Endotracheal tube cleaning apparatus

A cleaning apparatus including an elongate tubular member utilized by extending into an endotracheal tube. A cleaning assembly provided at a distal end of the elongate tubular member radially expands to engage the interior wall of the endotracheal tube, for cleaning thereof by an outer periphery, achieving an effective cleaning engagement. A fluid impervious bladder portion provides an effective seal preventing fluid seepage during cleaning withdrawal. Further, a ventilator coupling connects to the endotracheal tube, a first inlet port couples to a ventilator assembly to supply air to a patient, and a second inlet port receives the elongate tubular member there through into the endotracheal tube. Also, a bypass coupling assembly connects between the channel of the elongate tubular member and the ventilator assembly directing air into the channel of the elongate tubular member and out the distal end upon occlusion of airflow.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an endotracheal tube cleaning apparatus to be used to effectively and efficiently clean the flow through passage of an endotracheal tube, including the effective removal of even solid buildup on the interior wall surface of the endotracheal tube safely, effectively, and in a self contained sterile assembly that does not have to be removed from the patient, does not significantly restrict airflow to the patient, and may be used to administer needed medication. Furthermore, the cleaning apparatus is structured to ensure that a patient is still capable of effective breathing, even during cleaning, and to enable effective examination and cleaning of the cleaning assembly during continued uses, thereby ensuring that excessive build up is not on the cleaning assembly during continued cleaning of the endotracheal tube. Also, during cleaning removal thereof, the cleaning apparatus is configured to minimize the possibility of fluid seepage past the cleaning assembly.

2. Description of the Related Art

Many patients in a hospital, and in particular, patients in an Intensive Care Unit (“ICU”) must be fitted with endotracheal tubes to facilitate their respiration. Specifically, an endotracheal tube is an elongate, semi-rigid lumen which is inserted into a patient's nose or throat and projects down into airflow communication with the patient's respiratory system. As such, the patient either directly, or with the aid of a respiratory unit, is able to breathe more effectively through the endotracheal tube.

Recent studies have determined, however, that the accumulation of dried tracheo-bronchial secretions on the interior wall surface of an operating endotracheal tube effectively decreases the lumen cross section, and thereby significantly increases the work of breathing for the incubated patient. Moreover, increasing the work of breathing for the patient necessitates that a higher level of support be provided to compensate, and often results in the patient's intubation period and ICU stay being significantly prolonged. Furthermore, it is also seen that thick secretions on the walls of the endotracheal tube often serve as a nidus for continued infection in the lungs, leading to added morbidity and hospital costs for the incubated patient.

To date the only effective means of eliminating the accumulated secretions within an endotracheal tube completely, has been to exchange the contaminated endotracheal tube for a new tube. There are, however, several disadvantages to this procedure, such as temporary arrest of ventilatory support and the risk of complete loss of airway control. For example, re-intubation may be exceedingly difficult in patients with swelling of the soft tissue of the neck, and in patients having cervical spine immobilization, because upon removal of the endotracheal tube, the appropriate internal passages tend to close up and be otherwise difficult to isolate for reintroduction of a new endotracheal tube. Further, re-intubation of a patient can result in additional trauma to the oral, laryngeal and tracheal tissues.

Short of replacing the endotracheal tube completely, the only other means currently in use for maintaining endotracheal tubes somewhat clear is the use of flexible suction/irrigation catheters. Specifically, these suction/irrigation catheters, are passed down the endotracheal tube and upper airways and seek to evacuate contaminants from the lumen. Unfortunately, although the suction/irrigation catheters generally clear the airway of watery secretions, they are ineffective at clearing the inspissated secretions that have accumulated on the inner wall surface of the endotracheal tube over the course of days. In essence, the use of a suction/irrigation catheter merely delays the inevitable, namely, that the endotracheal tube be removed and replaced.

One somewhat recent attempt to address the problems associated with the maintenance of endotracheal tubes is seen to provide a two part assembly which is introduced into the flow through passage of the endotracheal tube. Specifically, a thin interior, solid segment having a plurality of retracting bristles and a sealing gasket at an end thereof is contained within an exterior lumen. In use, the entire coupled assembly is introduced into the endotracheal tube, but the interior segment is pushed through the outer tube so that the bristles expand to engage the wall surface, and the gasket member, such as a foam cylinder or balloon, expands to completely seal off the area behind the bristles. The entire device, including the upwardly angled bristles is then pulled upwardly with the gasket element completely sealing off the tube there below so that any debris removed by the bristles is retained. Such a device, however, does not provide for accurate insertion indication to prevent over-insertion into the endotracheal tube, and completely seals off the endotracheal tube during removal so as to result in a potentially hazardous interruption to ventilation and/or a negative pressure or suction behind the cleansing device. Furthermore, it is seen from the need to include the bristles that direct engagement of a gasket type member, such as the balloon, with the interior wall surface of the endotracheal tube, does not provide for the complete and effective removal of secretions, due primarily to the smooth exterior surface of the gasket. Moreover, the smooth resilient material surface also results in substantial friction between the rubbery gasket and the plastic wall surface, thereby making it quite difficult to smoothly and effectively pull the cleansing device from the endotracheal tube. Additionally, it is seen that upwardly angled bristle members are susceptible to complete or partial retraction as they encounter obstacles and attempt to scrape clean the interior of the endotracheal tube, and in fact, the bristle members are often quite sharp and may be damaging to the endotracheal tube or to a patient if inadvertently projected beyond the endotracheal tube so that the outwardly projecting bristle members become stuck outside the endotracheal tube. Also, because of the collapsing configuration of bristles, gaps will naturally exist between adjacent bristles and some areas of the tube are not engaged, and as secretions begin to build up beneath the bristles, their collapse is further restricted. Further, such a single function device necessitates that additional items be introduced into the tube, generally resulting in additional trauma to the patient, if some suction is necessary.

As such, there is still a substantial need in the art for a cleaning device that can be used to clear endotracheal tube secretions effectively, and on a regular basis, thereby expediting ventilatory weaning and extubation of ICU patients. Further, there is a need for an effective endotracheal tube cleaning apparatus which can be easily and effectively introduced into the endotracheal tube, and which can be easily removed, even though it effectively removes solid secretion buildup, due to its friction minimizing engagement with the interior wall surface of the endotracheal tube and/or because of its alleviation of negative pressure/suction within the endotracheal tube upon removal thereof. Additionally, there is a need for a cleaning device which can be accurately extended into the endotracheal tube without substantial risk of over introduction, will not become lodged through the endotracheal tube in the event that it protrudes slightly from the end of the endotracheal tube, and which can be utilized for multiple functions, such as the introduction of medication deep into the patient's airway.

