WO2022133525A1

WO2022133525A1 - Artificial airway device, system, and method of use thereof

Info

Publication number: WO2022133525A1
Application number: PCT/AU2021/051530
Authority: WO
Inventors: Vernon Vivian
Original assignee: Genesis Airway Innovations Pty Ltd
Priority date: 2020-12-23
Filing date: 2021-12-21
Publication date: 2022-06-30

Abstract

An artificial airway device comprising a mask configured to form a seal around a patient's larynx and an airway tube having a first end opening into an interior of the mask and having a second end extending outside of the patient's mouth. The artificial airway device further includes a gastric tube having a first end opening at an oesophageal seal located at the tip of the mask and having a second end extending outside of the patient's mouth. The airway tube and the gastric tube are moveable independently of each other, allowing for improved stability, flexibility, and manoeuvrability of the artificial airway device. The artificial airway device may further comprise a bite block for preventing obstruction of the tube by biting and provides more access to the oral cavity.

Description

ARTIFICIAL AIRWAY DEVICE, SYSTEM, AND METHOD OF USE THEREOF

FIELD OF THE INVENTION

[0001 ] This invention relates to an artificial airway device, system and/or method of use thereof. In particular, the invention relates, but is not limited, to a laryngeal mask airway (LMA) device preferably with an improved bite block slidably mounted thereon.

BACKGROUND TO THE INVENTION

[0002] Reference to background art herein is not to be construed as an admission that such art constitutes common general knowledge in Australia or elsewhere.

[0003] Laryngeal mask airway (LMA) devices are well known devices used for establishing airways in and ventilating unconscious patients while preventing aspiration of secretions or stomach contents into the lungs. The mask portion of the laryngeal mask airway device is used to seal the laryngeal inlet to protect the airway while allowing ventilation in an unconscious patient.

[0004] Current laryngeal mask airway devices are known to be hard to insert and manipulate into a patient’s larynx; can be prone to leakage when utilised with positive pressure ventilation; pose a risk of gastric insufflation and aspiration. The most current laryngeal mask airway devices are provided with both an airway tube and a gastric tube, however these are fixed together and have limited manoeuvrability and flexibility. Manoeuvrability and flexibility of the tubing of a laryngeal mask airway device is important to allow surgeons to manipulate the positioning of the device during surgical procedures. Furthermore, some laryngeal mask airway devices are provided with a bite block to prevent a patient from biting tubing which would restrict the flow of air or gastric waste through tubing and/or cause damage to the tubing. The bite blocks utilised in the current laryngeal mask airway systems are fixed in shape and location which limits placement options, and does not provide the dual function of being able to splint the jaw open in various positions for surgical access to the oral cavity. There are currently no flexible laryngeal mask airway devices or systems on the market that effectively address each of these issues.

OBJECT OF THE INVENTION

[0005] It is a preferred object of this invention to provide an artificial airway device, system and/or method that overcomes or ameliorates one or more of the disadvantages or problems described above, or which at least provides a useful alternative.

[0006] Other preferred objects of the present invention will become apparent from the following descriptions.

SUMMARY OF THE INVENTION

[0007] In one form, although not necessarily the only or broadest form, the invention resides in an artificial airway device comprising: a mask configured to form a seal around a patient’s larynx; an airway tube having a first end opening into an interior of the mask and having a second end extending outside of the patient’s mouth; and a gastric tube having a first end opening at an oesophageal seal located at a tip of the mask and having a second end configured to extend outside of the patient’s mouth, wherein the airway tube and the gastric tube are moveable independently of each other.

[0008] Preferably, the gastric tube is made with reinforced tubing. Preferably, the tubing is reinforced with wire. [0009] Preferably, the airway tube is made with reinforced tubing. Preferably, the tubing is reinforced with wire.

[0010] Preferably, the artificial airway device further comprises a bite block slidably attached to the gastric tube and the airway tube. The bite block is preferably configured to protect the airway tube and/or the gastric tube from obstruction or damage by the patent’s teeth if the patient bites down when the gastric tube and the airway tube are located within the patient’s mouth or to splint the jaw open.

