Patent Description:
When a patient has been administered general anesthesia for a surgical procedure or for emergency airway access in cases requiring ventilatory support, it is common to insert a device, such as an endotracheal tube, through the mouth or nose and into the trachea to establish and maintain a patent airway. In most cases, the endotracheal tube includes an inflatable cuff that surrounds the tube and that is inflated with air or another fluid to seal the tube within the trachea. Such a seal both ensures that air can reach the patient's lungs, for instance when positive pressure ventilation is performed, and that the lungs do not aspirate contents from the patient's stomach, for instance when the patient vomits while an individual is unconscious or only partially awake. Unfortunately, however, inflation of the endotracheal tube cuff can place excessive pressure on the patient's adjacent tissues, such as mucosa of the trachea, which can cause tissue damage.

Over the past two decades additional airway devices such as the laryngeal mask airway (LMA) have become a common airway management device used by the anesthesia and emergency responder community. Such devices do not have a cuff that is inflated within the trachea and further is not inserted into a trachea. Instead, an elliptical mask is provided at the end of a tube and is deployed within the pharynx to form a seal on top of the glottis. As a cuff is not inflated within the trachea, the type of damage to trachea that can be caused by endotracheal tubes is avoided. However, LMAs do not always form an adequate seal over the glottis and, therefore, may not actually secure the airway as would an endotracheal tube. This can, for example, be the case when the mask is not fully inflated or the inflated mask does not fit well the anatomy of the patient. Even if the mask fits well to the patient anatomy and creates a good seal, the pressure applied to the pharynx can cause tissue trauma and its related complications, such as throat pain, nausea and vomiting.

In addition, difficult trachea intubation is frequently encountered during emergency resuscitation outside of the hospital setting. LMA is a recommended alternative in case trachea intubation is difficult or impossible. However, the LMA may not be inserted appropriately by the medical professional and/or a gas jet generated from positive pressure ventilation may cause gas to enter the stomach.

Prior art examples of insertable tubes via the mouth are disclosed in published <CIT>), <CIT>), published <CIT>), <CIT>) and published <CIT>). The document <CIT>, for example, discloses a fluid delivery and airway management device including a tubular member dimensioned for introducing a fluid into a trachea of a mammal, the tubular member having a proximal portion, a distal portion, and a middle portion between the proximal portion and the distal portion. The tubular member is dimensioned for positioning of the proximal portion in an oral cavity of a mammal, the middle portion in an oropharynx of the mammal and the distal portion in an esophagus of the mammal. An inflatable oral cavity balloon is positioned at the proximal portion and dimensioned to occlude the oral cavity. An inflatable esophageal balloon is positioned at the distal portion and dimensioned to occlude the esophagus. Apertures may be formed within the middle portion such that a fluid introduced into the tubular member is output through the apertures to a trachea. The device also includes a stabilizer. The stabilizer is positioned along a portion of tubular member positioned to anchor the gum thus stabilizes the device in the mouth.

In view of the above discussion, it can be appreciated that it would be desirable to have an alternative means for establishing a patent airway.

The present disclosure may be better understood with reference to the following figures. Matching reference numerals designate corresponding parts throughout the figures, which are not necessarily drawn to scale.

The invention relates to a pharyngeal tube for establishing an airway within a patient as defined in the claims. As described herein, the pharyngeal tube comprises: an elongated hollow tube including a proximal end and a distal end; a mouthpiece provided at the proximal end, wherein the mouthpiece is configured to provide an airtight seal at the mouth of the patient; and one or more lateral openings provided at or near the distal end of the hollow tube, the one or more lateral openings being formed in a lateral wall of the hollow tube; wherein a distal tip of the hollow tube is sealed so that air cannot escape the tube from its distal tip. The mouthpiece comprises an inner flange and an outer flange that are configured for placement on both the inside and outside of the patient's lips so as to form the airtight seal at the patient's mouth. The pharyngeal tube is configured to establish a patient airway without inflating a balloon or other sealing element within the trachea or pharynx by only sealing at the patient's mouth. In an embodiment, the inner flange is configured to be positioned between the patient's teeth and lips, and the outer flange configured to be positioned on the outside of the patient's lips. The hollow tube comprises multiple lateral openings or the hollow tube comprises a single lateral opening. In some embodiments, the pharyngeal tube further comprises a pressure relief valve configured to vent air from the hollow tube when pressure within the hollow tube exceeds a predetermined pressure threshold. In some embodiments, the hollow tube further includes an inner septum that divides the tube into first and second lumens that are connected at the distal end of the tube. In certain embodiments, the hollow tube further comprises an inner channel that that extends along the inner surface or in the wall of the tube. In some embodiments, the inner channel is configured to exist as a suction or injection catheter. In other embodiments, the inner channel is configured to exist as a catheter that can be used as a carbon dioxide or other gas sampling line. In some embodiments, the suction catheter is associated with a reservoir in which fluid removed from the hollow tube can be deposited. In some embodiments, the hollow tube has multiple inner channels. A first channel is for inspiratory gas flow and a second channel is for expiratory gas flow in order to reduce dead space of ventilation. In some embodiments, the first lumen is for inspiratory gas flow and the second lumen is for expiratory gas flow. In alternative embodiments the inner channel contains a gastric tube. In still other embodiments a gastric tube is attached and runs parallel to the pharyngeal tube.

