WO2025043279A1

WO2025043279A1 - Nasal catheter apparatus

Info

Publication number: WO2025043279A1
Application number: PCT/AU2024/050907
Authority: WO
Inventors: Andrew Wallis
Original assignee: Innovgas Pty Ltd
Current assignee: Innovgas Pty Ltd
Priority date: 2023-08-28
Filing date: 2024-08-26
Publication date: 2025-03-06
Anticipated expiration: 2026-02-28

Abstract

There is proposed a nasal catheter for a patient comprising an elongate body, being at least partly resiliently deformable and having a secondary pathway or pathways, a primary passageway extending inwardly of one end of the elongate body, a generally flexible pipe adjoining the primary passageway for connection to a gas supply. The elongate body being configured for insertion in through a nostril of the patient, whereby the elongate body reversibly engages with a nasal vestibule and extends into or adjacent the nasopharynx of the patient for delivery of oxygen and/or anaesthetic agent thereinto.

Description

NASAL CATHETER APPARATUS

FIELD OF THE INVENTION

The present invention relates to a method and apparatus for providing oxygen and/or anaesthetic gas to a patient and in particular to an apparatus being positionable in the nasal passage of a patient.

BACKGROUND OF THE INVENTION

It is sometimes necessary to lightly anaesthetise or sedate a patient during a surgical procedure or in other medical situations. Sedation, also known as monitored anaesthesia care, is typically used for minor surgeries or for shorter, less complex procedures, when an injection of local anaesthetic is not sufficient and deeper general anaesthesia is not required.

The types of procedures where sedation may be used includes biopsies, endoscopies, or the treatment of skin lesions. For instance, the patient may be sedated to have a skin cancer removed from their face. Skin cancers can be removed with cryotherapy (liquid nitrogen), curettage (scraping), cautery (burning) or by excision, wherein it may be necessary to sedate the patient to keep them comfortable during the procedure.

The sedated patient typically maintains regular spontaneous breathing. However, an anaesthetist will usually provide additional oxygen to the patient to avoid oxygen desaturation. The anaesthetist may also provide an anaesthetic agent to maintain sedation and this may be intravenous or gaseous. The oxygen and anaesthetic agents may be delivered by way of a nasal cannula, which is positioned through the nasal vestibule and extends into the nasal cavity. The nasal cannula may be held in place by a portion of medical adhesive tape or the flexible pipe attached to the nasal cannula may be secured around the ears of the patient.

There can however be issues when the medical procedure is undertaken on the patient’s face, wherein the nasal cannula and attached flexible tube may obstruct the surgeon. Furthermore, where the medical procedure relates to cauterization of lesions or cancers on a patient’s face, the delivery of flammable oxygen adjacent the nasal vestibule, along with the use of a source of ignition, poses a risk of combustion of the flammable oxygen therefore putting in danger the patient and medical practitioners.

There are suggested in the published prior art various devices that attempt to overcome some of the above issues. For instance, U.S. Patent No. 7,735,492 (Ventus Medical Inc.) discloses a nasal device constructed from memory material foam, which is insertable into a single nostril of a patient, and includes a passageway attachable to a single inlet pipe having an airflow resistor, through which oxygen can be delivered.

Another device is disclosed in U.S. Patent Application No. 20140014108 (DILLARD), which comprises a nasal cannula that can diffuse the gas flow out of a plurality of orifices formed in the nostril prongs of the nasal cannula device.

These suggested devices however have various limitations including that the oxygen/gas can still escape out through the nostril of the patient into the surrounding environment, which poses a combustion risk. Furthermore, the delivery of the oxygen/gas from the outlet/s can lead to localised drying of the nasal mucosa and it may be difficult to securely position the device within the nasal cavity, such that the gas is not directed straight onto the mucosa.

It should be appreciated that any discussion of the prior art throughout the specification is included solely for the purpose of providing a context for the present invention and should in no way be considered as an admission that such prior art was widely known or formed part of the common general knowledge in the field as it existed before the priority date of the application.

SUMMARY OF THE INVENTION

It is an object of at least some of the illustrated embodiments to provide for an apparatus that supplies a gas and/oxygen to a sedated patient in a diffused manner to thereby inhibit localised drying of the nasal mucosa of the patient. It is further objects of the illustrated embodiments to provide a nasal catheter being securely positionable within the nasal passage, or to overcome at least some of the aforementioned problems, or at least provide the public with a useful alternative. The foregoing objects should not necessarily be considered as cumulative and various aspects of the invention may fulfil one or more of the above objects. The invention could broadly be understood to comprise a nasal catheter having a body being at least partly reversibly compressible and including a primary passageway in fluid communication with a plurality of secondary pathways, for diffused delivery of oxygen or an anaesthetic agent into the airways of a patient.

