WO2024084445A1 - Tube médical - Google Patents

Tube médical Download PDF

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Publication number
WO2024084445A1
WO2024084445A1 PCT/IB2023/060597 IB2023060597W WO2024084445A1 WO 2024084445 A1 WO2024084445 A1 WO 2024084445A1 IB 2023060597 W IB2023060597 W IB 2023060597W WO 2024084445 A1 WO2024084445 A1 WO 2024084445A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
medical tube
medical
wall
support structure
Prior art date
Application number
PCT/IB2023/060597
Other languages
English (en)
Inventor
Elmo Benson Stoks
Thomas James Edwards
Leo McKenzie RODGER
David Johnathan Seymour Graham
Jason Allan KLENNER
Brent Ian Laing
Kevin Blake Powell
Fadi Karim Moh'd MASHAL
Michael Paul Ronayne
David VAN BOKHOVEN
Matthew Joseph LUCAS
Michael John ANDRESEN
Sean Alexander CRAIG
Suzanne Marie BELL
Original Assignee
Fisher & Paykel Healthcare Limited
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
Application filed by Fisher & Paykel Healthcare Limited filed Critical Fisher & Paykel Healthcare Limited
Publication of WO2024084445A1 publication Critical patent/WO2024084445A1/fr

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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875—Connecting 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • 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. mouth-to-mouth respiration; 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0833—T- or Y-type connectors, e.g. Y-piece
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/105—Filters
    • A61M16/106—Filters in a path
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • 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
    • A61M2205/75—General characteristics of the apparatus with filters

Definitions

  • the present disclosure relates to a medical tube and, in particular, a medical tube for conveying a gas to a patient.
  • This disclosure also relates to a patient gas delivery system.
  • Various medical tubes are available for conveying a breathable gas to a patient.
  • some medical tubes provide a corrugated monolithic polymer wall to assist in delivering a breathable gas to a patient.
  • Other medical tubes provide a polymer membrane, supported by a reinforcing bead, to deliver a gas to a patient.
  • these traditional tubes are applied in a relatively generic manner and are not tailored to particular applications. This can lead to, for example, less desirable patient experiences.
  • the connector portions associated with medical tubes may be press fit, glued, fastened or overmoulded onto a tube wall. These assembly processes may be time consuming, adding to the cost of the tubes. Furthermore, some assemblies may leak and/or mechanically fail, given the nature of the connection between the connector and tube wall, which provides a number of issues.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; a support structure together with the barrier forming a tube wall, such that a lumen is provided; and a connector configured to connect to a device in order to allow gas flow within the lumen, wherein at least part of the connector is integrally formed with the support structure.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; and a support structure together with the barrier forming a tube wall, such that a lumen is provided for gas flow, wherein the tube wall comprises differences in mechanical properties therealong.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; and a support structure together with the barrier forming a tube wall, such that a lumen is provided for gas flow, wherein the barrier encapsulates the support structure.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube including: a barrier; and a support structure, the support structure being configured to interact with the barrier to assist in defining a tube wall, wherein the support structure includes one or more tube-wall shaping members connected to one or more connecting members to assist in resisting a Brazier effect.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; and a support structure together with the barrier forming a tube wall, such that a lumen is provided for gas flow, wherein the support structure comprises differences in mechanical properties therearound.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; and a support structure together with the barrier forming a tube wall, such that a lumen is provided for gas flow, wherein the support structure comprises a visual indicator to provide connection indicia.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; a support structure together with the barrier forming a tube wall, such that a lumen is provided; and a patient interface, wherein at least part of the tube wall is integrally formed with at least part of the patient interface.
  • the present disclosure provides a medical tube for conveying a gas to a patient, the medical tube comprising: a barrier; a support structure together with the barrier forming a tube wall, such that a lumen is provided; and an accessory, wherein at least part of the tube wall is integrally formed with the accessory.
  • the accessory may be a coupler.
  • the coupler may be a tube clip.
  • the coupler may include an engagement portion.
  • the engagement portion may be configured to engage with a patient interface.
  • connection indicia may assist in determining an orientation for connecting.
  • connection indicia may include a colour and/or shade.
  • the colour and/or shade may be different to surrounding colour and/or shades of the medical tube.
  • the support structure may provide one or more apertures transverse to the gas flow.
  • the tube wall may include an outer shape, wherein the outer shape is varied to provide differences in mechanical properties.
  • the outer shape has an associated cross section and the associated cross section may vary to provide differences in mechanical properties.
  • the outer shape may vary with respect to a longitudinal axis of the tube wall.
  • the outer shape may include a taper to provide differences in mechanical properties.
  • the taper may provide a portion of a first cross sectional area that is larger than another portion of a second cross sectional area.
  • the support structure may include one or more members.
  • the one or more members may vary to provide differences in mechanical properties.
  • the one or more members may include at least one member where its size varies over its length.
  • the one or more members may include one set of members that are located outboard, in a direction away from a central axis, compared to another set of members.
  • the one or more members may assist in defining the outer shape.
  • the one or more members may be integrally formed.
  • the one or more members may include a plurality of members that provide a skeletal- type structure.
  • the one or more members may include one or more tube-wall shaping members and/or one or more bridging members.
  • the one or more tube-wall shaping members may be annular.
  • An inner shaping surface of the one or more tube-wall shaping members may be different to an outer shaping surface of the one or more tube-wall shaping members.
  • the inner shaping surface may be substantially planar in a direction parallel to the longitudinal axis of the tube wall.
  • the one or more tube-wall shaping members may extend at an oblique angle to the longitudinal axis of the tube wall.
  • a thickness of the one or more tube-wall shaping members may vary along the tube wall.
  • a pitch of the one or more tube-wall shaping members may vary.
  • the pitch may vary with respect to the longitudinal axis of the tube wall.
  • the pitch may be measured at a unstretched state of the tube wall.
  • the one or more bridging members may connect the one or more tube-wall shaping members together.
  • a number of the one or more bridging members connecting to the one or more tube-wall shaping members may vary between regions of the tube wall.
  • the one or more bridging members may connect to the one or more tube-wall shaping members in: a first orientation; and a second orientation, wherein the first orientation is different to the second orientation.
  • the first orientation may be in a first area and the second orientation may be in a second area.
  • the first orientation may be approximately 90 degrees offset from the second orientation.
  • the one or more bridging members may include at least two bridging members providing a connection between parts of the one or more tube-wall shaping members.
  • the at least two bridging members may be positioned on opposite sides of the tube wall to each other.
  • the one or more bridging members may extend in a linear direction.
  • the one or more bridging members may extend parallel to the longitudinal axis of the tube wall.
  • a region of the support structure may favour bending about a side thereof where the one or more bridging members are omitted.
  • the region of the support structure may be constrained in bending about a further side thereof due to the one or more bridging members.
  • the support structure and barrier may define a second lumen for gas flow.
  • the second lumen may be adjacent, nested, coaxial, partitioned and/or colinear with the lumen.
  • the support structure may be resiliently biased to conform to a first curvature along a length of the tube wall.
  • the support structure may include a first region and a second region.
  • the first region may be configured with a first flexibility and the second region may be configured with a second flexibility.
  • the second flexibility may be greater than the first flexibility.
