A nasal cannula, conduit and securement system

Abstract

This invention relates to a medical breathing tube comprising a tubular body, the system defining a lumen extending between open ends of the body, and an internal component surrounding and supporting the tubular body within the lumen. The internal component may be a coated, encapsulated internal component, the coating layer securing the internal component to the tubular body. The internal component may also provide, or separately provide, a series of staggered crests and troughs (e.g., corrugations) on the tubular body. A patient interface (such as a face mask or nasal cannula) may be connected to this tube. A system for securing the patient interface in an operating position may also be used.

Description

[Technical Field]

[0001] Field of the Invention This disclosure generally relates to components of a medical system for delivering gas to and from a patient. In one particular aspect, the disclosure relates to catheters, and more specifically, breathing tubes for inspiratory, expiratory, and / or combined respiratory limbs of a respiratory system. In another particular aspect, the disclosure relates to nasal cannulas and catheters that form part of a respiratory system. In yet another particular aspect, the disclosure relates to nasal cannulas that form part of a respiratory system. In yet another particular aspect, the disclosure relates to positioning a patient interface, such as a cannula, in an operating position for a user. [Previous Technology]

[0002] Background of the Invention: In assisted ventilation, breathing gases are supplied to a patient via a flexible breathing tube. The patient's exhaled gases can be delivered to or exhaled from the patient's environment via a similar breathing tube. Gas is typically delivered to the patient via a user interface, but may also include a short, dedicated breathing tube to couple the interface to the breathing tube. Each breathing tube is ideally lightweight, resistant to kinking or squeezing, yet flexible to ensure sufficient effectiveness and comfort for the patient.

[0003] Typically, the size of the breathing tube is approximately 10 mm to 25 mm in internal diameter bore (covering both neonatal and adult use). Dedicated user interface tubes can be smaller, with an internal diameter of approximately 2 mm for neonatal use. The smaller size of dedicated user interface breathing tubes makes them less visually intrusive and reduces weight on the patient's face. The breathing tube is preferably flexible, allowing it to bend easily and improving patient comfort, which in turn increases patient compliance with treatment.

[0004] In medical applications such as assisted breathing, the gas inhaled by the patient is preferably delivered at near body temperature (typically 33°C to 37°C) and with relatively high humidity (often close to saturation). In other medical applications, such as continuous positive airway pressure (CPAP) systems or positive pressure ventilation systems that provide positive pressure breathing gas to patients with obstructive sleep apnea (OSA), the breathing gas may be heated and / or humidified to varying degrees to improve user comfort, or it may be supplied without heating or humidification.

[0005] The same tubing can also be used to supply inflatable gases for laparoscopic surgery. These inflatable gases are ideally lightweight, resistant to kinking or squeezing, and possess similar flexibility to reduce obstruction and distraction in the operating room. The inflatable gas (typically carbon dioxide, but can be other gases or gas mixtures) can also be humidified.

[0006] Furthermore, the gas supplied to the patient can be delivered through a nasal cannula. Especially in the case of infants and newborns, the flexibility of the connected tubing becomes an important consideration. Improving the flexibility of the tubing supplying gas to the patient helps to improve comfort and, consequently, improves compliance with this gas delivery process.

[0007] Furthermore, an alternative or improved system for interface positioning or operational positioning of interfaces such as nasal cannulas is excellently proposed. Such an alternative or improved system can further contribute to improving the compliance of gas delivery processing.

[0008] The patent specification, other external documents, or other information sources have been described in the specification, generally to provide context for discussing the features of the disclosure. Unless otherwise specifically stated, reference to such external documents does not imply an admission that such documents or other information are derived from prior art or constitute part of common knowledge in the art.

[0009] Other aspects and advantages disclosed herein will become more apparent from the detailed descriptions that follow, which are provided for illustrative purposes only. [Summary of the Invention]

[0010] Summary of the Invention The purpose of this invention is to provide a component or a method of manufacturing a component, which, at least with respect to the foregoing description, makes certain improvements or will provide a useful option for the public or medical professionals.

[0011] In the first aspect, this document discloses a method for manufacturing a medical tube in a broad sense, the method comprising providing an inner part, extruding a tubular body that encloses the inner part, the tubular body defining a lumen surrounding the inner part.

[0012] Preferably, the method further comprises: i) applying a pressure reduction to (or to) the interior of the lumen, such that the pressure reduction radially inwards the tubular body within the lumen or the outermost periphery defined by the inner profile, the outermost periphery of the inner profile defining a plurality of alternating peaks and valleys along one length of the tubular body; or ii) applying an extension (or stretch) to at least a portion or region of the tubular body surrounding the inner profile, such that the release of the extension (or stretch) returns (or permits) the extended (or stretched) portion or region of the tubular body back to (or permits) the lumen or radially inwards the outermost periphery defined by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along one length of the tubular body; or iii) a combination of i) and ii).

[0013] Preferably, the tubular system is provided by extrusion or by extruding a material from a die.

[0014] Preferably, the tubular body is extruded around the inner part, and the method of applying pressure reduction allows one inner surface of the tubular body to be at least partially attached to or connected to at least a portion of the inner part. Preferably, the pressure reduction difference between the pressure inside the lumen and the pressure surrounding the tubular body is more preferably that the pressure inside the lumen (provided to the lumen) is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than the pressure inside the lumen (provided to the lumen)).

[0015] Preferably, the tubular body is a single-walled body.

[0016] Preferably, the pressure reduction system is applied to or adjacent to the formation of the lumen.

[0017] Preferably, the pressure reduction system is applied to or adjacent to a die head.

[0018] Preferably, the lumen experiences the decompression when it leaves an extrusion die.

[0019] Preferably, the tubular body and the internal components are co-extruded.

[0020] Preferably, the tubular body formed in this way is corrugated.

[0021] Preferably, the crests of the corrugated tubular body formed in this way are defined by the outermost periphery of the internal component.

[0022] Preferably, the troughs of the corrugated tubular body formed in this way are defined by the inwardly withdrawing portion of the tubular body that is drawn inward between the internal components.

[0023] Preferably, the internal component is a skeleton or internal support structure that supports the tubular body.

[0024] Preferably, the internal component is a continuous length, a series of semi-continuous lengths, or a series of separated lengths.

[0025] Preferably, the internal component is a screen.

[0026] Preferably, the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected by one or more connecting rods.

[0027] Preferably, the internal component is supportive or supports the cavity within the tube thus formed.

[0028] Preferably, the internal component is supported or supported within the cavity of the tube thus formed.

[0029] Preferably, the internal component is a spiral element or component.

[0030] Preferably, the internal component has a spacing that varies along the length (or section) of the tube.

[0031] Preferably, the internal component is a spiral wound element (or member) having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the spacing between adjacent turns is about 1 mm to about 1.5 mm.

[0032] Preferably, the internal component has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

[0033] Preferably, the internal component is a spiral wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm. Preferably, it has a diameter of about 0.1 mm to about 1.5 mm.

[0034] Preferably, the internal component is made of a medical-grade material, preferably medical-grade stainless steel.

[0035] Preferably, the tubular body has a wall thickness of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm.

[0036] Preferably, the tubular body has an internal diameter (or lumen) of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.

[0037] Preferably, the tubular body has an outer (or outer) diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. Preferably, it has an outer (or outer) diameter of about 3 mm to about 5 mm.

[0038] Preferably, the tubular body is wrinkled, and the corrugations have a depth of about 0.1 mm to about 0.5 mm.

[0039] Preferably, the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

[0040] Preferably, the ratio of the diameter of the internal component (e.g., the diameter of the actual internal component element or member) to the outer diameter (e.g., the outermost diameter) of the internal component is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0041] Preferably, the ratio of the corrugation depth to the outer (i.e., outer) pipe diameter is about 0.05 to about 0.09.

[0042] Preferably, the characteristics of the tubular body enable the tube to have the desired flexibility and / or structural support.

[0043] Preferably, the tubular body is (preferably extruded therefrom) a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

[0044] Preferably, the tubular system is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer can be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0045] Preferably, the tubular body is a breathable tube or is made of a breathable material, such as breathable thermoplastic polyurethane or breathable polyamide.

[0046] Preferably, the pressure reduction is applied when the tubular body is in a molten, semi-molten, or unhardened state. Preferably, the pressure reduction is about 0 to about -2 Pa (absolute), more preferably about 0 to about -1 Pa (absolute), even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably, this pressure reduction is a pressure difference between the inner side of the lumen and the area surrounding the tubular body.

[0047] Preferably, the internal component is conductive, and more preferably, the internal component is a heater.

[0048] Preferably, the internal component includes a conductive member or a heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

[0049] Preferably, the piping system further includes a heater, more preferably an electric heater (such as a heater wire or heater circuit).

[0050] Preferably, the tubular system is defined as flexible by means of the test of increased flow resistance with bending, according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0051] Preferably, the medical tube is a breathing tube.

[0052] Preferably, the internal component includes one or more separate components.

[0053] Preferably, the internal component includes one or more components.

[0054] Preferably, the tube includes one or more internal components. In a second aspect, the invention can be broadly categorized as consisting of a medical tube comprising: a tubular body defining a lumen extending between open terminals of the body, and an internal component surrounding and supporting the tubular body within the lumen, the outermost periphery of the internal component defining a plurality of alternating peaks and valleys along a length of the tubular body.

[0055] Preferably, the tubular body is an extruded tube.

[0056] Preferably, the tubular body is a continuous tube.

[0057] Preferably, the tubular body is a continuously extruded tube.

[0058] Preferably, the crests of the corrugated tubular body are defined by the outermost periphery of the internal component.

[0059] Preferably, the corrugated tubular system is defined by the inwardly withdrawing portion of the tubular body that is drawn inward between the internal components.

[0060] Preferably, the internal component is a continuous length, a series of semi-continuous lengths, or a series of separated lengths.

[0061] Preferably, the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected by one or more connecting rods.

[0062] Preferably, the internal component supports the tubular body and defines the cavity within it.

[0063] Preferably, the internal component is a skeleton or internal support structure that supports the tubular body.

[0064] Preferably, the tubular body is substantially not supported by the troughs from the internal member, but is supported by the internal member at the crests.

[0065] Preferably, the wall of the tubular body is suspended between adjacent crests.

[0066] Preferably, the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

[0067] Preferably, the tubular body is a breathable tube, or is made of or from a breathable material such as breathable thermoplastic polyurethane or breathable polyamide.

[0068] Preferably, the internal component is a spirally wound rib or a rib element.

[0069] Preferably, the internal component is a spiral element or component.

[0070] Preferably, the internal component has a spacing that varies along a length (or section) of the tube. Preferably, the internal component is a spiral wound element having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the spacing between adjacent turns is about 1 mm to about 1.5 mm.

[0071] Preferably, the internal component has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

[0072] Preferably, the internal component is a spiral wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm. Preferably, it has a diameter of about 0.1 mm to about 1.5 mm.

[0073] Preferably, the internal component is made of a medical-grade material, preferably medical-grade stainless steel.

[0074] Preferably, the tubular body has a wall thickness of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm.

[0075] Preferably, the tubular body has an internal diameter of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.

[0076] Preferably, the tubular body has an outer (or outer) diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. Preferably, it has an outer (or outer) diameter of about 3 mm to about 5 mm.

[0077] Preferably, the tubular body is wrinkled, and the corrugations have a depth of about 0.1 mm to about 0.5 mm.

[0078] Preferably, the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

[0079] Preferably, the ratio of the diameter of the internal component (e.g., the diameter of the actual internal component element or component) to the outer diameter (e.g., the outermost diameter) of the internal component is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0080] Preferably, the ratio of the corrugation depth to the outer (i.e., outer) pipe diameter is about 0.05 to about 0.09.

[0081] Preferably, the characteristics of the tubular body enable the tube to have the desired flexibility and / or structural support.

[0082] Preferably, the tubular system is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer can be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0083] Preferably, the internal component is a plurality of rings spaced longitudinally along the cavity.

[0084] Preferably, the shape of the rings is a complex surface or a ring.

[0085] Preferably, the internal component is one or more separate elements linked to each other.

[0086] Preferably, the internal component is a plurality of reinforcing ribs regularly spaced along the cavity.

[0087] Preferably, each reinforcing rib includes one turn of a spiral reinforcing wire.

[0088] Preferably, one of the turns of the spiral reinforcing line includes a complete turn around the lumen.

[0089] Preferably, one of the spiral reinforcing lines includes the line located between adjacent crests of the internal member.

[0090] Preferably, the tubular system is defined as flexible by the test of the increase in flow resistance with bending, according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0091] Preferably, one end of the tube is integrated with a nose fork, which is suitable for insertion into a user's nostril as a nasal interface for delivering breathing gas to a user.

[0092] Preferably, the internal component is a screen.

[0093] Preferably, the internal component is a wire suitable for heating or sensing the properties of the gas inside the tube.

[0094] Preferably, the internal component is conductive, and more preferably, the internal component is a heater.

[0095] Preferably, the internal component includes a conductive member or a heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

[0096] Preferably, the piping system further includes a heater, more preferably an electric heater (such as a heater wire or heater circuit).

[0097] Preferably, the tube is a breathing tube.

[0098] Preferably, the internal component includes one or more separate components.

[0099] Preferably, the internal component includes one or more components.

[0100] Preferably the tube includes one or more internal components.

[0101] In a third aspect, the present invention can be broadly categorized as comprising a nasal cannula configuration including: at least one nasal fork having an air outlet suitable for insertion into a user's nostril and an air inlet fluidly connected to the air outlet, and a corrugated gas delivery tube comprising a tubular body defining a lumen and an internal member surrounding the interior of the lumen, the internal member supporting the tubular body, the outermost periphery of the internal member defining a plurality of alternating peaks and valleys along a length of the tubular body, wherein the air inlet of the nasal fork is integrally formed with an end of the tube such that the lumen is fluidly connected to the air outlet of the nasal fork.

[0102] Preferably, the nose fork is shaped to be substantially anatomically conform to the inside of a user's nose or nostril.

[0103] Preferably, the nose fork tip is curved or otherwise shaped or assembled to avoid a user's nasal septum.

[0104] Preferably, the nasal cannula has a substantially flat or contoured backing that is assembled to rest on a user’s face, preferably serving as a stabilizing element for the fork head at a user’s nostril.

[0105] Preferably, one or more ribs extend between one front of the backing and the sleeve, the ribs providing a contact surface for a thin strip or other suitable fastener to fasten or attach the sleeve to a user’s face, preferably the thin strip includes an adhesive portion or is an adhesive tape or a contact adhesive tape.

[0106] Preferably, the two nose forks are integrally formed with a single corrugated delivery tube.

[0107] Preferably, the sleeve includes a pair of nose forks, each fork being integrally formed with one of the terminals of a pair of gas delivery tubes, or being attachable (or connectable) to the terminal.

[0108] Preferably, the cannula is made of a polymer such as a thermoplastic polymer, preferably a polymer or polymer suitable for medical breathing tubes.

[0109] Preferably, the sleeve configuration is made of one or more of the following: thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide; more preferably, the polymer may be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, it is a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0110] In the fourth aspect, the present invention can be broadly said to include a user interface including a nasal cannula as defined in the third aspect.

[0111] Preferably, the nose forks of each nasal cannula are arranged to be adjacent to each other and the individual delivery tubes extend in the opposite direction away from the nose forks.

[0112] Preferably, it further includes a wire bundle that extends and couples between the nasal cannulas.

[0113] Preferably, the tube is a breathing tube.

[0114] Preferably, the piping system is defined as in the first or second orientation, for example, the piping system is manufactured by means of the method defined in the first orientation or the method defined in the second orientation.

[0115] In the fifth aspect, the present invention can be broadly described as including a method of manufacturing a nasal cannula, the method comprising: providing an inner mold, extruding a tubular body to enclose the inner mold, the tubular body defining a lumen surrounding the inner mold, and attaching a nasal cannula thereto.

[0116] Preferably, the method further comprises: i) applying a pressure reduction to (or to) the interior of the lumen, such that the pressure reduction radially inwards the tubular body within the lumen or the outermost periphery defined by the inner profile, the outermost periphery of the inner profile defining a plurality of alternating peaks and valleys along a length of the tubular body; or ii) applying an extension (or stretch) to at least a portion or region of the tubular body surrounding the inner profile, such that release of the extension (or stretch) returns (or permits) the extended (or stretched) portion or region of the tubular body back to (or permits) the lumen or radially inwards the outermost periphery defined by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body; or iii) a combination of i) and ii).

[0117] Preferably, the method includes covering one end of the tubular body with a molded nose fork.

[0118] Preferably, the tubular body thus formed is a tube as defined by the method of the first aspect or as defined by the tube of the second aspect.

[0119] Preferably, one end of the tube formed by the tubular body is positioned within a mold or part for molding or forming a nose tube, preferably the mold or part is closed, and the nose tube is fitted around the tube or one end of the tube for molding or forming.

[0120] Preferably, the nasal cannula is a polymer, such as a thermoplastic polymer, and more preferably a polymer suitable for medical breathing tubes.

[0121] Preferably, the formed nasal cannula is made of one or more of the following: a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, it is a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0122] Preferably, the tubular body is a breathable tube, or is made of or from a breathable material such as breathable thermoplastic polyurethane or breathable polyamide.

[0123] Preferably, a nasal cannula mold is provided, which can receive one end of the tube formed by manufacturing the tubular body, such that the operation of the mold assists in the molding of the nasal cannula, a portion of the nasal cannula being molded by the end of the tube.

[0124] Preferably, the nasal cannula configuration manufactured by the nasal cannula is in fluid communication with one end of the tube formed by the manufacture of the tubular body.

[0125] In the sixth aspect, the present invention may be broadly described as including a fixation system for a user interface and / or a user interface tube, comprising: a skin patch defining a fixation footprint, the skin patch having a user side and an interface side, the user side of the skin patch being assembled to attach to or adhere to a user's skin, and a fixation patch, at least a portion of the fixation patch being assembled to extend over the user interface and / or the associated user interface tube and fixed to the user side of the skin patch to fix the user interface to the user, the fixation patch and the skin patch being assembled to allow the fixation patch to be accommodated in or demarcated by the fixation footprint of the skin patch when the fixation system is applied to a patient with a suitable or compatible user interface.

[0126] Preferably, the skin patch has the same or a larger surface area as the fixation patch.

[0127] Preferably, the fixing patch is shaped or otherwise assembled to correspond to the geometry or other characteristics of the user interface and / or the associated user interface tube.

[0128] Preferably, the fixing patch has at least one wing.

[0129] Preferably, the fixing patch has a pair of wings disposed at one end of the patch, the wings being assembled to fix the skin patch to either side of a user interface and / or an associated user interface tube.

[0130] Preferably, the fixing patch has a tube end wing that is assembled to extend or to extend below the user interface tube and to fix to the skin patch.

[0131] Preferably, the user side of the skin patch has a skin-sensitive adhesive (such as a hydrocolloid) that attaches or adheres the skin patch to a user's skin.

[0132] Preferably, the skin patch has a surface of sufficient area such that the surface disperses the attachment or adhesive force pressure across the user's skin.

[0133] Preferably, the skin patch is assembled to attach or adhere to a user’s face.

[0134] Preferably, the skin patch is assembled to attach or adhere to a user’s face, particularly near the user’s upper lip and / or cheek.

[0135] Preferably, the fixation system is assembled to receive and / or fix a nasal cannula and / or connected tubes that extend from one or both sides of a user’s face.

[0136] Preferably, the fixation system is configured for use with an infant or newborn.

[0137] Preferably, the fixation system is assembled for use with a nasal cannula as defined in the third aspect.

[0138] Preferably, the fixing system is configured for use with one of the first and / or second orientations defined.

[0139] In the seventh aspect, the present invention can be broadly described as including a fixing system for a user interface and / or user interface tube, comprising a two-part releasable attachment or connection configuration comprising a skin patch and a user interface patch: the skin patch having a patient side and an interface side, the patient side of the skin patch being attachable to a user's skin (e.g., by means of an adhesive, typically a skin-sensitive adhesive such as a hydrocolloid), the interface side of the skin patch being provided as the first component of a two-part releasable attachment or connection system, and the user interface patch having an interface side and a patient side, the patient side of the user interface patch being provided as the complementary second component of the two-part releasable attachment or connection system. The interface side of the user interface patch may be attached to or connected to the user interface and / or a connected user interface tube, for example by means of an adhesive or may be formed as a component of the user interface, or may be provided as the back surface of the user interface when the user interface is provided as the second component of the two-component system.

[0140] Preferably, the interface side of the skin patch has one of a hook or a ring, and the second component of the second patch has the other of the hook or ring, such that the first and second components (and patches) are releasably attached or connected to each other.

[0141] Preferably, the first patch can be positioned and / or attached to a user's facial skin.

[0142] Preferably, the user interface patch is positionable, attachable, or linked to or connected to a user interface.

[0143] Preferably, the user interface patch is integrally formed with a user interface or forms a component of the user interface.

[0144] Preferably, the two-part releasable attachment or connection system on the skin patch occupies less than about 90%, or about 85%, or about 75%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or about 10% of the interface side of the skin patch.

[0145] Preferably, the first component of the two-part releasable attachment or connection system is adhered to or can be adhered to the user interface side of the skin patch.

[0146] Preferably, the user side of the skin patch has a skin-sensitive adhesive (such as, for example, a hydrocolloid) for attaching or adhering the skin patch to a user's skin.

[0147] Preferably, the skin patch has a surface of sufficient area such that the surface disperses the attachment pressure or adhesive force across the user's skin.

[0148] Preferably, the skin patch is assembled to be attached or adhered to a user’s face.

[0149] Preferably, the skin patch is assembled to be attached or adhered to a user’s face adjacent to the user’s upper lip and / or cheek.

[0150] Preferably, the fixation system is assembled to receive and / or fix a nasal cannula and a connected tube that extends from one or both sides of a user’s face.

[0151] Preferably, the fixation system is configured for use with an infant or newborn.

[0152] Preferably, the fixation system is configured for use with a nasal cannula as defined in any one or more of the third orientations.

[0153] Preferably, the fixing system is configured for use with one of the first and / or second orientations defined.

[0154] Preferably, the fixing patch as defined above is applied or can be applied above the user interface and is fixed or can be fixed to the skin patch to provide additional fixation.

[0155] Preferably, the first component of the two-part releasable attachment or connection system includes a substrate that is fixed to or used to fix to the skin patch.

[0156] Preferably, the substrate includes at least one slit or at least one slot, having a substrate region separated by the slit or slot.

[0157] Preferably, the base portion includes a plurality of slots or grooves or both, which together divide the base portion into a meandering body.

[0158] Preferably, the slots and / or grooves are disposed in the substrate such that a first set of at least one set of slots or grooves extends into the substrate from one edge of the substrate, and a second set of slots or grooves extends into the substrate from the other edge of the substrate, wherein the slots or grooves of one set intersect with the slots or grooves of the other set, such that a path along the substrate from one end to the other without intersecting the slots or grooves of one set follows a zigzag or meandering path that is much longer than a straight line between the two ends.

[0159] Preferably, one of the plurality of slits or slots is curved.

[0160] Preferably, the plurality of slits or slots are curved and such curved slits or slots are substantially parallel.

[0161] Preferably, the slits or slots are configured as a herringbone pattern extending from the edge of the base portion.

[0162] Preferably, the base system is divided into sections by a meandering slot or groove.

[0163] Preferably, the base portion is divided into multiple parts by a spiral slit or groove.

[0164] Preferably, the base part is divided into details by slots or grooves arranged in substantially concentric circles.

[0165] Preferably, the concentric circles are centered at approximately the center of the base portion.

[0166] Preferably, the slots or grooves divide the base into multiple islands, each island being joined to an adjacent island or multiple islands by a narrow bridge.

[0167] Preferably, the base part is divided into multiple parts by an S-shaped slit.

[0168] Preferably, the base portion is divided into multiple parts by a T-shaped slit.

[0169] Preferably, the substrate covers at least 70% of the area of ​​the skin patch.

[0170] Preferably, for a boundary defining the shortest path around the perimeter of the substrate, the substrate covers at least 80% of the area inside the boundary.

[0171] In the eighth aspect, the present invention can be broadly described as including a method of manufacturing a medical tube, the method comprising: providing an inner part encapsulated within a coating layer, and providing a tubular body covering the inner part, the tubular body defining a lumen surrounding the inner part, the tubular body being disposed to cover the inner part such that the coating layer is connected to an inner surface of the tubular body, wherein the inner part remains encapsulated.