In addition to the referenced needs in the industry, it is also noted that an effective cleaning device should preferably be configured to maintain air flow/ventilation to a patient during substantially all phases of cleaning. Moreover, the device should maintain maximum sterile integrity as to those components which will be ultimately introduced into the patient, providing for effective cleaning and/or monitoring thereof.

SUMMARY OF THE INVENTION

The present invention is directed towards an endotracheal tube cleaning apparatus to be used to clean an endotracheal tube while it is being used in an intubated patient. Typically, the endotracheal tube is of the type that includes a central lumen, defined by an interior wall structure that extends from a distal end to a proximal end of the tube.

Specifically, the endotracheal tube cleaning apparatus includes an elongate tubular member having a diameter, or transverse dimension, smaller than lumen or interior diameter of the endotracheal tube. Further, the elongate tubular member includes a distal end that is structured to be introduced and extend into the lumen of the endotracheal tube. Defined within the elongate tubular member, and extending from generally its first/proximal end to its second/distal end is a length, which may comprise a channel therein. The channel provides a fluid flow through conduit that terminates in an outlet port defined in the elongate tubular member, generally near the second end thereof. Also disposed in overlying relation to at least a portion of the elongate tubular member is a cleaning assembly. In at least one embodiment, the cleaning assembly is disposed in a vicinity of the distal end of the elongate tubular member. The cleaning assembly, which may be at least partially removably secured to the elongate tubular member, includes an inflatable or expandable resilient material bladder having an exterior cleaning surface, such as an exterior abrasive surface. The exterior cleaning surface is structured to affirmatively engage the interior wall structure of the endotracheal tube with some outward cleaning pressure, for subsequent cleaning of the endotracheal tube upon reciprocating movement of the elongate tubular member within the endotracheal tube. Furthermore, in one embodiment, the irregular configuration of the exterior cleaning surface may be discontinued at an intermediate portion of the inflatable bladder such that the inflatable bladder forms a generally fluid impervious seal with the interior of the endotracheal tube, and any secretions that may slip past the irregular configuration will generally not move past the fluid impervious seal and will be effectively withdrawn from the endotracheal tube. Moreover, such provides an effective mechanism to gather samples of those secretions for subsequent testing.

In other embodiments, the cleaning assembly may be comprised of a resilient bladder and an outer periphery, which may be a sheath member disposed in at least partially overlying relation to the bladder. Further, the cleaning assembly may be secured to the elongate tubular member at a point opposite the second/distal end of the elongate tubular member. For instance, the cleaning assembly may have an attachment end which is disposed opposite to the distal end of the elongate tubular member that is introduced and extended into the lumen of the endotracheal tube. In at least one embodiment, the cleaning assembly may be secured to the elongate tubular member at the attachment end. Indeed, in some embodiments, the outer periphery of the cleaning assembly, such as a sheath member, may include the attachment end, and therefore effectuate the attachment of the cleaning assembly to the elongate tubular member opposite the distal end.

In further embodiments of the present invention, the elongate tubular member may also be structured to include a recessed portion near the distal end. This recessed portion has a smaller diameter or transverse dimension than the remaining length of the elongate tubular member, effectively creating a space differential between the exterior of the tubular member in the recessed portion compared to the rest of the tubular member. The recessed portion may comprise the entire circumference of the tubular member, creating a circular band of recessed space, or it may comprise a discrete recessed area over only a portion of or along a side of the tubular member.

Moreover, in at least one embodiment, the cleaning assembly is disposed near the distal end of the tubular member such that at least a part of the cleaning assembly is disposed in overlying relation to the recessed portion thereof. The recessed portion may be sufficiently spaced in length and depth to accommodate the cleaning assembly therein. In one embodiment, the cleaning assembly fits entirely within the recessed portion of the tubular member when the cleaning assembly is not inflated or expanded, such that in its uninflated state, its outer periphery is, at its maximum, in line with or substantially flush with the outer edge defined by the transverse dimension of the remaining elongate tubular member. For example, the cleaning assembly may be structured so that the outer periphery may extend beyond the elongate tubular member when the cleaning assembly is in at least a partially expanded configuration. In one embodiment, the bladder of the cleaning assembly is disposed in at least partially surrounding relation to the elongate member. Further, in embodiments in which the elongate tubular member includes a recessed portion, the bladder may be disposed in at least partially surrounding relation to the recessed portion. When it is not expanded, the cleaning assembly may not extend beyond the tubular member. In at least one embodiment, the cleaning assembly is structured to expand radially outward.

Additionally, the endotracheal tube cleaning apparatus may, in one embodiment, include a ventilator coupling. The ventilator coupling is structured to be coupled in fluid flow communication with the endotracheal tube, and includes a first inlet port and a second inlet port defined therein. Specifically, the first inlet port is structured to be coupled to a ventilator assembly and thereby provide air to the patient in a conventional manner through the endotracheal tube. The second inlet port, however, is structured to receive the elongate tubular member there through for subsequent passage into the endotracheal tube, and as such is preferably disposed in axial alignment with the endotracheal tube.

In order to ensure that the patient is consistently ventilated, a bypass coupling assembly may also be provided. The bypass coupling assembly is disposed/connected in fluid flow communication between the channel of the elongate tubular member and the ventilator assembly. Moreover, it is structured and disposed to automatically direct the fluid from the ventilator assembly, into the channel of the elongate tubular member, and out the distal end of the channel, upon occlusion of a flow of air through the endotracheal tube at a point of the endotracheal tube upstream of the distal end of the channel. Accordingly, if normal ventilation stops, ventilation through the bypass coupling assembly will continue.

It is an object of the present invention to provide an endotracheal tube cleaning apparatus which can efficiently and easily be routinely utilized to maintain the flow through passage of an endotracheal tube free from the accumulation of dried tracheobronchial secretions.

A further object of the present invention is to provide an endotracheal tube cleaning apparatus which can easily and effectively be oriented so as to prevent over insertion into endotracheal tubes of varying lengths.

Yet another object of the present invention is to provide an endotracheal tube cleaning apparatus which can absorb watery secretions as well as remove dried secretions from the interior wall surface of an endotracheal tube.

Also an object of the present invention is to provide an endotracheal tube cleaning apparatus which provides sufficient abrasion to remove dried secretions from the interior wall surface, but which is also substantially smooth and easy to slidingly remove from the endotracheal tube while it is engaged with the interior wall surface thereof.

