HK1139611B - Apparatus for maintaining a surgical airway and method of the same - Google Patents

Description

Device and method for maintaining surgical airway

Cross Reference to Related Applications

This application is PCT international application filed in the name of Russ Hauge and claiming priority from us provisional patent application No. 60/875429 entitled "apparatus for maintaining a surgical airway and method thereof", filed 2006, 12, 18.

Technical Field

The present invention relates to devices for maintaining a surgical airway and methods thereof. More particularly, the present invention discloses a device that is inserted and held in a patient's mouth.

Background

Devices for maintaining a surgical airway are well known and widely used, for example, to enable a patient to maintain breathing during surgery and outpatient procedures. Generally, the device may be used during gastric and/or bronchial surgery and in outpatient cases, such as patients suffering from sleep apnea.

In previous applications, oxygen nasal cannula and mouthpiece combinations have been used. Difficulties are encountered, however, when the patient does not have a nasal airway or is unable to breathe through his/her nasal cavity. The use of an oxygen delivery nasal cannula and mouthpiece limits the flow of oxygen to the patient. The device can only deliver 28% -40% oxygen concentration to the patient. Furthermore, the mouthpiece may not be optimally fixed and therefore may not always remain in place. The apparatus also requires a number of improvements in order to be able to monitor carbon dioxide.

While these previous applications have provided certain improvements to maintaining a surgical airway, there is a need for improvements to the devices. There is a need for an improved device for maintaining a surgical airway that provides optimal oxygen flow and that is equipped with monitoring and detecting end-tidal carbon dioxide (ETCO)₂) The ability of the cell to perform. It would be desirable to have a device that could be better secured to remain in place while maintaining adequate access to the airway. There remains a need for improved devices to maintain a surgical airway that requires less equipment and can be conveniently used.

Disclosure of Invention

It is an object of the present invention to overcome the above difficulties and thereby provide an improved device for maintaining a surgical airway and method thereof.

In one embodiment, an apparatus for maintaining a surgical airway includes an elongated body that is insertable orally into a patient. The elongated body defines a leading end and a trailing end. An opening is defined through the leading end and the trailing end such that surgical equipment may be inserted into the elongated body and through the opening. The fixing member is connected to the tail end. The securing member holds the elongated body in a position such that the airway remains open for treatment of the patient while supporting oxygen flow to the patient.

In one embodiment, the means for maintaining a surgical airway includes an elongated portion connected to the trailing end of the elongated body. The elongated portion is configured to be disposed at least partially at an external location corresponding to a mouth of a patient. The elongated portion defines an access opening.

In one embodiment, an apparatus for maintaining a surgical airway includes at least one fastener support. The securing member support engages the securing member to hold the elongated body in a position such that the airway of the patient remains open.

In another embodiment, the apparatus for maintaining a surgical airway defines at least one aperture therethrough. The aperture is capable of opening into at least one flow channel. Preferably, the flow channel is formed in the elongate body and is capable of delivering fluid to the patient and/or monitoring fluid released from the patient, for example delivering supplemental oxygen or monitoring end-tidal carbon dioxide.

In another embodiment, the elongated body defines an arcuate portion proximate the leading end. The bowed portion enables the elongated body to hold the tongue of the patient in a rearward position to prevent a pharyngeal reflex when the elongated body is inserted.

The device may be constructed and arranged for single use.

An apparatus for maintaining a surgical airway provides an improved surgical airway. The device provides a more reliable surgical airway that can be discarded after a single use. The elongated body provides a structure that includes bite block protection and prevents the tongue from obstructing the airway (oropharynx). The device is capable of monitoring the patient's end-tidal carbon dioxide release so that oxygen can be delivered to the patient more quickly. The device also provides a supplemental oxygen flow to the patient at a higher concentration and improved rate without obstructing access to the airway.

The device may be used in a variety of applications where maintenance of a surgical airway is desired. Such applications include esophago-gastric dilatation (EGD), gastroscopy, bronchoscopy, and deep anesthesia care (MAC) cases. The device also facilitates treatment of other outpatient patients, such as patients with sleep apnea. The apparatus for maintaining a surgical airway requires the use of less equipment for use, for example, without the need for a mask to cover the patient's face. The device is aesthetically designed, has improved performance, and is user friendly.