[0011 ] Preferably, the artificial airway device further comprises one or more collars fixed to the airway tube and slidably attached to the gastric tube to keep the tubes in proximity.

[0012] Preferably, the mask inflates to form a compression fit over the larynx of the patient.

[0013] Alternatively, the mask may provide a compression fit over the larynx of the patient using a gel-like substance, such as medical grade thermoplastic elastomer.

[0014] In another form, the invention resides in a bite block comprising: a first surface having one or more openings; a second surface having one or more openings; a first pair of jaw engaging surfaces; a second pair of jaw engaging surfaces; and one or more channels extending between the one or more openings of the first surface and the one or more openings of the second surface configured for the passage of one or more tubes.

[0015] Preferably, a surface of the first pair of jaw engaging surfaces comprises a depression for receiving and securing teeth of an upper jaw of a user when the bite block is configured so that the first pair of jaw engaging surfaces are positioned along a substantially horizontal plane. [0016] Preferably, the second pair of jaw engaging surfaces comprises depressions for receiving and securing teeth of the upper jaw and the lower jaw of the user when the bite block is configured so that the second pair of jaw engaging surfaces are positioned along a substantially horizontal plane.

[0017] Preferably, the one or more openings of the first surface comprise a clip lock mechanism extending partially into the channel for locking the bite block to the one or more tubes at a preferred location.

[0018] Preferably, the bite block may be one component or may comprise a split clip mechanism so that the bite block can be split open and clipped around the one or more tubes.

[0019] Preferably, the first surface is an anterior surface and the second surface is a posterior surface.

[0020] Alternatively, the first surface is an anterior surface and the second surface is a lateral surface, the lateral surface adjacent the anterior surface.

[0021 ] Further preferably, the second surface is one of the first pair of jaw engaging surfaces.

[0022] Preferably, the one or more channels extending between the one or more openings of the first surface and the second surface define an open channel for receiving the one or more tubes.

[0023] Preferably, the bite block tapers away from the first surface.

[0024] Further preferably, the first pair of jaw engaging surfaces are parallel and the second pair of jaw engaging surfaces taper away from the first surface.

[0025] In another form, the invention resides in an artificial airway system comprising: the artificial airway device as hereinbefore described; and the bite block as hereinbefore described. [0026] In another form, the invention resides in a method of installing the artificial airway system, comprising: attaching the bite block to the airway tube and/or the gastric tube of the artificial airway device; inserting the artificial airway device into the mouth of the patient; and securing the artificial airway device against the larynx of the patient.

[0027] Further features and advantages of the present invention will become apparent throughout the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] By way of example only, preferred embodiments of the invention will be described more fully hereinafter with reference to the accompanying figures, wherein:

[0029] Figure 1 illustrates a front view of an artificial airway system, according to an embodiment of the present invention;

[0030] Figure 2 illustrates a side view of an artificial airway device, according to an embodiment of the present invention;

[0031 ] Figure 3 illustrates a rear view of an artificial airway device, according to an embodiment of the present invention;

[0032] Figure 4 illustrates a front view of a collar attached to tubing of an artificial airway device, according to an embodiment of the present invention;

[0033] Figure 5 illustrates a perspective view of the collar attached to an artificial airway device, according to the embodiment of Figure 4;

[0034] Figure 6 illustrates a front view of a bite block, according to a further embodiment of the present invention;

[0035] Figure 7 illustrates a rear view of the bite block, according to the embodiment of Figure 6; [0036] Figure 8 illustrates a top proximal view of the bite block in the horizontal position, according to the embodiment of Figure 6;

[0037] Figure 9 illustrates a side view of the bite block in a vertical position, according to the embodiment of Figure 6;

[0038] Figure 10 illustrates a proximal view of the bite block according to the embodiment of Figure 6, wherein the bite block is releasably tightened to an airway tube of an artificial airway device;

[0039] Figure 11 illustrates a rear view of the bite block according to the embodiment of Figure 6, wherein the bite block is connected to an airway tube of an artificial airway device and is deployed in a horizontal position;

[0040] Figures 12A and 12B illustrate the bite block according to according to the embodiment of Figure 6, demonstrating multiple configurations of the bite block in use.

