STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT N/A BACKGROUND OF THE INVENTION 1. Field of the Invention This invention generally relates to endotracheal tubes, and more particularly, to an endotracheal tube having a dedicated lumen and suction trigger for the aspiration of secretions pooled in the trachea above the cuff. The invention further comprises a lavage port for intermittently irrigating the trachea above the cuff prior to aspiration of pooled secretions and multiple suction eyelets strategically placed.

2. Description of Related Art A well known problem with endotracheal tubes is the buildup of excessive secretions above the cuff of the tube in the trachea.

The conventional endotracheal tube provides a lumen that extends between a proximal end and a distal end for inflating the cuff.

The inflatable cuff is joined to the tube above the distal end to prevent the passage of fluids and gases to and from the lungs when inflated and to create enough pressure to facilitate proper ventilation through the while preventing the back flow of gases.

The cuff is inflated so that it engages the trachea wall thereby providing a proper seal. However, as the trachea is sealed, oral secretions tend to pool or build up above the cuff.

Endotracheal intubation is used for mechanically ventilating a patient's lungs when the patient cannot breathe normally and/or for introducing anesthetic gases into the lungs. However, the

intubated, pulmonary patient is almost always placed at risk by pooled secretions between the inflated cuff and oral pharyngeal area. The accumulations and stagnation of the oral secretions broods infectious organisms resulting in serious health concerns.

The oral secretions eventually leak into the patient's lungs or find their way into the lungs when the endotracheal cuff is deflated. Thus, intubated patients are always at risk of developing bronchitis, pneumonia and other infections in the lungs and trachea because of pooled secretions entering the trachea and lungs during intubation and extubation of the tube. If these secretions could be quietly and conveniently aspirated the foregoing health concerns could be eliminated or reduced.

Endotracheal tubes are not new in the art and several have provided structure for draining fluid from the lungs and/or insufflating the lungs with oxygen or other gases. Other known devices have even addressed the problem of removing pooled secretions from the upper tracheal area, but have failed to solve the problem as contemplated by the instant invention. That is, current devices are either unreliable, not practical for use and/or not conveniently employed for the quick removal of secretions. Accordingly, even though background devices exist in this field, they do not contemplate and/or adequately address the above-noted problems with a structurally and functionally convenient device. Known tracheal devices are not capable of controlling a constant supply of air pressure, irrigating the trachea to dilute the secretions, and/or providing strategically placed suction eyelets for avoiding complete occlusion of the venting passage. For instance, U. S. Patent No. 5,143,062, issued to Peckham, discloses an endotracheal tube comprising a double lumen and suction eye to which air is circulated to create an indirect suction for evacuating contaminated secretions that pool within the trachea above an inflated cuff. The double lumen provides a supply port and return port for circulating air. This

design, however, does not provide adequate suction necessary for aspirating secretions. The Peckham device, is not practical for convenient hospital use and appears to be unsuitably thick. In addition, the Peckham device does not disclose multiple evacuation vents, a suction trigger, and a lavage port for irrigating the tracheal area with saline.

U. S. Patent No. 4,840,173, issued to Porter, III, discloses an endotracheal tube having an exterior tube that is merged into a ventilation tube as an appendage and continues along the exterior of the ventilation tube. Since the Porter suction tube is exterior to the ventilation tube and provides an eyelet at its most distal end, the Porter patent requires that the cuff have a rigid section proximal to the suction eye to prevent the cuff from being sucked up against said opening. By contrast, the instant invention provides suction eyelets that are positioned so that the cuff is not drawn up against the eyelets during aspiration. The Porter invention is also distinct from the instant invention as it comprises extra thickness by virtue of the exterior disposed ventilation tube. Porter also fails to disclose a suction trigger, cannot be manufactured by known extrusion techniques and does not provide a lavage port bifurcated from the suction port for irrigating and simultaneously removing fluids above the cuff.

