AU721704B2

AU721704B2 - Disposable oxygenating device

Info

Publication number: AU721704B2
Application number: AU62936/96A
Authority: AU
Inventors: Philip Stuart Esnouf
Original assignee: Teleflex Life Sciences ULC
Current assignee: Teleflex Life Sciences ULC
Priority date: 1995-09-12
Filing date: 1996-07-02
Publication date: 2000-07-13
Anticipated expiration: 2016-07-02
Also published as: AU6293696A

Description

Q:\OPER\GCP\62936.C 3/2/00 -1- DISPOSABLE OXYGENATING DEVICE This invention relates to a disposable oxygenating device.

In the post operative treatment of patients, it is usually desirable to supply oxygen or oxygen enriched air to a patient for a period of say 5 to 15 minutes to assist in reoxygenating the patient to offset the effects of the anaesthetic. Usually oxygen is available in recovery i .rooms from suppliers which are capable of delivering oxygen at a rate of about 4 to 6 litres 15 per minute. Unfortunately this is less than the rate of inspiration of a typical adult patient.

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:Some attempts have been made to provide an oxygen storage device which can store oxygen from a relatively low capacity supply so as to be able to deliver the oxygen or oxygen enriched air to the patient at a relatively high rate during inspiration.

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S. 20 An object of the present invention is to provide a disposable oxygenating device which is capable of delivering oxygen or oxygen rich air to a patient at relatively high flow rates.

oS According to the present invention there is provided a disposable oxygenating device including a body and a collapsible imperforate bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration IR cycle, expiration products pass through the body and are expelled through said outlet and Q:'opcrfgcp(.2B9 )6SPE DOC-L./1{ -2wherein the device does not include a valve.

The invention also provides a method of oxygenating a patient having an endotracheal tube or laryngeal mask applied to him or her using a disposable oxygenating device having a non-resilient inflatable bag made from sheet plastics material including coupling the device to the endotracheal tube or laryngeal mask continuously supplying oxygen to the bag to thereby inflate the bag with oxygen, permitting the bag to collapse during an inspiration cycle of the patient whereby oxygen from the bag is delivered to the patient through the endotracheal tube or laryngeal mask, and providing an outlet in the device whereby, during an expiration cycle, products of expiration are permitted to escape the device.

The invention also provides a disposable oxygenating device including a body and -a non-resilient collapsible bag coupled thereto, the body consisting of an integral moulding 15 from plastics material and has first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in 20 use, during an inspiration cycle, oxygen from the bag passes through the second coupling o.

means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet.

The invention also provides a disposable oxygenating device including a body and a collapsible bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag Spasses through the second coupling means and, during an expiration cycle, expiration Q ojcX gqcp.2'6l(SPE DOC13((I4I)I -3products pass through the body and are expelled through said outlet and wherein the bag is formed from seamed plastics material and is imperforate.

The invention also provides a disposable oxygenating device including a body and a non-resilient collapsible bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet and wherein 00.° the bag is formed from high density polyethylene sheet material.

The invention also provides a disposable oxygenating device comprising a body and a non-resilient collapsible bag coupled thereto, the body including first coupling means oooe ;being couplable to a source of oxygen, second coupling means being couplable to an ooo° endotracheal tube or laryngeal mask, a connecting spigot having an open end, an oxygen •0 duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, and wherein the collapsible bag is connected to the spigot, the arrangement being *Ol such that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet characterised in that the outlet orifice is located adjacent to the open end of the spigot.

The invention also provides a disposable oxygenating device comprising a body and a non-resilient collapsible bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, a socket being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers O.'oECliCpIg 1 23SPE.DOC- I i/0i41 -4oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet which is located generally opposite to the socket, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the socket and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet.

It is preferred that the bag is formed from a film of plastics material. Preferably the material comprises high density polyethylene.

Preferably the film is about 15 microns in thickness.

The bag may have a vent hole near an end thereof remote from the body.

s* Preferably the bag has a capacity in the range 250 to 500ml.