[0041 ] Figure 13 illustrates a front bottom perspective view of a bite block, according to a further embodiment of the present invention.

[0042] Figure 14 illustrates a rear top perspective view of the bite block according to the embodiment of Figure 13.

[0043] Figure 15 illustrates a perspective view of the bite block according to the embodiment of Figure 13, wherein the bite block is connected to an airway tube of an artificial airway device.

DETAILED DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 illustrates a front view of an artificial airway system 100, comprising an artificial airway device 200 with attached collars 245 and 265.

[0045] Figures 2 and 3 illustrate side view and rear view representations of the above-referenced artificial airway device 200.

[0046] The artificial airway device 200 comprises a mask 205 having a seal portion 210 that is configured to seal around a patient’s larynx. The seal may be formed by inflating the seal portion 210 using an inflation system 215. The inflation system 215 preferably comprises an inflation tube 220 and an inflation valve and indicator system 225.

[0047] Alternatively, the seal portion 210 may be formed using a gel-like substance, such as a medical grade thermoplastic elastomer that moulds to provide a compression fit to seal around the patient’s larynx.

[0048] The artificial airway device 200 further comprises an airway tube 230 having a first end 235 opening into an interior 237 of the mask 205 and having a second end 240 configured to extend outside of the patient’s mouth. A connector 242 is provided on the second end 240 of artificial airway device 200 for attachment to a gas source (not illustrated) and means of ventilation (not illustrated).

[0049] The artificial airway device 200 further comprises a gastric tube 250 having a first end 255 opening at an oesophageal seal 257 located at the tip of the mask 205 and having a second end 260 configured to extend outside of the patient’s mouth. Having the first end 255 of the gastric tube 250 opening at the oesophageal seal 257 lessens the likelihood of regurgitant fluids entering the pharynx of the patient and leading to aspiration.

[0050] Additionally, having gastric tube 250 extending through the interior of the mask 205 to the oesophageal seal 257 provides increased rigidity of the mask 205 preventing the oesophageal seal 257 folding over during insertion. Additionally, this increased rigidity of the mask 205 limits the risk of the epiglottis of the patient downfolding and obstructing the larynx.

[0051 ] The gastric tube 250 has a wide channel to allow for easy insertion of an orogastric tube, the orogastric tube being used for drainage of large volumes of gastric contents and act as a vent for gas from the stomach, preventing gastric distention. [0052] Preferably, the airway tube 230 and the gastric tube 250 are made using wire reinforced tubing. Using flexible wire reinforced tubing allows both the airway tube 230 and the gastric tube 250 to be positioned away from the surgical field. This is particularly useful in procedures where a surgeon and/or anaesthesiologist are working in the same area, such as procedures involving the mouth, head or neck.

[0053] The use of the flexible wire reinforced tubing for the airway tube 230 and the gastric tube 250 also allows for simple repositioning of the tubes during a procedure without risking loss of seal of the seal portion 210 against the patient’s larynx. Further, the flexibility of the airway tubes allows them to conform to the oropharynx of a patient with unusual anatomy when an airway seal cannot be obtained using more rigid laryngeal mask airway masks. The use of non-flexible PVC or silicone tubing provides an increased risk of the seal portion 210 dislodging from its seal position during surgery if the tubing was bumped or attempted to be moved and is liable to kinking and airway obstruction if bent which would result in airway obstruction.

[0054] Further, the use of flexible wire reinforced tubing allows for a greater internal diameter of tubing when compared to plain silicone/PVC tubing allowing greater volumes of secretions to be drained.