In one aspect of the invention, but not necessarily the broadest or only aspect, there is proposed a nasal catheter comprising: an elongate body being at least partly resiliently deformable, and having a first end and a second end, the elongate body further including at least one secondary pathway; a primary passageway extending inwardly of the first end of the elongate body, being in communication with the at least one secondary pathway; a generally flexible pipe adjoining, or at least partly forming, the primary passageway, the flexible pipe extending outwardly from the first end of the elongate body, wherein a free end of the flexible pipe being configured for engagement with a gas supply tubing; and wherein the elongate body being configured for insertion in through a nostril of a patient, whereby the elongate body being configured for reversible engagement with a nasal vestibule of the patient, such that the second end of the elongate body extending into or adjacent the nasopharynx of the patient for delivery of oxygen and/or anaesthetic agent thereinto.

In one form, a plurality of pathways extend through the elongate body.

In one form, the elongate body is constructed from a silicon material and includes a generally tubular portion, a number of spaced-apart, dome-shaped resiliently deformable flanges and a rounded tip including the secondary pathways extending therethrough.

The reader should however appreciate that the secondary pathways may also be located along a length of the generally tubular portion, between adjacent flanges.

The elongate body may be constructed from any soft spongy plastic-like or silicon material, such as but not limited to medical grade silicon, rubber compounds, elastomers, copolymers or polymer mixes with elastomeric properties, rubber or any material with suitable elastomeric properties. The dome-shaped resiliently deformable flanges preferably sequentially increase in diameter between the second end and the first end, wherein the domeshaped resiliently deformable flange adjacent the first end has the largest diameter, and the dome-shaped resiliently deformable flange adjacent the second end has the smallest diameter.

In one form, four dome-shaped resiliently deformable flanges are attached to the generally tubular portion, such that the annular free edges of the domes project outwardly and rearwardly.

The skilled addressee will appreciate that the configuration of the flanges means that as the elongate body is inserted into the nasal passage of the patient the edges of the dome-shaped flanges tend to fold inwardly towards the tubular portion as it impacts the sides of the nasal passage. This deformable configuration of the elongate body means that the risk to damage to the mucosa of the nose is reduced.

Furthermore, the practitioner can slightly retract the elongate body within the nasal passage, which will cause the edges of the dome-shaped flanges to flare out slightly as they frictionally engage the inner surface of the nasal passage. This means that the elongate body will engage with the sides of the nasal passage to effectively seal the nostril and inhibit the escape of gas/oxygen outwardly therethrough.

Additionally, the flaring out of the edges of the dome-shaped flanges will inhibit the inadvertent dislodgment of the nasal catheter in use. The reader will however appreciate that the due to the flexible nature of the silicon material applying greater force will cause the dome-shaped flanges to fold back on themselves, to allow the full retraction of the elongate body from within the nostril without causing damage to the mucosa of the nose. The primary passageway includes at least one outlet in communication with, or connected to, at least some of the plurality of secondary pathways. The primary passageway may include a number of outlets along its length. In this way the oxygen or gas permeates into the elongate body along at least some of its length, wherein the oxygen or gas moves through the secondary pathways and exits the elongate body at a number of locations along at least a part of its length.

The movement of the gas or oxygen out of the elongate body means that it is introduced into the nasopharynx of the patient in a diffused fashion. This inhibits localised drying out of the nasal mucosa during use. In contrast, much of the prior art discloses a direct jet of oxygen or gas from the end of a pipe being introduced into the nasopharynx, which can lead to localised drying of the nasal mucosa due to the jet of oxygen or gas being directed straight onto the mucosa, causing patient discomfort and possible nasal bleeding.

The reader should appreciate that since the elongate body is at least partly reversibly deformable, in use a practitioner is able to compress or squash the elongate body, such as the second end, before insertion into the nasal passage of a patient. Alternatively, the body is generally configured to deform as it passes in through the nasal passage. This therefore allows the elongate body to be inserted with less pressure and/or trauma to the delicate nasal mucosa of the patient.

On appropriate positioning into or adjacent the nasopharynx, the reversibly deformable section can then re-expand or move back into a generally undeformed or partially undeformed arrangement such that it conforms to the specific nasopharynx/nasal passage configuration of the patient. This means that the elongate body will be less likely to be inadvertently dislodged or moved, and will decrease the risk of oxygen leaking back past the elongate body through gaps therearound.

Preferably, the elongate body towards the second end may include, at least a portion, being reversibly deformable to a greater extent than the rest of the elongate body.

The free end of the flexible pipe preferably includes a coupling for engagement with the gas supply tubing.

