Abstract:
A thoracic catheter system comprises a flexible thoracic catheter for inserting into a thoracic cavity of a human. A distal end of the thoracic catheter has a plurality of apertures. A proximate end of the thoracic catheter is designed to extend out of the thoracic cavity. A three way valve is one of fused with and removablely attached to the proximal end of the thoracic catheter.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Patent Application No. 62/072,075 filed Oct. 29, 2014, the contents of which are incorporated herein by reference in its entirety. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       FIELD OF THE INVENTION 
       [0003]    The present invention generally relates to thoracic catheters. The present invention further relates to medical imaging, drug delivery, and fluid control devices. 
       BACKGROUND OF THE INVENTION 
       [0004]    The use of thoracic catheters (also referred to as a chest drain, chest tube, intercostal drain, tube and tube thoracostomy) is widely known, and became popular after the widespread use during the World War II and the Korean War. A thoracic catheter is known as a flexible/semi-flexible tube which is inserted into the chest cavity (pleural and/or pericardial space) and is used to remove/evacuate air (pneumothorax) or fluids (blood, effusion, chyle or pus) from such cavities. 
         [0005]    Common indications for thoracic catheter insertions include but are not limited to presence of pneumothorax, tension pneumothorax, large pleural effusions, chylothorax, hemothorax, and empyema. Thoracic catheters are frequently used in the postoperative setting following a thoracotomy, esophagectomy, video-assisted thoracoscopy surgery (“VATS”) and cardiac surgeries. Once the thoracic catheter or chest tube is in place, it is sutured or otherwise attached to the skin to prevent movement. The chest tube is then connected to the drainage container (e.g., a canister) using additional tubing and connectors. The canister may also be connected to a suction source (e.g., negative 20 cm of water pressure) or it may be left on a water seal. 
         [0006]    Drainage of the pleural space by means of a thoracic catheter is the most common intervention in thoracic trauma, and there are more than one million thoracic catheters that are placed annually in the United States. 
         [0007]    Despite the fact that thoracic catheters are used quite commonly worldwide, an ideal functioning design for the device has proven thus far stubbornly elusive, regardless of the significant market forces motivating such an improvement. The most frequent complication associated with a thoracic catheter is clogging or blockage of the catheter lumen by thrombus formation or debris that is inside the catheter lumen. This clogging can cause major subsequent complications and non-functioning or malfunctioning of the tube. The presence of a clot inside the catheter lumen can also cause stasis of the drainage, cause infections and/or deterioration of infections (e.g., in cases with empyema). One prospective study reported a thirty-six percent rate of clogging and non-functioning of the thoracic catheter in patients undergoing cardiac surgeries. [J. R. Karimov, et al. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study.  Eur. J. Cardiothorac. Surg.  44(6):1029-36 (2013).] This complication was reported to be more common in urgent procedures and/or reoperations and in cases with increased intra-operative blood transfusions. Such clogging was also associated with a higher risk of atrial fibrillation development in the patient, which could potentially be a lethal complication. Interestingly, more than eighty percent of the clogging in the thoracic catheter was found to be in the internal portion of the tube (i.e., the non-visible or intra-thoracic portion that is inside the patient&#39;s chest cavity), which makes the diagnosis of this complication by bedside visualization and or inspection very difficult or impossible. 
         [0008]    Due to the same reason, management of this complication can be complex and challenging. The thoracic catheter can become clogged at any time after its placement, and it is known that clinicians generally underestimate the prevalence of this failure to drain. Clogging of the tube can even become life threatening in cases where bleeding in the chest goes undiagnosed due to lack of drainage. When a thoracic catheter clogs, it can cause accumulation of blood around the heart (pericardial tamponade) and the lungs (hemothorax). In case of the pneumothorax, blockage in the thoracic catheter can cause tension pneumothorax, which is life threatening. 
