Source: https://patents.google.com/patent/AU2011315319B2/en
Timestamp: 2019-04-20 00:56:24
Document Index: 166788804

Matched Legal Cases: ['art 100', 'art 100', 'art 100', 'art 104', 'art 104', 'art 104', 'art 100', 'art 100', 'art 120']

AU2011315319B2 - Artificial airway device - Google Patents
AU2011315319B2
AU2011315319B2 AU2011315319A AU2011315319A AU2011315319B2 AU 2011315319 B2 AU2011315319 B2 AU 2011315319B2 AU 2011315319 A AU2011315319 A AU 2011315319A AU 2011315319 A AU2011315319 A AU 2011315319A AU 2011315319 B2 AU2011315319 B2 AU 2011315319B2
AU2011315319A
AU2011315319A1 (en
2013-05-02 Publication of AU2011315319A1 publication Critical patent/AU2011315319A1/en
2016-06-02 Publication of AU2011315319B2 publication Critical patent/AU2011315319B2/en
The invention relates to an artificial airway device (1) to facilitate lung ventilation of a patient, comprising an airway tube (2), a gastric drain tube (3) and a mask (4) at one end of the airway tube (2), the mask (4) including a backplate (5) and having a peripheral formation (6) capable of forming a seal around the circumference of the laryngeal inlet, the peripheral formation (6) surrounding a hollow interior space (7) or lumen of the mask (4) and the airway tube (2) opening into the lumen of the mask, wherein the mask includes an atrium (8) for passage to the gastric drain tube (3) of gastric matter leaving the oesophagus.
Previous laryngeal masks designed for example according to U.S. patent. No. 4,995,388 (Figs. 7 to 10); U.S. patent. No. 5,241,956; and U.S. patent. No. 5,355,879 provided channels to accept regurgitant fluids arising from the oesophagus in which the diameter of the channels is approximately constant and equivalent to the diameter of the constricted area of the anatomy known as the upper oesophageal sphincter. Such devices, once pressed against the sphinctral region provide conditions in which liquids arising from the oesophagus maintain approximately the same velocity as they pass through the tube of the device. Such devices, when correctly positioned, mimic the anatomy of the sphincter, but not that of the oesophagus, in which conditions of lower flow and therefore of higher pressure prevail during reflux of fluids. Such a position of the device may be undesirable however, because the principal object of such devices having a drainage tube communicating with the oesophageal opening is to avoid leakage of any gastric fluids arising from the oesophagus from leaking around the sides of the device, because such leakage risks contamination of the larynx by these fluids with consequent grave risk to the patient.
Furthermore, existing devices provided with gastric drainage tubes do not have tubes with a diameter as great as that of the oesophageal sphincter and therefore can only offer an increase in velocity of fluids entering the drainage tube, which as seen above results in a reduced pressure in the narrower tube, which will tend to cause fluids from the higher pressure region to force the distal end of the device away from the sphincter,
Any discussion of the prior art throughout the specification should in no way he considered as an admission that such prior art is widely known or forms part of common general knowledge in the field,
According to a first aspect, the present invention provides an artificial airway device to facilitate lung ventilation of a patient, comprising an airway tube, a gastric, drain tube and a mask at one end of the airway tube, the mask including a backplate and having a peripheral formation capable of forming a seal around the circumference of the laryngeal inlet, the peripheral formation surrounding a hollow interior space or lumen of the mask and the airway tube opening into the lumen of the mask, wherein the mask includes an atrium for passage to the drain tube of gastric matter leaving the oesophagus, wherein the atrium is defined by the backplate, and, wherein the defining part is a wall of the backplate.
Unless the context clearly requires otherwise, throughout the description and the claims, the words ‘‘comprise’*,· “comprising”, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the: sense of “including, but not limited to”.
According ίο an embodiment of the invention there is provided an artificial airway device to facilitate lung, ventilation of a patient, comprising an airway tube, a gastric drain tube and a mask at one end of the at least one airway tube, the mask including a baekplate and having a peripheral formation, capable of forming a seal around the circumference of the laryngeal inlet, the peripheral formation surrounding a hollow interior space or lumen of the mask and the airway tube opening into the lumen of the mask, wherein the mask includes an atrium for passage to the gastric drain tube of gastric matter leaving the oesophagus. As will be appreciated, the atrium provides an enlarged space or conduit that potentially substantially reduces the risk of the mask becoming dislodged on the occurrence of regurgitation or vomiting of matter, allowing the integrity of the airway, to be maintained, and thereby potentially greatly minimises the risk of gastric insuflation.
