Abstract:
A sump assembly having a tubular body with a drain at the distal end for use with an endotracheal tube which provides for the removal of the secretions around and near the endotracheal tube cuff, while the endotracheal tube remains in the nasal or throat passages of the patient.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to provisional applications Serial No. 60/127,716, filed Apr. 5, 1999. 
    
    
     BACKGROUND OF THE INVENTION 
     In certain instances of accident or illness, it is necessary to perform intubation of the trachea in order to allow continued breathing by a patient. Such a process was first described in the late 1800&#39;s. The trachea was intubated via the mouth utilizing a short metal tube for purposes of resuscitation and positive pressure ventilation. Since that time the endotracheal tube has evolved to a disposable flexible plastic tube of varying diameters and lengths used in newborns, children and adults. 
     In the case of the larger endotracheal tubes, a low pressure, high volume, thinwalled, rubberized cuff is inflated with air using a small separate line and valve system. This allows the cuff to create a seal between the endotracheal tube at its distal portion and the trachea of the patient. The proximal portion of the tube projecting from the mouth or nose of the patient allows connection to standard ventilating devices. 
     Endotracheal tubes also are temporarily used for inhaling general anesthesia or establishment of an artificial airway or for purposes of ventilatory support. In some instances, the endotracheal tube may remain in place for up to two or three weeks or longer. Complications arising from endotracheal intubation of the trachea are development of tracheitis, bronchitis, or pneumonia. What is known to the medical profession, is that various types of illnesses related to the trachea tube, and the fluid accumulations that may occur, frequently lead to illnesses, and their complications, which can have serious results. Studies have revealed secretions around the endotracheal tube cuff tend to pool in the space above the cuff as well as in the posterior oropharynx. These secretions arise from the mouth, nose, sinuses, gastroesophageal secretions and products of enteral feeding. 
     Furthermore, gastric reflux and accumulation of oral/nasal secretions during surgery can result in aspiration while the patient is intubated during surgery, particularly in high risk operative procedures. High risk patients are those who undergo emergency surgery, like in trauma or obstetric cases, long operations (four hours or more), upperD.N. abdominal surgeries requiring manipulation of the stomach or patients with known hiatal hernia or severe gastroesophageal reflux disease. The precise incidence is unknown since it often occurs in an occult fashion and only is implicated retrospectively when the postoperative patient develops pneumonia or respiratory failure six to twenty-four hours after surgery. 
     A safe, effective and reliable means for evacuating these secretions from above the endotracheal tube cuff would most generally reduce the severity and/or frequency of ventilator associated pneumonia and other diseases. 
     SUMMARY OF THE INVENTION 
     It is one object of the invention to provide an apparatus and method for the safe, effective and reliable means for evacuating these secretions from above the endotracheal tube cuff. 
     Another object of the invention is to provide such an apparatus that can be introduced into the patient adjacent a prepositioned endotracheal tube. 
     Another object of the invention is to provide such an apparatus that can be introduced into the patient adjacent a prepositioned endotracheal tube by using preattached clips that can slidingly engage the prepositioned endotracheal tube. 
     Still another object of the invention is to provide such an apparatus that can be introduced into the patient attached to and along side the endotracheal tube. 
     The present invention provides a sump assembly which allows removal of the secretions around and near the endotracheal tube cuff, while the endotracheal tube remains in the nasal or throat passages of the patient. Such secretions are typically located in the pharynx, supraglottic region, infraglottic region, and trachea region. The endotracheal tube sump of the present invention reduces the pooling of secretions by removal thereof, thus preventing pneumonia, bronchitis and other related diseases. The sump fits partially around the tracheal tube and when being installed or removed follows the path of the endotracheal tube down to the endotracheal tube cuff. 
     The endotracheal tube sump includes a tubular body with a distal end and a proximal end. The distal end includes a drain which can be formed as part of the tubular body or formed of flexible, or perhaps even semi-rigid, e.g. formed of a polymer, or other appropriate material, and even in certain instances rubber containing silicone. This drain contains at least one port, or perhaps several ports, through which secretions enter into the tubular body to be removed through the proximal end by a suction means. Located at or near the distal end is a guide affiliated with the drain. Another guide, ring or partial annulus, identified as a proximal guide can be positioned at the proximal end of the tubular body. Depending on the length of the tubular body, one or more proximal guide may be provided. The guide is comprised of an open ring of flexible material and is sized to easily fit around the endotracheal tube. Hence the sump is slidably inserted into the patient, and follows the path of the endotracheal tube. 