5 Preferably further, the body is injection moulded from plastics material and the bag is adhered, bonded or welded thereto.

**oo It will be appreciated that the device can be constructed of low cost materials so o..t that it is cheap enough for disposal after a single use. This thereby avoids the need for 20 sterilisation and/or autoclaving.

C The invention will now be further described with reference to the accompanying drawings, in which: Figure 1 is a schematic view of a first embodiment of a disposable oxygenating device constructed in accordance with the invention; Figure 2 is a plan view of the elbow shown in Figure 1; Figure 3 is an end view of the elbow shown in Figure 1; and Figure 4 schematically illustrates the manner in which the device is used.

Q.\operngcp\62936SPE, DOC -I -4A- The disposable oxygenating device 2 shown in Figures 1 to 4 comprises an elbow and a collapsible bag 16. The elbow 40 is preferably injection moulded from plastics material S S S S @5 S. 5*OS 0* a Se 0S *5 S Se

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5 5**5 such as high density polyethylene. It generally comprises a hollow body having an inlet spigot 6 having an oxygen supply duct 7. The spigot 6 can be inserted in an oxygen supply tube 8 which is connected to a supply of compressed oxygen (not shown). The elbow includes a tapered socket 10 which can be coupled to a male coupling 12 which is formed on the end of an endotracheal tube (oral or nasal) or laryngeal mask (not shown). The socket has an internal bore which is compatible with complementary fittings on endotracheal tubes or laryngeal masks. Preferably the bore is 15mm. The elbow 40 further includes a coupling connector or spigot 14 to which is connected a collapsible bag 16.

In the preferred form of the invention, the collapsible bag 16 is formed from high density polyethylene film having a thickness in the range from 5 to 15 microns and preferably microns in thickness. The volume of the bag is in the range from 250 to 500ml.

Preferably the length is about 170mm and the diameter about 80mm. The bag 16 may be formed from a continuous tube of plastics material which is heat welded so as to have closed 15 ends, one of which is heat welded or adhered to the spigot 14 and the other forms a closed end.

The disposable oxygenating device of the invention is particularly useful for oxygenating patients who are recovering from general anaesthesia which has been 20 administered by a laryngeal mask or an endotracheal tube. The laryngeal mask or endotracheal tube are left in the patient and the socket 10 of the device is coupled to the coupling 12 of the mask or tube. An oxygen supply tube 8 which is coupled to a source of oxygen normally limited to a flow rate of about 4 to 6 litres a minute is connected to the inlet spigot 6. Oxygen passes through the inlet orifice 22 and may draw some air into the elbow 40 through the opening 44 so that the bag 16 is filled with oxygen enriched air. When the patient inspires, the oxygen rich air passes from the bag 16 through the socket 10 into the laryngeal mask or endotracheal tube. It will be noted that the internal passage from the coupling spigot 14 to the socket 10 is relatively wide and unconstricted so as to provide for good fluid flow therethrough. With the device of the invention, the rate of delivery of oxygen rich air can be optimum, say at about 20 litres per minute, which is normally much greater than that available in many recovery rooms.

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hr Q:\OPER\GCP\62936.C 3/2/00 -6- In the preferred embodiment of the invention the outlet orifice 22 is located at the end of a conduit 42 which extends through the coupling spigot 14 so that oxygen passes directly into the interior of the bag 16. In this embodiment, the elbow 40 has a single relatively large opening 44 which is generally oppositely disposed to the socket 10, as seen in Figure 1.