It is preferred that the atrium is defined by a part of the baekplate, and in particular that the defining part is a wall of the baekplate. This provides a compact construction that utilises existing mask structures to provide the gastric conduit, The wall may comprise an outer skin and an inner skin, the atrium being formed between the skins and the skins may be formed from a resiliently deformable material that'Is softer in durometer than the material of the airway tube to aid in insertion.
Figure 1 is a ventral view of a device according to the invention;
Referring in particular to Figures 1 to 6, the device 1 as illustrated includes two gastric drain tubes 3 disposed on either side of airway tube 2 and bonded thereto. It is preferable that the drain tubes 3 are formed from a sufficiently soft resiliently deformable material to be collapsible so that insertion of the device is made easier and also that the space within the anatomy required to accommodate the device in situ is minimised. As an example, the material of the gastric drain tubes 3 is preferably of 20 to 30 Shore durometer. Airway tube 2 is formed from a more rigid materia] than the drain tubes 3 such that it is not collapsible and has a preformed fixed curve as illustrated in Figure 3. As an example, the airway tube 2 may be of 80 Shore durometer. it is bonded to the drain tubes such that a portion 2a of its length protrudes dorsally thereabove. As will be appreciated, this forms a hollow or pocket 2b on the ventral side. The drain tubes and airway tube may be formed from any known suitable material.
In the presently described embodiment backplate 5 comprises inner and outer skins 5a, 5b that together define a space therebetween, as shown schematically in Figure 4. The space so defined is atrium 8 from which proximally, drain tubes 3 lead off and distally, inlet 8a enters (as shown in Figure 2). Thus atrium 8 can be regarded as a manifold that connects the single gastric inlet 8a with the two gastric drain tubes 3. One method of constructing the mask 4 is illustrated in Figure 6, from which it can be seen that the gastric drain tubes 3 and backplate 5 are integrally formed. It will be appreciated that in the illustrations the material from which the backplate 5 and drain tubes 3 are formed is transparent to aid in understanding of the construction of the device 1.
As mentioned above, mask 4 includes peripheral formation 6 which in this embodiment takes the form of an inflatable cuff of generally known form. Cuff 6 includes an inflation line 6a at its proximal end and has a gastric inlet aperture 6b at its distal end that communicates via a bore with an inner aperture 6c (Figure 2). The bore is defined by a collapsible tube. Means may be provided to keep the tube collapsed until the cuff is inflated, such as a press-stud or “ziplock” arrangement. Referring to the exploded view in Figure 6, it can be seen that the dorsal surface of Cuff 6 is bonded to backplate 5 so that the material of the dorsal surface of the cuff 6 forms a bridge between the inner and outer skins 5a, 5b thus closing off the ventral side of atrium 8 except where gastric inlet aperture 6b enters the cuff. Thus it can be seen that gastric inlet 6b is in fluid communication with atrium 8 via aperture 6c. In an alternative method of construction the cuff 6 may be formed with a web across its aperture that itself forms the ventral surface of atrium 8.
Referring now to Figures 26 to 33, the gastric drain and airway tube and backplate combination part 100 will be described. This combination part 100 consists of a precurved tube 101. The tube 101 is not circular in cross-section but has a flattened section, as taught in previous patents, for ease of insertion and fit through the interdental gap. The tube 101 has flattened dorsal and ventral surfaces 101a, 101b and curved side walls 101c extending from a proximal end lOld to a distal end lOle. Towards the proximal end lOld on the dorsal surface there is disposed a fixation tab 102 and at the end is attached a plate 102a (Figure 33). Plate 102a includes three apertures, two gastric apertures 102b either side of an airway aperture through which an airway conduit 107 extends. At its distal end the combination part 100 is cut at an angle relative to its longitudinal axis to provide a flared outer backplate part 104 integrally formed therewith, for example by molding. As an alternative the flared backplate part 104 can be separately formed, in particular from a transparent or translucent material. The backplate part 104 includes a circumferential lip 104a. Finally, it will be noted that combination part 100 includes a substantially coaxially disposed inner tube extending from the distal end to the proximal end, the inner tube effectively establishing a separation of the inner space into two gastric conduits 106 and an airway conduit 107. It will be noted that unlike in prior art constructions, this results in an airway conduit 107 contained within a gastric drain conduit. In the longitudinal sectional view shown in Figure 27 it can be seen that the airway conduit 107 terminates in a cylindrical connector extension 109 at its distal end.
