TW202421216A - A nasal cannula, conduit and securement system - Google Patents

Abstract

This invention relates to medical breathing tubes comprising a tubular body, the body defining a lumen extending between open terminal ends of the body and an internal form enclosed within the lumen and supportive of the tubular body. The internal form may be of a coated encapsulated internal form, the coating securing the internal form to the tubular body. The internal form may also or separately provide for a series of alternative crests and troughs (e.g. corrugations) of the tubular body. Patient interfaces (such as masks or nasal cannula) can be connected to such tubing. A system for securing patient interfaces in an operational position may also be utilised.

Description

Nasal cannulas, catheters and fixation systems

Invention Field

The disclosure herein generally relates to components of a medical system for delivering gases to and from a patient. In one particular aspect, the disclosure relates to catheters, and more specifically, breathing tubes used in the 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 another particular aspect, the disclosure relates to nasal cannulas that form part of a respiratory system. In another particular aspect, the disclosure relates to positioning a patient interface such as a cannula in an operative position for a user.

Invention Background

In assisted breathing, breathing gases are supplied to the patient through a flexible breathing tube. Gases exhaled by the patient can be directed to or exhaled from the patient's environment through a similar breathing tube. Gases are typically administered to the patient through a user interface, which may also include a short, dedicated breathing tube to couple the interface to the breathing tube. Each breathing tube is ideally lightweight and resistant to kinking or pinching, but also flexible to ensure adequate performance and comfort for the patient.

Typical breathing tube sizes range from about 10 mm to about 25 mm internal diameter bore (covering both neonatal and adult use). Dedicated user interface tubes can be smaller, with an internal diameter of about 2 mm for neonatal use. The small size of dedicated user interface breathing tubes makes them less visually invasive and reduces weight on the patient's face. The breathing tubes are preferably flexible, allowing them to be easily bent to improve patient comfort, which in turn improves patient compliance with treatment.

In medical applications such as assisted breathing, the gas inhaled by the patient is preferably delivered at close to body temperature (usually 33°C to 37°C) and with relatively high humidity (usually 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.

The same tubes can also be used to supply inflation gases for laparoscopic surgery. Such inflation gases are also ideally lightweight, resistant to kinking or pinching, and have similar flexibility to reduce obstruction and distraction in the operating room. The inflation gas (typically carbon dioxide, but can be other gases or gas mixtures) can also be humidified.

Additionally, gas supplied to the patient may be provided through a nasal cannula. Particularly in the case of infants and newborns, the flexibility of the associated tubing becomes an important consideration. Improving the flexibility of the tubing supplying gas to the patient cannula helps improve comfort and, as a result, compliance with such gas delivery procedures.

In addition, an alternative or improved system for positioning an interface or the operation positioning of an interface such as a nasal cannula is advantageously provided. Such an alternative or improved system can further help improve the compliance of the gas delivery process.

References to patent specifications, other external documents, or other sources of information have been made in the specification, generally to provide a context for discussing features of the disclosure. Unless specifically stated otherwise, reference to such external documents is not an admission that such documents or other sources of information are in any way prior art or form part of the common general knowledge in the art.

Other aspects and advantages disclosed in this article will become more apparent from the detailed description below, which is only intended as an example.

Summary of the invention

The object of the present disclosure is to provide a component or a method of making a component which is at least somewhat improved with respect to the above description or which will provide a useful choice to the public or medical practitioners.

In a first aspect, the present disclosure broadly includes a method of manufacturing a medical tube, the method comprising providing an inner mold, extruding a tubular body around the inner mold, the tubular body defining a lumen surrounding the inner mold.

Preferably, the method further comprises: i) applying a decompression to (or to) the interior of the lumen, such that the decompression draws the tubular body radially inwardly in the lumen or at the outermost periphery defined by the inner mold, the outermost periphery of the inner mold defining a plurality of alternating peaks and valleys along a length of the tubular body, or ii) applying an extension (or stretching) to at least a portion or a region of the tubular body surrounding the inner mold, such that the release of the extension (or stretching) returns (or allows) the extended (or stretched) portion or region of the tubular body to be radially inwardly drawn inwardly in the lumen or at the outermost periphery defined by the inner mold, 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).

Preferably the tubular body is provided by extrusion or by extruding a material from a die.

Preferably, the tubular body is extruded around the inner mold, and the reduced pressure is applied in a manner that allows an inner surface of the tubular body to become at least partially attached or connected to at least a portion of the inner mold, preferably the reduced pressure difference between the pressure inside the lumen and the pressure surrounding the tubular body, and more preferably 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)).

Preferably the tubular body is a single-wall body.

Preferably the decompression is applied at or adjacent to the formation of the lumen.

Preferably the reduced pressure is applied at or adjacent to a die.

Preferably the lumen experiences the depressurization when exiting from an extrusion die.

Preferably the tubular body and the inner moulding part are co-extruded.

Preferably the tubular body so formed is corrugated.

Preferably, the wave peaks of the corrugated tubular body thus formed are defined by the outermost periphery of the inner molded part.

Preferably, the wave valleys of the corrugated tubular body thus formed are defined by the inwardly drawn portion of the tubular body drawn inwardly between the inner molded parts.

Preferably the inner moulding member is a frame or internal support structure supporting the tubular body.

Preferably the inner profile is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths.

Preferably the inner moulding part is a screen.

Preferably the inner moulding is one or a combination of a helical spring or a helical wound element, a helical wound frame or a helical wound rib, annular disc, ring, or a plurality of separate support members interconnected or interconnectable by one or more connecting rods.

Preferably the inner moulding member is supportive or supports the lumen within the tube so formed.

Preferably the inner moulding member supports or bears against the lumen within the interior of the tube so formed.

Preferably the inner profile is a spiral element or member.

Preferably the inner moulding has a spacing which varies along the length (or section) of the tube.

Preferably, the inner molded part is a spirally 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.

Preferably, the inner mold 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.

Preferably the inner molded part 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 A diameter of 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.

Preferably the inner moulding member is a medical grade material, preferably a medical grade stainless steel.

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.

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, the tubular body has an outer (or external) 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 external) diameter of about 3 mm to about 5 mm.

Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

Preferably, the ratio of the spacing of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold 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.

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

Preferably the ratio of the corrugation depth to the outer (ie, external) tube diameter is about 0.05 to about 0.09.

Preferably the properties of the tubular body result in the tube having the desired flexibility and/or structural support.

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

Preferably, the tubular body is (preferably extruded from) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, 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.

Preferably, the tubular body is a breathable tube, or is made of a breathable material, such as breathable thermoplastic polyurethane (type) or breathable polyamide.

Preferably, the decompression is applied when the tubular body is in a molten state, or a semi-molten state, or a state that has not yet hardened. Preferably, the decompression 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 decompression is a pressure difference between the inner side of the lumen and the surrounding area of the tubular body.

Preferably the inner moulding part is electrically conductive, preferably the inner moulding part is an electric heater.

Preferably the inner moulding comprises an electrically conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

Preferably the tube further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

Preferably the tubular body is defined as flexible by passing a test for increase in resistance to flow with bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

Preferably the medical tube is a breathing tube.

Preferably the inner moulding comprises one or more separate components.

Preferably the inner moulding comprises one or more components.

Preferably the tube comprises one or more inner moulding parts. In the second aspect, the invention may be broadly said to consist of a medical tube comprising: a tubular body defining a lumen extending between open ends of the body, and an inner moulding part surrounding the interior of the lumen and supporting the tubular body, the outermost periphery of the inner moulding part defining a plurality of alternating peaks and valleys along a length of the tubular body.

Preferably the tubular body is an extruded tube.

Preferably the tubular body is a continuous tube.

Preferably the tubular body is a continuous extruded tube.

Preferably, the peaks of the corrugated tubular body are defined by the outermost periphery of the inner molded part.

Preferably, the corrugated tubular body is defined by an inwardly drawn portion of the tubular body drawn inwardly between the inner molded parts.

Preferably the inner profile is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths.

Preferably the inner moulding is one or a combination of a helical spring or a helical wound element, a helical wound frame or a helical wound rib, annular disc, ring, or a plurality of separate support members interconnected or interconnectable by one or more connecting rods.

Preferably, the inner mold supports the tubular body and defines the lumen therein.

Preferably the inner moulding member is a frame or inner support structure supporting the tubular body.

Preferably the tubular body is substantially unsupported by the troughs from the inner moulding member and is supported by the inner moulding member at the crests.

Preferably the walls of the tubular body are suspended between adjacent wave crests.

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

Preferably 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.

Preferably the inner profile is a helically wound rib, or rib element.

Preferably the inner profile is a spiral element or member.

Preferably the inner mold has a pitch that varies along a length (or section) of the tube. Preferably the inner mold is a spirally wound element having a pitch 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 pitch between adjacent turns is about 1 mm to about 1.5 mm.

Preferably, the inner mold 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.

Preferably the inner molded part 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 A diameter of 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.

Preferably the inner moulding member is a medical grade material, preferably a medical grade stainless steel.

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.

Preferably, the tubular body has an inner 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.

Preferably, the tubular body has an outer (or external) 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 external) diameter of about 3 mm to about 5 mm.

Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

Preferably, the ratio of the spacing of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold 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.

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

Preferably the ratio of the corrugation depth to the outer (ie, external) tube diameter is about 0.05 to about 0.09.

Preferably the properties of the tubular body result in the tube having the desired flexibility and/or structural support.

Preferably, the tubular body is (preferably extruded from) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, 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.

Preferably the inner moulding member is a plurality of rings spaced longitudinally along the lumen.

Preferably, the rings are in the shape of a complex surface or a ring.

Preferably the inner moulding is one or more separate components linked to each other.

Preferably, the inner profile is a plurality of reinforcing ribs regularly spaced along the lumen.

Preferably each reinforcing rib comprises a turn of a helical reinforcing wire.

Preferably, one turn of the helical reinforcement wire comprises one complete revolution around the lumen.

Preferably, one turn of the helical reinforcing wire comprises the wire between adjacent wave crests of the inner profile.

Preferably the tubular body is defined as flexible by passing a test for increase in resistance to flow with bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

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

Preferably the inner moulding part is a screen.

Preferably the inner moulding is a wire suitable for heating or sensing the properties of the gas inside the tube.

Preferably the inner moulding part is electrically conductive, preferably the inner moulding part is an electric heater.

Preferably the inner moulding comprises a conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

Preferably the tube further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

Preferably the tube is a breathing tube.

Preferably the inner moulding comprises one or more separate components.

Preferably the inner moulding comprises one or more components.

Preferably the tube comprises one or more inner moulding parts.

In a third aspect, the present invention can be broadly described as consisting of a nasal cannula configuration comprising: at least one nasal prong having an air outlet adapted 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 inner molded part enclosing the lumen, the inner molded part supporting the tubular body, an outermost periphery of the inner molded part defining a plurality of alternating peaks and valleys along a length of the tubular body, wherein the air inlet of the nasal prong is integrally formed with a terminal end of the tube such that the lumen is fluidly connected to the air outlet of the nasal prong.