[0172] Preferably, the step of providing an inner part includes: providing an elongated part encapsulated within a coating suitable for application to a medical tube, and manufacturing a support inner part for a medical tube from the coated elongated part.

[0173] Preferably, the uncoated elongated part is immersed in a coating material bath to apply the encapsulating coating layer.

[0174] Preferably, the bath contains a grade of melt polymer with a temperature above about 150°C.

[0175] Preferably, the internal component is manufactured by spirally winding the elongated component into a spiral shape.

[0176] Preferably, the method further includes: providing an uncoated elongated member, encapsulating the elongated member in a coating suitable for application on a medical tube.

[0177] Preferably, the method further comprises: i) applying a pressure reduction to (or to) the interior of the lumen, such that the pressure reduction draws the tubular body radially inward; or ii) applying an extension (or stretch) to at least a portion or region of the tubular body surrounding the interior member, such that release of the extension (or stretch) returns (or permits) the extended (or stretched) portion or region of the tubular body to (or allows) radial inward extraction; or iii) a combination of i) and ii).

[0178] Preferably, the tubular body is drawn radially inward from the lumen or the outermost periphery defined by the inner profile, the outermost periphery of the inner profile defining a plurality of alternating peaks and valleys along one length of the tubular body to form a corrugated tube.

[0179] Preferably, the tubular system is provided by extrusion or by extruding a material from a die.

[0180] Preferably, the tubular body is extruded around the inner part, and the method of applying pressure reduction allows one inner surface of the tubular body to be at least partially attached to or connected to at least a portion of the inner part. Preferably, the pressure reduction difference between the pressure inside the lumen and the pressure surrounding the tubular body is more preferably that the pressure inside the lumen (provided to the lumen) is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than the pressure inside the lumen (provided to the lumen)).

[0181] Preferably, the tubular body provides a temperature around the internal component such that the coating is connected to at least a portion of the tubular body.

[0182] Preferably, the tubular system surrounds the internal component at a temperature that allows the coating to fuse with the internal component.

[0183] Preferably, the tubular system is at least partially fused with the coating.

[0184] Preferably, the tubular body is a single-walled body.

[0185] Preferably, a pressure reduction system is applied to or adjacent to the formation of the lumen.

[0186] Preferably, the pressure reduction system is applied to or adjacent to a die head.

[0187] Preferably, the lumen experiences the decompression when it leaves an extrusion die.

[0188] Preferably, the tubular body system is extruded simultaneously with the internal part manufactured from the elongated part.

[0189] Preferably, the tubular body formed in this way is corrugated (either axial or helical corrugated).

[0190] Preferably, the crests of the corrugated tubular body thus formed are defined by the outermost periphery of the internal component.

[0191] Preferably, the troughs of the corrugated tubular body thus formed are defined by the inwardly drawn portion of the tubular body that is drawn inward between the internal components.

[0192] Preferably, the internal component is a skeleton or internal support structure that supports the tubular body.

[0193] Preferably, the internal component is a continuous length, a series of semi-continuous lengths, or a series of separated lengths.

[0194] Preferably, the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected by one or more connecting rods.

[0195] Preferably, the internal component is supportive or supports the cavity within the tube thus formed.

[0196] Preferably, the internal component is a spiral element or component.

[0197] Preferably, the internal component has a spacing that varies along one length (or section) of the tube.

[0198] Preferably, the internal component is a spiral wound element (or member) having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the spacing between adjacent turns is about 1 mm to about 1.5 mm.

[0199] Preferably, the internal component has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

[0200] Preferably, the internal component is a spiral wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm.

[0201] Preferably, the internal component is made of a medical-grade material, preferably a medical-grade stainless steel coated with a suitable material, preferably a polymer-grade or a stainless steel.

[0202] Preferably, the tubular body has a thickness of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm.

[0203] Preferably, the tubular body has an internal diameter (e.g., lumen) of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.

[0204] Preferably, the tubular body has an outer (or outer) diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. Preferably, it has an outer (or outer) diameter of about 3 mm to about 5 mm.

[0205] Preferably, the tubular body is wrinkled, and the corrugations have a depth of about 0.1 mm to about 0.5 mm.

[0206] Preferably, the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

[0207] Preferably, the ratio of the diameter of the internal component (e.g., the diameter of the actual internal component element or component) to the outer diameter (e.g., the outermost diameter) of the internal component is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0208] Preferably, the ratio of the corrugation depth to the outer (i.e., outer) pipe diameter is about 0.05 to about 0.09.

[0209] Preferably, the characteristics of the tubular body enable the tube to have the desired flexibility and / or structural support.

[0210] Preferably, the tubular body is (preferably extruded therefrom) a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

[0211] Preferably, the tubular system is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer can be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0212] Preferably, the tubular body is a breathable tube or is made of a breathable material, such as breathable thermoplastic polyurethane or breathable polyamide.

[0213] Preferably, the pressure reduction is applied when the tubular body is in a molten, semi-molten, or unhardened state. Preferably, the pressure reduction is about 0 to about -2 Pa (absolute), more preferably about 0 to about -1 Pa (absolute), even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably, this pressure reduction is a pressure difference between the inner side of the lumen and the area surrounding the tubular body.

[0214] Preferably, the internal component is conductive, and preferably the internal component is a heater.

[0215] Preferably, the internal component includes a conductive element or a heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

[0216] Preferably, the piping system further includes a heater, more preferably an electric heater (such as a heater wire or heater circuit).

[0217] Preferably, the tubular system thus formed is defined as flexible by the test of the increase in flow resistance with bending, according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0218] Preferably, the medical tube is a breathing tube.

[0219] Preferably, the internal component includes one or more separate components.

[0220] Preferably, the internal component includes one or more components.

[0221] Preferably, the piping system includes one or more internal components.

[0222] In the ninth aspect, the present invention can be broadly described as including a method of manufacturing a medical tube, the method comprising: i) providing an inner part, ii) providing a tubular body that covers the inner part, the tubular body defining a lumen enclosing the inner part, and applying a pressure reduction to (or to) the lumen, or applying an extension (or stretch) to at least a portion or a region of the tubular body enclosing the inner part, or iii) a combination of i) and ii).

[0223] Preferably, a greater decompression or a greater extension (or stretching) or a combination of both is applied to draw the tubular body radially inward toward the lumen along the length of the tubular body and an outermost periphery defined by the inner profile, wherein when the greater decompression is applied or the extension (or stretching) is released or both, the outermost periphery of the inner profile defines a plurality of alternating peaks and valleys.

[0224] Preferably, the internal component is enclosed in a coating layer, and the tubular body provides a cover for the internal component such that the coating layer is connected to one of the inner surfaces of the tubular body, wherein the internal component remains enclosed.

[0225] In the tenth aspect, the present invention can be broadly described as including a medical tube comprising: a tubular body, the present invention defining a lumen extending between open terminals of the body, and an internal member surrounding the lumen and supporting the tubular body, and a coating layer encapsulating the internal member, the coating layer fixing the internal member to the tubular body.

[0226] Preferably, the coating and the tubular system are fused together along the tube.

[0227] Preferably, the coating and the tubular system are fused together along the tube at the separated position.

[0228] Preferably, the coating and the tubular system are substantially continuously welded along the longitudinal direction of the tube.

[0229] Preferably, the outermost periphery of the internal component defines a plurality of alternating peaks and valleys along one length of the tubular body.

[0230] Preferably, the crests of the corrugated tubular body are defined by the outermost periphery of the internal component.

[0231] Preferably, the corrugated tubular system is defined by the inwardly withdrawing portion of the tubular body that is drawn inward between the internal components.

[0232] Preferably, the internal component is a continuous length, a series of semi-continuous lengths, or a series of separated lengths.

[0233] Preferably, the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected by one or more connecting rods.

[0234] Preferably, the internal component supports the tubular body and defines the cavity within it.

[0235] Preferably, the internal component is a spiral element or component.

[0236] Preferably, the internal component has a spacing that varies along one length (or section) of the tube.

[0237] Preferably, the internal component is a skeleton or internal support structure that supports the tubular body.

[0238] Preferably, the tubular body is substantially not supported by the troughs from the internal member, but is supported by the internal member at the crests.

[0239] Preferably, the walls of the tubular body are suspended between adjacent wave crests.

[0240] Preferably, the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

[0241] Preferably, the internal component is a spirally wound rib or a rib element.

[0242] Preferably, the internal component is a spiral wound strip, and the coating layer encapsulates the strip.

[0243] Preferably, the internal component is a spiral wound wire, and the coating layer encapsulates the wire.

[0244] Preferably, the coating provides a surface ready to be connected to the tubular body.

[0245] Preferably, the internal component is a spiral wound element (or member) having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the spacing between adjacent turns is about 1 mm to about 1.5 mm.

[0246] Preferably, the internal component has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

[0247] Preferably, the internal component is a spiral wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm. Preferably, it has a diameter of about 0.1 mm to about 1.5 mm.

[0248] Preferably, the internal component is made of a medical-grade material, preferably medical-grade stainless steel.

[0249] Preferably, the tubular body has a wall thickness of one of the following: about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm. Preferably, the wall thickness is one of about 0.1 mm to about 0.2 mm.

[0250] Preferably, the tubular body has an inner diameter (or lumen) of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm. Preferably, it has an outer diameter of about 3 mm to about 5 mm.

[0251] Preferably, the tubular body is wrinkled, and the corrugations have a depth of about 0.1 mm to about 0.5 mm.

[0252] Preferably, the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

[0253] Preferably, the ratio of the diameter of the internal component (e.g., the diameter of the actual internal component element or component) to the outer diameter (e.g., the outermost diameter) of the internal component is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0254] Preferably, the ratio of the corrugation depth to the outer (i.e., outer) pipe diameter is about 0.05 to about 0.09.

[0255] Preferably, the characteristics of the tubular body enable the tube to have the desired flexibility and / or structural support.

[0256] Preferably, the tubular body has an outer (or outer) diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

[0257] Preferably, the tubular system is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer can be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0258] Preferably, the internal component is a plurality of rings spaced longitudinally along the cavity.

[0259] Preferably, the shape of the rings is a complex surface or a ring.

[0260] Preferably, the internal component is one or more separate elements linked together.

[0261] Preferably, the internal component is a plurality of reinforcing ribs regularly spaced along the cavity.

[0262] Preferably, each reinforcing rib includes one turn of a spiral reinforcing wire.

[0263] Preferably, one of the turns of the spiral reinforcing line includes a complete turn around the lumen.

[0264] Preferably, one of the spiral reinforcing lines includes the line located between adjacent crests of the internal member.

[0265] Preferably, the tubular system is defined as flexible by means of the test of increased flow resistance with bending, according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0266] Preferably, one end of the tube is integrated with a nose fork, which is suitable for insertion into a user's nostril as a nasal interface for delivering breathing gas to a user.

[0267] Preferably, the internal component is a screen.

[0268] Preferably, the internal component is a wire suitable for heating or sensing the properties of the gas inside the tube.

[0269] Preferably, the internal component is conductive, and more preferably, the internal component is a heater.

[0270] Preferably, the internal component includes a conductive element or a heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

[0271] Preferably, the piping system further includes a heater, more preferably an electric heater (such as a heater wire or heater circuit).

[0272] Preferably, the tube is a breathing tube.

[0273] Preferably, the internal component includes one or more separate components.

[0274] Preferably, the internal component includes one or more components.

[0275] Preferably the tube includes one or more internal components.

[0276] In the eleventh aspect, the present invention can be broadly described as including a medical tube comprising: a tubular body defining a lumen extending between open terminals of the body, and an internal component encapsulated within the lumen and supporting the tubular body.

[0277] Preferably, the outermost periphery of the internal component defines a plurality of alternating peaks and valleys along one length of the tubular body.

[0278] Preferably, the internal component is encapsulated in a coating layer, which fixes the internal component to the tubular body.

[0279] In the twelfth aspect, the present invention can be broadly described as including a nasal cannula configuration comprising: at least one nasal fork having an air outlet suitable for insertion into one of a user's nostrils and an air inlet fluidly connected to the air outlet, the fork being shaped to conform to the anatomical curvature of a user's nostrils.

[0280] Preferably, the nose fork tip is shaped to avoid contact with the user's nasal septum at the base of the user's nose.

[0281] Preferably, the nose fork is shaped to avoid contact with the internal structure of a user's nose.

[0282] Preferably, the nose fork is shaped to substantially align the breathing gas flow through the outlet with the user's upper respiratory tract.

[0283] Preferably, the nose fork is shaped to extend generally upward and backward into a user's nostril, and the nose fork has a curvature including at least two inflection points.

[0284] Preferably, the nose fork defines a cavity extending between the air inlet and the air outlet, the shape of which changes from a generally circular shape at the air inlet to a generally elliptical shape at the air outlet.

[0285] Preferably, the fork head system is shaped to maximize the cross-sectional area of ​​the lumen.

[0286] Preferably, the interface further includes a support extending along the upper lip of a user.

[0287] Preferably, the interface includes two nose forks symmetrically spaced about the sagittal plane of a user, the forks extending from a base inward in the direction below the user's nose on a common support disposed along the upper lip of the user.

[0288] Preferably, the nose forks extend from the support toward the user's nasal septum and curve upward and backward around a corner of the user's nostril into the user's nostril. Each fork extends along a generally inclined rearward track and is oriented to the outlet relative to two middle and lateral reflection points of the user's upper respiratory tract.

[0289] Preferably, the fork tip has a shaped track that matches the anatomical shape of the user's nostrils. More preferably, i) in a first part (or stage) of such a fork tip, the track moves horizontally toward the midline of the face; ii) in a second part (or stage) of the fork tip, the track curves upward directly into the nostril toward the crown of the head; iii) in a third part (or stage) of the fork tip, the track rolls backward into the head following the anatomical curvature of the nostril; and iv) in a fourth part (or stage), the track is horizontally inclined toward the center of the cannula to align the outlet with the user's upper respiratory tract.

[0290] Preferably, the fork has a cross-section that changes along the central track. For example, the cross-section may be generally circular at the base of the track (i.e., in the first section of the region) and become generally elliptical toward the track or the end point of the fork (e.g., in the fourth section of the region).

[0291] Preferably, the cross-sectional area system generally decreases along the track from the first part (or stage) to the end of the fourth part (or stage).

[0292] Preferably, the nasal cannula further includes one of the contoured backing or face pads that is assembled to rest on a user's face.

[0293] Preferably, the backing or face pad is pre-shaped to be substantially curved to match the contour of a user’s face or upper lip area.

[0294] Preferably, each fork unit can accept an independent flow from a gas source.

[0295] In the thirteenth aspect, the present invention can be broadly described as including a nasal cannula configuration comprising: at least one nasal fork having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly connected to the air outlet, and a gas delivery tube including a tubular body defining a lumen and an internal member surrounding the interior of the lumen, the internal member supporting the tubular body, wherein the air inlet of the nasal fork is integrally formed with one end of the tube such that the tubular lumen is fluidly connected to the air outlet of the nasal fork.

[0296] Preferably, the outermost periphery of one of the internal components defines a plurality of alternating peaks and valleys along the length of one of the tubular bodies.

[0297] Preferably, the fork head is shaped to conform to the anatomical curvature of a user's nostril.

[0298] Preferably, the nose fork tip is curved or otherwise shaped or assembled to avoid a user's nasal septum.

[0299] Preferably, the nasal cannula has one of the contoured backing or face pads that is assembled to rest on a user's face, preferably as a stabilizing element for the fork head at a user's nostril.

[0300] Preferably, one or more ribs extend between the front of one of the backing or face pads and the sleeve, the ribs providing a contact surface for a thin strip or other suitable fastener to fasten or attach the sleeve to a user’s face, preferably the thin strip includes an adhesive portion or is an adhesive tape or a contact adhesive tape.

[0301] Preferably, the two nose forks are integrally formed with a single corrugated delivery tube.

[0302] Preferably, the cannula is made of a liquid silicone rubber or a polymer such as a thermoplastic polymer, preferably a polymer or polymer suitable for medical breathing tubes.

[0303] Preferably, the sleeve configuration is made of one or more of the following: thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide; more preferably, the polymer can be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, it is a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0304] Preferably, this type of sleeve can be used in combination with the sleeve as defined in any of the above aspects.

[0305] In the fourteenth aspect, the present invention may be broadly described as including a user interface comprising a pair of nasal cannulas as defined in the thirteenth aspect.

[0306] Preferably, in such a user interface, the nose forks are arranged to be adjacent to each other and the individual delivery conduits extend in the opposite direction away from the nose forks.

[0307] Preferably, such a user interface further includes a wire harness that extends and couples between the nasal cannulas.

[0308] Preferably, the tube is a breathing tube.

[0309] Preferably, in such a user interface, the system is defined as in any of the aforementioned aspects.

[0310] Preferably, in this user interface, the fork head is glued or otherwise bonded to the tube.

[0311] In the fifteenth aspect, the present invention can be broadly described as including a nasal cannula configuration comprising: at least one nasal fork having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly connected to the air outlet, the at least one nasal fork including a backing liner configured to rest against a user's face, wherein a lip extends to cover at least a portion of the periphery of a rear surface of the backing liner, the rear surface being configured to receive or hold a user interface patch such that, in use, the user interface patch can be releasably attached or connected to or attached to a skin patch of a user's face.

[0312] Preferably, the lip is a barrier.

[0313] Preferably, the lip is deformable.

[0314] Preferably, the lip extends at least partially over the periphery of one of the forks that is substantially adjacent to the backing.

[0315] Preferably, the lip is a series of one or more separate lips.

[0316] Preferably, the one or more separate lips are adjacent, contiguous or overlapping lips.

[0317] Preferably, the lip is an extended circular lip that covers the periphery of the backing surface.

[0318] Preferably, in use, the lip substantially forms a fluid seal or fluid barrier between the rear surface of the backing and one of the user interface patches facing the sleeve surface.

[0319] Preferably, the backing is a substantially flat or flat or contoured (such as a pre-formed curve) backing that is assembled to rest on a user’s face.

[0320] Preferably, the backing assists in stabilizing the fork tip at one of the nostrils of a user.

[0321] Preferably, the at least one fork extends outward from the at least one nose fork, away from the nasal septum of a user.

[0322] Preferably, the bushing system is further defined by any of the aforementioned aspects.

[0323] Preferably, the bushing can operate as defined in any of the aforementioned orientations of the fixed system.

[0324] Preferably, the user interface patch is receptable or can be held on the rear surface of the backing (or backing assembly) as defined in any of the aforementioned orientations.

[0325] Preferably, at least the lip is water-repellent.

[0326] Preferably, at least the lips include at least one outer peripheral lip and at least one inner peripheral lip, each of which is provided for contacting a user’s face.

[0327] Preferably, the air inlet of the sleeve is fluidly connected to the tube as defined in any of the aforementioned directions.

[0328] In the sixteenth aspect, the present invention can be broadly said to include a component of a releasable fastener, which includes a base portion supporting a distributed mechanical fastener across its surface. The base portion is flexible but substantially non-stretchable. The base portion is divided into multiple zones by at least one slit or at least one slot, such that by independent bending of the different divisions of the base portion, the base portion can substantially conform to a lower composite bending surface.

[0329] Preferably, the base portion includes a plurality of slots or grooves or both, which together divide the base portion into a meandering body.

[0330] Preferably, the slots and / or grooves are disposed on the substrate such that a first set of at least one set of slots or grooves extends into the substrate from one edge of the substrate, and a second set of slots or grooves extends into the substrate from the other edge of the substrate, wherein the slots or grooves of one set intersect with the slots or grooves of the other set, such that a path along the substrate from one end to the other without intersecting the slots or grooves of one set follows a zigzag or meandering path that is much longer than a straight line between the two ends.

[0331] Preferably, one of the plurality of slits or slots is curved.

[0332] Preferably, the plurality of slits or slots in the slits or slots are curved and the curved slits or slots are substantially parallel.

[0333] Preferably, the slits or grooves are configured as a herringbone pattern extending from the edge of the base portion.

[0334] Preferably, the base system is divided into sections by a meandering slot or groove.

[0335] Preferably, the base portion is divided into multiple parts by a spiral slit or groove.

[0336] Preferably, the base part is divided into details by slots or grooves arranged in substantially concentric circles.

[0337] Preferably, the concentric circles are centered at approximately the center of the base portion.

[0338] Preferably, the slots or grooves divide the base into multiple islands, each island being joined to an adjacent island or multiple islands by a narrow bridge.

[0339] Preferably, the base part is divided into multiple parts by an S-shaped slit.

[0340] Preferably, the base part is divided into multiple parts by a T-shaped slit.

[0341] Preferably, the substrate covers at least 70% of the area of ​​the skin patch.

[0342] Preferably, a boundary is defined around the shortest path surrounding the base, and the base portion covers at least 80% of the area inside the boundary.

[0343] In the seventeenth aspect, the present invention can be broadly described as including a user interface assembly comprising: a fixation system for the user interface and / or a component (e.g., a tube or tubing) connected to the user interface, and a tube connected to the user interface to provide at least a portion of a breathing circuit to a user of the interface, wherein the fixation system comprises a two-part releasable attachment (or connection) configuration comprising: a skin patch and a user interface patch, the skin patch having a patient side and an interface side, the patient side of the skin patch being attachable to a user's skin (e.g., by means of an adhesive, typically a skin-sensitive adhesive such as a hydrocolloid), the interface side of the skin patch being provided to the first component of a two-part releasable attachment or connection system, and the user interface patch having an interface side and a patient side. The patient side of the user interface patch is provided with a complementary second component of the two-part releasable attachment or connection system. The interface side of the user interface patch can be attached (or connected) to the user interface and / or to a component (e.g., a tube or pipe) connected to the user interface. The tubing system includes: a tubular body, the system defining a lumen extending between open terminals of the body, an internal component surrounding and supporting the tubular body within the lumen, and a coating layer encapsulating the internal component, the coating layer securing the internal component to the tubular body.

[0344] Preferably, the interface is a nasal cannula.

[0345] Preferably, the interface system includes one or a pair of nose forks.

[0346] Preferably, the interface system includes a fixed system.

[0347] Preferably, the tube is a medical breathing tube.

[0348] Preferably, the interface is a nasal cannula configuration comprising: at least one nasal fork having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly connected to the air outlet, the at least one nasal fork including a backing configured to rest on a user's face, wherein a lip extends to cover at least a portion of the periphery of a rear surface of the backing, the rear surface being configured to receive or hold a user interface patch such that, in use, the user interface patch can be releasably attached or connected to or attached to a skin patch of a user's face.

[0349] Preferably, the lip is a barrier.

[0350] Preferably, the lip is deformable.

[0351] Preferably, the lip extends at least partially over the periphery of one of the forks connected to the backing.

[0352] Preferably, the lip is an extended circular lip that covers the periphery of the backing surface.

[0353] Preferably, the lip is a series of one or more separate lips.

[0354] Preferably, the one or more separate lips are adjacent, contiguous or overlapping lips.

[0355] Preferably, in use, the lip substantially forms a fluid (or liquid) seal or fluid barrier between the rear surface of the backing and one of the user interface patches facing the sleeve surface.

[0356] Preferably, the backing is a substantially flat or flat or contoured (such as a pre-formed curve) backing that is assembled to rest on a user’s face.

[0357] Preferably, the backing assists in stabilizing the fork tip at one of the nostrils of a user.

[0358] Preferably, the at least one backing is located away from the nasal septum of a user and extends laterally from the at least one nose fork.

[0359] It should be understood that various embodiments of the aforementioned tube can be combined with user interfaces or nasal cannulas such as those described herein.

[0360] It should be understood that various embodiments of the aforementioned fixation system may be combined with user interfaces or nasal cannulas such as those described herein.

[0361] It should be understood that multiple embodiments of the aforementioned user interface assembly can be combined as described herein in the application.

[0362] The term "includes" in the specification and claims means "at least partially constitutes". When interpreting the various statements in the specification and claims that include the term, features other than the term or prefixes may also be presented. Related terms such as "comprising" and "containing" shall be interpreted in the same manner.

[0363] The disclosure herein may also be broadly defined to include any individual or group of parts, elements and features mentioned or indicated in the description and / or disclosure herein, and any combination of any two or more of such parts, elements, features or statements disclosed herein, and when a particular integer is mentioned herein and there are known equivalents in the art related to the disclosure herein, such known equivalents are considered to be incorporated herein as if individually stated.

[0364] This article reveals the composition that includes both the preceding and following examples.