  • the first region and the second region may have different radial compliance.
  • the first region may be configured to bend in a first direction with respect to a first plane and the second region is configured to bend in a second direction with respect to a second plane.
  • the first direction and the second direction may be different.
  • the first region may be constrained from bending in the second direction and/or the second region may be constrained from bending in the first direction.
  • a structure of the first region may be different to a structure of the second region.
  • the barrier may encapsulate the support structure in a manner to mechanically position the support structure in place.
  • a portion of the barrier may be configured to rotate with respect to a portion of the support structure.
  • a thickness of the barrier may be approximately between 10pm to 200pm.
  • a thickness of the barrier may be adjusted along the tube wall.
  • the barrier may be a breathable material.
  • a connector may be integrally formed with the support structure.
  • the connector may include a swivelling connector.
  • One end of the tube wall may include the swivelling connector.
  • the support structure may connect to a manifold.
  • the manifold may form part of a patient interface.
  • the support structure may comprise a connector at a second end that is configured to connect to a patient interface and/or medical device.
  • the connector at the second end may be integrally formed with the support structure.
  • the medical tube may further include a filter.
  • the filter may be integrally formed with the tube wall.
  • the tube wall may include one or more vents.
  • the one or more vents may include an exhalation port.
  • the exhalation port may include a non-linear surface at one end.
  • the tube wall may comprise two or more limbs.
  • the tube wall may comprise three or more limbs.
  • a size of one limb may be different to a size of another limb.
  • the size of the one limb or the another limb may relate to a diameter, cross-sectional area and/or length.
  • the diameter may be an internal diameter.
  • the diameter may relate to an internal diameter of the one limb and/or the another limb.
  • One limb may include a different connector to another limb.
  • the support structure and barrier may assist in defining at least three lumens.
  • the tube wall may be configured to collapse and/or expand from a first configuration to a second configuration.
  • the support structure assists in forming one or more frustoconical portions.
  • the one or more frustoconical portions may be configured to collapse and/or expand.
  • the one or more frustoconical portions may include two frustoconical portions, whereby the size of the two frustoconical portions may be different.
  • the barrier may have a biasing crease.
  • the biasing crease may promote deflection into or out of the lumen during tube bending or water absorption.
  • the present disclosure provides a patient gas delivery system, the system including one or more of the medical tubes as herein described.
  • the one or more medical tubes may include a plurality of medical tubes.
  • the system may further include a patient interface connected to the one or more medical tubes.
  • the patient interface may be a nasal cannula, a mask and/or a insufflation tube.
  • the mask may be in the form of a continuous positive airway pressure (CPAP) mask.
  • CPAP continuous positive airway pressure
  • Figure 1 illustrates a perspective view of a medical tube for conveying a gas to a patient, according to an example of the present disclosure
  • Figure 2 illustrates a perspective view of a support structure of the medical tube shown in Figure 1 ;
  • Figure 3 illustrates a close up view 'A' of the support structure shown in Figure 2;
  • Figure 4 illustrates a close up view ' B' of the support structure shown in Figure 2;
  • Figure 5 illustrates an end view of the support structure shown in Figure 2;
  • Figure 6 illustrates a cross sectional side view of the support structure, taken across line C-C in Figure 5;
  • Figure 7 illustrates a perspective view of the support structure, shown in Figure 1, including reference planes;
  • Figure 8 illustrates a partial cross sectional view of the medical tube shown in Figure 1;
  • Figure 9 illustrates a perspective cross sectional view of a further support structure, according to an example of the present disclosure.
  • Figure 10 illustrates an end view of a first multiple lumen arrangement, according to an example of the present disclosure
  • Figure 11 illustrates an end view of a second multiple lumen arrangement, according to an example of the present disclosure
  • Figure 12 illustrates an end view of a third multiple lumen arrangement, according to an example of the present disclosure
  • Figure 13 illustrates an end view of a fourth multiple lumen arrangement, according to an example of the present disclosure
  • Figure 14 illustrates a perspective view of bifurcated medical tube, according to an example of the present disclosure
  • Figure 15 illustrates a perspective view of a further bifurcated medical tube, according to an example of the present disclosure
  • Figure 16 illustrates a front view of a patient gas delivery system, according to an example of the present disclosure
  • Figure 17 illustrates a front view of a medial tube incorporating a filter, according to an example of present disclosure
  • Figure 18 illustrates a perspective view of the medical tube in Figure 17 connected to a patient interface, according to an example of the present disclosure
  • Figure 19 illustrates a perspective view of a medical tube, in a first configuration, according to an example of the present disclosure
  • Figure 20 illustrates a perspective view of a medical tube, in a second configuration, according to an example of the present disclosure
  • Figure 21 illustrates a front partial view of the medical tube in Figure 20
  • Figure 22 illustrates a partial view of the members shown in Figure 21 ;
  • Figure 23 illustrates a perspective view of a medical tube including a patient interface, according to an example of the present disclosure
  • Figure 24 illustrates a perspective view of a patient gas delivery system, according to an example of the present disclosure
  • Figure 25 illustrates a front view of a connecting part as shown in Figure 24
  • Figure 26 illustrates a perspective view of a medical tube, according to an example of the present disclosure
  • Figure 27 illustrates a cross sectional view of the medical tube as shown in Figure 26;
  • Figure 28 illustrates a cross sectional end view of the medical tube as shown in Figure 26;
  • Figure 29 illustrates a partial view of the cross sectional view shown in Figure 27, according to an example of the present disclosure
  • Figure 30 illustrates a further cross sectional end view of the medical tube as shown in Figure 26;
  • Figure 31 illustrates a perspective view of a further medical tube, according to an example of the present disclosure
  • Figure 32 illustrates a cross sectional view of the further medical tube shown in Figure 31 ;
  • Figure 33 illustrates a partial cross sectional view of a medical tube, according to an example of the present disclosure.
  • Figure 34 illustrates a partial cross sectional view of a further medical tube, according to an example of the present disclosure
  • Figure 35 illustrates a perspective cross sectional view of a further support structure, according to an example of the present disclosure.
  • Figure 36 illustrates a perspective view of a multi-limb medical tube, according to an example of the present disclosure.
  • the present disclosure relates to a medical tube that can be tailored to provide a range of mechanical properties, including at both a structural and material level, to achieve better patient outcomes.
  • the stiffness, weight and strength of the medical tube may be varied along the tube to provide a better, tailored product.
  • FIG. 1 illustrates a perspective view of a medical tube 10a, according to an embodiment of the present disclosure.
  • the medical tube 10a includes a tube wall 100a and connectors 200a, 300a.
  • the tube wall 100a is formed from a supporting structure 1000a and a barrier 2000a.
  • the use of a reference numeral followed by a lower case letter in this specification typically indicates alternative embodiments of a general element identified by the reference numeral.
  • supporting structure 1000a is similar to but not identical to the supporting structure 1000b.
  • references to an element identified only by the numeral refer to all embodiments of that element. Accordingly, a reference to supporting structure 1000, for instance, is intended to include both the supporting structure 1000a and the supporting structure 1000b.
  • the tube wall 100a and connectors 200a, 300a provide a lumen 110a to carry a breathable gas to a patient.
