阅读说明：本技术 用于维持患者中的气道的装置 (Apparatus for maintaining an airway in a patient ) 是由 K·巴斯卡 于 2019-12-13 设计创作，主要内容包括：一种适用于维持患者中的气道的装置,该装置包括罩和气道管,该罩在正确插入患者体内时适于围绕喉部入口形成密封,当装置被正确插入患者体内时,该气道管用于通过罩向患者的肺部提供通气气体和/或麻醉气体,其中所述气道管具有第一近侧开口和第二近侧开口。(A device adapted to maintain an airway in a patient, the device comprising a mask adapted to form a seal around the laryngeal inlet when the device is correctly inserted into the patient, and an airway tube for providing ventilation gas and/or anaesthetic gas through the mask to the lungs of the patient when the device is correctly inserted into the patient, wherein the airway tube has a first proximal opening and a second proximal opening.)

1. A device adapted to maintain an airway in a patient, the device comprising a mask adapted to form a seal around the laryngeal inlet when correctly inserted into the patient, and an airway tube for providing ventilation gas and/or anaesthetic gas through the mask to the lungs of the patient when the device is correctly inserted into the patient, wherein the airway tube has a first proximal opening and a second proximal opening.

2. The device of claim 1, wherein the airway tube comprises a bifurcated tube having a first proximal opening and a second proximal opening, or the airway tube comprises a first tube having a second tube extending from one side of the first tube.

3. The device of claim 1 or claim 2, wherein the airway tube comprises a bifurcated tube having a distal portion and the airway tube comprises a bifurcated tube forming a proximal portion of the airway tube.

4. The device of claim 2 or claim 3, wherein the furcation tube is formed as a separate portion attached to a distal portion of the airway tube.

5. The device of any one of the preceding claims, wherein the airway tube comprises a stem connected to or formed with the mask at its distal end.

6. The device of any one of the preceding claims, wherein the airway tube comprises a first tube and a second tube to form a suction channel and a vent channel in the device.

7. The device of any one of the preceding claims, wherein the airway tube comprises a stem, a first airway tube and a second airway tube, the first and second airway tubes in fluid communication with the stem.

8. The device of any one of the preceding claims, wherein the first opening is connected to a source of ventilation and/or anaesthetic gases during use and the second opening provides access to the airway tube to enable an endotracheal tube to be inserted through the airway tube and into the patient's larynx.

9. The device according to any of the preceding claims, wherein at least one of the first or second openings is provided with a valve, seal or check valve, or both the first and second openings are provided with a valve, seal or check valve, or a valve, seal or check valve is positioned upstream of a bifurcation point in at least one of the tubes upstream of the bifurcation point.

10. The device of any one of claims 1 to 9, wherein the airway tube has a first tube and a second tube in fluid communication with an airway tube stem, and a valve, seal or check valve is located in the first tube or in the second tube, or in each of the first tube and the second tube.

11. The device of any one of claims 1 to 9, wherein a valve, seal or check valve is located in the stem of the airway tube.

12. The device of any one of claims 1 to 8, wherein a valve, seal or check valve is located at or near the first opening and the first opening is adapted to pass an endotracheal tube or other instrument therethrough.

13. The device of any one of the preceding claims, wherein the airway tube comprises an airway tube stem and a bifurcated connector is attached to a proximal end of the airway tube stem, the bifurcated connector having a first arm and a second arm, a valve, seal or check valve being located in the first arm or in the second arm, or a valve, seal or check valve being located in each of the first and second arms.

14. The device of any one of the preceding claims, wherein the check valve may comprise a duckbill valve or a slit valve.

15. Apparatus according to any preceding claim, wherein the check valve comprises a plurality of valve portions, each valve portion having a surface extending inwardly from its periphery, the valve portions having one edge which in use abuts an edge of the inwardly extending surface of an adjacent valve portion and another edge which in use abuts an edge of the inwardly extending surface of an adjacent valve portion when in the closed position, the surface having a skirt extending therefrom.

16. The device of claim 16, wherein the surface and the skirt define a closed upstream region and an open downstream region, and wherein, in use, when in a closed position, an edge of a surface of one valve portion and an edge of the skirt abut an edge of a surface of an adjacent valve portion and an edge of the skirt, wherein if gas attempts to flow from a downstream end to an upstream end, gas will flow into the open downstream region and act to push the valve portions into contact with each other.

17. The device of claim 16 or claim 17, wherein the valve comprises three valve portions or four valve portions.

18. A bifurcated connector for attachment to the proximal end of an airway tube stem of a laryngeal mask, the bifurcated connector having a first arm and a second arm, a valve, seal or check valve being located in the first arm or in the second arm, or a valve, seal or check valve being located in each of the first arm and the second arm.