Implementation Method

[0366] Detailed Description of Preferred Embodiments Medical tubing (i.e., breathing tubing) has several limitations. Some of these limitations may stem from performance reasons, such as weight, flexibility, and flow characteristics. Other limitations may be controlled by regulatory authorities and must be met before the tubing can be used for medical purposes. Controlled limitations may include evaluating the structural integrity of the tubing and the biocompatibility or sterility of the tubing components (for hygiene purposes). One such limitation is the flow resistance induced by bending, which can be defined according to the relevant tests proposed in ISO 5367:2000(E) (Fourth Edition, June 1, 2000).

[0367] Biocompatibility of materials is useful, for example, the material can interact or come into contact with respiratory gases or other fluids, and will not leach or produce material that could be consumed or ingested by the user or patient into the respiratory gases or other fluids. Sterility can also be used to assist in the transfer or transmission of disease to the user or patient with little or no (if any).

[0368] Therefore, multiple standards must be considered during the design and testing of medical tubing, reflecting the variety of tubing available in the medical field. The specific requirements and details of different medical procedures and applications also contribute to the availability of a variety of medical tubing. The characteristics of different medical applications mean that tubing particularly suitable for a specific procedure may not meet the standards for different medical applications.

[0369] The application-specific configuration of medical tubing complicates and restricts the design process for interconnections. Furthermore, stringent regulations governing component use often require medical professionals to strictly adhere to component guidelines and instructions. Tubing

[0370] A medical tube 100 is schematically illustrated in Figure 1. In a first embodiment, the medical tube 100 is corrugated. However, the tube may also be manufactured or produced with a smooth outer surface (e.g., Figure 24) or a generally smooth inner surface (e.g., Figures 3B, 3C). In a specific embodiment, the tube 100 includes a tubular body 102. The tubular body 102 defines a lumen 107 extending between open terminals of the body 102. An internal member 110 is surrounded within the lumen 107. The internal member is a support for the tubular body. The outermost periphery of the internal member defines a plurality of staggered crests and troughs along the longitudinal direction of the tubular body.

[0371] The illustrated tube 100 has a corrugated profile and includes multiple crests 104 and troughs 105. The crests 104 and troughs 105 surround the circumference of the tube 100 and extend alternately along the tubular body 102 (or its wall) (i.e., in a direction generally parallel to the longitudinal axis 101 of the tube 100).

[0372] The tubular body 102 defines a lumen 107 extending between the two ends of the tube 100. For medical applications, the passage of gas through the tube 100 is confined within the lumen 107, and the tubular body 102 defines the outer boundary of the passage. The tube 100 preferably has an opening adjacent to the end. Ideally, the opening is configured to be substantially coaxial with the lumen (i.e., aligned with the longitudinal axis 101 in this particular embodiment) to reduce flow disturbances within the tube 100.

[0373] The illustrated tube 100 also includes a tubular body 102 that is fitted with an inner member 110 that surrounds, encloses, or encircles the tube 100. The tubular body 102 surrounds the inner member 110 within the lumen of the tube 100. The inner member 110 provides a framework defining the general shape and contributes to the structural characteristics of the tube 100. Preferably, the inner surface or inner surface of the tubular body 102 is fixed to the inner member 110. By shrinking and nesting the tubular body 102 around the inner mold 110 (e.g., Figure 3D), the tubular body 102 is applied in a molten, semi-molten, or even unhardened state to encase the inner mold, such that the inner surface of the tubular body 102 is fused and connected (or bonded) to the inner mold 110 (e.g., Figure 3C), or even by providing a tubular body having at least one inner wall layer and one outer wall layer with the inner mold sandwiched between the two layers (e.g., Figure 3B), the tubular body 102 and the inner mold 110 can be fixed together.

[0374] The internal component 110 preferably defines the basic skeleton structure, providing a longitudinal axis 101 surrounding the tube 100 and supporting the tubular body 102. The tubular body 102 is fitted around the internal component 110, and the corrugations of the tubular body 102 reflect the structure of the reinforcing skeleton provided by the internal component 110. The crests 104 of the corrugations correspond to the reinforcing ribs supporting the tubular body 102 (i.e., the shape of the internal component 110). The troughs 105 of the corrugations are preferably unsupported sections of the tubular body 102, which are suspended between adjacent reinforcing ribs.

[0375] The internal component 110, as illustrated in Figures 1, 2, 3-3D, 24A, and 24B, comprises a continuous helical skeleton having a structure similar to a helical spring. This skeleton creates helical corrugations in the tubular body 102, visible on the left side of Figure 1. In this embodiment, the internal component 110 is continuously fixed to the tubular body 102 at the crest 104 of the corrugations. The tubular body 102 conforms to the contour of the internal component 110, enclosing the various reinforcing ribs. In this embodiment, the contact interface between each reinforcing rib and the tubular body 102 may exceed half the circumferential surface of the rib.

[0376] Figure 3 illustrates another embodiment of the medical tube 200. In this embodiment, the internal component 210 includes a plurality of rings along the longitudinal axis 201 of the tube 200. Each ring 210 provides a peripheral reinforcing rib whose position coincides with the crest 204 of the tubular body 202. Individual rings form a reinforcing skeleton for the internal component 210 illustrated herein. Accordingly, the tube 200 has peripheral corrugations with separate crests 204 and troughs 205 extending around the longitudinal axis 201 along the tube 200. When the tube is twisted (i.e., when torque is applied), adjacent rings can link together to counteract the narrowing of the lumen. These rings can be formed from gaskets or discs with orifices to allow flow through them. Preferably, these rings are tortuous or annular.

[0377] Another embodiment of the tube 1100 is illustrated in Figure 24B. The tube 1100 has a structure similar to the corrugated tube 100 shown in Figure 1, including a tubular body 1102 and an internal member 1110. However, the tubular body 1102 of the tube 1100 illustrated in Figure 24B defines a smooth or uncorrugated or unwrinkled outer wall.

[0378] The internal component may have an external coating, as illustrated in the cross-sectional tube diagrams of Figures 24A and 24B. The coating illustrated in Figures 24A and 24B is approximately 35 micrometers thick and the tube wall is approximately 150 micrometers thick. The coating 1111 completely encapsulates the internal component 1110. In another embodiment, the internal component may also be preferably partially coated, such as by covering longitudinally separated sections of the coating on the internal component 1110.

[0379] The internal component 1110 may be coated to improve the bonding strength formed by the tubular body 1102, improve the biocompatibility or sterility of the tube interior, and / or separate the internal component from the tube contents (such as preventing corrosion of the internal component). Preferably, the coating layer is thin enough that it does not negatively affect the mechanical properties of the internal component, such as reduced elasticity or flexibility.

[0380] The tube in Figure 3B is typically a sandwich assembly, consisting of a thin-walled polymer tube inserted into the center of an internal component, such as a helical spring. This assembly is then extruded through a cross-shaped die, which extrudes molten material and similarly extrudes thin-walled polymer tubes to encase the assembly. Utilizing the sag of the extruded molten material and / or the pressure difference applied between the two layers by a vacuum, or by a positive pressure applied to the inside of the inner tube or the outside of the outer tube, or a combination of both, the molten outer tube contacts the inner tube. The contact of the molten outer tube with the inner tube creates a connection between them, leaving a tube composed of the inner and outer walls of the tubular body upon cooling. The internal component (e.g., a helical spring wire reinforcement) remains sandwiched between the two wall layers.

[0381] This type of tube can be formed with a fairly smooth bore to provide low flow resistance, while the outer wall layer of the tube is corrugated to assist the flexibility of the tubular body. The internal profile is mechanically locked in place by a clamping effect. Therefore, pre-coated internal profiles are not required to achieve this adhesion to the tube wall, although this option exists. The tube can be made of two thin layers bonded together with similar materials, with the internal profile (e.g., a spring) locked away from the gas path. This provides an extremely flexible yet robust roll-resistant and kink-resistant tube. The mechanically locked spring positioning helps maintain the integrity of the tube structure under axial stress, and the absence of the spring in the gas path reduces the requirements for the biocompatibility or sterility of the internal profile assembly.

[0382] The tube in Figure 3C is generally an embedded structure. In this embodiment, the tube is manufactured by extruding a polymer tube (tubular body) around an internal component (such as a helical spring) using a cross-extrusion die. A dragging speed is used to achieve sag, combining internal vacuum or external positive pressure (or both), drawing the polymer between the coils of the internal component (such as the spring) until the internal component is surrounded and mechanically locked in place. The formed tubular body is typically corrugated (flexible) and does not require a pre-coated internal component for adhesion, although this option exists. The tubular body has a sufficiently high temperature that, once it is fitted with the internal component, the tubular body self-contacts and self-welds from the extrusion heat. In this respect, the weld line or weld zone is shown as W in Figure 3C.

[0383] The tube in Figure 3D typically has a heat-shrinkable structure. It is formed by placing an internal component (e.g., a coil spring) longitudinally within a tubular body, its walls being thin and formed using heat-shrinkable tubing or energy forming. Heat (or suitable energy to cause material shrinkage) is then applied, causing the tubular body to shrink and adhere tightly to the internal component (e.g., the spring), and the shrinkage creates corrugations in the open spaces along the wall surface between subsequent wall sections supported by the internal component. This leaves a corrugated tube reinforced with an internal component (e.g., a metal wire). The corrugations result in good flexibility. If the inner surface or inner wall of the tubular body is pre-coated with a suitable adhesive, the internal component and the tube wall will be further attached or connected to each other.

[0384] The tube in Figure 3E represents yet another form. The tubular body can be formed (e.g., by extrusion) and then pulled or dragged through the inner form 110 or its interior. Thus, the inner form 110 can substantially surround the tubular body (i.e., the inner form becomes a form outside the tubular body). Refer, for example, to Figure 3E. The inner form 110 functions to support or maintain the tubular body 102 in a desired form, shape, or configuration. As in several other embodiments described herein, the inner form 110 functions to define a series of staggered crests and troughs, the circumferential surface of which defines troughs 105. The crests 104 between supported sections (via the inner form 110) are not directly supported by the inner form 110. The advantage of this structure and configuration is that it further reduces the need for pre-coating of the internal components 110 for reasons of biocompatibility or sterility (e.g., hygiene), but the internal components 110 can be pre-coated to reduce corrosion or other effects from the environment.

[0385] Several advantages of coating internal components with appropriate materials include: - Improving the overall strength and durability of the tube by more securely securing the internal component to the tubular body. - Reinforcing the tubular body to improve resistance to swelling and degradation caused by exposure to chemicals. - Improving biocompatibility or sterility by increasing the range of permissible materials that can be used in the internal component, because the coating provides a biocompatibility (or sterility) barrier or layer of material surrounding the internal component itself (perhaps the internal component can be colored to improve aesthetics and / or product identification). - Protecting the internal component from contact with the tube contents (to reduce corrosion or other degradation of the internal component).

[0386] Coating the internal components with a suitable material can mitigate the tendency of the internal components to separate from the tubular body when stress is applied to the connection, for example, when some materials swell due to exposure to certain chemicals (such as oils, alcohols and / or detergents), or when breathable materials are exposed to water vapor or aqueous solutions.

[0387] In various embodiments (e.g., Figures 1, 2, 3, 24A and 24), the internal profile supports the tubular body against narrowing and contraction of the lumen. The tubular body may advantageously be made of, constitute, or contain suitable polymers such as thermoplastic elastomers, propylene-based elastomers, liquid silicone rubber (LSR), breathable thermoplastic polyurethane, or breathable polyamide. The polymer may be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the thermoplastic elastomer family, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers, or breathable polyamide. Using breathable materials to make the tubular body can also provide the additional advantage of breathability for such medical tubing or circuits. Particularly suitable polymer materials are those having a Scholl A content of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. Such materials can also be used to assemble nasal cannula configurations, as will be described in detail later.

[0388] The tubular body may be made of, constitute, or contain a variety of thermoplastic polyurethanes, thermoplastic polyester elastomers, or liquid silicone rubber (LSR), including permeability grades. The best-chosen material grades possess advantageous mechanical properties (e.g., durability, tear resistance, and high elasticity) and selectively provide good transparency for detecting water accumulation inside the tube.

[0389] The coating layer may be made of the same or different materials as the tubular body. Preferably, the coating layer 1111 is chemically compatible with the tubular body 1102, such that the coating layer 1111 and the tubular body 1102 can be fused together to form an internal component 1110 linked to the tubular body 1102. The internal component may be made from a suitable other polymer material that is chemically compatible with the material of the tubular body 1102. In one form, the coating layer 1111 may be an impermeable material (even if the tubular body 1102 is permeable), such that the internal component 1110 is isolated from any moisture within the lumen. Preferably, both the tubular body and the coating layer may be made of, constitute, or contain durable thermoplastic polyurethane (TPU). When the tubular body is made of, constitutes, or contains thermoplastic polyurethane, the coating layer may also be made of, constitute, or contain a variety of polymers. Ideally, the polymer grade selected for the coating is tough and has good abrasion resistance to allow the internal components to be manipulated (such as rolled into a spiral) after coating.

[0390] Furthermore, the tubular body can be extruded or otherwise formed to minimize the wall thickness, thereby reducing the weight of the tube and further improving its flexibility. The internal components 110 can be made from elastic materials such as suitable metals or polymers to accommodate further bending.

[0391] Excellently, the minimum wall thickness of the tubular body helps improve the flexibility of the tube. Furthermore, this advantage stems from the tube being made of a breathable material, the breathability of which is enhanced by the reduced or minimum wall thickness. This combination of reduced or minimum wall thickness and the use of breathable materials is particularly superior when used as part of a medical breathing circuit or system.

[0392] The tube structure enhances its extensibility by accumulating the auxiliary length of the tubular body suspended between the reinforcing ribs of the internal component 110.

[0393] As shown in Figure 3E of the alternative embodiment, the tubular body is provided with additional length by means of the additional length of the tubular body suspended between the troughs formed by the internal member 110, thereby providing extensibility to the tubular body.

[0394] The additional auxiliary length of the wall causes undulations in the spacing between the internal components, allowing the tube to expand and contract longitudinally without significant narrowing of the lumen. The additional auxiliary length of the tube wall itself allows for longitudinal expansion and contraction with minimal tensile or compressive deformation, stress curling, or straightening.

[0395] The flexibility of a tube can also be improved by changing the spacing between adjacent reinforcing ribs around the periphery to accommodate bending. Changing the rib spacing around the periphery allows the internal components to simultaneously expand and contract on opposite sides of the tube to accommodate bending of the lumen, without pinching or twisting the tube, while still meeting the flexibility requirements defined by ISO 5367:2000(E) (4th edition, June 1, 2000).

[0396] Furthermore, the internal components may be conductive. Conductive internal components can assist in various optional additional features for the operation or use of such tubes. For example, the internal components may be (or may contain) a heater. For example, the internal components may contain one or more components.

[0397] In another embodiment, the internal component may include one or more conductive components, heaters or sensors (e.g., flow sensors, temperature sensors, humidity sensors, pressure sensors, etc.).

[0398] In some embodiments, the tube may include a heater such as an electric heater (e.g., heater wire, heater circuit, etc.).

[0399] Installing a heater or heating element can help maintain the humidity of the gas passing through the pipes and other related components. Heating can also alleviate the problem of "exterior dripping". Installing sensors can effectively assist in providing data feedback systems, aiding the connected heater control system or information feedback to the user monitor or surveillance system.

[0400] It should also be understood that the internal component 110 can be provided with a variable or altered pitch along the longitudinal direction of the tubular body.

[0401] In another aspect of the invention, one or more internal profiles 110 may be provided. In this way, the internal profiles may be provided in a double helix or other configuration to support the tube, while still maintaining the flexibility and extensibility of such a tube structure.

[0402] The medical tubing structure described above and illustrated, for example, in Figures 1-3E, 24A, or 24B, is particularly suitable for user interfaces, where a short, dedicated length of the tubing is coupled to the interface to the respiratory system. The flexibility and extensibility of the tubing compensate for patient movement, while the internal component 110 counteracts narrowing of the gas lumen (e.g., pinching, kinking, and rolling) caused by forces attributable to movement.

[0403] The tube can be used for both adults and newborns, but is well-suited for newborn interfaces, where the tube is minimally required. For example, a newborn interface tube according to the illustrated structure may have an inner diameter (or lumen diameter) of about 1.5 mm to about 4.5 mm, an outer diameter of about 1.6 mm to about 4.6 mm, and a wall thickness of about 0.05 mm to about 0.25 mm. Preferably, the inner diameter is about 2.4 mm to about 3 mm, the outer diameter is about 2.6 mm to about 3.4 mm, and the wall thickness is about 0.1 mm to about 0.2 mm.

[0404] The internal diameter (or lumen diameter) of the tubular body may be from about 1.5 mm to about 4.5 mm, or from about 1.6 mm to about 4.4 mm, or from about 1.7 mm to about 4.3 mm, or from about 1.8 mm to about 4.2 mm, or from about 1.9 mm to about 4.1 mm, or from about 2.0 mm to about 4.0 mm, or from about 2.1 mm to about 3.9 mm, or from about 2.2 mm to about 3.8 mm, or from about 2.3 mm to about 3.7 mm, or from about 2.4 mm to about 3.6 mm, or from about 2.5 mm to about 3.5 mm, or from about 2.6 mm to about 3.4 mm, or from about 2.7 mm to about 3.3 mm, or from about 2.8 mm to about 3.2 mm, or from about 2.9 mm to about 3.1 mm. The internal diameter (or lumen diameter) can be approximately 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, or 4.5 mm.

[0405] The outer diameter of the tubular body may be about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm. The outer diameter can be approximately 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, or 4.6 mm. Preferably, it is approximately 3 mm to approximately 5 mm.

[0406] The wall thickness of the tubular body may be from about 0.05 mm to about 0.25 mm, or from about 0.06 mm to about 0.24 mm, or from about 0.07 mm to about 0.23 mm, or from about 0.08 mm to about 0.22 mm, or from about 0.09 mm to about 0.21 mm, or from about 0.10 mm to about 0.20 mm, or from about 0.11 mm to about 0.19 mm, or from about 0.12 mm to about 0.18 mm, or from about 0.13 mm to about 0.17 mm, or from about 0.14 mm to about 0.16 mm. The wall thickness can be about 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, or 0.25 mm. Preferably, it is about 0.1 mm to about 0.2 mm.

[0407] The tubular body may have a corrugation depth of about 0.1 mm to about 0.5 mm.

[0408] The corrugation depth can be defined by the distance between a point at the minimum radius of the longitudinal axis (centerline) of the tubular body and a point at the maximum radius of the longitudinal axis (centerline) of the tubular body.

[0409] In one embodiment of the present invention, the ratio of the distance between the inner components to the outer diameter (e.g., the outermost diameter) of the inner components is about 0.10 to about 0.50, preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0410] In another embodiment, the ratio of the inner part diameter (e.g., the diameter of the actual inner part element or component) to the outer diameter (e.g., the outermost diameter) of the inner part is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and more preferably 0.06.

[0411] In yet another embodiment, the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09.

[0412] Furthermore, another embodiment may require the physical properties of the tubular body to necessitate that the tube have the desired flexibility and / or structural support.

[0413] This size of tubing is useful for newborns because, despite the limited gas flow lumen, it still meets the peak inspiratory flow requirements of newborns. The small and lightweight tubing reduces pressure on the infant's face and minimizes visual obtrusion at the interface. The flexibility and light weight of the tubing enhance patient comfort and simplify the fit and adjustment process for physicians.

[0414] The internal components are preferably made of stainless steel wire, preferably grade 302, 304, or 306, or other elastic materials with suitable biocompatibility or sterility, and can be wound into a spiral skeleton of appropriate size to support the tubular body. Ideally, the outer diameter of the spiral skeleton is from about 1.7 mm to about 4.4 mm, and the metal wire used to form the skeleton may have a diameter of from about 0.05 mm to about 0.3 mm. The spacing between the spiral skeletons is preferably from about 0.4 mm to about 1.8 mm to provide the desired tube flexibility, but may be from about 1 mm to about 1.5 mm. Preferably, the outer diameter of the spiral skeleton is from about 2.4 mm to about 3.4 mm, the wire diameter is from about 0.15 mm to about 0.2 mm, and the spacing between the spiral skeletons is from about 0.8 mm to about 1.4 mm.

[0415] The outer diameter of the internal components (e.g., the spiral skeleton) may be from about 1.7 mm to about 4.4 mm, or from about 1.8 mm to about 4.3 mm, or from about 1.9 mm to about 4.2 mm, or from about 2.0 mm to about 4.1 mm, or from about 2.1 mm to about 4.0 mm, or from about 2.2 mm to about 3.9 mm, or from about 2.3 mm to about 3.8 mm, or from about 2.4 mm to about 3.7 mm, or from about 2.5 mm to about 3.6 mm, or from about 2.6 mm to about 3.5 mm, or from about 2.7 mm to about 3.4 mm, or from about 2.8 mm to about 3.3 mm, or from about 2.9 mm to about 3.2 mm. The outer diameter of the helical skeleton can be approximately 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

[0416] The diameter of the internal components (or the lines used to form the skeleton) may be about 0.05 mm to about 0.30 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.10 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.22 mm, or about 0.14 mm to about 0.21 mm, or about 0.15 mm to about 0.20 mm, or about 0.16 mm to about 0.19 mm. The diameter of the wire used to form the skeleton can be approximately 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, or 0.30 mm. Preferably, it is approximately 0.1 mm to approximately 0.4 mm.

[0417] The distance between internal components (e.g., spiral skeletons) may be from about 0.40 mm to about 1.80 mm, or from about 0.45 mm to about 1.75 mm, or from about 0.50 mm to about 1.70 mm, or from about 0.55 mm to about 1.65 mm, or from about 0.60 mm to about 1.60 mm, or from about 0.65 mm to about 1.55 mm, or from about 0.70 mm to about 1.50 mm, or from about 0.75 mm to about 1.45 mm, or from about 0.80 mm to about 1.40 mm, or from about 0.85 mm to about 1.35 mm, or from about 0.90 mm to about 1.30 mm, or from about 0.95 mm to about 1.25 mm, or from about 1.00 mm to about 1.2 mm, or from about 1.05 mm to about 1.15 mm. The spacing between the helical skeletons can be approximately 0.40 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.6 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.95 mm, 1.0 mm, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm, 1.3 mm, 1.35 mm, 1.4 mm, 1.45 mm, 1.5 mm, 1.55 mm, 1.6 mm, 1.65 mm, 1.7 mm, 1.75 mm, or 1.8 mm. Preferably, it is approximately 1 mm to approximately 1.5 mm.

[0418] In various forms of the invention, internal components can be provided to a tubular body having variable or varying spacing. In this way, once the internal components become parts constituting the tube, the spacing between the internal components can be variable. Variable spacing can have particular advantages, including increased areas of strength / support or flexibility. Such a system can also be used to support even thinner-walled tubular bodies.

[0419] In yet another embodiment, the varying spacing allows for variations in the density of the internal profile per unit tube length. This configuration is useful when the internal profile or a component of the internal profile serves as a heating source or sensor for gas flowing through the tube.

[0420] The internal component 110 may comprise a single continuous turn or multiple turns of wire linked end-to-end to form a helical skeleton, element, or rib. Alternatively, the internal component may comprise multiple separate rings. These rings may be linked longitudinally along the tube. Metal wire, elongated polymer, or other suitable couplings (including multiple wires or elongated polymers) may extend along the lumen to link the rings. Multiple links may be spaced apart around the periphery of these rings.

[0421] For neonatal use, an alternative to the tube is a transparent polyvinyl chloride (PVC) tube typically used to support and supply breathing air to a nasal cannula. The preferred user interface is independently supported by the interface tube (e.g., a dedicated skin liner), allowing for unrestricted tube movement and greater flexibility. Tube manufacturing method.

[0422] In addition to those described above, the medical tube may be manufactured by providing a tubular body that encloses an inner form (or, in another embodiment, by having an inner form enclose a tubular body). The tubular body defines a lumen and generally surrounds the inner form. In one embodiment, during manufacturing, decompression may be applied to the inner (or to) lumen, such that the decompression drags the tubular body radially inward along the lumen and the outermost periphery defined by the inner form. The outermost periphery of the inner form may define a plurality of staggered peaks and troughs along the longitudinal direction of the tubular body. The tube may also be made with a smooth surface, as shown in Figure 24B. In another embodiment, during manufacturing, elongation (or stretching) may be applied to a portion or area of ​​the tubular body surrounding the inner form, such that the elongation (or stretching) returns (or allows) the elongated (or stretched) portion or area of ​​the tubular body to drag the lumen and the outermost periphery defined by the inner form radially inward, the outermost periphery defining a plurality of staggered peaks and troughs along the longitudinal direction of the tubular body.

