Abstract:
In accordance with exemplary embodiments of the present disclosure, device and method can be provided which can facilitate imaging of biological tissues, e.g., luminal organs in vivo, using optical techniques. The exemplary device can include different designs an features of one or more catheters, which can illuminate the tissues, and collect signals from the inside of the lumen. In another exemplary embodiment according to the present disclosure, a balloon-catheter can be provided with the flexible neck, which can absorb most of the bending. According to still another exemplary embodiments of the present disclosure, a balloon-catheter tethered capsule can be provided, and according a yet further exemplary embodiment, a structured balloon design can be provided with one or more protuberances, thus enabling imaging of the structures in close contact, e.g., without compressing of the tissue.

Description:
FIELD OF THE DISCLOSURE 
       [0001]    The present disclosure relates generally to apparatus and method for imaging at least one portion of a structure which is provided at or in one or more luminal organs. 
       BACKGROUND OF THE DISCLOSURE 
       [0002]    An optical imaging device has become an important tool to assess and diagnose diseases arising from luminal organs. Imaging methods/procedures including optical coherence tomography (OCT) and optical frequency domain imaging (OFDI) are two exemplary gastrointestinal tissue imaging methods. Other exemplary methods/procedures include confocal microscopy and spectrally-encoded confocal microscopy (SECM). OCT and OFDI procedures can acquire back-scattered light that comes from the refractive index mismatch of cellular and sub-cellular components, thereby facilitating the generation of images of at least one tissue microstructure in vivo. Comprehensive imaging, achieved by the helical pullback scanning of the imaging optics, can facilitate such microscopic imaging information to be obtained from entire sections of one or more luminal organs. Based on this microstructural information, diseases from the luminal organs, such as esophagus, colon, vessels, ducts, and so on, can be identified and detected in the early stages. 
         [0003]    Optical tomography methods/procedures, including OCT and OFDI, can have a limited imaging depth range, e.g., from a few hundred micrometers to several millimeters. To obtain sufficient image contrast and resolution, the tissue should be located within the optical imaging range. In case of many luminal organs, which can have relatively large diameter (e.g., 5-8 cm for human colon, 2.5 cm for human esophagus, etc.), one preferable way to obtain images of the entire organ can be a centration of the imaging probe within the lumen. 
         [0004]    One possibility for such centration can be to utilize a balloon catheter. After the placement of the catheter, the balloon can be inflated, thus resulting in the centration of the imaging optics. This procedure facilitates the imaging catheter to obtain the images from the entire epithelial tissues of the luminal organs. Since balloon can be inflated and deflated, and the balloon-catheter can be used as a standalone device or with the endoscope through the accessory channel. 
         [0005]    However, the luminal organs can have complex structures thus causing the bending of the catheter and the decentering of the optical probe. This can cause the suboptimal imaging of the luminal organs. Some areas of the luminal organ may not be appropriately imaged when the decentering is greater than the imaging probe&#39;s imaging depth. Furthermore, due to the movement by the patient, which include breathing and heart beating, the bending issues and the associated decentering can occur frequently in a clinical setting, thus causing incomplete image acquisition. 
         [0006]    Currently, a placement of the OFDI balloon catheter utilizes a sedated upper endoscopy procedure. Unfortunately, upper endoscopy can be a costly procedure. An important contributor to the high cost of endoscopy is the preference of sedation, which can force the procedure to be conducted in a specialized environment, with continuous cardiopulmonary monitoring and nursing support. Patient cost can be an additional factor, as sedation results in prolonged recovery times and loss of productivity. 
         [0007]    In general when passing a catheter, transnasal access can be better tolerated than the transoral approach because of a more vigorous gag reflex encountered in unsedated transoral procedures. Standard transnasal procedures, such as nasogastric tube (NG tube) insertion, can be conducted in millions of patients annually, with few (if any) major complications. Unsedated, transnasal balloon dilation can be conducted in the outpatient setting, without complication, and is well tolerated. (See Rees CJ, “In-office unsedated transnasal balloon dilation of the esophagus and trachea. Current opinion in otolaryngology &amp; head and neck surgery”, 2007; 15(6):401-4). Because the diameter of the balloon catheter is small enough to be threaded into the standard nasogastric tube, it can be also used for esophagus imaging procedures, without sedation. 
