Nasal cannula
11420002 · 2022-08-23
Assignee
Inventors
- Alicia Jerram Hunter EVANS (Auckland, NZ)
- Craig Karl WHITE (Auckland, NZ)
- Samantha Dale OLDFIELD (Auckland, NZ)
- Milanjot Singh Assi (Auckland, NZ)
- Erik Robertus Scheirlinck (Auckland, NZ)
- Callum James Thomas SPENCE (Auckland, NZ)
- Laurence Gulliver (Auckland, NZ)
- Dexter Chi Lun Cheung (Auckland, NZ)
- Michael Robert Barraclough (Auckland, NZ)
- Matthew Jon Payton (Auckland, NZ)
Cpc classification
A61B1/00165
HUMAN NECESSITIES
A61M16/14
HUMAN NECESSITIES
A61M16/147
HUMAN NECESSITIES
A61M16/0488
HUMAN NECESSITIES
A61M2206/14
HUMAN NECESSITIES
International classification
A61B1/273
HUMAN NECESSITIES
A61B1/267
HUMAN NECESSITIES
A61B1/00
HUMAN NECESSITIES
A61M16/20
HUMAN NECESSITIES
A61M16/14
HUMAN NECESSITIES
Abstract
The disclosure relates to a nasal cannula comprising a port configured for delivery of a medicament into a flow of a fluid being delivered by the nasal cannula to a user and/or configured for interfacing with a medicament delivery device or an instrument. The disclosure also relates to a nasal cannula comprising an asymmetric profile to reduce an amount of occlusion of one nare of a user to provide access for an instrument to the nare with the nasal cannula in use.
Claims
1. A nasal cannula configured to deliver a flow of fluid to a user, the nasal cannula comprising: a manifold part, the manifold part having an inlet configured to receive the flow of fluid, and at least one outlet configured to deliver the flow of fluid to one or both of the user's nares, wherein the at least one outlet comprises at least one non-sealing patient interface, wherein the manifold part includes a patient-contacting surface and the inlet is located on a lateral side of the manifold part adjacent the patient-contacting surface; and a port located on the manifold part, the port configured to perform at least one of: delivering a medicament into the flow of fluid being delivered by the nasal cannula to the user, or interfacing with a medicament delivery device, wherein the port comprises an opening, the opening being at least one of closable or re-closable, and wherein the non-sealing patient interface comprises a non-sealing nasal prong that extends proximally, a path through the port being aligned with a flow path through the nasal prong of the nasal cannula.
2. The nasal cannula as claimed in claim 1, wherein the port comprises a guide for directing a flow of medicament into the flow of fluid, or for directing the medicament delivery device into at least one of the nasal cannula or the user's airway.
3. The nasal cannula as claimed in claim 2, wherein the guide provides for a pre-determined geometry of the port to direct, locate, or position the medicament delivery device, or an outlet of the medicament delivery device, at a desired angle or orientation relative to the nasal cannula.
4. The nasal cannula as claimed in claim 1, wherein the port extends from the manifold part to the nasal prong of the nasal cannula, or wherein the nasal cannula further comprises a second port and a second non-sealing nasal prong, the port and the second port extending from the manifold part to the nasal prong and the second nasal prong respectively.
5. The nasal cannula as claimed in claim 1, wherein the port is arranged to face away from the user's face when in use.
6. The nasal cannula as claimed in claim 1, further comprising a moulded or otherwise shaped region configured for accepting, receiving, locating, or seating of the medicament delivery device relative to the port.
7. The nasal cannula as claimed in claim 1, wherein with the medicament delivery device in-situ with the port, the port seals about the medicament delivery device.
8. The nasal cannula as claimed in claim 1, wherein the port comprises of a seal, the seal being self-closing.
9. The nasal cannula as claimed in claim 1, wherein the port comprises a rigid component configured to support the medicament delivery device when in-situ with the port.
10. The nasal cannula as claimed in claim 1, wherein the nasal cannula or the port comprises a plurality of in-line atomisation or nebulisation of medicament dispensers, the plurality of in-line atomization or nebulization of medicament dispensers configured to deliver medicament via the port.
11. The nasal cannula as claimed in claim 10, wherein the plurality of in-line atomization or nebulization of medicament dispensers comprise a plurality of ribs or serrations within a nasal prong of the nasal cannula.
12. The nasal cannula as claimed in claim 1, further comprising a medicament supply tube extending from the port.
13. The nasal cannula as claimed in claim 12, wherein the supply tube is formed within a wall of the nasal prong of the nasal cannula or located within a lumen of the nasal prong.
14. The nasal cannula as claimed in claim 12, wherein an inlet end of the supply tube is located at the port or extends from the port so as to allow the medicament delivery device to be connected to the port remotely from the manifold part.
