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WO2025043279A1 - Appareil de cathéter nasal - Google Patents

Appareil de cathéter nasal Download PDF

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Publication number
WO2025043279A1
WO2025043279A1 PCT/AU2024/050907 AU2024050907W WO2025043279A1 WO 2025043279 A1 WO2025043279 A1 WO 2025043279A1 AU 2024050907 W AU2024050907 W AU 2024050907W WO 2025043279 A1 WO2025043279 A1 WO 2025043279A1
Authority
WO
WIPO (PCT)
Prior art keywords
elongate body
patient
nasal
oxygen
accordance
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/AU2024/050907
Other languages
English (en)
Inventor
Andrew Wallis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovgas Pty Ltd
Original Assignee
Innovgas Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2023902769A external-priority patent/AU2023902769A0/en
Application filed by Innovgas Pty Ltd filed Critical Innovgas Pty Ltd
Publication of WO2025043279A1 publication Critical patent/WO2025043279A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12036—Type of occlusion partial occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12104—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in an air passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12159—Solid plugs; being solid before insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/01—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes specially adapted for anaesthetising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0461—Nasoendotracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/0007—Special media to be introduced, removed or treated introduced into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0241—Anaesthetics; Analgesics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0625—Mouth
    • A61M2210/065—Throat; Pharynx

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • U.S. Patent No. 7,735,492 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.
  • DILLARD 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.
  • 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.
  • 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 anae
  • a plurality of pathways extend through the elongate body.
  • 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 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.
  • 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 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the elongate body may be over-moulded onto the first portion of the flexible pipe.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • the flexible pipe can be repositioned during the medical procedure to access other areas of the patient’s face.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • the elongate body 12 is constructed from an open-cell foam material, whereby the adjoining cells delineate the pathways 22.
  • the pipe 14 extends into the elongate body 12 thereby forming a primary passageway 24 which includes a number of outlets 26.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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 barrier 28 acts to plug the nostril to inhibit rearward movement of the gas/oxygen out therethrough into the surrounding environment.
  • FIG. 3a there is illustrated a method of providing oxygen and/or anaesthetic agent to the patient 34.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • adhesive tape 54 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the flexible pipe 14 extends three quarters of the way along the length of the central bore 66.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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 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.
  • 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.
  • 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.
  • 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 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.
  • 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.

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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Surgery (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

L'invention concerne un cathéter nasal pour un patient qui comprend un corps allongé, est au moins partiellement déformable élastiquement et a une voie ou des voies secondaires, un passage primaire s'étendant vers l'intérieur d'une extrémité du corps allongé, un tuyau généralement flexible étant adjacent au passage primaire pour une connexion à une alimentation en gaz. Le corps allongé est conçu pour être inséré à travers une narine du patient, le corps allongé venant en prise de manière réversible avec un vestibule nasal et s'étendant dans le nasopharynx du patient, ou étant adjacent à celui-ci, pour l'administration d'oxygène et/ou d'un agent anesthésique dans celui-ci.
PCT/AU2024/050907 2023-08-28 2024-08-26 Appareil de cathéter nasal Pending WO2025043279A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2023902769 2023-08-28
AU2023902769A AU2023902769A0 (en) 2023-08-28 Nasal catheter apparatus

Publications (1)

Publication Number Publication Date
WO2025043279A1 true WO2025043279A1 (fr) 2025-03-06

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Application Number Title Priority Date Filing Date
PCT/AU2024/050907 Pending WO2025043279A1 (fr) 2023-08-28 2024-08-26 Appareil de cathéter nasal

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060048775A1 (en) * 2004-09-09 2006-03-09 Dunlap Ivan L Nasopharyngeal airway device and method of use
US20060102418A1 (en) * 2004-11-12 2006-05-18 Moldex-Metric, Inc. Earplug
US20070000499A1 (en) * 2005-06-25 2007-01-04 Institut Franco-Allemand De Recherches De Saint-Louis Earplug and manufacturing method
WO2011081772A1 (fr) * 2009-12-30 2011-07-07 Acclarent, Inc. Systèmes et procédés pour anesthésier le tissu de l'oreille
US20130073015A1 (en) * 2005-05-13 2013-03-21 Allan Rozenberg Methods and devices for non-invasive cerebral and systemic cooling alternating liquid mist/gas for induction and gas for maintenance
WO2013191801A2 (fr) * 2012-06-17 2013-12-27 Astuce, Inc. Système et procédé pour améliorer le résultat d'une ischémie cérébrale
US20160271375A1 (en) * 2013-12-17 2016-09-22 Biovision Technologies, Inc. Methods for treating sinus diseases
US20170296759A1 (en) * 2016-04-14 2017-10-19 Novaplast Corporation Delivery Device and Method for Intranasal Administration of Topical Therapeutic Agents
WO2019077586A1 (fr) * 2017-10-20 2019-04-25 Beck Medical, Ltd. Dispositif nasal pour traitement

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060048775A1 (en) * 2004-09-09 2006-03-09 Dunlap Ivan L Nasopharyngeal airway device and method of use
US20060102418A1 (en) * 2004-11-12 2006-05-18 Moldex-Metric, Inc. Earplug
US20130073015A1 (en) * 2005-05-13 2013-03-21 Allan Rozenberg Methods and devices for non-invasive cerebral and systemic cooling alternating liquid mist/gas for induction and gas for maintenance
US20070000499A1 (en) * 2005-06-25 2007-01-04 Institut Franco-Allemand De Recherches De Saint-Louis Earplug and manufacturing method
WO2011081772A1 (fr) * 2009-12-30 2011-07-07 Acclarent, Inc. Systèmes et procédés pour anesthésier le tissu de l'oreille
WO2013191801A2 (fr) * 2012-06-17 2013-12-27 Astuce, Inc. Système et procédé pour améliorer le résultat d'une ischémie cérébrale
US20160271375A1 (en) * 2013-12-17 2016-09-22 Biovision Technologies, Inc. Methods for treating sinus diseases
US20170296759A1 (en) * 2016-04-14 2017-10-19 Novaplast Corporation Delivery Device and Method for Intranasal Administration of Topical Therapeutic Agents
WO2019077586A1 (fr) * 2017-10-20 2019-04-25 Beck Medical, Ltd. Dispositif nasal pour traitement

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