  • a longitudinal axis 12 extends along the middle, central portion of the lumen 110a.
  • the tube wall 100a has an outer shape 120a. That is, the outermost parts and/or surfaces of the tube wall 100a define its outer shape 120a.
  • the outer shape 120a is tapered along the longitudinal axis 12. That is, a cross section of the tube wall 100a, in a transverse direction to the longitudinal axis 12, transitions from a larger area to a smaller area.
  • the tube wall 100a is continuously tapering along its length. In this regard, the tube wall 100a extends transversely to the longitudinal axis 12.
  • the narrowed portion closer to the patient may have relatively increased flexibility for useability whilst the larger flow area away from the patient reduces the potential pressure drop (or resistance to flow) of the tube 10a.
  • the sizing of tubes may be tailored to the relevant patient population. For example, small tubes on the face of small patients, such as neonatal and paediatric patients, are desirable but these increase the resistance to flow.
  • Connector 200a is located at one end of the tube wall 100a.
  • the connector 200a includes a connector body 210a.
  • the connector body 210a is substantially cylindrical in this embodiment.
  • the connector body 210a is configured to connect with a cylindrical body of another medical component.
  • the connector 200a may include a sealing surface for sealing with another medical component.
  • the connector body 210a may form a 'male' or 'female' connector.
  • the connector 200a may also form part of an assembly, including a patient interface, manifold or further connector including a swivelling component. On this basis, the connector 200a is configured to attach to, for example, another device and/or patient interface.
  • a protrusion 220a extends from the connector body 210a.
  • the connector 200a is integrally formed with the supporting structure 1000a.
  • the connector 300a is integrally formed with the supporting structure 1000a and located at an opposite end of the tube wall 100a.
  • the integration of the supporting structure 1000a and connectors 200a, 300a assists in reducing the likelihood of the connectors 200a, 300a from detaching from the tube 10a. This reduces the risk of pneumatic leaks and increases the ease of manufacturing.
  • the connector 300a includes a connector body 310a that is substantially cylindrical (like connector body 210a).
  • the connector body 310a has a smaller diameter / cross section compared to the connector body 210a.
  • the (cylindrical) walls of the connectors 200a, 300a extend in a substantially linear manner, parallel to the longitudinal axis 12.
  • FIGS 2 to 8 illustrate the supporting structure 1000a in further detail.
  • the support structure 1000a may be manufactured by, for example, injection moulding or additive manufacturing (including 3D printing). Other methods may be used which can provide a varying structure that comprises one or more areas/regions with a localised tailored response.
  • the supporting structure 1000a could be produced through extrusion in combination with segmenting by laser or other means to produce an analogous structure. That is, the support structure 1000a can be, for example, an extruded tube form which is subsequently segmented.
  • the support structure 1000a may be formed from a polymer, including thermoplastics and thermoset plastics.
  • the supporting structure 1000a is formed from nylon but, as mentioned, a range of polymers could be implemented (including thermoset plastics or a preferable thermoplastic). Overall, the support structure 1000a is uniquely different to prior art forms and is not, for instance, bound by two dimensional die shapes. Desirable properties for the material from which the supporting structure 1000a is formed include an appropriate elastic or flexural modulus, toughness (including recovery from crush), softness or hardness (including softness for patient contacting portions), optical transmission/transparency (including for condensate, sputum, and other foreign matter within the lumen), biocompatibility, rheology (for processing), reusability (including suitability for sterilisation and other such characteristics) and other such properties. In addition, desirable properties of the supporting structure (and barrier 2000a) may include end-of-life considerations (eg, recyclability, disposable etc).
  • the supporting structure 1000a includes a plurality of members 1100a.
  • the members 1100a form a skeletal-type structure. That is, (separate) members 1100a are linked together to form a framework.
  • the framework supports the barrier 2000a.
  • the members 1100a include tube-wall shaping members 1110a and bridging members 1120a in this embodiment.
  • tube-wall shaping members 1110a may, for example, be included alone.
  • the tube-wall shaping members 1110a may be, for example, tapered rings that are then sleeved with, or dipped in, a barrier 2000a as part of forming its overall structure.
  • a further example of these potential other embodiments is shown in Figures 19 and 20.
  • the tube-wall shaping members 1110a are substantially annular or ring-shaped.
  • the tube-wall shaping members 1110a include an inner shaping surface 1112a and an outer shaping surface 1114a.
  • the inner shaping surface 1112a extends around the longitudinal axis 12. In this manner, the inner shaping surface 1112a assists in forming a perimeter of the lumen 110a.
  • the inner shaping surface 1112a extends substantially parallel with the longitudinal axis 12 of the lumen 110a.
  • the barrier 2000a substantially forms the inner surface of the lumen 110a.
  • the outer shaping surface 1114a includes a curved area in a direction parallel with the longitudinal axis 12.
  • the inner and outer surfaces 1112a, 1114a are different in this embodiment. More specifically, a cross-section of each tube-wall shaping member 1110a, taken along the longitudinal axis 12, can be substantially D-shaped (as shown in Figure 8).
  • the dimensions and shape of the inner and outer shaper surface 1112a, 1114a may be varied depending on the application. For example, the thickness of the tube-wall shaping members 1110a may be increased or decreased depending on a desired structural strength.
  • the inner and outer surfaces 1112a, 1114a may provide a cross-section, for each tube-wall shaping member 1110a, which is triangular, square, trapezoidal, polygonal, circular, or any other shape.
  • the supporting structure 1000a provides a number of apertures 1116a.
  • the apertures 1116a are located: i) between portions of the tube-wall shaping member(s) 1110a; or ii) between separate tube-wall shaping members 1110a.
  • the apertures 1116a extend transversely to the gas flow through the lumen 110a. In this regard, the apertures 1116a extend in a direction towards the longitudinal axis 12.
  • the apertures 1116a extend peripherally about the support structure 1000a. In this embodiment, the apertures 1116a are partially annular. That is, the apertures 1116a are at least partially ring shaped.
  • the apertures 1116a also have a greater distance circumferentially around the tube 10a, in this embodiment, compared to their distance parallel with the longitudinal axis 12.
  • the bridging members 1120a in this embodiment assist in defining at least part of the apertures 1116a (as shown further in Figure 4).
  • the bridging members 1120a connect one or more of the tube-wall shaping members 1110a together.
  • the bridging members 1120a extend in a substantially linear manner. In this embodiment, the bridging members 1120a extend substantially parallel to the longitudinal axis 12. In further embodiments, the bridging members 1120a may extend transversely to the longitudinal axis 12.
  • the bridging member 1120a may extend in a direction that is at an oblique angle to the longitudinal axis 12.
  • the bridging members include a first end 1122a, which connects to a portion of one tube-wall shaping member 1110a.
  • a second end 1124a of the bridging members 1120a connects to a separate tube-wall shaping member 1110a but, in further embodiment, it may connect to a further portion of the same tube-wall shaping member 1110a.
  • this may occur when the tube-wall shaping member 1110a extends along an arcuate path or, for instance, the bridging members 1120a extend arcuately.
  • the members 1100a are differently arranged between a first region 1010a, a second region 1020a, a third region 1030a and a fourth region 1040a of the supporting structure 1000a.