15. The nasal cannula as claimed in claim 12, wherein the supply tube comprises a small diameter outlet such that the outlet operates as a nozzle to spray or otherwise disperse the medicament from the supply tube.
16. The nasal cannula as claimed in claim 1, wherein the port is adapted to receive a nozzle or an outlet of the medicament delivery device or to be received in the nozzle or the outlet of the medicament delivery device.
17. The nasal cannula as claimed in claim 1, wherein the port is located on a side of the manifold part opposite another side of the manifold part where the at least one outlet is located.
18. The nasal cannula as claimed in claim 1, wherein the nasal cannula is configured to perform one or more of: delivering the flow of fluid to the user to provide high flow support; delivering the flow of fluid at a flow rate of above 15 L/min; or delivering the flow of fluid that comprises a humidified gases flow.
19. A nasal cannula configured to deliver a flow of fluid to a user, the nasal cannula comprising: a manifold part, the manifold part having an inlet configured to receive the flow of fluid, and at least one outlet configured to deliver the flow of fluid to one or both of the user's nares, wherein the at least one outlet comprises at least one non-sealing patient interface, wherein the manifold part includes a patient-contacting surface and the inlet is located on a lateral side of the manifold part adjacent the patient-contacting surface; and a port located on the manifold part, the port configured to perform at least one of: delivering a medicament into the flow of fluid being delivered by the nasal cannula to the user, or interfacing with a medicament delivery device, wherein with the medicament delivery device in-situ with the port, the port seals about the medicament delivery device, and wherein the non-sealing patient interface comprises a non-sealing nasal prong that extends proximally, a path through the port being aligned with a flow path through the nasal prong of the nasal cannula.
20. A nasal cannula configured to deliver a flow of fluid to a user, the nasal cannula comprising: a manifold part, the manifold part having an inlet configured to receive the flow of fluid, and at least one outlet configured to deliver the flow of fluid to one or both of the user's nares, wherein the at least one outlet comprises at least one non-sealing patient interface, wherein the manifold part includes a patient-contacting surface and the inlet is located on a lateral side of the manifold part adjacent the patient-contacting surface; and a port located on the manifold part, the port configured to perform at least one of: delivering a medicament into the flow of fluid being delivered by the nasal cannula to the user, or interfacing with a medicament delivery device, wherein the port comprises of a seal, the seal being self-closing, and wherein the non-sealing patient interface comprises a non-sealing nasal prong that extends proximally, a path through the port being aligned with a flow path through the nasal prong of the nasal cannula.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
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DETAILED DESCRIPTION
(45) In some instances it may be desirable to deliver a flow of respiratory gases to a patient via one or both nares and allow for the insertion of airway instruments or devices, for example a tube, via one of the nares. In some instances it may be desirable to allow an instrument to be inserted via a nare of a user and optionally, to block flow to that nare of the user, or to block flow to both nares or stop flow completely.
(46) In some embodiments, a nasal cannula may comprise an asymmetric profile to reduce the size of the cannula under or near one nare of a user. For example, with reference to
(47) A cannula typically comprises a frame or manifold part. A conduit or interface tube may be attached to the frame or manifold part. The frame or manifold part supports the nasal prongs in a spaced apart relation for fitment into the patient's nares. The frame may optionally include a pair of rigid or semi rigid arms that extend across the cheeks to locate the cannula on the face. The arms may comprise an overmolded thermoplastic or other suitable material. The cannula may comprise a headgear to secure the cannula in an operational position on the user's head. In some configurations the nasal cannula may comprise a securement structure. A system for the securement of such a patient interface (e.g. nasal cannula) to the face can allow for a removable or connectable arrangement. For example, a securement structure or system may comprise a series of patches or pads, for connection to a user's face, and then one or more additional pads or patches for connection to the interface, the exposed surfaces of these pads or patches being provided with capability to connect or attach, preferably in a removable manner, to the other patches or pads. With reference to
(48) In some embodiments the prong on the reduced in size side of the cannula may be shorter in length than the other nasal prong (for example as shown in
(49) In some configurations the nasal prong 11 at the ‘reduced in size’ side of the cannula may have an oval cross section or a shape that is flatter than a circle (for example as shown in
(50) An example of where a cannula comprising an asymmetric profile may be particularly useful is in suspended laryngoscopy. Equipment associated with the suspended laryngoscope is placed very close under the patient's nares and in some cases a prior art high flow cannula cannot be used as the cannula is too large to fit in place under the laryngoscope.
(51) A gases supply tube or conduit may be connected to the cannula, or the cannula may comprise a conduit connection for connecting a supply tube or conduit. In some embodiments, the supply conduit or conduit connection may be provided to a side of the cannula opposite to the reduced side of the cannula, as shown in
(52) Unless otherwise indicated, one side of the cannula is intended to mean the portion of a cannula that is located on one side of a user's face in use (e.g. a left hand side of a user's face). An opposite side of the cannula is the portion of the cannula that is located on the other side of a user's face in use (e.g. a right hand side of a user's face). The terms “left” and “right” are intended to relate to the left hand side and right hand side of the user or patient.
