AU2016277769B2

AU2016277769B2 - Gas Flow Indicator Device

Info

Publication number: AU2016277769B2
Application number: AU2016277769A
Authority: AU
Inventors: Matthew MATUSIK
Original assignee: VPAS GROUP Pty Ltd
Current assignee: VPAS GROUP Pty Ltd
Priority date: 2016-12-29
Filing date: 2016-12-29
Publication date: 2020-05-07
Anticipated expiration: 2036-12-29
Also published as: AU2016277769A1

Abstract

A gas flow indicator device (10) has an elongate housing (12) defining a chamber (20) enabling gas flow from an inlet (22) at a first end (16) to an outlet (24) at a second end (18). An indicator member (26) within the chamber (20) extends from adjacent the first end (16) over part of the length of the chamber (20) and is of annular form enabling gas to enter the chamber along a bore (28) through the indicator member (26). The indicator member (26) is spaced from an inner surface (30) of a peripheral sidewall (14) of the housing (12) to define an annular space (32) within the chamber (20). A concealment member (34) is movable from the first end (16) by a sufficient pressure generated by gas flow through the chamber (20), against a biasing member (36) acting to bias the concealment member (34) to the first end (16). An annular skirt (38) of the concealment member (34) is receivable into the annular space (32) so one end (40) of the skirt (38) provides a seal against an annular surface (42) at an end wall (44) at the first end (16), while a transverse wall (48) at the other end (46) of the concealment member (34) defines an opening (50) providing resistance to gas flow. The one end (40) of the skirt (38) can be held in sealing engagement at the annular surface (42) to conceal the indicator member (26) from view through an adjacent window (52) of the housing (12). Increasing gas flow rate to achieve the sufficient pressure overcomes the bias, enabling the concealment member (34) to move towards the second end (18), exposing the indicator member (26) to view through the window (52), and thereby providing a visual indication of gas flow. cncnifinntinn alli' 14 '20 -0-- 12 56! W44

Description

GAS FLOW INDICATOR DEVICE

FIELD OFTHE INVENTION [0001] The present invention relates generally to gas monitoring device. More particularly, the present invention relates to gas flow indicator device for gas delivery devices or systems and gas supply conduits.

[0002] It will be convenient to hereinafter describe the invention in relation to gas flow indicator device for medical devices, systems or conduits that deliver breathing gas to an individual’s airway. However, it is to be appreciated that the present invention is not limited solely to that use. For example, an alternative use for gas flow indicator device of the invention could include breathing gas delivery devices or systems and gas supply conduits for use in the aviation industry. Also, the gas flow indicator device of the invention could be used for other, non-breathing gas applications, and the invention should not be construed as limited to any one or more of the specific examples provided herein.

BACKGROUND OF THE INVENTION [0003] Any discussion of documents, devices, acts or knowledge in this specification is included to explain the context of the invention. It should not be taken as an admission that any of the material forms a part of the prior art base or the common general knowledge in the relevant art in Australia, Europe, New Zealand, the United States of America or elsewhere, on or before the priority date of the disclosure herein.

[0004] Unless stated otherwise, throughout the ensuing description, gas” or “gases refers to any suitable gas, mixture of gases, vapour or a gas/vapour mixture that, as such, can be monitored using the gas flow indicator device of the invention. A gas with which the flow indicator device can be used can entrain an aerosol. In the context of medical or other respiratory applications of the gas flow indicator device, gas refers to any suitable breathing gas, generally oxygen, a mixture of specification_au, 1

2016277769 29 Dec 2016

- 2 oxygen and inert gas and/or pharmacological agent, air and oxygen-enriched air. Similarly, the expression gas delivery device, gas delivery system or “gas delivery conduit” refers to any suitable device, system and conduit for supplying gas to, or at, a desired location such as, in the context of a medical or other respiratory application, to or into an individual's airway. Examples of suitable device, devices, system or conduit include, but are not limited to face masks, mouth pieces, nasal cannulas and gas supply conduits. For non-spontaneous breathing applications suitable device, devices, systems and conduits may include manual resuscitator devices, such as, for example, bag valve masks and endotracheal tubes.

[0005] Supplemental gas is widely used in the medical field. For example, supplemental oxygen is used to assist or maintain safe blood oxygen levels for a patient. The duration of supply of supplemental oxygen varies, depending on the condition of the patient and/or the particular circumstance necessitating supplemental oxygen being administered. Common scenarios include patients having a cardiorespiratory disease or dysfunction and surgical/anaesthetic intervention that mandates supplementation of atmospheric air with higher concentrations of inspired oxygen in order to achieve normal oxygen tensions in the patient's blood. Failure to deliver supplemental oxygen can lead to risk of reduced arterial oxygen tension that, if not corrected, can contribute directly to increased morbidity and mortality.

[0006] Failure of supplemental gas delivery is an acknowledged and feared system risk in hospitals. To safeguard against this, more often than not there are multilevel complex alarms and flow sensors within the hospital's in-built gas piping circuitry, and/or at gas supply outlets provided throughout hospital facilities. In addition, anaesthetic machines, intensive care ventilators, or the likes, have mandatory flow sensors engineered into their design to detect and alert of gas supply failure.

[0007] The gas supply systems of most hospitals generally are monitored, from the source to the supply outlet. The same applies to complex anaesthetic machines and ventilators. However, the most commonly used, and often most specification_au, 2

-32016277769 29 Dec 2016 simple, gas delivery devices, systems and conduits, are not provided with any effective gas flow indicator device. Hence, their use can lead to the failure of gas delivery going unnoticed. This risk is increased in situations involving gas supply from portable gas tanks or cylinders.

[0008] One of the most commonly used gas delivery devices for spontaneously breathing patients is the gas delivery mask, or oxygen mask. Sometimes called the Hudson Mask, with reference to the early mask innovations of the Hudson Company, most such masks are made of a clear plastics material and include a body that is sized to seat over the nose and mouth of a patient. With conventional mask designs, gas is introduced through a gas inlet, and expiratory gases are vented from either around the side of the mask or through appropriately placed ventilation apertures. Gas is supplied to the gas inlet from a gas supply source, commonly by way of a length of clear plastic conduit. The gas supply source may be an in-built hospital supply source, or a gas tank or cylinder.

[0009] Oxygen masks usually are designed to increase a patient's inspired fraction of oxygen, such as from about 21% to about 40%. The oxygen flow rate required to achieve this is about 6 litres per minute (6 L/min). When oxygen flow into the mask fails the prescribed inspired oxygen concentration is not achieved. Of greater concern, the patient re-breathes their expired gases which can’t be replenished satisfactorily by entrainment of air around the side of the mask, ultimately leading to the inspiration of a gas mixture with a low level of oxygen (less than 21% oxygen) and a risk of hypoxemia. Oxygen masks are not presently provided with any visual indicator confirming the presence of oxygen flow into the mask, or in the oxygen supply conduit proximate the mask. With the use of a mask, it is not inherently obvious to a medical practitioner, to a carer or even to the patient when there is an insufficient or complete lack of oxygen flow. A visual inspection of the oxygen delivery system (e.g. conduit and mask) will not generally indicate whether or not oxygen is or flowing. For this reason, medical practitioners often find it necessary to use audible cues as a means of identifying that there is a flow of oxygen. However, even putting ones ear or a stethoscope adjacent to a mask may sometimes still not make clear whether gas is flowing, and the medical practitioner specification_au, 3

-42016277769 29 Dec 2016 still has no way of knowing whether oxygen is being supplied at the prescribed flow rate of oxygen, such as about 6 L/min.