U. S. Patent No. 4,796,615, issued to Bullock, et al, teaches a non-analogous quick disconnect connector for use with a system for measuring depth of anesthesia of a patient. Consequently, Bullock fails to address or contemplate the above-noted problems in the art and does not teach or disclose multiple suction eyelets, a suction trigger, a distal Murphy eye and a lavage port.

U. S. Patent No. 4,762,125, issued to Lehman, et al, discloses a balloon tip suction catheter that is used by inserting it into an endotracheal tube to remove secretions. As disclosed, Lehman requires two devices for aspirating secretions from the trachea area. In addition, Lehman fails to disclose a distal Murphy eye,

multiple suction eyelets defined longitudinally above the cuff, a suction trigger and a lavage port for irrigating the trachea area prior to aspiration of the pooled secretions.

U. S. Patent Nos. 4,637,389 and 4,607,635, issued to Heyden, disclose a tracheal tube device having an expandable channel for the insertion of an external suction catheter. The Heyden devices are designed to adjust to the depth of a suction catheter for removing secretions between the tube and the wall of the intubated pathway by providing a plurality of vents along the length of the tube. However, the plurality of vents along the tube actually limits the suction force needed for aspirating pooled secretions.

In addition, Heyden requires an additional device for aspirating secretions. Furthermore, Heyden fails to disclose a distal Murphy eye, a suction trigger and a lavage port.

U. S. Patent No. 4,632,108, issued to Geil, discloses a non- analogous, flexible tubular assembly having a third lumen for removing smoke generated during laser surgery. The Geil device fails to disclose a suction trigger, a distal Murphy eye, a plurality of suction eyelets and a lavage port for irrigation.

Geil does not disclose this structure since it addresses a completely different problem.

U. S. Patent No. 4,584,998, issued to McGrail, discloses a complex trachea tube having up to four lumens, none of which remove pooled secretions in the trachea area above the cuff.

Based on this disclosure, one lumen provides material irrigation and pressure monitoring and a second lumen provides insulfation of oxygen into the lungs. These two lumens communicate through a common distal opening thus providing a supply and return line similar to Peckham. McGrail does not disclose multiple suction eyelets, a suction trigger, a distal Murphy eyelet or a lavage port.

U. S. Patent No. 4,305,392, issued to Chester, discloses an endotracheal tube having a suction chamber in the shape of a

protruding bulge and having four ports. The suction chamber communicates with a lumen extending from the bulge toward the proximal end of the tube. Chester does not disclose a plurality of suction eyelets, a suction trigger, or a lavage port.

U. S. Patent No. 4,156,428, issued to Henkin, discloses a tracheal tube having an expandable cuff system. The Henkin device primarily addresses an expandable cuff system as controlled by a liquid, valve and reservoir system. Henkin is thus non-analogous.

In addition, Henkin fails to disclose a distal Murphy eye, a plurality of suction eyelets, a suction trigger and a lavage port.

U. S. Patent No. 4,119,101, issued to Igich, discloses a multiple lumen and a tracheal tube and cuff system having additional lumens for jointly and severally removing the fluid and increasing medicines into the lungs. The Igich device is designed for irrigating and aspirating the lungs. It does not address the problems associated with the moving or aspirating pooled secretions around the trachea area. Thus, Igich fails to disclose a distal Murphy eye, a plurality of suction eyelets, a suction trigger and a lavage port in communication with the suction eyelets.

As the background devices fail to disclose a multiple lumen endotracheal tube having a plurality of suction eyelets, a distal Murphy eyelet, a suction trigger and lavage port, there exists a need for such a device that could be used to quickly, conveniently and inexpensively remove the pooled secretions from an intubated patient's trachea area to reduce or prevent the complications attributed to conventional endotracheal tubes. The need for such a device is apparent based on this void in the background art and in the marketplace. As such a device has not been disclosed or provided, there exists a need for a multiple lumen endotracheal tube having a suction trigger in communication with a plurality of suction eyelets, a lavage port in communication with the suction eyelets and a distal Murphy eye.

BRIEF SUMMARY OF THE INVENTION In light of the foregoing, it is an object of the present invention to provide a pharyngeal evacuation endotracheal tube that quickly and virtually automatically aspirates pooled secretions from the trachea area above the cuff.