Preferably the nasal prongs are shaped to substantially anatomically conform to the interior of a user's nose or nostrils.

Preferably the nasal prongs are curved or otherwise shaped or configured to avoid a user's nasal septum.

Preferably the nasal cannula has a substantially planar or flat or contoured backing configured to rest on a user's face, preferably as a stabilizer for the prongs in a user's nostrils.

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

Preferably the two-nose fork is integrally formed with a single corrugated delivery tube.

Preferably the sleeve comprises a pair of nose prongs, each prong being integrally formed with, or attachable (or attachable) or connectable (or connectable) to, one end of a pair of gas delivery tubes.

Preferably the sleeve is configured to be made of a polymer such as a thermoplastic polymer, preferably a polymer or polymers suitable for use in medical breathing tubes.

Preferably, the sleeve is configured to be made of any one or more of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, such as a styrene block copolymer. 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.

In a fourth aspect, the present invention may be broadly said to comprise a user interface comprising a pair of nasal cannulas as defined by the third aspect.

Preferably, the nasal prongs of each nasal cannula are arranged adjacent to each other and the individual delivery tubes extend in opposite directions away from the nasal prongs.

Preferably, it further includes a wiring harness that extends and couples between the nasal cannulas.

Preferably the tube is a breathing tube.

Preferably the tube is as defined in the first or second aspect, for example the tube is manufactured by a method as defined in the first aspect or by a tube as defined in the second aspect.

In the fifth aspect, the invention may be broadly said to include 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.

Preferably, the method further comprises: i) applying a decompression to (or to) the interior of the lumen, so that the decompression draws the tubular body radially inwardly in the lumen or the outermost periphery defined by the inner mold, the outermost periphery of the inner mold defining a plurality of alternating peaks and valleys along a length of the tubular body, or ii) applying an extension (or stretching) to at least a portion or a region of the tubular body surrounding the inner mold, so that the release of the extension (or stretching) returns (or allows) the extended (or stretched) portion or region of the tubular body to be radially inwardly drawn inwardly in the lumen or the outermost periphery defined by the inner mold, 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).

Preferably the method comprises molding a nose prong about a terminal end of the tubular body.

Preferably the tubular body so formed is a tube as defined by the means of the first aspect or as defined by the tube of the second aspect.

Preferably, one end of the tube so formed by the tubular body is positioned in a mold or a mold for molding or forming a nasal cannula, preferably the mold or mold is closed, and the nasal cannula is molded or formed around the one or one end of the tube.

Preferably the nasal cannula is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

Preferably, the nasal cannula is formed from any one or more of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, such as styrene-embedded or 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.

Preferably 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.

Preferably, a nasal cannula mold is provided which can receive one end of the tube formed by the manufacture of the tubular body, so that operation of the mold assists in the molding of the nasal cannula, a portion of which is molded by enclosing the tube end.

Preferably, the nasal cannula manufactured by the nasal cannula is configured to be fluidly connected to one end of the tube formed by manufacturing the tubular body.

In a sixth aspect, the invention may be broadly described as comprising 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 configured to attach to or adhere to the skin of a user, and a fixation patch, at least a portion of which is configured to extend over the user interface and/or associated user interface tube and to be 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 configured so that the fixation patch can be contained within or delimited by the fixation footprint of the skin patch when the fixation system is applied to a patient with a suitable or compatible user interface.

Preferably the skin patch has the same or a larger surface area than the fixing patch.

Preferably the mounting patch is shaped or otherwise configured to correspond to the geometry or other features of the user interface and/or an associated user interface tube.

Preferably the fixing patch has at least one wing.

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

Preferably the fixing patch has a tube end wing which is configured to extend or be used to extend under the user interface tube and be fixed to the skin patch.

Preferably the user side of the skin patch has a skin sensitive adhesive (such as a hydrophilic colloid) which attaches or adheres the skin patch to a user's skin.

Preferably the skin patch has a surface of sufficient area so that the surface distributes the attachment or adhesive force pressure across the user's skin.

Preferably the skin patch is configured to be attached or adhered to a user's face.

Preferably the skin patch is configured to be attached or adhered to a user's face, particularly adjacent to the user's upper lips and/or cheeks.

Preferably the securing system is configured to receive and/or secure a nasal cannula and/or associated tubing extending from one or both sides of a user's face.

Preferably the securement system is configured for use with an infant or newborn.

Preferably the fixation system is configured for use with a nasal cannula as defined by a third aspect.

Preferably the fixing system is configured for use with a tube as defined by the first and/or second face.

In the seventh aspect, the invention may be broadly said to comprise a fixing system for a user interface and/or user interface tube, comprising a two-part releasable attachment or connection arrangement, the arrangement 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 being attachable to the skin of a user (e.g. by an adhesive, typically a skin-sensitive adhesive such as a hydrophilic colloid), the interface side of the skin patch being provided with the first part of a two-part releasable attachment or connection system, and The user interface patch has an interface side and a patient side, the patient side of the user interface patch being provided with the complementary second component of the two-component releasable attachment or connection system, the interface side of the user interface patch being attachable or connectable to the user interface and/or associated user interface tube, for example by adhesive or being formed as a component of the user interface, or being provided as a back surface of the user interface when the user interface is provided with the second component of the two-component system.

Preferably, 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, so that the first and second components (and the patch) are releasably attached or connected to each other.

Preferably the first patch is positionable and/or attachable to the facial skin of a user.

Preferably the user interface patch is positionable, or attached or attachable, or linked to or with a user interface.

Preferably the UI patch is integrally formed with a UI or forms a component of the UI.

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.

Preferably the first component of the two-component releasable attachment or coupling system is bonded or bondable to the user interface side of the skin patch.

Preferably the user side of the skin patch has a skin sensitive adhesive (such as, for example, a hydrophilic colloid) that attaches or adheres the skin patch to a user's skin.

Preferably the skin patch has a surface of sufficient area so that the surface distributes the attachment pressure or adhesive force across the user's skin.

Preferably the skin patch is configured to be attached or adhered to a user's face.

Preferably the skin patch is configured to be attached or adhered to a user's face adjacent the user's upper lips and/or cheeks.

Preferably the securing system is configured to receive and/or secure a nasal cannula and associated tubing that extends from one or both sides of a user's face.

Preferably the securement system is configured for use with an infant or newborn.

Preferably the fixation system is configured for use with a nasal cannula as defined by any one or more of the third aspects.

Preferably the fixing system is configured for use with a tube as defined by the first and/or second face.

Preferably the fixing patch as defined above is applied or applicable over the user interface and is fixed or fixable to the skin patch to provide additional fixation.

Preferably the first component of the two-part releasable attachment or coupling system comprises a substrate secured to or for securing to the skin patch.

Preferably the base portion comprises at least one slit or at least one slot, with regions of the base portion separated by the slit or slot.

Preferably the base portion includes a plurality of slits or grooves or both, which together divide the base portion into a serpentine body.

Preferably, the slits and/or grooves are arranged on the substrate so that a first set of at least one set of slits or grooves extends into the substrate from one edge of the substrate, and a second set of slits or grooves extends into the substrate from the other edge of the substrate, and the slits or grooves of one set are interlaced with the slits or grooves of another set so that a path along the substrate portion from one end to the other end without crossing the slits or grooves of one set follows a saw-like or winding path that is much longer than a straight line between the two ends.

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

Preferably, the plurality of slits or slots are curved and the curved slits or slots are arranged substantially in parallel.

Preferably the slits or slots are arranged to extend from the edge of the base portion into a herringbone pattern.

Preferably, the base body is divided into separate parts by a meandering slit or groove.

Preferably, the base portion is divided into a plurality of portions by a spiral slit or groove.

Preferably the base portion is divided into sub-portions by slits or grooves arranged in substantially concentric circles.

Preferably the concentric circles are centered approximately at the center of the base portion.

Preferably, the slits or grooves divide the base portion into a plurality of islands, each island being connected to an adjacent island or islands by a narrow bridge.

Preferably, the base portion is divided into multiple portions by an S-shaped slit.

Preferably, the base portion is divided into multiple portions by a T-shaped slit.

Preferably, the base portion covers at least 70% of the area of the skin patch.

Preferably, for a boundary defining the shortest path around the periphery of the substrate, the substrate portion covers at least 80% of the area inside the boundary.

In the eighth aspect, the present invention broadly comprises a method for manufacturing a medical tube, the method comprising: providing an inner mold enclosed in a coating, and providing a tubular body enclosing the inner mold, the tubular body defining a lumen surrounding the inner mold, the tubular body being arranged to enclose the inner mold such that the coating is bonded to an inner surface of the tubular body, wherein the inner mold remains enclosed.

Preferably, the step of providing an inner mold comprises: providing an elongated molded part enclosed within a coating layer suitable for application to a medical tube, and manufacturing a supporting inner molded part for a medical tube from the coated elongated molded part.

Preferably the uncoated elongate member is dipped into a bath of coating material to apply the encapsulating coating.

Preferably the bath contains a molten polymer level at a temperature above about 150°C.

Preferably the inner profile is manufactured by helically winding the elongate profile into a spiral form.

Preferably, the method further comprises: providing an uncoated elongated member, encapsulating the elongated member in a coating suitable for application to a medical tube.

Preferably, the method further comprises: i) applying a decompression to (or to) the interior of the lumen, so that the decompression draws the tubular body radially inward, or ii) applying an extension (or stretching) to at least a portion or a region of the tubular body surrounding the inner molded part, so that the release of the extension (or stretching) returns (or allows) the extended (or stretched) portion or region of the tubular body to be radially drawn inward, or iii) a combination of i) and ii).

Preferably the tubular body is radially inwardly drawn at the lumen or outermost periphery defined by the inner mold, the outermost periphery of the inner mold defining a plurality of alternating peaks and valleys along a length of the tubular body to form a corrugated tube.

Preferably the tubular body is provided by extrusion or by extruding a material from a die.

Preferably, the tubular body is extruded around the inner mold, and the reduced pressure is applied in a manner that allows an inner surface of the tubular body to become at least partially attached or connected to at least a portion of the inner mold, preferably the reduced pressure difference between the pressure inside the lumen and the pressure surrounding the tubular body, and more preferably 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)).

Preferably the tubular body is provided around the inner mold at a temperature such that the coating is bonded to at least a portion of the tubular body.

Preferably the tubular body is provided around the inner moulding at a temperature which permits the coating to fuse to the inner moulding.

Preferably the tubular body is at least partially fused to the coating layer.

Preferably the tubular body is a single-wall body.

Preferably a reduced pressure is applied at or adjacent to the formation of the lumen.

Preferably the reduced pressure is applied at or adjacent to a die.

Preferably the lumen experiences the depressurization when exiting from an extrusion die.

Preferably the tubular body is extruded simultaneously with the manufacture of the inner form from the elongate form.

Preferably the tubular body so formed is corrugated (which may be axial or helical).

Preferably, the wave peaks of the thus formed corrugated tubular body are defined by the outermost periphery of the inner molded part.