The gas supply tubing is connectable to a source, such as but not limited to an oxygen source for providing pure oxygen, or a source of anaesthetic agent or a mix thereof.

The coupling at the free end of the flexible pipe, may be a male hose coupling including an annular ridge or ridges, wherein a conventional flexible gas supply tubing may be pushed over the male hose coupling and retained by the annular ridge or ridges.

In one form, the gas supply tubing is an oxygen supply tubing. The primary passageway and flexible pipe may be unitary in construction, wherein a first portion of a length of pipe, having at least one outlet is located within the elongate body, and a second portion of the flexible pipe extends rearwardly or outwardly from the first end of the elongate body and includes at its free end, an inlet and the coupling.

In one form, the elongate body may be over-moulded onto the first portion of the flexible pipe. Alternatively, the first portion of the flexible pipe may be inserted into a void created in the elongate body and glued or ultrasonically welded into place.

The elongate body may have a length of between 20mm to 50mm. In one form, the elongate body may be 25mm in length and the flexible pipe may be inserted into a central bore of the elongate body around 18mm along its length and held in place by glue or ultrasonic welding. The reader should appreciate that the around 5- 7mm of the elongate body forward of the flexible pipe has a greater degree of flexibility than the portion into which the flexible pipe is inserted, thereby allowing it to compress or collapse to a greater degree.

Accordingly, the second end of the elongate body will tend to compress or collapse as it come into contact with the internal structures within the nasal cavity. This will effectively block or inhibit movement of the gas out through the end of the central bore, and will tend to force the gas out through the plurality of secondary pathways, such that it diffuses out into the nasopharynx of the patient. In still another form, the elongate body comprises a tube-shaped length of compressible foam material, with a central bore, wherein the flexible pipe, having a single outlet, may be inserted into the central bore and glued or ultrasonically welded in place.

In another form, the elongate body may be die cut from a block or length of open-cell foam material. The first end of the elongate body may include a barrier that blocks the adjacent paths extending therethrough or rearwardly of the elongate body. The blocking of these adjacent paths in the open-cell foam, thereby further inhibits movement of the gas or oxygen out from the first end of the elongate body and into the surrounding environment. The barrier may be a layer or coating applied to the first end.

The elongate body may be constructed from an open-cell foam material, such as but not limited to, latex foam, foam rubber, polyurethane foam or polymer sponge. The open-cell foam material provides the plurality of secondary pathways that extend through the elongate body and are in communication with the primary passageway. The configuration permits the gas or oxygen to move through the primary passageway and the secondary pathways of the elongate body, such that the gas or oxygen can be introduced in a diffused fashion into the nasopharynx of the patient.

The elongate body may alternatively be constructed from a resiliently deformable fibrous cellulose material or any other type of matrix material which delineates multiple pores or paths that permit the gas or oxygen to flow therethrough. The material from which the elongate body is constructed may be recyclable, biodegradable or compostable.

The blocking of the nostril is particularly important where the gas being supplied to the patient is flammable gas or oxygen, which poses a risk of combustion during the medical procedure, such as during cautery where a source of ignition is used to burn cancer or lesions off a patient’s face. The apparatus of the present invention therefore inhibits escape of oxygen outwardly through the corresponding nostril of the patient into the surrounding environment to minimise this risk of ignition.

Alternatively, the elongate body may be of uniform construction and the outlet or outlets of the primary passageway being directed towards the second end of the elongate body, whereby the gas or oxygen tends to move outwardly therethrough and is inhibited from escaping through the nasal vestibule into the surrounding environment. In the immediately preceding form, the convoluted path through the elongate body towards the first end or configuration of the elongate body acts as the barrier to inhibit movement of the gas/oxygen therethrough and into the surrounding environment.

The reader will therefore appreciate that the nasal catheter provides both a delivery means for diffusely introducing oxygen into or adjacent the nasopharynx and a nasal plug or barrier to thereby inhibit movement of the oxygen outwardly from the nostril into the surrounding environment.

The barrier at the first end of the elongate body may be formed by dipping the first end of the elongate body into a liquid that when dry, blocks the open cells adjacent the first end of the elongate body. Alternatively, the elongate body may be contracted from two types of material namely, a generally non-porous portion at the first end and a generally porous portion forming the second end. In one form, an annular disk of closed cell foam material is attached to an elongate portion of open-cell foam material, to thereby form the elongate body, wherein the ring of closed cell foam is positioned at the first end, and the flexible pipe extends through a centre void of the annular disk.

The elongate body may be constructed in different lengths and/or sizes, such as small, medium and large, to accommodate different ages, sexes and anatomical variations.

The elongate body is preferably both compressible and flexible laterally, such that upon insertion into the nostril of the patient it can bend and move past the conchae within the nasopharynx.