The above and various other advantages and novel features which characterize an apparatus for maintaining a surgical airway are described in detail below. For a better understanding of the apparatus, its advantages, and the objects obtained by its use, reference should also be made to the drawings which form a further part hereof, and to accompanying descriptive matter, in which there are illustrated and described specific examples of the apparatus.

Drawings

Like reference symbols in the various drawings generally indicate corresponding elements. The illustrated embodiments are merely exemplary and in accordance with the principles of the invention described herein.

FIG. 1 illustrates a front perspective view of one embodiment of an apparatus for maintaining a surgical airway.

Fig. 2 shows a front plan view of the device of fig. 1.

Fig. 3 shows a front side view of the device of fig. 1.

FIG. 4 shows an end view of the device of FIG. 1 showing one embodiment of the front end.

Fig. 5 shows a side cross-sectional view of the device of fig. 1.

Fig. 6 illustrates a front side view of another embodiment of an apparatus for maintaining a surgical airway.

Fig. 7 shows a front plan view of the device of fig. 6.

Fig. 8 shows an elevational side cross-sectional view of the device of fig. 6 taken along line 8-8 of fig. 7.

Fig. 9 shows a front perspective view of the device of fig. 6 taken along line 9-9 of fig. 6.

Fig. 10 shows a front rear perspective view of the device of fig. 6 taken along line 10-10 of fig. 6.

Fig. 11 illustrates a front side view of another embodiment of an apparatus for maintaining a surgical airway.

Fig. 12 shows a front plan view of the device of fig. 11.

Fig. 13 shows a front side cross-sectional view of the device of fig. 11 taken along line 13-13 of fig. 12.

Fig. 14 shows a front perspective view of the device of fig. 11 taken along line 14-14 of fig. 11.

Fig. 15 shows a front rear perspective view of the device of fig. 11 taken along line 15-15 of fig. 11.

Fig. 16 illustrates a front perspective view of another embodiment of an apparatus for maintaining a surgical airway.

Fig. 17 shows a front side view of the device of fig. 16.

Fig. 18 shows a front, top and cross-sectional view of the device of fig. 16.

Fig. 19 shows a front rear perspective view of the device of fig. 16.

Fig. 20 shows a front perspective view of the device of fig. 16.

Detailed Description

Fig. 1-5 provide one exemplary embodiment of an apparatus 10 for maintaining a surgical airway. The device 10 is similar to the device disclosed in co-pending U.S. application serial No. 11/445797 filed on 2006, 6, 2, which is hereby incorporated by reference in its entirety.

An apparatus 10 for maintaining a surgical airway (hereinafter referred to as an apparatus) includes an elongated body 12 defining first and second ends. The elongated body 12 may be inserted orally into a mouth of a patient. One of the first or second ends of the elongated body 12 defines a leading end 14. The other of the first or second ends defines a trailing end 16. The leading end 14 may be inserted orally into a patient, and the trailing end 16 may be inserted orally following the leading end 14. Disposed proximate the leading end 14, the elongated body 12 includes a lead-in portion 18. Disposed proximate the trailing end 16, the elongated body includes a tail portion 19. The leading portion 18 and the trailing portion 19 will be discussed further below.

The opening 17 is defined by the leading and trailing ends 14, 16. Preferably, surgical equipment may be inserted into the elongated body 12 through the opening 17. In some preferred applications, the patient can be treated with the required medical instruments through the openings 17, for example during a gastric and/or bronchoscopy procedure or during a suction procedure. The opening 17 provides an airway that remains open when the elongated body 12 is inserted into a patient through the mouth. The opening 17 thus enables the insertion of a therapeutic device and maintains the flow of gas and oxygen to the patient for his/her breathing.

A fastener 30 is attached to the trailing end 16. During use, the securing member 30 secures the elongated body 12 in place and prevents movement thereof. As an exemplary embodiment, the fixing member 30 may be an elastic band having elastic physical characteristics. The securing member 30 may include a plurality of securing holes 32 therethrough and along the side surfaces of the strap. The securing holes 32 are removably connected with supports on the elongated body 12 or with suitable connectors (described below) that may be used to connect the elongated body 12. As a preferred example, the opposite ends of the securing member 30 are removably attached proximate the trailing end 16 of the elongated body 12 by securing apertures 32.