[0423] In another embodiment, the combination of applying pressure to the lumen and elongating (or stretching) to the tubular body can be used to manufacture the tube.

[0424] Figures 4 and 5 illustrate an apparatus for manufacturing reinforced medical tubing. The illustrated apparatus includes an extruder 310 and a connected die 317. Raw material (typically thermoplastic beads, but may be any other form of raw material as a masterbatch) is fed into the extruder, where it is heated and pressurized or passed through the die 317 to form a tubular body of medical tubing 301, such as the tubing discussed above. The tubing 301 then advances through an air purging tube 340, where air passes through the tube 301 to cool the tubular body.

[0425] A device for clamping or applying elongation (or stretching) to the tubular body may be used. In this way, the tubular body is allowed to stretch to fit around or encircle the inner form, and then, when the elongation (or from the stretched state) is released to the clamping relationship with the inner form, it takes on the outermost peripheral shape defined by the inner form.

[0426] Potential materials for forming the tubular body include thermoplastic elastomers, propylene-based elastomers, thermoplastic breathable polyester elastomers, liquid silicone rubber (LSR), breathable thermoplastic polyurethane, or breathable polyamide, such as those discussed above with a Shore A of about 30 to about 90.

[0427] The raw material for the tubular body is fed, for example, into a hopper 312 mounted at the top. The hopper 312 allows the raw material to enter the extruder 310's barrel through a funnel under the action of gravity or another suitable feeder system. The feed screw 313 is housed within the extruder's barrel and feeds the material along the barrel toward the die 317. The feed screw 313 is coupled to a rotary drive 314, rotating the screw about a longitudinal axis.

[0428] The material is heated to a molten or semi-molten state inside the barrel. As the raw material moves along the barrel, the barrel can be actively heated or heated by friction, which is sufficient to melt the material.

[0429] Suitable extrusion machines for manufacturing medical tubing are supplied by Welex. Welex extrusion machines, equipped with a 30-40 mm diameter screw and typically a 12-16 mm annular die with a 0.5-1.0 mm clearance, have been found suitable for the rapid production of low-cost tubing. Similar extrusion machines are exemplified by Kuhne (Germany), AXON Plastics Machinery (Sweden), AMUT (Italy), and Battenfeld (Germany and China).

[0430] To assist in the co-extrusion of the tubular components, the tubular body material can be fed tangentially into the die head 317. As the inner mold advances through the die head 317, the tubular body can be extruded to enclose the inner mold, with the molten or semi-molten tubular body laid on the inner mold. During cooling, the molten tubular body preferably adheres to the inner mold, firmly fixing the various components of the tubular body together.

[0431] In this specific embodiment, the die 317 (illustrated in Figure 5) is adapted to be configured orthogonally to the extruder 310, having a side port 320 adjacent to the extruder outlet 315. Molten or semi-molten material leaving the extruder 310 is fed into the side port 320 of the die 317 and released into the peripheral compartment. The peripheral compartment exits at a nozzle 325, through which the inner profile 302 is stretched. The pressure generated by the extruder 310 forces the material around the inner profile 302 through the narrowing section 325, so that the tubular body 301 directly extrudes and fits the inner profile. Preferably, the inner profile advances continuously through the die 317 at a substantially constant rate (but the advance rate can be adjusted to change the thickness along the tubular body at a constant extrusion rate).

[0432] The suction system is applied to the inside of the die head through the vacuum port 321. The suction reduces the internal pressure of the extruded tube, causing the molten or semi-molten tubular body to be drawn onto the internal mold and forming corrugations on the inner surface of the tube. Preferably, the tubular body from the extrusion process is still adhesive enough to hold the internal mold.

[0433] Pressure reduction is applied inside the tubular body or lumen, for example, by applying a vacuum or reducing pressure to the lumen channel. Furthermore, the pressure reduction can be relative or comparative. For example, the pressure surrounding the tubular body can be increased so that the pressure inside the tube is considerably lower than the pressure around the tubular body. In this way, the tubular body experiences a pressure difference that encourages it to be pulled (or pushed) radially inward. The pressure inside the lumen and outside the tubular body can therefore be any suitable pressure that results in the lumen having a lower pressure than around the tubular body. Therefore, the inner surface of the lumen is pulled or pushed (by pressure difference) into contact with the inner profile, forming or having the outermost circumferential shape of the inner profile in the embodiments illustrated in Figures 1, 2, 3, and 24A. Part of the tubular body may be drawn in radially inward beyond the outermost circumferential surface of the inner profile without the support of the inner profile, thus further emphasizing the shape defined by the inner profile.

[0434] When the internal component is coated (e.g., for the tubes in Figures 24A and 24B), the coating must shield it from excessive heat to prevent damage. In one particular embodiment, the internal component may be manufactured from wire made from medical-grade stainless steel (but non-medical-grade materials may also be used, requiring an encapsulating coating to provide a biocompatible layer or a sterile and corrosion-resistant barrier). The wire may be encapsulated in a suitable coating by being drawn through a material bath. The increased temperature of the coating material in the bath may also partially sterilize the wire by killing any biological contaminants.

[0435] For example, coating a metal wire with an appropriate polymer grade involves drawing the wire through a molten polymer bath at a temperature exceeding 150°C, but could be, for example, exceeding 180°C or about 200°C (a temperature sufficient to allow the polymer melt to coat the surface of the internal part). Once the coating has sufficiently cooled, the wire can be used to form the internal part. The internal part can be manufactured by spirally winding the coated wire around a mandrel.

[0436] In other examples, the internal part can be coated or encapsulated by dip coating in a polymer bath or by applying polymer to the internal part via an extrusion die. Other applications

[0437] It is anticipated that this embodiment will identify other medical applications that are particularly suitable. For example, applications requiring lightweight and high flexibility, with sufficient resistance to rolling, squeezing, and kinking, include delivery and disposal limbs in surgical humidification systems, including applications where the use of breathable medical tubing is preferred. User Interface

[0438] This tube can be incorporated into a user interface, such as a nasal cannula, to deliver breathing air to a user. An illustrative nasal interface incorporating this tube is shown in Figures 6 to 12. The illustrated interface 400 includes a pair of nasal prongs 402. Each prong 402 is coupled to one end of a tube 401. The other end of the tube 401 can be coupled to a supply catheter to interconnect the prongs 402 to the respiratory system. The tube 401 can be coupled to individual supply catheters, or additionally combined (e.g., via a Y-coupling or other suitable connector such as a manifold) to form a single connector with supply catheters and auxiliary delivery of breathing air to the interface 400. One embodiment of the user interface 400, illustrated in Figure 12, is shown as being worn by an infant.

[0439] Each fork 402 defines a lumen extending between the user end 410 and the tube end 415 of the fork 402. The tube end 415 of the fork 402 is coupled to the interface tube 401. The user end 410 of the fork 402 is configured to deliver breathing air to the user's nostrils and is connected to an orifice 411 for this purpose. The orifice 411 may be configured concentrically with the end of the fork 402, so that the flow out of the fork 402 is minimally disturbed. The tube end of the fork 402 may be anatomically shaped and / or closely conform to the user's nostrils, while the end of the fork 402 (i.e., the end connected to the orifice 411) is, for example, bent away from the nasal septum to reduce the possibility of irritation.

[0440] The user end 410 and the pipe end 415 of the fork 402 are connected by an arched bend connector. In this specific embodiment, the user end 410 and the pipe end 415 are configured to be approximately orthogonal, with the bend connector at approximately 90 degrees. Preferably, in one form, the bend connector may have a smooth transition between two adjacent sections of the fork 402 (corresponding to a larger radius of curvature) to reduce flow interference within the fork 402.

[0441] The interface tube 401 is coupled to the tube end 415 of the fork head 402. Preferably, the fork head 402 is coupled to the tube 401 to form an integrated assembly. In this specific embodiment, the tube end 415 of the tube 401 and the fork head 402 is configured to be concentric with the fork head 402 extending around the tube 401. Preferably, most of the tube end section 415 is formed to cover the tube 401 to increase the contact area and strengthen the connection between the fork head 402 and the tube 401.

[0442] The fork heads 402 are preferably kept apart. In this specific embodiment, a backing or wiring harness 403 is coupled to the two-nose fork heads 402. The backing 403 preferably maintains the fork heads 402 in a fixedly spaced relationship. Different interface 400 sizes can be manufactured to accommodate variations in the nose spacing.

[0443] The illustrated backing 403 also includes a housing 404 that generally surrounds or captures at least a portion of the tube end 415 of the fork 402. The housing 404 is coupled with a coupling 405 for attaching a helmet to securely position the interface 400. On both sides of the tube 401, a pair of forks 406 project outward from the backing 403. The forks 406 increase the contact area between the interface 400 and the patient, distributing the interface holding force over a larger area and reducing the pressure applied to the user's face.

[0444] The user side (i.e., the side facing away from the user's face) of the backing 403 and fork 406 can be outlined to reflect the intended anatomical structure. The backing 403 and fork 406 can also be made of flexible material to allow the structure to adapt to a specific individual's face.

[0445] The fork holder may include a portion that allows the user (or caregiver) to more easily pull or tear the fork holder 106 off the user's skin or skin patch. Such a fin improves the ease of application / removal of the interface from the user.

[0446] The housing 404 may incorporate ribs between the front of the fork carriage 406 and the portion of the housing 404 that connects the fork head 402 and the interface tube 401, as illustrated in Figures 12 and 13. When the interface 400 is secured to the user, the ribs increase the usable interface contact area for the medical tape. The ribs also increase the torsional rigidity of the fork carriage, assisting in stabilizing the position of the fork head 402.

[0447] The fork head 402, backing 403, and fork carriage 406 are preferably made of a suitable polymer. Preferably, individual sleeves (e.g., fork head 402 and tube 401) are formed by a sleeve molding process in which the fork head 402 fits over the outside of the tube 401. The sleeve molding process typically involves inserting one end of a preformed tube 401 into a suitable mold, while the material used to manufacture the fork head is injected into the outside of the tube inside the mold, retaining the tube 401. Preferably, the fork head 402, backing 403, and fork carriage 406 are both formed by a single sleeve molding process to create a completely integrated interface.

[0448] The configuration or design of the fork head can take various forms. In a preferred embodiment, a delivery tube sleeve enclosing a molded fork head and / or sleeve is described in U.S. Patent Publication No. 2010 / 0192957, the entire contents of which are incorporated herein by reference. Fork Head

[0449] Another preferred geometry of the nose fork head is illustrated in Figures 25A to 25D, combining a common base support pad and a face support pad, illustrated in Figures 26A to 26D, and shown in close-up in Figures 27A and 27B. The numbering features of the fork heads illustrated in these figures are indicated by similar numbers to the same features presented in the previous figures (Figures 6 to 13) (but prefixed to identify specific embodiments).

[0450] In Figures 25A to 25D, the geometry of the fork head 1402 is illustrated by scan lines 1420 representing the fork head track and ellipses 1130 to 1135 representing the shape and orientation of the lumen within each fork head along a specific track. Each fork head 1402 follows a scan path and is shaped to conform to the anatomical geometry / curvature / contour of the user's nostrils. The fork heads are molded or shaped to conform to the anatomical shape and curvature of the user's nostrils. Ideally, the fork heads maximize the gap between the fork head and the internal structure of the nostrils by anatomically matching the nostril path.

[0451] In a preferred embodiment, the fork tip is pre-molded or pre-formed according to the anatomical shape of the nostril, as opposed to a fork tip made of a material that conforms to the anatomical shape of the nostril.

[0452] The geometry of the fork heads, illustrated below, will be described with respect to the interface being fixed to the user's face during use. The interface is configured such that the fork heads 1402 are arranged approximately symmetrically around the user's sagittal plane. Each fork head extends from a base 1415 provided on a common support extending along the user's upper lip. The fork heads 1402 are spaced apart on the support to avoid the nasal septum. The spacing of the fork heads 1402 at the base 1415 is selected to present the maximum gap between the fork heads and the user's nasal septum (at the base of the nose) for each face size range (i.e., a specific interface size) corresponding to each interface.

[0453] The initial stages of each forkhead track 1420 before the base 1415 are represented by ellipses 1130 and 1131 (first stage). During this stage, the forks are substantially coaxial with the individual breathing tubes. The scanning path of the two tracks 1420 generally extends along the user's upper lip from both sides of the sagittal plane toward the nasal septum. The forkhead 1402 scans relative to the user's upper lip through a slightly posterior or rearward curve (towards the user's coronal plane), as illustrated by the rotation of the lumen (represented by the change in direction of ellipses 1130, 1131, and 1132). The internal flow path defined by the shape of the lumen remains circular during this stage.

[0454] From the base 1415, each fork 1402 scans upwards or upwards (away from the transverse plane) toward the user's head, and backwards or backwards (towards the user's coronal plane) relative to the user's upper lip. Between ellipses 1131 and 1133 (second stage), the fork lumen smoothly transitions along the user's upper lip from a generally mid-lateral direction to a predominantly inclined backward direction, guiding the gas flow toward the upper rear of the user's head. During this stage, the fork lumen slightly narrows into an elliptical shape to utilize the available space inside the nostrils.

[0455] In the third stage (between ellipses 1133 and 1134), the fork head continues along the inclined rearward track, towards the upper rear of the user's head (away from the lateral plane and towards the coronal plane), smoothly reducing the inclination rate (the upper component of the fork head track 1420 causes the lumen to move away from the lateral plane). During this stage, the fork head 1402 has negligible convergence towards the sagittal plane (or mid-lateral component). During this stage, the fork head lumen further narrows, becoming more elliptical.

[0456] In the final stage (between ellipses 1134 and 1135), the fork head 1402 continues along an inclined rearward trajectory, slightly converging towards the sagittal plane from the middle to the outer side. The middle to the outer side convergence of the fork head 1402 begins at the beginning of the fourth stage of the adjacent ellipse 1134 (or slightly earlier), at the reversal point of the illustrated trajectory. Adjacent to the final ellipse 1135, there is a second reversal point that reduces the convergence of the fork head, orienting the fork head outlet 1411 rearward (towards the coronal plane), with a slightly middle to the outer side component towards the sagittal plane (indicated by the direction of the final ellipse 1135 in Figure 25B).

[0457] During the fourth stage, the inclination rate of the fork track 1420 continues to decrease until the individual tracks 1420 are substantially parallel to the transverse plane of the fork outlet 1411 (denoted by ellipse 1135). The middle and outer sides and vertical adjustments of the adjacent last ellipse 1135 fork track 1420 are used to position the fork outlet 1411 substantially aligned with the upper respiratory tract passage to reduce soft tissue irritation caused by exhaled breathing gas. The fork lumen of the outlet 1411 is elliptical, with the main axis of the ellipse positioned substantially on the transverse plane. The outlet 1411 guides breathing gas upward or upward toward the top of the user's head (away from the transverse plane) and backward or backward (towards the user's coronal plane).

[0458] The shape of the fork tip 1402 (both the track and the lumen) illustrated in Figures 13, 14, and 25 to 27 avoids contact with the user's nasal septum, thus reducing the risk of injury to tissues in this area. By aligning the fork tip outlet with the user's upper respiratory tract, the fork tip improves user comfort and therapeutic efficacy. The lumen shape maximizes the longitudinal cross-sectional area of ​​the fork tip and minimizes flow resistance by utilizing the anatomically available space in the patient's nostrils. The fork tip lumen is shaped to avoid sealing the user's nostrils.

[0459] An independent gas source can supply each fork. In this way, when a pair of forks are used, one fork can be supplied with breathing gas, while the other fork can be supplied with medical gas, such as gas used to improve the user's respiratory therapy or breathing.

[0460] This anatomical fork tip may have a shaped track that matches the anatomical shape of the user's nostrils. In the first part (or stage) of this fork tip, the track moves horizontally toward the midline of the face. In the second part (or stage) of this fork tip, the track curves upward directly into the nostrils toward the top of the head. In the third part (or stage) of this fork tip, the track follows the anatomical curvature of the nostrils into the head. And in the fourth part (or stage), the track is horizontally inclined toward the center of the cannula to align with the outflow port and the user's upper respiratory tract.

[0461] This type of anatomically shaped fork has a cross-section that changes along the central track. For example, the cross-section is approximately circular at the base of the track and becomes approximately elliptical towards the track or fork tip. Furthermore, the diameter of the cross-section approximately decreases along the track from the first section (or stage) to the end of the fourth section (or stage).

[0462] The fork tip is preferably made of a soft, flexible material to further reduce trauma to the soft tissues of the nostrils. One example of a potential material is a biocompatible thermoplastic elastomer or liquid silicone rubber (LSR).

[0463] The nasal interface 1400, which incorporates the fork 1402, is illustrated in Figures 26A to 26D, 27A, and 27. The interface includes the nasal fork 1402, a common support extending below the nose along the patient's upper lip and supporting the nasal fork 1402, a pair of forks or face pads 1406, and integrally formed tubes 1401, all generally symmetrically spaced about the sagittal plane. The interface is formed as a single, unified component, with the tubes 1401 directly connected to the base 1415 of the nasal fork 1402. The open distal ends of each integrally formed tube 1401 are assembled to receive a suitable breathing tube (such as tube 100). The breathing tube may be attached or otherwise secured to the interface tube 1401. The face pads 1406 are anatomically shaped with distributed and calibrated curvatures reflecting the facial geometry of the intended user. The anatomical shape of the face pad 1406 allows the interface to match the user's face at a predetermined position, where the contour of the face pad 1406 matches the user's facial contour. The pre-shaped face pad 1406 compensates for the anatomical anatomy of the nose fork 1402, improving the placement of the nose fork 1402 while maintaining accuracy and speed inside the user's nostrils.

[0464] The pre-shaped or contoured face pad 1406 conforms to the user's facial features, reducing pressure applied to the patient's face by any holding mechanism (adhesive tape, helmet, or other device). This reduces the possibility of pressure-induced pain. The anatomical shape of the face pad 1406 facilitates engagement, improving the stability of the interface 1400 and the nose fork head 1402, and thus enhancing comfort and therapeutic efficacy.

[0465] In another embodiment, a nasal cannula configuration 2000 is provided, comprising at least one nasal fork 2001, the fork or each fork 2001 having an air outlet 2002 adapted for insertion into a user's nostril, and an air inlet 2003 in fluid communication with the air outlet 2002. At least one nasal fork 2001 includes a backing 2004, the backing 2004 being assembled to rest against a patient's face, and at that location, a lip portion 2005 extending around at least a portion of the periphery of the rear surface 2006 of the backing 2004. The backing 2004 is assembled to receive or hold a user interface patch 2007. In use, the user interface patch 2007 can be releasably attached or connected to, or can be fixed to, a skin patch 2008 on the user's face. Lips

[0466] The lip 2005 is generally designed as a barrier to provide a seal, such as a fluid seal. However, it should be understood that the lip 2005 is designed as a solid barrier, rather than necessarily a fluid seal, and is sufficient to prevent most fluids (such as nasal or oral mucus, or milk or fluids used to wash the user's face) from leaking under the backing 2004 to the back surface 2006.

[0467] Ideally, the lip 2005 operates to prevent most of the fluid from leaking beneath the backing 2004 to the rear surface 2006. Otherwise, such leakage would impair the adhesion or connection between the user interface patch 2007 and the user's face or the skin patch 2008 applied to the user's face. This series of patches provides a fixation system for positioning the nasal cannula relative to the user's nostrils, or assists in positioning the nasal cannula in a better location or position. Such fluid leakage would also result in blockage on the face-to-face interface surfaces of the user interface patch 2007 or the skin patch; thus, the patch surface would become odorous or sticky and unhealthy. Such damage should be avoided as much as possible, as it would be unpleasant to the user or their caregiver, or even affect the ability of the nasal cannula to maintain a better position. The lip 2005 is positioned around the rear surface 2006 of the backing 2004 in an attempt to minimize one or more of these harmful effects.

[0468] According to this embodiment, the lip 2005 is deformable. For example, the lip 2005 can be shaped such that a portion of the lip contacts the user's face, or the skin patch 2008 can be bent or flexible. In this way, when pressure is applied to the lip 2005, such as when pressure is applied by the bonding force between the user interface patch 2007 and the skin patch 2008, the lip 2008 can be allowed to deform to more effectively conform to its contact surface, improving the possibility of more effective fluid sealing or fluid barrier.

[0469] This lip 2005 may extend at least around the periphery (or part of the periphery) of the backing 2004, for example, around a region substantially adjacent to one of the connected forks. For example, the lip 2005 is configured to block most of the flow system from the rear of the backing in the user's mouth and nose area. In other words, nasal mucus leaving the user's nostrils or saliva leaving the user's mouth may drip back into the backing of the nasal cannula (depending on the user's head position), or even during breastfeeding, milk leaking from the baby's mouth and dripping into the area surrounding the nasal cannula configuration 2000. Also, washing the baby's or user's face may generate fluid that drips into the area surrounding the nasal cannula 2000.

[0470] All such fluids (and others not necessarily mentioned above) may affect the effectiveness of the fixation patch system used to secure or position the sleeve to the user's face. Furthermore, negative effects from odorous or sticky substances clogging the fixation patch are undesirable.

[0471] Accordingly, in one embodiment, a lip 2005 is preferably provided to extend from the backing 2004 to at least one area of ​​the rear surface 2006, near or adjacent to the nose fork 2001 or the user's nostril. In this case, the lip 2005 may not extend entirely around the periphery of the backing.

[0472] In other embodiments, the lip may be formed from a series of smaller or segmented lips, which may or may not be adjacent to each other to assist in forming a barrier or seal. For example, as shown in Figure 35, a series of segmented lips may be provided, extending together around part or all of the rear surface 2006 of the backing 2004. The lip 2005 may be generated or formed from a series of one or more separate lips, as shown in Figure 35. Furthermore, these segmented lips may be adjacent, adjacent, or even overlapping each other when forming the lip 2005.

[0473] In this way, the lips can work together to form a barrier or seal against fluid intrusion.

[0474] However, it should be understood that the lip 2005 can be configured to extend completely around the periphery of the backing. In this case, the lip 2005 will be a continuous, endless lip.

[0475] The lips may be formed (or treated) with water-repellent properties or characteristics, thereby further helping to reduce the passage of liquid through the lip barrier.

[0476] The portion of the lips that contacts the user's skin can be spoon-shaped. For example, the lips can have a contoured shape to effectively provide a pair of parallel, spaced lips, an outer lip and an inner lip as a whole. In this way, each set of lips contacts the user's skin, helping to provide a liquid barrier or seal. It should also be understood that a series of parallel lips can be used.

[0477] As mentioned above, the backing 2004 may be substantially planar or flat or even contoured (such as the pre-shaped curve shown in Figures 28-34) and is assembled to rest against the user's face. The backing 2004 may generally extend laterally from at least one nose fork 2001, away from the user's nasal septum. This backing 2004 may assist in operation as a stabilizing element for the nose fork 2001 within the user's nostrils. In this respect, this backing 2004 may include the various rib features described in other embodiments.

[0478] It should also be understood that the nasal cannula configuration 2000 of this embodiment may have a pair of nasal forks 2001 for insertion into the user's nostrils, each fork 2001 having adjacent or connected backings 2004. When a pair of forks 2001 are provided, the forks may be independent of each other, or the fork structures may be joined together using a wiring harness to provide additional stability, as previously described in other embodiments.

[0479] The sleeve 2000 of this embodiment may additionally include the features of the fluid connection (or integrally formed) tubes 100, 200, 400, 1100 as described herein, and / or may utilize the user interface patch and skin patch fixing system 500, 600 as described herein, and / or may have a permissible air inlet fluidly connected to the reinforced medical tubes 100, 200 as described herein. Furthermore, it should be understood that the nose fork 2001 may be any of the fork shapes or configurations described above, including the anatomical fork shape shown in Figures 25A-27B.

[0480] One embodiment of the nasal cannula 2000 is shown in Figures 28-34.

[0481] Figures 28 and 29 show a nose cannula configuration 2000 with a backing 2004 connected to a skin patch 2008 fixed to the user's face. The lip area 2005 is shown in contact with the skin patch 2008, thereby providing a fluid barrier to prevent fluid from leaking to the backing 2004 and the underside of the rear surface 2006 where the user interface patch 2007 is fixed. As shown, the user interface patch 2007 is located inside the lip area 2005.