  • the different arrangements and/or orientations of the members 1100a allow tailored mechanical properties to be achieved.
  • the fourth region 1040a (closer to a patient) may be more flexible compared to one or more of the other regions 1020a, 1030a, 1040a.
  • the stiffness of the tube 10a is greater further away from the connector 300a. This may be due to a variety of reasons, including the arrangement of bridging members 1120a (or the lack of bridging members 1120a closer to the patient).
  • the crush resistance, or radial compliance may also vary between regions of the supporting structure 1000a.
  • the stiffness, flexural strength, toughness and weight of the tube 10a may be varied and tailored to certain applications. This variation may, for example, be achieved by: i) changing the size, location and/or number of bridging members 1120a between the tube-wall shaping members 1110a; ii) changing the shape and/or size of the tube-wall shaping members 1110a; iii) changing the pitch of the tube-wall shaping members 1110a (the pitch being relative to the longitudinal axis 12 when the tube 10a is at a resting, unstretched state); and/or iv) changing the materials, in part or as a whole, of the bridging members 1120a and/or tube-wall shaping members 1110a.
  • a) Increasing thickness, density and/or axial alignment of bridging members 1120a may increase stiffness and flexural strength (dependent on the relative plane of bending). For instance, as the area moment of inertia of the bridging members 1120a increases due to a great thickness, the resulting stress in the bridging members 1120a will decrease, providing greater flexural strength. Similarly, bending stiffness will increase as the area moment of inertia of the bridging members 1120a increases. In addition, more bridging members 1120a helps distribute the force load associated with the tube 10a. Aligning the bridging members 1120a can also increase the stiffness / flexural strength in the aligned plane of the bridging members 1120a.
  • I ncreasing the thickness for the tube-wall shaping members 1110a may increase mechanical properties such as radial crush resistance and strength. For instance, in a similar manner to increasing the thickness of the bridging members 1120a, increasing the thickness of the tube-wall shaping members 1110a will increase the area moment of inertia of the tube-wall shaping members 1110a. This increases the strength and stiffness of the tube-wall shaping members 1110a and other mechanical properties such as crush resistance. Crush resistance may be considered the ability of the tube to resist applied force(s) which acts to reduce the cross-sectional area of the lumen. c) Increasing the pitch between tube-wall shaping members 1110a may increase flexibility of the tube 10a.
  • the supporting structure 1000a can provide tensile strength so a relatively thin barrier 2000a can be implemented.
  • the (tailored) supporting structure 1000a allows for a load path through the supporting structure 1000a to reduce the likelihood of barrier breakage etc.
  • a prior art tube may typically fail in a region adjacent to a connector portion owing to stress concentration resulting in transference of the load path from a connector to a barrier.
  • the supporting structure 1000a disclosed herein has a continuous load path through the supporting structure 1000a, between the connectors 200a, 300a, which reduces stress on the barrier 2000a.
  • the first region 1010a includes two bridging members 1120a between each of tube-wall shaping members 1110a.
  • the two bridging members 1120a are located at equidistant positions from each other around the tube-wall shaping members 1110a.
  • the two bridging members 1120a are substantially located at 180° from each other around the tube-wall shaping members 1110a.
  • the location / orientation of the bridging members 1120a alternates between adjacent tube- wall shaping members 1110a. That is, the location of two bridging members 1120a is offset 90° between each tube-wall shaping member 1110a.
  • the bridging members 1120a are located on: i) a left/right side of one side of a tube-wall shaping member 1110a; and ii) a top/bottom side of another side of the tube-wall shaping member 1110a.
  • the tube-wall shaping members 1110a closest to the connector 200a are integrally formed with the connector 200a, either directly or via integrally formed bridging member(s) 1120a.
  • the diameter of the tube-wall shaping members 1110a is larger closer to connector 200a compared to the connector 300a.
  • the first region 1010a is configured to bend along plane xz and plane yz, and all planes rotationally in between the xz and yz planes.
  • the first region 1010a bends, for example, into and out of line with the z axis.
  • the first plane 1012a extends in the same direction as the xy plane shown in Figure 7.
  • the alternating nature of the bridging members 1120a in the first region 1010a also constrains the ability to twist or extend the first region 1010a along the longitudinal axis 12. This ability to resist twist or extension may also allow for a thinner barrier 2000a.
  • a thinner barrier 2000a may be desirable compared to a relatively thicker barrier 2000a as it may, for example, increase breathability (where a breathable material is used), increase clarity, increase flexibility, and/or minimise material usage.
  • each pair of tube-wall shaping members 1110a is limited to movement relative to each other by pivoting about the opposing bridging members 1120a.
  • Each pair of tube-wall shaping members 1110a may form a unit and, as these units are connected together, the overall properties of a region are provided based on the nature and connection of these units.
  • the second region 1020a includes two bridging members 1120a between each of the tube-wall shaping members 1110a.
  • the bridging members 1120a in the second region 1020a are arranged in a linear array. Accordingly, sets of bridging members 1120a extend in a linear formation along opposing sides of the tube-wall shaping members 1110a in the second region 1020a. This provides a difference in flexibility in the supporting structure 1000a between the lateral and vertical planes of the second region 1020a. That is, the second region 1020a can bend in line with the yz plane with further ease. However, the second region 1020a is limited from flexing in the xz plane (from left to right).
  • the third region 1030a includes two bridging members 1120a, between each of tube-wall shaping members 1110a, which are arranged in a linear array.
  • the linear arrays of bridging members 1120a in the third region 1030a are offset 90° compared to the linear arrays of bridging members 1120a in the second region 1020a. That is, the bridging members 1120a extend along the xz plane in the second region 1020a whilst they extend along the yz plane in the third region 1030a. In this regard, the bridging members 1120a in the third region 1030a extend along a different side of the support structure 1000a compared to the bridging members 1120a in the second region 1020a.
  • the third region 1030a is configured to favour pivoting/bending about either the second plane 1022a or a third plane 1032a on sides of the tube-wall shaping members 1110a where the bridging members 1120a are omitted.
  • third region 1030a is constrained from pivoting in the yz plane.
  • the third region 1030a is however configured to bend in line with the xz plane shown in Figure 7.
  • the support structure 1000a may be biased in a manner causing the tube to adapt to a curvature suited to the cheek/face of a patient (or another region of the patient). That is, the support structure 1000a has a neutral position which accommodates the curvature of a region of a patient.
  • the support structure may have regions that preferentially flex in a certain direction (whilst being restrained in one or more other directions).
  • the thickness of the barrier 2000a may also be varied to provide preferential flexing. For example, the thickness of the barrier 2000a may be thinner in certain areas, allowing further flexibility. In other areas, the barrier 2000a may be thicker to limit flexing.
  • the fourth region 1040a includes a tube-wall shaping member 1110a that spirals, in a circular, tapered manner, towards connector 300a.
  • the tube-wall shaping member(s) 1110a in the fourth region are therefore angled at an oblique angle to the longitudinal axis 12.
  • the fourth region 1040a does not have bridging members 1120a between parts of the tube-wall shaping member 1110a. Accordingly, the tube-wall shaping member 1110a is continuous in this region and is not formed from separate components.
  • the tube-wall shaping member 1110a extends along a helical path in the fourth region 1040a, being somewhat analogous to a (tapered helical) spring.
