Nasopharyngeal airway system device

A nasopharyngeal airway device is provided to be used in conjunction with an oxygen source and a capnometer. In one or more non-limiting embodiments, the nasopharyngeal airway device provides adequate oxygen delivery and monitors capnography output more efficiently. The device includes a nasal trumpet having one or more lumens, and a nasal cannula having a tube portion and at least two prongs. A first prong is insertable into a nasal cavity of a human subject, wherein the remaining prongs are equal in number to a number of one or more lumens of the nasal trumpet. The remaining prongs are adjacent to each other on the tube portion and configured to snugly fit into the nasal trumpet. The gases may pass into the nasal cannula from their respective ends into the prongs which may be separated by a single closure in the cannula so as to prevent the mixture of gasses.

FIELD OF THE DISCLOSURE

The present invention relates to a system and device for sedation monitoring when administering anesthesia versus sedation in a hospital or clinical setting. In particular, the system and device herein relate to embodiments that allow for sedation monitoring using a nasopharyngeal airway device.

BACKGROUND

Annually in the United States, there are about 250 million sedation procedures completed for patients undergoing an endoscopy or a dental procedure in a year. In adhering to best practice standards in sedation, optimal management of the patients during these sedation procedures is imperative. These standards of practice include adhering to the standards for basic anesthetic monitoring developed by the Standards and Practice Parameters Committee (CSPP) of the American Society of Anesthesiologists (ANA), guidelines from the American Association of Nurse Anesthetists (AANA), and recommendations from the Anesthesia Patient Safety Foundation (APSF). Many unique and specific responsibilities need to be considered by providers involved in the management of patients during sedation. Patient selection criteria, adequately trained staff, accessibility to emergency medication and equipment, and abiding by standards of care are all part of providing quality care.

Sedation monitoring comprises of obtaining body temperature, pulse oximetry, electrocardiogram, blood pressure, oxygen analysis when oxygen is delivered through a breathing system, and end-tidal carbon dioxide (CO2) when administering anesthesia. A monitor for the presence of expired carbon dioxide when administering moderate or deep sedation is a standard of care where supplemental oxygen is provided for such patients to their lungs and their exhaled carbon dioxide level (capnography) is monitored.

Currently, such procedures are completed with a nasal cannula device that provides both oxygen and carbon dioxide monitoring at the level of the external nares. Two main issues arise with providing oxygen and accurate carbon dioxide monitoring to a sedated patient during a surgical procedure with a nasal cannula. Firstly, a nasal cannula cannot ensure adequate/predictable airway flow to the lungs, especially through an anatomical barrier, for example a deviated septum that is present in about 70-80% of the population. Secondly, this deviated septum also can hinder the ability to accurately detect carbon dioxide. This altered anatomy has often been bypassed with a nasopharyngeal airway, however, this has the drawback of an inability to detect carbon dioxide or provide a closed system for accurate monitoring.

Accordingly, there is still an unsolved need for sedation monitoring during anesthesia administration using a nasopharyngeal airway device that may address these and other existing issues.

SUMMARY

One or more embodiments are provided below for a nasopharyngeal airway system device. The nasopharyngeal airway system (NPAS) provides the ability for providers administering sedation to abide by the standards of care to monitor end-tidal carbon dioxide and the delivery of supplemental oxygen when needed. The nasopharyngeal device of the present invention addresses the aforementioned drawbacks by providing adequate oxygen delivery through variations of nasal anatomy while predictably monitoring capnography output which isn't currently available through the traditional nasopharyngeal airway devices. The unique connection between the nasal piece and the nasopharyngeal airway addresses both problems of delivering adequate oxygen to the lungs through the nasopharyngeal airway component while the carbon dioxide sensor at the level of the oropharynx and laryngopharynx provides capnography monitoring. The NPAS device inherently implements standards of care surrounding sedation and/or anesthesia.

The NPAS device may be configured in different sizes to address both pediatric and adult nasal airways. The nasopharyngeal device of the present invention is advantageous over current devices as it is beneficial with long sedation cases to execute consistent monitoring, improve quality of care, implement standards of care, and minimize distractions for the provider, allowing increased efficiencies throughout procedures. The NPAS device can also have a cascade effect potentially minimizing delays in trouble shooting monitoring errors, decreasing turnover time between cases, and increasing patient volume by opening up patient selection criteria due to the increased sensitivity of monitoring. This is advantageous to the provider and support staff, and most importantly increases safety for the patient.

DETAILED DESCRIPTION

The term “coupled to” as used herein may mean a direct or indirect connection via one or more components.