19. A method for positioning an endotracheal tube into a patient, the method comprising: establishing an airway in a patient using a device according to any one of the preceding claims; providing ventilation gas and/or anesthetic gas to the patient through one of the first opening or the second opening of the device; and inserting an endotracheal tube through the other of the first or second openings while maintaining the supply of ventilation gas and/or anesthetic gas.

20. A device suitable for maintaining an airway in a patient, the device comprising an airway tube for providing ventilation gas and/or anaesthetic gas to the lungs of the patient through a mask when the device is correctly inserted into the patient, wherein the airway tube has a valve, seal or check valve, or the device is fitted with a connector having a valve, seal or check valve.

21. The device of claim 21, further comprising a mask adapted to form a seal around the laryngeal inlet when properly inserted into the patient.

22. The device of claim 21, wherein the device comprises an endotracheal tube.

Technical Field

The present invention relates to a laryngeal mask, and more particularly to a laryngeal mask that also allows insertion of a medical device, such as an endotracheal tube, into a patient.

Background

During surgery performed under general anesthesia, the maintenance of a viable airway is critical. For many years, maintenance of a viable airway during such surgery has been achieved by inserting a tracheal tube into the patient. Endotracheal tubes are typically inserted through the mouth or nose into the larynx, through the vocal cords and into the trachea. Since the endotracheal tube must be inserted through the vocal cords, there is often difficulty in properly positioning the endotracheal tube.

Many supraglottic airway devices or laryngeal masks can now also be used to maintain a viable airway. An inventive laryngeal mask was developed by Archibald Brain, and described in British patent No. 2,111,394 (which corresponds to U.S. Pat. No. 4,509,514). The device is described as being an artificial airway device. The device comprises a curved flexible tube opening at one end which opens into the interior of a hollow mask portion shaped to fit easily into the actual and potential space behind the throat and to seal circumferentially around the throat entrance without penetrating into the interior of the throat. Commercial forms of the device have an inflatable and deflatable collar or cuff extending around the circumference of the mask. The inflatable collar is adapted to form a seal around the laryngeal inlet when the collar is inflated. In addition, the mask portion includes an inflatable posterior portion adapted to compress the posterior portion of the larynx and thereby increase the sealing pressure around the laryngeal inlet.

British patent No. 2,111,394 describes the shape of the mask and the shape of the inflatable portion or portions which (when assembled) ensure that it approximates the space between the laryngeal inlet and the wall of the lower part of the throat at the rear thereof. Since the walls of the tissue forming the back of the larynx are relatively rigid, inflation of the mask forces it more tightly against the tissue surrounding the laryngeal inlet, thus forming an airtight seal, while tending to anchor the mask in place.

In use of the device described in GB 2,111,394, the device is inserted through the patient's mouth and inserted down the larynx through the epiglottis until the distal end of the mask rests in the base of the larynx, thereby abutting the upper end of the normally closed oesophagus. The inflatable ring on the mask is then inflated to seal around the entrance to the throat. Thus, the airway of this patent is reliable and unobstructed, and the laryngeal mask can be directly connected to a conventional anesthesia circuit hose for positive pressure or spontaneous breathing.

Many other suppliers now also offer laryngeal masks. In fact, the inventors have developed a cover sold under the trademark BASKA MASK. The inventors have also acquired a number of patents for their products, including australian patent nos. 2004260552, 2008291688 and 2010234212 and australian patent application No. 2015230697, the entire contents of which are incorporated herein by cross-reference.

Supraglottic airway devices, another name for laryngeal masks, have found widespread use. They are used in emergency situations and planned procedures. However, supraglottic airway devices may have some limitations during use, as they may not achieve adequate ventilation, or not adequately protect against lung inhalation (lung inhalation). For these reasons, intubation and ventilation of the patient using endotracheal tubes are still widely practiced.

It is well known that insertion of an endotracheal tube can sometimes be very difficult, especially in emergency situations. It may be difficult to properly place the endotracheal tube, and the endotracheal tube may take a long time to be properly inserted. In this case, the use of a supraglottic airway device can be significantly faster to facilitate the establishment of a viable airway for the patient.

If a supraglottic airway device has been inserted into a patient, but there is a concern that it will not achieve adequate ventilation or adequate protection from lung inhalation, an endotracheal tube may be inserted. In those cases the insertion of an endotracheal tube is necessary to isolate and protect the airways and more importantly to achieve sufficient oxygenation to overcome any risk of hypoxia, brain damage or death.