  • the tube-wall shaping member 1110a in the fourth region 1040a may provide distinct tube-wall shaping parts therealong.
  • the fourth region 1040a of the support structure is also relatively unconstrained compared to the other regions 1010a, 1020a, 1030a. That is, there is no limit placed on the direction in which the fourth region 1040a can bend.
  • the fourth region 1040a can bend/twist about the xy, yz, xz planes without the constraint of the bridging members 1120a.
  • the fourth region 1040a can also extend in the longitudinal direction of tube 10a, its extension being primarily limited by the nature of the barrier 2000a. This assists with, for instance, providing further patient comfort as the fourth region 1040a can be more easily manipulated to suit the patient's requirements.
  • the barrier 2000a forms the tube wall 100a with the support structure 1000a.
  • the barrier 2000a is applied onto the support structure 1000a to form a pneumatic seal which defines a gas flow passage (ie, lumen 110a).
  • the barrier 2000a may have a thickness between, for example, 20pm to 200pm. As indicated above, this thickness may be adjusted along the tube wall 100a to provide another option to tailor the tube 10a and change the mechanical properties along the tube 10a. That is, the layered thickness of the barrier 2000a may be set at different thicknesses during manufacturing to provide a different measured thickness along its length when the tube wall 100a is in an unstretched state.
  • the barrier 2000a may comprise polyurethane.
  • MVTR moisture vapour transmission rate
  • 'Breathable material refers to a non-porous permeable material that allows the passage of water molecules through a monolithic wall of the permeable material via the solution-diffusion mechanism, without allowing the bulk passage of liquid water or bulk flow of respiratory gases all the way through the wall.
  • the water molecules in the wall are molecularly dispersed in the media, and are therefore without a state (solid, liquid, or gas), although they are sometimes referred to in the art as vapor (e.g., the rate of transfer is often referred to as a MVTR or the like).
  • a monolithic wall does not contain open channels or pores from one major surface to another, such that pathogens could be carried through such channels alongside air or liquid water drops via the pore flow mechanism.
  • this definition is not intended to exclude a tube formed from such a breathable material which may have one or more holes provided through the material, such as might arise from a manufacturing defect for example, which may result in pore flow in negligible amounts which does not affect the overall performance of the tube and compliance with the leakage requirements of ISO 5367:2014.
  • some small molecule transport of respiratory gases may occur in trace or de minimis amounts (i.e.
  • the barrier 2000a may be applied to the support structure 1000a through a sleeving, wrapping, injection moulding or dipping process - there are numerous methods by which a lightweight polymer barrier may be applied to the support structure 1000a. Each of these methods have their own benefits / compromises.
  • a dipping/solution coating may provide a tube 10a with a smoother internal lumen 110a in comparison to wrapping.
  • the support structure 1000a is typically submerged in a polymer/solvent bath during the dipping process. The viscosity of the dipping solution and resulting surface tension of the polymer solution may influence the design of support structure 1000a, and distance between neighbouring tube-wall shaping members 1110a.
  • the barrier 2000a may encapsulate the support structure 1000a. That is, the barrier 2000a surrounds the support structure 1000a in a continuous manner.
  • the barrier 2000a therefore mechanically encapsulates the support structure 1000a and, in this embodiment, a chemical bond is not necessarily required.
  • This provides a number of advantages including allowing a greater selection of materials, including for the support structure 1000a, as the material is not compromised during manufacturing.
  • This non-chemically bonded arrangement can also be useful for designing deflection/resistance in the tube wall, including when the tube wall 100a includes a breathable material.
  • a portion of the barrier 2000a may be configured to rotate with respect to a portion of the support structure 1000a.
  • the support structure 1000a and barrier 2000a may be chemically bonded.
  • Intermediate layers may also be located between the support structure 1000a and the barrier 2000a. The intermediate layers may promote adhesion.
  • the barrier 2000a includes an inner surface 2100a, an outer surface 2200a, an inner support engaging surface 2300a and an outer support engaging surface 2400a.
  • the inner surface 2100a provides a substantially smooth, cylindrical surface.
  • the inner surface 2100a defines the outer perimeter of the lumen 110a.
  • the inner surface 2100a is uniformly formed and avoids, for example, joins and/or crevices that may create further flow turbulence (and a greater pressure drop).
  • the outer surface 2200a includes an area/region that follows the outer shaping surface 1114a to encapsulate the support structure 1000a. The outer surface 2200a therefore extends in an undulating manner in this embodiment.
  • the inner support engaging surface 2300a rests on the inner shaping surface 1112a, enclosing this portion of the support structure 1000a whilst being supported thereby.
  • the outer support engaging surface 2400a encloses the outer shaping surface 1114a of the support structure 1000a and is supported thereby. That is, the outer shaping surface 1114a extends along at least part of the perimeter of the support structure 1000a to assist in encapsulating the support structure 1000a .
  • the barrier 2000a may also, at least in part, cover the connectors 200a, 300a.
  • the barrier 2000a may interact with the connector bodies 210a, 310a to form a pneumatic seal.
  • the protrusions 220a, 330a may assist in positioning the barrier 2000a in order to avoid it interacting with a further connecting device.
  • certain areas including the connectors 200a, 300a or other sensitive areas
  • the connectors 200a, 300a may be partially masked to prevent the barrier 2000a enclosing over the free end of the connectors 200a, 300a.
  • Figure 9 illustrates a further support structure 1000b, according to an embodiment of the present disclosure.
  • the members 1100b are arranged in a similar manner to the members 1100a.
  • the connectors 200b, 3300b are different to the connectors 200a, 300a.
  • the first connector 200b comprises connection and alignment features.
  • the connector 200b comprises a pair of locking fingers 230b with recesses 232b. Each of the recesses 232b is configured for receiving or engaging with a connection feature of a corresponding connector.
  • the connector 200b may provide a visual alignment aid with a corresponding connector.
  • the locking fingers 230b may serve to rotatably orient the connector during connection with a corresponding connector.
  • the connector 3300b forms part of a patient interface 3100b.
  • the connector 3300b forms a manifold.
  • the manifold includes a protrusion 3320b and an interface connecting part 3340b.
  • the manifold is connected to the support structure 1000b.
  • the interface connecting part 3340b may assist in providing a terminal end to engage a part including (nasal) prongs or other parts of a patient interface. As detailed further below, the prongs can be potentially contiguous with the barrier material.
  • the interface connecting part 3340b may form an integrally moulded headgear connector.
  • the connector 3300b (or support structure 1000b) may also include, for example, one or more integrally formed accessories.
  • an accessory could include a coupler.
  • the coupler could assist in connecting to, for instance, another part of the patient interface.
  • the tube 10 may form part of a patient gas delivery system.
  • the system may include a plurality of tubes 10 and interact with a number of other devices (e.g., patient interfaces in the form of a full face, total face, oral, oro-nasal, or nasal mask, along with nasal pillows etc).
  • Figure 35 illustrates a further support structure 1000o that is similar to the support structure 1000b. That is, the support structure 1000o includes a connector 200o, a support structure 1000o with members 1100o etc. However, the patient interface 3100o includes prongs 3400o.