[0010] For non-spontaneously breathing patients, one of the most commonly used manual resuscitator gas delivery devices is the bag valve mask or BVM. Sometimes called the AMBU bag or mask, with reference to the proprietary name appointed by the inventors' of the original BVM, such devices consist of a flexible air chamber (the bag) attached to a face mask or endotracheal tube via a shutter valve. When the mask is properly applied to a patient (or endotracheal tube is correctly inserted into the patient’s trachea) and the bag is squeezed, the device forces air into the patient's lungs. When the bag is released, it self-inflates from its supply end, drawing in either ambient air or oxygen supplied by an oxygen supply source, while also allowing the patient's lungs to deflate to the ambient environment (but not to the bag) by way of a one-way expired air valve. The BVM generally includes two inlet ports for drawing in ambient air or oxygen. When available, oxygen is supplied to one of the inlet ports from a gas supply source, commonly by way of a length of clear plastic conduit. The gas supply source may be an in-built hospital supply source, or a gas tank or cylinder. The other inlet port can then be used to draw in ambient air, or to connect a reservoir for catching unused oxygen between compressions of the bag. In case oxygen flow is not sufficient to fill the bag, the reservoir generally includes a one-way valve for drawing in ambient air to ensure that the BVM continues to supply at least ambient air to the patient.

[0011 ] BVMs are designed to deliver up to 100% inspired oxygen to a patient. With a loss of supplemental oxygen supply into the bag, the BVM will continue to entrain ambient air (with an oxygen concentration of about 21%) with which to ventilate the patient. However, patients requiring the use of such manual resuscitator devices often have severely compromised respiratory function, which means that they require much higher inspired oxygen concentrations than that of ambient air. Therefore, any loss of supplemental oxygen supply can have catastrophic sequelae if undiagnosed. As with the case of the common oxygen mask described above, loss of oxygen supply to a BVM can be, and often is, missed as there is presently no visual flow indicator device provided at or proximate the specification_au, 4

-52016277769 29 Dec 2016

BVM confirming supplemental oxygen inflow. Again, although the presence of a sound may indicate that gas is flowing, the medical practitioner still has no way of knowing whether the required flow rate of oxygen is present at the BVM.

[0012] Often gas tanks or cylinders are used to supply oxygen to masks or BVM's, most commonly in emergency, perioperative, critical care or transport scenarios. While some cylinders do have ball-type flow indicators at their supply outlets, the cylinders are often placed in positions in which they are visually obscured, such as under a patient's bed or transportation trolley, or placed sideways rendering the ball-type flow indicators inaccurate. Additionally, most cylinders do not have alarms in the event of cylinder oxygen supply running empty during use to indicate oxygen supply failure. Even more concerning is that newer designs of oxygen cylinders commonly no longer have ball-type or other flow indicator incorporated into their design. Hence, failure of supply of supplemental gas to gas delivery devices or systems is a real and likely problem.

[0013] A substantial advance in the art is provided by the gas flow indicator device disclosed in our International Patent Application No.: PCT/AU2013/000884, published under WO 2014/026221 A1 on 20 February 2014, and its counterparts in Australia (Application No.: 2013302298), Europe (Application No.: 13829326.1), New Zealand (Application No.: 705892) and the United States of America (Application No.: 14/421,039). The gas flow indicator device of those Applications comprises a gas flow chamber including a transparent portion and an opaque portion, an inlet port, an outlet port, and a gas flow signal means movably disposed within the gas flow chamber; wherein, when there is no gas flow or less than a predetermined gas flow rate, the gas flow signal means is disposed at least substantially within one of the transparent portion and the opaque portion; and wherein, when there is gas flow and the predetermined gas flow rate has been achieved or is being maintained, the gas flow signal means is moved to be disposed at least substantially within the other of the transparent portion and the opaque portion. Typically, the gas flow signal means is biased to a rest position substantially within the one of the transparent and opaque portions and includes a bellows device or a piston device.

specification_au, 5

-62016277769 29 Dec 2016 [0014] While the gas flow indicator device, of our earlier patent Applications identified above, works effectively and is reliable, it is relatively complex and requires careful attention to detail in its manufacture. The present invention is concerned with providing an improved form of gas flow indicator device.

DISCLOSURE OF THE INVENTION [0015] According to the present invention, there is provided a gas flow indicator device including an elongate housing that has a peripheral sidewall that extends between first and second opposite ends and that defines a gas flow chamber through which gas is able to flow from an inlet port at the first end to an outlet port at the second end. Within the chamber, the device has a gas flow indicator member that extends from adjacent to the first end of the housing over part of the length of the chamber towards the second end. The indicator member is of annular form such that gas flowing through the chamber from the inlet port to the outlet port enters the chamber along a bore that extends through the indicator member. The indicator member is spaced from an inner surface of the sidewall of the housing to define, with that inner surface, an annular space that forms part of the chamber. The device further includes a concealment member that is movable from the first end of the housing in response to a sufficient pressure generated by gas flow from the inlet port to the outlet port, against the action of a biasing member acting to bias the concealment member to the first end. The concealment member has an annular peripheral skirt that, under the bias of the biasing member on the concealment member, is receivable into the annular space, such that one of opposite ends of the skirt is able to seal against an annular surface of the housing at or adjacent to an end wall of the housing at the first end of the housing. The concealment member also includes, at the other of the opposite ends of the skirt, a transverse wall that defines an opening through which the flow of gas from the inlet port to the outlet port is able to pass, with the opening providing resistance to such flow. The arrangement is such that the one of opposite ends of the skirt is able to be held in sealing engagement with the annular surface at or adjacent to the end wall of the housing whereby the indicator member is concealed from view, through a laterally adjacent viewing window portion of the housing when there is no gas flow specification_au, 6

2016277769 29 Dec 2016

- 7 or a gas flow rate generating less than the sufficient pressure but such that, with increasing gas flow rate the sufficient pressure is achieved and the bias of the biasing member is thereby overcome to enable the concealment member to move towards the second end of the housing and expose the indicator member to view through the viewing window portion of the housing and provide a visual indication indicative of gas flow. The movement of the concealment member to expose the indicator member moves the one of opposite ends of the skirt of the concealment member from the annular surface at or adjacent to the end wall of the housing, and most preferably thereby enables a secondary gas flow to the outlet that passes around the one of opposite ends of the skirt between the concealment member and the housing. Substantial or full exposure of the indicator member preferably shows that not only is gas flowing, but also that a desired or minimum flow rate, such as 6 L/min, has been achieved and is being maintained. The arrangement enables such satisfactory operation to be seen, such as with only a quick glance being all that is required to obtain confirmation of the correct or required operation. In effect, the arrangement is such that the device is readily able to function as if in the nature of an “on” or “off” switch, indicating respectively the there is, or there is not, gas being supplied to a patient (preferably at a desired or minimum flow rate, e.g. such as about 6 L/min).

[0016] In one convenient arrangement, the concealment member is made of an opaque material through which the indicator member is not able to be seen when the one end of the skirt of the concealment member is held in sealing engagement with the annular surface at or adjacent to the end wall of the housing. When the concealment member is moved to expose the indicator member, the outer surface characteristics of the indicator member are able to be seen by being directly viewed and, as detailed herein, those characteristics preferably are such as to highlight exposure of the indicator member after movement of the concealment member. However, the concealment member need not be opaque in order to make possible its concealment or exposure of the indicator member. Thus, the concealment member may be semi-opaque, translucent or even transparent but of a material of a colour that interacts with the colour of the indicator member in a visually distinctive manner resulting in an observer being able to readily distinguish between a specification_au, 7

-82016277769 29 Dec 2016 condition in which the actual colour of the indicator member is concealed, or only visible through the concealment member and seen as if of a colour other than its actual colour, and a condition in which the actual colour of the indicator member can be seen by direct viewing made possible by the concealment member being withdrawn or retracted by a sufficient gas flow rate moving the concealment member against the action of the bias member.

[0017] The biasing member may act in compression or in tension in biasing the concealment member to the first end of the housing. Thus, the biasing member may be compressed between, such as compressed by, the concealment member and the second end and provide the required bias in seeking to expand. Alternatively, the biasing member may be within the concealment member, and tensioned by being expanded between, such as by being connected in relation to, each of the transverse wall of the concealment member and the first end of the housing so as to provide the bias in seeking to contract. While other arrangements are possible, the biasing member preferably comprises a coil spring in each of those alternatives.