(53) In some embodiments, as illustrated in
(54) The embodiments described above may be useful as they may not require any adjustment of the cannula on the user's face in order to insert an instrument into a nare of the user, yet a flow of gases is still delivered to both nares.
(55) In some configurations a ‘frame’ of a cannula may comprise a strap or may be a strap for securing the cannula in place on a patient's face in use.
(56) In some configurations a nasal cannula comprises a removable or extendable prong. For example, with reference to
(57) As illustrated in
(58) As illustrated in
(59) As illustrated in
(60) The embodiments described with reference to
(61) Allowing the flow to continue to flow through both orifices may prevent large pressure changes in the system. If the gas supply is sensitive to pressure changes (e.g. a blower) this may also help to reduce potential fluctuations in flow and/or humidity, or a reduction in flow if the supply is not able to overcome the increase in pressure.
(62) As illustrated in
(63) As shown in
(64) The embodiments described with reference to
(65) With reference to
(66) As shown in
(67) In some configurations, a cannula has a first prong attached to and in fluid communication with a first conduit part, and a second prong attached to and in fluid communication with a second conduit part, wherein the second conduit part is slidable relative to and in fluid communication with the first conduit part to displace the second prong from the first prong. In some embodiments, as illustrated, the second conduit part comprises an aperture in a side wall to align with the first prong when the second prong is positioned for alignment with a nare of the user, so that the first prong is in fluid communication with a flow of gases provided via an inlet of the cannula.
(68) As shown in
(69) As shown in
(70) As shown in
(71) As shown in
(72) As shown in
(73) In some embodiments, the cannula comprises a valve 174. The valve may be actuated from open to closed by inserting an instrument through the cannula. The valve may be located within the manifold part of the cannula and between the prongs or outlets of the cannula. The valve is closed by the instrument extending through a second prong of the cannula so that gas flow from an inlet of the cannula is directed to a first prong of the cannula. When the instrument is inserted through the aperture the instrument actuates a valve element (e.g. a flap) against a valve seat to fluidly isolate one nasal prong or outlet from the other nasal prong or outlet and stop or reduce flow to the prong that receives the instrument. In some configurations, the cannula may comprise two sealable apertures, each aperture aligned with a corresponding prong. The cannula may comprise two valves, each valve corresponding with a prong. In such an embodiment, an instrument may be inserted simultaneously via both nares of the user. In some embodiments, the cannula may comprise a pressure relieve valve in the event that flow from both nasal prongs or nasal outlets is blocked.
(74) In some configurations, one or both prongs may be configured to be torn from a manifold part of the cannula. However, unlike the configuration described with reference to
(75) The nasal cannula configurations described with reference to
(76) Furthermore, in all embodiments, the arrangement described for modifying or manipulating one nasal prong may be applied for modifying or manipulating both nasal prongs, for example if access to both nares is desired. Where both nasal prongs or outlets can be blocked, a pressure relief valve may be provided to limit a maximum pressure that the system may be exposed to.
(77) With reference to
(78) In some embodiments, the left and right sides of the cannula may be in fluid communication when coupled together as shown in
(79) With reference to
(80) A cannula may be secured in place on a user's face by a dermal patch. A dermal patch may be adhered to a user's face, for example by a dermatologically sensitive adhesive. A second patch (interface patch) may be attached to a face side of a cannula. The dermal patch and the interface patch each have one half of a two-part releasable connection, for example one patch may have the hooks of a hook and loop connection and the other patch may have the loops of a hook and loop connection (for example the connection may be Velcro®). Thus the patches retain the cannula in position on the user's face. In some configurations, where a dermal patch is used to secure the cannula in place on the users face, the cannula 190 may be held in the extended position (
(81) In some configurations, the expandable region 193 of the cannula may be formed from an elastic material to stretch between an extended position and a non-extended position. In use, where no instrument is required, the expandable region may be in a non-stretched state so that both prongs interface with the nares of the user. Where an instrument is to be inserted, the expandable region formed from elastic material may be stretched to an extended position and held in the extended or stretched position by a dermal patch that is attached to the user's face. The cannula may be held in the stretched state by a dermal patch as described above. Alternatively, the cannula may comprise a frame that defines an extended position and a retracted position. For example, in the expanded condition (
(82) The embodiments described with reference to
(83) In some embodiments, a patient interface such as a cannula or face mask may be adapted to interface with an airway instrument, for example a scope or diagnostics instrument, or an airway tube or conduit. To interface with an airway instrument a cannula may comprise a guiding channel to receive and guide the instrument. For example, as illustrated in
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(85) A face mask (e.g. nasal mask or full face mask) includes a seal to seal against the face of a user. In some configurations, a face mask may have thinned portions in the seal on one side or on all sides. The thinned portions in the seal allow for a tube or other airway instrument to be inserted, and may allow for a seal to be created over the tube or instrument. The thinned portion of the seal may be more malleable and pliable and hence may conform to the shape of the tube while still maintaining a seal. The tube may be a nasogastric tube (NG or NT tube, e.g., a tube inserted through the nostrils).