[0482] Figures 30-34 show further details of the nasal cannula 2000.

[0483] As shown in Figures 31 and 34, the rear surface 2006 is initially not provided with a user interface patch; that is, the rear surface 2006 is assembled to receive or fix the user interface patch 2007. This user interface patch 2007 can be attached to the rear surface 2006 by adhesive or other suitable connectors. Once the patch is in place, it is ready to be attached to or receive a skin patch.

[0484] In one embodiment, the user interface patch may be a component of a two-part connection system, such as a ring in a hook and loop system. In this case, the surface of the skin patch 2008 facing the interface will include a hook that engages with the ring of the user interface patch. Referring to Figure 32, a user interface patch with a ring fixed to its rear surface 2006 is illustrated, ready to be connected to the hook of the skin patch.

[0485] Figure 33 shows a cross-sectional view of a sleeve 2000 through which a hook 2009 with a skin patch engages with a ring 2010 of a user interface patch. It also shows a lumen 2011 or gas passage through which gas is supplied from the inlet of the sleeve to the outlet 2002 of the nose fork 2001. Fixation system

[0486] An example of a fixation system for securing a user interface and / or user interface tube to a patient is shown in Figures 15 to 17. Fixation system 500 is shown as supporting a nasal cannula on an infant's face.

[0487] Advantageously, the system provides a generally faster and more easily modified or simplified user interface for user positioning. Furthermore, these effects also facilitate improvements or simplifications in applying other user interfaces or removing user interfaces from the user when the user cycles between different treatments (such as gas therapy, for example, continuous positive airway pressure (CPAP) or high-flow applications).

[0488] Some user interfaces are specifically designed to interact with or respond to the system of the described embodiments. In addition, unmodified user interfaces can be responded to by the described embodiments and can be located quite easily, with minimal installation time involved.

[0489] In several embodiments provided by a fixed system, such a system can provide rapid positioning of the interface to the user and can provide reliable positioning of the interface.

[0490] An easy-to-position user interface is particularly useful for users. Providing a system that allows caregivers (such as nurses) to apply the fixation system with one hand is especially beneficial when the user of the interface is an infant.

[0491] In another embodiment, the fixing system provides a first level of fixing of the user interface to the user. For example, this first level of fixing may be as shown in Figures 15 to 17. When the user requires additional or higher security for the user interface positioning or fixing, a second level of interface fixing may be used. This additional layer may be achieved by applying a patch, such as patch 660. Such patch 660 may be an adhesive patch and may be mounted on the user interface and / or the top of the tube and adhered to a portion of the skin patch 550.

[0492] The fixation system 500 includes a two-part releasable attachment or connection configuration 551. The releasable connection configuration 551 acts between a pair of patches, respectively fixing them to the patient and user interfaces.

[0493] The first patch is a skin patch 550 that is adhered to or otherwise attached to the patient's skin. The skin patch has a user side facing the user's skin and an interface side facing the user interface. The user side of the skin patch 550 can be attached to the user's skin by means of a sensitive skin adhesive such as a hydrophilic colloid. The user interface side of the skin patch is provided with a first component 553 of a two-part releasable attachment or connection configuration 551.

[0494] The second patch is a user interface patch 552. The user interface patch 552 also has a patient side and an interface side. When the system 500 is engaged, the patient side of the user interface patch 552 is provided with an adjacent skin patch. A complementary second component 553 of a two-part releasable attachment or connection configuration is fixed to the patient side of the user interface patch 552, so that individual components of the two-part releasable attachment or connection configuration 551 can easily engage when patches 550 and 552 are close together. The interface side of the user interface patch 552 is fixed to the user interface. The user interface patch can be integrated with the user interface or appropriately adhered to it.

[0495] A portion or corner of the user interface patch 552 may include an area not attached to the skin patch 550. Its general purpose is to allow an area (or fin) to be more easily grasped by the user or caregiver to be removed from or detached from the interface. For example, the backing 2004 also includes such a corner area.

[0496] The two-part releasable attachment or connection configuration 551 may include hook and loop material (such as Velcro), a magnet or an array of magnets disposed on individual patches with appropriate perforations, and an adhesive configuration that actuates when the two patches are pressurized to adhere or coupled to another suitable release liner. The interface side of the skin patch 550 may have one of the hook or loop materials, while the patient side of the user interface patch 552 may have the other of the hook or loop materials, such that the skin patch and the user interface patch are releasably attached or connected to each other.

[0497] When referring to hook and ring materials, it refers to any of a wide variety of regional mechanical fasteners. For example, the Vickers product range includes hook and ring products where the hook assembly includes an upright nylon hook (formed as a cut ring through a woven backing sheet) that engages any complementary ring stack material. The Vickers product range also includes raised hook products, typically smaller in size and matched with "fluffy" nonwoven fiber backing materials. These hook materials are designed to work with a range of ring substrates, and in some cases, these hook materials are also used as ring substrates. Other similar systems include the Dual-Lock reusable fastener system from 3M in St. Paul, Minnesota, USA. A common feature of these reusable fastener systems is engagement at any contact point between the two components of the system. Because multiple connectors are distributed throughout the product area, precise alignment of individual connectors is not required. A wide range of releasable fastener systems within this field can be used in releasable attachment systems to provide releasable attachment between skin patches and user interfaces.

[0498] A two-part releasable attachment or connection system may be bonded to the interface side of a skin patch with an appropriate adhesive and occupy up to 100% or less than about 90%, or about 85%, or about 75%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or about 10% of the interface side surface area of ​​the skin patch.

[0499] According to several embodiments, the skin patch 550 is generally a planar pad with a thickness less than both its width and length. In several embodiments, the pad has an overall oval shape, but may be other shapes.

[0500] The pad includes a first component 553 of a two-part releasable attachment system 551. In several embodiments, the skin patch is structured such that the first component 553 of the releasable attachment system includes a substrate and a plurality of fasteners (having effective hooks, effective rings, or other elements) disposed across the area of ​​the substrate. The substrate is secured to the body of the skin patch. In several embodiments, the substrate is secured by an adhesive or by direct adhesion during skin patch formation.

[0501] In several embodiments, the substrate area is smaller than the skin patch area and is positioned on the skin patch so as not to reach any edge of the skin patch. In this manner, the substrate edge extends from the edge of the skin patch around the periphery of the substrate. Patch

[0502] In several embodiments, the substrate of the first component of the two-part releasable attachment system is flexible, such that the substrate plane can be bent to conform to a surface that bends in one direction. However, the substrate is typically not also stretchable to conform to a surface that bends in two orthogonal directions. However, the padding of the skin patch can be stretchable and conformable to surfaces that bend in more than one direction, such as conforming to the contour of the body worn on the patient.

[0503] According to several embodiments, this difficulty can be mitigated by providing a first component 553 of a two-part releasable attachment system, wherein the first component is in the form of a base portion divided into multiple regions by at least one slit or at least one slot, such that different components of the base portion can be bent independently, thus the overall form of the base portion can be deformed to substantially match a surface bent in two directions. This also applies even if the base portion is bent in only one direction at individual locations.

[0504] Examples of this form are illustrated in Figures 36B to 36R. The padding profile of a skin patch is illustrated in Figure 36A. This configuration is particularly useful for shape types where complex curvature is the biggest problem, where two or more bends of the substrate interact easily. Typically, such shapes are fat, short, wide, short and fat, or short and fat without being slender. For example, such shapes will have a short perimeter relative to their area. If it is concave or hollow around the perimeter, consider the virtual perimeter, which is the shortest enclosing path outside the shape. Such shapes will have a small ratio of the square of the length of this virtual perimeter to the area of ​​the shape. The lowest ratio is about 12.6:1 for a circle, about 16:1 for a square, and 18:1 for a 2-to-1 rectangle. Although more slender shapes have higher ratios, for example, a 5-to-1 rectangle has a perimeter square to area ratio of 29:1. In several embodiments, the improvement described with reference to Figures 36B to 36R is particularly well-suited for patch shapes having a ratio of the square of the shortest perimeter length to the perimeter interior area of ​​less than 25. In other embodiments, the improvement described with reference to Figures 36B to 36R is particularly well-suited for releasable attachment base portions having a ratio of the square of the shortest perimeter length to the base coverage area of ​​less than 25.

[0505] As with the variations in Figures 36A-36R, the substrate can be formed into multiple discontinuous parts, but the preferred form of the substrate is a single continuous part.

[0506] In some embodiments, the releasable attachment base substantially covers the entire area of ​​the skin patch 550. In other embodiments, the base substantially covers a large portion of the skin patch area, such as 50% or more, 60% or more, 70% or more, or 80% or more of the skin patch area.

[0507] Referring to Figure 36A, in several embodiments, the skin patch 550 includes a generally elliptical or oval body 3602 with a small outer extension 3600 at one end. In a preferred embodiment, this shape does not have acute angles. Rounded or radiused corners or curved edges are less likely to be lifted than acute angles. In several specific embodiments of the fastener base, the fastener base includes an overall shape that generally matches the overall shape of the skin patch 550, including extensions into the extension 3600.

[0508] In the specific embodiments of Figures 36B, 36F, 36G, and 36H, the base portion does not extend entirely into the edge of the skin patch 550. A narrow section is maintained between the skin patch edge and the base edge, surrounding at least a portion of the edge. This narrow section may extend around the entire periphery of the base. In several embodiments, such as the embodiment of Figure 36B, this section between the edge of the skin patch 550 and the base edge may be wider in some locations than in others. For example, in Figure 36B, a wider section 3615 is provided intended to be positioned away from the nose. This provides attachment to a section closer to the nose, but allows the user to begin tearing away from the section farther from the nose to release the releasable fastener. Other embodiments of Figures 36C to 36R may provide a base size and positioning configuration on the skin patch. For example, in various cases, the example configuration may be constructed to a smaller area of ​​the skin patch and positioned closer to the nose end of the skin patch.

[0509] The size of other specific embodiments may not extend to the edge of the skin patch. Generally, in the embodiments of Figures 36B to 36R, the substrate portion comprises a crouching overall shape, occupying a high percentage of the internal area of ​​the stretched periphery (the shortest path surrounding the shape). In general, the substrate portion is formed as a single body, but may also be formed from a plurality of closely interwoven minor bodies (e.g., two bodies), as in Figure 36R. Within this body, the substrate is divided into multiple and / or elongated shapes by at least one slot or slit, such that adjacent portions (or sub-portions) of the substrate are opposite each other across the slot, slit, or gap. Depending on the configuration of the slot, slit, or gap (or multiple slots, slits, or gaps), the substrate allows the underlying skin patch to be stretched in one or more directions, except by bending or forming a composite curve. Several prominent features and characteristics will then be described with reference to different substrate portions and configurations.

[0510] In each case, certain aspects of the embodiments are described. Different variations can be constructed using these aspects. An aspect of one embodiment can be easily combined with aspects of other embodiments. The configuration of slots or grooves may be oriented in other directions, or may be mirrored or reversed.

[0511] The substrate 3603 in Figure 36B is generally meandering. The substrate has one end adjacent to the first end 3304 of the skin patch and a second end adjacent to or toward the second end 3305 of the skin patch. The substrate is shaped as a series of loops divided by slits 3306. 3306 may be perpendicular to a line between ends 3304 and 3305 or at some other angle. For example, the slits 3306 may be angled such that the upper end of each slit is closer to the first end 3304 than the lower end of each slit, or vice versa, the lower end of each slit is closer to the first end 3304 than the upper end of each slit. There may be at least three slits, at least four slits, or at least five slits. The meandering shape provides that the shortest uncut path between the first end and the second end of the substrate is at least twice the actual linear distance between these locations.

[0512] The serpentine slit series provides the intersection of the serpentine path, which can be bent in different directions to allow the substrate to conform to the underlying composite surface. For example, the bend 3307 can be bent independently of the straight section 3308, and the outer surface of the skin patch pad is allowed to bend and protrude in two orthogonal directions.

[0513] The meandering shape of the substrate 3603 includes curved or radiusd corners. Curved or radiusd corners are less likely to be lifted, for example, by accidental contact, than acute corners. Similar modifications may be made to any of the embodiments illustrated in Figures 36B to 36R.

[0514] The base portion of Figure 36C is broadly similar to the base portion of Figure 36B. The illustrated base portion 3309 completely covers the skin patch. One end fills the first end 3304 of the skin patch, while the other end reaches the other end 3305 of the skin patch. A series of staggered slits 3310 reach the staggered edges of the base portion, causing the meandering body to extend between the two ends 3304 and 3305. The base portion illustrated in Figure 36C has substantially the same flexible characteristics as the base portion of Figure 36B.

[0515] The base portion of Figure 36D generally has the same structure as the base portion of Figure 36C, but the base portion 3311 of Figure 36D includes a slit 3312, which is further away from the nose tip 3304 at the upper end than at the lower end, while the slit 3310 of the base portion of Figure 36C is closer to the nose tip 3304 at the upper end than at the lower end.

[0516] Other similar meandering shapes are provided by the base portion 3313 in Figure 36G and the base portion 3318 in Figure 36H. In these cases, narrow slots are provided along the longitudinal direction of the base portion to divide the base portion into a series of adjacent islands 3321 and 3322 respectively. The slots 3318 and 3319 are wider than the slits in the aforementioned embodiments. A series of narrow bridges 3323 and 3324 are respectively joined between the islands 3321 and 3322, so that the patch forms a continuous meandering structure. The continuous meandering structure or the monolithic structure improves the ease of positioning the base portion on the skin patch.

[0517] In the embodiment shown in Figure 36G, the slot 3319 is substantially orthogonal to a line between the ends 3304 and 3305 of the skin patch. In Figure 36H, similar to Figure 36C, the slot 3320 is oriented so that its upper end is closer to the nose tip 3304 than its lower end. In these embodiments, the width of each bridge 3323, 3324 is much smaller than the slot length. For example, the average bridge width may be less than 0.2 or less than 0.1 of the average slot length.

[0518] Other meandering embodiments will be described below with reference to Figures 36M, 36O and 36E.

[0519] Another base configuration including a series of islands connected by bridges is illustrated in Figure 36F. In this embodiment, the base portion 3325 includes islands 3326 and slots 3327. Bridges 3328 connect the islands. In this illustrative form, the bridge system of Figure 36F is positioned along the midline between ends 3304 and 3305. This configuration can be described as having a central member and a series of leaf portions extending from both sides of the member. In this specific embodiment, the slots 3327 extend inwardly at equal intervals from each edge. These slots are oriented substantially perpendicular to the line between ends 3304 and 3305. The slots 3327 extend inwardly from the edges on opposite sides of the aligned axis. In addition, the slots 3327 may be staggered. As in Figures 36H and 36B to 36D, the slots 3327 may be oriented at a non-orthogonal angle relative to the line between ends 3304 and 3305.

[0520] In the configurations of Figures 36B, 36C, 36D, and 36F to 36H, the slots or slits are substantially parallel to each other. In the configuration of Figure 36E, a series of slits 3329 and 3330 extend on opposite sides of the substrate. In this embodiment, the first set of slits 3329 is oriented at a non-parallel angle relative to the second set of slits 3330. More specifically, in this particular embodiment, the upper end of the slit 3329 is further away from the end 3304 of the skin patch than the lower end, while the upper end of the slot 3330 is closer to the end 3304 of the skin patch than the lower end. In some embodiments, the slits 3329 and 3330 pass through the centerline of the substrate (extending from the centerline of end 3304 to end 3305), such that there is no straight path between ends 3304 and 3305. The slits 3329 and 3330 form a herringbone pattern.

[0521] The embodiments described in Figures 36B to 36H are generally regular patterns. Figure 36I illustrates an embodiment with a more irregular pattern. In this embodiment, the substrate 3331 substantially covers the entire surface of the skin patch and is divided by irregular slits. For example, slit 3333 extends in an approximately S-shape from an adjacent edge 3304, creating a series of interlacing fingers from either side of the substrate 3331. A second slit 3333 extends from one edge of the substrate adjacent edge 3305 of the skin patch. This slit form includes a corner or a dogleg and divides into a cross slit 3335 at the intersection 3334. Slits 3332 and 3333 divide the area of ​​the substrate 3331 into multiple zones or segments of approximately equal width, having interlacing fingers and long joints. In this embodiment, the slit is mostly integrated into the base portion 3331, and is only connected to the edge of the base portion 3331 at two locations.

[0522] The similar arrangement of the interlacing fingers is evident in the base portion 3336 of Figure 36J and the base portion 3337 of Figure 36R. In the base portion 3336 of Figure 35J, a single narrow slot 3337 with a small width extends longitudinally along the base portion from one edge of the adjacent end 305 of the base portion to the adjacent edge end 3304 via a meandering path. In this embodiment, the single slot 3337 touches the edge of the base portion 3336 only at one location. The slot 3337 divides the base portion 3336 into two main parts, each including a series of fingers 3338 and 3339. The fingers 3338 and 3339 are interlaced. The position of the slot 3337 and the long leg direction of the bend 3341 orient the fingers 3338 and 3339 along a direction that crosses but forms an angle with a line between the ends 3304 and 3305.

[0523] In another embodiment illustrated in Figure 36R, a single meandering slot 3342 extends from the upper edge of slot 3337 to the lower edge of slot 3337. Slot 3342 extends along a meandering path including a straight portion 3343 and a bend 3344. This divides slot 3337 into two laterally separated portions, each including an elongated finger 3345. The fingers of one portion intersect with the fingers of the other portion. In this embodiment, the intersecting fingers are substantially oriented along a line extending between parallel ends 3304 and 3305.

[0524] Another embodiment, including a single slot or slit, is illustrated in Figure 36K. In this embodiment, the single slit 3346 extends in a generally helical configuration from the adjacent end 3305 at the edge location to a position generally centered on the base portion 3347. The helical slit 3346 divides the base portion 3347 into a single continuous helical base material. In several embodiments, multiple helical slits begin at different positions around the periphery of the base portion 3347, dividing the base portion into multiple intersecting helices of base material.

[0525] The embodiment in Figure 36Q includes a substantially continuous curved slit, while the embodiments in Figures 36B to 36J and 36R mainly use straight slits, although there are curved portions in some cases. Figures 36K to 36P illustrate other base portion embodiments with curved slits.

[0526] In the embodiments of Figures 36K and 36L, the base portions 3348 and 3349 are each divided by a plurality of curved slits 3350, which are generally arranged in a series of concentric circles in each example. Some of the slits 3350 extend from the edges of the base portions 3348 and 3349.

[0527] Other slots 3351 begin and end inside the bodies of base portions 3348 and 3349. For example, in base portion 3348, each slot 3351 draws an arc greater than 315 degrees but less than 360 degrees, creating circular and annular portions inside base portion 3348, which are connected to other portions of base portion 3348 by narrow bridges. The slots 3351 in base portion 3349 operate in a similar manner to create circular and annular portions connected by narrow bridges.

[0528] In Figure 36K, the arrangement of slits 3350 and 3351, and especially the bridges between the portions divided by these slits, allows the continuous uncut material between the ends 3305 and 3304 of the base portion and the center 3352 of the base portion to form a meandering path. In Figure 36L, the arrangement of the curved slits 3350 and the substantially circular slits 3351 makes the bridges substantially aligned, thereby providing a straighter path between at least one end 3305 of the base portion and the center 3352 of the base portion.

[0529] Another series embodiment is illustrated in Figures 36N to 36P. In this series, base portions 3353, 3354, 3355, and 3356 are each divided by a series of narrow curved slots, each slot extending from the upper or lower edge of the base portion into the interior of the base portion body. The base portions are arranged in parallel. In some embodiments, the spacing between the curved slots is substantially uniform along the longitudinal direction of the base portion. In some embodiments, the slots extend across most, but not entirely, the width of the base portion. For example, the slots extend across more than 70%, more than 80%, or more than 90% of the width of the base portion. The slots may have radiusized corners at their closed ends.

[0530] In the configuration shown in Figure 36M, the slots extend from alternating sides of the base portion, with slots 3357 and 3358 extending from the upper edge of the base portion, and slots 3359 and 3360 extending from the lower edge of the base portion. This divides the base portion into a generally meandering length. In this embodiment, the curvature of each base slot is such that the upper and lower ends of each slot are further away from end 3304 than the middle portion.

[0531] In the embodiment of Figure 36N, all four curved slots 3361 extend from the same edge of the base portion. This shape is like a comb, with a series of fingers extending in the same direction from a single spine. As for embodiment 36N, in this example, the slots are curved such that the upper and lower ends of each slot are further away from the first end 3304 of the skin patch than its middle portion.

[0532] Figure 360 ​​illustrates yet another embodiment similar to the embodiment in Figure 36N. In Figure 360, curved slots 3362 and 3363 extend from the lower and upper edges of the substrate, respectively. The slot series 3362 intersects with the slot series 3363, forming a continuous path that meanders or spirals along the substrate. In the embodiment of Figure 360, the upper and lower ends of each curved slot are further away from the first end 3304 of the skin patch than its middle portion.

[0533] Another variation is illustrated in Figure 36P. In this embodiment, the curved slot 3364 extends from the same edge of the substrate. It may extend from the upper or lower edge. All the curved slots 3364 are arranged in a parallel configuration. The upper and lower ends of the curved slots are further away from the first end 3304 of the skin patch than the middle portion.

[0534] Another embodiment of the user interface and / or tube fixation system is illustrated in Figures 18 to 23. The fixation system 600 includes a skin patch 650 and a fixation patch 660. The fixation patch 660 extends over the user interface and / or tube and adheres to the skin patch 650 to fix the user interface and / or tube to the patient.

[0535] The skin patch 650 defines a fixed footprint to be attached to the patient and has a similar configuration to the skin patch 550 corresponding to the previous fixing embodiment. The user side of the skin patch 650 is assembled to be attached to or adhered to the user's skin.

[0536] The fixation patch 660 extends over the user interface and / or the associated user interface tube and adheres to the skin patch 650 to secure the user interface to the patient. The fixation patch 660 and the skin patch 650 are assembled to allow the fixation patch to be contained within or demarcated by the fixation footprint of the skin patch when the fixation system is applied to the patient with a suitable or compatible user interface. The fixation patch 660 is contained within the fixation footprint of the skin patch 650, reducing unnecessary contact with the patient's skin and the possibility of potential irritation. Ideally, the skin patch 650 has the same or larger surface area as the fixation patch 660.

[0537] Regarding embodiments where the interface includes a two-part releasable attachment to a skin patch, in this embodiment including the fixing patch 660, the skin patch 650 is provided with a connection system element for releasably connecting the fixing patch 660. For example, the skin patch 650 may include one component of a two-part mechanical fastening system traversing its surface or part of its surface, while the fixing patch 660 has the other component of the fastening system.

[0538] In this way, the size of the skin patch can reduce the possibility of applying tape or any additional tape extending onto the user's skin. It is preferable to avoid or reduce the application, or repeated application and removal of adhesive to the user's skin. This embodiment advantageously reduces the need for repeated application of adhesive or tape to the user's skin to mount and position the user interface in the operating position. Adhesive tape or other skin adhesive patches (when repeatedly applied and removed) pose particular problems for infants. Problems include, but are not limited to, skin irritation caused by adhesive chemicals (or adhesive removal chemicals, such as solvents) or tape chemicals (e.g., due to skin sensitivity), and damage to the user's skin caused by repeated application and removal of skin patches or tape to position or reposition the interface to the user. When therapeutic treatments are repeated cyclically (i.e., from one type of treatment to another, and then repeated again), repositioning or adjustments may be required. Therefore, the embodiment preferably provides a system for placing or positioning the user interface while still reducing the possibility of problems related to adhesive tape adhering to the user's skin.

[0539] It is important to understand that repositioning interfaces, especially for infants, has several interconnected drawbacks and problems. These include "lion's nose," skin abrasions, or skin allergies, stemming from the traditional tape technique of applying user interfaces (e.g., nasal cannulas) to the user. These problems also occur when users repeatedly switch between different treatment options, traditionally involving removing the helmet or tape or user interface, and then installing a new device and user interface or interface positioning helmet or other armor. Therefore, proposing a fixation system that is ready to receive the user interface when applied to the user is a significant advancement towards reducing the problems previously faced by users. Furthermore, improved ease of installation is an added benefit in terms of both complexity and the time and effort required from caregivers (e.g., nurses).

[0540] The fixing patch can be shaped or otherwise assembled to accommodate the geometry or other features of the user interface and / or the connected user interface tube. An illustrated fixing patch has multiple wings 661 to accommodate the user interface tube and increase the contact area of ​​the fixing patch 660 exposed to the skin patch 650. The fixing patches illustrated in Figures 22 and 23 each have a pair of wings disposed at one end of the patch. The wings 661 are assembled to secure the skin patch to either side of the user interface and / or the connected user interface tube, and to reduce the possibility of bulges around the interface and / or tube around 660.