Preferably, the wave valleys of the thus formed corrugated tubular body are defined by the inwardly drawn portion of the tubular body drawn inwardly between the inner molded parts.

Preferably the inner moulding member is a frame or inner support structure supporting the tubular body.

Preferably the inner profile is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths.

Preferably the inner moulding is one or a combination of a helical spring or a helical wound element, a helical wound frame or a helical wound rib, annular disc, ring, or a plurality of separate support members interconnected or interconnectable by one or more connecting rods.

Preferably the inner moulding member is supportive or supports the lumen within the tube so formed.

Preferably the inner profile is a spiral element or member.

Preferably the inner moulding has a pitch which varies along a length (or section) of the tube.

Preferably the inner molded part is a spirally 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.

Preferably, the inner mold 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.

Preferably the inner molded part 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 A diameter of 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 the inner moulding is a medical grade material, preferably a medical grade stainless steel coated with a suitable material, preferably a polymer grade or a stainless steel.

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.

Preferably, the tubular body has an inner 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.

Preferably the tubular body has an outer (or external) 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 external) diameter of about 3 mm to about 5 mm.

Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

Preferably, the ratio of the spacing of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold 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.

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

Preferably the ratio of the corrugation depth to the outer (ie, external) tube diameter is about 0.05 to about 0.09.

Preferably the properties of the tubular body result in the tube having the desired flexibility and/or structural support.

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

Preferably, the tubular body is (preferably extruded from) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, 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.

Preferably, the tubular body is a breathable tube, or is made of a breathable material, such as breathable thermoplastic polyurethane (type) or breathable polyamide.

Preferably, the decompression is applied when the tubular body is in a molten state, or a semi-molten state, or a state that has not yet hardened. Preferably, the decompression 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 decompression is a pressure difference between the inner side of the lumen and the surrounding area of the tubular body.

Preferably the inner moulding part is electrically conductive, preferably the inner moulding part is an electric heater.

Preferably the inner moulding comprises a conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

Preferably the tube further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

Preferably the tubular body so formed is defined as flexible by passing the test for increase in flow resistance with bending according to ISO 5367:2000(E) (4th edition, June 1, 2000).

Preferably the medical tube is a breathing tube.

Preferably the inner moulding comprises one or more separate components.

Preferably the inner moulding comprises one or more components.

Preferably the tube comprises one or more inner moulding parts.

In the ninth aspect, the present invention broadly comprises a method for manufacturing a medical tube, the method comprising: i) providing an inner mold, ii) providing a tubular body covering the inner mold, the tubular body defining a lumen enclosing the inner mold, and applying a decompression to (or to) the inside of the lumen, or applying an extension (or stretching) to at least a portion or a region of the tubular body enclosing the inner mold, or iii) a combination of i) and ii).

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

Preferably, the inner mold is enclosed in a coating, and the tubular body is provided to cover the inner mold so that the coating is bonded to an inner surface of the tubular body, wherein the inner mold remains enclosed.

In the tenth aspect, the present invention broadly includes a medical tube comprising: a tubular body, the body defining a lumen extending between the open ends of the body, an inner molded part enclosing the lumen and supporting the tubular body, and a coating encapsulating the inner molded part, the coating fixing the inner molded part to the tubular body.

Preferably, the coating layer and the tubular body are welded along the tube.

Preferably the coating and the tubular body are welded at separate locations along the tube.

Preferably, the coating layer and the tubular body are welded substantially continuously along the longitudinal direction of the tube.

Preferably the outermost periphery of the inner moulding member defines a plurality of alternating peaks and valleys along a length of the tubular body.

Preferably, the peaks of the corrugated tubular body are defined by the outermost periphery of the inner molded part.

Preferably, the corrugated tubular body is defined by an inwardly drawn portion of the tubular body drawn inwardly between the inner molded parts.

Preferably the inner profile is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths.

Preferably the inner moulding is one or a combination of a helical spring or a helical wound element, a helical wound frame or a helical wound rib, annular disc, ring, or a plurality of separate support members interconnected or interconnectable by one or more connecting rods.

Preferably, the inner mold supports the tubular body and defines the lumen therein.

Preferably the inner profile is a spiral element or member.

Preferably the inner moulding has a pitch which varies along a length (or section) of the tube.

Preferably the inner moulding member is a frame or inner support structure supporting the tubular body.

Preferably the tubular body is substantially unsupported by the troughs from the inner moulding member and is supported by the inner moulding member at the crests.

Preferably the walls of the tubular body are suspended between adjacent wave crests.

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

Preferably the inner profile is a helically wound rib, or rib element.

Preferably the inner moulding member is a spirally wound strip and the coating layer encapsulates the strip.

Preferably the inner moulding is a helically wound wire and the coating encapsulates the wire.

Preferably the coating provides a surface to be joined to the tubular body.

Preferably, the inner molded part is a spirally 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.

Preferably, the inner mold 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.

Preferably the inner molded part 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 A diameter of 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.

Preferably the inner moulding member is a medical grade material, preferably a medical grade stainless steel.

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. Preferably about 0.1 mm to about 0.2 mm.

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 (or external) diameter of about 3 mm to about 5 mm.

Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

Preferably, the ratio of the spacing of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold 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.

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

Preferably the ratio of the corrugation depth to the outer (ie, external) tube diameter is about 0.05 to about 0.09.

Preferably the properties of the tubular body result in the tube having the desired flexibility and/or structural support.

Preferably, the tubular body has an outer (or external) 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, the tubular body is (preferably extruded from) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, 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.

Preferably the inner moulding member is a plurality of rings spaced longitudinally along the lumen.

Preferably, the rings are in the shape of a complex surface or a ring.

Preferably the inner moulding is one or more separate components linked to each other.

Preferably, the inner profile is a plurality of reinforcing ribs regularly spaced along the lumen.

Preferably each reinforcing rib comprises a turn of a helical reinforcing wire.

Preferably, one turn of the helical reinforcement wire comprises one complete revolution around the lumen.

Preferably, one turn of the helical reinforcing wire comprises the wire between adjacent wave crests of the inner profile.

Preferably the tubular body is defined as flexible by passing a test for increase in resistance to flow with bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

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

Preferably the inner moulding part is a screen.

Preferably the inner moulding is a wire suitable for heating or sensing the properties of the gas inside the tube.

Preferably the inner moulding part is electrically conductive, preferably the inner moulding part is an electric heater.

Preferably the inner moulding comprises a conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

Preferably the tube further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

Preferably the tube is a breathing tube.

Preferably the inner moulding comprises one or more separate components.

Preferably the inner moulding comprises one or more components.

Preferably the tube comprises one or more inner moulding parts.

In the eleventh aspect, the present invention can be broadly said to include a medical tube comprising: a tubular body, the body defining a lumen extending between the open ends of the body, and an inner molded part enclosed within the lumen and supporting the tubular body.

Preferably the outermost periphery of the inner moulding member defines a plurality of alternating peaks and valleys along a length of the tubular body.

Preferably the inner moulding member is enclosed in a coating which secures the inner moulding member to the tubular body.

In aspect 12, the invention may be broadly said to comprise a nasal cannula arrangement comprising: At least one nasal prong having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly coupled to the air outlet, the or each prong being shaped to follow the anatomical curvature of a user's nostril.

Preferably the nasal prong is shaped to avoid contacting a user's nasal septum at the base of a user's nose.

Preferably the nose prong is shaped to avoid contacting the internal structure of a user's nose.

Preferably, the nasal prong is shaped to substantially align the flow of breathing gas flowing through the outlet with the upper airway of a user.

Preferably, the nasal prong is shaped to extend generally upwardly and rearwardly into a user's nostril, the nasal prong having a curvature including at least two inflection points.

Preferably, the nose prong 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.

Preferably the prongs are shaped to maximize the cross-sectional area of the lumen.

Preferably, the interface further comprises a support extending along a user's upper lip.

Preferably, the interface comprises two nasal prongs symmetrically spaced about a user's sagittal plane, the prongs extending inwardly from a base under the user's nose on a common support disposed along a user's upper lip.

Preferably, the nasal prongs extend from the support body toward the user's nasal septum and bend upward and backward around a corner of the user's nostril into the user's nostril, each prong extending along a generally inclined posterior trajectory and through two medial and lateral inflection points of the air outlet relative to the user's upper respiratory tract.

Preferably the prongs have a shaped track that matches the anatomical shape of the user's nostrils. More preferably, i) in a first portion (or stage) of such prongs, the track moves horizontally toward the midline of the face; ii) in a second portion (or stage) of the prongs, the track curves upward directly into the crown of the nostril toward the head; iii) in a third portion (or stage) of the prongs, the track rolls back into the head following the anatomical curvature of the nostril; and iv) in a fourth portion (or stage), the track tilts horizontally toward the center of the cannula to align the outflow port with a user's upper airway.

Preferably, the forks have a cross-section that changes along the center track. For example, the cross-section may be substantially circular at the base of the track (i.e., in the first region), and become substantially elliptical toward the track or fork end (e.g., in the fourth region).

Preferably the cross-sectional area substantially decreases along the track from the first portion (or stage) to the end of the fourth portion (or stage).

Preferably the nasal cannula further comprises a contoured backing or facial cushion configured to rest on a user's face.

Preferably the back or face pad is pre-formed to be substantially curved to match a contour of a user's face or upper lip area.

Preferably each prong is adapted to receive an independent flow from a gas source.

In aspect 13, the present invention broadly comprises a nasal cannula configuration comprising: At least one nasal prong 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 comprising a tubular body defining a lumen and an inner molded part enclosing the lumen, the inner molded part supporting the tubular body, wherein the air inlet of the nasal prong is integrally formed with a terminal end of the tube so that the tube lumen is fluidly connected to the air outlet of the nasal prong.

Preferably an outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

Preferably the prongs are shaped to follow the anatomical curvature of a user's nostrils.

Preferably the nasal prongs are curved or otherwise shaped or configured to avoid a user's nasal septum.

Preferably the nasal cannula has a contoured backing or facial pad configured to rest on a user's face, preferably acting as a stabilizer for the prongs in a user's nostrils.

Preferably one or more ribs extend between a front face of the back or face pad and the sleeve, the ribs providing a contact surface for a tape or other suitable fastener used to snap or attach the sleeve to a user's face, preferably the tape includes an adhesive portion or is an adhesive tape or a contact adhesive tape.

Preferably the two-nose fork is integrally formed with a single corrugated delivery tube.

Preferably the sleeve is configured to be made of a liquid silicone rubber or a polymer such as a thermoplastic polymer, preferably a polymer or polymers suitable for use in medical breathing tubes.

Preferably, the sleeve is configured to be made of any one or more of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer family, such as a styrene block copolymer. 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.

Preferably, such a sleeve can be used in combination with the tube defined in any of the above aspects.

In aspect 14, the present invention may be said to broadly comprise a user interface comprising a pair of nasal cannulas as defined in aspect 13.

Preferably in such a user interface, the nose prongs are arranged adjacent to each other and the individual delivery tubes extend in opposite directions away from the nose prongs.