         [0009]    In a survey which included North American cardiothoracic surgeons and specialty cardiac surgery nurses, 100% of the responders confirmed that they have had problems with thoracic catheters getting clogged and (87%) reported adverse patient outcomes from a clogged tube. [S. Shalli, et al. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management.  J. Card. Surg.  24(5):503-9 (2009).] More than 50% of the participants confirmed that they are not satisfied with currently available chest tubes and procedures to avoid chest tube occlusion. Some of the responders even mentioned that they forbid the current technique for unclogging thoracic catheters, namely the stripping, tapping, and/or squeezing maneuver, for fear of causing more bleeding by the negative pressures generated. In addition, the survey respondents noted that patients experience increasing discomfort with increasing drain size and did not think that increasing the size of the thoracic catheters was a good strategy to prevent clogging of the tubes. The conclusion of the survey highlighted the frequent clogging problems with current postsurgical chest drainage systems and observed a pressing need for new and innovative solutions to prevent clogging complications and to address clinician concern and patient pain. 
         [0010]    Another challenge with the current thoracic drainage system is when a patient who already has a thoracic catheter in place requires a video-assisted thoracoscopic surgery (“VATS”) procedure. For the VATS operation, in the current practice, the surgeon is taught to make additional incisions (“port sites”) and insert ports, which are used for entry of a camera and instruments. The inventors noted that a single incision VATS, which would spare the patient from having extra incisions and/or port insertions while undergoing VATS would be ideal, as it would decrease postoperative pain and result in a higher patient satisfaction compared with the conventional three-port VATS. The inventors also realized that a thoracic catheter should be designed that could also function as the lone port for a single incision VATS, which would spare the patient even from a single extra port. Outside experts in the field of thoracic catheters have expressed skepticism of single incision VATS due to current technological limitations. 
         [0011]    As the above description clearly shows, there is a long felt and unresolved need for a better designed thoracic catheter, including methods and devices to help detect and/or prevent blockages in such catheters and providing the capability to use such catheters as port site when performing VATS procedures. 
       SUMMARY OF THE INVENTION 
       [0012]    Wherefore, it is an object of the present invention to overcome the above mentioned shortcomings and drawbacks associated with the prior art. 
         [0013]    Another object of the present invention is to provide a thoracic catheter comprising a disposable flexible or semi-flexible tube with a plurality of side holes disposed on a distal end. A three way valve is preferably fused and/or removably attached to a proximate end of the catheter. The distal end of the tube is inserted into the chest (thoracic) cavity to, inter alia, evacuate fluid and/or air, sample tissue, or act as a port in video assisted thoracoscopy surgery. 
         [0014]    A further object of the present invention is to provide a thoracic catheter device that may also be used as a drug delivery device for anticoagulants, antibiotics, and chemotherapeutics, as a delivery device for contrast for medical imaging, for a plethora of existing interventional radiology procedures that utilize thoracic catheters or access to the thoracic cavity, for pleurodesis, for access to the mediastinum as an alternative approach for mediastinoscopy, and as a port of entry video-assisted thoracoscopy surgery. 
         [0015]    Among the many advantages of the disclosed novel design is the ability to directly visualize a clot or an impedance to flow in a thoracic catheter, which as described above, is a common, recognized, and unresolved problem with the day-to-day management in patients with thoracic catheters. With the disclosed device, a physician can directly visualize any blockage and intervene through irrigation and suction. Additionally, as noted above, this device could act as an entry port for video assisted thoracoscopy surgery. Standard video-assisted thoracoscopy surgery requires three or more ports. This single port option would dramatically decrease patient discomfort and medical and surgical complications. 
         [0016]    Additionally, a novel method and device for clearing the catheter of blockage is envisioned. A clearing component of known length is inserted into the catheter to scrape the interior walls of the catheter or otherwise clear the catheter of blockage, preferably with a slight to moderate concurrent negative pressure applied. The head of the clearing component may be, for example, bristle, screw, and/or rotary blade shaped, and will preferably rotate as it is inserted into the catheter. The head will be connected and supported by a flexible linear support body. In a preferred embodiment, the screw or cutting angled component head will preferably, as it rotates, pull the blockage in a direction towards the proximate end of the catheter upon encountering the blockage, whereby the negative pressure will also aid in moving the blockage and any debris out of the catheter and away from the patient. Additionally or alternatively, the head of the cleaning component could have an extendable clasp that grabs hold of the blockage and allows the blockage to be pulled or pulled and/or suctioned out. 