It is another object of the instant invention to provide an oral pharyngeal evacuation endotracheal tube that has a central valve in communication with a vacuum source for aspirating pooled secretions above the cuff.

It is a further object of the instant invention to provide an oral pharyngeal evacuation endotracheal tube that aspirates pooled secretions in the tracheal area above the cuff.

It is an additional object of the instant invention to provide a pharyngeal evacuation endotracheal tube having a plurality of suction eyelets oriented for preventing occlusion.

It is an additional object of the instant invention to provide a pharyngeal evacuation endotracheal tube that can simultaneously irrigate the tracheal area to loosen and/or dilute pooled secretions for facilitating easier suction.

It is yet another object of the instant invention to provide a pharyngeal evacuation endotracheal tube that is cost effective and easily made by existing manufacturing techniques.

In light of these and other objects, the instant invention comprises a multiple lumen, flexible, oral pharyngeal evacuation endotracheal tube. The inventive tube generally comprises a main lumen, suction lumen, cuff lumen, lavage port, inflatable cuff, plurality of suction eyelets above the cuff and a Murphy eyelet at the distal end of the main lumen. The cuff lumen is built into or extends through the main lumen and communicates with the inflatable cuff for selectively inflating and deflating the cuff with an external source. The suction lumen is built into or extends through the wall of the main lumen and communicates with

the trachea area outside the main lumen by way of the suction eyelets. The suction lumen and suction eyelets facilitate the removal of pooled secretions in the tracheal area above the cuff.

The lavage port communicates with the suction lumen to provide an irrigation source through the suction lumen to eliminate clogging and dilute dense secretions. The lavage port is bifurcated from the suction tube. The lavage port irrigates the trachea area through the suction lumen and suction eyelets.

The main lumen comprises the main body of the invention. The main lumen has an inflatable cuff exteriorly disposed near its distal end, and an adapter at its proximal end for mechanical communication with an AMBU bag or ventilator circuit. The distal end of the main lumen defines a Murphy's eye to prevent ventilatory shutdown caused by clogging or obstruction. The main lumen of the tube is the largest of the three lumens and is inserted into a patient's trachea for ventilation and/or anesthetic treatment of the patient's lungs. The secondary or cuff inflation lumen fluidly communicates with the cuff for inflating and deflating the cuff. The cuff lumen is terminated at the proximal end with an external tube and pilot valve for pressure monitoring and pneumatic or fluid charging and deflating of the cuff.

The suction lumen provides a passage for the suction or evacuation of supra cuff and chordal secretions in the tracheal area. The suction lumen extends outside the proximal end of the endotracheal tube. The suction tube extension includes a suction trigger that communicates with the suction lumen at one end and a vacuum source at the other end. The suction trigger is preferably preconfigured with an adapter that mates with and/or communicates with the vacuum source. The suction lumen is about the size of a small-bore nasal gastric tube with a series of suction eyelets at the suction lumen's distal end. The suction lumen's distal end defines a plurality of suction eyelets which are situated superior

to or above the cuff for receiving pooled secretions and can dwell inferior or superior to the vocal chords of the intubated patient.

Secretions are suctioned through the suction eyelets and suction lumen when the suction trigger is actuated. Control of the applied suction can be low-pressure constant, low pressure intermittent or trigger controlled similar to that of a Ballard suction catheter. Any clogging of the endotracheal tube is alleviated by simply reverse lavaging the tube with a gastric type syringe through the lavage port.

The suction and cuff lumens are preferably integrated into the wall of the main lumen. These additional lumens may be conveniently formed in the wall of the main lumen by known extrusion techniques. The cuff lumen and suction lumen ports are positioned outside the endotracheal tube's main body and preferably comprise tubes that extend from the proximal end of the main lumen while remaining in communication with the lumen passages in the main lumen. Accordingly, the suction and cuff lumen tubes may extend through the main lumen or through the main lumen wall, in an alternative embodiment.