Another object of the present invention is to provide an endotracheal tube cleaning apparatus which can provide effective cleaning pressure on the interior wall surface of the endotracheal tube, but which provides minimal risk of external contamination through the rupture of a resilient material bladder thereof.

A further object of the present invention is to provide an endotracheal tube cleaning apparatus which can alleviate negative pressure deep within the endotracheal tube while the cleaning device is engaging the wall surface of the endotracheal tube during cleaning.

Still another object of the present invention is to provide an endotracheal tube cleaning apparatus which can simultaneously provide abrasive dried secretion removal with effective suction/irrigation to remove watery secretions.

Yet another object of the present invention is to provide an endotracheal tube cleaning apparatus which can be utilized to perform a variety of functions during a single insertion.

Another object of the present invention is to provide an endotracheal tube cleaning apparatus which can be utilized to suction a patient's airway and will not harm the patient if inserted beyond the tube for that purpose.

Also an object of the present invention is to provide an endotracheal tube cleaning apparatus which automatically functions to ensure that a patient is ventilated, even if normal air flow through the endotracheal tube is occluded during cleaning.

A further object of the present invention is to provide an endotracheal tube cleaning apparatus which can provide for effective, isolated irrigation of the cleaning assembly, thereby permitting safe re-introduction and added cleaning of the endotracheal tube therewith.

Also an object of the present invention is to provide an endotracheal tube cleaning apparatus which can assist with the introduction of medication at an effective deployment site within the patient's airway.

Another object of the present invention is to provide an endotracheal tube cleaning apparatus which is convenient to grasp and manipulate and which provides for easy adjustment of the inflated amount of the resilient material bladder.

An added advantage of the present invention is to provide an endotracheal tube cleaning apparatus which is substantially sterile and contained both during introduction and during removal and internal irrigation.

A further object of the present invention is to provide a cap assembly which remains in a substantially protected state both when in use and not in use.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Shown throughout the Figures, the present invention is directed toward an endotracheal tube cleaning apparatus, generally indicated as10. In particular, the endotracheal tube cleaning apparatus10is constructed for use with an endotracheal tube80that is conventionally utilized to enable a patient to breathe, and as such, is generally inserted down the throat of a patient as illustrated inFIG. 1. Such an endotracheal tube80is preferably of the type including a flow through passage82having an interior wall surface83that defines its interior diameter. Generally, however, after prolonged periods of use, the endotracheal tube80will exhibit a buildup of secretions85that form on the interior wall surface83and can thereby obstruct airflow through the flow through passage82. The endotracheal tube cleaning apparatus10of the present invention, among other functions, is structured to facilitate the removal of those secretions85in a convenient and effective manner.

In particular, the endotracheal tube cleaning apparatus10of the present includes an elongate tubular member20having a first/proximal end24and a second/distal end22. The elongate tubular member20, which is preferably of a semirigid construction so as to allow it to bend and conform to the operative configuration of the endotracheal tube80within a patient, has a length at least equivalent to a length of the endotracheal tube80. As such, the endotracheal tube cleaning apparatus10can effectively reach deep down into the length of the endotracheal tube80for effective cleaning of even the most remotely introduced portions thereof. Furthermore, the elongate tubular member20is structured with a diameter smaller than the interior diameter of the endotracheal tube80, and in fact, is preferably quite narrow so as to facilitate the introduction of the elongate tubular member20into endotracheal tubes of varying sizes and permit normal airflow thereabout in most circumstances. Preferably disposed on an exterior surface of the elongate tubular member20is a gradiated indicia62. In particular, it is generally not favorable for the second end22of the elongate tubular member20to penetrate beyond an open end of the endotracheal tube80, as it may come in contact with interior organs and/or tissue of the patient. As such, upon knowing the dimensions of the endotracheal tube80being utilized within the patient, a user can make note of an appropriate marking on the indicia62, which may include lines or preferably numerals, to ensure that the elongate tubular member20is not over inserted into the endotracheal tube80.

Preferably defined within the elongate tubular member20is an inflation channel30. Specifically, the inflation channel30is structured to extend from generally the first end24of the elongate tubular member20towards the second end22of the elongate tubular member20. Moreover, the inflation channel30will preferably terminate in an outlet port32defined generally near the second end22of the elongate tubular member20. The outlet port32of the inflation channel30is structured and disposed so as to permit the escape of a fluid, such as air, there through, subsequent to its passage through the length of elongate tubular member20within the inflation channel30. As illustrated in the preferred embodiment of the drawings, the outlet port32of the inflation channel30preferably extends out a side of the elongate tubular member20, in a vicinity of the second end22of the elongate tubular member20, and may preferably extend into an annular track defined in the elongate tubular member20.

Secured to the elongate tubular member20, also generally at the second end22thereof as part of a cleaning assembly40′ is a resilient material bladder40. Preferably the resilient material bladder40engages the elongate tubular member20within the annular track, and as such is disposed over the outlet port32of the inflation channel30. Accordingly, the resilient material bladder40is structured and disposed to be in fluid flow communication with the outlet port32and hence the inflation channel30. Therefore, when a fluid, such as air, exits the inflation channel30through the outlet port32, it will pass into the resilient material bladder40to result in a corresponding inflation thereof. Specifically, the resilient material bladder40is formed of an expandable material and is preferably structured to inflate to at least a diameter that is approximately equivalent to a diameter of the interior wall surface83of the endotracheal tube80, thereby exerting some outward pressure on the endotracheal tube80when it is inflated. Additionally, the resilient material bladder40may be sized to be variably inflated and thereby permit effective use of the endotracheal tube cleaning apparatus10within endotracheal tubes80having varying interior diameters. The resilient material bladder40may be secured to the elongate tubular member20in a variety of fashions, and may take on a variety of configurations effective to provide for appropriate inflation and secure retention at generally the second end22of the elongate tubular member20. By way of example, the resilient material bladder40can have an inner-tube type configuration secured to the elongate tubular member20and having inlet opening connected in fluid flow communication with the outlet port32of the inflation channel30. Alternatively, the resilient material bladder40can have a tire-type configuration wherein the resilient material40has a generally C-shaped cross section and forms a seal between its edges and the exterior surface of the elongate tubular member20in order to captivate air there between for the resultant inflation of the resilient material bladder40. Along these lines, the resilient material bladder may be structured to be removable from the elongate tubular member20, such as after a single use. In such an embodiment, rather than securing the edges of the resilient material bladder to the elongate tubular member, such as using an adhesive, the resilient material bladder40is removably seated within the annular track33. Accordingly, the generally resilient nature of the resilient material bladder40preferably maintains it secured in place, however, when necessary, it may be pulled out of the track and slid off of the elongate tubular member. Furthermore, if desired it is noted that the entire distal end of the elongate tubular member may be structured to be removable as a unit, thereby providing for the disposability of the resilient material bladder40as well.

