Airway assist device and method

An airway assist device (AAD) is provided. The device includes an upper AAD component and a lower AAD component. The upper AAD component includes and upper tooth guide connected to an upper plate having a pair of depending legs. The upper AAD component further includes an upper force receiving plate. The AAD also includes a lower AAD component. The lower AAD component includes a lower tooth guide connected to a lower plate. The lower AAD component further includes a lower force receiving plate. The upper and lower AAD components are connected in a way that allows relative longitudinal movement between the two components between a neutral position and a plurality of extended positions. A ratchet mechanism inhibits movement of the lower plate from any extended position toward the neutral position. The ratchet mechanism may be manually disengaged to allow the lower AAD component to return to the neutral position. An oxygen delivery housing may be connected to the upper plate to distribute oxygen.

FIELD OF THE INVENTION

The present invention relates generally to an airway assist device that allows for mandibular distraction.

BACKGROUND OF THE INVENTION

Maintaining a patient airway is essential and a prime tenet of the ABC's of resuscitation. Numerous human conditions can create upper airway obstruction that mandate interventional treatment. Some conditions that can create upper airway obstructions include conditions related to anesthesia, obstructive sleep apnea (OSA), cardiopulmonary collapse and convulsions. Multiple strategies exist to maintain an airway. These include Esmarch technique (bimanual jaw-thrust), nasopharyngeal (Wendl) airways, oropharyngeal (Guedel) airways, bag and mask, supraglottic airway (SGA) that include the laryngeal mask airway (LMA), endotracheal intubation and mandibular advancement/repositioning devices/appliances (MAD's/MRA's).

It would be desirable to provide a device and method to maintain airway patency, and particularly the oropharynx and retropalatal space by providing an improved device that allows for lower jaw protrusion and/or distraction. It may also be desirable to have a device to maintain airway patency that can also supply oxygen and/or monitor end-tidal carbon dioxide wave form and respiratory rate.

SUMMARY OF THE INVENTION

According to an embodiment, there is provided an airway assist device (AAD). The AAD comprises a first airway assist component including an upper plate and an upper tooth guide. The AAD further comprises a second airway assist component including a lower plate and a lower tooth guide connected to the lower plate. The first airway assist component is connected with the second airway assist component to allow relative longitudinal movement between the first and second airway assist components between a neutral position and at least one extended position. A ratchet mechanism acts between the first and second airway assist components. The ratchet assembly allows for movement of the second airway assist component from the neutral position to an extended position and inhibits movement of the second airway assist component from an extended position toward the neutral position. An oxygen delivery housing is connected to the upper plate.

According to an embodiment, there is provided a method of maintaining airway patency. The method comprises positioning an upper tooth guide of a first airway assist device component relative to a patient and positioning a lower tooth guide of a second airway assist device component relative to a patient. A force is applied to the second airway assist device component in a direction away from the patient to move the second airway assist device component relative to the first airway assist device component to distract the patient's mandible; and maintaining the second airway assist device component in an extended position by a ratchet mechanism.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

An embodiment of an airway assist device (AAD) are generally shown at10in the Figures. The AAD10may be useful to allow for lower jaw protrusion and/or distraction that opens the posterior airway (PAW) space and may also allow for supplemental oxygen delivery. The protrusion may, in some instances, allow for anterior displacement of the vertical ramus of the mandible to provide access to the internal carotid artery and major cranial nerves. As best shown inFIG. 3, the AAD10may comprise a first or upper AAD component generally indicated at12and a second or lower AAD component, generally indicated at14. The upper AAD component12may comprise an injection molded component. The lower AAD14component may comprise an injection molded component. The upper AAD component12and lower AAD component14may comprise any suitable material.

In the embodiment shown, the upper AAD component12has an upper plate16. The upper plate16is preferably connected to an upper tooth guide18. The upper tooth guide18preferably envelopes a dentate or edentulous alveolar ridge of the patient. All or part of the upper tooth guide18may be covered with a relatively soft material. By way of non-limiting example, the upper tooth guide18may be overmolded with a relatively soft urethane material.