The foregoing has outlined various features of the present disclosure in order that the detailed description that follows may be better understood and is not indicative of all possible embodiments of the invention. Additional features and advantages of the disclosure will be described hereinafter.

Referring to the drawings in general, not necessarily shown to scale, it will be understood that the illustrations are for the purpose of describing particular implementations of the disclosure and are not intended to be limiting thereto. While most of the terms used herein will be recognizable to those of ordinary skill in the art, it should be understood that when not explicitly defined, terms should be interpreted as adopting a meaning presently accepted by those of ordinary skill in the art.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention, as claimed. In this application, the use of the singular includes the plural, the word "a" or "an" means "at least one", and the use of "or" means "and/or", unless specifically stated otherwise. Furthermore, the use of the term "including", as well as other forms, such as "includes" and "included", is not limiting. Also, terms such as "element" or "component" encompass both elements or components comprising one unit and elements or components that comprise more than one unit unless specifically stated otherwise.

As described above, it would be desirable to have means for establishing a secure airway that minimize or avoid common complications, such as failure of establishing a patent airway, patient tissue trauma, or nausea with risk of aspiration associated with conventional devices. Disclosed herein are examples of such device and means. In one embodiment, a pharyngeal tube is used to establish a patent airway without inflating a balloon or other sealing element within the trachea or pharynx but only at the opening of the mouth. As used herein the term secure airway indicates a patent airway with an open pathway between a patient's lungs and the outside world. The pharyngeal tube comprises an elongated hollow tube that is configured for insertion into the pharynx via the mouth. At the proximal end of the tube are flanges that are configured for placement on both the inside and the outside of the patient's lips so as to form a seal at the patient's mouth. Near the distal end of the tube are one or more openings formed in the lateral walls of the tube that enable air to exit the tube in the lateral direction and enter the pharynx and trachea. As there is no opening provided at the distal tip of the tube, the air pressure is sufficient to maintain patency of the pharynx and no air is directed toward the esophagus, thereby minimizing or avoiding gastric insufflation. During expiration, the recoil of lung and chest wall generates a pressure gradient which allows the gas expired from lung to enter the side openings and exhaled through the pharyngeal tube.

In the following application, various specific embodiments are described. It is to be understood that those embodiments are example implementations of the disclosed inventions and that alternative embodiments are possible.

<FIG> illustrates an example embodiment of a pharyngeal tube <NUM>, which is shown inserted into a patient so as to establish a patent airway. As is shown in the figure, the pharyngeal tube generally comprises an elongated hollow tube <NUM> having a proximal end <NUM> that is configured via an adapter to connect to the hose <NUM> of a ventilator (not shown) and a distal end <NUM> that is configured to be positioned within the oropharynx in proximity to the epiglottis and the trachea. The tube <NUM> is made of a suitable biocompatible material, such as polyvinyl chloride, and can either be semi-rigid or flexible. The various dimensions of the tube <NUM>, including inner/outer diameter, length, curvature, etc., can be tailored so as to best suit the dimensions of patients of different sizes. Generally speaking, however, the tube <NUM> is long enough so that its distal end <NUM> can bypass the soft palate, tongue, and epiglottis, and the inner dimension (e.g., inner diameter) of the tube is sufficient to provide adequate air supply to the patient to maintain patency and facilitate adequate ventilation.