  • the connector 3300o forms a manifold that is integrally formed with the support structure 1000o. This assists with reducing unintended leaks from the tube 10o.
  • the barrier covering the support structure 1000o may be integrally formed with the prongs 3400o. That is, in a second step, when the barrier covers the support structure 1000o, it may also include the prongs 3400o. Accordingly, the patient interface 3100o may, at least in parts, be integrally formed with the tube 10o. This further reduces the potential of unintended leaks.
  • Figure 10 illustrates a tube 10c with a first lumen 110c adjacent a second lumen 110c';
  • Figure 11 illustrates a tube 10d with a first lumen 110d being coaxial with a second lumen 110d';
  • Figure 12 illustrates a tube 10e with a first lumen 110e being nested with a second lumen 110e';
  • Figure 13 illustrates a tube 10f with a lumen that has been partitioned into a first lumen 110f and a second lumen 110f .
  • the lumens 110c, 110c' are positioned next to each other. This may result in at least part of the external surface of one lumen facing at least part of the external surface of another lumen.
  • the lumens 110d, 110d' share a common axis and one lumen 110d' is enclosed by another lumen 110d.
  • one lumen 110e is located inside another lumen 110e (and they do not necessarily need to be coaxial).
  • lumens 11 Of, 11 Of' they typically share at least a common wall (allowing them to extend in a similar path).
  • the lumens may share the same (straight) line and be co-linear.
  • one lumen could be the primary conduit for delivering gas to a patient.
  • Subsequent lumen(s) could convey inspiratory/expiratory gases or be used to sense gas characteristics of the primary lumen.
  • the lumens may also include a non-circular cross-section.
  • Figure 14 illustrates a multi-limb medical tube 10g having a first lumen 110g that is coaxial with a second lumen 110g'.
  • the medical tube 10g includes a support structure 1000g.
  • the support structure 1000g includes a number of members 1100g.
  • the members 1100g include tube-wall shaping member(s) 1110g with bridging member(s) 1120g therebetween.
  • a barrier 2000g is connected to the support structure 1000g.
  • the combination of the support structure 1000g and barrier 2000g make an outer shape 120g that is Y-shaped.
  • the combination of the support structure 1000g and barrier 2000g assists in defining the lumen 110g.
  • a support structure 1000g' and barrier 2000g' assists in defining the lumen 110g'.
  • the support structures 1000g and 1000g' may interact to form an overall structure that assists in defining the lumens 110, 110g'.
  • Figure 36 illustrates a further multi-limb medical tube 10p.
  • the medical tube 10p includes a first connector 200p, a second connector 300p, a third connector 400p and a fourth connector 500p.
  • the connectors 200p, 300p, 400p, 500p are connectors that are configured to connect to other components.
  • the connectors 200p, 300p, 400p, 500p may be standard-type medical connectors.
  • the nature of the connector can differ between one or more of the connectors 200p, 300p, 400p, 500p. That is, one connector could be, for example, a twist-type connector whilst another connector could be a push-fit connector or swivelling connector.
  • the swivelling connector can pivot about an axis.
  • At least part of the connectors 200p, 300p, 400p may be integrally formed with the support structure 1000p.
  • part of it may be integrally formed with the support structure whilst another part is configured to swivel.
  • the support structure 1000p includes tube-wall shaping member(s) 111 Op with bridging member(s) 1120p therebetween.
  • the support structure 1000p forms a multi-limb structure to assist in defining multiple lumens.
  • the size and/or geometry of the tube-wall shaping member(s) 1110p may vary.
  • the size of the shaping member(s) 1110p may vary along each limb.
  • size may vary in, for example, diameter, cross-sectional area and/or length. This may assist in defining different size lumens.
  • the diameter of the lumens may define an internal diameter of the tube wall 100p.
  • the multi-limb medical tube 10p includes three lumens 110p, 110p', 11 Op".
  • One lumen 11 Op is in fluid communication with the first connector 200p.
  • the other lumens 11 Op', 11 Op" are respectively in fluid communication with the second connector 300p and third connector 400p.
  • the lumens 110p, 11 Op', 11 Op" are also in fluid communication with the fourth connector 500p.
  • the splitting / joining of the limbs of the medical tube 10p need not be located at the same point. For example, one limb may be split into two limbs and then one of those limbs may be further subdivided.
  • the branching / splitting of the limbs can be tailored to the medical requirements.
  • Figure 15 illustrates a further multi-limb medical tube 10h having one lumen 11 Oh.
  • the lumen 11 Oh is Y-shaped.
  • the medical tube 10h includes a support structure 1000h.
  • the support structure 1000h includes different shaped member(s) 1100h.
  • the member(s) 1100h include tube-wall shaping member(s) 1110h and bridging member(s) 1120h.
  • the tube-wall shaping member(s) 1110h vary in shape in defining the Y-shaped bifurcated medical tube 10h.
  • the length, curvature and/or direction of the bridging members 1120h also vary to accommodate the Y-shape.
  • FIG. 16 illustrates a patient gas delivery system 3000h.
  • the system 3000h comprises a plurality of tube and adaptors.
  • each tube may comprise a tailored support structure.
  • tubes may be integrally moulded which provides fewer connection points from which respiratory gas may leak.
  • the system 3000h includes a patient interface 3100h.
  • the patient interface 3100h may comprise a laryngeal mask airway (LMA).
  • the patient interface 3100h may comprise an endotracheal tube (ET).
  • LMA laryngeal mask airway
  • ET endotracheal tube
  • the patient interface 3100h is connected to one of the multi-limb tubes 10g, 10h.
  • the multi-limb tubes 10g, 10h may be integrally moulded to provide similar functionality to the collective inspiratory tube, expiratory tube, Y-piece, and/or catheter mount.
  • the multi-limb tubes 10g, 10h could be up to about several metres long.
  • the multi-limb tube may be further subdivided into a multi-lumen tube.
  • FIG. 17 illustrates a medical tube 10i.
  • the medical tube 10i includes a support structure 10OOi and a barrier 2000L
  • the support structure 10OOi may include a visual indicator.
  • the visual indicator may be used to provide connection indicia (including orientation etc.) for the tube 10i.
  • the visual indicator may include one or more colours and/or shades.
  • the medical tube 10i includes a filter 2600L
  • the filter 2600i is situated between an inspiratory tube 2500i and exhalation port 2700L
  • the exhalation port 2700i may include a non-linear end to assist in preventing occlusion by, for example, a blanket or the alike.
  • the inspiratory tube 2500i may be integrally formed with the filter 2600i and the exhalation port 2700L
  • the tube 10i may comprise a series of vent holes (i.e. , the series of holes provides a similar function to the exhalation port 2700i). Potentially the vent holes are downstream of the filter 2600j to exhaust gas.
  • the medical tube 10i can also include a patient interface 31 OOi.
  • the patient interface 31 OOi can be a non-invasive ventilation patient interface.
  • the patient interface 31 OOi may include a sealing interface for NIV/CPAP.
  • the patient interface 31 OOi may comprise a full face, total face, oral, oro-nasal, or nasal mask, along with nasal pillows.
  • FIG. 19 illustrates a medical tube 10j.
  • the medical tube 10j includes a first connector 200j and a second connector 300j.
  • the connectors 200j, 300j form part of the support structure 1000j.