The cleaning assembly40′ further comprises an outer periphery. For example, disposed in at least at least partially, but preferably completely, surrounding relation about the periphery of the bladder40, is an expandable, exterior sheath42. In at least one embodiment, the expandable exterior sheath42is specifically dimensioned, configured and disposed to sufficiently prevent passage of any portion of the resilient material bladder40down into the endotracheal tube80should the resilient material bladder40rupture during inflated use. Furthermore, the expandable, exterior sheath includes an exterior surface, which may be at least partially abrasive or other wise comprise an irregular surface structure which facilitates the cleaning of the interior surface83of the endotracheal tube80. This irregular surface configuration preferably extends along an entire or at least a majority of the exterior of the exterior sheath. As a result, the exterior surface of the sheath42will engage, with a degree of outward cleaning pressure, the interior surface83upon expansion or inflation of the bladder40and will thereby clean the interior surface83of the endotracheal tube80.

Preferably, the expandable exterior sheath40has a soft, expandable, mesh type configuration which can engage an entire circumference of the interior wall surface83along a relatively large surface area. Conversely, when the resilient material bladder40is collapsed, as illustrated inFIG. 4, the expandable exterior sheath42is also collapsed, but does not sag or droop. Rather, the gaps within the mesh type configuration of the expandable exterior sheath42will merely reduce and the mesh will normally maintain its more tightly packed mesh configuration. Alternatively, however, when the resilient material bladder40is inflated or expanded, the expandable mesh type configuration of the expandable exterior sheath42permits it to stretch out and maintain its at least partially covering relation over the resilient material bladder40. It is therefore seen, that the plurality of openings defined in the expandable exterior sheath42, when it is expanded and wrapped about an inflated, operable resilient material bladder40, provide an outer periphery, which may be a generally abrasive or irregularly configured. As set forth above, when passed over the interior wall surface83of the endotracheal tube80with some outward cleaning pressure, the sheath40will function to loosen the secretions85that are stuck to the interior wall surface83of the endotracheal tube80. Accordingly, effective cleaning results when the resilient material bladder40is inflated or expanded and the elongate tubular member20is pulled out from its inserted orientation within the flow through passage82of the endotracheal tube. It is also seen, however, that some in and out, reciprocating movement of the elongate tubular member20may be necessary to provide for complete and effective secretion85removal. Moreover, in the preferred embodiment, a small distance, namely a safety distance, is preferably maintained between the resilient material bladder40and the tip of the elongate tubular member20at the second end22. Accordingly, a risk of over introduction of the cleaning assembly40′ beyond the endotracheal tube80is minimized when an introduction distance is equated to a length of the elongate tubular member20, as will be described.

In addition to containing the resilient material bladder40in case of rupture, and providing the exterior, generally abrasive surface necessary for cleaning, the expandable exterior sheath42, which may be formed of a nylon or other soft material mesh, also provides a smooth exterior surface that facilitates movement during introduction and removal of the resilient material bladder40, and therefore the elongate tubular member20, into and out of the endotracheal tube80during cleaning. Specifically, because of the material construction of the resilient material bladder40, significant friction may be exhibited between the resilient bladder40itself, and the interior wall surface83of the endotracheal tube80. Such frictional resistance may make it quite difficult, or at least quite erratic during the removal and/or reintroduction of the resilient material bladder40into the endotracheal tube80. Furthermore, the expandable exterior sheath can more effectively absorb and/or remove the secretions if the resilient material bladder40can be retained in an inflated orientation as the endotracheal tube cleaning apparatus10is completely removed from the endotracheal tube80, because any dislodged secretions85are substantially prevented from dropping beneath the resilient material bladder40where they may fall into the patient. Furthermore, if desired, a quantity of medication can be administered, such as through application on the exterior sheath42. In particular, the medication can be administered either to the patient directly by passing the distal end of elongate tubular member completely through the endotracheal tube, or may be administered to the surface of the endotracheal tube, such as in the case of an anti-bacterial agent, mucolytic agent, saline solution, etc., to help clean and disinfect the endotracheal tube, to prevent future contamination, and/or for gradual distribution to the patient via the endotracheal tube.

Looking toFIG. 3A, in yet another embodiment of the present invention the exterior abrasive surface of the cleaning assembly40′ may be defined by a ribbed exterior surface47of the resilient material bladder40. In such an embodiment a plurality of ribs are defined in the resilient material bladder40, those ribs providing a sufficient abrasive surface, when the resilient material bladder is inflated, to gently clean the endotracheal tube. Furthermore, medication or a lubricating material may be placed on the ribs so as to facilitate movement within the endotracheal tube, and/or as may be necessary for the patient. As such, in this embodiment, although the exterior sheath may still be provided, it is not necessary.

Implementation of the endotracheal cleaning tube apparatus, specifically including the preferred embodiments as described herein, comprises a method of cleaning an endotracheal tube by first extending the tubular member20into the interior of the endotracheal tube80and along the length thereof, while the cleaning assembly40′ is maintained in its non-expanded position. More precisely, prior to inflation and expansion of the cleaning assembly40′, and in particular the expandable material bladder40, the tubular member20is disposed within the interior of the endotracheal tube80until the cleaning assembly40′ reaches a predetermined or preferred location substantially adjacent and innermost end of the endotracheal tube80. When so located, the cleaning assembly40′ is expanded into the operative, cleaning position.

As set forth above, outer, radial expansion of the cleaning assembly40′ comprises inflating the expandable material bladder40until it extends radially outward and in surrounding relation to the tubular member20and into confronting engagement with the interior wall surface83of the endotracheal tube80. The cleaning assembly40′ and in particular the expandable material bladder40and outer periphery are thereby disposed in the aforementioned cleaning position. Cleaning of the interior wall83of the endotracheal tube80is then best facilitated by an axial movement of the tubular member20and the cleaning assembly40′, while the outer periphery of the cleaning assembly40′, more particularly the outer peripheral surface of the expandable material bladder40, is disposed and maintained in confronting engagement with the interior wall83of the endotracheal tube80.