[0541] The fixing patch 661 illustrated in Figure 22 also has a tube end wing 661. The tube end wing 661 is assembled to extend below the user interface tube and fix to the skin patch 650 to connect the end of the fixing patch 660.

[0542] A second embodiment of the fixation system can be used to fix the tube to any part of the patient's body. The embodiment illustrated in Figures 15 to 23 is assembled to attach the user interface to the patient's face, particularly near the user's upper lip and / or cheek. The illustrated fixation system is suitable for neonatal use.

[0543] The user side of skin patches 550 and 650 preferably has a skin-sensitive adhesive (such as a hydrocolloid) to bond the patch to the user's skin, so that the application of each fixation system causes as little irritation as possible. Skin patches 550 and 650 preferably have sufficient surface area to distribute adhesive and interfacial holding forces over a sufficient area of ​​the user's face to reduce the accumulation of local pressure.

[0544] The fixation system illustrated in the figure is specifically designed to receive and / or secure the previously disclosed nasal cannula and associated tube. The tube may extend from one or both sides of the user's face. Furthermore, the fixation system may be assembled such that the user interface is secured to the skin patch via a two-part detachable attachment or connection configuration and a fixation patch above the interface and / or tube.

[0545] While certain embodiments have been described herein, other embodiments that will be readily apparent to those skilled in the art also fall within the scope of this disclosure. Thus, numerous changes and modifications may be made without departing from the spirit and scope of this disclosure. For example, multiple components may be repositioned as desired. Furthermore, not all features, aspects, and advantages are necessary for implementing this disclosure. Therefore, the scope of this disclosure is intended to be defined only by the following claims.

[0546] It should be understood that the various embodiments described above and referenced in the accompanying drawings can be combined with each other to achieve desired or advantageous results. For example, the tube can be connected to a sleeve attached to the present invention, or can be used in combination with other sleeves not specifically described herein. Similarly, the sleeve of the present invention can be used in combination with the fixation system of the present invention, or can be used in combination with or interchangeably with other fixation systems. Furthermore, the anatomically shaped fork head of the present invention can be combined with the aforementioned tubes, interfaces, or fixation systems, or can be used in combination with or interchangeably with other tubes, interfaces, or fixation systems. The combination of the foregoing various embodiments is particularly advantageous. Preferred features