     Beyond the last proximal guide, is attached a connecting fitting to a suction catheter. The fitting provides attachment of the sump assembly to an external suction means or vacuum source or other appropriate attachment, including syringe fittings, stop cocks and other devices intended to irrigate or provide installation of other materials. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side elevational view of one embodiment of the invention; 
     FIG. 2 is a front elevational view taken along line  2 — 2 ; 
     FIG. 3 is an cross sectional view taken along line  3 — 3 ; 
     FIG. 4 is a front elevational view taken along line  4 — 4 ; 
     FIG. 5 is a side elevational view of one embodiment of the invention when installed on an endotracheal tube; 
     FIG. 6 is a side elevational view of an sump assembly of this invention with the spiral configured tubular body being shown spiraling around the endotracheal tube for threading, by turning, downwardly towards the endotracheal cuff; and 
     FIG. 7 discloses a view of the lower end of the sump assembly, as it is turned in a threading like manner, and reaches its proximity above the cuff to function to evacuate secretions accumulated at that location within the trachea; 
     FIG. 8 is a side elevational view of another embodiment of the invention when installed on an endotracheal tube; 
     FIG. 9 is a side elevational view of another embodiment of the invention when installed on an endotracheal tube and inserted in a patient; 
     FIG. 10A is an enlarged perspective view of an alternative embodiment of a sump assembly clip of the present invention; 
     FIG. 10B is a top plan view thereof; 
     FIG. 10C is an end plan view thereof; 
     FIG. 10D is a side elevational view thereof; 
     FIG. 11 is a side elevational view of a sump assembly of the present invention being installed on an endotracheal tube; 
     FIG. 12 is a side elevational view thereof with the sump assembly fully installed; 
     FIG. 13A is an enlarged end plan view of an alternative embodiment of a sump assembly guide of the present invention in an open position for seating a tubing; and 
     FIG. 13B shows the guide of FIG. 13A in a closed position with the tubing seated in the cradle. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     FIG. 1 depicts a sump assembly of the present invention indicated generally by reference numeral  10 . Sump assembly  10  includes distal suction means or drain  12 , a front elevational view of which is shown in FIG. 2, fluidly connected to an elongated, tubular body or suction tube  13 . The drain  12  allows for suctioning or irrigation at the distal end of the sump assembly. The drain  12  has one or more ports  14  for entry of the secretions and fluids, and the number of ports employed, and formed into the distal end of the suction means, depends upon the degree of suction of vacuum means required in order to remove secretions of a select viscosity from its accumulation at the vicinity of the inward end of the previously employed and inserted endotracheal tube. The ports  14  in the drain permit entry of unwanted secretions into the drain  12  whereupon the secretions are removed via vacuum to a disposal receptacle. 
     In addition, the drain  12  has a radiopaque mark  16  to indicate its inserted location. The radiopaque mark  16  allows for positioning the distal suction means appropriately with respect to the endotracheal tube  30  (FIG. 5) already installed. The drain  12  is generally in the form of a ring open at the bottom to permit fitting around the endotracheal tube (See FIGS.  2  and  3 ). The drain  12 , may undertake any related shape, such as that as shown in FIGS. 1,  5 ,  6  or may even comprised openings  15  (See, FIGS. 8 and 12) formed in the distal end of the tubular body  13 . Thus, the shape of drain  12  is not necessarily critical to its functionality, but has to have sufficient structure. However, if the drain  12  also functions as a guide ring, as shown in FIGS. 1 and 5, for example, it must be configured so as to allow for its slide along the endotracheal tube  30  tube, during its insertion, or removal, and to locate proximate the lower end of the endotracheal tube, and just above its inflated cuff  32 , so as to provide means for removal of the secretions accumulated at that location, and to minimize the risk of generating complications or infections, as previously explained. As a guide ring, the drain  12  generally is configured as a clip, as shown in FIG.  2 . 
     The assembly may include one or more additional guide rings  20 , also configured like clips, positioned along the length of the tube  13  in a spaced apart relationship, to facilitate insertion and removal as will be explained below. 
     The relationship of the drain  12  of the present invention and the endotracheal tube  30  is depicted in FIG. 5 where the drain  12  approaches the position of the cuff  32  of the endotracheal tube. When the endotracheal tube  30  is installed in the patient, the cuff  32  is inflated to provide a snug, secure fit. The cuff  32  is inflated by injecting air into the cuff by bulb  34  which retains the injected air by means of a valve  35  so as to cause the inflation of said cuff, and to prevent the secretions generated above the cuff  32  from permeating downwardly, and into the trachea, and to prevent its localizing therebelow and causing the type of infection as previously described. The bulb  34  may be formed as a pump, having resiliency to it, and by squeezing of the same, sucking air into the bulb and forcing it downwardly through the tubing  36 , to inflate the associated cuff  32 . 
     Obviously, the valve also allows for deflation of the cuff, when operated to achieve this result. But, because the cuff, when inflated, acts as a barrier against downward migration of such secretions, they accumulate above the cuff, and the purpose of this current invention is to provide means for evacuating those secretions before they cause deleterious problems to the patient, because of their presence. 
     At the proximal end of the tube  13  is a connecting fitting  28 . The connecting fitting  28  can be connected to a vacuum source, such as a powered vacuum pump, a syringe or the like, or other suitable attachments. Furthermore, the suction can be discontinued and materials, such as antibiotics or other medications, can be introduced into the fitting with a syringe, flow through the tube  13  to be instilled in the patient through the ports  14  in the drain  12 . 