The securing member 30 connected to the elongated body 12 may be positioned around the neck or under the head of the patient to secure the apparatus 10 when the elongated body 12 is inserted orally into the patient. The plurality of fixation holes 32 enable fine adjustment of the fixation member 30 to provide an optimal and comfortable configuration for the patient. The securing member 30 thus stabilizes the elongated body 12 such that the opening 17 can remain open to the airway of the patient for treatment while maintaining oxygen flow to the patient.

The elongated body 12 may be constructed from a variety of materials, including but not limited to molded, relatively flexible plastic. It should be understood that the materials described are merely exemplary, as other materials may be equally or more suitable. As a preferred example, the material used to construct the elongate body is medically approved. It should also be understood that the elongated body 12 is limited in scope only to providing a suitably rigid elongated body structure that does not collapse, break or be bitten down while maintaining the patient's airway open.

The securing member 30 may be constructed of a number of materials including, but not limited to, soft, resilient rubber. It should be understood that the materials described are merely exemplary, as other materials may be equally suitable. As a preferred example, the material used to construct the fixation member is medically approved. The material used to construct the securing member 30 may be limited only by the physical features required to secure the elongated body 12 and provide a comfortable fit around the neck or under the head of the patient.

In another embodiment of the apparatus 10 for maintaining a surgical airway, the adapter 20 is attached to the trailing end 16 of the elongated body 12. In a preferred example, the adapter 20 can be inserted into the opening 17 of the elongated body 12 at the trailing end 16 and configured to be at least partially disposed outside of the patient's mouth when the device is inserted into the patient's mouth. The adapter 20 includes an access 27 to the opening 17 such that surgical equipment may be inserted into the access 27 to access the opening 17 of the elongated body 12. Preferably, the inlet 27 may be defined by an elongate portion 28. The elongated portion 28 provides a structure that extends outwardly from the patient's mouth so that the access 27 enables surgical equipment to be inserted into the opening 17.

As just one example, the elongated portion 28 is shown as defining the inlet 27 as a hollow cylindrical structure. However, it should be understood that the configurations described are merely exemplary, as other configurations and shapes may be equally or more suitable. As other non-limiting examples, the elongated portion may be oval or other arcuate shape.

In another embodiment, the joint 20 includes at least one fastener support 22. As shown, two fixture supports 22 are shown on opposite sides of the inlet 27. It will be appreciated that additional support may be employed as desired or necessary to support the securing member on the joint 20, and may be provided at other locations on the joint 20 than that shown. The securing member supports 22 engage the securing member 30 to hold the elongated body 12 and adapter 20 in a position such that the airway of the patient remains open. As just one preferred example, the fastener supports 22 are projections or prongs that extend outwardly from the trailing end 16 in the same direction as the elongated portion 28. The prongs 22 are connected to the securing member 30 through the securing holes 32 to connect the fitting 20 to the securing member 30.

However, it should be understood that the prong and aperture configurations are exemplary only, as other securing methods may be employed that may be equally or more suitable. It should also be understood that the securing member 30 may also be attached directly to the elongated body 12 without the use of a joint. For example, in configurations without a separate adapter piece, as well as in configurations where the elongated body 12 includes an extension and access port integrally formed thereon, and configurations where the elongated body includes a securing member support integrally formed thereon.

In another embodiment, the fitting 20 defines at least one aperture therethrough. As shown, the adapter 20 includes two apertures 24 disposed opposite each other on either side of the inlet 27. The bore 24 is capable of supporting the first and second flow conduits 44, 54. Preferably, the flow conduits 44, 54 are capable of delivering a supplemental supply of oxygen and monitoring end-tidal carbon dioxide along the side surfaces of the elongated body 12.

As one example, the first flow conduit 44 may be a tube insertable through one of the apertures 24. Preferably, the flow conduit 44 is constructed of a reinforced material so that the flow conduit 44 does not collapse or become occluded if bitten by a patient. It should be understood that the flow conduit 44 is a reinforcing material and may be similar to the plastic material of the elongated body 12. It should also be appreciated that the flow conduit 44 is suitably rigid for use by the patient and avoids the undesirable effects described. The flow conduit 44 may be disposed along the side groove 12a of the elongated body 12. Side grooves 12a along the sides of the elongated body 12The surface supports the flow conduit. The inserted end of the first conduit 44 enables carbon dioxide to be released therein for monitoring the ETCO₂. The opposite end may include a first fitting 44a that interfaces with a carbon dioxide detector (not shown) to monitor the ETCO₂。