[0055] The use of the flexible wire reinforced tubing for the gastric tube 250 minimises risk of the tube collapsing if suction is applied. The artificial airway device 200 thereby provides a double lumen device and system comprising fully reinforced and flexible tubes 230, 250.

[0056] Preferably, the airway tube 230 has a larger diameter than the gastric tube 250.

[0057] In a preferred embodiment, the airway tube 230 and the gastric tube 250 are separate independent tubes that can move independently of one another. The use of two separated wire reinforced tubes allows for improved stability, flexibility, and manoeuvrability of the artificial airway device 200 during insertion into the laryngopharynx of the patient as well as the ability to manipulate the positioning of the airway tube 230 and the gastric tube 250 independently before or during a procedure i.e. to manipulate the airway and gastric tubes out of the surgical fields for intra-oral and head and neck surgery.

[0058] Figure 4 illustrates a front view of one of the one or more collars 245, 265 according to an embodiment of the present invention. Figure 5 illustrates a perspective view of the one of the one or more collars 245, 265 of Figure 4 when attached to an artificial airway device 200 having an airway tube 230 and a gastric tube 250.

[0059] The one or more collars 245, 265 are preferably fixed to the airway tube 230 and slidably attached to the gastric tube 250 to keep the tubes in proximity. Preferably, the one or more collars 245, 265 are fixed around the airway tube 230 and the one or more collars 245, 265 are loosely fit around the gastric tube 250 to allow only the gastric tube to slide freely and to avoid the one or more collars 245, 265 from sliding into the surgical field causing disruption.

[0060] Figures 6 to 12 illustrate a bite block 300, according to a further embodiment of the present invention, wherein, as an example, the bite block 300 is configured for use on a single tubed artificial airway device 200.

[0061 ] The bite block 300 prevents obstruction of the tube by biting and provides more access to the oral cavity for surgeons by splinting the jaw open for surgical access.

[0062] While the preferred artificial airway device 200 comprises both an airway tube 230 and a gastric tube 250, elements of the bite block 300 will be described in detail below with reference to Figures 6 to 12 which illustrates a bite block 300 configured to connect to only an airway tube 230.

[0063] The bite block 300 as described below with reference to Figures 6 to 12 is not limited to use on an artificial airway device 200. The bite block -I Q-

300 may be utilised on any device or system that comprises tubing and/or requires insertion into the mouth of a patient during a medical procedure such as but not limited to an endotracheal tube.

[0064] The bite block 300 comprises a first surface 305 having an opening 310 (see Figure 6) and a second surface 315 having an opening 320 (see Figure 7).

[0065] Additionally, the bite block 300 may comprise a first pair of jaw engaging surfaces 325, 330 and a second pair of jaw engaging surfaces 335, 340.

[0066] The bite block 300 comprises a channel 345 extending between the opening 310 of the first surface 305 and the opening 320 of the second surface 315, the channel 345 configured for the passage of a tube (i.e. airway tube 230).

[0067] Preferably, the bite block 300 comprises more than one channel 345 so that the bite block 300 can be utilised on an artificial airway device 200 having both the airway tube 230 and the gastric tube 250. Alternatively, a single channel 345 may be configured or shaped to suitably receive a plurality of tubes, such as the airway tube 230 and the gastric tube 250. Optionally, the channel 345 may also extend to a surface adjacent the first surface 305 or the second surface 315. For example, the surface adjacent the first surface 305 or the second surface 315 may be the jaw engaging surface 325 as shown in Figure 8, which also comprises a depression 350 configured to receive teeth of a user.

[0068] Preferably, at least one of the surfaces of the first pair of jaw engaging surfaces 325, 330 of the bite block 300 comprises the depression 350 for receiving and securing teeth of an upper jaw of a user (i.e. patient being intubated) when the bite block 300 is configured so that the first pair of jaw engaging surfaces 325, 330 are positioned along a substantially horizontal plane, the horizontal plane being the transverse plane of the user’s head. When the first pair of jaw engaging surfaces 325, 330 are positioned along the substantially horizontal plane and inserted into the patient’s mouth, the patient’s jaw will be minimally ajar.