(86) Patient interfaces may have entry ports for instruments to be inserted through the interface and into a patient's airway. For example, as shown in
(87) In some embodiments, as illustrated in
(88) The various embodiments described above may be particularly suitable for use with a range of instruments or airway instruments, including airway tubes or conduits, oral or nasal catheters, drug (medicament) delivery devices (eg: spray bottle, atomiser device, syringe), surgical instruments including spatulas, introducers/bougies, stylets, guides, tube exchangers, oral/nasal endotracheal tubes, nasopharyngeal airways (nasal trumpets), and scopes or diagnostics instruments such as laryngoscopes (direct or video) endoscopes, rigid or flexible bronchoscopes, esophagoscopes and fibreoptic scopes.
(89) A patient interface 230, such as a nasal cannula, may comprise of a port 232 for delivery of a medicament into a flow F of a fluid (such as a gas) being delivered to a user and/or for interfacing with a medicament delivery device or an instrument. When a delivery device (dispenser) interfaces with a patient interface (e.g. nasal cannula) the dispenser may be used to dispense medicament into a flow path (e.g. a patient's airways) with or without a flow of fluid applied to the patient's airways via the cannula.
(90) The medicament may optionally include one or more excipients, such as pharmaceutically acceptable excipients. Such a medicament may be those suitable for being administered to the airway of a user, whether as an atomised, nebulised or dispersed or other form suitable to be introduced into a flow of gas for administration and/or delivery to a user.
(91) In some configurations, the port 232 may allow an instrument 1000 (e.g. a tube) or a medicament dispenser 234 (e.g. a spray bottle, atomiser device or syringe) to be insert thereto for dispensing of said medicament. For example, the port 232 may be located upon a manifold part 236 of the interface 230 such that dispensing of the medicament provides for dispersal into a relatively high flow rate of gas provided to the user, and which can carry the medicament into an airway of the user. For example, see
(92) Other instruments that the port 232 may be adapted to interface with include airway tubes or conduits, introducers/bougies, stylets, guides, tube exchangers, and scopes or diagnostics instruments such as endoscopes, rigid or flexible bronchoscopes, esophagoscopes and fibreoptic scopes.
(93) Alternatively, in still further embodiments, the port 232 may be provided upon one prong or as a feature of or integrated as a part of a pair of nasal prongs 233. For example, see
(94) In some configurations, the patient interface 230 may comprise of a shaped or otherwise moulded region 237 suitable for accepting or receiving or locating or seating of a medicament dispenser 234 or instrument 1000 to the interface 230. For example, in this manner a dispenser 234, such as a syringe, may be seated for greater or more accurate placement or control of its placement relative to the interface 230 which is located upon the user. A depression 237 in a manifold part 236 may be provided for such a seating or location of an instrument 1000 and/or a dispenser 234. For example, see
(95) In some configurations, the port comprises a closable opening 235 (e.g. shown in
(96) In some configurations, the port 232 may further comprise of a director or guide 238. The director or guide 238 may be used to direct an instrument more accurately, for example towards or up through a nasal prong 233, for example as shown in
(97) In some configurations, the port 232 may provide for an opening which provides for a relatively rigid component 239 (compared with other parts of the patient interface) to support an device 1000 or a dispenser 234 (e.g. such as a syringe tip) upon insertion or entrance to the port 232 (such as a port provided upon a manifold). Such a relatively more rigid component 239 can allow for a user to apply a force against the port 232 while inserting an instrument or undertaking a dispensing of medicament (or at least configuring such a dispenser relative to the interface and/or user for subsequent dispensing a medicament). Provision of a relatively more rigid component 239 may assist in a positive and/or more defined or more secure location or a more positive seating of an instrument or a dispenser 234 to the interface 230 and port 232. A nasal cannula may comprise a resilient material for contacting the user, beneath the user's nose and/or the user's nares. For example nasal prongs are preferably formed of a resilient material to be inserted into the user's nares. In some embodiments, the relatively more rigid component is more rigid than the resilient material of the cannula. In some embodiments the rigid component 239 may be integrated into the cannula by overmoulding of the resilient material of the cannula.