         [0008]    Another form of the OFDI catheter facilitating unsedated procedure is a capsule that can be swallowed. The endoscopic capsule endoscopy (ECE) can be easier to administer than transnasal endoscopy and, since swallowing a capsule is familiar to patients, and it can be better tolerated than transnasal procedures. Conventional capsule endoscopy procedures likely have a lack of control of the capsule at the GEJ, however, thus possibly resulting in few viable images obtained at the critical region of the esophagus. Due to the decreased diagnostic accuracy and the high cost of the single-use, disposable capsule (e.g., about $450), the cost-effectiveness analyses for BE screening with capsule endoscopy have not demonstrated a benefit over conventional endoscopy. Another procedure, i.e., string capsule endoscopy (SCE) can be used, and which tethers the capsule with a string to enable strict control of the pill camera&#39;s location and repeated visualization of the GEJ. (See Weston AP, “String capsule endoscopy: a viable method for screening for Barrett&#39;s esophagus”, Gastrointestinal endoscopy. 2008; 68(1):32-4). A recent study in 100 patients with SCE showed that this technique is well tolerated and has a comparable diagnostic performance to that of upper endoscopy. For example, the SCE capsules can be retrieved, sterilized, and reused, thereby significantly decreasing the cost of the capsule endoscopy. Nonetheless, the SCE procedures are likely subject to the same diagnostic accuracy limitations as endoscopy, however. 
         [0009]    An important characteristic of balloon catheters is the influence of the balloon on the tissue. In general, the centration balloon compresses imaged tissue, which can influence the diagnostic accuracy. The diagnostic process/procedure can be based on the structural differences that are characteristic for healthy and diseased tissues. Surface topology can be helpful in the analysis of the results, e.g., finger like projection in the epithelium is a typical feature for Barrett&#39;s esophagus. Additionally, a validation of the OFDI catheter imaging method/procedure can be performed by comparing the biopsy taken from the imaged region. It may be difficult to mimic exactly the same pressure conditions for the histology specimens. 
         [0010]    Thus, it may be beneficial to address and/or overcome at least some of the deficiencies of the prior approaches, procedures and/or systems that have been described herein above. 
       OBJECTS AND SUMMARY OF EXEMPLARY EMBODIMENTS 
       [0011]    t is therefore one of the objects of the present disclosure to reduce or address the deficiencies and/or limitations of such prior art approaches, procedures, methods, systems, apparatus and computer-accessible medium. 
         [0012]    For example, one object of the present disclosure is to provide an exemplary microscopic imaging device according to an exemplary embodiment for approximately centering an imaging probe within a luminal organ to enable comprehensive microscopy of the majority of the luminal organ. A further object of the present disclosure is to provide a device which can be configured to perform luminal organ microscopy that can operate in standalone mode, thus at least partially obviating the need for conscious sedation. Another object of the present disclosure is to utilize one or more in vivo microscopy technologies through one or more tethered capsule. It is yet object of the present disclosure to provide a balloon catheter that centers the optics while exerting a minimal effect of tissue surface topology for a substantial portion of a microscopic image dataset. 
         [0013]    In accordance with exemplary embodiments of the present disclosure, device and method can be provided which can facilitate imaging of biological tissues, e.g., luminal organs in vivo, using optical techniques. The exemplary device can include different designs an features of one or more catheters, which can illuminate the tissues, and collect signals from the inside of the lumen. In another exemplary embodiment according to the present disclosure, a balloon-catheter can be provided can with the flexible neck, which can absorb most of the bending. According to still another exemplary embodiments of the present disclosure, a balloon-catheter tethered capsule can be provided, and according a still further exemplary embodiment, a structured balloon design can be provided with one or more protuberances, thus enabling imaging of the structures in close contact, e.g., without compressing of the tissue. 
         [0014]    Thus, according to one exemplary embodiment of the present disclosure, apparatus and method can be provided for obtaining data for at least one portion within at least one luminal or hollow sample. For example, using a first optical arrangement, it is possible to transceive at least one electromagnetic radiation to and from the at least one portion. In addition, it is possible to use a second arrangement (which at least partially encloses the first arrangement), that includes at least one section which is more flexible than a neighboring portion thereof. Further, it is possible to actuate a third arrangement so as to position the first arrangement at a predetermined location within the at least one luminal or hollow sample. The third arrangement can include a balloon arrangement, a basket arrangement, and/or a further arrangement which extends from the second arrangement. 