[0018] Where the biasing member is a coil spring acting between the concealment member and the second end of the housing, compression of the spring can limit the extent to which the concealment member can move towards the second end of the housing simply as a consequence of the presence of the compressed spring. Where the biasing member is a coil spring within the concealment member, the arrangement may be such that the concealment member is able to move so as to contact the end wall at the second end of the housing, although the arrangement may be such that contact of the concealment member with the second end of the housing is precluded by the spring reaching its elastic limit.

[0019] The concealment member preferably is able to move, between a first position in which the indicator member is concealed and a second position in which the indicator member is sufficiently exposed, or fully or substantially fully exposed, over a distance enabling a clear visual indication of gas flow through the device. The arrangement is such that, when so exposed, the indicator member can readily specification_au, 8

-92016277769 29 Dec 2016 be seen through the viewing window portion of the sidewall of the housing by a person in close proximity, such as beside the bed of a patient being supplied oxygen through the device, and preferably also from a considerable distance such as from five to ten meters, or further, from the device. In order that the indicator member is viewable, the viewing window portion is at least translucent. However, the window portion preferably is sufficiently transparent to facilitate viewing of the indicator member, when exposed. The viewing window portion most preferably is of high transparency. Also, the viewing window portion most preferably extends around the full circumferential extent of the sidewall of the housing adjacent to the first end, although it could comprise two or more regions spaced circumferentially around that sidewall of the housing adjacent to the first end. Particularly where the viewing window portion extends around the full circumferential extent of the sidewall of the housing, it preferably is of a high-transparency plastics or glass material, with the material preferably also having a high level of clarity. The laterally adjacent portion of the housing, particularly where the viewing window portion extends fully around the circumferential extent of the sidewall of the housing, may be of a different material to that of a remaining extent of the length of the housing and, in that case, the material of which the remainder of the housing is made may be transparent, translucent or opaque, as required. However, the housing preferably is of unitary or integral form and made of a single material, preferable a rigid plastics material such as a suitable engineering plastics material. Where the housing is of unitary or integral form, and made of a transparent material, the remainder of the housing may be rendered opaque by provision of an external or internal lining or coating of an opaque material.

[0020] The housing may be of circular in cross-sections perpendicular to the direction of spacing between the first and second ends. The inner surface of the sidewall of the housing may be substantially cylindrical and of substantially constant circular transverse cross-section between the first and second ends, while the sidewall also may have an outer surface that is substantially cylindrical and of substantially constant circular cross-section. However, for reasons explained later herein, the outer surface of the sidewall may depart from such cylindrical form, at least along an initial section of its longitudinal extent from adjacent to the first end, specification_au, 9

- 102016277769 29 Dec 2016 with that initial section extending around the gas flow indicator member. In one convenient arrangement, the outer surface of the sidewall, over that initial section of its longitudinal extent, may smoothly increase in diameter to a maximum in a direction away from the first end towards the second end, and thereafter transition to smoothly decrease in diameter substantially to the diameter at the first end, so as to have a convex longitudinal form. The at least one viewing window portion discussed above preferably has such convex longitudinal form, with the portion of that form most preferably being circumferentially continuous around the housing.

[0021 ] At the first end of the housing, the inlet port may be defined by a spigot that projects from the first end of the housing in a direction away from the second end, and that enables connection of a gas supply conduit to the housing. In one arrangement, the spigot may have an extension into the interior of the housing to provide a tubular extension or hub on or around which the gas flow indicator member can be mounted. In that case, the indicator member may have an axial extent that is substantially the same as, or slightly greater than, the length of the hub. The indicator member may be a firm friction fit on the hub so as to secure the indicator member in position and, to assist in attaining a firm fit, the indicator member and the hub may have complementary surfaces by which they are mutually engaged. The surfaces may taper so as to decrease in cross-section towards the outlet end, for example frustoconically. The taper preferably is relatively slight, such as with a halfcone angle of about two to about six degrees. However other arrangements are possible. For example, the indicator member may be bonded or welded onto the hub, without the need for a friction fit. Alternatively, the indicator member may have an end, adjacent to the end wall at the first end of the housing, by which the indicator member is bonded or welded to the end wall. In a further alternative, the indicator member may have, at its end remote from the first end of the housing, a flange that overlaps the corresponding end of the hub, with the flange bonded or welded to that end of the hub. However, in another arrangement, the spigot does not have an extension that projects into the housing, with the indicator member being bonded or welded to the end wall of the housing at the first end, or mechanically engaged with that end wall such as by screw-threaded engagement or a snap fit in or around the inlet port.

specification_au, 10

- 11 2016277769 29 Dec 2016 [0022] The skirt of the concealment member preferably has an outer surface that is spaced from the inner surface of the sidewall of the housing, although relative sliding contact may be provided between those surfaces. Where there is spacing between the surfaces, this most preferably applies throughout the extent of movement of the concealment member longitudinally within the housing. The inner surface of the sidewall of the housing preferably is of substantially uniform circular cross-section. The device may have guide members that maintain the concealment member in a substantially co-axial relationship with the housing. Such guide members may comprise a plurality of circumferentially spaced projections that stand proud, or project inwardly, of the inner surface of the housing so as to be contactable with the outer surface of the skirt of the concealment member. In one convenient form, the guide members are provided by a plurality of longitudinal ribs on the inner surface of the sidewall of the housing, with three or four such ribs usually being sufficient. In an alternative arrangement, the plurality of guide members may stand proud, or project outwardly, of the outer surface of the skirt of the concealment member. In either case, the outer surface of the skirt of the concealment member may be of substantially uniform circular cross-section, although it preferably has a slight taper so as to decrease in cross-section towards the other end at which the transverse wall of the concealment member is provided, such as a taper providing a half-cone angle of from about two to about six degrees. The guide members not only centralise the concealment member, but also preferably obviate noise or vibrations due the concealment member rattling or oscillating laterally within the housing.

[0023] The inner surface of the skirt of the concealment member, when the indicator member is concealed, preferably is spaced from the outer peripheral surface of the indicator member. This avoids contact between the skirt of the concealment member and the indicator member, and thereby obviates friction that could resist movement of the concealment member relative to the indicator member. The skirt of the concealment member and the indicator member each may be of uniform wall thickness along its respective axial extent, while they may be of similar or substantially the same wall thickness.

specification_au, 11

- 12 2016277769 29 Dec 2016 [0024] At the second end, the housing may have an end wall that defines the outlet port. The end wall preferably is separable from the sidewall of the housing. In one convenient arrangement, the end wall comprises an annular peripheral rim that is engaged with the sidewall of the housing around the second end, a central hub portion and a plurality of circumferentially spaced connectors that extend between the rim and the hub.

[0025] According to a further aspect of the present invention, there is provided a gas delivery device, gas delivery system or gas supply conduit including the gas flow indicator device of any one of the preceding paragraphs.

[0026] These and other essential or preferred features of the present invention will be apparent from the description that now follows.