By virtue of this feature, the apparatus 10 can more effectively monitor the oxygenation of a patient so that oxygen can be delivered to the patient in need thereof more quickly. For example, when ETCO₂When increased, the oxygen level decreased. In previous applications, oxygen levels were monitored by pulse oximetry. However, the method requires waiting for a perfusion time of 15-30 seconds. In the embodiment provided by the apparatus 10, the oxygen level may be determined in a shorter time so that oxygen may be delivered to the patient before the critical point is needed.

As another example, the second flow conduit 54 may be a tube insertable through another aperture 24. Preferably, the flow conduit 54 is constructed of a reinforced material such that the flow conduit 54 does not collapse or become occluded if bitten by a patient. It will be appreciated that the flow conduit 54 is a reinforcing material and may be similar to the plastic material of the elongated body. It should also be appreciated that the flow conduit 54 is suitably rigid for use by the patient and avoids the undesirable effects described. The flow conduit 54 may be along the other side groove 12a of the elongated body 12. The side grooves 12a support the flow conduits along the side surfaces of the elongated body 12. The inserted end of the second tube 54 may vent the supplemental oxygen supply delivered to the patient. The opposite end may include a second fitting 54a that is connected to an oxygen supply (not shown). When the flow conduit 44 is described as being for an ETCO₂While the flow conduit 54 is described for oxygen delivery, it should be understood that either of the flow conduits 44, 54 may be used for delivery or monitoring purposes, and that the flow conduit 44 is not limited to ETCOs₂The flow conduit 54 is monitored and is not limited to oxygen delivery.

Although two flow conduits are shown, it should be understood that more or less than two conduits may be employed, if needed or desired, for conveying other fluids or for other monitoring purposes. It should be understood that supplying oxygen and monitoring end-tidal carbon dioxide are just some preferred examples of the fluids supported by the device. It may be desirable to deliver or monitor other fluids, including other gases and liquids. The term "fluid" is to be broadly construed to include any medium that can flow.

The joint 20 may be constructed of a variety of materials, including but not limited to molded flexible plastic. The adapter may be constructed of any material having suitable rigidity and similar to the elongated body 12 for maintaining an open airway of the patient. It should be understood that the materials described are merely exemplary, as other materials may be equally or more suitable. It should also be understood that the adapter 20 may be integrally formed with the elongate body 12, wherein the elongate body 12 and the adapter 20 may be represented as a one-piece device.

In another embodiment, the elongated body 12 includes a lead portion 18 proximate the leading end 14. Preferably, the guide portion 18 defines an arcuate portion. The arcuate portion defines an upper curved portion and a lower curved portion. The upper curved portion is disposed at the hard jaw and contacts the upper ridge of the patient's mouth just in front of the soft jaw. The lower curved portion is configured to contact a patient's tongue. The arching portion causes the elongated body 12 to hold the patient's tongue in a posterior position. In a preferred example, the lead portion 18 is configured to have a length such that its arcuate configuration is not deep enough to extend into the soft palate and thereby prevent pharyngeal reflex by the patient when the elongated body 12 is inserted.

In another embodiment of the elongated body 12, the flange 16a is disposed at the trailing end 16. Preferably, the flange 16a is annularly disposed about the outer surface of the elongated body 12. The flange 16a enables the patient to comfortably fit the device 10 around his/her mouth and helps prevent the entire device 10 from entering the patient.

Fig. 6-10 illustrate another embodiment of an apparatus 100 for maintaining a surgical airway. Similar to the apparatus 10, the apparatus 100 includes an elongated body 112, the elongated body 112 defining a leading end 114 having an arcuate leading portion 118 and a trailing end 116 having a trailing portion 119. The elongated body 112 includes an opening 117 defined through the leading and trailing ends 114, 116. In addition, the apparatus 100 includes a mount support 122 configured to engage a mount (not shown) to secure the apparatus 100 in place to maintain an open airway of the patient. In an exemplary embodiment and similar to the device 10, the retainer supports 122 are projections or prongs disposed on a flange 126 (described below) and extending outwardly from the trailing end 116. Although the fasteners are not shown, it should be understood that the fasteners 30 used with the device 10 may suitably employ fastener supports 122 in a manner similar to that previously described.