During such axial movement the accumulation or buildup of secretions85are dislodged from the interior wall surface83and are prevented from passing into the lungs of the patient by virtue of the maintenance of the outer peripheral surface of the cleaning assembly40′ and/or expandable material bladder40with the interior wall surface83. As set forth above due to the fact that the cleaning assembly40′ is disposed in surrounding relation to the tubular member and extends radially outward from this surrounding position into confronting engagement with the interior wall surface83, any dislodged portions of the secretions85will be prevented from passing beyond the expanded cleaning assembly40′ and into the patient.

As set forth above, the outer peripheral surface of the cleaning assembly40′ and/or the bladder40may be formed with an irregular surface defined by the aforementioned ribbed configuration47. As also described, the ribbed configuration47comprises the plurality of spaced apart ribs47′. In this preferred embodiment the irregular surface defined by the ribbed configuration47is disposed and maintained in confronting engagement with the interior wall surface83as the tubular member20as the cleaning assembly40′ moves axially within and along the length of the endotracheal tube80.

To accomplish an even greater cleaning action being exerted on the interior wall surface83, the tubular member20and the cleaning assembly40′ connected thereto may be moved axially within the endotracheal tube80in a reciprocal path of travel. Alternatively, sufficient cleaning action may be accomplished by merely pulling the tubular member20and the cleaning assembly40′ axially along the length of the endotracheal tube80as the tubular member20is being removed from the interior of the endotracheal tube80, as also described above.

Looking toFIGS. 8-11, in yet another embodiment of the present invention, the irregular configuration of the cleaning assembly, whether integrally defined with the inflatable bladder and/or defined as the exterior sheath may be preferably configured to extend only partially over the inflatable bladder40. Specifically, in some instances, certain secretions may seek or otherwise pass the irregular configuration, such as the exterior sheath42, as the cleaning assembly is being withdrawn from the endotracheal tube80. For example, in the case of the exterior sheath42, certain small gaps can be defined between the sheath and the surface of the bladder40. Accordingly, by terminating a proximal end of the irregular configuration at an intermediate portion of the bladder40, the bladder40will preferably engage directly the interior of the endotracheal tube and will form a generally fluid impervious seal. As a result, any secretions that are not removed by the irregular configuration portion will not be able to pass the seal between the bladder40and the wall of the endotracheal tube and will also be removed. In one embodiment, the exterior sheath member42preferably terminates at a proximal end43that is generally expandable with the bladder40, as illustrated. In such an embodiment, such as including a terminated mesh configuration, the bladder40is free to expand, the sheath member expanding with it to engage the endotracheal tube during withdrawal. Alternately, the proximal end of the sheath member42may terminate in a collar44, such as defined by a layer of adhesive or other binding material that secured the proximal end and limits expansion thereof. In such an embodiment the bladder40, upon inflation, may define two distinct sections, one with the bladder directly engaging to define the fluid impervious seal, and another with the exterior sheath member engaging to achieve the desired abrasive effect. Accordingly, a much greater cleaning can be achieved, and indeed, if desired a better a sample of secretions can be withdrawn and contained within the present invention after removal for lab test purposes. Of course, such a partial coverage defines only certain preferred embodiments, as a complete coverage by the irregular configuration portion may still be preferred in other embodiments, such as when an emergency blockage is to be removed and tighter engagement between an exterior sheath member and the bladder40is required to penetrate the blockage without “peeling back” the exterior sheath member42prior to commencement of cleaning.

FIGS. 12 through 15show additional embodiments of the present invention, wherein the cleaning assembly40′ is secured to the elongate tubular member20at an attachment end45. Specifically, in at least one preferred embodiment, the present invention comprises an elongate tubular member20having distal end22and a transverse dimension less than the lumen of the endotracheal tube80, and a cleaning assembly40′ disposed in overlying relation thereto having an attachment end45disposed in opposite relation to the second/distal end22of the elongate tubular member20. In at least one embodiment, the cleaning assembly40′ is secured to the elongate tubular member20at the attachment end45. In some embodiments, the cleaning assembly40′ may be secured to the elongate tubular member20exclusively at the attachment end45.

Moreover, the cleaning assembly40′, which overlies at least a portion of the elongate tubular member20, is further comprised of a resilient bladder40and an outer periphery. This outer periphery may be formed of an exterior sheath member42disposed in at least partially overlying relation to the resilient bladder40, and may be expandable. In at least one embodiment, the attachment end45may be formed in the exterior sheath member42, and may be secured or attached to the elongate tubular member20therethrough.FIGS. 12 and 13illustrate one example of this in which the exterior sheath member42is secured to the tubular member20at the attachment end45of the cleaning assembly40′, shown in the operative, non-expanded position (FIG. 12), and in the operative cleaning position (FIG. 13) wherein the expanded cleaning assembly40′ exerts a cleaning force on the interior wall83of the endotracheal tube80.

Attachment of the exterior sheath member42at the attachment end45prevents the sheath member42from becoming detached from the endotracheal tube cleaning apparatus10during use, such as may occur upon moving the cleaning assembly40′ back and forth during cleaning, which may be desired if, for example, there are dried secretions that resist being broken up or removed. In addition, attachment of the exterior sheath member42at the attachment end45reduces or eliminates the possibility of “peel-back” or a rolling effect of the exterior sheath member42toward the second/distal end22of the elongate tubular member20during cleaning use, which would limit or decrease the effectiveness of cleaning. Accordingly, when the cleaning assembly40′ is secured to the elongate tubular member20, especially at the attachment end45, the cleaning assembly10may be used in applications requiring greater force than if the cleaning assembly40′ were not attached. This may be especially useful if there is a significant build-up of dried secretions, to enhance the abrasive effect, or for other situations where an increased application of cleaning force is desired.

Additional embodiments of the invention include the exterior sheath member42attached at the attachment end45to the elongate tubular member20, wherein the elongate tubular member20comprises a recessed portion46. For example, the elongate tubular member20comprises a distal end22, a proximal end24, and a length defined therebetween. The recessed portion46comprises at least a portion of the length of the elongate tubular member20, and in some embodiments, the recessed portion46is disposed proximate or near the distal end22. This recessed portion46has a transverse dimension less than that of the rest of the elongate tubular member20, such that the exterior surface within the recessed portion46is reduced from the exterior surface of the elongate tubular member20. In the embodiment illustrated inFIGS. 14 and 15, this recessed portion46comprises the entire circumference of the tubular member20, creating a circular band of recessed space. In another embodiment, the recessed portion46comprises only a discrete portion of or is disposed along a side of the tubular member20(not shown). The cleaning assembly40′ is disposed in overlying relation to at least a part of the recessed portion46in these embodiments, such as is depicted inFIG. 14.