BRIEF DESCRIPTION OF THE DRAWINGS [0027] In order that the invention may be more clearly understood and put into practical effect there shall now be described in detail preferred constructions of a gas flow indicator device for gas delivery devices or systems and gas supply conduits in accordance with the invention. The ensuing description is given by way of non-limitative examples only and is with reference to the accompanying drawings, wherein:

[0028] Figure 1 is a schematic representation of gas flow indicator device according to the invention as incorporated into a face mask installed on a patient to receive a controlled gas supply;

[0029] Figure 2 shows a perspective view of a first preferred embodiment of a gas flow indicator device according to the invention, shown in an operating condition;

[0030] Figure 3 is an exploded view of the device of Figure 2, shown in a nonoperating condition in relation to a face mask;

specification_au, 12

- 132016277769 29 Dec 2016 [0031] Figure 4 is perspective view from one end of the device of Figure 2, this time shown in a non-operating condition;

[0032] Figure 5 is similar to Figure 4 but taken from the other end;

[0033] Figure 6 is a side elevation showing the device of Figure 2 in the nonoperating condition applicable to each of Figures 4 and 5;

[0034] Figure 7 corresponds to Figure 6, but shows the device in its operating condition;

[0035] Figures 8 and 9 correspond to views Figures 4 and 5, respectively, but in exploded views on an enlarged scale;

[0036] Figure 10 is a plan view from one end of the device of Figure 2;

[0037] Figure 11 is a sectional view of the device of Figure 2, taken on line XX of Figure 10;

[0038] Figure 12 corresponds to Figure 10, but is taken from the opposite end;

[0039] Figure 13 is a schematic representation of the device of Figure 2, illustrated in operation in accordance with the condition shown in Figure 7;

[0040] Figures 14 and 15 correspond to Figures 6 and 7, respectively, but with one component sectioned to better illustrate internal components;

[0041 ] Figures 16 to 18 show different preferred forms for one component of the device of Figure 2;

[0042] Figure 19 shows the device of Figure 2, in a view corresponding to Figure 6, as incorporated into a conduit flow-line;

specification_au, 13

- 142016277769 29 Dec 2016 [0043] Figure 20 corresponds to Figure 19, but shows the device and flowline in longitudinal section;

[0044] Figures 21 to 24 illustrate gas flow indicator device according to a second embodiment of the invention, shown in views corresponding to Figures 6, 11,13 and 10, with Figures 22 and 23 taken on line Y-Y of Figure 24;

[0045] Figures 25 to 28 show an end elevation, a side elevation, a perspective view and a section view taken on line Z-Z of Figure 26, respectively of a component suitable in the device of Figures 2 to 20, or the device of Figures 21 to 24;

[0046] Figures 29 to 36 provide respective sectional views illustrating alternatives for securing together two components for the device of the illustrated first or second embodiments of the invention shown in Figures 2 to 20 and Figures 21 to 24 respectively;

[0047] Figure 37 is similar to Figure 15, but highlights an encircled region of the device;

[0048] Figure 38 illustrates performance with the encircled region of Figure 37; and, [0049] Figures 39 to 42 illustrate different detail for components of the device of Figure 2, but also applicable to the device of Figures 21 to 24.

MODES FOR CARRYING OUT THE INVENTION [0050] In the following detailed description of the invention, reference is made to the drawings in which like reference numerals refer to like elements throughout, and which are intended to show by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilised and that procedural and/or structural changes may be made without departing from the spirit and scope of the invention.

specification_au, 14

- 152016277769 29 Dec 2016 [0051] Figure 1 schematically illustrates a patient P undergoing a procedure in which the patient P is receiving a controlled supply of required gas through a device 10 according to the invention. The device 10 is fitted into a face mask F held by strap S over the nose and mouth of the patient P and the required gas is passed to the device 10 from a source of supply (not shown) via a conduit C.

[0052] The device 10 comprises a gas flow indicator device that, as shown in Figures 2 to 15, is of elongate form. Device 10 includes an elongate housing 12 that, as shown in Figure 3, has a peripheral sidewall 14 that extends between first and second opposite ends comprising an inlet end 16 and an outlet end 18, respectively. The housing 12 defines a gas flow chamber 20 through which gas is able to flow from an inlet port 22 at the inlet end 16 to an outlet port 24 (see, for example, Figure 4) at the outlet end 18. Within the chamber 20 the device 10 has a gas flow indicator member 26 that extends from adjacent to the inlet end 16 of the housing 12 over part of the length of the chamber 20 towards the outlet end 18, typically less than half the length of the chamber 20, such as from 35 to 45% of the length. The indicator member 26 is of annular form such that gas flowing through the chamber 20 from the inlet port 22 to the outlet port 24 enters the chamber 20 along a bore 28 that extends through the indicator member 26. The indicator member 26 is spaced from an inner surface 30 (see, for example, Figure 7) of the sidewall 14 of the housing 12 to define, with that inner surface 30, an annular space 32 (again, see for example, Figure 7) that forms part of the chamber 20.

[0053] The device 10 has a concealment member 34 that is movable from the inlet end 16 of the housing 12 in response to a sufficient pressure generated by gas flow from the inlet port 22 to the outlet port 24. However, such movement of concealment member 34 is against the action of a biasing member 36 acting to bias the concealment member 34 to the first end 16 of housing 12. The concealment member 34 has an annular peripheral skirt 38 that is receivable into the annular space 32, such that one end 40 of the skirt 38 is able to seal against an annular abutment surface 42 defined by housing 12 at or adjacent to an end wall 44 of the housing 12 at the inlet end 16 of the housing 12. The concealment member 34 also includes, at the other end 46 of the skirt 38, a transverse wall 48 that defines an specification_au, 15

- 162016277769 29 Dec 2016 opening 50 through which the flow of gas from the inlet port 22 to the outlet port 24 is able to pass, with the opening 50 providing resistance to such flow. The arrangement is such that the end 40 of the skirt 38 is able to be held in sealing engagement with the annular abutment surface 42 of the housing 12 whereby the indicator member 26 is concealed from view, through a laterally adjacent viewing window portion 52 of the housing 12 that is at least translucent until, with increasing gas flow rate, the sufficient pressure is achieved and the bias of the biasing member 36 is thereby overcome to enable the concealment member 34 to move towards the outlet end 18 of the housing 12 and expose the indicator member 26 to view through the viewing window portion 52 of the housing 12 and provide a visual indication indicative of gas flow. As already outlined above, it is preferred that full exposure of the indicator member 26 shows that not only is gas flowing, but also that a desired or minimum predetermined flow rate, such as a flow rate of about 6 L/min, has been achieved and is being maintained. The movement of the concealment member 34 to expose the indicator member 26 moves the end 40 of the skirt 38 of the concealment member 34 from the annular abutment surface 42 of the housing 12, and most preferably thereby enables a secondary gas flow to the outlet port 24 that passes around the end 40 of the skirt 38 between the concealment member 34 and the housing 12 (as will be described in further detail below, with reference to Figure 13).

[0054] In the arrangement of Figures 2 to 15, the biasing member 36 is a coil spring that acts in compression in acting to bias the concealment member 34 to the inlet end 16 of the housing 12. Although the use of coil spring is described, and shown in the drawings, it will be appreciated that any suitable form of biasing member 36 may be utilised in accordance with the invention. As is shown in Figures 2 to 20, the preferred coil spring biasing member 36 may be compressed by and between the concealment member 34 and the outlet end 18 of the housing 12 so as to provide the required bias in seeking to expand. The concealment member 34 is able to move against the bias from the position shown Figures 4 to 6, in which the indicator member 26 is concealed, to the position shown in Figures 2 and 7 in which the indicator member 26 is sufficiently exposed, over a distance enabling a clear visual indication of gas flow through viewing window portion 52 of the housing 12 of specification_au, 16

- 172016277769 29 Dec 2016 the device 10. The arrangement is such that, when exposed, the indicator member 26 can readily be seen through the laterally adjacent viewing window portion 52 of the sidewall 14 of the housing 12 by a person in close proximity, such as beside the bed of patient P of Figure 1, and preferably also from a considerable distance such as from five to ten meters, or further, from the device 10 provided for patient P. Thus, the arrangement of device 10 is such that its operating condition can be readily determined, such as with only a quick glance being all that is required to obtain confirmation of the operation condition. The arrangement is such that device 10 is readily able to function, in effect, as if in the nature of an “on” or “off” switch, indicating respectively the there is, or there is not, gas being supplied to a patient P (preferably at a desired or minimum flow rate, e.g. such as about 6 L/min).