The extended portion 128 is located at the trailing end 116 of the elongated body 112 and extends outwardly and away from the elongated body 112. The elongated portion 128 is configured to be positioned such that it extends outwardly from the patient's mouth when the device 100 is inserted into the patient's mouth. The elongate portion 128 includes an access opening 127, the access opening 127 configured to allow surgical equipment and therapeutic materials to pass therethrough and into and be inserted through the opening 117 of the elongate body 112. As just one example, the elongated portion 128 is a hollow cylindrical structure that defines the inlet 127. The entrance 127 extends toward the opening 117, and the passage defined from the trailing end 116 to the leading end 114 widens as the opening defined by the entrance 127 reaches the opening 117. In this configuration, the widening channel may help prevent undercutting (undercut) during molding and forming of the device. It should be understood that the shape of the elongated portion 128 and the access opening 127 is not limited to a particular configuration, so long as the elongated portion 128 enables the access opening 127 to allow surgical equipment to pass therethrough and into the opening 117 of the elongated body 112.

The flange 126 is disposed proximate the trailing end 116 and is located between the elongated body 112 and the elongated portion 128. As shown, the flange 126 is oval in shape and is annularly disposed about the elongated body 112. The flange 126 may provide a panel structure so that the patient can comfortably fit the device 100 around his/her mouth while preventing insertion of the entire device 100 into the patient's mouth. As just one example, the flange 126 has an arcuate configuration that is convex facing the trailing end 116 and concave facing the leading end 114. This arch configuration may provide a more comfortable fit of the device 100, with the flange 126 located outside the patient's mouth and on his/her face. It will be appreciated that the flange 126 is not limited to the particular configuration shown and may be suitably modified to achieve the desired comfortable fit while preventing the entire device from being inserted into the patient's mouth.

The flange 126 includes an aperture 124 that extends through the flange 126 and into the elongated body 112. As best shown in fig. 7 and 9, the aperture 124 is defined by outwardly extending prongs having openings to the elongated body 112. The prong structure may allow a tube or fitting (not shown) to be connected to provide access to the aperture 124. It should be understood that the tubes and fittings are known and that any of the tubes and fittings previously described may be suitably connected to access the bore 124. It should be understood that the prong structures shown are merely exemplary, and the apertures are not limited to any particular structure, so long as they provide access to the flow channels 144 (described in detail below).

As previously described, the apertures 124 allow access to the flow channels 144 in the elongated body 112. Fig. 9 shows the bore 124 extending through the flange 126 (shown in phantom lines) to the flow channels 144 inside the elongated body 112. As best shown in fig. 7-10, flow channels 144 are formed within the elongated body 112 as distinct channels separate from the opening 117 or primary opening. Walls 146 formed in the elongated body 112 separate the flow channels 144 from the opening 117. In this configuration, the flow channels are formed as part of the elongated body 112, wherein the openings 117 and flow channels 144 provide distinct lumens (lunmen) through the elongated body 112. The flow channels 144 may allow for a more versatile device to maintain an airway that is not specific to any particular conduit, and may be adapted for any desired conduit to be connected to the prong structure provided with the apertures 124. As a preferred example, the passageway 144 is configured to allow delivery and monitoring of the patient, such as delivering oxygen to the patient and monitoring the patient's ETCO₂. In this manner, the flow passages 144 may operate similar to the previously described tube flow passages 44, 54.

As shown, the flow channels 144 are provided as two flow channels, located on opposite sides of the elongated body 112. The flow channels 144 are disposed adjacent the opening 117 and adjacent the sides of the inner surface of the elongated body 112. It should be understood that only one flow channel or more than two flow channels may be formed in the elongated body 112. It should also be understood that the illustrated flow channels 144 are not limited to being positioned on opposite sides or in any particular direction, so long as the flow channels are formed in the elongated body 112.