Preferably, the user interface further comprises a wiring harness extending and coupled between the nasal cannulas.

Preferably the tube is a breathing tube.

Preferably in such a user interface, the pipe is defined as in any of the aforementioned aspects.

Preferably in such a user interface, the prong is glued or otherwise bonded to the tube.

In aspect 15, the invention may be broadly said to include a nasal cannula configuration comprising: At least one nasal prong having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly coupled to the air outlet, the at least one nasal prong including a backing configured to rest on a user's face, wherein a lip extends over 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 coupled to or with a skin patch attached to a user's face.

Preferably the lip is a barrier.

Preferably the lip is deformable.

Preferably the lip extends at least partially around the periphery of a region substantially adjacent a prong coupled to the backing.

Preferably the lip is a series of one or more separate lips.

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

Preferably the lip is a loop lip extending around the periphery of the rear surface of the backing.

Preferably, in use, the lip substantially forms a fluid seal or fluid barrier between the rear surface of the backing and a sleeve-facing surface of the user interface patch.

Preferably the backing is a substantially planar or flat or contoured (such as a pre-formed curve) backing configured to rest on a user's face.

Preferably the backing assists in acting as a stabilizer for the prong(s) in the nostril(s) of a user.

Preferably, the at least one prong extends outwardly from the at least one nasal prong, away from a user's nasal septum.

Preferably the sleeve is further defined by any of the aforementioned aspects.

Preferably, the sleeve can operate as the fixing system defined in any of the above aspects.

Preferably the user interface patch is receivable or retainable on the rear surface of the backing (or backing assembly) as defined in any of the aforementioned aspects.

Preferably at least the lip(s) are water repellent.

Preferably at least the lip(s) comprise at least one outer peripheral lip and at least one inner peripheral lip, each of the lips being configured to contact a user's face.

Preferably, the air inlet of the sleeve is fluidly connected to the tube as defined in any of the above aspects.

In aspect 16, the invention may be said to broadly comprise a component of a releasable fastener comprising a base portion supporting a dispersed mechanical fastener across its surface, the base portion being flexible but substantially non-stretchable, the base portion being divided into a plurality of zones by at least one slit or at least one groove so that by independent bending of the different divided portions of the base, the base can substantially conform to a lower composite curved surface.

Preferably the base portion includes a plurality of slits or grooves or both, which together divide the base portion into a serpentine body.

Preferably, the slits and/or grooves are arranged on the substrate so that a first set of at least one set of slits or grooves extends into the substrate from one edge of the substrate, and a second set of slits or grooves extends into the substrate from the other edge of the substrate, and the slits or grooves of one set are interlaced with the slits or grooves of another set so that a path of the slits or grooves of one set from one end to the other end along the substrate portion without crossing follows a saw-like or winding path that is much longer than a straight line between the two ends.

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

Preferably, a plurality of the slits or slots are curved and the curved slits or slots are arranged substantially in parallel.

Preferably the slits or slots are arranged to extend from the edge of the base portion into a herringbone pattern.

Preferably, the base body is divided into separate parts by a meandering slit or groove.

Preferably, the base portion is divided into a plurality of portions by a spiral slit or groove.

Preferably the base portion is divided into sub-portions by slits or grooves arranged in substantially concentric circles.

Preferably the concentric circles are centered approximately at the center of the base portion.

Preferably, the slits or grooves divide the base portion into a plurality of islands, each island being connected to an adjacent island or islands by a narrow bridge.

Preferably, the base portion is divided into multiple portions by an S-shaped slit.

Preferably, the base portion is divided into multiple portions by a T-shaped slit.

Preferably, the base portion covers at least 70% of the area of the skin patch.

Preferably, a boundary of the shortest path around the periphery of the substrate is defined, with the substrate portion covering at least 80% of the area within the boundary.

In aspect 17, the invention may be broadly said to include a user interface assembly comprising: a fixing system for the user interface and/or a component (e.g., such as a tube or pipe) 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 fixing system comprises a two-part releasable attachment (or connection) configuration, the 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 the skin of a user (e.g., by an adhesive, typically a skin-sensitive adhesive such as a hydrophilic colloid), The interface side of the skin patch is provided with the first component of a two-component releasable attachment or connection system, and The user interface patch has an interface side and a patient side, The patient side of the user interface patch is provided with the complementary second component of the two-component releasable attachment or connection system, The interface side of the user interface patch is attachable (or connectable) to the user interface and/or the component (such as a tube or tube) connected to the user interface, and Wherein the tube comprises: A tubular body, the body defining a lumen extending between open ends of the body, An internal molded part surrounding the interior of the lumen and supporting the tubular body, and A coating layer encapsulates the inner molded part, the coating layer fixes the inner molded part to the tubular body.

Preferably the interface is a nasal cannula.

Preferably the interface comprises one or a pair of nose prongs.

Preferably the interface includes a fixing system.

Preferably the tube is a medical breathing tube.

Preferably, the interface is a nasal cannula configuration comprising: at least one nasal prong having an outlet suitable for insertion into a user's nostril and an air inlet fluidly connected to the outlet, the at least one nasal prong comprising a backing configured to rest on a user's face, wherein a lip extends over at least a portion of the periphery of a rear surface of the backing, the rear surface being configured to receive or retain a user interface patch so that, during use, the user interface patch can be releasably attached or connected to or with a skin patch attached to a user's face.

Preferably the lip is a barrier.

Preferably the lip is deformable.

Preferably the lip extends at least partially around the periphery of a region substantially adjacent a prong coupled to the backing.

Preferably the lip is a loop lip extending around the periphery of the rear surface of the backing.

Preferably the lip is a series of one or more separate lips.

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

Preferably, in use, the lip substantially forms a fluid seal, or fluid barrier, between the rear surface of the backing and a sleeve-facing surface of the user interface patch.

Preferably the backing is a substantially planar or flat or contoured (such as a pre-formed curve) backing configured to rest on a user's face.

Preferably the backing assists in acting as a stabilizer for the prong(s) in the nostril(s) of a user.

Preferably, the at least one backing extends laterally from the at least one nasal prong away from a user's nasal septum.

It should be understood that multiple embodiments of the aforementioned tube may be used in combination with a user interface or nasal cannula as described herein.

It should be understood that various embodiments of the aforementioned fixation system may be used in combination with a user interface or nasal cannula as described herein.

It should be understood that multiple embodiments of the aforementioned user interface assembly may be used in combination as described herein.

The term "comprising" as used in the specification and patent claims means "consisting at least in part of". Features other than or prefixed to the term may also be presented when interpreting the various statements in the specification and patent claims that include the term "comprising". Related terms such as "comprising" and "comprising" are to be interpreted in the same manner.

The disclosure herein may also be broadly understood to include individual or collective parts, elements and features described or indicated in the description of the present case and/or the disclosure content, and any or all combinations of any two or more of such parts, elements, features or descriptions disclosed herein, and when specific integers are mentioned herein and there are known equivalents in the art related to the disclosure herein, such known equivalents are deemed to be incorporated herein as if individually described.

This article discloses the composition of the preceding text and also covers the following text examples.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Medical tubing (i.e. breathing tubes) has a number of limitations. Some of these limitations may be for performance reasons, such as weight, flexibility, and flow characteristics. Other limitations may be dictated by regulatory authorities and must be met before the tubing can be used in medical applications. The dictated limitations may include evaluation of the structural integrity of the tubing and the biocompatibility or sterility (for hygiene purposes) of the tubing components. One limitation is the resistance to flow induced by a bend, which can be defined based on the relevant tests set out in ISO 5367:2000(E) (4th edition, June 1, 2000).

Biocompatibility of a material is useful, for example, if the material can interact or come into contact with respiratory gases or other fluids and it does not leach or produce material into respiratory gases or other fluids that could be consumed or ingested by the user or patient. Sterility can also be used to assist in the absence or minimal (if any) transfer of disease to the user or patient.

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

The application-specific configurations of medical tubing complicate and restrict the associated design process. In addition, strict regulatory requirements for component use often limit medical practitioners to strictly follow component guidelines and instructions. Tubing

The medical tube 100 is schematically illustrated in FIG. 1. In a first embodiment, the medical tube 100 is corrugated. However, the tube can also be produced or manufactured to have a smooth outer surface (e.g., FIG. 24), or a substantially smooth inner surface (e.g., FIG. 3B, 3C). In a specific embodiment, the tube 100 includes a tubular body 102. The tubular body 102 defines a lumen 107 extending between the open ends of the body 102. An inner mold 110 is surrounded within the lumen 107. The inner mold is a support for the tubular body. The outermost periphery of the inner mold defines a plurality of staggered wave crests and troughs along the longitudinal direction of the tubular body.

The illustrated tube 100 has a corrugated profile, including a plurality of wave crests 104 and wave troughs 105. The wave crests 104 and wave troughs 105 surround the circumference of the tube 100 and extend alternately along the tubular body 102 (or its wall surface) (i.e., in a direction substantially parallel to the longitudinal axis 101 of the tube 100).

The tubular body 102 defines a lumen 107 extending between the two ends of the tube 100. For medical purposes, the passage of gas through the tube 100 is confined to 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 arranged to be substantially coaxial with the lumen (i.e., aligned with the longitudinal axis 101 in this embodiment) to reduce flow disturbances within the tube 100.

The illustrated tube 100 also includes an inner mold 110 that is disposed to sheath, surround or encircle the tubular body 102. The tubular body 102 surrounds the inner mold 110 within the lumen of the tube 100. The inner mold 110 provides a framework that defines the general shape and contributes to the structural properties of the tube 100. Preferably, the inner face or inner surface of the tubular body 102 is fixed to the inner mold 110. The tubular body 102 and the inner mold 110 can be fixed together by shrinking the tubular body 102 to nest the inner mold 110 (for example, FIG. 3D ), applying the tubular body 102 in a molten state, a semi-molten state, or even an unhardened state to cover the inner mold so that the inner surface of the tubular body 102 is fused and connected (or bonded) to the inner mold 110 (for example, FIG. 3C ), or even 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 (for example, FIG. 3B ).

The inner profile 110 preferably defines a skeleton infrastructure, arranged around the longitudinal axis 101 of the tube 100 and supporting the tubular body 102. The tubular body 102 is arranged to encase the inner profile 110, and the corrugation of the tubular body 102 reflects the structure of the reinforcing skeleton provided by the inner profile 110. The peaks 104 of the tube corrugation correspond to the reinforcing ribs (i.e. the shape of the inner profile 110) supporting the tubular body 102. The troughs 105 of the tube corrugation are preferably unsupported sections of the tubular body 102, which are suspended between adjacent reinforcing ribs.

The inner mold 110 as illustrated in Figures 1, 2, 3-3D, 24A, and 24B comprises a continuous spiral skeleton having a structure similar to a spiral spring. The skeleton generates the spiral wave pattern of the tubular body 102, which is visible on the left side of Figure 1. In this embodiment, the inner mold 110 is continuously fixed to the tubular body 102 at the wave crests 104 of the wave pattern. The tubular body 102 follows the contour of the inner mold 110 and wraps around each reinforcing rib. In this embodiment, the contact interface between each reinforcing rib and the tubular body 102 can exceed half of the circumference of the rib.