[0055] While the laterally adjacent viewing window portion 52 is at least translucent, it preferably is transparent to facilitate viewing of the indicator member 26, when exposed. The viewing window portion 52 most preferably is of high transparency, and most preferably extends around the full circumferential extent of the sidewall 14 of the housing 12 adjacent to the first end 16, as shown in each of Figures 2 to 15. However, such window portion could comprise two or more regions spaced circumferentially around sidewall 14. Particularly where the viewing window portion 52 extends around the full circumferential extent of the sidewall 14, it preferably is of a high-transparency plastics or glass material, with the material preferably also having a high level of clarity. The laterally adjacent viewing window portion 52, particularly where it extends fully around the circumferential extent of the sidewall of the housing 12, may be of a different material to that of a remaining extent of the length of the housing 12 and, in that case the material of which the remainder of the housing 12 is made may be transparent, translucent or opaque, as required. However, the housing 12 preferably is of unitary or integral form and made of a single material, preferable a rigid plastics material such as a suitable engineering plastics material.

[0056] The housing 12 is of circular in cross-sections perpendicular to the direction of spacing between the inlet and outlet ends 16 and 18, of device 10. The inner surface 30 of the sidewall 14 of the housing 12 may be substantially cylindrical specification_au, 17

- 182016277769 29 Dec 2016 and of substantially constant circular transverse cross-section between the first and second ends 16 and 18, while the sidewall 14 also may have an outer surface that is substantially cylindrical and of substantially constant circular cross-section. However, as shown in each of Figures 2 to 15, for reasons explained later herein with reference to Figures 37 and 38, the outer surface 54 of the sidewall 14 departs from such cylindrical form along an initial section of its longitudinal extent from adjacent to the first end 16, that substantially corresponds to the viewing window portion 52. Over that initial section, the outer surface 54 of the sidewall 14 smoothly increases in diameter to a maximum in a direction away from the inlet end 16 towards the outlet end 18, and thereafter smoothly decreases in diameter substantially to the diameter at the first end 16, so as to have a convex longitudinal form. The convex longitudinal form most preferably is circumferentially continuous around the housing 12.

[0057] The inlet port 22 is defined by a spigot 56 that projects from the inlet end of the housing 12 in a direction away from the outlet end 18, with the spigot 56 enabling connection of device 10 to a gas supply conduit C. The spigot 56 has an extension that projects into the interior of the housing 12 to provide a tubular hub 58 on or around which the gas flow indicator member 26 is securely mounted. The indicator member 26 has an axial extent that is substantially the same as, or slightly greater than, the length of the hub 58. The indicator member 26 may be a firm friction fit on the hub 58 so as to secure the indicator member 26 in position and, to assist in attaining a firm fit, the indicator member 26 and the hub 58 may have complementary surfaces by which they are mutually engaged. The surfaces may taper so as to decrease in cross-section towards the outlet end 18, for example frustoconically, such as with a half-cone angle of about two to about six degrees. Alternatively, the indicator member 26 may be bonded or welded onto the hub 58, without the need for a friction fit. In a further alternative, the indicator member 26 may have an end adjacent to the end wall 44 at the inlet end 16 of the housing 12, by which the indicator member 26 is bonded or welded to the end wall 44. In another alternative, the indicator member 26 may have, at its end remote from the inlet end 16 of the housing 12, a flange that overlaps the corresponding end of the hub 58, with the flange bonded or welded to that end of the hub 58. However, in another specification_au, 18

- 192016277769 29 Dec 2016 arrangement (not shown), the spigot 56 does not have an extension that projects into the housing, in which case the indicator member 26 may be bonded or welded to the end wall 44 of the housing 12, or mechanically engaged with that end wall 44 such a by screw-threaded engagement or a snap- fit in or around the inlet port 22.

[0058] The skirt 38 of the concealment member 34 has an outer surface 60 that is spaced from the inner surface 30 of the sidewall 14 of the housing 12, although relative sliding contact may be provided between those surfaces. Where there is spacing between the surfaces 30 and 60, this most preferably applies throughout the extent of movement of the concealment member 34 longitudinally within the housing 12. The inner surface 30 of the sidewall 14 of the housing 12 preferably is of substantially uniform circular cross-section. The outer surface 60 of the skirt 38 of the concealment member 34 may be of substantially uniform circular cross-section although, as shown, it preferably has a slight taper so as to decrease in cross-section towards the end at which the transverse wall 48 of the concealment member 34 is provided. The slight taper may be such as to provide a half-cone angle of from about two to about six degrees. The inner surface of the skirt 38 of the concealment member 34, when the indicator member 26 is concealed, is preferably spaced from the outer peripheral surface 62 of the indicator member 26. This avoids contact between the skirt 38 of the concealment member 34 and the indicator member 26, and thereby obviates friction that could resist movement of the concealment member 34 relative to the indicator member 26. The skirt 38 of the concealment member 34 and the indicator member 26 each may be of uniform wall thickness along its respective axial extent, while they may be of similar or substantially the same wall thickness.

[0059] At the outlet end 18 of device 10, the housing 12 has an end wall 64 that defines the outlet port 24. The end wall 64 preferably is separable from the sidewall 14 of the housing 12. In the arrangement shown in Figures 2 to 15, the end wall 64 comprises an annular peripheral rim 66 that is engaged with the sidewall 14 of the housing 12 around the outlet end 18, a central hub 68 and a plurality of circumferentially spaced connectors 70 that extend between the rim 66 and the hub 68. The coil spring comprising biasing member 36 is positioned co-axially within specification_au, 19

-202016277769 29 Dec 2016 housing 12 and with respect to transverse wall 48 of concealment member 34 and end wall 64. A respective end of biasing member 36 may be attached to walls 48 and 64, or the member 36 may simply be held between walls 48 and 64 under compression. The arrangement of end wall 64 is such that it forms an end cap for device 10 that not only provides a means of retaining component parts of device 10 within housing 12, but also acts as a grill that prevents foreign objects from entering into device 10.

[0060] In use, required gas such as oxygen or oxygen-enriched air is supplied through device 10. In the arrangement of Figure 1, for example, the gas is supplied through conduit C so as to flow through spigot 56 and then through inlet port 22 and bore 28. From bore 28, the gas flows into a sub-chamber 72 defined within concealment member 34, indicator member 26 and end wall 44 of housing 12, before flowing through opening 50 of transverse wall 48, of concealment member 34, to pass into chamber 20, before exiting through outlet port 22 into facemask F. The gas received into mask F then can be inhaled by patient P, and is supplied at a rate appropriate for the patient’s P needs. Balancing the pressure at which the gas is supplied to conduit C, and the resistance to the flow of gas through conduit C and through device 10, enables compliance with the patient’s P needs. Within device 10, the resistance to flow is determined by the size of opening 50 relative to the area of transverse wall 48, of concealment member 34, and the compressibility of the spring comprising biasing means 36. Opening 50 is such as to resist gas flow from sub-chamber 72 to chamber 20, causing a generation of gas pressure against transverse wall 48 that, supplemented by pressure against the tapered inner surface 74 of skirt 38, acts to oppose the bias of biasing member 36 and tends to move concealment member 34 away from the inlet end 16 of housing 12, towards the outlet end 18. The resistance to gas flow provided by opening 50 is designed to result in the pressure in sub-chamber 72 increasing to a level at which such movement of concealment member 34 occurs, with consequential breaking of the sealing engagement between the end 40 of skirt 38 of concealment member 34 and the annular abutment surface 42 defined by housing 12. The gas flow through opening 50 is somewhat centralised in a gas stream along an axial line through device 10, as depicted in Figure 13 by solid-line arrows A-A. However, with that specification_au, 20

- 21 2016277769 29 Dec 2016 break in sealing engagement between end 40 of skirt 38 and abutment surface 42, a second gas stream commences, with this being radial, outwardly between end 40 and abutment surface 42, and then as an annular curtain of gas passing to outlet port 24 between the inner surface 30 of sidewall 14 of housing 12 and the outer surface 60 of skirt 38 of concealment member 34. In Figure 13, the dotted-line arrows B-B depict the second, annular curtain gas stream.