Fig. 11-15 illustrate another embodiment of an apparatus 200 for maintaining a surgical airway. Device 200 is similar to device 100 except that device 200 includes a smaller sized passageway than device 100. That is, inlet 227, opening 217, and flow channel 244 may be configured to be smaller in size than device 100. It will be appreciated that the dimensions of the channel and the overall size of the embodiment may be modified as required to suit the patient's use. As with the apparatus 100, the apparatus 200 includes an elongated body 212 defining a leading end 214 having an arcuate leading portion 218 and a trailing end 216 having a trailing portion 219. The elongated body 212 includes an opening 217 defined through the leading and trailing ends 214, 216. In addition, the device 200 includes a mount support 222 configured to engage a mount (not shown) to secure the device 200 in place to maintain an open airway of the patient. As with the device 100, the fastener supports 222 are projections or prongs disposed on the flange 226 extending outwardly from the trailing end 216, and it will be appreciated that the fastener 30 for the device 10 may be adapted to employ the fastener supports 222 as previously described.

The extended portion 228 is disposed at the trailing end 216 of the elongated body 212 and extends outwardly and away from the elongated body 212. The elongated portion 228 is configured to be positioned such that it extends outwardly from the patient's mouth when the device 200 is inserted into the patient's mouth. The elongate portion 228 includes an entrance 227, the entrance 227 being configured to allow surgical equipment and therapeutic material to pass therethrough and into and be inserted through the opening 217 of the elongate body 212.

The flange 226 is disposed proximate the trailing end 216 and between the elongated body 212 and the elongated portion 228. The flange 226 may provide a panel structure so that the patient can comfortably fit the device 200 around his/her mouth while preventing the entire device 200 from being inserted into the patient's mouth. As just one example, the flange 226 further includes an arcuate structure that is convex facing the trailing end 216 and concave facing the leading end 214.

The flange 226 includes an aperture 224 that extends through the flange 226 and into the elongated body 212. As best shown in fig. 12 and 14, the apertures 224 are also defined by outwardly extending prongs having openings to the elongated body 212. The prong structure may allow a tube or fitting (not shown) to be connected to provide access to the aperture 224.

The aperture 224 allows access to the flow channels 244 in the elongated body 212. Fig. 14 shows the apertures 224 extending through the flange 226 (shown in phantom lines) to the flow channels 244 inside the elongated body 212. As best shown in fig. 12-15, the flow channels 224 are formed within the elongated body 212 as distinct channels separate from the opening 217 or main opening. Walls 246 formed in the elongated body 212 separate the flow channels 244 from the opening 217. Also in this configuration, the flow channels 244 are formed as part of the elongated body 212, wherein the openings 217 and flow channels 244 provide different lumens through the elongated body 212.

Fig. 16-20 illustrate another embodiment of an apparatus 300 for maintaining a surgical airway. The apparatus 300 is similar to the apparatus 100 and 200, while also including a cored out area 329, and shows how an accessory structure may be attached to the apparatus. A cored out region 329 is disposed about the elongated portion 328 and proximate the trailing end 316. The cored-out area 329 extends through the flange 326 and terminates at an opening 317 (best shown in fig. 18-19) in the elongated body 312. In this configuration, cored out region 329 can help facilitate formation of the device as a single integrally molded part.

Further, the fork structure with fittings 354, 356 connected to the aperture 324 is also shown. In one example only, the fitting 354 is coupled to the bore by a tube 358 that is inserted into the flange 326 to access the flow passage 344. In another example, the fitting 356 is secured to the flange 326 at the aperture 324. It should be understood that the fitting secured to the flange (i.e., fitting 356) may be connected in a variety of ways, such as, but not limited to, a press-fit or adhesive arrangement. As with fitting 354, fitting 356 may include a tube that is insertable into the bore to access flow channel 344.

As with devices 100 and 200, device 300 includes an elongated body 312 defining a leading end 314 having an arcuate leading portion 318 and a trailing end 316 having a trailing portion 319. The elongated body 312 includes an opening 317 defined through the leading and trailing ends 314, 316. In addition, the apparatus 300 includes a fastener support 322 configured to engage a fastener, as previously described.

An elongate portion 328 is disposed at the trailing end 316 of the elongated body 312 and extends outwardly and away from the elongated body 312. The elongated portion 328 is configured to be positioned such that it extends outwardly from the patient's mouth when the device 300 is inserted into the patient's mouth. The elongate portion 328 includes an access opening 327 configured to allow surgical equipment and therapeutic material to be inserted therethrough and into the opening 317 of the elongate body 312.