Preferably, the nasal catheter is inserted into only one nostril of the patient. In this way the patient is still able to expel air out through their unblocked nostril.

The generally flexible pipe can be positioned over the patient’s face at a location that does not impede the practitioner during the medical procedure. The flexible pipe can then be taped in place or otherwise held in place. Furthermore, the flexible pipe can be repositioned during the medical procedure to access other areas of the patient’s face.

In another aspect of the invention there is proposed a method of providing oxygen and/or anaesthetic agent to a patient, including: providing a nasal catheter, comprising an elongate body and a flexible pipe, in accordance with any one of the above aspects; inserting the elongate body into a nostril of the patient, wherein a first end being positioned at or adjacent the nasal vestibule of the nostril and a second end extending into or adjacent the nasopharynx of the patient; affixing a gas supply tubing to an end of the flexible pipe; and operating a source of oxygen and/or anaesthetic agent connected to the gas supply tubing, wherein oxygen and/or anaesthetic agent is caused to flow through the elongate body and into the nasopharynx of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate implementations of the invention and, together with the description and claims, serve to explain the advantages and principles of the invention. In the drawings,

Figure 1a is a perspective view of a nasal catheter of the present invention;

Figure 1 b is a schematic view of a second end of the nasal catheter of Figure 1 a illustrating the plurality of secondary pathways;

Figure 2 is a schematic view of the nasal catheter of Figure 1 a inserted into the nasal passage of a patient;

Figure 3a is a schematic view of the nasal catheter of Figure 1 a, in a first position, being inserted into the nasal passage of the patient;

Figure 3b is a schematic view of the nasal catheter of Figure 3a, in a second partially inserted position;

Figure 3c is a schematic view of the nasal catheter of Figure 3b, in a third fully inserted position, illustrating movement of a gas therethrough;

Figure 4 is a partial cross-sectional view of the nasal catheter of Figure 1a;

Figure 5 is a partial cross-sectional view of another embodiment of the nasal catheter;

Figure 6 is a partial cross-sectional view of still another embodiment of the nasal catheter;

Figure 7 is a front view of the patient of Figure 2, illustrating the flexible pipe of the nasal catheter in a first arrangement;

Figure 8 is a front view of the patient of Figure 2, illustrating the flexible pipe of the nasal catheter in a second arrangement;

Figure 9 is a side schematic view of another embodiment of the nasal catheter;

Figure 10 is an end view of another embodiment of the elongate body of the nasal catheter, comprising a tubular length of open-cell foam material;

Figure 11 is a side schematic view of the nasal catheter of Figure 10, in an uncompressed arrangement; Figure 12 is a side schematic view of the nasal catheter of Figure 11 , illustrating the compression of the tip of the second end;

Figure 13 is still another embodiment of the nasal catheter of the present invention;

Figure 14 is an end view of the nasal catheter of Figure 13;

Figure 15 is a perspective view of the elongate body of the nasal catheter of

Figure 13, illustrating the flexible tube position within the elongate body;

Figure 16 is a schematic view of the nasal catheter of Figure 13 in use;

Figure 17 is a perspective view of the elongate body of the nasal catheter of Figure 13;

Figure 18 is a rear perspective view of the elongate body of Figure 13;

Figure 19 is a schematic view of the elongate body of Figure 13 being inserted into the nasal passage of a patient; and

Figure 20 is the schematic view of Figure 19, illustrating the elongate body being partly retracted wherein the dome-shaped flanges flare out to engage with the sides of the nasal passage.

DETAILED DESCRIPTION OF THE ILLUSTRATED AND EXEMPLIFIED EMBODIMENTS

Similar reference characters indicate corresponding parts throughout the drawings. Dimensions of certain parts shown in the drawings may have been modified and/or exaggerated for the purposes of clarity or illustration.

Referring to the drawings for a more detailed description, there is illustrated a nasal catheter 10, demonstrating by way of examples, arrangements in which the principles of the present invention may be employed. The nasal catheter 10 has a compressible body 12 including a primary passageway 24 in communication with a plurality of pathways 22 extending through the body 12, for delivery of oxygen and/or an anaesthetic agent into the airways of a patient 34.

In one embodiment, as illustrated in Figure 1a, the nasal catheter 10 includes an elongate body 12 being at least partly resiliently deformable, a length of generally flexible pipe 14 and a coupling 16. The elongate body 12 has a first end 18 and a generally tapered resiliently deformable second end 20.

The elongate body 12 is generally constructed from a resiliently deformable open-cell foam material or fibrous material which forms the plurality of pathways 22 extending therethrough, as illustrated in Figure 1 b. The reader will appreciate that the material used to construct the elongate body 12 may be latex foam, foam rubber, polyurethane foam, polymer sponge, fibrous cellulose material or any other type of matrix.