As is apparent in <FIG>, a mouthpiece <NUM> is provided at the proximal end <NUM> of the tube <NUM>. This mouthpiece <NUM> includes both an inner flange <NUM> configured to be positioned between the patient's lips and teeth or gums, and an outer flange <NUM> configured to be positioned against the outside of the patient's lips. With such a configuration, the mouthpiece <NUM> or inner/outer flanges <NUM>, <NUM> can form an airtight seal at the patient's mouth, thereby preventing leakage of the pressurized air that is delivered using the pharyngeal tube <NUM>. In some embodiments, the inner or outer flanges <NUM>, <NUM> may be generally oblong-shaped. The inner flange <NUM> is generally smaller in size than the outer flange <NUM> so that it may be easily inserted in a patient's mouth and positioned between the lips and teeth or gums. The outer flange is shaped to be larger than a patient's mouth to allow an airtight seal to be formed. In some embodiments, the inner or outer flanges <NUM>, <NUM> or mouthpiece <NUM> may be any suitable biocompatible material that is flexible or semi-flexible, which aids formation of the airtight seal. While the embodiments shown are generally planar, some embodiments of the inner or outer flanges <NUM>, <NUM> or mouthpiece <NUM> may be shaped or contoured to aid formation of an airtight seal, such as, but not limited to a convex-shape. Analysis of a nonlimiting prototype's generally planar inner or outer flanges, comprised of silicone, illustrated that such flanges were capable of sustaining a desired airway pressure, such as of <NUM> H2O or greater. In some embodiments, an elastic strap may secure ends of the outer flange <NUM> or mouthpiece <NUM> (e.g. <FIG>). Placement of the strap about the patient's head may further aid formation of an airtight seal.

Provided at or near the distal end <NUM> of the tube <NUM> are one or more side openings <NUM> of sufficient size and shape to allow pressurized air to be delivered through the tube to the patient or ejected in reverse direction from the tube during expiration. Further, the tube <NUM> or openings <NUM> may also maintain patency of the pharynx and trachea enabling adequate ventilatory support. Because this design also allows positive end expiratory pressure (PEEP), for instance at <NUM>-<NUM> H2O, the pharynx is kept patent. If the patient is kept on spontaneous breathing, the negative pressure generated during inspiration and positive pressure generated by the recoiling of chest wall and lung create the pressure gradient through the side openings and allow air in during the inspiratory phase and out during the expiratory phase. If the patient is kept on mechanical ventilation, the inward gas flow is generated by the pressure gradient in the inspiratory phase and the reverse flow is generated by the recoiling of chest wall and lung as it occurs in the spontaneous breathing. The airtight seal of the device occurs at the mouth, therefore positioning of the device does not require a seal at the glottis. In the illustrated embodiment, these openings <NUM> may take the form of small circular shaped openings that are formed in the lateral wall of the tube <NUM>, but it shall be understood by one of ordinary skill that any other shaped opening(s) may be utilized in other embodiments. Accordingly, the openings <NUM> may be referred to as lateral openings. Notably, while multiple openings <NUM> are shown in <FIG>, in some embodiments a single, relatively large opening can be provided instead of multiple relatively small openings (e.g. <FIG>). Such an embodiment allows for the insertion of a bronchoscope. This single large opening would be orientated to face anteriorly and a bronchoscope can be inserted through the large side opening. In addition, an endotracheal tube can be inserted using the bronchoscope as the guide wire. The single opening can be arranged at different angles relative to the central axis of the tube <NUM> and are in no way limited to the particular arrangements or orientations shown in the figures.

Although one or more lateral openings <NUM> are provided near the distal end <NUM> of the tube <NUM>, it is noted that the distal tip <NUM> of the tube is sealed (i.e., comprises no openings) so that air can only escape from the tube in lateral directions.

With further reference to <FIG>, the proximal tip of the tube <NUM> can comprise a suitable connector <NUM> that is configured to connect to the ventilator tube.

To use the pharyngeal tube <NUM>, it is passed through the patient's mouth, soft palate, tongue, and epiglottis until the distal end <NUM> is positioned in the pharynx adjacent to the trachea. In some embodiments, the distal end <NUM> may reach the proximal portion of esophagus or possibly enter trachea through glottis. The patient's lips are positioned between the inner and outer flanges <NUM>, <NUM> so as to form a seal. For example, the inner flange <NUM> is positioned between the patient's lips and teeth or gums, and an outer flange <NUM> is positioned against the outside of the patient's lips. Next, the ventilator tube can be connected to the connector <NUM> located at the proximal tip of the tube <NUM>. When this positioning is performed, the tube <NUM> will be positioned in similar manner to that shown in <FIG>.

