Ratcheting means  205  may be spring-loaded and enable the operator to operate enclosing means  115 . 
         [0051]    It should be understood that enclosing means  115 , tension cord channel  120 , handle, and ratcheting means  205  may be replaced with any suitable contraction mechanism used to close open-end  112 . In some embodiments, the material of sheath  105  may be extruded over the mesh top  110  to create junction. Still other techniques and methods may be employed in combing the sheath  105  with mesh top  110 . 
       III. Apparatus Operation 
       [0052]      FIG. 3  is a flow chart setting forth the general stages involved in a method  300  consistent with an embodiment of the disclosure for operating the apparatus implementing a sheath for removal of foreign bodies. 
         [0053]    Although the stages illustrated by the flow charts are disclosed in a particular order, it should be understood that the order is disclosed for illustrative purposes only. Stages may be combined, separated, reordered, and various intermediary stages may exist. Accordingly, it should be understood that the various stages illustrated within the flow chart may be, in various embodiments, performed in arrangements that differ from the ones illustrated. Moreover, various stages may be added or removed from the flow charts without altering or deterring from the fundamental scope of the depicted methods and systems disclosed herein. Ways to implement the stages of method  300  will be described in greater detail below. Further, although method  300  describes a method for kidney stone removal in a specific way, apparatus  100  may not be limited to such procedures. 
         [0054]    Method  300  may begin at starting block  305  and proceed to stage  310  where apparatus  100  may be inserted into the kidney through the urethra. Prior to insertion, an insertion channel of the subject (e.g., urethra) may undergo dilation. Further still, a guide-wire may first be inserted into the channel (e.g., into the kidney through the urethra). 
         [0055]      FIG. 4  illustrates the insertion of the guide-wire  405  in the direction of a target object  410  (e.g., calculi or foreign body). Then, apparatus  100  may be inserted over the guide-wire.  FIG. 5  illustrates the insertion of the apparatus over the guide-wire. In some embodiments, a radiopaque ring may be used to make sure apparatus  100  is properly placed. Upon the insertion of apparatus  100  into the kidney, the guide-wire (and dilator) may then be removed. 
         [0056]    Next, a ureteroscope may be inserted through the sheath  105  of apparatus  100 .  FIG. 6  illustrates an inserted ureteroscope  605 . Ureteroscope  605  may be used for viewing target object  410  and guiding apparatus  100  towards the stone. 
         [0057]    From stage  310 , where apparatus  100  is inserted into the kidney, method  300  may advance to stage  320  where target object  410  may be captured within mesh top  110  of inserted apparatus  100 . In some embodiments, capturing device (e.g., stone basket) may be employed to grasp and move target object  410  into mesh top  110 .  FIG. 7  illustrates such a capturing device  705  for capturing target object  410 . 
         [0058]    Capturing device  705  may be inserted into the kidney through apparatus  100 . An operator may navigate capturing device  705  towards target object  410  and grasp target object  410 . Capturing device  705  may be controlled by an operator and, upon grasping of object  410 , may be pulled, along with object  410 , into mesh top  110 , as shown in  FIG. 8  and  FIG. 9 . Once within mesh top  110 , closing means  115  may be operated to secure target object  410  within mesh top  110 .  FIG. 10  illustrates a mesh top enclosing target object  410 . 
         [0059]      FIGS. 11A-D  show another illustration of the capturing process. In  FIG. 11A , target object  410  is grasped and captured by a capturing device  705  (e.g. basket), illustrated as tension line similar to that of enclosing means  115 . The line may pull object  410  into mesh top  110 . Upon receiving object  410  at open end  112  of mesh top  110 , the resulting force from object  410  compresses mesh top  110  may cause mesh top  110  to expand the open end  112 . In this way, the diameter of open end  112  may increase to accommodate the girth of object  410 . 
         [0060]      FIG. 11B  shows the expansion as a result of the result of the closed braided fabrication of mesh top  110 , designed to expand upon axial compression and stretch upon extension. In other embodiments of the present disclosure, the expansion of open end  112  may be regulated by enclosing means  115 , which may be adapted to both enclose and enlarge open end  112 .  FIG. 11C  illustrates the fabric of mesh top  110  stretching to secure and encompass object  410 . 