(98) In some configurations, the port comprising a relatively more rigid component provides for a pre-determined angle of insertion by the instrument or the dispenser to the port. In this manner, such a relatively rigid component requires a device (e.g. instrument or dispenser) to be successfully inserted to the port at a particular angle, such an angle may be that which may more accurately allow insertion of the instrument or dispenser or delivery of the medicament.
(99) In some alternative configurations, the port 232 may comprise of a relatively softer or more flexible or compressible component that seals over the port 232 when not in use. Such a component can optionally provide for a seal about an instrument or a dispenser 234 or parts of the dispenser 234 (e.g. such as the tip of a syringe) when the instrument/dispenser 234 is inserted into the port 232. A seal may help minimise or reduce leaks between the device and the port 232 when they are operationally engaged, optionally particularly so during a medicament dispensing operation.
(100) In some embodiments, the port 232 may be covered by a relatively elastic or elasticated cover material that stretches when the instrument/dispenser is inserted and allows extension. Such a cover may provide for a seal. A small cut or opening in the end of the elastic or elasticated cover is normally in a closed configuration and can seal the port 232 when relaxed, preventing leak; and when an instrument/dispenser is inserted into the port 232 and pushed through the elastic or elasticated cover, the cut or opening may be stretched over the end of the instrument/dispenser, thereby being opened sufficiently to allow for the instrument or dispenser to be inserted and/or medicament to be dispensed/deposited through it.
(101) In still further alternative configurations, the port 232 may be formed of a relatively more rigid component or a material covered by, or surrounded by at least one layer of a relatively compressible material. In this manner, when the instrument or dispenser is inserted into the port 232, the relatively softer or compressible materials could be compressed or be conformable to the shape of the immediate surfaces of the instrument or dispenser, thereby assisting to promote a sealing around the instrument or dispenser. This can allow for the instrument or dispenser to remain substantially supported by the relatively more rigid component 239 or the structure underneath, yet provided with a sealing capability about a perimeter or other portion of the port 232 which becomes engaged or operatively in contact with the instrument or dispenser.
(102) In some embodiments, the port 234 is adapted or configured to allow for a relatively long, thin instrument or medicament dispenser, such as a conduit or tube, to be inserted or to be ingressed into the port 232. Such a dispenser can then be extended to project along at least a length of or through the flowpath of the patient interface 230 or a component such as a gas supply conduit associated with the interface 230. Optionally, such a medicament dispenser may terminate at the outlet from one or more of said nasal prongs 233, alternatively such a medicament dispenser may terminate within the nasal cannula (i.e. upstream of the outlet from one or more nasal prongs) or may terminate at a position beyond the outlet of the one or more nasal prongs 233 (i.e. downstream of the outlet from the one or more nasal prongs). In some configurations outlet of the dispenser may terminate at a small distance beyond the outlet of a nasal prong downstream of the nasal cannula. For example, a small distance may be a distance that is less than an internal diameter of the outlet of the nasal prong, or less than twice the internal diameter of the outlet of the nasal prong, or a distance less than half the length of the nasal prong.
(103) In some embodiments the nasal cannula may comprise a medicament supply tube that extends from the port so that medicament may be delivered further downstream from the port 232, for example, as illustrated in
(104) In an alternative embodiment as shown in
(105) As shown in
(106) Preferably the supply tube 243 comprises a small diameter outlet 243a, such that the outlet operates as a nozzle or spray nozzle to assist with dispersing the medicament into a flowpath of the cannula or the patient's airway, either with or without a flow of gases provided by the cannula. For example, the supply tube may have an outlet with an internal diameter of less than 2 mm, or less than 1 mm. The diameter of the supply tube outlet is preferably substantially smaller than the internal diameter of a nasal prong. For example, the nasal prong may have an internal diameter of 4 mm or 5 mm or greater than 5 mm. The internal cross sectional area of the spray tube outlet may be less than 20% or 10% of the internal cross sectional area of the outlet of a nasal prong of the nasal cannula. In a preferred embodiment the tube 243 has a small diameter relative to the internal diameter of the nasal prong. In some embodiments the tube 243 has a constant cross section along its length. Preferably the spray tube is formed of a relatively rigid material to retain its shape during use, for example a curved shape to correspond with a curvature of the nasal prong 233.
(107) Alternatively, in some further embodiments, connection or insertion of a dispenser to the port 232 may promote a protrusion (e.g. such as a lumen provided) to extend along and through one or more nasal prongs 233. In such a manner, there can be allowed for a deposition of a medicament further downstream from the port 232, or alternatively closer to the airway of a user. For example, if a long dispenser is instead used rather than a syringe tip (i.e. as was used in
(108) In some embodiments, insertion of the dispenser may promote a protrusion 2310 to extend from the port 232 (e.g. at least as an extension through the nasal prong 233). See for example
(109) In some embodiments, when in an extended position, the protrusion 2310 allows for maintenance of the flowpath through the cannula or of a flow of gases to one or a pair of nasal prongs 233 of the cannula 230. In yet other embodiments, when in an extended position, the protrusion 2310 may engage with one or a pair of nasal prongs 233 or the flowpath to one or each said nasal prong 233 so as to block a flow of gases to one both nasal prongs of a pair of nasal prongs.