In the case where a supraglottic airway device has been inserted into the patient, a tracheal tube may be inserted into the patient through the supraglottic airway device. It is important that oxygen be delivered to the patient without interruption during intubation of the endotracheal tube by the supraglottic airway device. Time is of paramount importance during insertion of the endotracheal tube, as hypoxia can cause damage to the brain in a short period of time. Intubation of an endotracheal tube by a supraglottic airway device is not easy and can take considerable time, especially in the hands of inexperienced operators. Bronchoscopes can be used to guide endotracheal tubes through the supraglottic airway device, but these bronchoscopes may not be usable in certain settings. Even if available, it can take a considerable amount of time to set up these devices, especially in an unexpected emergency.

During insertion of the endotracheal tube and/or bronchoscope through a conventional supraglottic airway device/laryngeal mask, the patient is not ventilated for oxygenation and/or anesthesia, which compromises patient safety. Furthermore, with currently available laryngeal masks, an endotracheal tube with a maximum inner diameter of about 7.5mm is about the largest endotracheal tube that can be used.

It will be clearly understood that, if a prior art publication is referred to herein, that reference does not form part of the common general knowledge in the art in australia or any other country.

Disclosure of Invention

The present invention relates to a laryngeal mask that may at least partially overcome at least one of the above disadvantages or provide the consumer with a useful or commercial choice.

In view of the above, the present invention resides broadly in one form in a device adapted to maintain an airway in a patient, the device comprising a mask adapted to form a seal around the laryngeal inlet when the device is correctly inserted into the patient, and an airway tube for providing ventilation gas and/or anaesthetic gas through the mask to the lungs of the patient when the device is correctly inserted into the patient, wherein the airway tube has a first proximal opening and a second proximal opening.

In one embodiment of the invention, the airway tube includes a bifurcated tube having a first proximal opening and a second proximal opening. In one embodiment, the airway tube includes a first tube having a second tube extending from one side of the first tube.

In one embodiment, the airway tube comprises a bifurcated tube. In one embodiment, the airway tube has a distal portion and the airway tube includes a bifurcated tube forming a proximal portion of the airway tube.

In this specification, the term "proximal" will refer to the portion that is closer to the doctor or operator during use, and the term "distal" will refer to the portion that is further from the doctor or operator during use.

In one embodiment, the bifurcated portion may be formed as a separate portion attached to the distal portion of the airway tube. Either the airway tube or the bifurcated portion (or both) may be provided with one or more connectors to enable the distal portion to be connected to the bifurcated portion.

In other embodiments, the bifurcation may be positioned closer to the distal end of the airway tube.

The airway tube may include a stem connected to or formed with the mask at its distal end. The rod may comprise a single or integral tube or a plurality of tube sections connected together. The airway tube may include a first tube and a second tube to form a suction channel and a vent channel in the device.

In one embodiment, the airway tube includes a stem, a first airway tube and a second airway tube, the first and second airway tubes in fluid communication with the stem.

In one embodiment, the first opening is connected to a source of ventilation gas and/or anesthetic gas during use, and the second opening provides access to an airway tube to enable an endotracheal tube to be inserted through the airway tube and into the patient's larynx.

In one embodiment, at least one of the first opening or the second opening may be provided with a valve, a seal or a check valve. In one embodiment, the first opening and the second opening are each provided with a valve, a seal or a check valve. In another embodiment, a valve, seal or check valve is positioned upstream of the bifurcation in at least one of the tubulars upstream of the bifurcation.

In another embodiment, where the airway tube has a first tube and a second tube in fluid communication with the airway tube stem, a valve, seal, or check valve may be located in the first tube or in the second tube, or a valve, seal, or check valve may be located in each of the first tube and the second tube.

The check valve may allow gas to pass from the proximal end of the device to the distal end of the device, but may prevent gas from exiting the proximal end of the device. The seal can also prevent gas from exiting the proximal end of the device.

In another embodiment, the valve, seal or check valve may be located in the stem of the airway tube.

In one embodiment, the valve, seal or check valve is located at or near the first opening, and the first opening is adapted to pass an endotracheal tube or other instrument therethrough.

In another embodiment, the airway tube includes an airway tube stem and the bifurcated connector is attached to a proximal end of the airway tube stem. The bifurcated connector has a first arm and a second arm. The valve, seal or check valve may be located in the first arm or in the second arm, or the valve, seal or check valve may be located in each of the first and second arms.