As shown, the upper plate16extends from the upper tooth guide18. The upper plate16is preferably generally rectangular. While the upper plate16is described as being generally rectangular, it will be appreciated that the upper plate16may take any suitable geometrical configuration. As best seen inFIG. 3, the upper plate16preferably includes a pair of legs20a,20bdepending therefrom. The legs20a,20bdepend from opposite sides of the upper plate16. Each leg20a,20bhas a lip22a,22bextending therefrom respectively. Each lip22aand22bextends in a direction inwardly or toward the direction of the centerline of the upper plate16. The upper surfaces of each lip22aand22bare preferably generally rectangular and are preferably relatively smooth and parallel with the bottom surface of the upper plate16. The bottom surfaces of each lip22aand22bmay be angled or ramped. The bottom side of the upper plate16, legs20a,20band lips22aand22bpreferably cooperate to form a guide to receive a lower plate30, as will be described in more detail below.

The upper plate16preferably includes a pair of spaced apart slits26. A center portion28of the upper plate16is thereby formed between the slits26. Outer portions29of the upper plate are adjacent the slits26. The legs20a,20bdepend from the respective outer portions29. The center portion28may flex relative to the outer portion29of the upper plate16in the vertical direction as the AAD10is best shown inFIG. 7.

As best seen inFIGS. 5 and 7, the center portion28of the upper plate16further includes a pawl38extending from the bottom surface thereof. The pawl38is part of a ratchet mechanism that is used to maintain the AAD10in an appropriate extended position, as will be described in more detail below.

The upper AAD component12further includes an upper force receiving plate generally indicated at24. In the embodiment shown, the upper force receiving plate24extends transversely and preferably perpendicularly to the upper plate16and is connected thereto. As shown, the upper force receiving plate24extends upwardly from the upper plate16. The upper force receiving plate24may be generally curved as shown in the Figures. It will be appreciated, however, that the upper force receiving plate24may take any suitable geometric configuration. In certain embodiments, the upper force receiving plate24may even constitute the end of the upper plate16. It will further be appreciated that the upper force receiving plate24may be disposed at locations on the upper plate16other than at the end thereof.

The upper force receiving plate24is preferably divided into a plurality of sections; two outermost sections24aand a center section24b. As shown inFIG. 2, the slits26are preferably contiguous from the upper plate16and onto the upper force receiving plate24. Each of the sections24ais preferably secured to the outer portions29of the upper plate16. The center section24bis preferably secured to the center portion28of the upper plate16. In one embodiment as shown, the outermost sections24aand center section24bare integrally formed with the outer portions29and center portion28, respectively of the upper plate16. The center section24bcan flex in the vertical direction, as is best shown inFIG. 7, relative to the outermost sections24aand along with the center portion28of the upper plate16.

The upper AAD component12is preferably molded as a single piece. And as set forth above a relatively softer urethane material may be molded over, or otherwise placed over, the upper tooth guide18. The upper AAD component12is preferably rigid. It will be appreciated, however that the legs20a,20bmay flex slightly relative to the upper plate16when AAD is being assembled, and the center portion28and center section24bcan flex relative to the outer portions29of the upper plate16and the outermost sections24aof the upper force receiving plate24, respectively.

In the embodiment shown, the lower AAD component14has a lower plate30. The lower plate30is preferably connected to a lower tooth guide32. The lower tooth guide32further may include a lower dental guard34. The lower tooth guide32may extend such that it may engage the lingual aspect of the mandible of a patient. All or part of the lower tooth guide32and dental guard34may be covered with a relatively soft material. The lower dental guard34may be relatively longer and extend relatively further downwardly as shown in the embodiments ofFIGS. 1-8or may extend relatively less downwardly as shown in the embodiments ofFIGS. 9-12By way of non-limiting example, the lower tooth guide32and/or the lower dental guard34may be overmolded with a relatively soft urethane material.