With reference toFIG. 14, the cleaning assembly40′, specifically the bladder40and the exterior sheath member42, are disposed in the recessed portion46. In one example of the operative, non-expanded position of this embodiment, the bladder40and exterior sheath member42remain entirely within the depth of the recessed portion46. That is, the outer periphery of the cleaning assembly40′ is structured to extend beyond the outer edge or transverse dimension of the elongate tubular member20when the cleaning assembly40′ is at least partially expanded. For instance, the cleaning assembly40′ may be expanded radially outward. Accordingly, the cleaning assembly40′, when disposed in the recessed portion46, may not protrude from the elongate tubular member20and therefore may not come in contact with the interior wall surface83of the endotracheal tube80while placing or positioning the cleaning apparatus10into the operative position. This may be particularly useful when cleaning narrow endotracheal tubes, as it allows for an easier placement of the elongate tubular member20within the endotracheal tube80. For instance, there is less of a risk of dislodging and/or pushing dried secretions into the patient during the placement of the elongate tubular member20into the operative position, prior to inflation and subsequent cleaning. Once properly placed, the bladder40is expanded or inflated and the cleaning apparatus10is now in cleaning position in which the exterior cleaning surface of the cleaning assembly40′, and more in particular, the outer periphery or sheath member42contacts the endotracheal tube80in cleaning engagement, and the cleaning assembly40′ exerts a cleaning force on the endotracheal tube80once expanded.FIG. 15shows one example in which the cleaning assembly40′ extends radially outward when expanded.

The cleaning assembly40′ may be expanded or inflated by introduction of a fluid, such as air. Referring now toFIG. 2, disposed opposite the outlet port32of the inflation channel30, and also connected in fluid flow communication with the inflation channel30is an inlet port34. Specifically, the inlet port34is structured to permit the introduction of a fluid, preferably air, into the inflation channel30for subsequent inflation of the resilient material bladder40. While this inlet port34may be positioned anywhere in the elongate tubular member20, it is preferred that it be positioned generally near the first end24thereof in order to permit the facilitated introduction of fluid there through when the elongate tubular member20is substantially introduced into the endotracheal tube80. Moreover, in a preferred embodiment the inlet port34is operatively disposed at a slight angle from an axis of the elongate tubular member20to permit facilitated introduction of air into the channel30.

Looking to the preferred embodiment of the figures, coupled to the elongate tubular member20, preferably at its first end24, is a handle assembly190. Specifically, the handle assembly190is preferably disposed in a generally perpendicular orientation relative to the elongate tubular member20, and may include a generally T-shaped configuration. As such, it is seen that a user may grasp the handle assembly190with the elongate tubular member20extending out from between the user's fingers, and reciprocating movement of the elongate tubular member20within the endotracheal tube80is greatly facilitated.

Preferably included within the handle assembly190is an inflation assembly. In particular, the inflation assembly is structured to facilitate the introduction of the fluid into the inflation channel30of the elongate tubular member20through the inlet port34. In the preferred embodiment, the inflation assembly includes a chamber192defined therein and disposed in fluid flow communication via a conduit194with the inlet port34. As such, it is seen that the handle assembly190preferably encases the first end24of the elongate tubular member20such that the interconnection with the inlet port34is internally contained. Of course a number of coupled interconnections can be achieved between the conduit194and the inlet port34and chamber192, such as threaded, snap-fit, friction, or molded connections. Moreover, the conduit194may include a separate flexible element or may be molded directly into the body of the handle assembly190. Looking to the chamber192, although a variety of separate and/or integrally molded inflation mechanisms may be provided for connection at the chamber192, it is preferably structured to receive a hypodermic syringe193therein. The syringe193, which typically includes a threaded hub tip, is structured to screw into, or be otherwise coupled within the chamber192so as to direct air or liquid exiting the syringe193into the conduit194. Accordingly, with the perpendicular configuration of the handle assembly190, it is seen that a user grasping the handle assembly190may also easily place his/her thumb in actuating relation on the syringe193. Therefore, a user can actually control the amount of fluid within the inflatable bladder40, and the outward pressure being exerted thereby on the endotracheal tube80, while reciprocating movement of the elongate tubular member20is performed. Also, although separate valve means may be provided to restrict the escape of fluid after the resilient material bladder has been filled, in circumstances were the syringe193is coupled to the handle assembly190and therefore the channel30at the inlet port34, it functions to prevent the escape of air and the deflation of the resilient material bladder40while pressure is maintained thereon by the user.

Also in the preferred embodiment, the endotracheal tube cleaning apparatus10of the present invention includes an equilibrium channel50. Specifically, the equilibrium channel50includes a distal end and a proximal end and is defined in the elongate tubular member20so as to extend from generally the first end24of the elongate tubular member20to generally the second end22of the elongate tubular member20, at a point beyond the resilient material bladder40. Moreover, the equilibrium channel50includes ports52and54at generally the first and second ends of the elongate tubular member20. Accordingly, the equilibrium channel50will provide a passage that significantly alleviates suction/negative pressure behind the resilient material bladder40as it is being removed from the endotracheal tube80in its inflated orientation. It is understood, that when the resilient material bladder40is inflated it effectively forms a seal with the interior wall surface83of the endotracheal tube80. Therefore, as the elongate tubular member20is pulled for cleaning, a suction effect behind the resilient material40can result. Not only can this suction effect make it substantially more difficult to remove the endotracheal tube cleaning apparatus10from the endotracheal tube80, but some trauma can result to the patient as a result of this suction effect and a loss of continued ventilation through the endotracheal80can result. Through the positioning of the equilibrium channel50, the suction pressure is alleviated, and in fact, some air flow may be provided to the patient there through. Moreover, as will be described subsequently, the equilibrium channel50can be used as a conduit for various other functions of the present invention.

While the elongate tubular member20may be structured so as to be extended directly through a conventional Y-connector of the ventilator assembly170implemented in a normal fashion at an exposed end of the endotracheal tube80, thereby permitting the continuance of air flow through one inlet of the Y-connector, while permitting introduction of the elongate tubular member20through the other inlet of the Y-connector, in the preferred embodiment, a ventilator coupling160is provided. Specifically, the ventilator coupling160includes at least two, but preferably three inlet ports162,163&165, and an outlet port164. The outlet port164is structured to be coupled, preferably directly with the endotracheal tube80, in a standard manner so as to allow complete access to the endotracheal tube80there through. Similarly, the first inlet port165is structured to be coupled directly to the ventilator assembly170at a connector hub171thereof. A typical press fit engagement may also be provided. Along these lines, however, and because ventilators having varying sized connector hubs171may be provided, the preferred third inlet port163is also provided and configured of an alternative diameter to be coupled to a ventilator assembly. For example, one inlet port may be 22 mm and another 15 mm. Of course, when a particular inlet port163or165is not in use for connection with the ventilator assembly170, it may be used to provide access for other purposes and to other implements, or it may be merely sealed of by a corresponding cap166or167. Looking to the second inlet port162, it is structured to receive the elongate tubular member20there through, and is therefore preferably disposed directly in axial alignment with the entrance of the endotracheal tube80.