[0061 ] As illustrated in Figure 13, the pressure of gas within the sub-chamber 72 of the concealment member 34, against transverse wall 48, acts against the bias of biasing means 36 and enables initiation of movement of concealment member 34 that permits generation of the second gas stream depicted by arrows B-B. This results in a reduction of pressure within concealment member 34, although the reduced pressure against wall 48 is supplemented by gas pressure against the annular area of end 40 of skirt 38, as well as a reduced pressure prevailing over the tapered outer surface 60 of skirt 38 relative to the pressure over the tapered inner surface 74 of skirt 38. The overall balance achieved with application of a gas supply pressure within a typical range is such that the concealment member 34 is moved against the biasing member 36 a distance exposing a sufficient axial extent of indicator member 26 whereby indicator member 26 is visible through the laterally adjacent viewing window portion 52 of housing 12. The arrangement is such that concealment member 34 typically is moved beyond the position shown in Figure 13, such as to a position able to be seen in each of Figures 2, 7 and 15, so that the external surface 62 of indicator member 26 is exposed and able to be viewed through the laterally adjacent window portion 52 of housing 12. For this, the spacing within chamber 20 between the outlet end 18 of housing 12 and the nearer end of indicator member 26 is able to accommodate concealment member 34 and the compressed coils of the spring comprising biasing member 36. However, with termination of or an interruption to gas flow through device 10, the bias provided by biasing member 36 acts to return the concealment member to its position in which it conceals indicator member 26 from view.

[0062] The indicator member 26 preferably is made of or coated with a material that maximises its visibility. Thus, the material may have a strong, vibrant specification_au, 21

- 22 2016277769 29 Dec 2016 colour, or it may be iridescent, fluorescent or highly reflective, so as to draw the eye E of a person charged with observing the patient P from time to time to ensure a required supply of gas is being maintained. In addition to such materials and effects, the outer surface 62 of indicator member 26 may be marked, textured or patterned as shown in Figures 16 to 18. Thus, Figure 16 shows indicator member 26 as provided graduated markings 78 facilitating fine-tuning and observance of maintenance of the flow of gas through device 10, such as by appropriate adjustment of a source of gas supply. Figure 17 shows an indicator member 26 having an outer surface 62 that is textured to maximize its exposure being observed, even in low lighting conditions. Figure 18 shows an indicator member 26 that is patterned in a checkerboard to provide a plurality of areas differing in colour, texture or both colour and texture.

[0063] Reverting to Figure 3, which shows an example of a face mask F with which the device 10 is usable. The mask F has a main body M, a gas inlet G, ventilation apertures V and, around the edge of body M, openings O by which, as shown in Figure 1, the mask F can be retained in position on the face of a patient P by straps S. The gas inlet G is of tubular form and the outlet end 18 of device 10 is a neat sliding fit in inlet G. The device 10 has a peripheral bead 80 around the exterior of housing 12 that ensures the outlet end 18 of device 10 is not inserted too far into inlet G of face mask F.

[0064] In the form of device 10 depicted in Figures 8, 9, 11 and 13, ease of assembly of device 10 readily can be appreciated. The indicator member 26 first is inserted into the outlet end 18 of housing 12 and fitted onto and secured in relation to the hub 58 provided as an extension of spigot 56. The concealment member 34 then is positioned over indicator member 26 to position the inlet end 40 of skirt 38 of member 34 against the abutment surface 42. The coil spring to comprise biasing member 36 then is positioned within the outlet end 18 of housing 12 and compressed down onto transverse wall 48 of concealment member 34 by application of end wall 64 so as to securely engage the rim 66 of wall 64 onto the outlet end 18 of housing 12.

specification_au, 22

-232016277769 29 Dec 2016 [0065] Figures 19 and 20 show device 10 in a different arrangement to that of Figure 1. In Figures 19 and 20, the device 10 is installed in a conduit line that has an inlet conduit length C1 connected onto spigot 56 in the manner shown for conduit C of Figure 1. However, member 10 is provided with an outlet end wall 64 that has an integral spigot 76 that projects axially away from housing 12. The spigot 76 has a second conduit length C2 connected, with gas passing through device 10 being received into conduit length C2 by which the gas is passed to a required location. The required location maybe, for example, a face mask, bag valve mask or endotracheal tube, etc.

[0066] Figures 21 to 24 illustrate an alternative form of device 11 according to the invention. The structure of device 11 generally will be understood from the description of device 10 of the preceding Figures, and corresponding components have the same reference numeral, plus 1. Description of Figures 21 to 24 therefore will be limited to principle matters of difference between device 10 and device 11. The principle feature of difference resides in the device 11 having a biasing member 37 preferably comprising a coil spring that is located within the concealment member 35. The biasing member 37 is in tension so that the inlet end 41 of skirt 39 of the concealment member 35 is pulled into sealing engagement with an annular abutment surface 43 defined by housing 13 at or adjacent to an end wall 45 of the housing 13 at the inlet end 17 of the housing 13. The biasing member 37 has one of opposite ends engaged with end wall 45 of housing 13, around the inlet port 23. The other of the opposite ends of the biasing member 37 is secured to an annular boss 77 that is provided on the transverse wall 49 of concealment member 35, within sub-chamber 73, and that defines the opening 51 in transverse wall 49. Thus, as can be appreciated from a comparison of Figures 22 and 23, the movement of concealment member 35 to expose the indicator member 27 increases tension in the biasing means 37. Termination or interruption of gas flow through device 11 thus results the bias provided by member 37 returning concealment member 35 to its position in which it conceals indicator member 27 and prevents member 27 from being viewed through window portion 53 of housing 13.

specification_au, 23

- 24 2016277769 20 Apr 2019 [0067] Figures 25 to 28 show a housing 12 suitable for the device 10 shown in Figures 2 to 20, but with a modification that also can be adopted in the housing 13 of the device 11 of Figures 21 to 24. The modification is in the provision, along the inner surface 30 of the sidewall 14 of housing 12, of a number of longitudinally extending, circumferentially spaced ribs 82. In the arrangement shown, there are four ribs 82, although there may only be three (or less) or there may be more than four ribs 82. The ribs 82 preferably are uniformly spaced from each other around inner surface 30 of housing 12, while the cross section of each rib 82 is such that it substantially bridges the spacing between the inner surface 30 of housing 12 and the outer surface 60 of skirt 38 of concealment member 34 without impeding movement of the concealment member 34 with or against the bias of the biasing member 36. Despite this, the ribs 82 do serve to centralize the concealment member 34 during such movement and when stationary. Ribs 82 also serve to obviate noise or vibrations due to the concealment member 34 rattling or oscillating laterally within housing 12 during use of device 10.

[0068] It is to be appreciated that while ribs 82 are illustrated in Figures 25 to 28, other alternative centralizing formations could be provided. For example, inner surface 30 of sidewall 14 of housing 12 could have formed thereon a plurality of small protrusions that are spaced over, both along and around, the inner surface 30. In a further alternative, the centralizing and/or noise reduction formations, such as ribs or protrusions could be provided over the outer surface 60 of skirt 38 of concealment member 34, rather than over inner surface 30 of the sidewall 14 of housing 12.

[0069] Figures 29 to 32 illustrate alternative construction detail by which indicator member 26 may be secured concentrically on the hub 58 comprising a continuation of spigot 56 of device 10 of Figures 2 to 20. The same alternatives apply to the securement of the indicator member 27 on the hub 59 in the device 11 of Figures 21 to 24. In Figure 29, the indicator member 26 is a neat fit on hub 58, such as to provide a strong friction fit or with securement enhanced by a film providing adhesive bonding. Figure 30 shows an arrangement in which indicator member 26 is spaced slightly from hub 58 but is secured by an

-252016277769 29 Dec 2016 adhesive bonding layer 84 between the opposed surfaces of member 26 and hub 58. In the alternative of Figure 31, more clearly illustrated by the enlarged detail of Figure 32, a fusible fin 86 is provided around the end of indicator member 26 opposed to end wall 44 of housing 12 and, when the fin 86 is heated by any suitable arrangement, the fin 86 melts to bond that end of member 26 to wall 44.