As best seen inFIG. 3, the lower plate30extends from the lower tooth guide32. The lower plate30is preferably generally rectangular. While the lower plate30is described as being generally rectangular, it will be appreciated that the lower plate30may take any suitable geometrical configuration. The lower plate30has a plurality of teeth36. The teeth36are preferably located in a position below the top surface of the lower plate30. It will be appreciated, however, that the teeth36may extend above the top surface of the lower plate30. The teeth36of the lower plate30cooperate with the pawl38on the upper plate16to form a ratchet mechanism. The teeth36and pawl38cooperate to allow the lower plate30to move outwardly, from the perspective of the patient, relative to the upper plate16from a neutral position to an extended position and to become secured in any number of extended positions. More specifically each tooth36has a generally vertical surface36aand a ramped or angled surface36b. Similarly, the pawl38includes a generally vertical surface38aand a ramped or angled surface38b. The generally vertical surface38aof the pawl38can engage the generally vertical surface36aof a tooth36to inhibit longitudinal movement of the lower plate30in one direction. The ramped surface36bof the teeth36allows longitudinal movement of the lower plate30in one direction by engaging the ramped surface38band guiding the pawl38over the respective tooth36. More specifically, as the lower plate30is moved outwardly, away from the patient, the ramped surface36bof each tooth36engages the ramped surface38bof the pawl38to thereby guide the pawl38over the respective tooth36. This allows the lower plate30to be moved in the outward longitudinal direction relative to the patient. Once the pawl38passes over the tooth36, the pawl38descends and the vertical surface38aof the pawl38can engage the vertical surface36aof the tooth to inhibit movement of the lower plate30in the longitudinal direction toward the patient. That is, the pawl38is biased in such a way to cause the pawl38to descend into engagement with the plurality of teeth36. In this way, a clinician can move the lower plate30to the desired extended position relative to the upper plate16and the ratchet mechanism will maintain the lower plate30in the desired extended position. It will be appreciated that any number of teeth36may be used and may be placed to allow any number of desired extended positions.

The lower AAD component14further includes a lower force receiving plate generally indicated at40. In the embodiment shown, the lower force receiving plate40extends transversely to the lower pate30and is connected thereto. As shown, the lower force receiving plate40extends downwardly from the lower plate30. The lower force receiving plate40may be generally curved as shown in the Figures. It will be appreciated, however, that the lower force receiving plate40may take any suitable geometric configuration. It will be appreciated that the lower force receiving plate40may be disposed at locations on the lower plate30other than at the end thereof.

The back side of the lower force receiving plate40may include an area or surface42that acts as a hard stop as the lower AAD component14is moved from an extended position to the neutral position. As shown inFIGS. 4aand 4b, the surface42may engage a portion of the leg20aand leg20b, not shown, to inhibit further movement of the lower AAD component14in a direction toward the patient. Such a hard stop may prevent the lower AAD component14from moving past the neutral position.

The lower tooth guide32may include an area or surface44that acts as a hard stop as the lower AAD component14is moved to a fully extended position. As shown inFIG. 4b, the surface44may engage a portion of the leg20aand leg20b, not shown, to inhibit further movement of the lower AAD component14in the direction away from the patient. Such a hard stop may prevent the lower AAD component14from moving outwardly to a fully extended position past a predetermined amount. This may reduce the ability of the lower AAD component14from move too far and causing dislocation at the mandibular joint. In one preferred embodiment, the length of travel allowed between the hard stops may be about 15 mm.

The lower AAD component14is preferably molded as a single piece. And as set forth above a relatively softer urethane material may be molded over, or otherwise placed over, the lower tooth guide18. The lower AAD component14is preferably rigid.

As set forth above, the bottom side of the upper plate16, legs20a,20band lips22aand22bpreferably cooperate to form a guide to receive a lower plate30. More specifically, when the AAD10is assembled, the lower plate30is received in the space between the bottom side of the upper plate16, the legs20aand20band the lips22aand22b. When the AAD is assembled, the lower plate30is moveable in the longitudinal direction relative to the upper plate16within the guide or space formed between the bottom side of the upper plate16, legs20a,20band lips22aand22b.

As shown inFIGS. 9-11, the AAD may further include an oxygen delivery housing generally indicated at46. The oxygen delivery housing may comprise an enclosure wall48. The enclosure wall48provides a generally bowl shaped enclosure wall. The enclosure wall48is shaped to provide a space50between the enclosure wall48and the upper plate16as best viewed inFIG. 10. The enclosure wall48preferably extends from the upper plate16. The periphery of the enclosure wall48is preferably sealed to the upper plate16near the upper tooth guide18. The enclosure wall48may take any suitable configuration and should provide an adequate space50for allowing oxygen delivery.