     The subject matter of this invention is to provide for a clamping of the sump assembly  10  onto the endotracheal tube  30 , as shown, and then sliding it by means of its guides whether the guides be a drain  12 , or only guide rings  20 , downwardly upon the previously implanted endotracheal tube, until it locates at the position desired. Furthermore, in order to facilitate such manipulation, it is likely that lubricating means may be provided internally of the drain  12 , and the guide ring  20 , either in the form of some type of lubrication, which may be manually placed thereon, in order to reduce any friction generated between these components and the endotracheal tube. Or, the tube  13  may be a compound tube, and have a separate channel that extends downwardly through the guide ring  20 , and into the drain  12  to dispense a small amount of lubricant thereon, during insertion and withdrawal of the assembly, in order to facilitate its application. Or, even a separate tube, such as that similar to what is shown at  13 , may be applied to the guide ring  20 , and the drain  12 , to add lubrication in the manner as previously described. 
     This device may also be utilized for delivery other materials, as stated above, such as irrigants, antibiotics, or other solutions into the vicinity of the lower end of the inserted endotracheal tube. Additionally, diagnostic sampling of secretions may be performed, in order to provide for their testing, to determine the extent of any bacterial or other contamination, and the type of infection that may be generated at the vicinity of the cuff  32 , so that proper treatment may be prescribed. 
     As can be seen in FIGS. 6 and 7 of the drawings, the endotracheal tube  30 , with its previously located cuff  32 , and having its air tube  36  attached thereto, will have been emplaced into the trachea and downwardly into the vicinity of its final location. In an alternative embodiment the tubular body or tube  13 , is preformed into a spiraling configuration, as can be noted, and can be applied to the endotracheal tube  30 , by turning or rotating, in a manner of threading to provide for its shifting downwardly upon the endotracheal tube  30 , as it is turned, in a spiral fashion, to attain a locating of drain  12  just proximately above the cuff  32 , and once it achieves this location, its intake ports  14  will allow for evacuation of secretions accumulated at that location, just above the cuff, to attain the results as explained for this invention. This is just an alternative or modification to the concept of this invention, which is to use a tubing, which may be turned in a screwlike motion, to thread it onto the tubing  30 , until such as it achieves a locating as disclosed in FIG.  7 . Thus, the spirally configured tube  13  will function as a guide, for the sump assembly, to provide for its subsequent locating downwardly within the trachea, in order to provide for the evacuation of the accumulation of fluids at that location, and hopefully a minimization of the generation of any infections, at that location. 
     FIG. 8 illustrates another embodiment of the sump assembly of the present invention, particularly the guides  40 . As can be seen, the embodiment of the invention shown in FIG. 8 does not have a separate drain structure but includes drain openings  15  formed in the distal end of tube  13 . Since there is no separate drain structure to function as a guide, this sump assembly includes a guide  40  at the distal end, proximate the openings  15 . Furthermore, additional guides  40  are spaced toward the proximal end. The guides  40  are shown in greater detail in FIGS. 10A-10D and include a semicircular clip section  42  and a circular tube channel  44  formed like a boss at the tip of the clip. The tube  13  is positioned in the tube channel  44  and can be secured there in by ultrasonic welding or other appropriate means. The sump assembly illustrated in FIG. 8 is installed on the endotracheal tube in the same manner as other embodiments. 
     FIG. 9 illustrates a representative embodiment of a sump assembly  10  of the present invention placed in a patient along with an endotracheal tube. For reference, the physiological structures of the patient will be referenced as landmarks and include the epiglottis E, the vocal cords V and the accumulated secretions S above the cuff  32  of the endotracheal tube  30 . As will be appreciated, the sump assembly  10  of the present invention is optimally placed adjacent the endotracheal tube  30  with a drain opening  15  accessible by the secretions S when suction is applied through the tube  13 . 
     FIGS. 11 and 12 better illustrate the installation of a sump assembly  10  of the present invention adjacent an endotracheal tube  30 . As shown, the distally positioned guide  20  is placed over the proximal end of the endotracheal tube  30 . The assembly is urged down the endotracheal tube with the guide  20  keeping it adjacent the tube. As the sump assembly moves down the length of the endotracheal tube, subsequent guides  20  are attached to the endotracheal tube, as shown in FIG.  12 . The endotracheal tube  30  illustrated in FIG. 12 includes indexing marks  46  which can be aligned with indexing marks  48  on the sump tube  13 . Alignment of the appropriate indexing marks aid in the proper positioning of the drain opening  15  with respect to the cuff  32 . 
     FIGS. 13A and 13B illustrate another alternative embodiment of guide. It will be noted that guide  50  includes a clip  54  and a tubing cradle  56 . The guide  50  is constructed from a resilient material, such as plastic. By applying pressure such as squeezing the legs  58  of the clip  54 , the cradle  56  opens for the insertion of the tubing  13 . Release of the legs  58  of the clip allows the cradle to close and secure the tube  13  therein. 
     Variations or modifications to the subject matter of this invention may occur to those skilled in the art upon review of the summary herein, and upon undertaking a study of the description of its preferred embodiment. Such variations may be within the scope of this invention.