[0069] Having the jaw of the patient being minimally ajar is useful in procedures to prevent biting of the tube when the patient emerges from anaesthesia or to stabilize the tube when not operating in the oral cavity.

[0070] Preferably, the second pair of jaw engaging surfaces 335, 340 comprises depressions 355, 360 for receiving and securing teeth of the upper jaw and the lower jaw of the user when the bite block is configured so that the second pair of jaw engaging surfaces 335, 340 are positioned along the substantially horizontal plane (transverse plane of the user’s head). When the second pair of jaw engaging surfaces 335, 340 are positioned along the substantially horizontal plane and inserted into the patient’s mouth, preferably at a side location of the jaw, the patient’s jaw will be widely ajar.

[0071 ] Preferably, the bite block 300 tapers away from the first surface 305. This provides an improved ergonomic form factor that accommodates the pivoting motion of the user’s jaw. Further preferably, the first pair of jaw engaging surfaces 325, 330 are parallel and the second pair of jaw engaging surfaces 335, 340 tapers away from the first surface 305. The first pair of jaw engaging surfaces 325, 330 are preferably engaged when the bite block 300 is located at a forward location of user’s jaw, and the second pair of jaw engaging surfaces 335, 340 are preferably engaged when the bite block 300 is located at a side location of the jaw. Tapering of the bite block 300 is therefore significant for improving fitment and user comfort when locating the bite block 300 at a side location of the jaw and engaging the second pair of jaw engaging surfaces 335, 340. The person skilled in the art will understand that the sizing of the bite block 300 and angle of the taper may vary according to user demographic and human factors. [0072] Having the jaw of the patient being widely ajar allows for increased surgical access during dental or maxillofacial procedures, for example. This also allows for the tubing 230, 250 to be stabilised laterally giving maximal intraoral access with the tubing 230, 250 out of the way of a surgical field. This further prevents accidental dislodgement of the artificial airway device or other device, prevents damage to the tubing by surgical equipment, and minimises obstruction to the surgical field.

[0073] Preferably, the opening 310 of the first surface comprises a clip lock mechanism 365 (see Figure 6) extending partially into the channel 345 for locking the bite block 300 to the airway tube 230 at a preferred location.

[0074] Additionally, the bite block 300 may comprise a split clip mechanism (not illustrated) so that the bite block 300 can be split open and clipped around the one or more tubes 230, 250. The split clip is particularly useful if the artificial airway device 200 or other system is already set up and sliding the bite block 300 onto the tubing would not be possible without taking off components of the artificial airway device 200. The split clip mechanism may be a mechanical hinge or a gap in the bite block 300 that can be manually expanded to receive the one or more tubes 230, 250, before returning to shape.

[0075] According to an alternate embodiment, the bite block 300 is slidably attached to the airway tube 230 and the gastric tube 250 of the artificial airway device 200 to protect the airway tube 230 and the gastric tube 250 from being obstructed or damaged by the patent’s teeth if the patient bites down when the gastric tube and the airway tube are located within the patient’s mouth. The bite block 300 may also function as the one or more collars 245, 265 as previously described, for example, providing the beneficial function of keeping the tubes 230, 250 in proximity, when necessary or desired. [0076] The bite block 300, the artificial airway device 200 and all further components described herewith are not limited to one size. These components may be of varying sizes to allow for use with a varying patient size and age.

[0077] In this specification, adjectives such as first and second, forward and backward, upward and downward, upper and lower, top and bottom and the like may be used solely to distinguish one element or action from another element or action without necessarily requiring or implying any actual such relationship or order. Where the context permits, reference to an integer or a component or step (or the like) is not to be interpreted as being limited to only one of that integer, component, or step, but rather could be one or more of that integer, component, or step etc.

[0078] The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. The invention is intended to embrace all alternatives, modifications, and variations of the present invention that have been discussed herein, and other embodiments that fall within the spirit and scope of the above described invention.