FIG. 3 illustrates another embodiment of a medical tube 200. In this embodiment, an inner mold 210 comprises a plurality of rings along the longitudinal axis 201 of the tube 200. Each ring 210 provides a peripheral reinforcing rib located coincident with the crests 204 of the tubular body 202. The individual rings constitute the reinforcing framework of the illustrated inner mold 210. Accordingly, the tube 200 has a peripheral corrugation with separate crests 204 and troughs 205 extending along the tube 200 around the longitudinal axis 201. When the tube is twisted (i.e. when torque is applied), adjacent rings may link to counteract narrowing of the lumen. The rings may be formed by washers or disks with orifices to allow flow therethrough. Preferably the rings are complex surfaces or toroids.

Another embodiment of the tube 1100 is illustrated in FIG24B. The tube 1100 has a structure similar to the corrugated tube 100 shown in FIG1, including a tubular body 1102 and an inner molded part 1110. However, the tubular body 1102 of the tube 1100 illustrated in FIG24B defines a smooth or non-corrugated or non-wrinkled outer wall.

The inner form may have an outer coating, such as illustrated in the cross-sectional tube of Figures 24A and 24B. The coating illustrated in Figures 24A and 24B is about 35 microns thick and the tube wall is about 150 microns thick. The coating 1111 completely encapsulates the inner form 1110. In another form, the inner form may also be partially coated, such as by encasing separate longitudinal sections of the coating of the inner form 1110.

The inner mold 1110 may be coated to increase the strength of the bond formed with the tubular body 1102, improve the biocompatibility or sterility of the interior of the tube, and/or to separate the inner mold from the contents of the tube (e.g., to prevent corrosion of the inner mold). Preferably, the coating is thin enough so that it does not negatively affect the mechanical properties of the inner mold, such as reducing elasticity or flexibility.

The tube of Figure 3B is typically a sandwich assembly, made of a thin-walled polymer tube inserted into the center of an internal molded part such as a coil spring. The assembly is then passed through a cross-tube extrusion die, which extrude the melt and similarly extrude the thin-walled polymer tube around the outside of the assembly. The molten outer tube contacts the inner tube by stretching the extruded melt, and/or by a vacuum applied to the pressure differential between the two layers, or by a positive pressure applied to the inside of the inner tube or the outside of the outer tube, or a combination of the two. The contact of the molten outer tube with the inner tube creates a connection between the two, leaving a tube composed of the inner and outer walls of the tubular body once cooled. The internal molded part (such as a coil spring wire reinforcement) remains sandwiched between the two wall layers.

Such a tube may be formed with a relatively 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 inner profile is mechanically locked in place by a clamping effect. Thus a pre-coated inner profile may not be required to achieve such bonding to the tube wall, but the option exists. The tube may be two thin layers of similar material bonded together, with the inner profile (e.g. a spring) locked in place away from the gas path. This provides a very flexible yet strong tube that is resistant to rolling and kinking. The mechanical locking spring is positioned to assist in maintaining the integrity of the tube structure under axial stress, while the absence of the spring in the gas path relaxes the biocompatibility or sterility requirements of the internal mold assembly.

The tube of Figure 3C is generally an embedded structure. The tube of this embodiment is manufactured by passing an inner mold (such as a coil spring) through a cross extrusion die, extruding a polymer tube (tubular body) to cover the outside of the inner mold (such as a spring). Using a drag speed to achieve vertical stretching, combined with internal vacuum or external positive pressure (or both), the polymer is sucked between the coils of the inner mold (such as a spring) until the inner mold is surrounded and mechanically locked in place. The formed tubular body is usually corrugated (flexible) and does not require a pre-coated inner mold to achieve bonding, but this option exists. The tubular body has a high enough temperature that once it covers the inner mold, the tubular body contacts itself and melts itself from the heat of extrusion. In this regard, the weld line or weld zone is shown as W in Figure 3C.

The tube of Figure 3D usually has a heat shrink structure. The tube is made by placing an internal mold (such as a coil spring) longitudinally inwardly of a tubular body, which has a thin wall and is heat shrinkable or energy forming. Heat (or energy suitable for causing the material to shrink) is then applied, causing the tubular body to shrink and adhere tightly to the internal mold (such as a spring), and the shrinkage causes the formation of corrugations in the open space along the wall between the subsequent wall sections supported by the internal mold. This leaves a corrugated tube reinforced with internal molds (such as metal wires). The corrugations lead to good flexibility. If the inner surface or inner face of the tubular body is pre-coated with a suitable adhesive, the inner mold and the tube wall will be further attached or connected to each other.

The tube of FIG. 3E is of yet another form. The tubular body may be formed (e.g., by extrusion) and then pulled or dragged through or within the inner form 110. The inner form 110 may thus substantially surround the tubular body (i.e., the inner form becomes a form external to the tubular body). See, for example, FIG. 3E. The inner form 110 functions to support or maintain the tubular body 102 in a desired form, shape, or configuration. As with several other embodiments described herein, the inner form 110 functions to define a series of alternating peaks and troughs, the circumference of the inner form defining the troughs 105. The peaks 104 between the supported sections (by the inner form 110) are not directly supported by the inner form 110. An advantage of this structure and configuration is that it further reduces the need for the inner mold 110 to be pre-coated for biocompatibility or sterility (e.g., hygiene) reasons, but the inner mold 110 can be pre-coated to reduce corrosion or other effects from the environment.

Some advantages of coating the inner form with an appropriate material include: - Improving the overall strength and durability of the tube by more securely securing the inner form to the tubular body. - Strengthening the tubular body to improve resistance to expansion and degradation due to exposure to chemicals. - Improving biocompatibility or sterility by increasing the range of permissible materials that can be used for the inner form, as the coating provides a biocompatible (or sterile) barrier or layer of material around the inner form itself (perhaps the inner form can be colored to improve aesthetics and/or product identification). - Protecting the inner form from contact with the tube contents (to reduce corrosion or other degradation of the inner form).

Coating the inner form with a suitable material can mitigate the tendency of the inner form to separate from the tubular body when the connection is stressed, such as occurs when some materials swell due to exposure to certain chemicals (such as oils, alcohols and/or cleaning agents), or when breathable materials are exposed to water vapor or aqueous solutions.

In various embodiments (e.g., FIGS. 1, 2, 3, 24A, and 24), the inner mold supports the tubular body against narrowing and contraction of the lumen. The tubular body may advantageously be made of or composed of or include a suitable polymer such as a thermoplastic elastomer, a propylene-based elastomer, a liquid silicone rubber (LSR), a breathable thermoplastic polyurethane, or a breathable polyamide. The polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a family of thermoplastic elastomers such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers, or breathable polyamide. The use of a breathable material to form the tubular body can also be used to provide additional advantages in the breathability of such medical tubes or circuits. Particularly suitable polymer materials are those 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. Such materials can also be used to form nasal cannula configurations, which are described in detail below.

The tubular body may be made of or consist of or include various thermoplastic polyurethanes, thermoplastic polyester elastomers or liquid silicone rubbers (LSR), including breathable grades. The material grades are preferably selected to have favorable mechanical properties (such as durability, tear resistance and high elasticity) and optionally provide good transparency to detect water accumulation inside the tube.

The coating layer can be made of the same material or a different material from the tubular body. Preferably, the coating layer 1111 is chemically compatible with the tubular body 1102, so that the coating layer 1111 and the tubular body 1102 can be welded together to form a joint where the inner mold 1110 is linked to the tubular body 1102. The inner mold can be made of a suitable other material polymer that is chemically compatible with the tubular body 1102 material. In one form, the coating layer 1111 can be an airtight material (even if the tubular body 1102 is airtight) so that the inner mold 1110 is isolated from any moisture in the lumen. Preferably, both the tubular body and the coating can be made of, consist of, or include a durable thermoplastic polyurethane (TPU). When the tubular body is made of, consists of, or includes a thermoplastic polyurethane, the coating can also be made of, consist of, or include a plurality of polymers. Preferably, the grade of polymer selected for the coating is strong and has good abrasion resistance to allow the inner mold to be manipulated (e.g., rolled into a spiral) after coating.

In addition, the tubular body can be extruded or otherwise formed so that the wall has a minimum thickness to reduce the weight of the tube and further improve the flexibility of the tube. The inner mold 110 can be made of a flexible material such as a suitable metal or polymer to cope with further bending.

Advantageously, the minimal wall thickness of the tubular body assists in improving the flexibility of the tube. Again, such advantages are obtained from the tube being made of a gas permeable material, the gas permeability of such medical tube being improved by the reduced or minimal wall thickness. Such a combination of reduced or minimal wall thickness and the use of a gas permeable material is particularly advantageous when used as part of a medical breathing circuit or system.

The structure of the tube enhances extensibility by accumulating additional auxiliary lengths of the tubular body suspended in the valleys between the reinforcing ribs of the inner mold 110.

As shown in FIG. 3E of an alternative embodiment, the extensibility of the tubular body is provided by suspending the tubular body at the peaks between the troughs formed by the inner mold member 110 to provide additional auxiliary length.

The additional auxiliary length of the wall allows the spacing of the internal molded parts to fluctuate, so that the tube can expand and contract in the longitudinal direction without significant narrowing of the lumen. The additional auxiliary length allows the tube to expand and contract in the longitudinal direction with minimal tensile or compressive deformation or stress curling or straightening of the tube wall itself.

The flexibility of the tube can also be improved by allowing the spacing between adjacent reinforcing ribs to vary around the circumference of the tube to accommodate bending. Varying the rib spacing around the circumference of the tube allows the internal molding to expand and contract simultaneously on opposite sides of the tube to accommodate bending of the tube lumen without pinching or kinking the tube and still meeting the flexibility requirements defined in ISO 5367:2000(E) (Fourth Edition, June 1, 2000).

Furthermore, the inner mold may be electrically conductive. An electrically conductive inner mold may facilitate a number of optional additional features for the operation or use of such a tube. For example, the inner mold may be (or may include) an electric heater. For example, the inner mold may include one or more components.

In another embodiment, the internal mold may include one or more conductive components, electric heaters or sensors (such as flow sensors, temperature sensors, humidity sensors, pressure sensors, etc.).

In some embodiments, the tube may include a heater such as an electric heater (e.g., heater wires, heater loops, etc.).

Providing heat or heaters can help maintain the humidity of the gas passing through the tubes and other related components. Heating can also alleviate the problems associated with "skin dripping". Providing sensors ideally assists in providing data feedback systems to assist the associated heater control system or to provide information back to the user monitor or monitoring system.

It should also be understood that the inner mold 110 can be provided with a variable spacing or a variable spacing along the longitudinal direction of the tubular body.

In yet another aspect of the present invention, one or more inner molds 110 may be provided. In this way, a double helix or other configuration of the inner mold may be provided to support the tube, but still maintain the flexibility and extensibility of such a structural tube.