The suction trigger used may vary depending on the type of suction preferred, i. e. low constant, low intermittent or trigger controlled. For instance, the suction trigger may comprise a momentary release trigger which automatically closes once released. The suction trigger may also incorporate a locking feature to prevent inadvertent suctioning. The suction trigger may also have a throttling mechanism or comprise a simple two- position valve, i. e. an on/off valve. The suction trigger may comprise any known fluid or pneumatic switch. The suction lumen port comprises a tube extension which may be retrofitted to connect to virtually any suction trigger known in the art.

Accordingly, different suction triggers may be employed to effectuate the desired suction. The preferred suction trigger is disclosed herein.

In an alternative embodiment, the instant invention may comprise a tracheostomy tube instead of an endotracheal tube. The tracheostomy tube is merely a shorter, rigid version of the endotracheal tube of the instant invention and is inserted through the neck instead of through the mouth. Accordingly, the tracheostomy tube of the instant invention comprises a main lumen, a suction lumen, a cuff inflation lumen, lavage port, an inflatable cuff and a plurality of suction eyelets above the cuff, as described above.

In accordance with these and other objects, which will become apparent hereinafter, the instant invention will now be described with particular reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS Fig. 1 is a front perspective view of the preferred embodiment of the oral pharyngeal evacuation tube of the instant invention.

Fig. 2 is a cross sectional view of the preferred embodiment of the oral pharyngeal evacuation tube of the instant invention taken along cross section lines 2-2 of Fig. 1.

Fig. 3 is a cross sectional view of the preferred embodiment of the oral pharyngeal evacuation tube of the instant invention taken along cross section lines 3-3 of Fig. 1.

Fig. 4 is a cross sectional view of the preferred embodiment of the oral pharyngeal evacuation tube of the instant invention taken along cross section lines 4-4 of Fig. 1.

Fig. 5 is a cross sectional view of the preferred embodiment of the oral pharyngeal evacuation tube of the instant invention taken along cross section lines 5-5 of Fig. 1.

Fig. 6 is a front perspective view of the oral pharyngeal evacuation tube of the instant invention inserted into the trachea and showing an alternative embodiment for the suction eyelet arrangement.

Fig. 7 is a side elevational view of the preferred embodiment of the oral pharyngeal evacuation tube of the instant invention inserted through a patient's mouth into the trachea.

Fig. 8 is a front perspective view of an alternative embodiment of the oral pharyngeal evacuation tube of the instant invention.

Fig. 9 is a side elevational view of the alternative embodiment of the oral pharyngeal evacuation tube of the instant invention inserted through a patient's neck into the trachea.

DETAILED DESCRIPTION OF THE INVENTION With reference to the drawings, Figs. 1-7 depict the preferred embodiments of the instant invention which is generally referenced by the numeric character 10, and Figs. 8 and 9 depict the alternative embodiment which is generally referenced by numeric character 10'. The endotracheal tube of the instant invention preferably comprises a multiple lumen, flexible, tube for insertion in the trachea of a patient, as shown in Figs. 6 and 7. However, in an alternative embodiment the instant invention 10'may comprise a shorter, rigid, plastic tube for insertion through the throat, as shown in Figs. 8 and 9. Both embodiments comprise a main lumen 12, suction lumen 20, inflatable cuff lumen 24, lavage port 16,17, inflatable cuff 28, plurality of suction eyelets 22 above the cuff and at least one Murphy eyelet 27 at the distal end 12b of the main lumen 12. Both embodiments may also comprise a suction trigger device 30, pilot balloon 19 for the cuff 28 and adapter 25 disposed at the main lumen's 12 proximal end 12a. The instant invention is preferably manufactured from known plastic, rubber, thermoplastic, thermoresin, synthetic rubber, styrene or other known materials that are medically safe.