<FIG> shows the intubated patient in front view. Once the tube <NUM> has been so positioned, pressurized air generated by the ventilator can be delivered to the tube <NUM>. This air flows through the tube <NUM> and is ultimately ejected from the lateral openings <NUM>. The pressure provided by this ejection maintains the pharynx orientation such that the air is delivered to the patient's lungs. Also shown in <FIG> is a ventilator tube <NUM> connectable to tube <NUM>, and a strap <NUM> that secures the mouthpiece <NUM> or outer flange <NUM> to the patient's head. Such a tube <NUM> can serve as the conduit for spontaneous ventilation as well, if the patient's own ventilatory effort can generate adequate pressure gradient through the tube <NUM>.

As discussed previously, the pharyngeal tube need not include multiple openings. For example, the tube can instead comprise a single, relatively large opening. <FIG> illustrates an example of such an embodiment. As shown in this figure, the pharyngeal tube <NUM> is similar in many ways to the pharyngeal tube <NUM> shown in <FIG> and <FIG>. Therefore, the pharyngeal tube <NUM> generally includes an elongated hollow tube <NUM> having a proximal end <NUM> and a distal end <NUM>. A mouthpiece <NUM> is provided at the proximal end <NUM> of the tube <NUM> and includes an inner flange <NUM> and an outer flange <NUM>. In this embodiment, however, a single, relatively large lateral opening <NUM> is provided at or near the distal end <NUM> of the tube <NUM>. In the illustrated embodiment, this opening <NUM> is positioned on the inner side of a curve traced by the tube <NUM> such that, when inserted, it will face the trachea. As a nonlimiting example, with this relatively larger lateral opening <NUM> in comparison to other embodiments, a bronchoscope (not shown) can be passed through the tube <NUM> and out through the opening into the trachea. In addition, the large lateral opening <NUM> can be used to perform tracheal intubation. As with the tube <NUM>, the distal tip <NUM> of the tube <NUM> is sealed. In the illustrated embodiment, the pharyngeal tube <NUM> also includes a pressure relief valve <NUM> that is configured to vent air from the tube <NUM> when the pressure within the tube exceeds a predetermined threshold, for example, <NUM> of water.

It shall be understood that the exemplary embodiments discussed above may incorporate other features from further embodiments discussed herein or vice versa. For example, the pressure relief valve <NUM> may be included in the initial embodiment of <FIG> or any of the other embodiments discussed herein. Further, it shall be recognized by one of ordinary skill that various features discussed further herein, such as but not limited to an inner septum, inner channel, integrated of separate gastric channel, etc., are not limited to the embodiments shown and may be incorporate or merged with other embodiments.

<FIG> illustrates a further embodiment for the elongated tube that can be used in a pharyngeal tube of the type described above. Illustration of the proximal end of the elongated tube, mouthpiece, and other components are omitted for clarity, but it shall be understood they may be present. As shown in <FIG>, the tube <NUM> can comprise an inner septum <NUM> that separates the inside of the tube into two lumens. In this embodiment, the septum does not run the full length of the tube such that the two lumens join each other at the distal end of the tube. Pressurized air can be delivered to a first lumen <NUM> defined by the septum <NUM> and ejected from one or more lateral opening(s) <NUM>. If any fluid enters and collects in the bottom of the tube <NUM>, it can be removed via a second lumen <NUM> defined by the septum <NUM>, which can be connected to a suction source (not shown). With this functionality, the gas enters via the first lumen and exhaled via the second lumen in order to reduce dead space ventilation and improve breathing efficiency.