         [0017]    The present invention also relates to a thoracic catheter device comprising a distal end with a plurality of holes, with the distal end being designed to be inserted into a human body, and a proximate end remaining exterior to the human body. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate various embodiments of the invention and together with the general description of the invention given above and the detailed description of the drawings given below, serve to explain the principles of the invention. It is to be appreciated that the accompanying drawings are not necessarily to scale since the emphasis is instead placed on illustrating the principles of the invention. The invention will now be described, by way of example, with reference to the accompanying drawings in which: 
           [0019]      FIG. 1  is a schematic drawing of the thoracic catheter system of the disclosed invention with a distal end of a thoracic catheter inserted into the chest cavity of a patient and a proximate end connected to a suction canister; 
           [0020]      FIG. 2  is a schematic drawing of a second embodiment of the thoracic catheter system including a three way valve; 
           [0021]      FIG. 3  is a schematic drawing of the thoracic catheter system according to 
           [0022]      FIG. 1 , connected to the three way valve similar two  FIG. 2 , further including a thoracoscopy device and further connection to wall suction; 
           [0023]      FIG. 4  is a schematic drawing of the system in  FIG. 3 , wherein the thoracoscopy device is inserted in and through the three way valve and through the thoracic catheter and extends out a terminal hole in the distal end of the thoracic catheter into the thoracic cavity of the patient; 
           [0024]      FIG. 5  is a partial see-through diagrammatic front view of the three way valve of  FIGS. 3 and 4 ; 
           [0025]      FIG. 6  is an exploded view of the three way valve of  FIG. 5  in a first stable open position where all three external ports on the outer collar are aligned with a respective through hole in the hollow body; 
           [0026]      FIG. 7  is an exploded view of the three way valve of  FIG. 5  in a first stable closed position, 45 degrees from the first stable open position, where all three external ports on the outer collar are closed off from all of three through holes in the hollow body; 
           [0027]      FIG. 8  is an exploded view of the three way valve of  FIGS. 3 and 4  in a second stable open position, 90 degrees from the first stable open position, where the front and the right side through holes in the hollow body, with respect to the figure, are aligned with a respective external port on the outer collar, and the left side through hole in the hollow body, with respect to the figure, is aligned with a solid surface of the collar, and thus fluidly closed, and a third external port is aligned with a solid surface of the back of the hollow body, with respect to the figure, and thus fluidly closed; 
           [0028]      FIG. 9  is an exploded view of the three way valve of  FIG. 5  in a second stable closed position, 90 degrees from the first stable closed position and 45 degrees from the second stable open position, where all there external ports on the outer collar are closed off from all of the through holes in the hollow body; 
           [0029]      FIG. 10  is an exploded view of the three way valve of  FIG. 5  in a third stable open position, 90 degrees from the second stable open position, where the left side and the right side through holes in the hollow body, with respect to the figure, are aligned with a respective external port on the outer collar, and the front through hole in the hollow body, with respect to the figure, is aligned with a solid surface of the collar, and thus fluidly closed, and a third external port is aligned with a solid surface of the back of the hollow body, with respect to the figure, and thus fluidly closed; 
           [0030]      FIG. 11  is an exploded view of the three way valve of  FIG. 5  in a third stable closed position, 90 degrees from the second stable closed position and 45 degrees from the third stable open position, where all there external ports on the outer collar are closed off from all of the through holes in the hollow body; 
           [0031]      FIG. 12  is an exploded view of the three way valve of  FIG. 5  in a fourth stable open position, 90 degrees from the third stable open position, where the front and the left side through holes in the hollow body, with respect to the figure, are aligned with a respective external port on the outer collar, and the right side through hole in the hollow body, with respect to the figure, is aligned with a solid surface of the collar, and thus fluidly closed, and a third external port is aligned with a solid surface of the back of the hollow body, with respect to the figure, and thus fluidly closed; and 
           [0032]      FIG. 13  is an exploded view of the three way valve of  FIG. 5  in a fourth stable closed position, 90 degrees from the third stable closed position and 45 degrees from the fourth stable open position, where all there external ports on the outer collar are closed off from all of the through holes in the hollow body. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0033]    The present invention will be understood by reference to the following detailed description, which should be read in conjunction with the appended drawings. It is to be appreciated that the following detailed description of various embodiments is by way of example only and is not meant to limit, in any way, the scope of the present invention. 