In one possible embodiment, the elongate body 12 is constructed from an open-cell foam material, whereby the adjoining cells delineate the pathways 22.

As further illustrated in Figures 1a and 1 b, the pipe 14 extends into the elongate body 12 thereby forming a primary passageway 24 which includes a number of outlets 26.

The reader will appreciate that the primary passageway 24 is in communication with the plurality of secondary pathways 22, by way of the outlet/s 26. This thereby permits the gas or oxygen to be introduced into the nasopharynx of the patient 34 in a diffused fashion, to thereby inhibit localised drying of the nasal mucosa or impact damage to the mucosa from a direct jet of gas, as may occur with the devices suggested in the prior art. The reader will now appreciate that conventional nasal oxygen delivery devices use a single continuous stream of gas which tends to cause localised drying of the mucosa of the nose. This can result in bleeding due to the orientation of the stream being directed toward the more delicate nasal tissue and the velocity of the stream of gas/oxygen.

The first end 18 of the elongate body 12 of the present embodiment, as illustrated in Figure 1a, includes a barrier 28, which further inhibits movement of gas or oxygen out through the patient’s nostril from within the nasopharynx 40 and into the surround environment, when the nasal catheter 10 is positioned within the nasal vestibule 36, as will be discussed with respect to Figure 2.

The length of generally flexible pipe 14, is envisaged to form the primary passageway 24 within the elongate body 12, however, the reader should appreciate that the pipe 14 may adjoin a primary passageway formed within the elongate body 12. As further illustrated in Figure 1a, the flexible pipe 14 extends rearwardly from the first end 18 of the elongate body 12 and includes the coupling 16 at a free end thereof. The coupling 16 in the present embodiment is a male hose coupling including an annular ridge 30, wherein a conventional flexible gas supply tubing 46, as illustrated in Figure 3c, may be pushed over the male hose coupling 16 and retained by the annular ridge 30.

Figure 2 illustrates the nasal catheter 10 in position within the nasal passage 32 of a patient 34. As shown, the elongate body 12 extends through the nasal vestibule 36 and bends, such that it projects past, or adjacent to, the conchae 38 within the nasopharynx 40, such that the second end 20 of the elongate body 12 is positioned above or forward of the soft palate 42. The diffused introduction of the gas or oxygen directly into or adjacent the nasopharynx 40 provides an anatomic reservoir of oxygen for the patient during the medical procedure.

As further illustrated in Figure 2, the elongate body 12 is inserted in through the nostril 44 of a patient, such that the first end 18 is positioned adjacent the nasal vestibule 36. As the reader will appreciate, the elongate body 12 is resiliently deformable or compressible, such that upon insertion in through the nasal vestibule 36 the elongate body 12 tends to expand to thereby reversibly engage the edge of the nasal vestibule 36, to thereby hold the nasal catheter 10 in position and inhibits leakage of gas/oxygen out through the nostril 44 from around the elongate body 12.

The configuration of the first end 18 having a barrier 28, also inhibits air flow movement out through the rear of the first end 18. This is important in the cases where a flammable gas such as oxygen is used. This configuration reduces the risk of ignition, during medical procedures which involve a heat source, such as during cautery or burning of facial skin cancer.

As illustrated in Figures 1 a and 2, the barrier 28 at the first end 18 may be constructed from a different non-porous material to that of the main part of the elongate body 12. The non-porous part 28 abuts or is affixed to the open-cell foam part of the elongate body 12. The reader should however appreciate that the barrier 28 may be a layer or coating that is applied to the first end 18 to inhibit movement of gas or oxygen therethrough. The skilled addressee will appreciate that the barrier 28 acts to plug the nostril to inhibit rearward movement of the gas/oxygen out therethrough into the surrounding environment.

Turning to Figures 3a to 3c, there is illustrated a method of providing oxygen and/or anaesthetic agent to the patient 34. As illustrated in Figure 3a, the tip of the elongate body 12 is inserted in through the nasal vestibule 36 of one of the nostrils 44 of the patient 34 in the direction of the solid arrow.

The reader should appreciate that the tip of the second end 20 may be manually compressed by a practitioner prior to inserting in through the patient’s nostril.

The elongate body 12 continues to be inserted into the nostril 44, as illustrated in Figure 3b, wherein the elongate body 12 bends for positioning the second end 20 within the nasopharynx 40.

As illustrated in Figure 3c, when the elongate body 12 has been inserted into the nasal passage 32 to the full extent, the first end 18 is positioned at, and engages with, the nasal vestibule 36 to effectively plug the corresponding nostril 44. The resiliently deformable nature of the elongate body 12 assists in sealing any gaps around the nostril entrance, and holds the nasal catheter 10 in place during use.