In one embodiment, the check valve may comprise a duckbill valve or a slit valve. In one embodiment, the check valve comprises one or more valve portions, each valve portion having a surface extending inwardly from its periphery, the valve portion having one edge which in use abuts an edge of the inwardly extending surface of an adjacent valve portion or a side wall of the airway tube and another edge which in use abuts an edge of the inwardly extending surface of an adjacent valve portion or a side wall of the airway tube when in the closed position, the surfaces having a skirt extending therefrom. In one embodiment, the surface and skirt define a closed upstream region and an open downstream region. In use, when in the closed position, an edge of the face of one valve portion and an edge of the skirt abut a corresponding edge of the face of an adjacent valve portion and an edge of the skirt, or an edge of a side wall of the airway tube. In this way, a seal is formed. Additionally, if gas attempts to flow from the downstream end to the upstream end, the gas will flow into the open downstream region and act to push the valve portions into contact with each other.

In one embodiment, the valve comprises three valve portions. In another embodiment, the valve comprises four valve portions. The valve may comprise more than four valve portions. Although the valve may also comprise two valve portions, it is believed that a more effective seal will be obtained when three or more valve portions are used. The valve may also comprise a single valve portion which seals against the side wall or wall of the pipe on which it is mounted or positioned.

When the endotracheal tube is inserted through the valve, the surface of the valve portion and the skirt will surround the endotracheal tube and provide a seal over the extended length of the endotracheal tube, thereby improving the seal around the endotracheal tube. If gas attempts to flow upstream from the downstream end, the gas will also enter the open downstream end of the valve portion and force the valve portion into closer contact with the endotracheal tube, thereby improving the seal.

The mask may comprise any mask capable of forming a seal around the laryngeal inlet of the patient. In one embodiment, the cover may include an inflatable cuff that is selectively inflatable and deflatable by an inflation tube. In this embodiment, the Mask may be similar to the Mask of the airway device sold by laryngel Mask company and invented by achibald Brain. An example of such a shield is described in U.S. Pat. No. 4,509,514.

In other embodiments, the mask portion may include a resilient conformal portion (resilient conformal projection) capable of forming a seal around the laryngeal opening without the need for inflation. Some examples of these types of covers are given in australian patent/patent application nos. 2004260552, 2008291688 and 2010234212 and 2015230697 in the name of the applicant.

In one embodiment, the airway tube comprises a primary airway tube having a secondary airway tube or airway passage that joins or enters the primary airway tube.

In a second aspect, the invention provides a bifurcated connector for attachment to the proximal end of an airway tube stem of a laryngeal mask, the bifurcated connector having a first arm and a second arm, a valve, seal or check valve being located in the first arm or the second arm, or in each of the first arm and the second arm.

In a third aspect, the present invention provides a method for positioning an endotracheal tube into a patient, the method comprising: establishing an airway in a patient using the device of the first aspect of the invention; providing ventilation gas and/or anesthetic gas to the patient through one of the first opening or the second opening of the device; and inserting an endotracheal tube through the other of the first or second openings while maintaining a supply of ventilation gas and/or anesthetic gas.

In a fourth aspect, the present invention provides a device suitable for maintaining an airway in a patient, the device comprising an airway tube for providing ventilation gas and/or anaesthetic gas to the lungs of the patient when the device is correctly inserted into the patient, wherein the airway tube has a valve, seal or check valve, or the device is fitted with a connector having a valve, seal or check valve.

The device of the fourth aspect of the invention may comprise an endotracheal tube. The device of the fourth aspect of the invention may comprise a supraglottic airway device. The device may include a mask adapted to form a seal around the laryngeal inlet when properly inserted into a patient.

In one embodiment, the valve, seal or check valve is fitted to the airway tube of the device. In one embodiment, a valve, seal or check valve is fitted to the proximal end of the airway tube of the device. In one embodiment, the valve, seal or check valve is located in a connector attached to the proximal end of the airway tube of the device.

In order to use an embodiment of the device according to the fourth aspect of the invention with a cover such that the device of the fourth aspect of the invention can be used as a conventional supraglottic airway device, a connector or a short tube may be inserted through the valve, seal or check valve to open the valve, seal or check valve. The ventilation gas and/or anesthetic gas may then be provided through the connector or short tube in a conventional manner.

In some embodiments, the endotracheal tube can be inserted through a valve, a seal, or a check valve.

In some embodiments, the connector or adapter has a first proximal opening and a second proximal opening, at least one of the first proximal opening or the second proximal opening having a valve, seal or check valve therein, and the distal end is connected to the airway tube such that the distal end extends through the valve, seal or check valve of the device. The ventilation gas and/or anesthetic gas may be connected to one of the first proximal opening or the second proximal opening, in particular to the proximal opening without a valve, seal or check valve, and the bronchoscope or other surgical instrument may be inserted through the other proximal opening with a valve, seal or check valve.

In one embodiment, the airway tube of the device has a relatively large diameter, and the valve, seal or check valve fits into the relatively large diameter airway tube. Connectors or stubs having different diameters, particularly smaller diameters, can be inserted through the valves, seals or check valves of the airway tube of the device to effectively provide a simple adapter that allows a smaller diameter fitting to be connected thereto.