         [0061]    Referring now to  FIG. 11D , enclosing means  115  may be operated to secure object  410  within mesh top  110  by closing open end  112 . It should be understood that enclosing means  115  is illustrated conceptually. For example, various implementations of enclosing means  115  may call for the integration of the tension line within braided fabric of the mesh top  110 . Still, other implementations may be provided so as to coincide with the utility of enclosing open end  112 . The closure of open end  112  may also serve to more securely enclose object  410  within mesh top by the closing means  115 . 
         [0062]    Once object  410  is captured in stage  320 , method  300  may continue to stage  330  where object  410  may be physically fragmented.  FIG. 12  illustrates an embodiment of object fragmentation. For example, a laser  1205  or other device (e.g., a lithotripter) for kidney stone ablation (e.g., electrohydraulic, pneumatic, ultrasonic devices) may be inserted through sheath  105  of apparatus  100 . The lithotripter may protrude into mesh top  110  at a location approximately adjacent to object  410 . In turn, fragmentation may be initiated within mesh top  110  or, in other words, in a controlled fragmentation zone. 
         [0063]    Having fragmentation occur in a controlled fragmentation zone has plurality of advantages. For instance, the fragments may all be contained within mesh top  410 , thereby eliminating the need to repeat the navigation and capture process for stone fragments. Additional advantages are listed below. 
         [0064]    After object  410  is fragmented in stage  330 , method  300  may proceed to stage  340  where the apparatus and stone pieces may be removed. Fragments, may more easily pass through the subject&#39;s channel (e.g., urethra) upon the withdrawal of apparatus  100  from the channel. Furthermore, withdrawal of apparatus  100  may create a friction between the subject&#39;s channel and mesh top  100 . In some embodiments of the present disclosure, the friction may cause an extension of mesh top  110  which, in turn, due to mesh top  100 &#39;s braided fabric design, cause a tightening (or decrease of inner diameter) of mesh top  100 &#39;s grasp of object fragments.  FIG. 13  illustrates the removal of the smaller, more manageable pieces of object  410 . Once the apparatus and object fragments are removed in stage  340 , method  300  may then end at stage  350 . 
       IV. Advantages 
       [0065]    Apparatus  100  is may be easily incorporated into current procedures. For example, the stages illustrated by method  300  (some of which are undertaken to currently perform a ureteroscopy procedure) may remain substantially the same (with exception to, at least, the enclosure of object  410  within mesh top  110  prior to fragmentation. In this way, apparatus  100  may make a large impact with very little disturbance to the performance of conventional ureteroscopy procedures. 
         [0066]    Additional advances of the various embodiments disclosed herein include, but are not limited to, for example:
       Apparatus  100  may be embodied in a disposable design,   Apparatus  100  may not be dependent on basket, scope or lithotripter type, although it may be compatible with a variety of device types,   Does not require a kidney wall to trap the stone (stone may be trapped within mesh top  110 ),   Mesh top  110  may be attached directly to/integrated with sheath  105 .       
 
         [0071]    This is more practical because a practicing physician (e.g., apparatus  100 &#39;s user) may not face a large learning curve as they may simply replace their existing sheath&#39;s with apparatus  100 ,
       Since mesh top  110  encloses stones prior to fragmentation, a sweeping through the kidney may not be needed to recover stone fragments,   Apparatus  100  may work throughout the urinary system and not limited to the kidney, and   Apparatus  100  does not require ablation against the kidney walls.       
 
       V. Claims 
       [0075]    While the specification includes examples, the disclosure&#39;s scope is indicated by the following claims. Furthermore, while the specification has been described in language specific to structural features and/or methodological acts, the claims are not limited to the features or acts described above. Rather, the specific features and acts described above are disclosed as example for embodiments of the disclosure. 
         [0076]    Insofar as the description above and the accompanying drawing disclose any additional subject matter that is not within the scope of the claims below, the disclosures are not dedicated to the public and the right to file one or more applications to claims such additional disclosures is reserved. 
         [0077]    Although very narrow claims are presented herein, it should be recognized the scope of this disclosure is much broader than presented by the claims. It is intended that broader claims will be submitted in an application that claims the benefit of priority from this application.