The flange 326 is disposed proximate the trailing end 316 and is located between the elongated body 312 and the elongated portion 328. The flange 326 may provide a panel structure to enable a patient to comfortably fit the device 300 around his/her mouth while preventing the entire device 300 from being inserted into the patient's mouth. The flange 326 also includes an arcuate configuration that is convex toward the trailing end 316 and concave toward the leading end 314.

The flange 326 includes an aperture 324 that extends through the flange 326 and into the elongated body 312. As one example best shown in fig. 18 and 19, the apertures 324 are also defined by outwardly extending prongs having openings to the elongated body 312. The prong structure allows the tubes or fittings (i.e., fittings 354, 356 and tube 358) to be connected so as to enter the bore 324.

As previously described, the apertures 324 allow access to the flow channels 344 in the elongated body 312. Fig. 19 shows the apertures 324 extending through the flange 326 to the flow channels 344 inside the elongated body 312. Flow channels 344 are formed within the elongated body 312 as distinct channels separate from the opening 317 or primary opening. Walls 346 are also formed in the elongated body 312 separating the flow channels 344 from the openings 317. Also in this configuration, the flow channels 344 are formed as part of the elongated body 312, wherein the openings 317 and flow channels 344 provide different lumens through the elongated body 312.

As just one preferred example, the devices 100, 200, and 300 may be constructed of a medically approved injection molded material, such as, but not limited to, a medically approved plastic material. The material may be, but is not limited to, an approved polypropylene material. It should be understood that any suitable material for the device 10 described above may be used for the devices 100, 200, and 300. In the illustrated construction, the devices 100, 200, and 300 can be formed such that the elongated body (including the openings and flow channels), the flange, and the elongated portion are all constructed as a one-piece, unitary structure that is injection molded. Unlike the device 10 shown in fig. 1-5, the devices 100, 200, and 300 do not include a separate connector component because the flange and elongate portion are integrally formed with the elongated body as a one-piece structure. Furthermore, the flow channels are formed in the elongated body and are not provided as separate flow conduits along the outer side surface of the elongated body.

The foregoing embodiments may provide an improved device for maintaining an open airway, with a number of advantages. For example, the rigid outer structure of the elongated body provides a bite block that prevents the patient from closing his/her mouth and preventing the airway from collapsing. Thus, the occluder function is beneficial in keeping the airway in an open position. For example, in situations where a patient may experience a seizure, the outer structure of the elongated body prevents the opening from collapsing even when the patient bites on the device. As a preferred example, any of the devices described may be constructed and arranged for single use, for example, on a per patient basis.

Any of the devices described may include various sizes suitable for adults and children. As one example of an adult size, the elongated body may include a length from the leading end to the trailing end of about 4.0 inches, and in a preferred example about 3.5 inches. The insertable portion of the elongated body may be about 2.5 inches in length. The elongated body may have a width in a range of about 1.0 inch to about 2.0 inches and be suitable for both men and women. The width of the elongated body including the flange may be about 2.5 inches to about 3.0 inches. The elongated body alone may have a height or thickness of about 0.75 inches to about 1.0 inches. The height of the elongated body including the flange may be about 1.5 inches. The opening in the elongated body may include a width of about 11/8 inches. In some other examples, the opening may include a width of about 1.3 inches. If a separate fitting is used (fig. 1-5), the height of the fitting inlet may be in the range of about 5/8 inches to about 1/2 inches. For some other examples (fig. 6-21) without a separate adapter piece, the entrance to the elongated body opening may have a width of about 5/8 inches to about 1.0 inches.

However, it should be understood that the dimensions are exemplary only. Other dimensions may be used as may be appropriate or better suited to achieve the desired functionality of the above-described embodiments. Thus, the size of any of the devices, and in particular the size of the elongate body, is limited to providing appropriate dimensions relative to the age and sex of the patient, and may be sized as required to fit the patient for optimal results.

The described embodiments provide a safer surgical airway that can be discarded after a single use. The elongated body provides a structure that includes bite block protection and prevents the tongue from occluding the airway (oropharynx). The device can be used to monitor ETCO of a patient₂. The supplemental oxygen flow can be provided to the patient at a higher concentration and improved rate without impeding access to the airway. The oxygen concentration provided by the device can be improved by 60-80%. In addition, the apparatus for maintaining a surgical airway requires less equipment for its use, e.g., no mask is required to cover the patient's face. The device is aesthetically designed, has improved performance, and is convenient to use.