The medical tube structure as described above and illustrated in, for example, Figures 1-3E, 24A, or 24B is particularly suitable for use in a user interface where a short dedicated length of the tube couples the interface to a respiratory system. The flexibility and extensibility of the tube compensates for patient movement, while the inner mold 110 resists narrowing of the gas lumen (e.g., pinching, kinking, and rolling) caused by the forces due to movement.

The tubes can be used for both adults and newborns, but are well suited for neonatal interfaces where specialized tubing is minimal. For example, a neonatal interface tube according to the illustrated structure can have an inner diameter (or lumen diameter) of the tubular body 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. A preferred inner diameter is about 2.4 mm to about 3 mm, an outer diameter is about 2.6 mm to about 3.4 mm, and a wall thickness of about 0.1 mm to about 0.2 mm.

The inner diameter (or lumen diameter) of the tubular body can be 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. The inner diameter (or lumen diameter) may 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.

The outer diameter of the tubular body can 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 may be about 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 about 3 mm to about 5 mm.

The wall thickness of the tubular body can be 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 0.10 mm to about 0.20 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. 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 about 0.1 mm to about 0.2 mm.

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

The corrugation depth can be defined by the distance between a point with the smallest radius from the longitudinal axis (midline) of the tubular body and a point with the largest radius from the longitudinal axis (midline) of the tubular body.

In one embodiment of the present invention, the ratio of the spacing of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold is about 0.10 to about 0.50, preferably about 0.20 to about 0.35, and more preferably about 0.28 or about 0.29.

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

In yet another embodiment, the ratio of corrugation depth to outer (ie, external) tube diameter is about 0.05 to about 0.09.

Still, another embodiment may require that the physical properties of the tubular body result in the tube having a desired flexibility and/or structural support.

This size tube is particularly useful for newborns because it can meet the peak inspiratory flow requirements of newborns despite the limited gas flow lumen. The small size and light weight of the tube reduces pressure on the baby's face and reduces the visual obtrusiveness of the interface. The flexibility and light weight of the tube improve patient comfort and simplify the matching and adjustment interface for the physician.

The inner mold is preferably made from stainless steel wire, most preferably grade 302, 304 or 306 or other elastic material with suitable biocompatibility or sterility, which can be wound into a helical skeleton of appropriate size suitable for supporting the tubular body. Ideally, the outer diameter of the helical skeleton is about 1.7 mm to about 4.4 mm, and the metal wire used to form the skeleton can have a diameter of about 0.05 mm to about 0.3 mm. The spacing of the helical skeleton is preferably about 0.4 mm to about 1.8 mm to provide the desired tube flexibility, but can be about 1 mm to about 1.5 mm. Preferably, the outer diameter of the helical skeleton is about 2.4 mm to about 3.4 mm, the wire diameter is about 0.15 mm to about 0.2 mm, and the spacing of the helical skeleton is about 0.8 mm to about 1.4 mm.

The outer diameter of the inner mold (e.g., spiral skeleton) can be about 1.7 mm to about 4.4 mm, or about 1.8 mm to about 4.3 mm, or about 1.9 mm to about 4.2 mm, or about 2.0 mm to about 4.1 mm, or about 2.1 mm to about 4.0 mm, or about 2.2 mm to about 3.9 mm, or about 2.3 mm to about 3.8 mm, or about 2.4 mm to about 3.7 mm, or about 2.5 mm to about 3.6 mm, or about 2.6 mm to about 3.5 mm, or about 2.7 mm to about 3.4 mm, or about 2.8 mm to about 3.3 mm, or about 2.9 mm to about 3.2 mm. The outer diameter of the helical backbone can be about 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.

The diameter of the inner mold (or the wire used to form the skeleton) can 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 frame 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, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, or 0.30 mm. Preferably, it is about 0.1 mm to about 0.4 mm.

The spacing of the internal molded parts (e.g., the spiral skeleton) can be about 0.40 mm to about 1.80 mm, or about 0.45 mm to about 1.75 mm, or about 0.50 mm to about 1.70 mm, or about 0.55 mm to about 1.65 mm, or about 0.60 mm to about 1.60 mm, or about 0.65 mm to about 1.55 mm, or about 0.70 mm to about 1.50 mm, or about 0.75 mm to about 1.45 mm, or about 0.80 mm to about 1.40 mm, or about 0.85 mm to about 1.35 mm, or about 0.90 mm to about 1.30 mm, or about 0.95 mm to about 1.25 mm, or about 1.00 mm to about 1.2 mm, or about 1.05 mm to about 1.15 mm. The spacing between the helical backbones can be about 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 about 1 mm to about 1.5 mm.

In various forms of the invention, the inner form can be provided with a tubular body having a variable or varying pitch. In this way, the pitch of the inner form once it becomes part of the tube can be a varying pitch. The varying pitch 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.

In yet another embodiment, the varying spacing allows the density of the inner mold to vary per unit tube length. Such a configuration is useful when the inner mold or a component of the inner mold provides a heat source or sensor for the gas flowing through the lumen.

The inner mold 110 may include a single continuous turn of wire or multiple turns linked end to end to form a spiral skeleton, element or rib. In addition, the inner mold may include multiple separate rings. The multiple rings may be linked longitudinally of the tube. Metal wire, thin polymer or other suitable couplings (including multiple wires or thin polymers) may extend along the lumen to link the multiple rings. Multiple links may be spaced around the circumference of the rings.

For neonatal use, an alternative to the tube is the clear polyvinyl chloride (PVC) tubing typically used to support and deliver respiratory gases to nasal cannulas. The preferred user interface is independently supported by the interface tube (e.g., a dedicated skin pad) to allow for unrestricted movement of the tube and greater flexibility of the tube. Tube Manufacturing Methods

In addition to the foregoing description, the manufacture of medical tubes can be performed by providing a tubular body to enclose an inner mold (or in another embodiment, by enclosing the tubular body with the inner mold). The tubular body defines a lumen that substantially surrounds the inner mold. In one embodiment, during manufacture, reduced pressure can be applied to (or to) the lumen so that the reduced pressure drags the tubular body radially inwardly of the lumen and the outermost periphery defined by the inner mold. The outermost periphery of the inner mold can define a plurality of staggered peaks and troughs along the longitudinal direction of the tubular body. The tube can 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 region of the tubular body surrounding the inner mold, so that the elongation (or stretching) returns (or allows) the elongated (or stretched) portion or region of the tubular body to drag the lumen and the outermost periphery defined by the inner mold radially inward, and the outermost periphery may define multiple staggered peaks and troughs along the longitudinal direction of the tubular body.

In yet another embodiment, a combination of applying a decompression to the lumen and stretching (or stretching) to the tubular body can be implemented in the manufacture of the tube.

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

An apparatus for clamping or applying elongation (or stretching) to the tubular body may be used, thereby allowing the tubular body to be stretched around or around the inner form, and then when the elongation (or from the stretched state) is released into a clamped relationship with the inner form, so as to assume the outermost peripheral shape defined by the inner form.

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 having a Shore A of about 30 to about 90.

The raw material of the tubular body is fed into a hopper 312 mounted on the top, for example. The hopper 312 allows the raw material to enter the barrel of the extruder 310 through the hopper under the action of gravity or another suitable feeder system. The feed screw 313 is housed in the barrel of the extruder and feeds the material along the barrel toward the die 317. The feed screw 313 is coupled to a rotary actuator 314, which rotates the screw around the longitudinal axis.

The material is heated inside the barrel to a molten or semi-molten state. As the material moves along the barrel, the barrel can be actively heated or frictionally heated to melt the material.

Suitable extruders for making medical tubing are supplied by Welex. Welex extruders equipped with a 30 to 40 mm diameter screw and typically a 12 to 16 mm annular die with a 0.5 to 1.0 mm gap have been found to be suitable for rapid production of low cost tubing. Similar extruders are available from Kuhne (Germany), AXON Plastics (Sweden), AMUT (Italy), and Battenfeld (Germany and China), for example.

To assist in the co-extrusion of the tube components, the tubular body raw material can be fed tangentially into the die 317. As the inner molded part advances through the die 317, the tubular body can be extruded to cover the inner molded part, and the molten or semi-molten tubular body is laid on the inner molded part. When cooled, the molten tubular body preferably adheres to the inner molded part, firmly fixing the tubular body components together.

In this embodiment, a die 317 (illustrated in FIG. 5 ) is adapted to be arranged orthogonally to the barrel of the extruder 310, with a side port 320 adjacent to the extruder outlet 315. The molten or semi-molten material exiting 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 form 302 is stretched. The pressure generated by the extruder 310 forces the material to pass through the constriction 325 around the inner form 302, so that the tubular body 301 is directly extruded around the inner form. Preferably, the inner mold is continuously advanced through the die 317 at a substantially constant rate (although the rate of advancement may be adjusted to vary the thickness along the tubular body at a constant extrusion rate).

Suction is applied to the inside of the die through vacuum port 321. Suction reduces the internal pressure of the tube cavity after extrusion, causing the molten or semi-molten tubular body to be drawn over the inner mold and form ripples on the inner surface of the tube. Preferably, the tubular body from the extrusion process is still adhesive enough to adhere to the inner mold.

Applying decompression inside the tubular body or lumen can be done, for example, by applying a vacuum or decompression to the lumen passage. Alternatively, decompression can be a relative decompression or a comparative decompression. For example, the pressure surrounding the tubular body can be increased so that the pressure inside the tube is relatively small compared to the pressure around the tubular body. In this way, the tubular body experiences a pressure differential that encourages the tubular body to be pulled (or pushed) radially inwardly. The pressure inside the lumen and outside the tubular body can therefore be any suitable pressure so that the lumen has a lower pressure than the surrounding of the tubular body. Thus, the inner surface of the lumen is pulled or pushed (by pressure difference) into contact with the inner mold, forming or having the shape of the outermost circumference of the inner mold in the embodiments illustrated in Figures 1, 2, 3 and 24A. Part of the tubular body may not be supported by the inner mold, but may be drawn radially inwardly more than the outermost circumference of the inner mold, thus further emphasizing the shape defined by the inner mold.

When the inner form is coated, (such as used in the tubes of Figures 24A and 24B), the coating must be shielded from contact with excessive heat sources to avoid damage. In one specific embodiment, the inner form can be made from metal wire from medical grade stainless steel (but non-medical grade materials are also possible, requiring an encapsulating coating to provide a layer of biocompatibility or sterility and corrosion protection). The metal wire can be encapsulated in the appropriate coating by drawing it through a bath of material. The elevated temperature of the coating material in the bath can also partially sterilize the metal wire by killing any biological contaminants.

For example, coating a metal wire with a suitable polymer grade involves drawing the wire through a bath of molten polymer at a temperature in excess of 150°C, but may be, for example, in excess of 180°C or about 200°C (a temperature sufficient to allow the polymer melt to coat the surface of the inner mold). When the coating has cooled sufficiently the wire can be formed into the inner mold. The inner mold can be manufactured by winding the coated wire helically around a mandrel.