         [0015]    The apparatus can be structured and sized to be insertable via a mouth and/or a nose of a patient. The first arrangement can include at least one cylindrical surface and/or at least one ellipsoidal ball lens which is/are configured to compensate for the at least one aberration. The third arrangement can include a balloon of the balloon arrangement, and the balloon can finable with a gas and/or a liquid. The second arrangement can include at least one portion which facilitates a guiding arrangement to be inserted there through. Further, using a further arrangement, it is possible to measure a pressure within the portion (s). The data can include a position and/or an orientation of the first arrangement with respect to the luminal or hollow sample(s). The electromagnetic radiation(s) can be provided at one or more wavelengths in a visible range. 
         [0016]    According to another exemplary embodiment of the present disclosure, the first arrangement can include a section which directs the electromagnetic radiation(s) toward the portion(s), and obtains the data. The apparatus can be configured and sized to be swallowed. The first optical arrangement can be used to transceive at least one first electromagnetic radiation to and from the portion(s), and transmit at least one second electromagnetic radiation so as to ablate, thermally damage or produce a structural change of or in the portion(s). It is also possible to provide a further arrangement that can at least partially enclose the second arrangement, and capable of extending to a position spatially outside a periphery of the section of the first arrangement. 
         [0017]    In still other exemplary embodiments of the present disclosure, it is possible to use a still further apparatus to receive and record the data and a position and a rotational angle of the first arrangement with respect to the sample(s). Such still further arrangement can include a scanning arrangement, and can detects the position and the rotation angle by digital counting of encoder signals obtained from the scanning arrangement during at least one scan of the sample(s). Further, with an additional arrangement, it is possible to receive the position and the rotational angle, and generate at least one image associated with the portion(s) using the position and the rotational angle. With the additional arrangement, it is also possible to correct at least one spatial distortion of the image(s). 
         [0018]    According to a further exemplary embodiment of the present disclosure, a processing arrangement can be provided which is capable of being controlled to receive a plurality of images of the sample(s) during at least two axial translations of the first arrangement with respect to the sample(s), where each of the axial translations can be provide at a rotational angle. The data can be interferometric data associated with the sample(s), which can be spectral-domain optical coherence tomography data and/or optical frequency domain imaging data. At least one portion of the apparatus can be coated with an anesthetic substance. 
         [0019]    In yet further exemplary embodiment of the present disclosure, apparatus and method can be provided for obtaining data for at least one portion within at least one luminal or hollow sample. For example, using an optical first arrangement, it is possible to transceive at least one electromagnetic radiation to and from the portion(s). In addition, it is possible to use a second arrangement which is configured to be actuated so as to position the first arrangement at a predetermined location within the luminal or hollow sample(s). At least one portion of the apparatus can have a shape of a pill, and, when actuated, a size of the second arrangement can be changed. 
         [0020]    It is also possible to provide a third arrangement that at least partially encloses the first arrangement, and includes at least one portion which is more flexible than a neighboring portion thereof. At least one portion of the apparatus can be coated with an anesthetic substance. The second arrangement can include a balloon and/or a basket. Another arrangement can be provided that fully encloses the first arrangement, and includes at least one portion which is more flexible than a neighboring portion thereof. The apparatus can be structured and sized to be insertable via a mouth and/or a nose of a patient. A processing arrangement can be provided which is capable of being controlled to receive a plurality of images of the sample(s) during at least two axial translations of the first arrangement with respect to the at least one sample, where each of the axial translations is provide at a rotational angle. The data can be interferometric data associated with the sample(s), which can be spectral-domain optical coherence tomography data and/or optical frequency domain imaging data. The entire apparatus can be coated with an anesthetic substance. 
         [0021]    According to yet another exemplary embodiment of the present disclosure, an apparatus can provide at least one electro-magnetic radiation to and/or from at least one portion within at least one luminal or hollow sample. The exemplary apparatus can include an optical first arrangement which can receive and/or transmit the electromagnetic radiation(s) to and/or from the portion(s). In addition, a balloon second arrangement can be provided which at least partially encloses the first arrangement, and comprises at least one area which includes (i) one or more nubs, (ii) one or more ridges), and/or (ii) one or more protuberances. For example, at least one section of the second arrangement can be configured or structured to allow the radiation(s) to be transmitted therethrough. 