The device may be used for known medical treatments such as, but not limited to, gastric and/or bronchial procedures, and may be used in outpatient cases, for example, patients experiencing sleep apnea. As just some additional examples, the procedures and applications may include use for esophago-gastric dilatation (EGD), gastroscopy, bronchoscopy, and for deep anesthesia care (MAC) cases. It should be understood that the apparatus may be used in many applications and procedures, and is not limited to those listed. It will be appreciated that any treatment requiring the maintenance of an open airway in a patient may employ the apparatus described above.

The above description provides the composition, manufacture, and use of an improved device for maintaining a surgical airway in accordance with the principles of the present invention. Since many embodiments of the apparatus for maintaining a surgical airway can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

Claims (14)

1. An apparatus for maintaining a surgical airway by oral insertion into a patient, comprising:

an elongated body orally insertable into a patient, the elongated body comprising a first end and a second end,

one of the first end or the second end defines a leading end that is orally insertable into a patient, the other of the first end and the second end defines a trailing end,

the elongated body includes an opening disposed through the elongated body between the leading end and the trailing end,

the opening extends through the leading end and the trailing end,

the opening comprising a main opening and distinct flow channels formed in the opening, wherein the distinct flow channels are formed as part of the elongated body, the main opening and the distinct flow channels being separated by walls to provide distinct lumens through the elongated body,

the main opening is configured to enable surgical equipment to be inserted therethrough for treating a patient, and the different flow channels are configured to support a flow of gas to or from the patient;

a flange integrally formed with the elongated body proximate the trailing end of the elongated body, the flange including at least one aperture extending through the flange and into the elongated body and permitting access to the different flow channels; and

a securing member connected to the trailing end, wherein the securing member is configured to hold the elongated body in a position such that an airway of a patient is maintained open when the elongated body is inserted into the patient through the oral cavity.

2. The apparatus of claim 1, wherein the securing member comprises an elastic band supportable on the elongated body and configured to be placed around the head or lower neck of the patient.

3. The device of claim 2, wherein the elastic band includes a plurality of securing holes such that the elastic band is removably coupled with the elongated body.

4. The device of claim 1, further comprising an access port disposed proximate the trailing end, the access port being configured for accessing the primary opening of the elongated body, the access port including an elongated portion extending outwardly from the trailing end and configured to extend outside of the patient's mouth, the flange and the elongated portion being integrally formed with the elongated body as a one-piece structure.

5. The apparatus according to claim 1, wherein the flange further comprises at least one securing member support that can engage the securing member to hold the elongated body in position to maintain the airway of the patient open.

6. The device of claim 5, wherein the anchor support is a tab extending outward from the trailing end in the same direction as the elongated portion.

7. The device of claim 1, wherein the at least one flow channel is configured to deliver oxygen to the patient to maintain the level of oxygen supplied to the patient during the procedure.

8. The apparatus of claim 1, wherein at least one flow channel is receptive of carbon dioxide from the patient so as to enable monitoring of end-tidal carbon dioxide of the patient.

9. The apparatus of claim 1, wherein the distinct flow channels comprise two flow channels formed in the opening of the elongated body, the flow channels being disposed adjacent the main opening and proximate the sides of the inner surface of the elongated body.

10. The device of claim 1, wherein one of the different flow paths is a flow path that can deliver oxygen to the patient and another of the different flow paths can receive carbon dioxide from the patient.

11. The apparatus according to claim 1 wherein the elongate body is formed of an injection molded material and is formed as a one-piece, integrally molded structure.

12. The apparatus of claim 1, wherein the elongated body comprises an arcuate portion proximate the anterior end, the arcuate portion comprising an upper curved portion and a lower curved portion, the upper curved portion configured to contact an upper ridge of the patient's mouth at the hard palate and just in front of the soft palate, and the lower curved portion configured to contact the patient's tongue, wherein the arcuate portion enables the elongated body to maintain the patient's tongue in a posterior position.

13. The device of claim 12, wherein the arcuate portion is configured with a length to extend into the soft palate while avoiding a gag reflex in the patient when the elongated body is inserted.

14. The device of claim 1, wherein the flange has an arcuate configuration that is convex facing the trailing end and concave facing the leading end and is configured so as not to enter the mouth of the patient when the elongate body is inserted into the patient.