Referring now to Figures 20 to 25, there is illustrated inner backplate wall 110. Inner backplate wall 110 comprises a generally elliptical body in the form of a shallow dish including side wall 111 and floor 112. At the distal, or narrower end of the elliptical dish, side wall 111 has a cylindrical aperture 111a formed therein that extends distally generally in line with the midline of the floor 112 . It will be noted that cylindrical aperture 111a is angled upwardly, relative to the plane of the floor 112 such that the angle of the axis of the bore of the cylindrical aperture is about 20 degrees relative thereto. Along its midline the floor 112 of the dish is raised to form a convex surface that extends longitudinally towards the wider, proximal end where it terminates in a cylindrical formation that may be referred to as a tube joint 113. Tube joint 113 includes bore 113a that provides a connecting passage between the upper and lower surfaces (as viewed) of floor 112. Tube joint 113 merges with and bisects side wall 111 and is angled upwardly at about 45 degrees relative to floor 112, terminating proximally some distance beyond the side wall 111 as shown in Figure 24.
Referring now to Figures 12 to 16, there is illustrated peripheral formation 120 which in this embodiment takes the form of an inflatable cuff. It will be noted that unlike many other laryngeal mask airway devices the cuff 120 is formed integrally as a separate part from the rest of the device, making it easier both to manufacture and attach to the device 1. The cuff 120 comprises a generally elliptical body with a narrower distal end 120a, a wider proximal end 120b and a central elliptical through-aperture 120c. As such it will be appreciated that the cuff resembles a ring. As can be seen from the sectional view in Figure 14, the elliptical body comprises a wall 123 that is generally circular in section at the distal end but deeper and irregularly shaped at the proximal end by virtue of an integrally formed extension 121 formed on the dorsal surface at the proximal end 120b. This dorsal surface extension 121 defines the proximal portion of an attachment surface 122 (Figures 11 and 12). The attachment surface 122 extends from the proximal end to the distal end around the entire dorsal inner circumference of the ring. At its distal end 120a the cuff has a cylindrical through bore 121 the axis of which extends in line with the midline of the ellipse and is angled upwardly as viewed in Figure 14 relative to the plane of the body, in other words from the ventral towards the dorsal side or when the device 1 is in use from the laryngeal to the pharyngeal side of the anatomy (L and P in Figure 14). The result is a circular section aperture through the cuff wall 123. The proximal end 120b of the cuff includes a port 124 that lets into the interior of the bore and the cuff.
Figure 11 illustrates how the parts of device 1 fit together and is most usefully viewed in combination with Figures 8 and 9. From these it can be seen that the combination part 100, and inner backplate wall 110 are combined to form the backplate 5, thus defining a conduit in the form of chamber or atrium 8 within the backplate 5. The peripheral part 120, in this embodiment an inflatable cuff, is attached to the backplate 5 by bonding to the attachment surface 122 such that the backplate 5 seats within it. The connector 130 is passed through the cylindrical bore 121 in the cuff wall and affixed therein in connection with the cylindrical aperture 111a.
1. An artificial airway-device to facilitate lung ventilation of a patient, comprising an airway tube, a gastric drain tube and a mask at one end of tile airway tube, the mask including a backplate and having a peripheral formation- capable of forming a seal around the circumference of the laryngeal inlet, the peripheral formation surrounding, a hollow interior space or lumen of the mask and the airway tube opening into the lumen of the mask, wherein the mask includes an atrium for passage to the drain tube of gastric matter leaving the oesophagus, wherein the atrium is defined by the backplate, and, wherein the defining part is. a wall of the backplate.
2. A device according to claim I, wherein the wall, comprises an outer skin and an inner skin.
3. A device according to claim 2, wherein the. atrium'is formed between the skins.
4. A device according to claim 2 or claim 3, the inner skin including an inlet to the atrium.
5. A device according to any one of claims 2 to 4, wherein the skins are formed from a resili.ently deformable material that is softer in durometer than the material of the airway tube,
6. A device according to any one of claims 2 to 5, the outer skin comprising a part of the gastric drain tube, the inner skin comprising a part of the airway tube,
7. A device according to claim 6, the pail of the gastric drain tube being an. integrally formed part thereof.
8« A device according to claim 6, the said part of the airway tube comprising a bore in fluid communication with the lumen of the mask.
9. A device according to any one of the preceding claims, wherein the airway tube is disposed within the gastric drain tube, I. 0, A device according to claim % wherein the airway tube establishes a separation of the space within the gastric drain tube into two gastric conduits, II, A device according to claim 9 or claim 10, wherein the or each gastric drain tube comprises an expansible materia!,.
AU2011315319A 2010-10-15 2011-10-06 Artificial airway device Active AU2011315319B2 (en)
AU2016219740A Division AU2016219740B2 (en) 2010-10-15 2016-08-29 Artificial airway device
AU2011315319A1 AU2011315319A1 (en) 2013-05-02
AU2011315319B2 true AU2011315319B2 (en) 2016-06-02
Free format text: FORMER OWNER(S): THE LARYNGEAL MASK COMPANY LIMITED