In embodiments of the fourth aspect of the invention where the device is an endotracheal tube, other instruments, such as a bronchoscope, may be inserted through the valve.

Any feature described herein can be combined with any one or more other features described herein in any combination within the scope of the invention.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that prior art forms part of the common general knowledge.

Drawings

Various embodiments of the present invention will be described with reference to the following drawings, in which:

FIG. 1 shows a view of a conventional airway device known in the prior art;

FIG. 2 shows a view of an apparatus according to an embodiment of the invention;

FIG. 3 shows a view of an apparatus according to another embodiment of the invention;

FIG. 4 shows a view of an apparatus according to a further embodiment of the invention;

FIG. 5 shows a view of an apparatus according to another aspect of the invention;

FIG. 6 shows a view of the device shown in FIG. 5 without the bifurcated adapter;

FIG. 7 shows a top view of a one-way valve suitable for use in embodiments of the present invention;

FIG. 8 illustrates a bottom view of the check valve shown in FIG. 7;

FIG. 9 shows a top isometric view of the check valve shown in FIG. 7 ready for final assembly into the form shown in FIG. 7;

FIG. 10 is a side isometric view of the check valve ready for assembly;

FIG. 11 is a front view of FIG. 10;

FIG. 12 is a side sectional view taken along section A-A in FIG. 11; and

fig. 13 is a side sectional view taken along section B-B in fig. 11.

Detailed Description

Those skilled in the art will appreciate that the drawings are provided to illustrate preferred embodiments of the invention. It is to be understood, therefore, that the present invention is not to be considered limited to the features shown in the drawings.

Fig. 1 illustrates a prior art device for establishing an airway in a patient in the form of a currently available laryngeal mask. The laryngeal mask 10 shown in fig. 1 includes an airway tube 12 and a mask portion 14. The mask portion 14 includes a backing plate 16 and an inflatable cuff 18 attached to the backing plate 16. The inflation tube 20 has a connector 22 that enables the inflation tube 20 to be connected to an injector to be in fluid communication with the inflatable cuff 18. Airway tube 12 is connected to mask portion 14 by connector 24. In some embodiments, the airway tube 12 may be integrally formed with the mask portion 14. A connector 26 at the proximal end of the tube 12 is capable of connecting the tube 12 to a tube that can supply ventilation gas or anesthetic gas.

In use of the device 10 shown in fig. 1, the cuff 18 is deflated and the mask is inserted into the throat of the patient. When the mask is properly positioned in the laryngo pharynx, the cuff 18 is inflated to form a seal around the laryngeal inlet of the patient. The gas supply tube is connected to the connector 26 such that gas is supplied down the airway tube 12 and into the chamber defined by the backplate 16 and inflatable cuff 18 and then into the patient's lungs.

Fig. 2 shows a view of an apparatus for maintaining an airway in a patient according to an embodiment of the invention. The device 30 shown in fig. 2 has a number of features similar to those shown in fig. 1. For example, the device has an airway tube 32 and a mask portion 34. The mask portion 34 includes a backing plate 36 and an inflatable cuff 38, the inflatable cuff 38 being inflated via an inflation tube 40. Inflation tube 40 is connected to the syringe by connector 42. This also allows the inflatable cuff to be selectively deflated, such as for removal of the device from the patient after the procedure is completed. A connector 44 connects the airway tube 32 to the mask portion 34. Alternatively, the cover portion 34 may be integrally formed with the airway tube 32.

The airway tube 32 includes a bifurcated airway tube having a first proximal end, generally indicated at 46, and a second proximal end, generally indicated at 48. A bifurcation point 50 is formed in the airway tube. The airway tube may be considered to have a main airway tube 52 and a side tube 54. The airway tube 52 has a first opening 56 and a check or duckbill valve 58. The second airway tube 54 has a second opening 60, the second opening 60 being formed by a connector 62, the connector 62 being attached to the distal end of the airway tube 54.

In use of the device 30 shown in fig. 2, the device is inserted into a patient with the inflatable cuff 38 in a deflated state. When properly inserted, the inflatable cuff is inflated to form a seal around the laryngeal inlet. The connector 62 of the second airway tube 54 is attached to a source of ventilation or anesthetic gas so that the patient can be supplied with ventilation or anesthetic gas. If no device is connected to the second airway tube 52, a check or duckbill valve 58 prevents gas from exiting through the opening 56 of the second airway tube 52. This maintains the necessary pressure within the device to ensure adequate ventilation of the patient.