The oxygen delivery housing46may further include a tubing connecting portion generally indicated at52. The tubing connecting portion52includes a generally cylindrical section54. The generally cylindrical section includes a fluid passageway56therethrough. The tubing connecting portion52extends from the enclosure wall48. The fluid passageway56is in fluid communication with the space50. The tubing connecting portion52may include a frustoconical section58. The frustoconical section58may aid in retaining tubing60on the tubing connecting portion52.

In one embodiment, tubing60is positioned about the tube connecting portion52. The tubing60may be positioned over the frustoconical section58to aid in retaining the tubing60on the connecting portion52. The other end of the tubing may be connected to a fluid source, such as by way of non-limiting example, an oxygen supply source (not shown). The tubing may be used to deliver oxygen to the space50which oxygen will, in turn, be delivered in the proximity of the patient's mouth.

As best seen inFIGS. 9 and 10, the upper plate16may include one or more openings62therethrough. The openings62are in positioned such that they are in an area beneath the space50provided by the enclosure wall48. The openings62are in fluid communication with the space50. It is most preferred that the openings62be positioned such that they near the section16aor curved section16bso that fluid, such as oxygen exiting therefrom is delivered in proximity to the patient's mouth. It will be appreciated, however, that the openings62can be positioned in any suitable location. Further, the openings62may have any desired size or shape. As shown, the openings62have a generally circular cross section. Further, while two openings62are preferred, it will be appreciated that any number of openings may be used.

The enclosure wall48may include one or more legs64, as best seen inFIG. 10. The legs64may be used to help secure the enclosure wall48with the upper plate16. The upper plate16may include one or more openings66for receiving the legs64. In order to secure the enclosure wall48with the upper plate16, the legs64may be positioned within the openings66. The legs64are inserted into the openings66until the periphery of the enclosure wall48engages the upper plate16. In this way, the space50is created. The legs64may be friction fit within the openings66. The legs64may also be heat staked to the openings66. It will be appreciated that the legs64may additionally or alternatively be ultrasonically welded to the opening66or secured with an adhesive. It will further be appreciated that the legs64and openings66may not be necessary in alternate embodiments. For example, the periphery of the enclosure wall48may be secured directly to the upper plate16in any suitable manner. By way of non-limiting example, the enclosure wall48may be secured to the upper plate16by ultrasonic welding or the use of adhesives. Similarly, it may be possible to make the enclosure wall48as a unitary piece with the upper plate16. It is preferred that the enclosure wall48be secured to the upper plate16in such a manner that it is sealed thereto to restrict, and preferably prohibit fluid from flowing between the enclosure wall48and the upper plate16.

An alternate embodiment of the AAD10′ is shown inFIGS. 12-14. In this alternate embodiment, the components of the AAD10′ are the same as those of the AAD10ofFIGS. 1-10, with the exception of modifications to the oxygen delivery/carbon dioxide housing46′ in this embodiment, and the other slight differences discussed below. The oxygen delivery housing46′ includes an enclosure wall48′. A septum68may extend from the enclosure wall48′ to the upper plate16to create two separate spaces50′,50″ as best seen inFIG. 14.

The oxygen delivery housing46′ may further include one or more tubing connecting portions generally indicated at52′,52″. The tubing connecting portions52′,52″ include a generally cylindrical section54′,54″ respectively. The generally cylindrical sections54′,54″ include a fluid passageway56′,56″ therethrough. The tubing connecting portions52′,52″ extend from the enclosure wall48′. The fluid passageways56′,56″ are in fluid communication with the spaces50′ and50″ as best shown inFIG. 14. The tubing connecting portions52′,52″ may include a frustoconical section (not shown) as described in connection with the embodiment ofFIGS. 9-11.

In the embodiment ofFIGS. 12-14, two separate tubing connecting portions52′,52″ are used to connect with two different sets of tubing60′,60″, respectively. In this embodiment, one of the tubing60′ is connected to a fluid source, such as an oxygen supply source and is used to deliver fluid, preferably oxygen, to the space50′ as best seen inFIG. 14. The upper plate16includes an opening62′ therethrough in fluid communication with the space50′. This allows fluid such as oxygen to be delivered through the opening62′ in the proximity of the patient's mouth, as described above. The opening62′ may be elongated to allow sufficient oxygen to be delivered to the patient. It will be appreciated that the opening62′ may take any satiable size and shape and may be located in any suitable location on the upper plate16. Further, any number of openings62′ may be used.

