ARTIFICIAL AIRWAY DEVICE
20190262563 ยท 2019-08-29
Inventors
Cpc classification
A61M16/047
HUMAN NECESSITIES
A61M16/0463
HUMAN NECESSITIES
International classification
Abstract
An artificial airway device 1 to facilitate lung ventilation of a patient, comprising an airway tube 2 including an airway lumen 3, a mask 4 at one end of the airway tube, the mask 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 surrounding a hollow interior space or lumen 7 of the mask and the airway lumen 3 opening into the lumen of the mask, wherein the airway tube 2 comprises an outer tube part 201 and an inner core 202, the inner core 202 defining partly or completely the airway lumen.
Claims
1. An artificial airway device to facilitate lung ventilation of a patient, comprising an airway tube including an airway lumen, 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 lumen opening into the lumen of the mask, wherein the airway tube comprises an outer tube part and an inner core, the inner core defining partly or completely the airway lumen.
2. A device according to claim 1, wherein the inner core further defines partly or completely one or more additional lumen.
3. A device according to claim 2, wherein the one or more additional lumen is adapted to receive a sensor or viewing device.
4. A device according to claim 2 or 3, wherein the one or more additional lumen includes a recess for location of a sensor.
5. A device according to claim 2, 3 or 4, wherein the one or more additional lumen further includes one or more lumen disposed to allow in use, for access to the oesophageal sphincter of the patient and/or removal of gastric fluid.
6. A device according to any one of claims 2 to 5, wherein the or each additional lumen is defined entirely by the inner core, or by a combination of the inner core and the outer tube part.
7. A device according to any preceding claim, wherein at least one groove is provided on the outer surface of the inner core.
8. A device according to claim 7, wherein two grooves are provided on the outer surface of the inner core.
9. A device according to claim 7 or 8, wherein the at least one groove provided on the outer surface of the inner core and an inner wall of the outer tube form at least one lumen when the inner core is inserted into the outer tube part.
10. A device according to any preceding claim, wherein the airway tube has a fixed curve portion.
11. A device according to any preceding claim, wherein the outer tube part takes the form of a tube having a fixed curve portion.
12. A device according to any preceding claim, wherein the outer tube part comprises a backplate portion.
13. A device according to any preceding claim, wherein the outer tube part comprises a straight portion.
14. A device according to any preceding claim, wherein the outer tube part comprises a through bore running throughout from its proximal to distal ends.
15. A device according to claim 13 or 14, wherein the inner surface of the outer tube part comprises raised guide tracks.
16. A device according to claim 15, wherein the raised guide tracks extend from near the proximal end to the distal end of the straight portion.
17. A device according to any one of claims 13 to 16, wherein the outer surface of the inner core comprises at least one further groove.
18. A device according to claim 17, wherein the at least one further groove provided on the outer surface of the inner core fits with a corresponding track provided on the inner surface of the outer tube part.
19. A device according to any preceding claim, wherein the inner core is dimensioned to fit inside the outer tube part.
20. A device according to any preceding claim, wherein the inner core extends substantially along the length of the outer tube part.
21. A device according to any preceding claim, wherein the inner core comprises an inner backplate portion.
22. A device according to any preceding claim, wherein the airway tube comprises silicone or PVC.
23. A device according to any preceding claim, wherein the outer tube part and/or the inner core comprise silicone or PVC.
24. A device according to any one of claims 3 to 23, wherein the sensor is a temperature sensor.
25. A device according to claim 24, wherein the temperature sensor is provided on the airway tube.
26. A device according to claim 25, wherein the temperature sensor is provided on the inner core.
27. A device according to claim 25, wherein the temperature sensor is provided on the outer tube part.
28. A device according to any one of the preceding claims, wherein the peripheral formation comprises an inflatable cuff, or a non-inflatable cuff.
29. A device according to claim 28, wherein when the peripheral formation comprises an inflatable cuff, the backplate overlies the cuff and is bonded to it, such that on deflation the cuff may be collapsed upon it, thereby encouraging the cuff to pack flat.
30. A method of treating a patient using a device according to any one of claims 1 to 29.
31. A method of manufacturing an airway tube for a laryngeal mask airway device, the method comprising the steps of forming an airway tube by providing an inner core and an outer tube part, the inner core defining an airway lumen, and inserting the inner core into the outer tube part.
32. A method according to claim 31, including the step of forming the inner core by injection moulding.
33. A method according to claim 31, including the step of forming the inner core by extrusion.
34. A method according to claim 31, 32 or 33, including the step of forming the outer tube by injection moulding.
35. A method according to claim 31, 32 or 33, including the step of forming the outer tube by extrusion.
Description
[0026] The invention will now further be described by way of example, with reference to the accompanying drawings, in which:
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[0057] In the discussion of the following exemplary embodiments, like parts will generally be given the same reference numerals throughout the description.