[0547] SP1. A corrugated medical tube comprising: a tubular body defining a lumen extending between open ends of the body, and an inner member surrounding the lumen and supporting the tubular body, the outermost periphery of the inner member defining a plurality of staggered crests and troughs along a length of the tubular body. SP2. The tube claimed in SP1, wherein the tubular body is an extruded tube. SP3. The tube claimed in either SP1 or SP2, wherein the tubular body is a continuous tube. SP4. The tube claimed in any one of SP1 to SP3, wherein the tubular body is a continuously extruded tube. SP5. The tube claimed in any one of SP1 to SP4, wherein the crests of the corrugated tubular body are defined by the outermost periphery of the inner member. SP6. A tube as claimed in any of SP1 to SP5, wherein the troughs of the corrugated tubular body are defined by the inward withdrawal of the internal component and by the inward withdrawal portion of the tubular body. SP7. A tube as claimed in any of SP1 to SP6, wherein the internal component is a continuous length, a single or series of semi-continuous lengths, or a series of separated lengths. SP8. A tube as claimed in any of SP1 to SP7, wherein the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting rods. SP9. A tube as claimed in any of SP1 to SP8, wherein the internal component is a support for the tubular body that internally defines the lumen. SP10. A tube as claimed in any of SP1 to SP9, wherein the internal profile is a skeleton or internal support structure supporting the tubular body. SP11. A tube as claimed in any of SP5 to SP10, wherein the tubular body is substantially supported by the internal profile on the peaks rather than on the troughs. SP12. A tube as claimed in any of SP5 to SP11, wherein the wall of the tubular body is suspended between adjacent peaks. SP13. A tube as claimed in any of SP5 to SP12, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes. SP14. The tube claimed in any of SP1 to SP13, wherein the tubular body is a breathable tube or made of a breathable material, such as a breathable thermoplastic polyurethane or a breathable polyamide. SP15. The tube claimed in any of SP1 to SP14, wherein the internal component is a spirally wound rib or rib element.SP16. The tube claimed in any of the requested forms SP1 to SP15, wherein the internal component is a helical winding element having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. SP17. A tube as claimed in any of the following samples SP1 to SP16, wherein the inner part has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. SP18. A tube as claimed in any of the following specifications SP1 to SP17, wherein the internal component is a spirally wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm. SP19. The tube claimed in claim SP18, wherein the internal component is made of a medical-grade material, preferably medical-grade stainless steel. SP20. The tube claimed in any one of claims SP1 to SP19, wherein the tubular body has a thickness of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm.SP21. A tube as claimed in any of SP1 to SP20, wherein the tubular body has an internal diameter of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm. SP22. A tube as claimed in any of SP1 to SP21, wherein the tubular body has an outer diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. SP23. The tubular system claimed in any of samples SP1 to SP22 is (preferably extruded therefrom) a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber (LSR), a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; more preferably, the polymer may be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic... The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably polymers having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. SP24. A tube as claimed in any of SP1 to SP24, wherein the internal element is a plurality of rings spaced longitudinally along the lumen. SP25. A tube as claimed in SP24, wherein the rings are in the shape of a tortuous surface or annular. SP26. A tube as claimed in any of SP1 to SP25, wherein the internal element is one or more separate elements linked together.SP27. A tube as claimed in any of SP1 to SP26, wherein the internal profile consists of a plurality of reinforcing ribs regularly spaced along the lumen. SP28. A tube as claimed in SP27, wherein each reinforcing rib comprises one turn of a helical reinforcing line. SP29. A tube as claimed in SP28, wherein one turn of the helical reinforcing line comprises a complete turn around the lumen. SP30. A tube as claimed in SP28, wherein one turn of the helical reinforcing line comprises the line located between adjacent crests of the internal profile. SP31. A tube as claimed in any of SP1 to SP30, wherein the tubular system is defined as flexible by the test of increased flow resistance with bending according to ISO 5367:2000(E) (4th edition, June 1, 2000). SP32. A tube as claimed in any of SP1 to SP31, wherein one end of the tube is integrated with a nose fork for insertion into a user's nostril to deliver breathing air to a user's nasal interface. SP33. A tube as claimed in any of SP1 to SP32, wherein the internal component is a screen. SP34. A tube as claimed in any of SP1 to SP33, wherein the internal component is a wire suitable for heating or sensing the properties of the gas inside the tube. SP35. A tube as claimed in any of SP1 to SP34, wherein the internal component is conductive, preferably a heater. SP36. A tube as claimed in any of SP1 to SP35, wherein the internal component includes a conductive element, a heater, or a sensor (such as a flow, temperature, humidity, or pressure sensor). SP37. A tube as claimed in any of SP1 to SP36, wherein the tube further includes a heater, more preferably an electric heater (such as a heater wire or heater circuit). SP38. A tube as claimed in any of SP1 to SP37, wherein the tube is a breathing tube. SP39. A tube as claimed in any of SP1 to SP38, wherein the ratio of the distance between the inner components to the outer diameter (e.g., the outermost diameter) of the inner components is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29. SP40. The tube claimed in any of the claimed forms SP1 to SP38, wherein the ratio of the diameter of the inner component (e.g., the diameter of the actual inner component element or member) to the outer diameter of the inner component (e.g., the outermost diameter) is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06. SP41. The tube claimed in any of the claimed forms SP1 to SP38, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09.SP42. A tube as claimed in any of SP1 to SP38, wherein the physical characteristics of the tubular body necessitate that the tube possess the desired flexibility and / or structural support. SPM11. A method of manufacturing a medical tube, the method comprising: providing an inner form protruding from a tubular body that encloses the inner form, the tubular body defining a lumen surrounding the inner form. SPM12. The method claimed in SPM11, further comprising: i) applying a decompression within (or to) the lumen such that the decompression radially inwards the tubular body within the lumen or by the outermost periphery defined by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body; or ii) applying an extension (or stretch) to at least a portion or region of the tubular body surrounding the inner profile such that release of the extension (or stretch) returns (or permits) the extended (or stretched) portion or region of the tubular body to (or permits) the lumen or by radially inwards the outermost periphery defined by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body; or iii) a combination of i) and ii). SPM13. The method claimed in SPM11 or SPM12, wherein the tubular body is provided by extrusion or by extruding a material from a die. SPM14. The method claimed in any of SPM11 to SPM13, wherein the tubular body is extruded around the inner mold, and the pressure reduction is applied in a manner that allows one inner surface of the tubular body to be at least partially attached to or connected to at least a portion of the inner mold, preferably the pressure reduction difference between the pressure inside the lumen and the pressure surrounding the tubular body, more preferably the pressure inside the lumen (supplying the lumen) is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than the pressure inside the lumen (supplying the lumen)). SPM15. The method claimed in any of SPM11 to SPM15, wherein the tubular body is a single-walled body. SPM16. The method claimed in any of SPM11 to SPM16, wherein the pressure reduction is applied on or adjacent to the formation of the lumen. SPM17. The method claimed in SPM14, wherein the pressure reduction is applied on or adjacent to a die. SPM18. The method claimed in SPM14, wherein the lumen experiences decompression as it exits an extrusion die. SPM19. The method claimed in any of SPM11 to SPM18, wherein the tubular body and the internal profile are co-extruded. SPM110. The method claimed in any of SPM11 to SPM18, wherein the tubular body thus formed is corrugated.SPM111. The method claimed in any of SPM11 to SPM110, wherein the crests of the corrugated tubular body thus formed are defined by the outermost periphery of the inner member. SPM112. The method claimed in any of SPM11 to SPM111, wherein the troughs of the corrugated tubular body thus formed are defined by the inwardly withdrawn portions of the tubular body drawn inward between the inner members. SPM113. The method claimed in any of SPM11 to SPM112, wherein the inner member is a skeleton or internal support structure supporting the tubular body. SPM114. The method claimed in any of SPM11 to SPM113, wherein the inner member is a continuous length, a series of semi-continuous lengths, or a series of separated lengths. SPM115. The method claimed in any of SPM11 to SPM113, wherein the internal component is a screen. SPM116. The method claimed in any of SPM11 to SPM113, wherein the internal component is a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting rods, or a combination thereof. SPM117. The method claimed in any of SPM11 to SPM117, wherein the internal component supports or supports the lumen within the tube thus formed. SPM118. The method claimed in any of the requested forms SPM11 to SPM113 or SPM117, wherein the internal component is a spiral wound element having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. SPM119. The method claimed in any of the requested forms SPM11 to SPM113 or SPM117, wherein the internal part has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.SPM120. The method claimed in any of the requested samples SPM118 or SPM119, wherein the internal component is a spirally wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm. SPM121. The method claimed in claimed embodiment SPM120, wherein the internal component is a medical-grade material, preferably medical-grade stainless steel. SPM122. The method claimed in any one of claimed embodiments SPM11 to SPM121, wherein the tubular body has a thickness of one of the following: about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm. SPM123. The method claimed in any of the requested forms SPM11 to SPM122, wherein the tubular body has an internal diameter of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.SPM124. The method claimed in any of the requested forms SPM11 to SPM123, wherein the tubular body has an outer diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. SPM125. The method claimed in any of SPM11 to SPM124, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes. SPM126. The method claimed in any of SPM11 to SPM125, wherein the tubular body is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide; more preferably the polymer can be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic... The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably polymers having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. SPM127. The method claimed in any of the requested embodiments SPM11 to SPM126, wherein the tubular body is a breathable tube, or is made of a breathable material, such as a breathable thermoplastic polyurethane (type) or a breathable polyamide. SPM128. The method claimed in any of SPM11 to SPM127, wherein the pressure reduction is applied when the tubular body is in a molten, semi-molten, or unhardened state, preferably the pressure reduction is about 0 to about -2 Pa (absolute), more preferably about 0 to about -1 Pa (absolute), even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably such pressure reduction is a pressure difference between the inner side of the lumen and the area surrounding the tubular body. SPM129. The method claimed in any of SPM11 to SPM128, wherein the internal component is conductive, preferably the internal component is a heater.SPM130. The method claimed in any of SPM11 to SPM129, wherein the internal component includes a conductive element or a heater or sensor (such as a flow, temperature, humidity, or pressure sensor). SPM131. The method claimed in any of SPM11 to SPM130, wherein the tubing further includes a heater, preferably an electric heater (such as a heater wire or heater circuit). SPM132. The method claimed in any of SPM11 to SPM131, wherein the tubular system is defined as flexible by the test of increased flow resistance with bending according to ISO 5367:2000(E) (4th edition, June 1, 2000). SPM133. The method claimed in any of SPM11 to SPM132, wherein the medical tubing is a breathing tube. SPM134. A tube as claimed in any of SPM11 to SPM133, wherein the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is from about 0.10 to about 0.50, more preferably from about 0.20 to about 0.35, and even more preferably from about 0.28 or about 0.29. SPM135. A tube as claimed in any of SPM11 to SPM134, wherein the ratio of the diameter of the internal component (e.g., the diameter of the actual internal component element or member) to the outer diameter (e.g., the outermost diameter) of the internal component is from about 0.02 to about 0.10, more preferably from about 0.05 to about 0.07, and most preferably 0.06. SPM136. A tube as claimed in any of SPM11 to SPM135, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09. SPM137. A tube as claimed in any of SPM11 to SPM136, wherein the physical characteristics of the tubular body necessitate that the tube possess desired flexibility and / or structural support. SP21. A medical tubing system comprising: a tubular body defining a lumen extending between open terminals of the body; an internal member surrounding and supporting the tubular body within the lumen; and a coating layer encapsulating the internal member, the coating layer securing the internal member to the tubular body. SP22. A medical tube as claimed in SP21, wherein the coating layer and the tubular body are fused along the tube. SP23. A medical tube as claimed in SP21 or SP22, wherein the coating and the tubular body are fused together along the tube at a separated position. SP24. A medical tube as claimed in SP22, wherein the coating and the tubular body are substantially continuously fused together along the longitudinal direction of the tube. SP25. A medical tube as claimed in any one of SP21 to SP24, wherein the outermost periphery of the inner part defines a plurality of alternating peaks and valleys along a length of the tubular body.SP26. A tube as claimed in SP25, wherein the crests of the corrugated tubular body are defined by the outermost periphery of the internal member. SP27. A tube as claimed in SP25 or SP26, wherein the corrugated tubular body is defined by an inwardly withdrawn portion of the tubular body drawn inward between the internal members. SP28. A tube as claimed in any of SP21 to SP27, wherein the internal member is a continuous length, a series of semi-continuous lengths, or a series of separated lengths. SP29. A tube as claimed in any of SP21 to SP28, wherein the internal member is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting rods. SP210. A tube as claimed in any of SP21 to SP29, wherein the internal profile supports the tubular body and defines the lumen therein. SP211. A tube as claimed in any of SP21 to SP210, wherein the internal profile is a skeleton or internal support structure supporting the tubular body. SP212. A tube as claimed in any of SP25 to SP27, wherein the tubular body is substantially not supported by the troughs of the internal profile but is supported by the internal profile at the crests. SP213. A tube as claimed in any of SP25 to SP27, wherein the walls of the tubular body are suspended between adjacent crests. SP214. A tube as claimed in any of SP21 to SP213, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes. SP215. A tube as claimed in any of SP21 to SP214, wherein the internal component is a helical rib or rib element. SP216. A tube as claimed in any of SP21 to SP215, wherein the internal component is a helical strip, and the coating layer encapsulates the strip. SP217. A tube as claimed in any of SP21 to SP216, wherein the internal component is a helical wire, and the coating layer encapsulates the wire. SP218. A tube as claimed in any of SP21 to SP217, wherein the coating layer provides a surface prepared for connection with the tubular body. SP219. A tube as claimed in any of SP21 to SP218, wherein the internal component is a helical winding element having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm.SP220. A tube as claimed in any of SP21 to SP219, wherein the internal component has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. SP221. The tube claimed in any of the following specifications SP21 to SP220, wherein the internal component is a spirally wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm. SP222. The tube claimed in any of SP21 to SP221, wherein the internal component is made of a medical-grade material, preferably medical-grade stainless steel. SP223. The tube claimed in any of SP21 to SP222, wherein the tubular body has a thickness of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm.SP224. A tube as claimed in any of SP21 to SP223, wherein the tubular body has an internal diameter of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm. SP225. A tube as claimed in any of SP21 to SP224, wherein the tubular body has an outer diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. SP226. As claimed in any of SP21 to SP225, the tubular system is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer can be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic elastomers. The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably, polymers having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. SP227. A tube as claimed in any of SP21 to SP226, wherein the internal element is a plurality of rings spaced longitudinally along the lumen. SP228. A tube as claimed in SP227, wherein the rings are in the shape of a tortuous surface or annular. SP229. A tube as claimed in any of SP21 to SP228, wherein the internal element is one or more separate elements linked together.SP230. A tube as claimed in any of SP21 to SP229, wherein the internal profile consists of a plurality of reinforcing ribs regularly spaced along the lumen. SP231. A tube as claimed in SP230, wherein each reinforcing rib comprises one turn of a helical reinforcing line. SP232. A tube as claimed in SP231, wherein one turn of the helical reinforcing line comprises a complete turn around the lumen. SP233. A tube as claimed in SP231, wherein one turn of the helical reinforcing line comprises the line located between adjacent crests of the internal profile. SP234. A tube as claimed in any of SP2 to SP233, wherein the tubular system is defined as flexible by the test of increased flow resistance with bending according to ISO 5367:2000(E) (4th edition, June 1, 2000). SP235. A tube as claimed in any of SP21 to SP234, wherein one end of the tube is integrated with a nose fork for insertion into a user's nostril as a nasal interface for delivering breathable air to a user. SP236. A tube as claimed in any of SP21 to SP235, wherein the internal component is a screen. SP237. A tube as claimed in any of SP21 to SP236, wherein the internal component is a wire suitable for heating or sensing the properties of a gas inside the tube. SP238. A tube as claimed in any of SP21 to SP237, wherein the internal component is conductive, preferably a heater. SP239. A tube as claimed in any of SP21 to SP238, wherein the internal component includes a conductive element, a heater, or a sensor (such as a flow, temperature, humidity, or pressure sensor). SP240. A tube as claimed in any of SP21 to SP239, wherein the tube further includes a heater, more preferably an electric heater (such as a heater wire or heater circuit). SP241. A tube as claimed in any of SP21 to SP240, wherein the tube is a heating tube. SP242. A tube as claimed in any of SP21 to SP241, wherein the ratio of the distance between the inner components to the outer diameter (e.g., the outermost diameter) of the inner components is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29. SP243. The tube claimed in any of the requested forms SP21 to SP242, wherein the ratio of the diameter of the inner part (e.g., the diameter of the actual inner part element or component) to the outer diameter of the inner part (e.g., the outermost diameter) is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.SP244. A tube as claimed in any of SP21 to SP243, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09. SP245. A tube as claimed in any of SP21 to SP244, wherein the physical properties of the tubular body necessitate that the tube possess desired flexibility and / or structural support. STM21. A method of manufacturing a medical tube, the method comprising: providing an inner form encapsulated within a coating layer, and providing a tubular body covering the inner form, the tubular body defining a lumen surrounding the inner form, the tubular body being configured to cover the inner form such that the coating layer is bonded to an inner surface of the tubular body, wherein the inner form remains encapsulated. STM22. The method claimed in STM21, wherein the step of providing an inner part comprises providing an elongated part encapsulating within a coating suitable for application to a medical tube, and manufacturing a support inner part for a medical tube from the coated elongated part. STM23. The method claimed in STM22, wherein the uncoated elongated part is immersed in a coating material bath to apply the encapsulating coating. STM24. The method claimed in STM23, wherein the bath contains a grade of molten polymer with a temperature above about 150°C. STM25. The method claimed in any of STM22 to STM24, wherein the inner part is manufactured by helically winding the elongated part into a helical form. STM26. A method as claimed in any of STM22 to STM25, comprising: providing an uncoated elongated member encapsulating the elongated member in a coating suitable for application to a medical tube. STM27. A method as claimed in any of STM21 to STM26, comprising: a) applying a decompression to (or into) the lumen such that the decompression draws the tubular body radially inward; or b) applying an extension (or stretch) to at least a portion or region of the tubular body surrounding the inner member such that release of the extension (or stretch) returns (or permits) the extended (or stretched) portion or region of the tubular body to (or permits) radial inward withdrawal; or c) a combination of a) and b). STM28. The method claimed in STM27, wherein the tubular body is radially drawn inward from the cavity or from the outermost periphery defined by the inner profile, the outermost periphery of the inner profile defining a plurality of alternating peaks and valleys along a length of the tubular body to form a corrugated tube. STM29. The method claimed in any of STM2 to STM28, wherein the tubular body is provided by extrusion or by extruding a material from a die.STM210. A method claimed in any of STM21 to STM29, wherein the tubular body is extruded around the inner formwork, and the pressure reduction is applied in a manner that allows one inner surface of the tubular body to become at least partially attached or connected to at least a portion of the inner formwork, preferably the pressure reduction difference between the pressure inside the lumen and the pressure surrounding the tubular body, more preferably the pressure inside the lumen (supply to the lumen) is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than the pressure inside the lumen (supply to the lumen)). STM211. A method claimed in any of STM21 to STM212, wherein the tubular body is provided around the inner formwork at a temperature such that the coating layer is connected to at least a portion of the tubular body. STM212. A method claimed in STM211 or STM212, wherein the tubular body is provided around the inner formwork at a temperature that allows the coating layer to fuse with the inner formwork. STM213. The method claimed in STM211 or STM212, wherein the tubular body is at least partially fused with the coating. STM214. The method claimed in any of STM21 to STM213, wherein the tubular body is a single-walled body. STM215. The method claimed in any of STM21 to STM214, wherein a pressure reduction is applied to or adjacent to the formation of the cavity. STM216. The method claimed in STM215, wherein the pressure reduction is applied to or adjacent to a die. STM217. The method claimed in STM216, wherein the cavity experiences the pressure reduction as it exits an extrusion die. STM218. The method claimed in any of STM21 to STM217, wherein the tubular body is extruded simultaneously with the fabrication of the internal part from the elongated profile. STM219. The method claimed in any of STM21 to STM218, wherein the tubular body thus formed is corrugated. STM220. The method claimed in STM219, wherein the peaks of the corrugated tubular body thus formed are defined by the outermost periphery of the inner member. STM221. The method claimed in STM29 or STM220, wherein the troughs of the corrugated tubular body thus formed are defined by the inwardly drawn portions of the tubular body drawn inward between the inner members. STM222. The method claimed in any of STM21 to STM221, wherein the inner member is a skeleton or internal support structure supporting the tubular body. STM223. The method claimed in any of the STM21 to STM222 requests, wherein the internal component is a continuous length, a series of semi-continuous lengths, or a series of separated lengths.STM224. The method claimed in any of STM21 to STM223, wherein the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting links. STM225. The method claimed in any of STM21 to STM224, wherein the internal component supports or supports the cavity within the tube thus formed. STM226. The method claimed in any of the STM21 to STM225, wherein the internal component is a helical winding element having a spacing between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. STM227. A method claimed in any of STM21 to STM226, wherein the internal component has an outermost diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 mm to approximately 4.5 mm, or approximately 1.8 mm to approximately 4.4 mm, or approximately 1.9 mm to approximately 4.3 mm, or approximately 2 mm to approximately 4.2 mm, or approximately 2.1 mm to approximately 4.1 mm, or approximately 2.2 mm to approximately 4 mm, or approximately 2.3 mm to approximately 3.9 mm, or approximately 2.4 mm to approximately 3.8 mm, or approximately 2.5 mm to approximately 3.7 mm, or approximately 2.6 mm to approximately 3.6 mm, or approximately 2.7 mm to approximately 3.5 mm, or approximately 2.8 mm to approximately 3.4 mm, or approximately 2.9 mm to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm. STM228. The method claimed in any of the STM21 to STM227 models, wherein the internal component is a helical wound element having a diameter of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm.STM229. The method claimed in any of STM21 to STM228, wherein the internal component is a medical-grade material, preferably a medical-grade stainless steel coated with a suitable material, preferably a polymer-grade or stainless steel. STM230. The method claimed in any of STM21 to STM229, wherein the tubular body has a thickness of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, or about 0.14 mm to about 0.16 mm. STM231. A method claimed by any of the STM21 to STM230 as requested, wherein the tubular body has an internal diameter of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm. STM232. A method claimed by any of the STM21 to STM231 as requested, wherein the tubular body has an outer diameter of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm. STM233. The method claimed in any of the STM21 to STM232, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.STM234. The method claimed in any of STM21 to STM233, wherein the tubular system is (preferably extruded therefrom) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic... The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably polymers having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. STM235. The method claimed in any of STM21 to STM234, wherein the pressure reduction is applied when the tubular body is in a molten, semi-molten, or unhardened state, preferably the pressure reduction is about 0 to about -2 Pa (absolute), more preferably about 0 to about -1 Pa (absolute), even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably such pressure reduction is a pressure difference between the inner side of the lumen and the area surrounding the tubular body. STM236. The method claimed in any of STM21 to STM235, wherein the internal component is conductive, preferably the internal component is a heater. STM237. The method claimed in any of STM21 to STM236, wherein the internal component includes a conductive member, a heater, or a sensor (such as a flow, temperature, humidity, or pressure sensor). STM238. A method as claimed in any of STM21 to STM237, wherein the tubing further includes a heater, preferably an electric heater (such as a heater wire or heater circuit). STM239. A method as claimed in any of STM21 to STM238, wherein the tubular body is defined as flexible by means of a test according to ISO 5367:2000(E) (4th edition, June 1, 2000) showing an increase in flow resistance with bending. STM240. A method as claimed in any of STM21 to STM239, wherein the medical tubing is a breathing tube. STM241. A method as claimed in any of STM21 to STM240, wherein the tubing is formed by co-extruding at least one helical reinforcement along with a tubular body having a continuous wall. STM242. As claimed in the method of STM241, a vacuum system is applied to a cavity region of the extruded tubular body, causing the continuous wall to form corrugations around the internal part.STM243. The method claimed in STM241 or STM242, wherein the extruded continuous wall is a single wall. STM244. The method claimed in any of STM21 to STM243, wherein the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29. STM245. The method claimed in any of STM21 to STM244, wherein the ratio of the diameter of the internal component (e.g., the diameter of the actual internal component element or member) to the outer diameter (e.g., the outermost diameter) of the internal component is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06. STM246. The method claimed in any of STM21 to STM245, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09. STM247. The method claimed in any of STM21 to STM246, wherein the physical characteristics of the tubular body necessitate that the tube possess desired flexibility and / or structural support. ST31. A medical tube comprising: a tubular body defining a lumen extending between open terminals of the body, and an internal member encapsulated within the lumen and supporting the tubular body. ST32. The tube claimed in ST31, wherein the outermost periphery of the internal member defines a plurality of alternating peaks and valleys along a length of the tubular body. ST33. The tube claimed in ST31 or ST32, wherein the internal member is encapsulated in a coating layer that secures the internal member to the tubular body. STM31. A method of manufacturing a medical tube, the method comprising: providing an inner profile, providing a tubular body that covers the inner profile, the tubular body defining a lumen enclosing the inner profile, and i) applying a pressure reduction to (or into) the lumen, or ii) applying an extension (or stretch) to at least a portion or region of the tubular body enclosing the inner profile, or iii) a combination of i) and ii). STM32. The method claimed by STM31, wherein a greater pressure reduction or a greater extension (or stretch), or a combination of both, is applied to draw the tubular body radially inward toward the lumen along a length of the tubular body and an outermost periphery defined by the inner profile, wherein when the greater pressure reduction is applied or the extension (or stretch) is released, or both, the outermost periphery of the inner profile defines a plurality of alternating peaks and troughs. STM33. As claimed in STM31 or STM32, the internal component is enclosed within a coating layer, and the tubular body provides a cover for the internal component such that the coating layer is connected to one of the inner surfaces of the tubular body, wherein the internal component remains enclosed.TA1. A fixation system for a user interface and / or user interface tube, comprising: a skin patch defining a fixation footprint, the skin patch having a user side and an interface side, the user side of the skin patch being assembled to attach to or adhere to a user's skin; and a fixation patch, at least a portion of the fixation patch being assembled to extend over the user interface and / or an associated user interface tube and fixed to the user side of the skin patch to fix the user interface to the user, the fixation patch and the skin patch being assembled to allow the fixation patch to be accommodated within or demarcated by the fixation footprint of the skin patch when the fixation system is applied to a patient with a suitable or compatible user interface. TA2. The fixation system as claimed in TA1, wherein the skin patch has the same or a larger surface area as the fixation patch. TA3. A fixing system as claimed in TA1 or TA2, wherein the fixing patch is shaped or otherwise assembled to conform to the geometry or other features of the user interface and / or the associated user interface tube. TA4. A fixing system as claimed in any of TA1 to TA3, wherein the fixing patch has at least one wing. TA5. A fixing system as claimed in any of TA1 to TA4, wherein the fixing patch has a pair of wings disposed at one end of the patch, the wings being assembled to secure to the skin patch on either side of a user interface and / or the associated user interface tube. TA6. A fixing system as claimed in any of TA1 to TA5, wherein the fixing patch has a tube-end wing, the tube-end wing being assembled to extend or for extending below the user interface tube and to secure to the skin patch. TA7. A fixation system as claimed in any of TA1 to TA6, wherein the user side of the skin patch has a skin-sensitive adhesive (such as a hydrocolloid) that attaches or adheres the skin patch to a user's skin. TA8. A fixation system as claimed in any of TA1 to TA7, wherein the skin patch has a surface of sufficient area to disperse the attachment or adhesive force across the user's skin. TA9. A fixation system as claimed in any of TA1 to TA8, wherein the skin patch is assembled to attach or adhere to a user's face. TA10. A fixation system as claimed in any of TA1 to TA9, wherein the skin patch is assembled to attach or adhere to a user's face, particularly adjacent to the user's upper lip and / or cheek. TA11. The fixation system claimed in any of the claims TA1 to TA10, wherein the fixation system is assembled to receive and / or fix a nasal cannula and / or connected tubes extending from one or both sides of a user's face.TA12. A fixing system as claimed in any of TA1 to TA11, wherein the fixing system is configured for use with an infant or newborn. TA13. A fixing system as claimed in any of TA1 to TA12, wherein the fixing system is configured for use with a tube defined as any one or more of COM1-COM17, COMM11-COMM19, or COM21-COM216. TA14. A fixing system as claimed in any of TA1 to TA13, wherein the fixing system is configured for use with a tube defined as any one or more of SP1-SP38, SP21-SP241, or ST31-ST33. COM1. A nasal cannula configuration comprising: at least one nasal fork having an outlet adapted for insertion into a user's nostril and an inlet fluidly connected to the outlet; and a corrugated gas delivery tube comprising a tubular body defining a lumen and an internal member surrounding the lumen, the internal member supporting the tubular body, the outermost periphery of the internal member defining a plurality of alternating peaks and valleys along a length of the tubular body, wherein the inlet of the nasal fork is integrally formed with an end of the tube such that the lumen is fluidly connected to the outlet of the nasal fork. COM2. The nasal cannula of COM1, wherein the nasal fork is shaped to substantially anatomically conform to the inside of a user's nose or nostril. COM3. The nasal cannula of COM1 or COM2, wherein the nasal fork is bent or otherwise shaped or assembled to avoid a user's nasal septum. COM4. A nasal cannula as claimed in any of COM1 to COM3, wherein the nasal cannula has a substantially flat or contoured backing that is assembled to rest on a user's face, preferably serving as a stabilizing element for the fork head at a user's nostril. COM5. A nasal cannula as claimed in COM4, ​​wherein one or more ribs extend between a front side of the backing and the cannula, the ribs providing a contact surface for a thin band or other suitable fastener for fastening or attaching the cannula to a user's face, preferably the thin band comprising an adhesive portion or being an adhesive tape or a contact adhesive tape. COM6. A nasal cannula as claimed in any of COM1 to COM5, wherein two nasal forks are integrally formed with a single corrugated delivery tube. COM7. A nasal cannula as claimed in any of COM1 to COM6, wherein the cannula comprises a pair of nasal forks, each fork being integrally formed with or attachable to (or connectable to) or connected to (or connectable to) one of a pair of gas delivery tubes. COM8. A nasal cannula as claimed in any of COM1 to COM7, wherein the cannula configuration is made of a polymer such as a thermoplastic polymer, preferably a polymer or polymer suitable for medical breathing tubes.COM9. A nasal cannula as claimed in any of COM1 to COM8, wherein the cannula is configured to be made of one or more of, or a combination of, a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; preferably, the polymer may be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic elastomers. The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably polymers having a Scholl A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. COM10. A user interface comprising a pair of nasal cannulas as claimed in any one of the requested embodiments COM1 to COM9. COM11. A user interface as claimed in the requested embodiment COM3, wherein the nose forks of each nasal cannula are arranged adjacent to each other and the individual delivery tubes extend in the opposite direction away from the nose forks. COM12. The user interface claimed in COM4, ​​further comprising a wire harness extending and coupled between the nasal cannulas. COM13. The nasal cannulas claimed in any of COM1 to COM12, wherein the cannulas is a breathing tube. COM14. The nasal cannulas claimed in any of COM1 to COM13, wherein the cannulas are defined as SP1-SP38, SP21-SP241, or ST31-ST33, or more than one or more of these definitions. COM15. The nasal cannulas claimed in any of COM1 to COM14, wherein the cannulas are connected from one side (e.g., left or right) to the air inlet of the nasal fork (or bifurcation). COM16. A nasal cannula as claimed in any of COM1 to COM14, wherein the tube connects from both sides (e.g., both the left and right sides) of the cannula to the air inlet of the nasal fork (or bifurcation). COM17. A nasal cannula as claimed in any of COM1 to COM16, wherein the cannula is an infant (or neonatal) nasal cannula. COMM11. A method of manufacturing a nasal cannula, the method comprising: providing an inner mold, extruding a tubular body to enclose the inner mold, the tubular body defining a lumen surrounding the inner mold, and attaching a nasal cannula thereto.COMM12. The method claimed in COMM11, further comprising: i) applying a decompression to (or to) the interior of the lumen, such that the decompression radially inwards the tubular body within the lumen or the outermost periphery defined by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body; or ii) applying an extension (or stretch) to at least a portion or region of the tubular body surrounding the inner profile, such that release of the extension (or stretch) returns (or permits) the extended (or stretched) portion or region of the tubular body back to (or permits) the lumen or radially inwards the outermost periphery defined by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body; or iii) a combination of i) and ii). COMM13. The method claimed in COMM11 or COMM12, wherein the method comprises fitting a molded nose fork onto one end of the tubular body. COMM14. The method claimed in any of COMM11 to COMM13, wherein one end of the tube formed by the tubular body is positioned within a mold or form for molding or shaping a nasal cannula, preferably the mold or form is closed, and the nasal cannula is fitted over the end of the tube during molding or shaping. COMM15. The method claimed in any of COMM11 to COMM14, wherein the nasal cannula is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes. COMM16. As claimed in any of the methods in COMM11 to COMM15, the nasal cannula is made of one or more of, or a combination of, a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic elastomers. The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably polymers having a Scholl A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. COMM17. The method claimed in any of COMM11 to COMM16, wherein the tubular body is a breathable tube, or is made of or from a breathable material such as a breathable thermoplastic polyurethane or a breathable polyamide.COMM18. A method as claimed in any of COMM11 to COMM17, wherein a nasal cannula mold is provided, the mold receiving an end of the tube formed by the manufacture of the tubular body, such that operation of the mold assists in the molding of the nasal cannula, a portion of the nasal cannula being molded by the end of the tube. COMM19. A method as claimed in any of COMM11 to COMM18, wherein the nasal cannula configuration manufactured by the nasal cannula is in fluid communication with an end of the tube formed by the manufacture of the tubular body. COM21. A nasal cannula configuration comprising: at least one nasal fork having an outlet adapted for insertion into a user's nostril and an inlet fluidly connected to the outlet; and a gas delivery tube comprising a tubular body defining a lumen and an internal member surrounding the lumen, the internal member supporting the tubular body, wherein the inlet of the nasal fork is integrally formed with an end of the tube such that the tubular lumen is fluidly connected to the outlet of the nasal fork. COM22. The nasal cannula of claim COM21, wherein the outermost periphery of one of the internal members defines a plurality of alternating peaks and valleys along a length of one of the tubular bodies. COM23. The nasal cannula of claim COM21 or COM22, wherein the fork is shaped to conform to the anatomical curvature of a user's nostril. COM24. A nasal cannula as claimed in any of COM21 to COM23, wherein the nasal fork is bent or otherwise shaped or assembled to avoid a user's nasal septum. COM25. A nasal cannula as claimed in any of COM21 to COM24, wherein the nasal cannula has a contoured backing or face pad that is assembled to rest on a user's face, preferably serving as a stabilizing element for the fork at a user's nostril. COM26. A nasal cannula as claimed in COM25, wherein one or more ribs extend from the front of one of the backing or face pads between the cannula and the cannula, the ribs providing a contact surface for a thin band or other suitable fastener for fastening or attaching the cannula to a user's face, preferably the thin band comprising an adhesive portion or being an adhesive tape or a contact adhesive tape. COM27. A nasal cannula as claimed in any of COM21 to COM26, wherein the two nasal forks are integrally formed with a single corrugated delivery tube. COM28. A nasal cannula as claimed in any of COM21 to COM27, wherein the cannula is made of a liquid silicone rubber or a polymer such as a thermoplastic polymer, preferably a polymer or polymer suitable for medical breathing tubes.COM29. A nasal cannula as claimed in any of COM21 to COM28, wherein the cannula is configured to be made of one or more of, or a combination of, a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; preferably, the polymer may be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastic elastomers. The family of elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably polymers having a Scholl A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. COM210. A user interface comprising a pair of nose cannulas as claimed in any one of COM221 to COM29. COM211. A user interface as claimed in COM210, wherein the nose forks are configured to be adjacent to each other and the individual delivery tubes extend in the opposite direction away from the nose forks. COM212. The user interface claimed in COM211, further comprising a wire harness extending and coupled between the nasal cannulas. COM213. The nasal cannulas claimed in any of COM21 to COM212, wherein the cannulas is a breathing tube. COM214. The nasal cannulas claimed in any of COM21 to COM213, wherein the cannulas are defined as SP1-SP38, SP21-SP241, or ST31-ST33. COM215. The nasal cannulas claimed in any of COM21 to COM24, wherein the cannulas are manufactured by a method defined as SPM11-SPM133, STM21-STM243, or STM31-STM33. COM216. A nasal cannula as claimed in any of COM21 to COM215, wherein the fork is glued or otherwise attached to the cannula. PWL1. A nasal cannula configuration comprising: at least one nasal fork having an outlet adapted for insertion into a user's nostril and an inlet fluidly connected to the outlet, the at least one nasal fork including a backing configured to rest against a user's face, wherein a lip extends to cover at least a portion of the periphery of a rear surface of the backing, the rear surface configured to receive or retain a user interface patch such that, in use, the user interface patch can be releasably attached or connected to or from a skin patch attached to a user's face. PWL2. A nasal cannula as claimed in PWL1, wherein the lip is a barrier.PWL3. A nose cannula as claimed in PWL1 or PWL2, wherein the lip is deformable. PWL4. A nose cannula as claimed in any of PWL1 to PWL3, wherein the lip extends to at least partially cover the periphery of a region substantially adjacent to a fork connected to the backing. PWL5. A nose cannula as claimed in any of PWL1 to PWL3, wherein the lip is a series of one or more separate lips. PWL6. A nose cannula as claimed in PWL5, wherein the one or more separate lips are adjacent, contiguous, or overlapping lips. PWL7. A nose cannula as claimed in any of PWL1 to PWL6, wherein the lip is a circular lip extending to cover the periphery of the rear surface of the backing. PWL8. A nasal cannula as claimed in any of PWL1 to PWL7, wherein, in use, the lip substantially forms a fluid (or liquid) seal or fluid (or liquid) barrier between the rear surface of the backing and one of the user interface patches facing the cannula surface. PWL9. A nasal cannula as claimed in any of PWL1 to PWL8, wherein the backing is a substantially flat or contoured (such as a pre-formed curve) backing assembled to rest on a user's face. PWL10. A nasal cannula as claimed in any of PWL1 to PWL9, wherein the backing assists as a stabilizing element of the fork at one of a user's nostrils. PWL11. A nasal cannula as claimed in any of PWL1 to PWL10, wherein the at least one fork extends laterally from the at least one nasal fork, away from a user's nasal septum. PWL12. A nasal cannula as claimed in any of PWL1 to PWL11, wherein the cannula is further defined by any one or more of COM1-COM17, or COMM11-COMM19, or COM21-COM216. PWL13. A nasal cannula as claimed in any of PWL1 to PWL12, wherein the cannula can operate as defined by the fixation system as defined in any one or more of TA1-TA14. PWL14. A nasal cannula as claimed in any of PWL1 to PWL13, wherein the user interface patch is receptible to or can be held on the rear surface of the backing as defined in any one or more of WP1-WP15. PWL15. A nasal cannula as claimed in any of PWL1 to PWL14, wherein the air inlet of the cannula is fluidly connected to or to a tube as defined by any one or more of SP1-SP38, SPM11-SPM133, SP21-SP241, STM21-STM243, ST31-ST33, and STM31-STM33. PWL16. A nasal cannula as claimed in any of PWL1 to PWL15, wherein at least the lip(s) is hydrophobic.PWL17. A nasal cannula as claimed in any of PWL1 to PWL16, wherein at least the lips include at least one outer peripheral lip and at least one inner peripheral lip, each lip being configured to contact a user's face. WP1. A component of a releasable fastener comprising a base portion supporting a distributed mechanical fastener across its surface, the base portion being flexible but substantially non-stretchable, the base portion being divided into multiple sections by at least one slit or at least one slot, such that by independent bending of the different sections of the base, the base portion can substantially conform to a lower composite curved surface. WP2. A fastening system as claimed in WP1, wherein the base portion includes multiple slits or slots or both, which together divide the base portion into a meandering body. WP3. A fastening system as claimed in WP2, wherein the slots and / or grooves are disposed on the substrate such that a first set of at least one set of slots or grooves extends into the substrate from one edge of the substrate, and a second set of slots or grooves extends into the substrate from the other edge of the substrate, the slots or grooves of one set intersect with the slots or grooves of the other set, such that a path along the substrate from one end to the other without intersecting the slots or grooves of one set follows a zigzag or meandering path much longer than a straight line between the two ends. WP4. A fastening system as claimed in any of WP1 to WP3, wherein one of the plurality of slots or grooves is curved. WP5. A fastening system as claimed in any of WP1 to WP3, wherein the plurality of slots or grooves are curved and the curved slots or grooves are substantially parallel. WP6. A fastening system as claimed in any of WP1 to WP3, wherein the slits or slots are configured in a herringbone pattern extending from the edge of the base portion. WP7. A fastening system as claimed in WP1, wherein the base portion is divided into sections by a meandering slit or slot. WP8. A fastening system as claimed in WP1, wherein the base portion is divided into multiple sections by a spiral slit or slot. WP9. A fastening system as claimed in WP1, wherein the base portion is divided into sections by slits or slots configured as substantially concentric circles. WP10. A fastening system as claimed in WP9, wherein the concentric circles are centered approximately at the center of the base portion. WP11. A fastening system as claimed in WP1, wherein the slits or slots divide the base portion into multiple islands, each island being joined to an adjacent island or islands by a narrow bridge. WP12. The fixing system claimed in WP1, wherein the base portion is divided into multiple parts by an S-shaped slit. WP13. The fixing system claimed in WP1, wherein the base portion is divided into multiple parts by a T-shaped slit.WP14. A fixation system as claimed in any of WP1 to WP13, wherein the substrate covers at least 70% of the area of ​​the skin patch. WP15. A fixation system as claimed in any of WP1 to WP14, wherein, for a boundary defining the shortest path surrounding the periphery of the substrate, the substrate covers at least 80% of the area inside the boundary. WP16. A fixation system as claimed in any of WP1 to WP15, wherein the system can be used in combination with fixation systems of TA1-TA14, or cannulas of COM1-COM17, or cannulas of PWL1-PWL17, or tubes of SP1-SP38, SP21-SP241, or ST31-ST33. 1. A medical breathing tube comprising: a tubular body defining a lumen extending between open ends of the body; an inner member surrounding and supporting the lumen; and a coating encapsulating the inner member, the coating securing the inner member to the tubular body. 2. The medical tube of claim 1, wherein the coating and the tubular body are plastically fused together along the tube. 3. The medical tube of claim 1 or 2, wherein the outermost periphery of the inner member defines a plurality of alternating peaks and valleys along a length of the tubular body. 4. The tube of any one of claims 1 to 3, wherein the peaks of the corrugated tubular body are defined by the outermost periphery of the inner member. 5. A tube as claimed in any of claims 1 to 4, wherein the internal component is a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting rods, or a combination thereof. 6. A tube as claimed in any of claims 1 to 5, wherein the tubular body is substantially not supported by the internal component at the troughs but is supported by the internal component at the crests. 7. A tube as claimed in any of claims 1 to 6, wherein the tubular body is a breathable tube, or is made of a breathable material, such as breathable thermoplastic polyurethane (or similar) or breathable polyamide. 8. A tube as claimed in any of claims 1 to 7, wherein the internal component is a helical wound metal wire, and the coating encapsulates the wire. 9. The tube claimed in any of claims 1 to 8, wherein the coating provides a surface that facilitates connection with the tubular body. 10. A medical breathing tube comprising: a tubular body defining a lumen extending between open ends of the body; and an internal member surrounding and supporting the lumen, the outermost periphery of the internal member defining a plurality of alternating peaks and valleys along a length of the tubular body. 11. The tube claimed in claim 10, wherein the tubular body is an extruded tube.12. The tube claimed in claim 10 or 11, wherein the tubular body is a continuous tube. 13. The tube claimed in any of claims 10 to 12, wherein the crests of the corrugated tubular body are defined by the outermost periphery of the internal member. 14. The tube claimed in any of claims 10 to 13, wherein the internal member is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting rods. 15. The tube claimed in any of claims 10 to 14, wherein the tubular body is substantially not supported by the internal member at the troughs but is supported by the internal member at the crests. 16. A tube as claimed in any of claims 10 to 15, wherein the tubular body is a breathable tube or made of a breathable material, such as a breathable thermoplastic polyurethane or a breathable polyamide. 17. A medical breathing tube comprising: a tubular body defining a lumen extending between open ends of the body, and an internal member surrounding and supporting the tubular body within the lumen. 18. A tube as claimed in claim 17, wherein the internal member is encapsulated within a coating layer that secures the internal member to the tubular body. 19. A medical tube as claimed in claim 17 or 18, wherein the coating layer and the tubular body are plastically fused together along the tube. 20. A medical tube as claimed in any of claims 17 to 19, wherein the coating and the tubular body are fused together along the tube at a separated position. 21. A medical tube as claimed in any of claims 17 to 19, wherein the coating and the tubular body are substantially continuously fused together along the longitudinal direction of the tube. 22. A medical tube as claimed in any of claims 17 to 21, wherein the outermost periphery of one of the inner components defines a plurality of alternating peaks and valleys along a length of the tubular body. 23. A medical tube as claimed in any of claims 17 to 22, wherein the outermost periphery of one of the inner components defines a plurality of alternating peaks and valleys (i.e., corrugations) along a length of the tubular body. 24. A tube as claimed in any of claims 22 or 23, wherein the peaks of the tubular body are defined by the outermost periphery of the inner component. 25. The tube claimed in any of claims 22 to 24, wherein the troughs of the tubular body are defined by the inwardly withdrawn portion of the tubular body that is drawn inwardly between the internal components. 26. The tube claimed in any of claims 17 to 25, wherein the internal components are a continuous length, a series of semi-continuous lengths, or a series of separated lengths.27. A tube as claimed in any of claims 17 to 26, wherein the internal component is one or a combination of a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disk, a ring, or a plurality of separate supports interconnected or interlocking by one or more connecting rods. 28. A tube as claimed in any of claims 17 to 27, wherein the internal component supports the tubular body internally defining the lumen. 29. A tube as claimed in any of claims 17 to 28, wherein the internal component is a skeleton or internal support structure supporting the tubular body. 30. A tube as claimed in any of claims 17 to 29, wherein the tubular body is substantially not supported by the internal component at the troughs but is supported by the internal component at the crests. 31. A tube claimed in any of claims 17 to 30, wherein the wall of the tubular body is suspended between adjacent crests. 32. A tube claimed in any of claims 17 to 31, wherein the tubular body is a breathable tube or made of a breathable material (e.g., breathable thermoplastic polyurethane or breathable polyamide). 33. A tube claimed in any of claims 17 to 32, wherein the internal profile is a spirally wound rib or rib element. 34. A tube claimed in any of claims 17 to 33, wherein the internal profile is a spirally wound metal wire, and the coating encapsulates the wire. 35. A tube claimed in any of claims 17 to 34, wherein the coating provides a surface that can be connected to the tubular body. 36. A tube claimed in any of claims 17 to 35, wherein the internal component has a spacing that varies along a length (or segment) of the tube. 37. A tube claimed in any of claims 17 to 36, wherein the internal component is a helical winding element having a spacing between adjacent turns of about 1 mm to about 1.5 mm. 38. A tube claimed in any of claims 17 to 37, wherein the internal component is a helical winding element having a diameter of about 0.1 mm to about 0.4 mm. 39. A tube claimed in any of claims 17 to 38, wherein the tubular body has a wall thickness of about 0.1 mm to about 0.2 mm. 40. A tube claimed in any of claims 17 to 39, wherein the tubular body has an outer diameter of about 3 mm to about 5 mm. 41. A tube as claimed in any of claims 17 to 40, wherein the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm. 42. A tube as claimed in any of claims 17 to 41, wherein the tubular body is defined as flexible by means of the test of increased flow resistance with bending according to ISO 5367:2000(E) (4th edition, 1 June 2000).43. A tube claimed in any of claims 17 to 42, wherein one end of the tube is integrated with a nose fork adapted for insertion into a user's nostril as a nasal interface for delivering breathable air to a user. 44. A tube claimed in any of claims 17 to 43, wherein the internal component is a wire adapted for heating or sensing the properties of a gas inside the tube. 45. A tube claimed in any of claims 17 to 44, wherein the internal component is conductive, preferably a heater. 46. A tube claimed in any of claims 17 to 45, wherein the internal component includes a conductive element, a heater, or a sensor (such as a flow, temperature, humidity, or pressure sensor). 47. A tube claimed in any of claims 17 to 46, wherein the tube further includes a heater or a heater (e.g., a heater wire or heater circuit). 48. A tube claimed in any of claims 17 to 47, wherein the internal component is composed of one or more separate components. 49. A tube claimed in any of claims 17 to 48, wherein the internal component comprises one or more separate components. 50. A tube claimed in any of claims 17 to 49, wherein the tube comprises one or more internal components. 51. A tube claimed in any of claims 17 to 50, wherein the ratio of the distance between the internal components to the outer diameter (e.g., the outermost diameter) of the internal components is from about 0.10 to about 0.50. 52. A tube claimed in any of claims 17 to 51, wherein the ratio is from about 0.20 to about 0.35. 53. A tube claimed in any of claims 17 to 52, wherein the ratio is about 0.28. 54. The tube claimed in any of claims 17 to 53, wherein the ratio is about 0.29. 55. The tube claimed in any of claims 17 to 54, wherein the ratio of the inner component diameter (e.g., the diameter of the actual inner component element or member) to the outer diameter of the inner component (e.g., the outermost diameter) is about 0.02 to about 0.10. 56. The tube claimed in any of claims 17 to 55, wherein the ratio is about 0.05 to about 0.07. 57. The tube claimed in any of claims 17 to 56, wherein the ratio is about 0.06. 58. The tube claimed in any of claims 17 to 57, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09. 59. A tube as claimed in any of the claims 17 to 58, wherein the physical characteristics of the tubular body necessitate that the tube possess the desired flexibility and / or structural support.60. A nasal cannula configuration comprising: at least one nasal fork having an outlet adapted for insertion into a user's nostril and an inlet fluidly connected to the outlet, the fork being shaped to conform to the anatomical curvature of a user's nostril. 61. The nasal cannula claimed in claim 60, wherein the nasal fork is shaped to avoid contact with the user's nasal septum at the base of the user's nose. 62. The nasal cannula claimed in claim 60 or 61, wherein the nasal fork is shaped to avoid contact with the internal structures of a user's nose. 63. The nasal cannula claimed in any of claim 60 or 62, wherein the nasal fork is shaped to substantially align a stream of breathing gas flowing through the outlet with the user's upper respiratory tract. 64. A nasal cannula as claimed in any of claims 60 or 63, wherein the nose fork is shaped to extend generally upward and rearward into a user's nostril, the nose fork having a curvature including at least two inflection points. 65. A nasal cannula as claimed in any of claims 60 or 64, wherein the nose fork defines a lumen extending between the air inlet and the air outlet, the shape of the lumen changing from a generally circular shape at the air inlet to a generally elliptical shape at the air outlet. 66. A nasal cannula as claimed in claim 65, wherein the fork is shaped to maximize the cross-sectional area of ​​the lumen. 67. A nasal cannula as claimed in any of claims 60 or 66, wherein the cannula further includes a support extending along a user's upper lip. 68. A nasal cannula as claimed in any of claims 60 or 67, wherein the cannula comprises two nasal forks symmetrically spaced about a user's sagittal plane, the forks extending inwardly from a base toward the user's nose on a common support disposed along the user's upper lip. 69. A nasal cannula as claimed in claim 68, wherein the forks extend from the support toward the user's nasal septum and curve upward and backward around the corner of the user's nostrils into the user's nostrils, each fork extending along a generally inclined posterior track and oriented through two mid-lateral reflection points relative to the user's upper respiratory tract. 70. A nasal cannula as claimed in any of claims 60 or 69, wherein the forks or forks have a shaped track conforming to the anatomical shape of the user's nostrils. 71. A nasal cannula as claimed in claim 70, wherein in a first part (or stage) of one of the forks, the track moves horizontally toward the midline of the face; in a second part (or stage) of one of the forks, the track curves upward directly into the nostril toward the coronal portion of the head; in a third part (or stage) of one of the forks, the track rolls backward into the head following the anatomical curvature of the nostril; and in a fourth part (or stage), the track is horizontally inclined toward the center of the cannula to align the outlet with the user's upper respiratory tract.72. A nose cannula as claimed in any of claims 60 or 71, wherein the forks or individual prongs have a cross-section that changes along the central track. 73. A nose cannula as claimed in any of claims 60 or 72, wherein the cross-sectional area substantially decreases along the track from the first section (or stage) to the end of the fourth section (or stage). 74. A nose cannula as claimed in any of claims 60 or 73, wherein the nose cannula further includes a contoured backing or face pad that is assembled to rest on a user's face. 75. A nose cannula as claimed in claim 74, wherein the backing or face pad is pre-shaped to be substantially curved to conform to the contour of a user's face or upper lip area. 76. A nose cannula as claimed in any of claims 60 or 75, wherein each fork is capable of receiving an independent flow from a gas source. 77. A fixation system for a user interface and / or a component (e.g., a tube or pipe) connected to the user interface, the fixation system comprising a two-part releasable attachment (or connection) configuration comprising: a skin patch and a user interface patch, the skin patch having a patient side and an interface side, the patient side of the skin patch being attachable to a user's skin (e.g., via an adhesive, typically a skin-sensitive adhesive such as a hydrocolloid), the interface side of the skin patch being provided with a first component of a two-part releasable attachment or connection system, and the user interface patch having an interface side and a patient side, the patient side of the user interface patch being provided with a complementary second component of the two-part releasable attachment or connection system. The interface side of the user interface patch can be attached (or connected) to the user interface and / or to a component (e.g., a tube or pipe) connected to the user interface. 78. A system as claimed in claim 77, wherein the interface side of the skin patch has one of a hook or a loop, and the second component of the second patch has the other of the hook or loop, such that the first and second components (and patches) are releasably attached or connected to each other. 79. A system as claimed in claim 77 or 78, wherein the first patch is positionable and / or attachable to a user's facial skin. 80. A system as claimed in any of claims 77 to 79, wherein the user interface patch is positionable, or attached, or can be attached, or connected to a user interface. 81. The system claimed in any of claims 77 to 80, wherein the user interface patch is integrally formed with or forms part of a user interface. 82. The system claimed in any of claims 77 to 81, wherein the two-part releasable attachment or connection system on the skin patch occupies less than about 90% of the interface side of the skin patch.83. A system as claimed in any of claims 77 to 82, wherein the first component of the two-part releasable attachment or connection system is adhered to or adhesible to the user interface side of the skin patch. 84. A system as claimed in any of claims 77 to 83, wherein the user side of the skin patch has a skin-sensitive adhesive (such as, for example, a hydrophilic colloid) for attaching or adhering the skin patch to a user's skin. 85. A system as claimed in any of claims 77 to 84, wherein the skin patch has a surface of sufficient area such that the surface disperses the attachment pressure or adhesive force across the user's skin. 86. A system as claimed in any of claims 77 to 85, wherein the skin patch is assembled to attach or adhere to a user's face. 87. A system as claimed in any of claims 77 to 86, wherein the skin patch is assembled to attach or adhere to a user's face adjacent to the user's upper lip and / or cheek. 88. A system as claimed in any of claims 77 to 87, wherein the fixation system is assembled to receive and / or fix a nasal cannula and associated tubing extending from one or both sides of a user's face. 89. A system as claimed in any of claims 77 to 88, wherein the fixation system is assembled for use with an infant or newborn. 90. A system as claimed in any of claims 77 to 89, wherein the component associated with the interface is a medical breathing tube. 91. A system as claimed in claim 90, wherein the medical breathing tube is as defined in any one or more of claims 1 to 59. 92. A system as claimed in any of claims 77 to 91, wherein the user interface is a nasal cannula. 93. A system as claimed in claim 83, wherein the nasal cannula is as defined in any one or more of claims 60 to 76. 94. A system as claimed in any of claims 77 to 93, wherein the first component of the two-part releasable attachment or connection system includes a substrate to which or for which it is secured. 95. A fixation system as claimed in claim 94, wherein the substrate includes at least one slit or at least one slot having a substrate region separated by the slit or slot. 96. A fixation system as claimed in claim 95, wherein the substrate includes a plurality of slits or slots or both, which together divide the substrate into a meandering body.97. A fastening system as claimed in claim 95, wherein the slots and / or grooves are disposed on the substrate such that a first set of at least one set of slots or grooves extends into the substrate from one edge of the substrate, and a second set of slots or grooves extends into the substrate from the other edge of the substrate, the slots or grooves of one set intersect with the slots or grooves of the other set, such that a path along the substrate portion from one end to the other without intersecting the slots or grooves of one set follows a zigzag or meandering path much longer than a straight line between the two ends. 98. A fastening system as claimed in any of claims 95 to 97, wherein one of the plurality of slots or grooves is curved. 99. A fastening system as claimed in any of claims 95 to 88, wherein the plurality of slots or grooves are curved and the curved slots or grooves are substantially parallel. 100. A fastening system as claimed in any of claims 96 to 88, wherein the slits or slots are configured in a herringbone pattern extending from the edge of the base portion. 101. A fastening system as claimed in claim 95, wherein the base portion is divided into sections by a meandering slit or slot. 102. A fastening system as claimed in claim 95, wherein the base portion is divided into multiple sections by a spiral slit or slot. 103. A fastening system as claimed in claim 95, wherein the base portion is divided into detailed sections by slits or slots configured as substantially concentric circles. 104. A fastening system as claimed in claim 103, wherein the concentric circles are centered approximately at the center of the base portion. 105. The fixation system claimed in claim 95, wherein the slits or slots divide the substrate into multiple islands, each island being joined to an adjacent island or islands by a narrow bridge. 106. The fixation system claimed in claim 95, wherein the substrate is divided into multiple parts by an S-shaped slit. 107. The fixation system claimed in claim 95, wherein the substrate is divided into multiple parts by a T-shaped slit. 108. The fixation system claimed in any of claims 94 to 107, wherein the substrate covers at least 70% of the area of ​​the skin patch. 109. The fixation system claimed in any of claims 100 to 108, wherein, with respect to a boundary defining the shortest path surrounding the perimeter of the substrate, the substrate covers at least 80% of the area inside the boundary.110. A user interface assembly comprising: a fixation system for the user interface and / or a component (e.g., a tube or tubing) connected to the user interface, and a tube connected to the user interface to provide at least a portion of a breathing circuit to a user of the interface, wherein the fixation system comprises a two-part releasable attachment (or connection) configuration comprising: a skin patch and a user interface patch, the skin patch having a patient side and an interface side, the patient side of the skin patch being attachable to a user's skin (e.g., via an adhesive, typically a skin-sensitive adhesive such as a hydrocolloid), the interface side of the skin patch being provided to a first component of the two-part releasable attachment or connection system, and the user interface patch having an interface side and a patient side, the patient side of the user interface patch being provided to a complementary second component of the two-part releasable attachment or connection system. The interface side of the user interface patch can be attached (or connected) to the user interface and / or to a component (e.g., a tube or pipe) connected to the user interface, wherein the tubing system includes: a tubular body defining a lumen extending between open terminals of the body; an internal component surrounding and supporting the tubular body within the lumen; and a coating encapsulating the internal component, the coating securing the internal component to the tubular body. 111. The interface claimed in claim 110, wherein the interface is a nose tube. 112. The interface claimed in claim 110 or 111, wherein the interface includes one or a pair of nose forks. 113. The interface claimed in claim 112, wherein the interface includes a fixing system as defined in any one or more of claims 77 to 109. 114. The interface claimed in any of the claims 110 to 113, wherein the tube is a medical breathing tube. 115. The interface claimed in claim 114, wherein the tube is as defined in any one or more of the claims 1 to 59. 116. The interface claimed in any of claims 110 to 115, wherein the interface is a nasal cannula configuration comprising: at least one nose fork having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly connected to the air outlet, the at least one nose fork including a backing configured to rest against a user's face, wherein a lip extends to cover at least a portion of the periphery of a rear surface of the backing, the rear surface configured to receive or hold a user interface patch such that, in use, the user interface patch can be releasably attached to or connected to, or attached to, a skin patch of a user's face. 117. The interface claimed in claim 116, wherein the lip is a barrier. 118. The interface claimed in claim 116 or 117, wherein the lip is deformable.119. The interface claimed in any of claims 116 to 118, wherein the lip extends to at least partially cover the periphery of a region of a fork substantially adjacent to the backing. 120. The interface claimed in any of claims 116 to 119, wherein the lip is a loop lip extending to cover the periphery of the rear surface of the backing. 121. The interface claimed in any of claims 116 to 120, wherein the lip is a series of one or more separate lips. 122. The interface claimed in claim 121, wherein the one or more separate lips are adjacent, contiguous, or overlapping lips. 123. The interface claimed in any of claims 116 to 122, wherein, in use, the lip substantially forms a fluid (or liquid) seal, or fluid barrier, between the rear surface of the backing and one of the user interface patch's facing surfaces of the sleeve. 124. The interface claimed in any of claims 116 to 123, wherein the backing is a substantially flat or contoured (such as a pre-formed curve) backing assembled to rest on a user's face. 125. The interface claimed in any of claims 116 to 124, wherein the backing assists as a stabilizing element of the fork head at one of a user's nostrils. 126. The interface claimed in any of claims 116 to 125, wherein the at least one backing extends laterally from the at least one nose fork head, away from a user's nasal septum. 127. The interface claimed in any of claims 116 to 126, wherein at least the lip system is water-repellent. 128. An interface as claimed in any of the claims 116 to 127, wherein at least the lips comprise at least one outer peripheral lip and at least one inner peripheral lip, each of the lips being for contact with a user’s face. [Simplified Explanation of the Diagram]