The present disclosure is generally drawn to various embodiments for nasopharyngeal airway systems. The use of nasopharyngeal airway systems is required in situations where an artificial form of airway maintenance is necessary and/or where tracheal intubation is impossible, inadvisable, unnecessary, or an additional monitoring device is desired. When a patient becomes unconscious, the muscles in the jaw commonly relax and can allow the tongue to slide back and obstruct the airway, especially in the supine position. This makes airway management necessary by using a device that maintains an open airway. The various embodiments of the nasopharyngeal airway system described in the present invention is one of the available tools to maintain an open airway. In one or more non-limiting embodiments, the present description provides embodiments for a nasopharyngeal airway system that makes it possible to provide adequate oxygen delivery and monitor capnography output. Capnography is a clinical procedure used for the measurement of CO2levels in respired air at the end of expiration (End Tidal CO2or ET CO2). In particular, the one or more non-limiting embodiments for a nasopharyngeal airway system device allows a more direct way of monitoring end tidal CO2.

Accordingly, the one or more non-limiting embodiments provided below describe a nasopharyngeal airway device and system used in conjunction with an oxygen source and a capnometer (measures end tidal CO2). The subjects in which the nasopharyngeal airway device and system may be used are human subjects, including both male and female subjects, and including adult and pediatric populations, such as geriatric, adolescent, infant, and neonate. In addition, the nasopharyngeal airway device and system can be modified and adapted for use in animal subjects where sedation and monitoring are utilized in veterinary sciences. Thus, the embodiments provided herein may be fashioned in multiple sizes to accommodate for variations in nasal anatomy including adult and pediatric sizes. Further details are provided below with reference to the Figures.

Turning to the figures,FIGS.1to7are pictorial illustrations depicting a nasopharyngeal airway system100which is an example of a system for efficiently and adequately providing oxygen and for monitoring end tidal CO2. In one or more non-limiting embodiments, the nasopharyngeal airway system100comprises a nasal trumpet110and a nasal cannula120. The nasal trumpet110is a tube that is designed to be inserted through a human subject's nasal passage down to the posterior pharynx to secure an open airway. As seen inFIG.2, the nasal cannula120is inserted into the nasal trumpet110, wherein an oxygen source and a capnometer are connected to the nasal cannula120.

FIG.1illustrates an expanded view of the device100. Specific attention is drawn to the nasal trumpet110which can be defined as having a proximal end112and a distal end114. The proximal end112and the distal end114are used herein to describe portions of the present invention with respect to when the nasal trumpet110is in use, and thus the proximal end112is the end that is on an outside of a subject's nasal passageway and the distal end114is the end that is inserted into the nasal passageway. The proximal end112is like most other nasal trumpets in that the proximal end112includes features that are designed to be flared to prevent the nasal trumpet110from being inserted fully into a nasal passageway.FIGS.1,2, and5-7illustrate the proximal end112with a flared end, which is an example of a feature which prevents the nasal trumpet from being fully inserted into a nasal passageway. The nasal trumpet110is tubular in structure and is dimensioned so that the distal end114is insertable through a nasal passageway and into the nasopharynx, preferably the posterior nasopharynx, of a subject. The distal end114is shown to have an angled tip (not blunt), such that the insertion of the distal end114is easier.

FIG.5illustrates a front view of the proximal end112of the nasal trumpet110.FIG.6illustrates a side view of the nasal trumpet110which provides a front view of the distal end114of the nasal trumpet110. An interior of the nasal trumpet110may be divided into two or more lumens. In the figures shown, the interior of the nasal trumpet110is divided into two lumens to allow more delivery of oxygen while also detecting CO2. For example, a first lumen116delivers oxygen and a second lumen118intakes ET CO2. It is to be understood that either side can deliver oxygen and detect ET CO2and is dependent on the nasal cannula120connections to the nasal trumpet110and how the external sources are connected to the nasal cannula120. The figures illustrate the double lumen in the nasal trumpet110extending from the proximal end112to the distal end114to keep the oxygen delivery and the ET CO2detection separated and prevent dilution. As shown, the first lumen116and the second lumen118are opposed to each, but it is to be understood that the lumens116,118do not have to be opposed to each other, and further can also be of different lengths, wherein one of the lumens can be longer than the other lumen. The illustrations also show the lumens116,118having a semi-circular geometry and having a similar radius. It is to be understood that the lumens116,118can have different radii. Additionally, the lumens116,118can also be of different shapes and the shape of the lumens can vary between the two. The shapes of the lumens can include, and are not limited to, an oval, a quadrilateral, a triangle, and a polygon.

In one or more non-limiting embodiments, the nasal cannula120is a tube that delivers supplemental oxygen to a subject and receives the ET CO2from the subject to monitor optimal respiration. The nasal cannula120has a tube portion125which includes two ends,126,127that receive and deliver oxygen and ETCO2. The tube portion125has one or more prongs projecting away from the tube portion125. As seen in one or more non-limiting embodiments inFIGS.1-4, the nasal cannula120includes a first prong121that is intended to be inserted into a nostril of a subject, and a second prong122and a third prong123that are intended to be inserted into the proximal end112of the nasal trumpet110. As seen in the Figures, the second and third prongs122,123are adjoined together, however each have a separate lumen so that the gasses (i.e., oxygen and CO2) do not mix with each other and negatively affect the concentration of each.