(110) Alternatively the insertion of the dispenser 234 may promote a protrusion 2310 to extend into a nasal prong 233 or a flowpath associated with a nasal prong, blocking the flow of gases to the user via that flowpath. See for example
(111) There may be a relatively high force required to cause the protrusion 2310 to extend. If the user wishes to allow high flow to continue during medicament delivery the user may insert the dispenser along the protrusion 2310 but not push so hard as to cause the protrusion to extend and block the flowpath through the cannula. The protrusion may be formed to tighten onto the dispenser when the dispenser is inserted into or through the protrusion. In this way, when the dispenser is retracted back through the protrusion to remove the dispenser from the nasal cannula the protrusion is pulled back to its original, unblocked position. For example, the protrusion may be formed from a soft/and or compressible or resilient material that tightens around the dispenser when inserted.
(112) In some embodiments, a scavenging mechanism or system may be utilised in conjunction with the patient interface 230 as described herein. Such a system may be utilised to collect exhaled gases from a user, including exhaled medicament which has not been absorbed or taken-up by the user. Such a system may comprise a recirculation system including filtration, for re-delivery of the collected gases and medicament to the user. Such a mechanism attached to the patient interface could cover the user's mouth and/or nose to prevent medicament being exhaled back into a room. In particular, such a mechanism or system: could use a one way valve attached to additional conduit that delivers that exhaled flow back to the system could allow the system to ‘scrub’ the excess medicament from the gas flow, thereby assisting in minimising wastage could be embodied in a face mask that is placed over a nasal cannula—such a face mask may be placed on the user during medicament delivery times.
(113) In some embodiments, a nasal cannula may be designed to have one or both prongs 233 relatively long, such that they extend relatively deep into the user's nasal cavity. Optionally, one or both nasal prongs may be curved to conform to nasal geometry, for example this may allow for improved capabilities of successfully delivering administered medicament into the user's airway.
(114) In various alternative configurations, one or both of a pair of nasal prongs may be extendable or comprises portions which are extendible in length, such as a protrusion 2310. For example, a nasal prong may comprise of an inner secondary prong portion, such as a protrusion 2310 which may comprise of corrugations or concertina-type sections which can be extended to lengthen and allow such a secondary prong to project further than a main nasal prong into a user's airway. Such an extended secondary prong may be utilised as a protrusion for improved for extending of the flowpath for delivery of medicament to a user's airway. In various instances, see
(115) In some embodiments, the port 232 may be a guiding channel or other shaped accommodation region for allowing improved access to the nares by a dispenser 234 without affecting the delivery of respiratory support. For example, the port may be a channel 203 in an outer surface of the prong as described above with reference to
(116) In some configurations there is a pre-formed medicament dispenser pre-loaded with medicament for use with the patient interface as described above.
(117) In some embodiments, the dispenser 234 may be pre-formulated with a pre-determined quantity of medicament in a ready-to-dispense configuration. For example, lignocaine may be provided in a dispenser 234 in a pre-determined quantity for administration to a user.
(118) In some embodiments, the dispenser may be provided with the cannula to ensure correct fit with the port(s). Or an attachment/adaptor may be provided to fit to existing dispensers, for example to attach to the end of a syringe.
(119) In some embodiments, the patient interface 230 may comprise of a reservoir 2312 for receiving and/or storing of a medicament. In other embodiments, the reservoir 2312 may be actuated manually or by other forms (e.g. such as by an electronic dosing or administration arrangement which allows for release of the medicament from the reservoir into the flowpath for delivery to the user). The reservoir may be permanently attached and refillable by the user, or be detachable and attached when desired.
(120) Where the dispensing of medicament may be manually actuated by a user, this may for example be by way of a button on the interface or by depressing a syringe plunger. Such actuation can allow for the release of the medicament from the reservoir 2312.
(121) In one example, actuation may result in the medicament being forced or encouraged to release out of reservoir and into the flowpath of the interface or a flowpath associated with the interface (e.g. that of a gas supply conduit). For example in
(122) As high gas delivery flow rates may be used, the medicament may be carried in the gas stream to the user's airway.
(123) For example, according to those various embodiments and configurations described herein, a flow rate of gases supplied or provided to an interface or via a system, such as through a flowpath, may comprise, but is not limited to, flows of at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 L/min, or more, and useful ranges may be selected between any of these values (for example, about 40 to about 80, about 50 to about 80, about 60 to about 80, about 70 to about 100 L/min, about 70 to 80 L/min).