As further illustrated in Figure 3c, a gas/oxygen supply tubing 46 is attached to the coupling 16 at an end of the flexible pipe 14. A source of oxygen and/or anaesthetic agent (not shown) can then be operated to cause oxygen and/or anaesthetic agent to flow, in the direction of the broken arrows, through the flexible pipe 14 and out of the elongate body 12, into the nasopharynx 40, for inhaling by the patient 34.

Figures 4 to 6, illustrate different embodiments of the primary passageway 24, that in the present embodiments are formed by a portion of the flexible pipe 14 retained within the elongate body 12. Figure 4 illustrates a partial cross-sectional view of the passageway 24 of Figure 1a, having multiple outlets 26. Figure 5 illustrates another embodiment, wherein the passageway 24 includes a single outlet 26 at an end thereof, which is in fluid communication with the secondary pathways 22 as discussed above. Figure 6 illustrates another alternate embodiment which includes a blind ended primary passageway 24 having a plurality of outlets 26. The skilled addressee will appreciate that even in the case of the passageway 24 having a single outlet 26, due to the elongate body 12 having a plurality of pathways 22 extending therethrough, the airflow is still introduced into the nasopharynx 40 in a diffused fashion rather than as a direct stream of air, which would cause localised drying of the mucosa.

Figures 7 and 8, illustrate the nasal catheter 10 in use, wherein the flexible pipe 14 and adjoining supply tubing 46, can be positioned over the patient’s face in a location that does not impede the practitioner during the medical procedure. For instance, in Figure 7, where the treatment area 50 is on one side of the nose, the supply tubing 46 can be positioned over the patient’s left ear 52 and the flexible pipe 14 held in place by adhesive tape 54.

Alternatively, where the treatment areas 50 and 56 are on both sides of the face, the flexible pipe 14 can be taped to the bridge 58 of the nose by way of adhesive tape 54 and the supply tubing 46 positioned between the patient’s eyes 60. The reader will appreciate that the present invention is useful in situations where the treatment area/s are around the nose or mouth of the patient, which prevents the use of a face mask for the delivery of gas/oxygen.

As further illustrated in Figures 7 and 8, the nasal catheter 10 is inserted into only one nostril 44 of the patient 34, wherein the patient can breathe out through the unblocked nostril 62.

In an alternate embodiment, as illustrated in Figure 9, the elongate body 12 may be of a uniform open cell construction and the outlets 26 of the primary passageway 24 are located towards the second end 20 of the elongate body 12. This will mean that the gas or oxygen tends to move outwardly towards the second end 20 and is inhibited from exiting the corresponding nostril via the first end 18, due to the convoluted paths through the elongate body.

In still another embodiment, as illustrated in Figures 10 to 12, the elongate body 12 comprises a tube shaped length 64 of die cut compressible foam material, with a central bore 66. The flexible pipe 14, having a single outlet 26, can be inserted into the central bore 66 and glued or ultrasonically welded in place. In one embodiment, the flexible pipe 14 extends three quarters of the way along the length of the central bore 66. During manufacture, the flexible pipe 14 is inserted and glued in place, while a layer or barrier 28 is applied to the first end 18, to inhibit rearward movement of gas out of elongate body 12 when positioned within the patient’s nostril.

As illustrated in Figure 12, when the elongate body 12 is inserted into the patient’s nose, the second end 20, forward of the flexible pipe 14, will tend to compress or collapse in on itself, as illustrated by the arrows, as it come into contact with the internal structures within the nasal cavity.

This will block or inhibit movement of the gas out through the end of the central bore 66, thereby forcing the gas/oxygen through the plurality of pathways 22, such that the gas/oxygen diffuses out into the nasopharynx 40 of the patient 34.

The reader should appreciate that the second end 20 of the elongate body 12 is reversibly deformable and a user is able to compress or squash the second end 20 before insertion into the nasal passage 32 of a patient 34. This therefore allows the elongate body 12 to be inserted with less pressure and/or trauma to the delicate nasal mucosa of the patient 34. The Inventor envisages that the present embodiment will operate in a similar fashion to foam ear plug, wherein upon appropriate positioning in the nasopharynx the reversibly deformable section can then re-expand and conform to the specific nasopharynx configuration of the patient 34. This means that the elongate body 12 will be less likely to move, and will decrease the risk of oxygen leaking back past the elongate body 12.