         [0022]    The section(s) can be provided away from the at least one area, which can be configured or structured to allow the radiation(s) to be transmitted therethrough, or prevent the radiation(s) from being transmitted therethrough. A third arrangement can be provided which is configured to receive the electro-magnetic radiation(s) from the portion(s), and generate image data as a function of the received electro-magnetic radiation(s). The third arrangement can be (i) a photoacoustic arrangement, (ii) a fluorescence arrangement, (iii) an optical spectroscopy arrangement, (iv) a laser speckle imaging arrangement, (v) an optical tomography arrangement, (vi) an ultrasound arrangement, and/or (vii) an arrangement which is configured to cause a change in the portion(s). The image data can be based on spectral-domain optical coherence tomography data and/or optical frequency domain imaging data. 
         [0023]    In yet further exemplary embodiment of the present disclosure, an apparatus can be provided for determining at least one characteristic of at least one portion of an internal anatomical structure. The apparatus can include a pill arrangement configured to transmit and/or receive an electromagnetic radiation to and/or from the structure therethrough, and configured to be swallowed. The apparatus can also include a tethering arrangement associated with the pill arrangement, and extending from the pill arrangement to an outer portion of the body when swallowed. The tethering arrangement can be configured to transmit and/or receive signals associated with (i) (a) the electro-magnetic radiation, information associated with a mechanical motion of the structure or information regarding a torque of the apparatus, and (b) an electrical signal, (ii) air provided thereto, or (iii) fluid provided therethrough. 
         [0024]    For example, a further arrangement can be provided which is configured to receive the electro-magnetic radiation(s) from the portion(s), and generate image data as a function of the received electro-magnetic radiation(s). The third arrangement can be (i) a photoacoustic arrangement, (ii) a fluorescence arrangement, (iii) an optical spectroscopy arrangement, (iv) a laser speckle imaging arrangement, (v) an optical tomography arrangement, (vi) an ultrasound arrangement, and/or (vii) an arrangement which is configured to cause a change in the portion(s). The image data can be based on spectral-domain optical coherence tomography data and/or optical frequency domain imaging data. The signals received and/or provided by the tethering arrangement are optical signals and/or electrical signals. 
         [0025]    These and other objects, features and advantages of the exemplary embodiments of the present disclosure will become apparent upon reading the following detailed description of the exemplary embodiments of the present disclosure, when taken in conjunction with the appended claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    Further objects, features and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments of the present disclosure, in which: 
           [0027]      FIG. 1  is a diagram of an exemplary embodiment of a OFDI imaging using a catheter according to the present disclosure; 
           [0028]      FIG. 2(   a ) is a diagram of a balloon catheter with the flexible neck during a transnasal placement, according to another exemplary embodiment of the present disclosure; 
           [0029]      FIG. 2(   b ) is a diagram of the balloon catheter with the flexible neck of  FIG. 2(   a ) during imaging; 
           [0030]      FIG. 3(   a ) is a diagram of a bended balloon catheter with a flexible neck, according to still another exemplary embodiment of the present disclosure; 
           [0031]      FIG. 3(   b ) is a diagram of a bended balloon catheter without a flexible neck, according to a further exemplary embodiment of the present disclosure; 
           [0032]      FIG. 4(   a ) is a diagram of a balloon-catheter with a tethered capsule device during a placement thereof, according to still further exemplary embodiment of the present disclosure; 
           [0033]      FIG. 4(   b ) is a diagram of the balloon-catheter with the tethered capsule device of  FIG. 4(   a ) during imaging; 
           [0034]      FIG. 5(   a ) is a diagram of a structural balloon designs with spherical protuberance(s), according to still another exemplary embodiment of the present disclosure; and 
           [0035]      FIG. 5(   b ) is a diagram of the structural balloon designs with ring protuberance(s), according to a further exemplary embodiment of the present disclosure. 
       
    
    
       [0036]    Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the subject disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described exemplary embodiments without departing from the true scope and spirit of the subject disclosure as defined by the appended claims. 
       DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0037]    A diagram of an exemplary embodiment of optical imaging catheter system/apparatus according to the present disclosure is shown in  FIG. 1 . This exemplary apparatus can include a microstructural imaging system  110 , a single mode optical fiber  115 , a marking laser for guided biopsy or tissue treatment  120 , a rotary junction  130 , an optical imaging catheter  140 , a data acquisition system  160  and a data processing and storage arrangement  170  (which include one or more computers and one or more data storage devices). The exemplary microstructural imaging system (e.g., system utilizing at least one of optical frequency domain imaging, optical coherence tomography, etc. modalities)  110  can detect a back-reflected light (or other electro-magnetic radiation) from one or more portions of an anatomical structure, such as the tissue  180 , to acquire signals and/or information regarding the tissue microstructures. 
         [0038]    For example, the optical signals and/or data from both the microstructural imaging modality and the marking/treatment laser platform are coupled into the single mode fiber  115  that can be connected to the rotary junction  130 . The rotary junction  130  can serve as the interface between the stationary imaging systems to the optical imaging catheter  140 , which can be rotating and/or translating. The imaging probe  150  can be rotated and translated for a helical scanning inside the catheter  140 . The optical imaging probe  150  can focus the optical imaging beam  155  onto the tissue  180 . Returning light signals (or signals associated with the electro-magnetic radiation) from the tissue  180  can be detected by the microstructural imaging system  110 . The signals can be acquired by the data acquisition system  160 . The data processing and storage arrangement/apparatus  170  can store and/or process the data which is based on the received signals, e.g., in a real-time, for an appropriate proper operation, and subsequent possible visualization and analysis. 
         [0039]      FIG. 2(   a ) is a diagram of a balloon catheter apparatus with the flexible neck during a transnasal placement, according to another exemplary embodiment of the present disclosure. The exemplary apparatus can comprise a long, small diameter drive-shaft  150  within a flexible protective sheath  210 . At the distal end of the catheter/apparatus, a positioning balloon  250  can be placed, which can center the optical probe within esophagus. The air for inflating of the balloon  250  can be delivered through an outer sheath  220 . The length of an imaging window of the inflated balloon, as shown in  FIG. 2(   b ), can define the length of the tissue scanned during imaging. The outer sheath  220  can be connected to the balloon  250  by a short segment of an additional flexible sheath, which can be called a flexible neck  230 . The flexible neck  230  can be also introduced and/or provided in a proximal end of the balloon  250 , e.g., in the inner protective sheath  210 . 
         [0040]    As shown at  FIG. 3(   a ), one role of the flexible neck  230  can be to absorb some, most or even all of the bending of the catheter/apparatus. Without the flexible neck  230 , e.g., the imaging part of the inner protective sheath  210  inside the balloon  250  would likely bends. Due to the complexity of the luminal organs and patient movement, the bending of the catheter/apparatus can occur often in clinical practice. Such bending may cause a decentration of the optical probe, and provide suboptimal imaging of the luminal organs with lower image contrast and resolution. 
         [0041]    A small diameter of the balloon catheter with flexible neck can facilitate its use and implementation for imaging of human esophagus, e.g., without sedation. For this purpose, the exemplary catheter can, in another exemplary embodiment of the present disclosure, be introduce through the nose. In order accomplish this mode of delivery of the exemplary device/apparatus, the exemplary catheter can be enclosed in an additional outer tube  240 , as shown in  FIG. 2(   b ). The exemplary outer tube  240  can be dimensionally and mechanically similar and/or identical to a standard nasogastric NG (feeding) tube. The deflated balloon-catheter can be enclosed in the outer tube  240 , and advanced to the stomach, e.g., using standard NG tube placement techniques. Following a confirmation that the exemplary device is in the stomach, the exemplary outer tube  240  can be withdrawn. After the retraction of the outer tube  240 , e.g., for 6-7 cm, the balloon  250  can be exposed and inflated, as shown at  FIG. 2(   b ). Following the imaging procedure, the balloon  250  can be deflated, the exemplary catheter withdrawn into the tube  240 , and the entire device can be removed from the patient. 