         [0034]    Turning now to  FIG. 1 , a brief description concerning the various components of the present invention will now be briefly discussed. As can be seen in this first embodiment, the invention is a thoracic catheter system  1  comprising a flexible or semi-flexible chest tube or thoracic catheter  2  made from plastic, silicone, rubber, metal, or some combination thereof. A distal end  4  of the thoracic catheter  2  is inserted into the thoracic cavity  6  of the patient  8  through an incision  9 , and a proximate end  10  of the thoracic catheter  2  is connected to a suction canister  12  or wall or other suction. The thoracic catheter  2  will preferably include special internal coatings, such as, inter alia, polytetrafluoroethylene (“Teflon”), Tethered-Liquid Perfluorocarbon (comprising a monolayer of perfluorocarbon and a layer of liquid perfluorocarbon), silver ionic, silver nanoparticles, copper, copper alloy, organosilanes, gold, titanium dioxide, and carbon nanotubes, to help prevent clot or blockage  14  formation and/or reduce the risk of infection. The thoracic catheter  2  is inserted into the chest or thoracic cavity  6  in the pleural and/or the pericardial space and is used to remove/evacuate air from the pneumothorax or fluids  16  from such cavities, such as, inter alia, blood, effusion, chyle or pus. The distal end  4  of the thoracic catheter  2  will preferably have one or more apertures  18  extend completely though the side or wall  20  of the thoracic catheter  2 . 
         [0035]    As shown in  FIG. 2 , the apertures  18  could be, for example, two, three, four, five, six, or seven in number, and could be preferably positioned radially/circumferentially aligned  22  along a circumference of the thoracic catheter  2 , and/or could also be axially aligned  24  along the length of the thoracic catheter  2 . Additionally, the apertures  18  could also be in different positions along the thoracic catheter  2 , such as helically aligned  26  or some other arrangement. The apertures  18  are preferably large enough to allow an endoscopic camera  28 , a suction hose  30 , or an endoscopic camera with integrated suction  32  ability (hereinafter collectively referred to as the thoracoscopy device  32 ) to pass within the thoracic catheter  2  and through such apertures  18 . The thoracoscopy device may also include an integrated irrigation ability  33 . A benefit of the circumferentially aligned  22  apertures  18  (preferably in a circumferential grouping of at least three or four apertures  18 ) in the thoracic catheter  2  is to allow a virtual  360  degree radial view for a camera  28 ,  32  at a single axial length. The apertures  18  are preferably all the same size, but one or more could be different sized. Further or additional apertures  18  could be added that are too small for the thoracoscopy device  32  to pass through, but which could nonetheless increase the draining ability of the thoracic catheter  2 . Among various designs, there could be a single circumferentially aligned  22  group of apertures  18 , a single axially aligned  24  group of apertures  18 , or multiple groups of axially spaced circumferentially aligned  22  apertures  18  and/or multiple groups of circumferentially spaced axially aligned  24  apertures  24 . A further embodiment provides for multiple helical groups  26  of apertures  18 , where at least two helixes  26  are circumferentially aligned, so as to provide at least partially the advantages of both circumferentially aligned  22  and axially aligned  24  aperture  18  groupings. The arrangement of apertures  18  in the thoracic catheter  2  could be chosen for both maximal drainage of the thoracic cavity  6  and maximal accessibility with the thoracoscopy device  32 . 