(124) Such relatively high flowrates of gases may assist in providing the supplied gases into a user's airway, or to different parts of a user's airway, for example such flowrates may allow for a delivery of such gases to the upper, middle or lower airway regions.
(125) Such relatively high flowrates can assist to, in combination with a medicament delivered to the flowpath or the flow of gases being delivered to the user, provide assisted delivery of medicament to a user's airway, or different parts of a user's airway. For example, such relatively high flowrates may effectively help drive or push medicament further into a user's airways than under normal respiratory conditions by the user.
(126)
(127) If liquid medicament is used, the gas flow may help to partially nebulise the medicament into smaller particles that can carry further down the airway. A valve may be provisioned to sit between the reservoir and a main gas supply conduit, such that the valve is normally closed. However, actuation of the reservoir may be used to put the valve under pressure (e.g. by squeezing or button actuation (not shown)) with the valve consequently opening and allowing the medicament to be made available for release into the gas stream (see
(128) In alternative configurations, the medicament in the reservoir 2312 may be released or made available to the flowpath by actuation of a negative pressure in the flowpath, thereby opening a valve or other member which may be sealing the reservoir from the flowpath. For example, if the patient were asked to inhale deeply a valve or seal can be opened and medicament released. The valve or seal may be designed such that normal tidal breathing does not create enough negative pressure to open it. In this way medicament delivery can also be timed with inspiration, avoiding wastage and encouraging the medicament to travel further down the airway particularly when the patient inhales deeply.
(129) In still further embodiments, where a valve or seal is used to close off the reservoir, the aperture of the valve may be designed to be small and create nebulised particles of a certain size that enable medicament delivery to a specific location.
(130) In other configurations, details of the above embodiments could be applied here as well however the medicament may be delivered via another channel, not necessarily through the nasal prongs. Such a channel may be sized differently to the prongs e.g. may have a smaller internal diameter to create high gas/medicament velocities and effectively jet medicament further down the user's airway than the prongs might otherwise be able to achieve. The channel could use gas delivered via a sidestream or other source of gas from the main gas flow, a separate gas flow or from another pressurized source, for example an aerosol canister, or may not deliver gas and only be used as a medicament delivery port. In this manner: there could be multiple channels for delivery of medicament (e.g. different medicament through each separate channel). a different medicament could be delivered through each channel, or prong, at the same time. flow through each channel/prong could be independently controlled to manage each medicament concentration or administration separately.
(131) In other configurations, the port 232 that dispenses the medicament (e.g. whether the port is located on the patient interface or as a port on a conduit associated with the gas flow) could be designed so that when liquid medicament is dispensed through it, the medicament is atomised. For example, inside one or each nasal prong 233 there could be serrations/ribs or walls/partitions 242 as shown in
(132) According to the configuration above, reducing particle size of the medicament being dispensed to a user can aid the medicament to be carried in the gas flow and delivered to the user. For example, the force of a depressed syringe containing liquid medicament or an automated piston, depressing the medicament through the features could be used to create the atomization or nebulisation (i.e. turning the medicament into particles or reducing medicament particle size). As such, nebulised or reduced particle sizes could be sized to target deposition at the larynx, or other desired locations depending on the target for the medicament.
(133) In some configurations, the port 232 on the interface 230 could comprise a single aperture but sized so as to cause nebulisation or atomization of liquid medicament when it is administered into and dispensed therefrom (i.e., the port may have a relatively small exit aperture through which dispensed medicament must pass, e.g. less than 1 mm diameter). For example, as shown in
(134) In some configurations, the reservoir 2312 may be provided as a part of the patient interface, or may be associated with a gas supply conduit (e.g. that conduit supplying gas to the patient interface) or may be provided as a reservoir at a source device for providing a gas flow to the patient interface. It will be appreciated the medicament may be delivered via main gas path or could be provided via a separate conduit up to interface.
(135) Dispensation of medicament can be controlled via mechanically actuated valve or by software. (e.g. mechanical actuation or may be electronically controlled).
(136) In various configurations, the delivery or dispensing of medicament can be timed to coincide with a user's inspiration, or a part of the inspiratory phase, to avoid wastage during exhalation phase of breath. As such, delivery of medicament may be timed to occur at the peak of inspiration to ensure the most flow possible is travelling down the user's airway and to encourage deep deposition. For example, if medicament delivery was desired during inspiration a population average of inspiratory pressures could be determined and a valve associated with the reservoir designed to open at pressures below this value. Medicament could be actuated by a pressure in a main gas conduit, or if a separate line was run next to the main gas conduit and terminated in the user's nares, then this could also be triggered in a similar way.