<FIG> illustrates yet another embodiment in which a separate channel is built into the elongated tube that can be used in a pharyngeal tube of the type described herein. Illustration of the proximal end of the elongated tube, mouthpiece, and other components are omitted for clarity, but it shall be understood they may be present. As shown in <FIG>, the tube <NUM> includes one or more lateral opening(s) <NUM> just like the tube <NUM>. In addition, however, the tube <NUM> includes a small inner channel <NUM> that extends along at least a portion of the inner surface of the tube. A small diameter suction catheter <NUM> can be passed through the channel <NUM> in order to remove any fluid that has collected within the tube <NUM>. This fluid can be deposited in a reservoir <NUM> associated with the catheter <NUM>. Channel <NUM> can also be used to sample carbon dioxide gas for measurement of end-tidal carbon dioxide concentration. Should gastric content enter the pharyngeal cavity, because the pharyngeal tube lies below the glottis when the patient is in a supine position, gravity will assist in sustaining the liquid in the lumen of the pharyngeal tube where the liquid could be removed by suction via the CO2 sampling line before it can be aspirated into the lungs. Such liquid in the CO2 sampling line of the pharyngeal tube would alert the medical professional and help manage aspiration. If it is used for sampling carbon dioxide, chamber <NUM> can serve as a reservoir to trap secretions emanating from the patient. In some embodiments the catheter <NUM> can be a built-in or integrated, instead of a channel for insertion of a catheter.

<FIG> illustrates yet another embodiment of the pharyngeal tube <NUM> that has a separate channel <NUM> for insertion of a gastric tube <NUM> as shown. This channel <NUM> is used for insertion of a gastric tube <NUM> that enters the esophagus for positioning distally. The proximal end of the channel <NUM> is adjacent to the proximal opening of the pharyngeal tube <NUM>, the channel runs through at least a portion of the pharyngeal tube, and the distal end of the channel is located at or near the distal end of the pharyngeal tube. A gastric tube <NUM> inserted through the channel <NUM> enters esophagus and then stomach. When ventilation occurs through a pharyngeal tube, gastric content including insufflated air can be suctioned out using negative pressure applied to the proximal end of the gastric tube <NUM>. In some embodiments the separate channel <NUM> allows the insertion of alternative devices, such as, but not limited to endoscopic or other devices.

<FIG> illustrates an embodiment of the pharyngeal tube <NUM> in which the gastric tube <NUM> is separated from and parallel to the pharyngeal tube. The gastric tube is inserted through the esophagus and then into the stomach. When ventilation occurs through a pharyngeal tube, gastric content including insufflated air can be suctioned out using negative pressure applied to the proximal end of the gastric tube.

<FIG> illustrates an embodiment in which the tube comprises a single, relatively large opening <NUM> similar to the embodiment of <FIG>. Various components sharing the same numbering as <FIG> are also present (see prior discussion of <FIG> for further detail). Starting near the proximal end of the pharyngeal tube <NUM> are perforations extending lengthwise <NUM> along the wall of the tube all the way to the opening <NUM> (<FIG>).

<FIG> illustrates an embodiment of the pharyngeal tube which encompasses the pharyngeal tube <NUM>, and further comprises an additional port <NUM> in the mouthpiece <NUM> that may allow an endoscope or the like to be inserted through the mouthpiece. The port <NUM> may be positioned on the mouthpiece adjacent to the opening for tube <NUM>. These ports may be fitted with any suitable one-way valve, by way of example but not limitation, a check valve, multiple flexible flap or membrane valve, for example, a duckbill valve. This allows the maintenance of a patent airway using positive pressure ventilation while also using the endoscope. This configuration allows the endoscopy to be performed with a patient under deep sedation and without tracheal intubation.

Claim 1:
A pharyngeal tube comprising:
an elongated hollow tube (<NUM>, <NUM>) including a proximal end (<NUM>, <NUM>) and a distal end (<NUM>, <NUM>) for establishing a patent airway for a patient;
a mouthpiece (<NUM>, <NUM>) provided at the proximal end, wherein the mouthpiece is configured to provide an airtight seal at the mouth of the patient, wherein the mouthpiece comprises an inner flange (<NUM>, <NUM>) and an outer flange (<NUM>, <NUM>) that are configured for placement on both the inside and outside of the patient's lips so as to form the airtight seal at the patient's mouth; and
one or more lateral openings (<NUM>, <NUM>, <NUM>) provided at or near the distal end (<NUM>, <NUM>) of the hollow tube, wherein the one or more lateral openings are formed in a lateral wall of the hollow tube, and a distal tip (<NUM>, <NUM>) of the hollow tube is sealed so that air cannot escape the tube from its distal tip,
wherein the pharyngeal tube is configured to establish a patent airway without inflating a balloon or other sealing element within the trachea or pharynx but only sealingat the patient's mouth.