[0058] For convenience of exposition, referring to
[0059] Referring to
[0060] The device 1 as illustrated further comprises a connector 8 disposed at the proximal end of the airway tube, the connector 8 including a main bore 9 for passage of gas to the airway tube lumen 3, the main bore including a wall defining a circumference and including a plurality of ports 12 to allow passage into the main bore, at least one port 12 being disposed for circumferential rotational movement about the main bore 9.
[0061] At its distal end, airway tube 2 is attached to mask 4. It will be noted that airway tube 2 terminates towards the proximal end of mask 4. Thus mask 4 does not suffer in terms of being made too rigid by the material of the airway tube.
[0062] With reference to
[0063] Outer tube 201 is illustrated in detail in
[0064] As mentioned, at its distal end outer tube 201 includes backplate portion 201c. One notable feature of the present invention is the construction of the backplate 5. As the skilled worker will appreciate, the term backplate, when used in the present technical field has come to denote that part of the mask that is surrounded by the cuff in the assembled device and which provides separation between the laryngeal and pharyngeal regions when the device is in situ in the patient. Supply of gas takes place through an aperture in the backplate via a fluid tight connection between the part of the backplate defining the aperture and the airway tube. In one known arrangement the backplate and airway tube are formed integrally which is a particularly convenient arrangement. In the prior art, backplates are generally bowl or dome shaped structures rather than flat structures and the term is therefore not entirely descriptive of the shape. In the presently described device 1, the outer tube 201 provides a part of the backplate, in particular, backplate portion 201c that acts an outer cover or skin, as illustrated in
[0065] 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 (
[0066] Referring now to
[0067] Insertion of the inner core 202 within the outer tube 201 provides an airway tube and backplate combination 200 comprising an airway lumen 210 provided at the centre of the inner core 202 and at least one additional lumen 212 which may be provided as a gastric conduit.
[0068] In the embodiment shown, for example in
[0069] The inner core 202 may comprise at least one further groove or recess on the outer surface thereof, wherein the at least one further groove may engage with the at least one track 220 provided on the inner surface of the outer tube. The provision of at least one track 220 on the inner surface of the outer tube and/or a corresponding further groove on the outer surface of the inner core guides and facilitates insertion of the inner core element 202 and may further provide a means for securing the inner core 202 in place within the outer tube 201.
[0070] As shown, for example, in
[0071] The airway tube may be formed by fitting together the inner core 202 and the outer tube part 201, wherein the inner core is inserted into the outer tube part 202. When the inner core element 202 is inserted within the outer tube part 201, the inner core element provides strength and rigidity to the airway tube and backplate combination part.
[0072] Airway tube 2 and its components is formed from a material such that it is not collapsible and has a preformed fixed curve as illustrated in
[0073] Referring now to
[0074] Connector 8 is illustrated in detail in
[0075] Access port part 8a comprises a main tube 13 including a generally cylindrical wall 10 having a bore 19 and respectively an outer larger diameter part 15, an inner smaller diameter part 16, and a branch tube 17. Branch tube 17 defines branch bore 18 and is attached to inner smaller diameter part 16 such that branch bore 18 is in fluid communication with bore 19. Branch tube 17 includes an outer constant diameter section 20 that is dimensioned to connect to a standard gas supply. Constant diameter section 20 is connected to a frustoconical section 21 that in turn connects to wall 10. Inner smaller diameter part 16 includes inner circumferential groove 22 adjacent distal end.
[0076] Main bore part 8b comprises a tubular wall 23 defining a bore 24 and proximal and distal ends 25, 26. Proximal end 25 is dimensioned to be received within bore 19 of access port part 8a and includes outer circumferential ridge 27 that is dimensioned to fit into inner circumferential groove 22 of access port part 8a.
[0077] Fixation part 8c comprises generally rectangular plate 28, and fixation tabs 29. Plate 28 includes a central through-bore 30 and two side through-bores 31 which extend between the major surfaces of the plate. Fixation tabs 29 extend from the minor end surfaces of the plate 28, and are hingedly attached thereto by webs 32. Each fixation tab 29 comprises a connector plate 33, a lower plate 34 and tabs 35. As viewed in
[0078] Referring to
[0079] Referring to
[0080] The parts are assembled by forming a connector 8 comprising an access port part 8a, main bore part 8b, fixation part 8c and insert part 8d. The plug component 8e of the connector comprises a circular cup insert 39 that is dimensioned to fit via an interface fit into bore 19 of access port 8a. The plug 8e is attached by a retaining strap 47 to skirt 43 and is dimensioned such that it fits within cup insert 39. Cap 46 including a depending knob 48 fits within through bore 41 when the cap is in place in the plug.