FIG.3illustrates that the tube portion125between the second and third prongs122,123, is closed off internally, which is indicated by the reference number124. The internal closure124ensures that the gasses do not mix in the tube portion125and each prong122,123is kept separate. In this example, the first and second prongs121,122deliver oxygen through and the third prong123receives ETCO2or vice versa. It is to be understood that alternatively as shown inFIG.8, the internal closure124can be formed between the first prong121and the second prong122, so that both the second and third prongs122,123are serving the same purpose which is separate from the purpose of the first prong121. For example, the second and third prongs122,123deliver oxygen through the nasal trumpet110and the first prong121receives ETCO2or vice versa.

As seen in the figures, the second and third prongs122,123have insertion tips122a,123athat are inserted into the proximal end112of the nasal trumpet. The insertion tips122a,123aare separated from each other by a gap such that the insertion tips122a,123acan be inserted into their respective lumen in the nasal trumpet110. The example inFIG.3illustrates a top perspective view of the nasal cannula120to provide a clear view of the gap between the insertion tips122a,123a. The insertion tips122a,123afit into the first and second lumens116,118, respectively, to provide an airtight connection with the nasal cannula120allowing the gasses to move between the nasal trumpet110and the nasal cannula120. The insertion tips122a,123ahave a shape that is commensurate with the shape of the lumens116,118. As discussed above in regard to the nasal trumpet, the lumens116,118can include different shapes and sizes, and thus, the insertion tips122a,123aon the second and third prongs122,123would be commensurate with those shapes and sizes.

In the non-limiting example shown in the figures, the first prong121is intended to be inserted directly into a subject's nostril to deliver supplemental oxygen. The second prong122is also denoted as delivering oxygen, while the third prong123is denoted as receiving the ET CO2. It is to be understood that the notations are only for the purposes of illustration and clarity, however, delivery of oxygen and receiving the ET CO2can be done through either of the adjoined prongs122,123. Also, as discussed above, the internal closure124separates the second and third prongs122,123thereby separating the gasses moving through them. Also discussed as an alternative embodiment, the second and third prongs122,123are not separated from each other and thereby share the same movement of gas, either delivery of oxygen or receiving of ETCO2. In this embodiment, the first prong121is separated from the second and third prongs122,123by the internal closure124being configured between the first prong121and the second prong122.

In use, the nasal trumpet110is inserted through a nasal passage of a subject, wherein the distal end114reaches down to the posterior pharynx to bypass obstructive anatomy to give access to provide an open airway and/or secure an open airway. The proximal end112of the nasal trumpet110is positioned just outside of the subject's nares. The nasal cannula120is then connected to the proximal end112of the nasal trumpet via the second and third prongs122,123. The insertion tips122a,123aof the second and third prongs122,123are inserted in to the first and second lumens116,118on the proximal end112of the nasal insert110. The first prong121of the nasal cannula120is inserted into the adjacent nostril and positioned just inside of the nasal vestibule. An oxygen supply is connected to the first end126of the tube portion125which delivers oxygen through the first and second prongs121,122. A capnometer is connected to the second end127which receives ETCO2from the third prong123. Additionally, internal closure124separates tube portion125between second and third prongs122,124. It is to be understood, that alternatively, the oxygen supply may be connected to second end127of the tube portion125and the capnometer may be connected to the first end126wherein the first prong121of the nasal cannula120receives ETCO2and second and third prongs122,123deliver oxygen. Additionally, internal closure124separates tube portion125between first prong121and second prong122.

Alternative embodiments exist for the nasopharyngeal airway system, which can be readily appreciated by people skilled in the arts. For example, the nasopharyngeal airway system may include a nasal trumpet that is configured from a material that is radio-opaque for allowing x-ray visualization and computed tomography (CT) visualization. Alternative embodiments may also include a balloon on the distal end of the nasal trumpet or anywhere along the nasal trumper. Other non-limiting embodiments may also include integration of a suction catheter.

Accordingly, the present description provides for various embodiments for a nasopharyngeal airway system delivering oxygen while measuring CO2exhaled from a subject undergoing sedation are described. Many advantages are offered by these nasopharyngeal airway systems as described above in one or more non-limiting embodiments.

The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated. The present invention according to one or more embodiments described in the present description may be practiced with modification and alteration within the spirit and scope of the appended claims. Thus, the description is to be regarded as illustrative instead of restrictive of the present invention.