The elbow 40 may be injection moulded from suitable plastics material such as high density polyethylene. Moulding could be facilitated if the conduit 42 were not separately formed so as to extend through the coupling. In this case the oxygen passage 7 from the inlet spigot 6 could be moulded into the side wall of the elbow and it would still function correctly provided that the outlet orifice 22 opens into the interior of the bag 16 or is located close to the interior of the bag 16. The bag 16 may be heat seamed and trimmed into the shape of a bag. Its neck could be heat sealed onto the coupling spigot 14. The inlet spigot 6 could be formed with barbs or may be smooth or provided with small serrations (not shown). The oxygen passage 7 through the opening 16 leading to the orifice 22 is preferably about in diameter. The spigot 6 itself may have a 4mm outer diameter. The socket 10 is preferably formed as a 15mm tapered fitting for receipt of the end of an endotracheal tube, laryngeal •mask or other device. The opening 44 preferably has a diameter of about In use of the device shown in Figures 1 to 3, the bag 16 is inflated with oxygen from 20 the supply tube 8 through the orifice 22. The supply tube 8 delivers the oxygen at a nominal 9*eo rate of say 6 litres per minute. During the inspiration cycle of the patient, oxygen collected o. in the bag 16 is delivered through the socket 10 to the tube 12. This preferably provides a volume of about 250ml of oxygen or oxygen rich air to the patient.

25 The bag 16 refills with oxygen from the oxygen supply tube 8 during the pause between the end of inspiration and commencement of expiration. The expiratory air tends to pass directly from the socket 10 through the opening 44. This prevents significant dilution of the oxygen in the bag 16 by the expiratory fluid passing into the elbow 40 from the tube 12. Experiments have shown that the device shown in Figures 1 to 3 performs well because the rate undiluted oxygen available from the bag 16 to the patient is greater than that from the Soxygen supply tube 8.

Q:\OPER\GCP\62936.C 3/2/00 -7- Figure 4 shows the preferred manner in which the device 2 is used. It will be seen that the bag 16 is located generally transversely to a reclining patient and the tube 8 extends on the opposite side of the patient. The endotracheal tube or laryngeal mask passes through the mouth of the patient in the usual way. In operation the bag 16 will collapse (or partly collapse) which provides a visual indication to recovery room staff that the patient is breathing.

It will be appreciated by those skilled in the art that the device of the invention can be made from inexpensive materials and is therefore cheap enough to be disposable. It does not need any valves which, if needed, could make manufacture more expensive and possibly compromise the reliability of the device.

As indicated above, the device can be used with oral or nasal endotracheal tubes or laryngeal masks. It is quite possible that the same device can be used in other applications 15 such as for coupling to a tracheostomy tube.

:i Many modifications will be apparent to those skilled in the art without departing from the spirit and scope of the invention.

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Claims

1. A disposable oxygenating device including a body and a collapsible imperforate bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet and wherein the device does not include a valve.

2. A device as claimed in claim 1 wherein the outlet orifice is directed towards the interior of the bag. i:

3. A device as claimed in claim 1 or 2 wherein the outlet orifice is located adjacent to the bag.

4. A device as claimed in claim 3 wherein the oxygen duct is formed in a conduit which 20 passes from the first coupling means through the body and terminates adjacent to the Sconnector. oo

5. A device as claimed in any preceding claim wherein the outlet is located generally 25opposite to the second coupling means.

6. A device as claimed in any preceding claim wherein the body is moulded from plastics material.

7. A device as claimed in any preceding claim wherein the bag is formed from sheet plastics material. Q.opcr gp 6,2936SPEDOC- t114/0 -9-

8. A device as claimed in claim 7 wherein the sheet plastics material comprises high density polyethylene.

9. A device as claimed in claim 7 or 8 wherein the thickness of said sheet plastics material is in the range 5 to 15 microns.

A device as claimed in claim 7, 8 or 9 wherein the volume of the bag is about 250ml when inflated.

11. A device as claimed in claim 10 wherein the bag is formed from an initially flat tube.

12. A device as claimed in any preceding claim wherein the first coupling means comprises a spigot which can be inserted, in use, into an oxygen tube.

13. A device as claimed in any preceding claim wherein the spigot has a nominal outer S diameter of 4mm.

14. A device as claimed in any preceding claim wherein the second coupling means 20 includes a 15mm tapered socket.

15. A device as claimed in claim 14 wherein the outlet comprises a single opening 10mm in diameter which is aligned with said tapered socket.