In other examples, the internal molded part can be coated or encapsulated by dipping through a bath containing the polymer or applying the polymer to the internal molded part through an extrusion die. Other Applications

It is expected that the present embodiment will find other medical uses for which it is particularly suitable. For example, applications involving light weight and high flexibility, sufficient resistance to rolling, pinching and kinking, and delivery limbs and waste limbs of surgical humidification systems, including uses preferably with breathable medical tubing. User Interface

The tube can be combined with a user interface, such as a nasal cannula for delivering breathing gases to the user. A nasal interface incorporating the tube is illustrated 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 conduit to interconnect the prongs 402 to a breathing system. The tube 401 can be coupled to individual supply conduits, or otherwise combined (e.g., by a Y-joint or other appropriate connector such as a manifold) to form a single connector with a supply conduit and assist in delivering breathing gases to the interface 400. One embodiment of the user interface 400 is illustrated in Figure 12 as being worn on an infant.

Each prong 402 defines a lumen extending between a user end 410 and a tube end 415 of the prong 402. The tube end 415 of the prong 402 couples the prong 402 to the interface tube 401. The user end 410 of the prong 402 is configured to deliver respiratory gases to the user's nostrils and is combined with an orifice 411 for this purpose. The orifice 411 can be arranged concentrically with the terminal end of the prong 402 so that the flow out of the prong 402 is minimally disturbed. The tube end of the prong 402 can be shaped as an anatomical shape and/or closely follow the user's nostril, and the terminal end of the prong 402 (i.e., the end that combines with the orifice 411) is, for example, bent away from the nasal septum to reduce the possibility of irritation.

The user end 410 and the tube end 415 of the fork 402 are connected by an arched elbow joint. In this specific embodiment, the user end 410 and the tube end 415 are arranged to be substantially orthogonal, and the elbow joint is about 90 degrees. Advantageously, in one form, the elbow joint can have a smooth transition between two adjacent sections of the fork 402 (corresponding to a larger radius of curvature) to reduce flow disturbances inside the fork 402.

The interface tube 401 is coupled to the tube end 415 of the yoke 402. Preferably, the yoke 402 is coupled to the tube 401 to create an integrated assembly. In this embodiment, the tube 401 and the tube end 415 of the yoke 402 are arranged concentrically with the yoke 402 extending around the tube 401. Preferably, most of the tube end section 415 is formed to sleeve the tube 401 to increase the contact area and strengthen the joint between the yoke 402 and the tube 401.

The prongs 402 are preferably maintained in a spaced relationship. In this embodiment, a backing or harness 403 is coupled to the two nose prongs 402. The backing 403 preferably maintains the prongs 402 in a fixed spaced relationship. Different interface 400 sizes can be manufactured to accommodate changes in nose spacing.

The illustrated backing 403 also includes a shell 404 that generally surrounds or captures at least a portion of the tube end 415 of the prong 402. The shell 404 incorporates a coupling 405 for attaching a helmet to secure the interface 400 in place. On either side of the tube 401, a pair of prongs 406 protrude outwardly from the backing 403. The prongs 406 increase the contact area of the interface 400 with the patient, distributing the interface retention force over a larger area and reducing the pressure applied to the user's face.

The user side of the backing 403 and fork 406 (i.e., the side that rests away from the user's face) can be contoured to reflect the expected anatomical structure. The backing 403 and fork 406 can also be made from a flexible material to allow the structure to adapt to a specific individual's face.

The fork may include a portion that allows the user (or caregiver) to more easily pull or tear the fork 106 from the user's skin or skin patch. Such fins can improve the ease of application/removal of the interface from the user.

The housing 404 may incorporate ribs in front of the fork 406 and between the portion of the housing 404 that connects the fork 402 and the interface tube 401, as illustrated in Figures 12 and 13. The ribs increase the useful interface contact area for the medical tape when securing the interface 400 to the user. The ribs may also increase the torsional stiffness of the fork, helping to stabilize the position of the fork 402.

The prongs 402, backing 403 and yoke 406 are preferably made of a suitable polymer. Preferably, the individual sleeves (e.g., the prongs 402 and tube 401) are made by a sleeve molding process in which the prongs 402 are sleeved over the outside of the tube 401. The sleeve molding process generally involves inserting one end of a preformed tube 401 into a suitable mold while the material used to make the prongs is injected into the outside of the tube inside the mold to retain the tube 401. Preferably, the prongs 402, backing 403 and yoke 406 are all made in a single sleeve molding process to form a fully integrated interface.

The configuration or design of the fork may take a variety of forms. In a preferred embodiment, a fork and/or sleeve having a delivery tube molded over the fork may be described in U.S. Patent Publication No. 2010/0192957, which is incorporated herein by reference in its entirety. Fork

Another preferred form of the geometry of the nose prong is illustrated in Figures 25A to 25D, the combined common base support pad and facial support pad are illustrated in Figures 26A to 26D, and are specifically illustrated in Figures 27A and 27B. The numbered features of the prongs illustrated in these figures are labeled with like numerals (but with a suffix to identify the specific embodiment) as the same features presented in the previous Figures (Figures 6 to 13).

The geometry of the prongs 1402 in FIGS. 25A-25D is illustrated with scanned lines 1420 representing the prong trajectory, and ellipses 1130-1135 representing the lumen shape and orientation within each prong at a particular trajectory. Each prong 1402 follows a scanned path and is shaped to follow the anatomical geometry/curvature/contour of the user's nostril. The prongs are molded or shaped to follow the anatomical shape and curvature of the user's nostril. Preferably, the prongs maximize the clearance between the prongs and the internal structures of the nostril by anatomically matching the nostril path.

In a preferred form, the prongs are pre-molded or pre-formed according to the anatomical shape of the nostril, as opposed to being made of a material that can conform to the anatomical shape of the nostril.

The geometry of the prongs will be described below for example with respect to the interface being secured to the user's face during use. The interface is configured so that the prongs 1402 are generally symmetrically arranged about the sagittal plane of the user. Each prong extends from a base 1415 disposed on a common support extending along the user's upper lip. The prongs 1402 are spaced apart on the support to avoid the nasal septum. The spacing of the prongs 1402 at the base 1415 is selected to present a maximum gap between the prongs and the user's nasal septum (at the base of the nose) for the range of face sizes that each interface is intended to accommodate (i.e., the particular interface size).

The initial stage of each prong track 1420 in front of the base 1415 is represented by ellipses 1130 and 1131 (first stage). During this stage, the prongs extend substantially coaxially with the respective breathing tubes. The scanning path of the two tracks 1420 extends generally along the user's upper lip from both sides of the sagittal plane toward the nasal septum. The prongs 1402 scan through a slight posterior or posterior curve (toward the user's coronal plane) relative to the user's upper lip, 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.

From base 1415, each prong 1402 scans upward or superior (away from the transverse plane) toward the user's head, and the prong 1402 scans backward or posteriorly relative to the user's upper lip (toward the user's coronal plane). Between ellipses 1131 and 1133 (second phase), the prong lumen smoothly transitions from a generally mediolateral direction to a primarily inclined posterior direction along the user's upper lip, directing the gas flow toward the upper rear of the user's head. During this phase, the prong lumen shrinks slightly to an elliptical shape to utilize the available space inside the nostril.

In the third phase (between ellipses 1133 and 1134), the prongs continue along the inclined posterior trajectory, toward the upper back of the user's head (away from the transverse plane and toward the coronal plane), smoothly decreasing the slope (the superior component of the prong trajectory 1420 causes the lumen to move away from the transverse plane). During this phase, the prongs 1402 have negligible convergence (or mediolateral component) toward the sagittal plane. During this phase, the prong lumen further decreases, becoming more elliptical.

In the final phase (between ellipses 1134 and 1135), prong 1402 continues along the inclined posterior trajectory with a slight mediolateral convergence toward the sagittal plane. The mediolateral convergence of prong 1402 begins at the beginning of (or slightly before) the fourth phase of adjacent ellipse 1134, at the inflection point of the illustrated trajectory. Adjacent to the final ellipse 1135, there is a second inflection point that reduces the convergence of the prong and orients the prong outlet 1411 posteriorly (toward the coronal plane) with a slight mediolateral component toward the sagittal plane (indicated by the orientation of the final ellipse 1135 in FIG. 25B ).

During the fourth phase, the slope of the fork track 1420 continues to decrease until the individual tracks 1420 are substantially parallel to the transverse plane (represented by ellipse 1135) at the fork outlet 1411. The fork track 1420 adjacent to the last ellipse 1135 is adjusted medially and laterally and up and down to position the fork outlet 1411 roughly aligned with the upper respiratory passage to reduce soft tissue irritation caused by exhaled respiratory gases. The fork lumen at the outlet 1411 is elliptical, and the main axis of the ellipse is arranged roughly in the transverse plane. The outlet 1411 guides the respiratory gases upward or upward toward the top of the user's head (away from the transverse plane) and backward or backward (toward the user's coronal plane).

The shape of the prong 1402 illustrated in Figures 13, 14, and 25-27 (both the track and the lumen) avoids contact with the user's nasal septum region, thereby reducing the risk of injury to tissue in this area. By aligning the prong air outlet with the user's upper airway, the prong improves user comfort and therapeutic efficacy. The lumen shape maximizes the longitudinal cross-sectional area of the prong, utilizing the anatomically available space of the patient's nares to minimize flow resistance. The prong lumen has a shape that avoids sealing the user's nares.

Independent gas sources can be supplied to each prong. In this way, when a pair of prongs are used, one prong can be supplied with breathing gas, while the other prong can be supplied with medical gas, such as gas used to improve the user's respiratory therapy or breathing.

Such an anatomical prong may have a shaped track that matches the anatomical shape of the user's nostrils. In a first portion (or stage) of the prong, the track moves horizontally toward the midline of the face. In a second portion (or stage) of the prong, the track curves upward directly into the nostril toward the top of the head. In a third portion (or stage) of the prong, the track follows the anatomical curvature of the nostril and enters the inside of the head. And in a fourth portion (or stage), the track tilts horizontally toward the center of the cannula to align the outflow port with the user's upper airway.

Such an anatomically shaped fork has a cross-section that changes along the central track. For example, the cross-section is generally circular at the base of the track and becomes generally elliptical toward the track or fork end. Also, the cross-section diameter generally decreases along the track from the first portion (or stage) to the end of the fourth portion (or stage).

The prongs are preferably made of a soft, bendable material to further reduce trauma to the soft tissue of the nostril. An example of a potential material is a biocompatible thermoplastic elastomer or liquid silicone rubber (LSR).