  • the support structure 10OOj comprises a plurality members 110Oj including tube-wall shaping members 1110j.
  • the tube wall-shaping members 1110j include a first size tube wallshaping member 110Oj and a second size tube wall-shaping member 110Oj.
  • Between the first and second size tube wall-shaping members 1110j are bridging members 1120j .
  • the bridging members 1120j are resiliently flexible.
  • the combination of the tube-wall shaping members 1110j and bridging members 1120j forms frustoconical portions.
  • the frustoconical portions may be bistable or multi-stable.
  • the geometry of the frustoconical portions, and the resiliently flexible nature of the bridging members 1120 allows the tube 10j to be adjusted in a variety of ways to assist in patient therapies.
  • the tube 10j may extend from the configuration shown in Figure 19 to the configuration shown in Figure 20. More specifically, the different angles between the bridging members 1120j connecting to each tube-wall shaping member 1110j, as shown in Figure 22, allows the frustoconical portions to resiliently collapse and extend.
  • the tube 10j is configured to, for example, bend to a position and hold that bent position.
  • the tube-wall shaping members 1110j are also connected with the assistance of the barrier 2000j.
  • the barrier 2000j is resiliently flexible, this allows the tube 10j to be collapsible/extendable.
  • the bridging members 1120j may be omitted with the barrier 2000j connecting the tube-wall shaping members 1110j together.
  • the resilient flexible nature of the barrier 2000j may be such that the tube 10j can be collapsed and expanded in a variety of ways to assist in patient therapies. For example, the tube 10j may be retracted and expanded based on the patient's position in a bed.
  • Figure 23 illustrates a medical tube 10k which has a tailored support structure 1000k that is integrated with a patient interface 3100k.
  • the patient interface 3100k may be a full face, total face, oral, oro-nasal, or nasal mask, along with nasal pillows.
  • the support structure 1000k includes a first region 1010k and a second region 1020k.
  • the tube-wall shaping members 1110k in the first region 1010k are arranged differently to the second region 1020k. This provides different mechanical characteristics between the regions 1010k, 1020k.
  • the support structure 1000k proximal to the patient interface 3100k may be configured to have greater flexibility than the support structure 1000k distal to the patient interface.
  • the integration of the patient interface 3100k with the tube-wall shaping members 1110k can assist in replacing an elbow structure and ball joint connection. That is, the tailoring of the barrier 2000k and support structure 1000k can provide adequate flexibility with the patient interface 3100k, which eliminates the need for, for instance, an elbow structure and ball joint connection. Furthermore, the integration of the support structure 1000k, barrier 2000k and patient interface 3100k reduces the potential for any uncontrolled leaks. This improves reliability.
  • the tube 10k may comprise a series of apertures/vents to maintain a controlled leak for bias flow in a NIV/CPAP system.
  • FIG. 24 illustrates a patient gas delivery system 3000I.
  • the system 3000I includes a patient interface 31001.
  • the patient interface 31001 may be a nasal cannula for nasal high flow (NHF).
  • the patient interface 31001 connects / forms part of a medical tube 101.
  • the medical tube 101 includes a patient interface tube and/or a heated breathing tube.
  • the patient interface tube may include a (tailored) support structure 10001.
  • the heated breathing tube may include a (tailored) support structure 10001'.
  • the interface tube and heated breathing tube may be releasably connected; however, in other examples, they may be integrally formed.
  • the barriers 20001, 20001' respectively overlap the support structures 10001,10001' to assist in defining at least part of the outer shape 1201 of the tube 101.
  • the tube 101 may further include an accessory, for example connecting part 32001.
  • the connecting part 32001 is in the form of a coupler.
  • the coupler may be a tube clip.
  • the connecting part 32001 includes a patient interface retaining part 32101 and a tube connecting part 32201.
  • the patient interface retaining part 32101 assists in providing an engagement portion 32151.
  • the engagement portion 32151 can be slipped over part of the patient interface 31001 in order to retain it to the patient interface 31001.
  • the engagement portion 32151 can be slipped over part of the head strap / head gear of the patient interface 31001.
  • the engagement portion could also be slipped over part of the head straps of the patient interface 3100k.
  • the tube connecting part 3220I includes a tube receiving portion 3222I.
  • the tube receiving portion 3222I is substantially circular but it may be other shapes in other examples.
  • the tube receiving portion 3222I is configured to receive the patient interface tube.
  • the connecting part 3200I is integrally form with the support structure 10001 and/or the barrier 20001. This fixes the connecting part 32001 in place and prevents the connecting part 32001 from sliding along the tube 101. Furthermore, less individual parts are provided in the system, easing manufacturing, assembly and use. [0141]
  • Figure 26 illustrates a further medical tube 10m.
  • the medical tube 10m may provide a connection between a heated breathing tube and prongs (or a portion thereof).
  • the tube 10m could be (integrally) connected with one of connectors 3300b, 3300o, in the form of a manifold, whilst at its other end it could be connected to a heater breathing tube.
  • the prongs could also include prongs 3400o.
  • the medical tube 10m includes a tube wall 100m.
  • the tube wall 100m assists in defining a lumen 110m.
  • the tube wall 100m has an outer shape 120m. As shown further in Figure 29, the outer shape 120m is made up of the tube-wall shaping members 1100m and the outer surface 2200m of the barrier 2000m.
  • the tube wall 100m assists in defining a lumen 110m.
  • the medical tube 10m includes a first connector 200m and a second connector 300m.
  • the tube-wall shaping members 1100m of the support structure 1000m are connected to the first connector 200m and the second connector 300m.
  • the first connector 200m may be configured to connect to a heated breathing tube.
  • the second connector 300m may be configured to connect to a cannula manifold.
  • the support structure 1000m is similar to the support structures 1000b, 1000o, shown in Figures 9 and 35 respectively, by providing, amongst other things, a tapered structure etc.
  • the first connector 200m may be substantially circular and, as shown in Figure 30, the second connector 300m is somewhat oval.
  • the outer shape 120m, along with the lumen 110m transitions from a circle to an oval.
  • the gas flow through the lumen 110m transitions from flowing along a circular surface to an oval surface.
  • the outer shape 120m of the tube wall 100m may also be tapered. By having a tapered tube wall 100m, the portion of the tube closest to the patient can be smaller, which is more comfortable on, for example, the face of a patient compared to larger tubes. As the tube 10m transitions to a larger size, the resistance to flow across the tube 10m is also reduced.
  • the gradual transition from a circular to oval shape along the patient interface tube also reduces the resistance to flow. Furthermore, having an oval-shaped tube wall closest to the patient allows the tube 10m to sit flatter on a patient's face. This also allows the tube 10m to protrude less away from a patient's face.
  • the support structure 1000m may be configured to provide appropriate flexibility to align the tube 10m along the face of a patient.
  • the barrier 2000m may comprise a first thickness 'a' and a second thickness 'b'.
  • the varying thickness may occur between neighbouring tube-wall shaping members 1100m.
  • the first thickness 'a' may be configured for flexibility of the tube 10m.
  • the outer surface 2200m of the barrier 2000m may include a valley between neighbouring tube-wall shaping members 1100m.