16. A device as claimed in any preceding claim characterised in that the body does not include any valves.

17. A method of oxygenating a patient having an endotracheal tube or laryngeal mask applied to him or her using a disposable oxygenating device having a non-resilient inflatable bag made from sheet plastics material including coupling the device to the endotracheal tube or laryngeal mask continuously supplying oxygen to the bag to thereby inflate the bag with oxygen, permitting the bag to collapse during an inspiration cycle of the patient whereby oxygen from the bag is delivered to the patient through the Q.'Op1r\gcp4,2'96SPE DOC-I endotracheal tube or laryngeal mask, and providing an outlet in the device whereby, during an expiration cycle, products of expiration are permitted to escape the device.

18. A method as claimed in claim 17 wherein the volume of the bag is such that oxygen therefrom is delivered to the patient at a rate which is greater than that available from the oxygen supply which supplies oxygen to the bag.

19. A method as claimed in claim 17 or 18 wherein oxygen is supplied to the bag through an orifice which is adjacent to the bag and the outlet is generally aligned with the endotracheal tube or laryngeal mask whereby products of expiration tend to pass through the device without entering the bag.

A disposable oxygenating device including a body and a non-resilient collapsible bag coupled thereto, the body consisting of an integral moulding from plastics material and has first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in use, during an inspiration 20 cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet. 00oo oooe

:21. A device as claimed in claim 20 wherein the bag is formed from sheet plastics material. *4

22. A device as claimed in claim 21 wherein the body and bag are formed from the a same material whereby the bag can be heat or ultrasonically welded to the connector.

23. A disposable oxygenating device including a body and a collapsible bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a Rconnector to which the bag is connected, an oxygen duct in fluid communication with the Q:.op.rgcp1,29'36SPE DOC-3 I0(l t -11- first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet and wherein the bag is formed from seamed plastics material and is imperforate.

24. A device as claimed in claim 23 wherein the sheet plastics material is high density polypropylene.

A disposable oxygenating device including a body and a non-resilient collapsible bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, second coupling means being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, the arrangement being Oa :Isuch that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet and wherein the bag is formed from high 20 density polyethylene sheet material.

26. A device as claimed in claim 23, 24 or 25 wherein the thickness of said sheet plastics material is in the range 5 to 15 microns.

27. A device as claimed in claim 23, 24, 25 or 26 wherein the volume of the bag is about 250ml when inflated.

28. A device as claimed in claim 27 wherein the bag is formed from an initially flat tube.

29. A disposable oxygenating device comprising a body and a non-resilient collapsible bag coupled thereto, the body including first coupling means being couplable to a source of TRA, oxygen, second coupling means being couplable to an endotracheal tube or laryngeal Q0 ipcr\gcp\62)93SPE DOC-I13/04IH0 -12- mask, a connecting spigot having an open end, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet, and wherein the collapsible bag is connected to the spigot, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the second coupling means and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet characterised in that the outlet orifice is located adjacent to the open end of the spigot.

30. A disposable oxygenating device comprising a body and a non-resilient collapsible bag coupled thereto, the body including first coupling means being couplable to a source of oxygen, a socket being couplable to an endotracheal tube or laryngeal mask, a connector to which the bag is connected, an oxygen duct in fluid communication with the first coupling means having an outlet orifice which in use delivers oxygen from the source of oxygen to inflate the bag with oxygen, and an outlet which is located generally opposite to the socket, the arrangement being such that, in use, during an inspiration cycle, oxygen from the bag passes through the socket and, during an expiration cycle, expiration products pass through the body and are expelled through said outlet. 20

31. A disposable oxygenating device substantially as hereinbefore described with reference to the accompanying drawings.

32. A method of oxygenating a patient substantially as hereinbefore described with •reference to the accompanying drawings. DATED this 13 th day of April, 2000 PHILIP STUART ESNOUF By his Patent Attorneys SDAVIES COLLISON CAVE