[0079] In this specification, the terms ‘comprises’, ‘comprising’, ‘includes’, ‘including’, or similar terms are intended to mean a non-exclusive inclusion, such that a method, system or apparatus that comprises a list of elements does not include those elements solely, but may well include other elements not listed.

Claims

1 . An artificial airway device comprising: a mask configured to form a seal around a patient’s larynx; an airway tube having a first end opening into an interior of the mask and having a second end extending outside of the patient’s mouth; and a gastric tube having a first end opening at an oesophageal seal located at the tip of the mask and having a second end extending outside of the patient’s mouth, wherein the airway tube and the gastric tube are moveable independently of each other.

2. The artificial airway device of 1 , wherein the gastric tube is made with wire reinforced tubing.

3. The artificial airway device of claim 1 or claim 2, wherein the airway tube is made with wire reinforced tubing.

4. The artificial airway device of any one of the preceding claims, further comprising a bite block slidably attached to the gastric tube and the airway tube to protect the airway tube and the gastric tube from obstruction or damage by the patent’s teeth if the patient bites down when the gastric tube and the airway tube are located within the patient’s mouth, and/or to splint open the patient’s jaw.

5. The artificial airway device of any one of the preceding claims, further comprising one or more collars slidably attached to the gastric tube and fixed to the airway tube to keep the tubes in proximity.

6. The artificial airway device of any one of the preceding claims, wherein the mask inflates to form a compression fit over the larynx of the patient.

7. The artificial airway device of any one of claims 1 to 5, wherein the mask provides a compression fit over the larynx of the patient using a gellike substance, such as medical grade thermoplastic elastomer.

8. A bite block comprising: a first surface having one or more openings; a second surface having one or more openings; a first pair of jaw engaging surfaces; a second pair of jaw engaging surfaces; and one or more channels extending between the one or more openings of the first surface and the one or more openings of the second surface configured for the passage of one or more tubes.

9. The bite block of claim 8, wherein a surface of the first pair of jaw engaging surfaces comprises a depression for receiving and securing teeth of an upper jaw of a user when the bite block is configured so that the first pair of jaw engaging surfaces are positioned along a substantially horizontal plane.

10. The bite block of claim 8 or claim 9, wherein the second pair of jaw engaging surfaces comprises depressions for receiving and securing teeth of the upper jaw and the lower jaw of the user when the bite block is configured so that the second pair of jaw engaging surfaces are positioned along a substantially horizontal plane. -16-

11. The bite block of any one of claims 8 to 10, wherein the one or more openings of the first surface comprise a clip lock mechanism extending partially into the channel for locking the bite block to the one or more tubes at a preferred location.

12. The bite block of any one of claims 8 to 11 , wherein the bite block may be one component or may comprise a split clip mechanism so that the bite block can be split open and clipped around the one or more tubes.

13. The bite block of any one of claims 8 to 12, wherein the first surface is an anterior surface and the second surface is a posterior surface.

14. The bite block of any one of claims 8 to 12, wherein the first surface is an anterior surface and the second surface is a lateral surface, the lateral surface adjacent the anterior surface.

15. The bite block of claim 14, wherein the second surface is one of the first pair of jaw engaging surfaces.

16. The bite block of any one of claims 8 to 15, wherein the one or more channels extending between the one or more openings of the first surface and the second surface define an open channel for receiving the one or more tubes.

17. The bite block of any one of claims 8 to 16, wherein the bite block tapers away from the first surface.

18. The bite block of claim 17, wherein the first pair of jaw engaging surfaces are parallel and the second pair of jaw engaging surfaces taper away from the first surface.

19. An artificial airway system comprising: -17- the artificial airway device of any one of claims 1 to 7; and the bite block of any one of claims 8 to 18.

20. A method of installing the artificial airway system of claim 19 comprising: attaching the bite block to the airway tube and/or the gastric tube of the artificial airway device; inserting the artificial airway device into the mouth of the patient; and securing the artificial airway device against the larynx of the patient.