In a preferred embodiment as illustrated in Figures 13 to 20, the elongate body 12 is constructed from a silicon material or a material having elastomeric properties. The elongate body 12, comprises a generally tubular portion 68, domeshaped resiliently deformable flanges 70, 72, 74, 76, and a rounded tip 78 through which the secondary pathway/s 22 extend. The dome-shaped flanges 70, 72, 74, 76 are spaced-apart along the generally tubular portion 68 and are both outwardly and rearwardly extending.

As illustrated in Figures 13 to 20, the dome-shaped resiliently deformable flanges 70, 72, 74, 76 sequentially increase in diameter between the second end 20 and the first end 18, wherein the dome-shaped resiliently deformable flange 70 adjacent the first end 18 has the largest diameter, and the dome-shaped resiliently deformable flange 76 adjacent the second end 20 has the smallest diameter. The flange 76 and rounded tip 78 are generally unitary in configuration and the rounded tip 78 includes four secondary pathways 22 extending therethrough. However, additional secondary pathways 22 may be located through the rounded tip 78 or along a length of the generally tubular portion, between adjacent flanges 70, 72, 74, and/or 76.

As illustrated in Figure 14, the secondary pathways 22 are in fluid communication with the outlet 26 of the primary passageway 24.

Figure 15 illustrates the position of the flexible pipe 14 that extends into the generally tubular portion 68 of the elongate body 12. The reader will appreciate that the flexible pipe 14 does not extend to the full length of the tubular portion 68 and the outlet 26 is spaced apart from the rounded tip 78. This means that the elongate body 12 forward of the end of the flexible pipe 14 has a greater degree of flexibility than the portion into which the flexible pipe 14 is inserted, thereby allowing it to compress or collapse to a greater degree.

As illustrated in Figure 16, the elongate body 12 is inserted into the nasal vestibule 36 wherein the secondary pathways 22 are positioned in or adjacent the nasopharynx 40. Figure 16 further illustrates how, at least some of, the flanges 70, 72, 74, 76, bear against the side of the nasal passage 32, as will be discussed with respect to Figure 19 and 20. The reader should appreciate that the elongate body 12 of Figure 16 has been exaggerated for the purposes of discussion and the length of the elongate body 12 is envisaged to be around 25mm and would therefore not extend as far into the nasal vestibule 36 as is currently illustrated in Figure 16.

As best illustrated in Figure 18, the four dome-shaped resiliently deformable flanges 70, 72, 74, 76 are attached to the generally tubular portion 68, such that the annular free edges 80 of the domes projected rearwardly.

As illustrated in Figure 19, the flanges 70, 72, 74, 76 are constructed from a soft spongy plastic-like or silicon material, the annular free edges 80 of the flanges 70, 72, 74, 76 tend to fold inwardly towards the tubular portion 68 as the elongate body 12 is inserted into the nasal passage 32 in the direction of the broken arrow. The annular free edges 80 are able to bear against and slide along the irregular side of the nasal passage 32. The deformable configuration of the elongate body 12 and material from which it is constructed means that the risk to damage of the mucosa of the nose is reduced. As illustrated in Figure 20, a practitioner can slightly retract the elongate body 12 in the direction of the broken arrow, which results in the annular free edges 80 of at least some of the flanges 70, 72, 74, 76 to frictionally engage the irregular surface of the nasal passage 32, which causes them to flare out slightly. This means that the elongate body 12 will engage with the sides of the nasal passage 23 to a greater extent, to effectively pneumatically seal the nostril 44 and thereby inhibit the escape of gas/oxygen outwardly therethrough.

Additionally, the flaring out of the edges 80 of the dome-shaped flanges 70, 72, 74, 76 will inhibit the inadvertent dislodging of the nasal catheter 10, while still permitting full retraction of the elongate body 12 from within the nostril 32 without causing damage to the mucosa of the nose, due to the flexible nature of the elongate body 12. The reader should appreciate that the flanges will tend to fold or roll back on themselves as the elongate body 12 is withdrawn from within the nasal passage.

The skilled addressee will now appreciate the advantages of the illustrated invention over the prior art. In one form, the nasal catheter provides both a delivery means for introducing oxygen into the nasopharynx in a diffused fashion. This diffused introduction of the gas or oxygen into the nasopharynx of the patient inhibits localised drying of the nasal mucosa and resultant damage thereto. Furthermore, the invention acts as a nasal plug to inhibit rearward movement of the oxygen outwardly through the nostril into the surrounding environment, thereby reducing the risk of combustion during a medical procedure, where a source of ignition is used, such as when skin cancers are burnt off the face of a patient.

Various features of the invention have been particularly shown and described in connection with the exemplified embodiments of the invention, however it must be understood that these particular arrangements merely illustrate the invention and it is not limited thereto. Accordingly, the invention can include various modifications, which fall within the scope of the invention.