If it is desired to insert an endotracheal tube into the patient through the device 30, an endotracheal tube (not shown) can be inserted through the check or duckbill valve 58 and along the airway tube 52 and main airway tube 32, through the airway cavity defined by the backing plate 36 and inflatable cuff 38 and into the laryngeal opening of the patient. While the endotracheal tube is being inserted into the patient, ventilation gas or anesthetic gas can be continuously supplied to the patient through the second airway tube 54. Thus, ventilation of the patient is not interrupted during insertion of the endotracheal tube. This has not previously been possible when inserting a tracheal tube into a patient through a laryngeal mask. The check or duckbill valve 58 can also form a seal around the endotracheal tube to thereby ensure that pressure is maintained within the airway device 30 during insertion of the endotracheal tube into the patient.

The check valve 58 may comprise a duckbill valve, which is well known to those skilled in the art. Many other check valves are known for anesthesia, and any of these valves may also be used.

Fig. 3 shows a perspective view of a device 70 according to a further embodiment of the invention. The device 70 has a number of features in common with the device 30 shown in figure 2 and for convenience these features will be indicated by like reference numerals but with a "'" added thereto. These features need not be described further.

The device 70 shown in fig. 3 has an airway rod 72, which airway rod 72 is connected to the mask portion 34 'via a connector 44'. The airway rod 72 is in the form of a distal airway tube. A furcation tube 74 having a connector 76 is attached to the proximal end 73 of the distal airway rod 72. The bifurcated airway tube 74 has a first tube 78 and a second tube 80. Tubes 78, 80 extend from a bifurcation point 82. The first tube 78 has a check valve or duckbill valve 84. The second airway tube 80 has an airway connector 86.

In use, the bifurcated airway tube 74 is connected to the airway tube stem 72, and the device 70 is inserted into the patient as described above with reference to the device of figure 2. The connector 86 is connected to a source of ventilation gas or anesthetic gas. If it is desired to insert an endotracheal tube into a patient through airway tube 70, the endotracheal tube may be inserted through check or duckbill valve 84 and second airway tube 78. Other surgical instruments (such as bronchoscopes, endoscopes, endoscopic lights, etc.) may also be inserted through the second airway tube 78. Ventilation of the patient may continue during insertion of the endotracheal tube or other instrument.

Fig. 4 shows another embodiment of the present invention. The device 90 shown in fig. 4 has a number of features in common with the device 30 shown in fig. 2, and for convenience these features will be referred to by like reference numerals with a "" being added thereto. These features need not be described further.

The device 90 shown in fig. 4 has a main airway tube 92 in the form of a single integral tube connected to the mask portion 34 or formed with the mask portion 34. A connector 94 is affixed to the proximal end of airway tube 92. Bifurcated connector 96 is in turn connected to connector 94. This places the bifurcated connector 96 in fluid communication with the airway tube 92. Bifurcated connector 96 has a first arm 98 and a second arm 100. A check valve or duckbill valve, shown schematically at 102, is fitted to the second arm 100.

In use of the device 90 shown in fig. 4, the device is inserted into a patient as described with reference to the device of fig. 2. Bifurcated connector 96 may be connected to connector 94 before or after device 90 is inserted into a patient. Once connected, the gas supply tube is secured to the second arm 98 of the bifurcated connector 96. This enables the supply of ventilation gas or anesthetic gas to the patient. If it is desired to insert an endotracheal tube through the device 90 into a patient, it can be inserted through the second arm 100 of the bifurcated connector 100. Also, during insertion of the endotracheal tube, ventilation gas can be continuously supplied to the patient through the first arm 98.

The device according to a preferred embodiment of the invention enables the establishment of an airway using a specific device. Because the other arm of the bifurcated portion of the device has a check valve, seal or valve therein, pressurized vent gas cannot escape through the other arm of the bifurcated portion of the device. This enables a viable venting to be continued. If an endotracheal tube is inserted through the other arm or tube of the bifurcated portion of the device, a seal is formed around the endotracheal tube, which also prevents ventilation gas from exiting the device through the other arm or tube of the bifurcated portion of the device. Thus, ventilation can be continued during insertion of the endotracheal tube.

Another advantage of the device according to the preferred embodiment of the present invention is the ability to use larger diameter endotracheal tubes in conjunction therewith. For example, in the embodiment shown in fig. 2-4, the main airway tube 32, 72, 92 is formed as a unitary tube having a larger inner diameter. Therefore, the endotracheal tube having an outer diameter almost as large as the inner diameter of the airway tube can be inserted into the patient without hindering the supply of ventilation gas to the patient.