In the preferred embodiment, the second inlet port162is coupled with a hub assembly120at an open second end128thereof. Specifically, the hub assembly120is structured to receive and preferably guide the elongate tubular member20there through and into the endotracheal tube80through the ventilator coupling160. Moreover, when retracted, the second end22of the elongate tubular member20is preferably disposed in the hub assembly120to provide some sanitary containment.

Extending from a first end127of the hub assembly120is a collapsible exterior sheath110. Specifically, the exterior sheath110is formed of a flexible, preferably transparent material, and is secured at opposite ends thereof between the handle assembly190and the hub assembly120. A typical collar coupling112and114is preferred so as to prevent separation. As such, a length of the exterior sheath110functions to restrict outward removal of the elongate tubular member20completely out of the hub assembly120. Moreover, the elongate tubular member20is maintained in a completely isolated, completely sterile environment to prevent its contamination and to prevent it from contaminating other items.

Furthermore, it is preferred that the hub assembly120include a seal assembly125disposed at the first end127thereof. The seal assembly125preferably includes a resilient gasket type configuration and is structured to maintain the elongate tubular member20generally concentrically disposed through the hub assembly120. Further, the seal assembly125is structured to engage the elongate tubular member20as it is withdrawn there through so as to substantially wipe off any accumulated secretions from its exterior surface and preferably provide a generally fluid impervious seal with the elongate tubular member20at the first end127of the hub assembly120.

In addition to providing an effective connection point with the ventilator coupling160, the hub assembly120is further structured and disposed to facilitate cleaning and irrigation of the second end22of the elongate tubular member20and the cleaning assembly40′, and can allow for testing of the cleaning assembly40′. For example, the hub assembly120is preferably somewhat narrow at the first end127, approximating a diameter of the endotracheal tube80, and thereby helping to guide the elongate tubular member20along a concentric path and permitting a user to get a feel for the cleaning process while actually viewing the cleaning assembly40′ if a slight, cleaning type inflation of the resilient material bladder40is desired. Conversely, the hub assembly is generally wider at the second end128so as to permit full inflation of the resilient material bladder40if a test of its integrity or the loosening of built up secretion is necessary.

In particular, the hub assembly120further includes a port122connected therewith. This port122may act as an irrigation port when cleaning of the second end22of the elongate tubular member120is desired. For example, as the elongate tubular member20is withdrawn from the endotracheal tube80after cleaning, the seal assembly125maintains all exterior excretions within the hub assembly. When the second end22of the elongate tubular member20is completely within the hub assembly120, the hub assembly120is preferably removed from the ventilator coupling160, and its second end128is preferably covered by a first cap section130of a sterile cap assembly, to be described in greater detail subsequently. Furthermore, the hub assembly120is preferably formed of a generally transparent material so as to permit viewing of the area to be cleaned. Once the hub assembly120is sealed, an irrigation fluid, preferably under some pressure is directed through the port122to wash off the second end22of the endotracheal tube20, and therefore the cleaning assembly40′. That irrigation fluid may then be drained or suctioned out.

Specifically, the port122is preferably coupled with a multi-port valve144. As such, one auxiliary port144′ of the multi-port valve144may be connected via an appropriate suction coupling148to a suction hose150, while another opening of the multi-port valve144is coupled in fluid flow communication with an irrigation fluid source, such as a syringe. Looking to the suction coupling148, it may be covered with a corresponding cap149when not in use, however it will preferably be connected to a typical suction pump via a suction hose150, a specimen trap152to filter out any suctioned particulate and collect them for analysis, and a secondary hose154connected to a suction source.

Furthermore, the suction means may also be coupled in fluid flow communication with the equilibrium channel50. Specifically, the suction means when coupled with the equilibrium channel are structured and disposed to withdraw residue cleaned from the interior wall surface83of the endotracheal tube80, and not captivated at or above the resilient material bladder40during cleansing. Moreover, the suction means can draw out watery secretions, which are generally more difficult to completely eliminate through the resilient material bladder40and expandable exterior sheath42, through the equilibrium channel50. Similarly, the suction means can function to suction a patient's airway, beyond the endotracheal tube, in some circumstances, by introducing the second end22of the tubular member20beyond the endotracheal tube80. With regard to the suction function, it is understood that the distal end port52of the equilibrium channel50may be disposed right at a tip of the second end22of the elongate tubular member20, may be disposed in a side wall of the elongate tubular member20, and/or may in fact include more than one port52so as to provide for more effective suction within the endotracheal tube80. Further, it is also understood that the equilibrium channel50may be divided into a pair of channels, one to provide for suction and another to provide for alleviation of removal resisting suction pressure behind the resilient material bladder40during inflated removal.

Looking more particularly the preferred embodiment of the figures, the port52is preferably connected to an elongate, preferably flexible conduit140disposed at an intake port195of said handle assembly190. Specifically, the intake port195of the handle assembly190is preferably connected in fluid flow communication with a port54of the equilibrium channel50disposed at the first end24of the elongate tubular member20. This interconnection is preferably internal of the handle assembly190and may be accomplished by a molded interior channel or segment of flexible tubing196. Of course, the intake port195of the handle assembly190may merely include an opening through which the conduit140extends for direct coupling with the port54of the equilibrium channel50or the interior channel196. Moreover, the equilibrium channel50may extend to the intake port195. In the preferred embodiment, however, a second multi-port valve146is coupled to the intake port195, and the conduit140is coupled at opposite ends141and142thereof to the corresponding multi-port valves144and146. In this configuration, it is seen that when the first multi-port valve144is positioned to direct flow between the suction coupling148and the conduit140, and the second multi-port valve146is positioned to permit flow from the conduit140to the intake port195, the suction is directed through the equilibrium channel50to achieve the airway suctioning function previously described. Moreover, use of these conventional multi-port valves144or146allows facilitated control of the application of suction merely by blocking or permitting flow. Conversely, during irrigation within the hub assembly120, the first multi-port valve144may positioned to direct flow between the conduit140and the port122, acting as the irrigation port, such that a syringe or other irrigation fluid source can be coupled with the conduit140, such as at an auxiliary port146′ of the second multi-port valve146positioned to direct an irrigation fluid into the conduit140, and can direct the fluid into the hub assembly120. Subsequent to irrigation, the first multi-port valve144can be positioned to permit flow between the suction coupling148and the port122on the hub assembly120to suction out the irrigation fluid and any loosened debris. Alternatively, the irrigation fluid may be directed from a syringe through the second multi-port valve146directly into the equilibrium channel50for cleaning thereof. As such, irrigation fluid directed through either area will accumulate in the hub assembly120where the cleaning assembly40′, which must also be cleaned, is disposed.