(137) Alternatively, the inspiration phase could be detected by measuring the interface pressure or pressure at some place in the system and the medicament delivery could be activated (e.g. by opening a valve, controlled by software) when the pressure falls below a pre-determined value, such as the (rolling) average. A pressure below the average pressure would indicate the user is causing a reduction in the pressure in the system and is therefore inspiring. The average could be calculated over a set number of breaths (e.g. 5 breaths) or time (e.g. 1 minute).
(138) In other configurations, if the medicament delivery conduit does not have gas flow through it the release of medicament could be activated via an additional electrically activated piston or other release system. Alternatively, delivery could be timed to activate with a certain inspiratory flow rate that matches a flow most likely to carry the medicament down the airway to deposit at the vocal cords (or other desired location). More specifically, if the medicament were delivered as part of the main gas flow, the gas flow could also be controlled to meet inspiratory demand to avoid wastage of medicament with high flow rates in excess of the inspiratory demand and to ensure delivery of the correct amount of medicament.
(139) In yet other configurations: High flow rates may be used to deliver dry powder medicaments. This may be desirable for depositing medicament in the nasal airway where blood flow is high and medicament may be quickly absorbed into the blood stream via the thin epithelium layer. An anti-coagulant may be added to powders. This may prevent the powder from caking and potentially blocking the medicament delivery port. This may be particularly important when the powder is delivered via a humidified gas conduit.
(140) Alternatively the powder may be delivered via a separate conduit that may use the same gas source as the main gas supply, or a side-stream supply of it, but is not humidified.
(141) Delivery via other airway equipment may be utilised, for example an attachment could be fitted to end of a laryngoscope to allow for delivery of medicament into a user's airway without requiring an additional medicament delivery device (e.g. atomiser or nebulisers etc.).
(142) Still further, in other configurations it may be possible to: Coat the medicament in a chemical that has a half life that degrades after set time (e.g. if it is known that at 70 litre per minute it takes 0.5 seconds for flow to reach the larynx, use a coating that will degrade sufficiently after 0.5 s). Coat the medicament in a chemical that degrades on contact with preferential tissue or materials, such as vocal cord tissue. For example, the vocal cords epithelium is stratified squamous epithelium. This type of epithelium is also present in the oral cavity and the nasal vestibule; however the rest of the conducting portion is lined by respiratory epithelium. If medicament is delivered via a nasal cannula, this avoids the oral cavity. If the delivered medicament is delivered at sufficient velocity and in a manner directed past the nasal vestibule, the majority of it should get past the nasal vestibule. Hence it may pass down to the vocal cords before coming in contact with any other stratified squamous epithelium, and deposit at this location. Nasal prong length could be extendable or adjustable for delivery of medicament further into airway. For example, with corrugations at the base of a nasal prong, similar to
(143) Another embodiment is explained in
(144) In further configurations: Medicament could be delivered as (gas-filled) bubbles. Bubbled delivered through prongs or additional medicament delivery channel. Prong diameter, or medicament channel diameter could be sized to control the diameter of the bubbles and encourage deposition at the larynx, or other location. Medicament bubbles could be delivered orally. The airway has a decreasing cross-section diameter as it extends towards the vocal cords from the mouth if the patient's mouth is open wide. Thus if the patient is asked to keep their mouth open and the bubble diameter is the same size as the trachea at the position of the vocal cords, the bubbles may travel down the airway and burst only at the vocal cords as they come into contact with an area the same size as them, depositing the medicament there.
(145) The medicament could be delivered via a coaxial conduit. The liquid medicament is pushed along the outer layer and flow is passed through the centre. The liquid medicament may form a film over the end of the conduit (e.g. prongs) when no flow is passed through it. When flow is re-started this may allow a bubble to form at the end and be pushed along with the gas stream. As an example, if two conduits are used (e.g. separate gas supply to a pair of nasal prongs) the flow may be delivered alternately through each conduit and a film may be able to form over the other conduit when flow is not delivered. Bubbles can thus be delivered alternately from each conduit/prong.
(146) Bubbles may be filled with a composition of gases that target deposition in a certain location. For example helium, nitrogen, and/or oxygen may be used to create a stokes number that targets deposition on the vocal cords taking account of the flow rate, medicament composition and particle drag, and oral/nasal anatomy.
(147) In further configurations: Once a user is reclined the medicament may delivered via a liquid bolus (rather than aerosolized). If the bolus is delivered while the patient is supine the effect of gravity may allow the medicament to flow down the back of the throat to the vocal cords.
(148) The foregoing description of the invention includes preferred forms thereof. Modifications may be made thereto without departing from the scope of the invention.
(149) The term “comprising” as used in this specification and claims means “consisting at least in part of”. When interpreting each statement in this specification and claims that includes the term “comprising”, features other than that or those prefaced by the term may also be present. Related terms such as “comprise” and “comprises” are to be interpreted in the same manner.
(150) To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting.
(151) The invention consists in the foregoing and also envisages constructions of which the following gives examples only.