In alternative embodiments, the check valves shown in fig. 2, 3 and 4 may be replaced by manually operable valves or may be replaced by seals or closure members. If a seal or closure member is provided, the seal or closure member forms a seal around the endotracheal tube when inserted therethrough to thereby prevent the escape of ventilation gas from the other opening of the bifurcated portion of the device. Similarly, if a manually operated valve is used, the manually operated valve may be opened when it is desired to insert an endotracheal tube therethrough. Ideally, the manually operated valve forms a seal around the outside of the endotracheal tube. Further, a removable cap may be placed over the opening of the valve. Indeed, according to the invention, one or more or even all of the openings of the device may be provided with a removable cap.

In addition to or in conjunction with endotracheal tubes, other medical devices may also be inserted through the apparatus of the present invention. For example, other devices may also be inserted, such as bronchoscopes, guide wires, ultrasound devices, endoscopic lights, endoscopes, clips, forceps, and the like.

A preferred form of the invention provides a valve, seal or check valve in the arm that receives the endotracheal tube (ETT) or other instrument. When no ETT or other instrument is present, the valve, seal or check valve prevents gas from exiting the device through it. Similarly, the valve, seal or check valve also forms a seal around the ETT or other instrument when inserted therethrough, and also prevents gas from exiting the device therethrough when the ETT or other instrument is present.

Intubation of ETTs through the supraglottic airway device (SGAD) is currently primarily attempted and performed in non-breathing patients. Maintaining positive pressure in the airway is absolutely necessary to keep the lungs expanded to avoid lung collapse in non-breathing patients. Therefore, IPPV (intermittent positive pressure ventilation), whether or not with CPAP (continuous positive airway pressure), is absolutely necessary for patients who have been compromised to maintain lung ventilation, lung distension, oxygenation, and prevent hypercapnia.

Attempting to insert an ETT or any other device through any other existing SGAD would open the airway to atmospheric pressure and atmospheric air for a considerable period of time, compromising oxygenation and lung collapse, leading to hypoxia and possible hypercapnia when the procedure may take time.

The second airway tube in the present invention is capable of ippv, cpap, oxygenation, and lung expansion with the aid of a check valve, or seal, which allows the ETT or other device to pass while maintaining airway pressure that maintains lung expansion and oxygenation of the patient, which is ultimately achieved by intubating the patient using the ETT.

All other SGADs currently known to the inventors do so without a main airway tube for ventilation and a valve, seal or check valve on the auxiliary airway tube to maintain airway pressure. The valve, seal or check valve is effective to prevent air from leaking around the instrument being passed therethrough, thereby maintaining airway pressure.

Fig. 5 shows a view of an airway device according to an embodiment of the fourth aspect of the invention. Airway device 110 includes a mask portion 112 and an airway tube 114. Inflation tube 116 can be used to selectively inflate and deflate mask portion 112. The airway tube 114 has a diameter greater than that of conventional supraglottic airway devices.

The valve 118 is suitably a check valve or one-way valve, such as a duckbill valve, and is fitted to the proximal end of the airway tube 114. The valve 118 may be mounted directly to the proximal end of the airway tube 114, or it may form part of an adapter 120 (as shown in figure 5) that is connected to the proximal end of the airway tube 114.

If the device 110 shown in fig. 5 is to be used as a supraglottic airway device, a tube 122 can be inserted through the valve 118. This opens the valve. The connector 125 at the end of the tube can then be directly connected to an airway connector for ventilation gas and/or anesthetic gas. This is not shown in fig. 5. In contrast, fig. 5 shows the bifurcated adapter 126 connected to the connector 125. The bifurcated adapter 126 has a first proximal end 128, the first proximal end 128 being connectable to a tube for supplying ventilation gas and/or anesthetic gas. The adapter 126 has a second proximal end 130, the second proximal end 130 being fitted with a valve, seal or check valve, such as a duckbill valve 132. This enables a bronchoscope or other surgical instrument to be inserted through the valve 132. In this arrangement, the device shown in fig. 5 operates in a similar manner to the device shown in fig. 1-4.

The tube 122 shown in fig. 5 may be only a conventional surgical tube for supplying gas, or it may comprise the tube of an endotracheal tube. Fig. 5 shows a tube 122 in the form of an endotracheal tube. Fig. 5 shows the in-use arrangement of the bronchoscope and endotracheal tube relative to airway device 110.

Fig. 6 shows the device of fig. 5 without the bifurcated adapter 126 connected thereto. In fig. 6, connector 124 has a standard connector end 130 and a truncated end 132. When connector 124 is inserted through valve 118, it opens valve 118 and allows standard hospital equipment to be connected to its standard connector end 130. Alternatively, a valved connector (such as connector/adapter 96 shown in fig. 4) may also be connected to end 130 of connector 124.