  • the second thickness 'b' allows for a greater surface area to bond onto the tube-wall shaping members 1100m. Accordingly, varying the thicknesses of 'a' and 'b' can assist in tailoring different parts of the tube 10m.
  • the inner surface 2100m of the barrier 2000m extends substantially linearly between neighbouring tube-wall shaping members 1100m.
  • the barrier 2000m may be a constant thickness if required.
  • FIG 31 illustrates a medical tube 10n.
  • the medical tube 10n includes tube wall 100n.
  • the tube wall 100n defines a lumen 11 On therethrough.
  • the tube wall 10n includes a support structure 1000n.
  • the support structure 1000n includes a plurality of tube-wall shaping members 1110n.
  • the barrier 2000n is located on an inner surface of the tubewall shaping members 1110n.
  • the thickness of the barrier 2000n may vary (in similar or different ways to barrier 2000m).
  • the barrier 2000n connects neighbouring tube-wall shaping members 1110n together. Each tube-wall shaping member 1110n varies in thickness therealong.
  • the tube-wall shaping member 1110n may increase / decrease in size around the axis 12n (depending on the direction of travel). In other words, the tube-wall shaping member 1110n may vary in thickness between different sides of the tube wall 100n.
  • this allows the support structure 1000n to provide differences in mechanical properties around the support structure 1000n. For example, if a cross section is taken across the tube 10n, in a direction that is transverse to the axis 12n, the mechanical properties of the support structure 1000n would vary around the cross section. That is, mechanical properties differ around the axis 12n.
  • Figure 33 illustrates the bending of the tube 10n in a first direction, towards the thicker side of the tube-wall shaping member 1110n.
  • Figure 34 illustrates the bending of the tube 10n in a second direction, towards the thinner side of the tube-wall shaping member 1110n.
  • the bending radius towards the thicker side of the tube-wall shaping members 1110n is greater compare to the thinner side. This could assist when the tube 10n is required to bent more easily to one side in medical therapies.
  • barrier 2000a having a biasing crease which promotes deflection into or out of the primary gases lumen during tube bending or water absorption. This could be added via post-processing annealing.
  • the tube 10 provides a number of non-obvious advantages.
  • the connectors 200, 300 may be integrally moulded with the support structure 1000, before the barrier 2000 is applied, this is particularly advantageous for reducing the potential for pneumatic leaks of gas within the lumen 110 at the connector portions.
  • This arrangement also assists in mitigating disconnection of the tube 10 at, for instance, the cuff portion. That is, the connectors 200, 300 are normally prevented from breaking away from other parts of the tube 10, making a more secure connection.
  • the support structure 1000 may also comprise a plurality of distinct regions with a tailored response dependent on the location and orientation of the members 1100. This again can provide better patient outcomes.
  • Mechanical properties including flexibility, strength, toughness, weight, crush resistance and/or hardness, can also be adjusted along the support tube wall 100 via altering the shape and/or material of the support structure 1000.
  • the barrier 2000 can also be adjusted to achieve different mechanical properties along the tube wall 100.
  • the material of the barrier 2000 can be adjusted to achieve a different elastic modulus, hardness or biocompatibility.
  • the pneumatic compliance of the tube 10 can be modified along the tube 10 via the support structure 1000 and/or barrier 2000.
  • Pneumatic compliance is a change in volume for a given change in pressure. It may be particularly important in therapy where delivery of a controlled volume of gas is important.
  • the terms ‘comprises’, ‘comprising’, ‘includes’, ‘including’, or similar terms are intended to mean a non-exclusive inclusion, such that a method, system or apparatus that comprises a list of elements does not include those elements solely, but may well include other elements not listed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Tube médical pour transporter un gaz vers un patient, le tube médical comprenant : une barrière ; une structure de support formant conjointement avec la barrière une paroi de tube, de telle sorte qu'une lumière est formée ; et un connecteur conçu pour le raccordement à un dispositif afin de permettre un écoulement de gaz à l'intérieur de la lumière, au moins une partie du connecteur étant formée d'un seul tenant avec la structure de support.
PCT/IB2023/060597 2022-10-21 2023-10-20 Tube médical WO2024084445A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263380475P 2022-10-21 2022-10-21
US63/380,475 2022-10-21

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WO2024084445A1 true WO2024084445A1 (fr) 2024-04-25

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050165366A1 (en) * 2004-01-28 2005-07-28 Brustad John R. Medical tubing having variable characteristics and method of making same
US20080202512A1 (en) * 2000-02-18 2008-08-28 Map Medizin-Technologie Gmbh Respiratory gas hose system for supplying a respiratory gas
WO2012122601A1 (fr) * 2011-03-15 2012-09-20 Resmed Limited Conduit de distribution d'air
US20140000626A1 (en) * 2010-10-18 2014-01-02 Fisher & Paykel Healthcare Limited Nasal cannula, conduit and securement system
US20140102456A1 (en) * 2011-06-08 2014-04-17 Resmed Limited Air delivery conduit
US20140277058A1 (en) * 2013-03-12 2014-09-18 Acclarent, Inc. Airway dilation shaft with staggered adjacent internal lumens
US20180093062A1 (en) * 2007-09-20 2018-04-05 Resmed Limited Retractable tube for cpap
US20190091435A1 (en) * 2017-09-28 2019-03-28 Koninklijke Philips N.V. Inflatable conduit and headgear including same
US20210252243A1 (en) * 2018-06-26 2021-08-19 ResMed Pty Ltd Headgear tubing for a patient interface
WO2022005402A1 (fr) * 2020-06-30 2022-01-06 ResMed Asia Pte. Ltd. Casque gonflable et interface patient
CN115120821A (zh) * 2021-03-26 2022-09-30 深圳迈瑞生物医疗电子股份有限公司 新生儿呼吸机及其压力发生器

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080202512A1 (en) * 2000-02-18 2008-08-28 Map Medizin-Technologie Gmbh Respiratory gas hose system for supplying a respiratory gas
US20050165366A1 (en) * 2004-01-28 2005-07-28 Brustad John R. Medical tubing having variable characteristics and method of making same
US20180093062A1 (en) * 2007-09-20 2018-04-05 Resmed Limited Retractable tube for cpap
US20140000626A1 (en) * 2010-10-18 2014-01-02 Fisher & Paykel Healthcare Limited Nasal cannula, conduit and securement system
WO2012122601A1 (fr) * 2011-03-15 2012-09-20 Resmed Limited Conduit de distribution d'air
US20140102456A1 (en) * 2011-06-08 2014-04-17 Resmed Limited Air delivery conduit
US20140277058A1 (en) * 2013-03-12 2014-09-18 Acclarent, Inc. Airway dilation shaft with staggered adjacent internal lumens
US20190091435A1 (en) * 2017-09-28 2019-03-28 Koninklijke Philips N.V. Inflatable conduit and headgear including same
US20210252243A1 (en) * 2018-06-26 2021-08-19 ResMed Pty Ltd Headgear tubing for a patient interface
WO2022005402A1 (fr) * 2020-06-30 2022-01-06 ResMed Asia Pte. Ltd. Casque gonflable et interface patient
CN115120821A (zh) * 2021-03-26 2022-09-30 深圳迈瑞生物医疗电子股份有限公司 新生儿呼吸机及其压力发生器

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