[0070] Further alternatives for securing indicator member 26 on hub 58 of device 10, with similar possible for securing member 27 on hub 59 of device 11, are shown in Figures 33 and 35, with Figures 34 and 36 providing respective enlarge detail. In the arrangement of Figures 33 and 34, the indicator member 26 is shown as having an in-turned flange 88 around the end of member 26 remote from end wall 44 of housing 12. The flange 88 overlaps the adjacent end of hub 58, with a fin 90 on flange 88 bearing against that adjacent end of hub 58. Heating of the fin 90 by any suitable arrangement enables the fin 90 to melt, with indicator member 26 then able to move more firmly onto hub 58 and be secured by flange 88 being fusion bonded to the adjacent end of hub 58. In the case of Figures 35 and 36, there is provided a mechanical securement of indicator member 26 onto hub 58. For this, the end of indicator member 26 opposed to end wall 44 of housing 12 has an array of circumferentially spaced, axially projecting hooked fingers 92. As indicator member 26 is moved onto hub 58, each finger 92 is forced to elastically flex so as to enter a respective aligned opening 94 through end wall 44 of housing 12. When indicator member 26 is fully received onto hub 58, each finger 92 is able to elastically recover, to locate its out-turned end against the outer surface of end wall 44 and thereby lock indicator member 26 on hub 58.

[0071] Figure 37 and, in particular, the enlarged detail of Figure 38, elaborates on the description above in relation to the viewing window portion 52 of the housing 12 of device 10 shown in Figures 2 to 20, with the same being applicable to the corresponding features of device 11 of Figures 21 to 24. As can be recognized from the schematic view of Figure 38, in particular, the longitudinally arcuate form of the outer surface 54 of housing 12 within the window portion 52, enables window portion 52 to function as a magnifying lens. The effect is such that light rays R shown as issuing out from indicator member 26 diverge out from window specification_au, 25

-262016277769 29 Dec 2016 portion 52. While the eye E of an observer is depicted as close to window portion 52, the lens effect is such as to permit viewing of indicator member 26 from a considerable distance, as indicator member 26 is seen as enlarged relative to its actual size and also to be viewed over a wider viewing angle. These factors, combined with the colour and other highlighting features of indicator member 26, facilitate indicator member 26 being readily viewed when it is exposed by movement of concealment member 34, as a consequence of a desired or required flow of gas through the device 10.

[0072] Figures 39 to 42 illustrate further variants possible to assist with recognition of the operating condition of device 10 of Figures 2 to 20, with the same being applicable to device 11 of Figures 21 to 24. Figures 39 and 41 show the same condition for device 10, with the indicator member (not visible) concealed by the concealment member 34, although Figure 41 shows internal structure consistent with this. Figures 40 and 42 also are the same condition for device 10, but with the indicator member 26 exposed as a consequence of movement of the concealment member 34 in response to a required gas flow, although Figure 42 shows internal structure consistent with this. The variant depicted in Figures 39 to 42 is the provision of patterning, colouring and texture differences adopted for the external surface 60 of the skirt 38 of concealment member 34, relative to the outer surface 62 of the indicator member 26. The contrast between surfaces 60 and 62 is such that a viewer is even more readily to distinguish the surface 60, seen through the window portion 52 when concealment member 34 is concealing the indicator member 26, from the surface 62 seen when indicator member 26 is exposed by movement of concealment member 34 as a consequence of a required flow of gas through device 10. Thus, checking that gas is flowing, as required can be even more reliably and readily confirmed. Also, as is evident from Figures 39 to 42, the length of the housing 12 between the transparent window portion 52 and the second end 18 may be opaque (or coated with an opaque material or coating, etc.) and of any suitable colour, thereby serving to maximise the visual contrast between the respective conditions in which the indicator member 26 is concealed or exposed. Also, where device 10 is to be one of a series as discussed later herein, that opaque specification_au, 26

- 27 2016277769 20 Apr 2019 length of the housing 12 may carry indicia that distinguishes that device 10 from others of the series.

[0073] At, or adjacent to the inlet end 16 or 17 of the respective devices 10 or 11, there may be at least one opening enabling ambient air to be drawn through the respective chamber 20 or 21, to mix with gas such as oxygen or oxygen-enriched air being supplied to a patient. The opening may be in the end wall 44 or 45, such as shown by hole 96 in device 10 of Figures 3, 8 and 9. Alternatively the, or each, opening may be in the side wall 14 or 15 of respective device 10 or 11, closely adjacent to the end wall 44 or 45. Where the opening or openings is/are in end wall 44 or 45, its/their position is such that it/they is/are fully covered by the nearer end or 41 of skirt 38 or 39 of the concealment member 34 or 35 when that end 40 or of the skirt 38 or 39 is in sealing engagement with the end wall 44 or 45. In any event, ambient air is precluded from being drawn into the chamber 20 or 21, through the opening or openings, until the seal between end 40 or 41 of skirt 38 or 39, of concealment member 34 or 35, is broken by the flow rate of the supply gas increasing to generate the sufficient pressure to cause the concealment member 34 or 35 to move against the action of the biasing member 36 or 37, to enable the secondary flow of the supplied gas around the exterior of the concealment member 34 or 35. It is the secondary flow, in passing across the at least one opening that draws in the ambient air, by creating a Venturi effect.

[0074] As will be appreciated, the gas flow indicator device of the invention enables enhanced ease of observation of a condition, namely exposure of the indicator member, confirming required supply of gas to a patient. With full exposure of the indicator member preferably also confirming that a desired or minimum gas flow rate, such as 6 L/min, has been achieved and is being maintained. The device has components that enable low cost production, readily assembled and provide reliable operation. Also, the device is such that it can be provided in a number of alternative forms each suited to providing a respective required gas flow rate. Thus, for a given standardised biasing member, it is possible to vary performance by selecting from a series of devices that differ in the size of the opening of respective concealment members and, hence, the gas flow rate required to move the

-282016277769 29 Dec 2016 concealment member to expose the respective indicator member. Alternatively, a series of devices may have a standardised such opening in the respective concealment members, but differ in the strength of the biasing action of the respective biasing members. Thus, in each case, a respective gas flow rate is required for each device of the series in order to overcome the resistance to flow provided by the respective opening of the concealment member in order for the concealment member to move against the action of the biasing member. The different devices of such series can be readily differentiated by the colour or indicia provided on the outer surface of the skirt of each concealment member, or elsewhere on the device, such as on the housing. Of course, the device also may be provided in a single standardised form, with the gas flow rate at any time within a suitable range of flow rates being apparent from the extent of exposure of the indicator member.

[0075] All components of the device of the invention are able to be of nonferrous materials, indeed none of the components need be metallic, making the device suitable for use with a face mask supplying gas to a patient while the patient is undergoing an MRI or other procedure precluding metals. Also, the device can be used in any orientation, in contrast for example to apparatus utilising a ball valve type of flow mechanism. Also, the construction of the device is such as to enable continuance of gas supply by minimising the risk of the concealment member becoming snagged, while enabling ongoing gas supply even if the concealment member does become snagged.

[0076] While this invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification(s). The present invention is intended to cover any variations, uses or adaptations of the invention following in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth.

specification_au, 28

-292016277769 29 Dec 2016 [0077] As the present invention may be embodied in several forms without departing from the spirit of the essential characteristics of the invention, it should be understood that the above described embodiments are not to limit the present invention unless otherwise specified, but rather should be construed broadly within the spirit and scope of the invention as defined in the attached claims. Various modifications and equivalent arrangements are intended to be included within the spirit and scope of the invention. Therefore, the specific embodiments are to be understood to be illustrative of the many ways in which the principles of the present invention may be practiced.

[0078] Where the terms “comprise”, “comprises”, “comprised” or “comprising” are used in this specification, they are to be interpreted as specifying the presence of the stated features, integers, steps or components referred to, but not to preclude the presence or addition of one or more other features, integers, steps, components to be grouped therewith.