The upper plate16further includes a second opening62″ therethrough in fluid communication with the space50″. This separate space50″ is in fluid communication with the associated passageway56″ and tubing60″ which may be use to convey the patient's exhaled gases to monitor the patient's end-tidal carbon dioxide wave form and respiratory rate. The tubing62″ may be connected to a carbon dioxide monitoring system (not shown). The opening62″ may be elongated to allow sufficient exhaled air containing carbon dioxide to be delivered from the patient to be monitored. It will be appreciated that the opening62″ may take any suitable size and shape and may be located in any suitable location on the upper plate16. Further, any number of openings62″ may be used.

The enclosure wall48and septum60are preferably secured to the to upper plate16in any suitable manner. By way of non-limiting example, the enclosure wall48′ and septum60may be secured to the upper plate16by ultrasonic welding or the use of adhesives. Similarly, it may be possible to make the enclosure wall48′ with the septum60as a unitary piece with the upper plate16. It is preferred that the enclosure wall48′ be secured to the upper plate16in such a manner that it is sealed thereto to restrict, and more preferably prohibit fluid from flowing between the enclosure wall48′ and the upper plate16. It is further preferred that the septum60be secured to the upper plate16and sealed thereto to restrict and more preferably to prevent fluid from flowing past the septum. This will create the two spaces50′,50″ which preferably are not in fluid communication with each other.

To assemble the AAD10, the upper AAD component12is positioned over the lower AAD component14as shown inFIG. 3. The upper plate16, which may have an oxygen delivery housing46,46′ thereon, may be aligned over the lower plate30. The upper plate16and lower plate30are moved toward each other as indicated by the arrows inFIG. 3. The lower plate30may contact the ramped surfaces of the lips22aand22bon the legs20aand20b, respectively. As the upper plate16and lower plate30continue to move toward each other, the legs20aand20bflex outwardly relative to the axial direction of the upper plate16. This allows the upper plate16to be positioned adjacent to the lower plate30. Once the lower plate30has moved past the lips22a,22b, the legs20a,20breturn to their unflexed position. In this position, the lower plate30is retained in the guide or space that is defined by the bottom side of the upper plate16, legs20a,20band lips22aand22b. The pawl38may engage one of the teeth32in the lower plate30. It is preferred that when the AAD10is assembled, the upper tooth guide18and lower tooth guard32are positioned adjacent each other as best seen inFIG. 4a. This may be referred to as the neutral or non-extended position. While the legs20aand20bhaving the ramped surfaces on the lips22aand22bare shown as depending from the upper plate16, it will be appreciated that the orientation of the may be reversed and the legs20aand20bhaving the lips22aand22bthereon may be part of the lower plate30and extend upwardly therefrom in such a manner as to retain the upper plate16. In such a position, (not shown) the upper plate16is retained in the guide or space defined by the lower plate30, legs20a,20band lips22aand22b.