With reference to Fig. 1, the main lumen 12 defines a central passage 29 and has a distal end 12b and a proximal end 12a. An

adapter 25 is typically attached or mounted to the main lumen 12 at the proximal end 12a for mechanical communication with an AMBU bag or ventilator circuit. The distal end 12b defines an angled opened end for feeding the tube into the trachea and a Murphy eyelet 27 to prevent ventilatory shutdown caused by clogging or obstruction in open distal end 12b. The open distal end 12b and Murphy eyelet 27 are shown in Fig. 1 and in cross-section in Fig.

5. The cuff 28 comprises a thin, flexible bag that is concentrically disposed on the main lumen 12 immediately above the open distal end 12b and Murphy eyelet 27. The cuff 28 may comprise an integral component or a membrane which is permanently joined to the main lumen 12 by techniques known in the art. When inflated, the cuff engages the trachea walls to provide a proper seal.

Consequently, oral secretions collect above the cuff.

The main lumen 12 defines a cuff lumen 24, suction lumen 20 and a plurality of suction eyelets 22. The cuff lumen 24 and suction lumen 20 preferably comprise passages bored or extruded in the wall of the main lumen 12, as shown in Fig. 2. This reduces thickness for practical use with a patient. In addition, this allows the lumens 20,24 to be formed in the main tube 12 by incorporating existing extrusion manufacturing techniques as used in making conventional endotracheal tubes. The suction eyelets 22 and Murphy eyelet 27 are cut, bored or formed in the wall of the main lumen 12 in communication with their respective lumens. The lumens 20,24 may alternatively comprise tubes which pass through the main lumen 12. The main lumen 12 may also have a colored or radio-opaque line along its exterior or within its wall that allows landmark identification when the tube has been inserted.

The cuff lumen 24 fluidly communicates with the cuff 28 for inflating and deflating the cuff 28. With reference to Figs. 2 and 3, the cuff lumen 24 passes longitudinally though the main lumen 12 and surfaces inside the cuff 28. At the proximal end 12a, the cuff lumen 24 extends outside the main lumen 12 by way of

a cuff inflation tube or port 18. The cuff inflation tube 18 is merely an extension of the cuff inflation lumen 24. The cuff inflation port 18 is terminated by a pilot balloon 19, such as those known in the art. The pilot balloon 19 is adapted for receiving a syringe or other device that can selectively introduce and remove air or fluid in the cuff 28. As seen in Figs. 6,7 and 9, the cuff 28 fully engages the tracheal walls when inflated.

The cuff 28 collapses when deflated as shown in Fig. 1.

The suction lumen 20 and suction eyelets 22 fluidly communicate with the pooled secretions in the trachea area above the cuff 28 for removing the pooled secretions. The suction lumen 20 provides a passage for the suction or evacuation of supra cuff and chordal secretions in the tracheal area. With reference to Figs. 2 and 4, the suction lumen extends longitudinally along the main lumen 12 and surfaces via the suction eyelets 22. The suction lumen 20 is about the size of a small-bore nasal gastric tube with a series of suction eyelets 22 at the suction lumen's distal end.

The suction eyelets 22 may be situated superior to or above the cuff 28 and can dwell inferior or superior to the vocal chords of the intubated patient. The invention 10 preferably comprises a plurality of suction eyelets 22 so that if any of the eyelets 22 becomes occluded the pooled secretions can still be aspirated through the other eyelets 22. The suction eyelets 22 are preferably spaced and situated in vertical or longitudinal alignment with respect to the cuff 28 so that the cuff 28 is not pulled against the eyelets 22 when a vacuum source is applied. The eyelets 22 are also sized and spaced for optimal aspiration. Two to four suction eyelets 22 are preferred as shown. However, the number may vary without departing from the scope and spirit of the invention. The suction lumen 20 preferably terminates in a closed end as seen in Fig. 1, but may terminate as an open end as shown in Fig. 6. The suction lumen 20 extends outside the proximal end 12a of the endotracheal tube via suction lumen tube or port 14.

The suction lumen port 14 Is merely an extension of the suction lumen 20. The suction lumen port 14 is mechanically and fluidly communicated with a suction trigger 20. The suction trigger 30 provides a device for selectively applying a suction to the suction lumen 20 to aspirate pooled secretions from the tracheal area above the cuff 28.