To insert an endotracheal tube (ETT) into a patient using the device of fig. 5 or 6, the following steps may be followed:

a truncated tube 124 with a 15mm universal connector is inserted through the carefully selected proximal end of the laryngeal mask 110(LM), which is fitted with a large valve to open the valve for venting and secure the connector to the LM.

The bronchoscope is passed through an adapter 126 with a smaller valve and 15mm junction, and from its connector end further through the selected ETT with cuff, for ease of use. At this stage, adapter 126 is not connected to the LM.

The LM is inserted and positioned in the patient and fixed. We now have an in-situ LM with a large valve and a standard 15mm connector on the LM. The ventilator is now connected and the patient's lungs are ventilated.

The truncated tube with 15mm connector 124 is removed from the LM which has been positioned in the patient and the ETT loaded with the bronchoscope and connector 125 and adapter 126 is quickly inserted through the large valve of the LM, thereby connecting the ventilator to adapter 126 on connector 128 for ventilation and advancing the ETT to the correct position for visualization through the bronchoscope. Once in place, the cuff of the ETT is inflated and secures the ETT in its proper position and continues to ventilate the patient's lungs.

When all of these steps are smooth and satisfactory, to remove the LM, the 15mm connector 125 is disconnected from the ETT, thereby holding the ETT in place, carefully removing the LM on the ETT and inserting the 15mm connector 125 back onto the ETT as soon as possible. Correct placement of ETT was checked and checked by listening to both lungs and ETT was fixed before continuing ventilation.

In some cases, during removal of the LM on a properly inserted ETT, the ETT may move with the LM and fall off as the length of the ETT may not be long enough to be held by the operator during removal of the LM. In this case, another ETT with a ferrule having a smaller diameter may be inserted through the outer end of the installed ETT until the entire ferrule of the second ETT enters the lumen of the first ETT, and then the smaller ETT ferrule is inflated to securely hold it. The operator can then have a use grip and length to safely remove the LM.

Figures 7 to 13 show various views of a valve that may be used in accordance with the present invention. Turning first to fig. 7 and 8, the valve 200 includes an upper peripheral portion comprised of peripheral margins 202, 204, 206. The peripheral edge region forms the upper peripheral edge of the valve (in which case the term "upper" is used to correspond to the "proximal" or "upstream" portion of the valve and the term "lower" is used to refer to the "distal" or "downstream" portion of the valve). The upper periphery of the valve may be used to join the valve 200 to the inner periphery of the tube of the airway device. The valve 200 includes a first valve portion 210, a second valve portion 212, and a third valve portion 214. Each of the valve portions 210, 212, 214 circumscribe approximately one-third of a circle or an angle of approximately 120 °.

As shown in fig. 9 and 10, the valve portions 202, 204, 206 may be molded with adjacent valve portions connected by regions 216, 218. These valve portions can then be rotated relative to each other to form the shape shown in fig. 7 and 8, and then the valve 200 can be attached to the inner wall of the tube of the airway device, such as by heat welding or by adhesive.

As shown in fig. 10, the valve portion 202 includes an upper surface 220 having a downwardly depending skirt 222 extending therefrom. As shown in fig. 12, an upper surface 220 and a downwardly depending skirt 222 are attached to an outer sidewall 224. The outer periphery 202 can also be seen. As shown in fig. 13, upper surface 220 is joined to outer wall 224 along line 226 and downwardly depending skirt 222 is joined to outer wall 224 along line 228.

As best shown in fig. 12 and 13, the downstream section 230 of the valve portion 210 is open and the upstream section 232 is closed. In this manner, if gas flows from the downstream region 230 toward the upper region 232, the gas will enter the open downstream region 230 and fill the closed upper region 232, which in turn will force the downwardly depending skirt 222 to firmly bond with the adjacent skirt in the closed position. If an endotracheal tube has been inserted through the valve 200, the endotracheal tube will deploy the valve portions 210, 212, 214, but the downwardly depending skirt wall and a portion of the upper surface of the valve portion will fit snugly over the endotracheal tube due to the flexibility and resiliency of the skirt and surface. As such, the valve 200 may be made of medical grade silicone or other suitable polymeric material having elasticity and flexibility. Furthermore, if gas attempts to leak through the valve 200 when an endotracheal tube has been inserted through the valve, the gas will enter the open downstream region 230 and the closed upstream region 232, and this will cause the gas to effectively inflate the skirts and surfaces of the valve portions to make them more conformable to the endotracheal tube. This also improves the seal around the endotracheal tube.

In this specification and in the claims (if any), the word "comprise" and its derivatives including "comprises" and "comprising" include each of the stated integers but do not preclude the inclusion of one or more other integers.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

In accordance with the provisions, the present invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to the specific features shown or described, since the means herein described comprise preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted by those skilled in the art, if any.