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

Claims

1. A nasal catheter for a patient comprising: an elongate body being at least partly resiliently deformable, and having a first end and a second end, the elongate body further including a secondary pathway or pathways; a primary passageway extending inwardly of the first end of the elongate body, being in communication with the secondary pathway or pathways; a generally flexible pipe adjoining, or at least partly forming, the primary passageway, the flexible pipe extending outwardly from the first end of the elongate body, wherein a free end of the flexible pipe being configured for engagement with a gas supply tubing; and wherein the elongate body being configured for insertion in through a nostril of a patient, whereby the first end of the elongate body being configured for reversible engagement with a nasal vestibule of the patient, and the second end of the elongate body extending into or adjacent the nasopharynx of the patient for diffused delivery of oxygen and/or anaesthetic agent thereinto, while inhibiting localised drying of a nasal mucosa of the patient.

2. The nasal catheter in accordance with claim 1 , wherein the elongate body includes a generally tubular portion and at least two spaced-apart, domeshaped resiliently deformable flanges.

3. The nasal catheter in accordance with claim 2, wherein the elongate body further including and a rounded tip at the second end, having the secondary pathway or pathways extending therethrough.

4. The nasal catheter in accordance with claim 2, wherein four dome-shaped resiliently deformable flanges are spaced apart along the length of the tubular portion, wherein the flanges sequentially increase in diameter between the second end and the first end.

5. The nasal catheter in accordance with claim 2, wherein the dome-shaped resiliently deformable flanges are attached to the generally tubular portion forming generally hollow flexible domes, such that respective annular free edges of the generally hollow flexible domes project outwardly and rearwardly.

6. The nasal catheter in accordance with claim 1 , wherein the free end the flexible pipe includes a coupling for connection to the gas supply tubing, which is in turn connectable to a source of gas and/or oxygen.

7. The nasal catheter in accordance with claim 1 , wherein the second end of the elongate body includes a tip that is compressible to a greater degree than the rest of the resiliently deformable part of the elongate body, wherein at least part of the elongate body expands or moves outwardly once in position within the nasopharynx to conform to the specific nasopharynx configuration of the patient, wherein the gas or oxygen is inhibited from leaking back past the elongate body and out through the nostril into a surrounding environment.

8. The nasal catheter in accordance with claim 6, wherein the primary passageway and generally flexible pipe may be unitary in construction, wherein a first portion of a length of pipe, having at least one outlet is positioned within the elongate body, and a second portion of the pipe extends rearwardly or outwardly from the first end of the elongate body and includes at its free end an inlet and the coupling.

9. The nasal catheter in accordance with claim 8, wherein the elongate body is over-moulded onto the first portion of the length of pipe, or the first portion of the length of pipe is inserted into a void formed in the elongate body and glued or ultrasonically welded into place or the elongate body frictionally engages the first portion of the length of pipe.

10. The nasal catheter in accordance with claim 1 , wherein the elongate body is at least partly constructed from a material selected from a group including, medical grade silicon, rubber compounds, elastomers having a polypropylene base, copolymers material, polymer material, or a material having elastomeric properties.

11 . The nasal catheter in accordance with claim 1 , wherein at least a part of the elongate body is constructed from an open-cell foam material, fibrous cellulose material or a material matrix delineating multiple pores or pathways that permit the gas or oxygen to flow therethrough.

12. The nasal catheter in accordance with claim 1 , wherein a first end of the elongate body includes a barrier or acts as a barrier to block the adjacent secondary pathway or pathways extending therethrough or rearwardly of the elongate body to thereby inhibit movement of the gas or oxygen out from the first end and into the surrounding environment.

13. The nasal catheter in accordance with claim 1 , wherein the elongate body is of uniform construction and the outlet or outlets of the primary passageway being directed towards the second end of the elongate body, whereby the gas or oxygen tends to move outwardly therethrough into the airways of a patient, and is inhibited from escaping through the nasal vestibule into the surrounding environment.

14. The nasal catheter in accordance with claim 1 , wherein the elongate body is constructed in different lengths and sizes to accommodate different ages, sexes and anatomical variations.

15. A method of providing oxygen and/or anaesthetic agent to a patient, including: providing a nasal catheter, in accordance with any one of claims 1 to 14; inserting the elongate body in through a nostril of the patient, wherein the first end being positioned at or adjacent the nasal vestibule of the nostril and at least a part of the elongate body bearing against a side of a nasal passage to thereby inhibit movement of a gas or oxygen out therethrough; affixing the gas supply tubing to an end of the flexible pipe; and operating a source of oxygen and/or anaesthetic agent connected to the gas supply tubing, wherein oxygen and/or anaesthetic agent is caused to flow through the elongate body in a diffused manner and into the nasopharynx of the patient.