The suction trigger 30 communicates with the suction lumen system 14,20 at one end and a vacuum source at the other end. An adapter 36 mechanically and fluidly joins the suction trigger 30 and suction lumen port or tube 14. The suction lumen port 14 is bifurcated, as indicated by reference numeral 13, prior to the connection with the suction trigger 13. The suction trigger 30 is preferably preconfigured with an adapter 34 that mates with and/or communicates with the vacuum source. Secretions are suctioned through the suction eyelets 22, suction lumen 20 and suction lumen port 14 when the suction trigger 20 switch 32 is actuated. The switch 32 is preferably momentary such that it returns to the closed position when released. This prevents the suction trigger 30 from being left on inadvertently. The suction trigger may also incorporate a locking feature to prevent inadvertent suctioning.

The switch 32 may be spring loaded to effectuate the momentary action. Control of the applied suction can be low-pressure constant, low pressure intermittent or trigger controlled similar to that of a Ballard suction catheter. Other types of suction triggers 30 meeting the noted specifications may be substituted without departing from the scope and spirit of the invention. On the other hand, a suction trigger 30 may comprise a throttling valve or a simple two-position valve. Clogging of the endotracheal tube, suction lumen 20 or suction eyelets 22 is alleviated by simply reverse lavaging the tube with a gastric type syringe through the lavage port 16.

The lavage port 16 comprises an extension tube which bifurcates from the suction lumen port 14. The lavage port 16

includes an adapter 17 for mating or connecting a saline bottle or other substituted liquid source. The lavage port 16 facilitates the irrigation of the trachea area above the cuff 28 to dilute the secretions and/or unclog the suction eyelets 22, suction lumen 20 or suction lumen port 14. To allow simultaneous suctioning with the trigger 30 and irrigation, the lavage port 16 may comprise another independent lumen that extends through the main lumen 12 and terminates above the cuff 28. In this alternative embodiment, the trachea area would be irrigated in the area around the suction eyelets 22. In another embodiment, the lavage port 16 may fluidly and mechanically communicate with the suction lumen 20 at a point closer to the suction eyelets 22.

In an alternative embodiment, the instant invention may comprise a tracheostomy tube 10'instead of an endotracheal tube, as shown in Figs. 8 and 9. The tracheostomy tube 10'is merely a shorter, rigid version of the endotracheal tube of the instant invention and is inserted through the neck instead of through the mouth. Accordingly, the tracheostomy tube 10'of the instant invention comprises a main lumen 12, suction lumen 20, cuff inflation lumen 24, lavage port 16,17, inflatable cuff 28, pilot valve 19 and plurality of suction eyelets 22 above the cuff, as described above with respect to the endotracheal tube 10. In addition, the tracheostomy tube 10'has an adapter which secures the tube 10'outside the neck.

To use the instant invention 10,10', the tube is situated orally through the trachea or inserted through the neck. After properly securing the tube 10 or 10', a syringe is inserted into the pilot valve 19 to inflate the cuff 28. The suction trigger 30 is then connected to a vacuum source and the lavage port 16,17 is connected to a saline or other fluid source. Once secretions start to accumulate in the intubated patient's trachea, the suction trigger switch 32 is depressed to apply the vacuum source to the suction lumen 20. The suction created draws the secretions

through the suction eyelets 22, suction lumen 20 and suction lumen port 14. A momentary vacuum should be sufficient. Upon releasing the switch 32, the suction ceases. If any blockage occurs, saline is introduced from the lavage port 16,17 and through the suction lumen port 14, suction lumen 20 and suction eyelets 22.

Thereafter, the accumulations are aspirated by triggering the suction trigger 30. The irrigation and suctioning may be done independently or simultaneously. The irrigation facilitates improved suctioning.

The instant invention has been shown and described herein in what is considered to be the most practical and preferred embodiment. It is recognized, however, that departures may be made therefrom within the scope of the invention and that obvious modifications will occur to a person skilled in the art.