The preferred embodiment of the present invention also includes a bypass coupling assembly. Specifically, the bypass coupling assembly is connected in fluid flow communication with the equilibrium channel50of the elongate tubular member20, and the ventilator assembly170. Moreover, the bypass coupling assembly is structured to automatically direct the air from the ventilator assembly170into the channel50of the elongate tubular member20and out the distal end of the channel50at the second end52of the elongate tubular member20, upon occlusion of a flow of air through the endotracheal tube at a point of the endotracheal tube upstream of the distal end of the channel50. Generally, this occlusion of air flow is a result of inflation of the resilient material bladder40, and as such the distal end of the channel50located in a vicinity of the second end22of the elongate tubular member20is downstream of that point and is still in fluid flow communication with the patient. In the preferred embodiment, the bypass coupling assembly includes a bypass port disposed in fluid flow communication with a ventilator inlet port165of the ventilator coupling160. As such, in the preferred embodiment, the port122of the hub assembly120acts as the bypass port. Moreover, the bypass coupling assembly includes the conduit140disposed in fluid flow communication between the bypass port122and the channel50of the elongate tubular member20. Accordingly, if flow through the endotracheal tube80is constricted, the air flow backs up into the hub assembly120where it escapes through the bypass port122. With proper positioning of the first and second multi-port valves144and146, that ventilating air flows into the channel50and out to the patient. Along these lines it is noted, that the endotracheal tube cleaning apparatus10of the present invention may be easily adapted, merely by selectively actuating/positioning the first and the second multi-port valves144and146, so as to selectively administer suction inside the endotracheal tube80through the channel50, administer suction within the hub assembly120in order to withdraw secretions and irrigation fluid therefrom, administer medication in liquid form to the patient through the channel50at a point beyond the endotracheal tube80and well within the patient's airway, irrigate the cleaning assembly40′ within the hub assembly120, irrigate the channel50, preferably into the hub assembly120, and ventilate the patient through the channel50by implementation of the bypass coupling. Accordingly, time consuming and potentially complex disconnection of the conduit140from its fluid flow communication between the bypass port122and the channel50of the elongate tubular member20can be eliminated, while still effectively performing a wide variety of functions.

In addition to the previously described preferred configuration of the endotracheal tube cleaning apparatus10of the present invention, the elongate tubular member20may include yet another elongate passage extending there through and having an outlet opening disposed generally at a point above the resilient material bladder40. As such, during cleaning a suction can be applied above the resilient material bladder40to remove any loosened debris and/or fluid that may affect or hinder the cleaning process of the resilient material bladder40. In this embodiment, the equilibrium channel50may be used to maintain respiratory air flow to the patient during cleaning as part of the bypass coupling assembly.

Yet another feature of the present invention, and preferably incorporated at the second multi-port valve146, are medication administration means. Specifically, a standard MDI adaptor180type fixture can be coupled to the second multi-port valve146when it is positioned to direct flow between the adaptor180and the channel50through the intake port195of the handle assembly190. As such, preferably upon removal of a protective cap183, a medication vial185can be applied at the adaptor180and medication is administered into the channel50. While the medication may flow directly down and out the distal end of the channel50, generally the medication, especially liquid medication, will remain in the handle assembly190or upper region of the equilibrium channel50until the second multi-port valve146is positioned to block off the adaptor180and thereby open the conduit140permitting the bypass coupling assembly to be operational. At that point, the flow of air through the bypass coupling assembly functions to push the medication out the port52of the channel50disposed at the second end22of the elongate tubular member20. As this can be accomplished when the elongate tubular member20is substantially introduced into the endotracheal tube80, and therefore the patient, substantially direct and focused administration of the medication in the airway is ultimately achieved.

Referring once again to the sterile cap assembly of the present invention, it is seen to include a first cap section130and a second cap section168. Specifically, the first cap section130of the sterile cap assembly is preferably structured to seal the second end128of the hub assembly120and thereby prevent an irrigating fluid from passing into the ventilator coupling160and subsequently into the endotracheal tube80, as previously described. In particular, the first cap section130includes a sterile engagement face132that is matingly coupled with the second end128of the hub assembly120. Moreover, it is preferred that the sterile engagement face132of the first cap section130be a male section structured to extend into the second end128of the hub assembly120to effectuate proper closure. Similarly, the second cap section168is preferably structured to be matingly coupled to the second inlet port162of the ventilator coupling160, upon the hub assembly120and the ventilator coupling160being separated from one another. Significantly, however, it is preferred that the sterile engagement face169of the second cap section168be a female section structured to receive the second inlet port162of the ventilator coupling160therein. Of course, the male and female configurations can be varied to correspond the necessary configurations of the hub assembly120and ventilator coupling160, so long as they are opposite configurations. Specifically, in the preferred embodiment, the first and second cap sections130and168are each positionable between an open position and a closed position. In their respective closed positions, the corresponding sterile engagement faces132and169of the first and second cap sections130and168are correspondingly coupled in sealing relation at the second end128of the hub assembly120and at the second inlet port162of the ventilator coupling160. When in the open position, however, due to the preferred opposing configurations of the sterile engagement faces132and169, the sterile engagement faces132and169are structured to be selectively and matingly coupled with one another. Such coupling functions to maintain sterility of the sterile engagement faces132and169when not being used to cover the respective openings. Moreover, such interconnection generally stows the sterile cap assembly. It is seen that in a preferred embodiment, the first cap section130is tethered by an elongate segment to the hub assembly120, preferably at an annular ridge129defined on the hub assembly120, and the second cap section168is similarly tethered by an elongate segment to the ventilator coupling160at preferably an annular ridge defined on the ventilator coupling160.

Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents. Furthermore, it is noted that the device of the present invention may also be utilized with similar medical tubes, such as a thoracostomy tube.

Now that the invention has been described,