         [0036]    The terminal/distal end  4  of the thoracic catheter  2  is preferably open with an aperture  18 , which also allows the thoracoscopy device  32  to pass through such distal end  4 , as shown in  FIG. 4 . The passage of the thoracoscopy device  32  not only helps with unclogging the thoracic catheter  2 , it also helps a physician to visualize and thus reposition the thoracic catheter  2  as needed. The camera  28  of the thoracoscopy device  32  would allow the physician operator to visualize inside the pleural and/or the pericardial cavities in the thoracic cavity  6  and even perform biopsy where required. The operator could reposition the thoracoscopy device  32 , use the set-up for drug delivery, contrast delivery, interventional radiology procedures, and pleurodesis. This could also provide access to the mediastinum and could be used as an alternative approach for conducting a mediastinoscopy. With the information gathered by non-invasive imaging (e.g., chest-x-rays and CT) and video-endoscopy, the operator could visualize and recognize malposition of the thoracic catheter  2  and a cause for blockage  14  if such is present. This would allow the operator to reposition and unblock the thoracic catheter  2  immediately. The thoracoscopy device  18  could additionally have biopsy functionality, or a similarly sized thoracoscopy biopsy instrument could be used. This would also provide a method to obtain microbiology specimens and/or biopsy of the lung and or pleura or mediastinum through the single thoracic catheter  18 , without starting an additional chest tube into the patient  8 . 
         [0037]    A second embodiment of the thoracic catheter system  1 , as shown in  FIG. 2 , includes a three way valve  42  which is one of fused/permanently attached and removably attached to the outer proximate end  10  of the thoracic catheter  2 . 
         [0038]    One embodiment of the three way valve or medical stopcock  42  consists of a chamber part or hollow body  44 , with three through holes  46  of preferably equal diameter at 90° degree intervals along a circumference of the hollow body  44 . While the hollow body  44  is shown in the shape of a sphere, it may also have the shape of an oblate spheroid, a prolate spheroid or a cylinder, for example. An inner surface of the hollow body  44  is preferably a smooth sphere, spheroid, or cylinder, except for the through holes  46  extending through the wall of the hollow body  44 . An outer ring  48  with the external ports  50  is placed around the hollow body  44  perimeter. The outer ring  48  can be rotated around the hollow body  44 , or, conversely, the hollow body  44  can be rotated within the outer ring  48 . The external ports  50  are preferably be rotated with the outer ring  48  with respect to the hollow body  44 , as shown in  FIGS. 5-13 , to allow for all three external ports  50  to open or closed as needed. When an external port  50  is rotationally aligned with a through hole  46 , a fluid connection is established between the external port  50  and the interior of the hollow body  44  and the external port  50  can be considered open or on. When an external port  50  is fully rotationally spaced from any through hole  46 , that external port  50  is fluidly isolated from the interior of the hollow body  44  and that external port  50  can be considered fluidly closed or in an off position. On the exterior of the hollow body  44  are preferably indicia to readily indicate the position of the through holes  46  with respect to the external ports  50 , like raised bumps or other visual or tactile indicators on the exterior surface of the hollow body  44  aligned with each through hole  46 , the through holes  46  being normally visually concealed by the outer ring  48 . Additionally there can be a flow path indicator  52  that shows which external ports  50  are fluidly connected to the interior of the hollow body  44  with a given relative rotation of the hollow body  44  and the outer collar  48 . This embodiment of the three way valve  42  has markings that clearly show the  8  rotationally stable on/off positions of the shown embodiment of the three-way valve  42 . The indicia and/or flow path indicator  52  eliminates the confusion of the older technology of three way valves  42  in the art with a single “off position.” The three way valve  42  is further described in PCT Patent Appin. No. PCT/US2015/012593 filed Jan. 23, 2015, the contents of which are incorporated herein by reference in its entirety. 
         [0039]    When the above three valve filter  42  is used with the thoracic catheter  2 , as shown in  FIGS. 2-4 , the three external ports  10  may be termed branch tubes  10 , including a downstream branch-tube  54 , which is preferably part of the external or proximate section  10  of the thoracic catheter  2 , an upstream branch-tube  56 , which is axially aligned with the downstream branch-tube  54 , and a merge-branch-tube  58 , preferably orthogonal to the downstream branch-tube  52 . All three branch tubes  10  extend from the hollow body  44 . One or more of the branch tubes  10  may further include a single direction flow valve (not shown). In the situations where the thoracoscopy device  32  equipped with the suction hose  30  is to be inserted in the patent  4 , as shown in  FIGS. 3 and 4 , one branch tube  10 , preferably the merge-branch tube  58 , would preferably be connected to the wall suction and a second branch tube  10 , preferably the upstream branch tube  56 , would be used for insertion of the thoracoscopy device  32  into the three way valve  42  and a third branch tube  10 , preferably the downstream branch-tube  54 , would be used for the thoracoscopy device  32  to access the thoracic catheter  2 , and via the thoracic catheter  2 , the patient&#39;s thoracic cavity  6 . 