         [0042]      FIG. 4(   a ) shows a diagram of a balloon-catheter tethered capsule device during placing inside patient, according to a further exemplary embodiment of the present disclosure. In such exemplary embodiment, the tether can comprise the long, small diameter driveshaft  150  within the flexible sheath  210 . In another exemplary embodiment, the tether can be a thin flexible tube that can contain a wire for transceiving electrical signals, an optical fiber for transceiving optical signals, and/or a hollow conduit for transmitting gas (i.e. air) or fluid (i.e. water). For example, as shown in  FIG. 4(   a ), a pressure sensing fiber  460  can be contained within or immediately adjacent to the sheath  210 . The sheath  210  can be terminated by a transparent, folded balloon  430  that can extend over a length of 3.0 cm in its uninflated state and can reside within rigid end-caps  420  to provide structure to the capsule. The entire device can be encapsulated within a custom-fit, transparent and highly elastic silicone rubber outer sheath  410 . The silicone balloon  410  can keep the capsule portion smooth during swallowing and the imaging balloon can impart a stability when it is fully inflated to an inflated state  450  for imaging at the GEJ, as shown at  FIG. 4(   b ). An elastic centering wire  440 , which can be fixed to the distal end cap and configured to freely translate within the distal lumen of the driveshaft, facilitates the centering of the drive-shaft in the balloon  410 . Such exemplary design can ease the manufacturing of the balloons, reduce or eliminate the astigmatism caused by an inner sheath, and facilitate the folded balloon  410  to expand to 6 cm when inflated. An optical pressure sensor  470  can be incorporated into the proximal end cap, and utilized by the exemplary apparatus. 
         [0043]    The tethered OFDI capsule can be swallowed while the patient is drinking a fluid, e.g., water. The exemplary capsule can travel to the stomach by peristalsis. After the capsule enters the stomach, the operator can pull up on the tether until resistance is perceived. At this point, the patient can swallow the exemplary capsule, and the capsule can be moved to the LES, e.g., guided by serial pressure measurements. When at the LES, the balloon  430  can be fully inflated to its inflated state  450 , which can facilitate the expansion of the silicone rubber sheath  410 . An helical OFDI procedure can then be conducted over the capsule&#39;s entire imaging window. After imaging, the balloon  430  can be deflated, and the capsule can return to its initial state, this allowing the capsule to be removed from the patient by reeling in the tether. Because the silicon rubber  410  encapsulates the entire tethered capsule device, the capsule and the tether can be sterilized and reused, thus possibly further reduce the costs. 
         [0044]      FIG. 5(   a ) shows a structured balloon  500  with the one or more spherical protuberances  510  according to yet another exemplary embodiment of the present disclosure. This exemplary balloon  500  can facilitate an elevation of the tissue in respect to the circumference of the balloon  500  used for imaging. The same or similar effect can be achieved by placing one or more rings  520  over the balloon surface  500 , as shown at  FIG. 5(   b ). In one further exemplary embodiment of the present disclosure, the number of protuberances can be minimized or reduced, to increase and/or maximize the imaging surface of the balloon. In yet another exemplary embodiment of the present disclosure, the protuberances should keep the balloon elevated over the tissue. As a result, the tissue surface will not be compressed by the surface of the balloon, thus possibly resulting in improvement of the visualization of the luminal tissue surface topology. The electro-magnetic radiation and/or light can be provided through the balloon  500 . In one exemplary embodiment, the electro-magnetic radiation or light can be prevented from being passed through one or more of the protuberances  510  and/or one or more of the rings  520 . According to another exemplary embodiment, the electro-magnetic radiation or light can also pass through one or more of the protuberances  510  and/or one or more of the rings  520 . 
         [0045]    The foregoing merely illustrates the principles of the disclosure. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. Indeed, the arrangements, systems and methods according to the exemplary embodiments of the present disclosure can be used with and/or implement any OCT system, OFDI system, SD-OCT system or other imaging systems, and for example with those described in International Patent Application PCT/US2004/029148, filed Sep. 8, 2004 which published as International Patent Publication No. WO 2005/047813 on May 26, 2005, U.S. patent application Ser. No. 11/266,779, filed Nov. 2, 2005 which published as U.S. Patent Publication No. 2006/0093276 on May 4, 2006, and U.S. patent application Ser. No. 10/501,276, filed Jul. 9, 2004 which published as U.S. Patent Publication No. 2005/0018201 on Jan. 27, 2005, and U.S. Patent Publication No. 2002/0122246, published on May 9, 2002, the disclosures of which are incorporated by reference herein in their entireties. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the disclosure and are thus within the spirit and scope of the present disclosure. Further, the exemplary embodiments described herein can operate together with one another and interchangeably therewith. In addition, to the extent that the prior art knowledge has not been explicitly incorporated by reference herein above, it is explicitly being incorporated herein in its entirety. All publications referenced herein above are incorporated herein by reference in their entireties.