[0365] The features, aspects, and advantages disclosed herein will now be described with reference to the accompanying drawings of preferred embodiments, which are intended to be illustrative but not limiting of the disclosure herein, and in the drawings: Figure 1 is a side view of a corrugated medical tube, one end of which is shown in cross-section to illustrate the arrangement of a tubular body enclosing an internal component. Figure 2 is a side view of the medical tube, the tubular body cut off and shown in cross-section to illustrate the continuous spiral internal component. Figure 3A is a side view of the medical tube, the tubular body cut off and shown in cross-section to illustrate a plurality of independent loops representing discrete internal components. Figure 3B is a side view of the medical tube, the tubular body cut off and shown in cross-section to illustrate a sandwich wall structure enclosing the internal component. Figure 3C is a side view of yet another embodiment, where the internal component is embedded within the wall. Figure 3D is a side view of yet another embodiment, where the tubular body is heated and shrunk to enclose the internal component. Figure 3E is a side view of yet another embodiment, where the internal components operate to maintain the tubular body in the desired form. Figure 4 is a schematic representation of an apparatus for forming a medical tube, the apparatus including a hopper, a feed screw, and a die head. Figure 5 is a schematic representation of a die head for forming a reinforced medical tube. Figure 6 is a perspective view of a nasal interface combining a pair of reinforced medical tubes, each coupled to a nasal fork. Figure 7 is a perspective view of the nasal interface of Figure 6 combined with a back assembly to stably position the interface and receive a helmet attachment. Figure 8 is a front view of the nasal interface of Figure 7. Figure 9 is a top view of the nasal interface of Figure 7. Figure 10 is a side view of the nasal interface of Figure 7. Figure 11 is a front view of the nasal interface of Figure 7 shown in cross-section. Figure 12 is a perspective view of the nasal interface of Figure 7 positioned on an infant's head. Figure 13 is a perspective view of the nasal interface of a pair of reinforced medical tubes, each coupled to a nose fork, wherein each nose fork is fixed to a wiring harness including multiple ribs and a pair of helmet accessories. Figure 14 is a perspective view of the nasal interface of a pair of reinforced medical tubes, each coupled to a nose fork, wherein each nose fork is fixed to a wiring harness including multiple ribs. Figure 15 shows a nasal cannula positioned at an operating position on the user's face, the cannula being positioned according to an embodiment of the seventh aspect. Figure 16 is a side view of the nasal cannula configuration of Figure 15. Figure 17 shows an embodiment according to the seventh aspect and its constituent assembly components. Figure 18 shows a nasal cannula positioned at an operating position on the user's face, the cannula being positioned according to an embodiment of the sixth aspect. Figure 19 is a side view of the nasal cannula configuration of Figure 18. Figure 20 shows an exploded perspective view of an embodiment according to the sixth aspect and its constituent assembly components. Figure 21 shows the relative layers from right to left (user not shown) according to an embodiment of the sixth aspect. Figure 22 shows one embodiment of the fixing patch according to the sixth face. Figure 23 shows another or alternative embodiment of the fixing patch according to the sixth face.Figure 24A is a close-up perspective view of a cut-open medical tube, with the corrugated tubular body removed to expose the coated helical internal components. Figure 24B is a close-up perspective view of a cut-open medical tube, with the smooth tubular body removed to expose the coated helical internal components. Figure 25A is a schematic front view of a pair of nose forks, illustrating the shape of the forks and internal lumen. Figure 25B is a schematic side view of a pair of nose forks, illustrating the shape of the forks and internal lumen. Figure 25C is a schematic front view of a pair of reverse nose forks, illustrating the shape of the forks and internal lumen. Figure 25D is a schematic perspective view of a pair of reverse nose forks, illustrating the shape of the forks and internal lumen. Figure 26A is a perspective view of a nose interface with a curved backing assembly. Figure 26B is a front view of a nose interface with a curved backing assembly. Figure 26C is a top view of a nose interface with a curved backing assembly. Figure 26D is a rear view of the nose interface with a curved backing assembly. Figure 27A is a close-up view of the nose fork illustrated in Figure 17D. Figure 27B is a close-up view of the nose fork illustrated in Figure 17C. Figures 28 and 29 show a nose cannula configuration in use with a backing assembly including a lip. Figure 30 is a front perspective view of a nose cannula configuration with a backing assembly including a lip. Figure 31 is a rear perspective view of a nose cannula configuration with a backing assembly including a lip. Figure 32 is a top rear perspective view of a nose cannula configuration with a backing assembly including a lip and a user interface patch on the back of the backing assembly. Figure 33 is a cross-sectional view of the nose cannula configuration in Figure 32 when the user interface patch is attached to a skin patch. Figure 34 is a side rear perspective view of the nose cannula configurations in Figures 30 to 33. Figure 35 is a rear view of another nasal cannula configuration as shown in Figures 28 to 34, illustrating a series of segmented lips. Figure 36A illustrates the outline of a skin patch according to several embodiments. Figures 36B to 36R illustrate various embodiments of a fastener base for securing the skin patch of Figure 36A.

Claims

1. A nasal cannula assembly for delivering respiratory gas to a patient, the nasal cannula assembly comprising: a pair of nose forks for insertion into a patient's nostrils, each nose fork defining a fork lumen extending between a user end and a tube end of each nose fork; a pair of tubes for supporting respiratory gas to an individual nose fork, each tube coupled to a tube end of an individual nose fork, and including a tubular body defining a lumen extending between open ends of the tubular body, wherein an internal member supports the tubular body; a pair of face pads, each face pad extending laterally from an individual nose fork, each face pad including a posterior surface extending laterally from the individual nose fork; and a fixation system connected to the posterior surfaces, the fixation system comprising: a skin patch and a user interface patch. The skin patch has a patient side and an interface side. The patient side of the skin patch is attachable to the user's skin by an adhesive. The interface side of the skin patch is provided with a two-part releasable first part. The user interface patch has a patient side and an interface side. The patient side of the user interface patch has the two-part releasable complementary second part. The interface side is attached to the rear surface of each facial pad, such that the two-part releasable first part and the complementary second part are releasably attached to attach the patient interface to the patient.

2. The nose cannula assembly of claim 1, wherein each tube and each individual tube end of the fork is configured to be concentric with the fork extending around the tube.

3. The nasal cannula assembly as requested in item 1, wherein the user end and the tube end of each fork are connected by means of an arched bend connector.

4. The nasal cannula assembly of claim 1, wherein a wire bundle coupled to the pair of nasal forks is used to maintain the nasal forks in a fixed spaced relationship.

5. The nasal cannula assembly as requested in item 1, wherein each nasal fork is supplied with gas by a separate individual tube.

6. The nasal cannula assembly of claim 1, wherein each nasal fork is shaped to extend generally upward and backward into the user's nostril.

7. The nasal cannula assembly of claim 1, wherein the outermost periphery of one of the internal components defines a plurality of alternating peaks and valleys along the length of one of the tubular bodies.

8. The nasal cannula assembly as requested in claim 1, wherein the tubular body is corrugated.

9. As in claim 1, the internal component of the nasal cannula assembly is a spiral element.

10. The internal component of the nasal cannula assembly as requested in item 9 is a spiral metal wire.

11. The nasal cannula assembly of claim 9 or 10, wherein the spiral element has a spacing of approximately 0.4 mm to 2 mm between adjacent turns.

12. The nasal cannula assembly of claim 1, wherein the tubular body has a wall thickness of about 0.1 mm to about 0.2 mm.

13. The nasal cannula assembly of claim 1, wherein the tubular body has an outermost diameter of about 1.6 mm to about 4.6 mm.

14. The nasal cannula assembly of claim 8, wherein the corrugations have a depth of about 0.1 mm to about 0.5 mm.

15. The nasal cannula assembly of claim 1, wherein the two-part releasable attachment of the first part has one of a hook or a ring, and the complementary second part has the other of the hook or ring.

16. The nasal cannula assembly of claim 1, wherein the skin patch includes hooks that engage a ring of the user interface patch.

17. The nasal cannula assembly of claim 1, wherein the skin patch comprises a generally oval body.

18. The nasal cannula assembly of claim 1, wherein a base portion is secured to the skin patch, the base portion supports a distributed mechanical fastener, and the base portion is flexible but substantially non-stretchable.

19. The nasal cannula assembly of claim 18, wherein the base portion is divided by slotting.

20. The nasal cannula assembly of claim 1, wherein the tubular body is formed of silicone rubber.

21. The nasal cannula assembly of claim 1, wherein the facial pads are formed of a flexible material.

22. The nasal cannula assembly of claim 1, wherein the tubing is joined by a connector to form a single connector having a gas supply conduit.

23. The nasal cannula assembly of claim 1, wherein the skin patch includes a wide section without the substrate, positioned laterally away from the user's nose to assist in the removal of the patch.

24. The nasal cannula assembly of claim 1, wherein the fixation system is configured for use in an infant or newborn.

Images