         [0040]    Returning to  FIGS. 3 and 4 , a preferred embodiment of the thoracic catheter system  1  would have two components including the disposable thoracic catheter device (equipped with the three way valve  42 ) and the thoracoscopy device  32  which is purposefully designed to work with the thoracic catheter system  1 . The thoracoscopy device  32  (including a camera equipped with a strong suctioning and flushing capability) would preferably be designed for this purpose and could be sterilized and reused. The disclosed system would make the thoracic catheters  2  more efficient and durable and/or salvageable in the event of clogging  14 . The incision site  9  of the thoracic catheter  2  could be used as a port  9  of entry when performing the VATS procedures (e.g., VATS talc pleurodesis, VATS decortications, etc.). The functionality of the above three way valve  42  would allow the thoracoscopy device  32  to be easily inserted into the thoracic catheter  2  to check blockage  14  and remove blockage  14  if present, while still maintaining wall suction if desired. Also, the ability to fully remove the thoracoscopy device  32  from the thoracic catheter  2 , while still maintaining wall suction, allows for other therapeutic or diagnostic procedures to be inserted/conducted via the upstream branch tube  56 . 
         [0041]    The disclosed thoracic catheter device  2  would preferably be packaged in a sterile container, stored on the operating room shelf, in the wards or in the ER, and opened when needed. The thoracic catheter devices could come in different sizes (for pediatric and adult patients). It is anticipated that physicians and surgeons would use the thoracic catheter devices whenever deciding to insert a thoracic catheter, or after making the incisions during a VATS procedure, or any other cardiac or thoracic surgeries. 
         [0042]    In use, it is anticipated that the thoracic catheter device  2  would be given to the physician by the circulating nurse. The physician would insert the thoracic catheter device  2  with the three way vale  42  extension outside of the patient body  4  and the sterile thoracoscopy device  32  camera  28  rolling inside the thoracic catheter device  2 . On a side-way of the three-way valve  42 , a suction  12  is attached. There is preferably also a suction extension adjusted on the thoracoscopy device camera itself. 
         [0043]    The consumers for this device would be hospitals (operation rooms, interventional radiology suits, wards, and emergency room), ambulatory clinics, outpatient settings, ambulances, and paramedic facilities which perform thoracic catheter  2  insertion for hemo- or pneumothorax in traumatic and non-traumatic settings (including but not limited to pulmonary diseases such as cancer, infectious disease, or collagen vascular diseases). It would also be targeted for use by facilities that perform cardiothoracic surgeries (coronary artery bypass graft, heart valve surgeries, intrathoracic lung surgeries, VATS procedures, etc.). This device aims to make thoracic catheters  4  more efficient, more durable and ultimately make clogged  14  tubes  2  salvageable without limiting the flow of the thoracic catheter  2 , and reducing the risk of infection, making the detection of any tube  2  malfunction easier, and make changing of the proximate end  10  catheter  2  tip position easier. This thoracic catheter system  1  will spare the patient  4  from having multiple procedures and/or multiple thoracic catheters  2  inserted. The operations would become more efficient, saving operating room time, and decreasing the recurrence of pleural effusion or pneumothorax or hemothorax in the patient  4 . The novel three way valve  42  portion of the thoracic device  2  disclosed will also allow for substantially easier usage and camera  28  placement. 
         [0044]    While various embodiments of the present invention have been described in detail, it is apparent that various modifications and alterations of those embodiments will occur to and be readily apparent to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present invention, as set forth in the appended claims. Further, the invention(s) described herein is capable of other embodiments and of being practiced or of being carried out in various other related ways. In addition, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items while only the terms “consisting of” and “consisting only of” are to be construed in a limitative sense. 
         [0045]    Where a definition or use of a term in a reference, which is incorporated by reference herein, conflicts or is contrary to the definition or use of that term provided herein, the definition or use of that term provided herein applies and the definition or use of that term in the reference does not apply