Claims

CLAIMS:

1. A gas flow indicator device including an elongate housing that has a peripheral sidewall that extends between first and second opposite ends and that defines a gas flow chamber through which gas is able to flow from an inlet port at a first end to an outlet port at a second end; wherein, within the chamber, the device has a gas flow indicator member that extends from adjacent to the first end of the housing over part of the length of the chamber towards the second end; the indicator member is of annular form such that gas flowing through the chamber from the inlet port to the outlet port enters the chamber along a bore that extends through the indicator member; the indicator member is spaced from an inner surface of the sidewall of the housing to define, with that inner surface, an annular space that forms part of the chamber; the device further includes a concealment member that is movable from the first end of the housing in response to a sufficient pressure generated by gas flow from the inlet port to the outlet port, against the action of a biasing member acting to bias the concealment member to the first end; the concealment member has an annular peripheral skirt that, under the bias of the biasing member on the concealment member, is receivable into the annular space, such that one of opposite ends of the skirt is able to seal against an annular surface of the housing at or adjacent to an end wall of the housing at the first end of the housing; and the concealment member also includes, at the other of the opposite ends of the skirt, a transverse wall that defines an opening through which the flow of gas from the inlet port to the outlet port is able to pass, with the opening providing resistance to such flow; wherein the arrangement is such that the one of opposite ends of the skirt is able to be held in sealing engagement with the annular surface at or adjacent to the end wall of the housing whereby the indicator member is concealed from view, through a laterally adjacent viewing window portion of the housing, when there is no gas flow or a gas flow rate generating less than the sufficient pressure but such that, with increasing gas flow rate the sufficient pressure is achieved and the bias of the biasing member is thereby overcome to enable the concealment member to move towards the second end of the housing and expose the indicator member to view through the viewing window portion of the housing and provide a visual indication indicative of gas flow.

- 31 2016277769 20 Apr 2019
2. The gas flow indicator device of claim 1, wherein movement of the concealment member to expose the indicator member moves the one of opposite ends of the skirt of the concealment member from the annular surface at or adjacent to the end wall of the housing, such as thereby to enable a secondary gas flow to the outlet that passes around the one of opposite ends of the skirt between the concealment member and the housing.
3. The gas flow indicator device of claim 1 or claim 2, wherein the biasing member acts in compression in biasing the concealment member to the first end of the housing, such as by the biasing member being compressed between, such as compressed by, the concealment member and the second end so as to provide the required bias in seeking to expand.
4. The gas flow indicator device of claim 1 or claim 2, wherein the biasing member acts in tension in biasing the concealment member to the first end of the housing, such as by the biasing member being within the concealment member, and tensioned by being expanded between, such as by being connected in relation to, each of the transverse wall of the concealment member and the first end of the housing so as to provide the bias in seeking to contract.
5. The gas flow indicator device of any one of claims 1 to 4, wherein the biasing member comprises a coil spring.
6. The gas flow indicator device of claim 3, wherein the biasing member comprises a coil spring acting between the concealment member and the second end of the housing, and wherein compression of the spring can limit the extent to which the concealment member can move towards the second end of the housing simply as a consequence of the presence of the compressed spring.
7. The gas flow indicator device of claim 4, wherein the biasing member comprises a coil spring within the concealment member, with the arrangement such that the concealment member is able to move so as to contact the end wall at the

-322016277769 20 Apr 2019 second end of the housing, or such that contact of the concealment member with the second end of the housing is precluded by the spring reaching its elastic limit.
8. The gas flow indicator device of any one of claims 1 to 7, wherein the concealment member is able to move, between a first position in which the indicator member is concealed and a second position in which the indicator member is sufficiently exposed whereby the indicator member can readily be seen through the viewing window portion of the sidewall of the housing by a person in close proximity and also from a considerable distance of up to five to ten meters, or further, from the device.
9. The gas flow indicator device of claim 8, wherein the viewing window portion is sufficiently transparent to facilitate viewing of the indicator member, wherein the viewing window portion extends around the full circumferential extent of the sidewall of the housing adjacent to the first end, or comprises two or more regions spaced circumferentially around that wall of the housing adjacent to the first end.
10. The gas flow indicator device of claim 8 or claim 9, wherein the viewing window portion is of a high-transparency plastics or glass material having a high level of clarity, and wherein the material of which the remainder of the housing is made is transparent, translucent or opaque.
11. The gas flow indicator device of any one of claims 8 to 10, wherein the housing is of unitary or integral form and made of a single material comprising a rigid plastics material or an engineering plastics material.
12. The gas flow indicator device of any one of claims 1 to 11, wherein the housing is circular in cross-sections perpendicular to the direction of spacing between the first and second ends, with the housing having an inner surface that is substantially cylindrical and of substantially constant circular transverse crosssection between the first and second ends, and with the sidewall also having an outer surface that is substantially cylindrical and of substantially constant circular cross-section.

- 33 2016277769 20 Apr 2019
13. The gas flow indicator device of claim 12, wherein the housing has an outer surface of the sidewall that departs from a cylindrical form, at least along an initial section of its longitudinal extent from adjacent to the first end, with that initial section extending around the gas flow indicator member, and wherein the outer surface of the sidewall, over that initial section of its longitudinal extent, smoothly increases in diameter to a maximum in a direction away from the first end towards the second end, and thereafter smoothly decreases in diameter substantially to the diameter at the first end, so as to have a convex longitudinal form.
14. The gas flow indicator device of any one of claims 1 to 13, wherein at the first end of the housing, the inlet port is defined by a spigot that projects from the first end of the housing in a direction away from the second end, and that enables connection of a gas supply conduit to the housing.
15. The gas flow indicator device of claim 14, wherein the spigot has an extension that projects into the interior of the housing to provide a hub on or around which the gas flow indicator member is mounted, with the indicator member preferably having an axial extent that is substantially the same as, or slightly greater than, the length of the hub, with the indicator member being a firm friction fit on the hub or by the indicator member being bonded or welded onto the hub, or by the indicator member having an end, adjacent to the end wall at the first end of the housing, by which the indicator member is bonded or welded to the end wall or the indicator member has, at its end remote from the first end of the housing, a flange that overlaps the corresponding end of the hub, with the flange bonded or welded to that end of the hub.
16. The gas flow indicator device of claim 14, wherein the indicator member is bonded or welded to an end wall of the housing at the first end, or mechanically engaged with that end wall by screw-threaded engagement or a snap fit in or around the inlet port.
17. The gas flow indicator device of any one of claims 1 to 16, wherein the skirt of the concealment member has an outer surface that is spaced from the inner surface

-342016277769 20 Apr 2019 of the sidewall of the housing, with a spacing between the surfaces throughout the extent of movement of the concealment member longitudinally within the housing.
18. The gas flow indicator device of claim 17, further including guide members that maintain the concealment member in a substantially co-axial relationship with the housing, such guide members preferably comprising a plurality of circumferentially spaced projections that stand proud, or project inwardly, of the inner surface of the housing so as to be contactable with the outer surface of the skirt of the concealment member, or the converse, or a plurality of longitudinal ribs on the inner surface of the sidewall of the housing or the outer surface of the concealment member.
19. The gas flow indicator device of any one of claims 1 to 18, wherein the inner surface of the skirt of the concealment member, when the indicator member is concealed, is spaced from the outer peripheral surface of the indicator member, thereby avoiding contact between the skirt of the concealment member and the indicator member, and thereby obviates friction that could resist movement of the concealment member relative to the indicator member, with the skirt of the concealment member and the indicator member each being of substantially uniform wall thickness along its respective axial extent and of similar or substantially the same wall thickness.
20. The gas flow indicator device of any one of claims 1 to 19, wherein at the second end, the housing has an end wall that defines the outlet port, with the end wall preferably being separable from the sidewall of the housing, such as by the end wall comprising an annular peripheral rim that is engaged with the sidewall of the housing around the second end, a central hub portion and a plurality of circumferentially spaced connectors that extend between the rim and the hub.
21. A gas delivery device, gas delivery system or gas supply conduit including the gas flow indicator device of any one of the preceding claims.