In order to use the AAD10,10′, the assembled AAD10,10′ in the neutral position, is positioned relative to a patient. The upper tooth guide18is positioned to envelope a dentate or edentulous alveolar ridge of the patient. The lower tooth guide32is positioned in such a way the dental guard34extends to the lingual aspect of the patient's mandible. By using an upper tooth guide18and a lower tooth guide32as set forth, the AAD10,10′ can be used with a dentate or non-dentate application with a variety of dental arch shapes. It will be appreciated that in some instances it may be necessary to place the AAD10,10′ in an extended position prior to positioning the AAD10,10′ relative to the patient. Once the AAD10,10′ is positioned relative to the patient, the patient's mandible can be distracted as follows. A clinician, such as a surgeon, can place his thumbs on the distal surfaces of outermost sections24a(those furthest away from the patient) of the upper force receiving plate24. The clinician can place his index or other fingers on the back side (closest to the patient) of the lower force receiving plate40. The clinician can hold his thumbs in the same position relative to the patient in such a way that the upper AAD component12remains in a relatively fixed position relative to the patient. The clinician can apply a force to the lower force receiving plate in a direction away from the patient, as shown by the arrows inFIGS. 4band8. By applying such a force, the lower AAD component14moves longitudinally and away, generally perpendicular in most instances, to the patient to an extended position, as best seen inFIGS. 4band8. The ratchet mechanism, pawl38and teeth36, allow movement of the lower AAD component14in one direction, outwardly away from the patient, while inhibiting movement in the opposite direction. Because there are several teeth36, the clinician can extend lower AAD component to any desired extended position along the distraction path relative to the upper AAD component12. This allows for relatively smooth lower jaw protrusion and/or distraction while minimizing any torque. This anterior mandibular distraction may result in anterior displacement of the vertical ramus of the mandible. In some instances, in may be desirable to distract the mandible sufficiently to result in subluxation of the mandibular joint. This, may, in turn, may allow for, inter alia, greater exposure to the carotid artery, major cranial nerves, or parapharyngeal space in order to perform certain procedures, if necessary. Of course, it is not necessary to distract the mandible sufficiently to result in subluxation of the mandibular joint. It is desired to distract and/or protrude the lower jaw to maintain airway patency, and particularly the oropharynx and retropalatal space. The length of travel of the lower AAD component14relative to the upper AAD component12can be controlled and the two components may remain in position relative to one another by the engagement of the ratchet mechanism to optimize airway patency.

The length of travel of the lower AAD component14relative to the upper AAD component12may be limited by the hard stop, the surface44on the lower AAD component engaging the legs20a,20bof the upper AAD component12. By providing a hard stop, the length of travel of the lower AAD component14relative to the upper AAD component can be controlled. This may help inhibit dislocation of the mandibular joint. In one embodiment, the lower AAD component14may extend up to about 15 mm before the hard stop occurs when the surface44engages the legs20a,20bto inhibit further extension of the lower AAD component14relative to the upper AAD component12.

Oxygen may be delivered to the patient through the AAD10,10′. Tubing60,60′ may be connected to an oxygen supply source (not shown). The tubing60,60′ is also connected to the generally cylindrical section54,54′ on the housing46,46′. Oxygen can then be supplied to the tubing60.60′ which, in turn flows through the fluid passageway56,56′ into the space50,50′. The oxygen then flows out the openings62,62′ for delivery to the patient.

Additionally, the end-tidal carbon dioxide wave form and respiratory rate of the patient may be monitored. The tubing60″ may be connected to a carbon dioxide monitoring system (not shown). The tubing60″ is also connected to the generally cylindrical section54″. As the patient breathes out, the exhale gases are supplied to the space50″ through the opening62″. The gases then flow through the fluid passageway56″ into the tubing62″ and to the carbon dioxide monitoring system. While it is described that the patient's end-tidal carbon dioxide may be monitored, it will be appreciated that any exhaled gases from the patient may be monitored in this way.

Once the clinician is done with the procedure, and the need for the AAD10,10′ ends, the AAD10,10′ can be returned to the neutral position. This may be done by the clinician applying an upward force to the center section24bof the upper force receiving plate24. As best seen inFIG. 7, the center section24bcan be raised sufficiently to raise the center section28of the upper plate16to disengage the pawl38from the teeth36of the lower plate30. Once the pawl38is disengaged from the teeth36, the lower AAD component14can return to the neutral position. A hard stop, surface42, on the lower force receiving plate40engaging the legs20a,20bof the upper AAD component12, inhibits movement of the lower AAD component14past the neutral position. Upon returning the AAD10,10′ to the neutral position, the clinician may then remove the AAD10from the patient.

The design of the AAD10,10′ may provide for a single use device which is relatively easy to use. The design also may avoid the need to require dental mold impressions for each patient. Also, the design of the AAD may provide an AAD that is atraumatic to the nasal cavity or the oral cavity.

The embodiment has been described in an illustrative manner. It is to be understood that the terminology which has been used is intended to be in the nature of words of description, rather than of limitation. Obviously, many modifications and variations are possible in light of the above teachings. It is therefore to be understood that the scope of the invention is set forth in the claims.