[0081] The connector 8 is inserted into the airway tube by inserting the insert part 8d into a recess provided at the distal end of the airway tube 2. The insert part 8d comprises depending legs 11, each depending leg 11 comprising an arcuate wall and being dimensioned such that the insert part 8d fits within the recess of the airway tube. The insert part of the connector passes through the central through-bore 30 of the fixation part 8c. The fixation part 8c is positioned at the distal end of the airway tube, wherein the major surface of the plate 28 extends along a length which is substantially perpendicular to the longitudinal axis of the laryngeal mask airway device. Fixation tabs 29 extend from the minor surfaces of the plate 28 and are hingedly attached thereto by webs 32. Each fixation tab comprises a connector plate 33, a lower plate 34 and tabs 35. With reference to
[0082] With reference to
[0083] The method may include the step of forming the inner core by injection moulding. As an alternative, the method may include the step of forming the inner core by extrusion.
[0084] The method may include the step of forming the outer tube by injection moulding. As an alternative, the method may include the step of forming the outer tube by extrusion.
[0085] In use, the device 1 is inserted into a patient to establish an airway as with prior art devices. Insertion is effected to the point where gastric inlet aperture 6b meets the patient's oesophageal sphincter, thus establishing fluid communication therebetween. If vomiting or regurgitation occurs, as with previous gastric access laryngeal masks, the material from the oesophagus passes into gastric inlet aperture 6b. However, unlike with previous devices the material passes into the atrium 58 formed between the dual backplate skins 5a, 5b, the volume of which is larger than the volume of the inlet aperture 6b. It will be appreciated that constructing a laryngeal mask with a backplate 5 in which is formed an atrium or conduit 58 for gastric material is a highly efficient and economical way to use existing mask structures. Forming gastric drain tubes from an expandable material so that the space they occupy in the anatomy is minimised until they are called upon to perform their function is advantageous because it makes insertion of the device easier and causes less trauma to the delicate structures of the anatomy when the device is in place, particularly if the device is left in place for an extended period. And still further advantages are obtained if these features are combined such that the atrium 58 is formed from the soft material of the gastric drain tubes makes because the mask, whilst being sufficiently soft to avoid trauma on insertion can yet provide a large volume atrium 58 that can expand under pressure of vomiting. Such expansion results in a dorsal deformation of the outer skin 5b resembling a dome that acts like a spring against the back wall of the throat when the mask is in situ, forcing the cuff 6 against the larynx and thereby helping to maintain the device in its sealed state. The use of the device comprising connector 8 has the advantages that an air supply can be connected to the device from any desired position relative to the patient's face, the position of the air supply tube can moved once it is attached to allow access by the clinician, and the position of the device in the patient is not disturbed by movement of the air supply. The use of a device comprising fixation straps allows the device to be positioned very precisely by virtue of the hinges which provide multiple points of articulation and allow the position and degree of insertion to be tailored precisely to the patient's anatomy. In use, the device comprising an inner core 202 and an outer tube 201 provides strength to the airway tube. In addition, the combination of the inner core 202 and outer tube 201 provides one or more lumen which provides at least one conduit for the insertion of a viewing device or sensor, and/or for the passage of gastric matter.
[0086] Thus, it can be seen that the above described embodiments address the problems of prior art devices in novel and inventive ways.
[0087] Features of the above-described embodiments may be re-combined into further embodiments falling within the scope of the present invention. Further, the present invention is not limited to the exemplary materials and methods of construction outlined above in connection with the exemplary embodiments, and any suitable materials or methods of construction may be employed. For example, although the cuff may be formed using a sheet of soft flexible silicone rubber, other materials such as latex or PVC may be used. PVC as a material is particularly suited to embodiments intended for single use, whereas the use of silicone rubber is preferred although not essential for embodiments intended to be re-used in a number of medical procedures.
[0088] Further, and as would be appreciated by the skilled person, various features of the present invention are applicable to a wide range of different laryngeal mask airway devices, and the invention is not limited to the exemplary embodiments of types of mask described above. For example, aspects of the invention may be applied to laryngeal mask airway devices featuring epiglottic elevator bars over the mask aperture, which bars are operable to lift the epiglottis of a patient away from the aperture upon insertion of an endotracheal tube or other longitudinally-extended element inserted through the airway tube so as to emerge into the hollow or lumen of the mask through the mask aperture. Aspects of the present invention may for example be applied to single or re-useable devices, devices featuring aperture bars or not, intubating devices which permit an endotracheal tube or similar to be introduced into the larynx via an airway tube of a mask, devices incorporating fiberoptic viewing devices and so forth, without restriction or limitation on the scope of the present invention.