The nasal interface 1400 incorporating prongs 1402 is illustrated in FIGS. 26A-26D, 27A and 27. The interface includes nasal prongs 1402, a common support extending along the patient's upper lip below the nose and supporting the nasal prongs 1402, a pair of prongs or facial pads 1406, and integrally formed tubes 1401, all spaced generally symmetrically about the sagittal plane. The interface is formed as a unitary or unified assembly, with the tubes 1401 directly linked to the base 1415 of the nasal prongs 1402. The open distal end of each integrally formed tube 1401 is configured 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 facial pad 1406 is anatomically shaped with assigned and calibrated curvatures, reflecting the intended user's facial geometry. The anatomical shape of the facial pad 1406 gives the interface to match the user's face at a predetermined location where the contour of the facial pad 1406 matches the user's facial contour. The pre-shaped facial pad 1406 compensates for the anatomical prong 1402, improving the accuracy and speed with which the prong 1402 is placed and retained inside the user's nostril.

Pre-forming or contouring the facial pad 1406 to the user's facial features reduces the pressure applied to the patient's face by any retaining mechanism (adhesive tape, headgear, or other device). This reduces the potential for painful compression. The engagement facilitated by the anatomical shape of the facial pad 1406 increases the stability of the interface 1400 and the nasal prong 1402, and thus improves comfort and therapeutic efficacy.

In yet another embodiment, a nasal cannula configuration 2000 is provided, comprising at least one nasal prong 2001, the prong or prongs 2001 having an air outlet 2002 suitable for insertion into a user's nostril, and an air inlet 2003 in fluid communication with the air outlet 2002. At least one nasal prong 2001 comprises a backing 2004 configured to rest on the patient's face, and where a lip 2005 extends around at least a portion of the periphery of a rear surface 2006 of the backing 2004. The backing 2004 is configured to receive or retain a user interface patch 2007. In use, the user interface patch 2007 can be releasably attached or linked to a skin patch 2008 fixed or fixable to the user's face. Lip

Lip 2005 generally acts as a barrier to provide a seal, such as a fluid seal, but it should be understood that lip 2005 is provided as a physical barrier, not necessarily a fluid seal, which is sufficient in itself to prevent most fluids (such as nasal or oral mucus, or milk or fluids used to wash the user's face) from leaking under backing 2004 to rear surface 2006.

Preferably, the lip 2005 operates to prevent most fluid from leaking under the backing 2004 to the rear surface 2006. Such leakage would otherwise compromise 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. Such a 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 preferred position or location. Such fluid leakage otherwise becomes clogged on the facing interface surface of the user interface patch 2007 or the skin patch; such patch surface then becomes odorous or slimy and unhealthy. Such damage should be avoided as much as possible, is unpleasant to the user or their caregiver, or even affects the ability of such a nasal cannula to remain in a preferred position. Providing such a lip 2005 around the rear surface 2006 of the backing 2004 attempts to minimize one or more of these deleterious effects.

According to this embodiment, the lip 2005 is deformable. For example, the lip 2005 can be shaped so 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 by the engagement 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 the surface it contacts, improving the possibility of a more effective fluid seal or fluid barrier.

Such a lip 2005 may extend at least around the periphery (or a portion of the periphery) of the backing 2004, such as around an area substantially adjacent to the coupled prongs. For example, the lip 2005 is configured to block most of the fluid from the backing from the user's mouth and nose area. In other words, nasal mucus that leaves the nostrils of the user's nose or saliva that leaves the user's mouth may drip back into the backing of the nasal cannula (depending on the user's head position), or even milk leaking from the baby's mouth during breastfeeding and then dripping into the area around the nasal cannula configuration 2000. Again, washing the baby's or the user's face may cause fluid to drip into the area around the nasal cannula 2000.

All of these fluids (and others not necessarily mentioned above) may affect the effectiveness of the fixed patch system used to fix or position the sleeve to the user's face. Again, the negative effects of the fixed system patch being blocked by odor or mucus are undesirable.

Accordingly, in one embodiment, a lip 2005 is preferably provided around the rear surface 2006 of the back lining 2004 extending from near or adjacent to the nose prong 2001 or the user's nostril to at least the area outside thereof. In this case, the lip 2005 may not completely extend around the periphery of the back lining.

In other embodiments, the lip may be formed from a series of smaller or segmented lips that may or may not be adjacent to one another to assist in forming a barrier or seal. For example, as shown in FIG. 35 , a series of segmented lips may be provided that together extend around a portion or all of the rear surface 2006 of the backing 2004. The lip 2005 may be created or formed from a series of one or more separate lips, as shown in FIG. 35 . Again, the segmented lips may be adjacent to, adjacent to, or even overlap one another when forming the lip 2005.

In this way, the lips may together form a barrier or seal to fluid intrusion.

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 loop-shaped endless lip.

The lip may be formed (or treated) to have water repellent properties or attributes, thereby further assisting in reducing the passage of liquid across the lip barrier.

The portion of the lip that contacts the user's skin may be spoon-shaped. For example, the lip may have a contoured shape that effectively provides a pair of parallel spaced lips, an outer peripheral lip and an inner peripheral lip of the lip assembly. In this way, a set of lips each contact the user's skin, helping to provide a liquid barrier or seal. It should also be understood that a series of parallel lips may be utilized.

As previously mentioned, the backing 2004 can be a substantially planar or flat or even contoured (such as the pre-curved curve shown in Figures 28-34) backing configured to rest on the user's face. The backing 2004 can generally extend outward from at least one nasal prong 2001, away from the user's nasal septum. Such a backing 2004 can assist in operating as a stabilizer for the nasal prong 2001 within the user's nostril. In this regard, such a backing 2004 can include the various rib features described in other embodiments.

It should also be understood that the nasal cannula configuration 2000 of the present embodiment may have a pair of nasal prongs 2001 for insertion into the user's nostrils, each prong 2001 having an adjacent or coupled backing 2004. When a pair of prongs 2001 is provided, the prongs may be independent of each other, or a harness may be utilized to couple the prong structures together to provide additional stability, as previously described in other embodiments.

The cannula 2000 of the present embodiment may additionally include the features of fluidly connected (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 allow fluid communication of the air inlet to the reinforced medical tubes 100, 200 as described herein. Again, it should be understood that the nasal prong 2001 may be any of the prong shapes or configurations described hereinabove, including the anatomical prongs of FIGS. 25A-27B.

An embodiment of the nasal cannula 2000 is shown in Figures 28-34.

Figures 28 and 29 show a nasal cannula configuration 2000 with a backing 2004 connected to a skin patch 2008 secured to the user's face. The lip 2005 is shown contacting the skin patch 2008, thereby providing a fluid barrier that could otherwise leak into the backing 2004 and the underside of the rear surface 2006 where the user interface patch 2007 is secured. As shown, the user interface patch 2007 is located on the inside of the lip 2005.

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

As shown in Figures 31 and 34, the rear surface 2006 is initially free of a user interface patch, i.e., the rear surface 2006 is configured to receive or secure a user interface patch 2007. Such a user interface patch 2007 may be attached to the rear surface 2006 by an adhesive or other suitable attachment. Once the patch is in place, it is ready to attach to or receive a skin patch.

In one form, the user interface patch can be a component of a two-component connection system, such as a loop of a hook and loop system. In this case, the surface of the skin patch 2008 facing the interface will include a hook that can engage the loop of the user interface patch. Referring to Figure 32, a user interface patch with a loop fixed to the rear surface 2006 is shown, ready to be connected to the hook of the skin patch.

FIG. 33 shows a cross-sectional view of a cannula 2000 extending through a hook 2009 with a skin patch and a ring 2010 engaging a user interface patch. Also shown is a lumen 2011 or gas passageway for delivering gas from the inlet of the cannula to the outlet 2002 of the nose prong 2001. Securing System

An example of a securing system for securing a user interface and/or a user interface tube to a patient is illustrated in Figures 15 to 17. The securing system 500 is shown supporting a nasal cannula on the face of an infant.

Advantageously, the system provides substantially faster and improved or simplified positioning of the user interface on the user. Again, these effects also result in improved or simplified application of other user interfaces or removal of the user interface from the user while the user is cycling between different therapies (e.g., gas therapy such as continuous positive airway pressure (CPAP) or high flow applications).

Some user interfaces are specifically configured to interact or respond to the system of the embodiments described. In addition, unmodified user interfaces can be responded to by the embodiments described and can be easily located, and the installation process involves very little time.

In various embodiments provided by the fixing system, such a system can allow the interface to be quickly positioned to the user and can provide a secure position of the interface.

A user interface that is easily positioned is particularly useful to the user. Providing a system that allows a caregiver (e.g., a nurse) to apply the securement system with one hand is particularly advantageous when the user of the interface is an infant.

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 can be shown in Figures 15 to 17. When the user requires additional or higher security of positioning or fixing the user interface, a second level of interface fixing can be used. This additional level can be applied by applying a patch from above, such as using patch 660. This patch 660 can be an adhesive patch and can be installed on the user interface and/or the top of the tube and adhered to a portion of the skin patch 550.

The fixation system 500 includes a two-part releasable attachment or connection arrangement 551. The releasable connection arrangement 551 acts between a pair of patches, respectively fixed to the patient and the user interface.

The first patch is a skin patch 550 that is adhered 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 a sensitive skin adhesive such as a hydrophilic colloid. The user interface side of the skin patch is provided with a first part 553 of a two-part releasable attachment or connection configuration 551.

The second patch is the user interface patch 552. The user interface patch 552 also has a patient side and an interface side. The patient side of the user interface patch 552 is disposed adjacent to the skin patch when the system 500 is engaged. The complementary second component 553 of the two-part releasable attachment or connection configuration is fixed to the patient side of the user interface patch 552 so that the individual components of the two-part releasable attachment or connection configuration 551 can be easily engaged when the patches 550, 552 are close. 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 bonded.

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

The two-part releasable attachment or connection arrangement 551 may include hook and loop material (such as Velcro), a magnet or array of magnets disposed on individual patches with appropriately arranged holes, an adhesive arrangement that is activated when the two patches are pressure bonded or coupled to another appropriate release paper. The interface side of the skin patch 550 may have one of the hook or loop material, and the patient side of the user interface patch 552 has the other of the hook or loop material, so that the skin patch and the user interface patch are releasably attached or connected to each other.

When referring to hook and loop materials, any of a wide variety of area type mechanical fasteners is meant. For example, the VIKLO product range includes hook and loop products where the hook assembly includes a vertical nylon hook (formed as a cut loop that passes through a woven backing sheet) that engages any complementary loop stack material. The VIKLO product range also includes raised hook products, which are typically smaller in size and matched to "plush" non-woven backing materials. These hook materials are designed to work with a range of loop substrates, and in some cases, these hook materials are also used as the loop substrate. Other similar systems include the Dual-Lock releasable fastener system available from 3M, St. Paul, Minnesota, USA. The common feature of these releasable fastener systems is that they engage any contact between two parts of the system. Because there are multiple connectors distributed throughout the product area, precise alignment of individual connectors is not required. A wide range of releasable fastener systems within the art can be used in a releasable attachment system to provide a releasable attachment between a skin patch and a user interface.

The two-part releasable attachment or coupling system can be bonded to the interface side of the skin patch with a suitable 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 surface area of the interface side of the skin patch.

According to some embodiments, the skin patch 550 is a substantially planar pad having a thickness less than both its width and length. In some embodiments, the pad has an overall oval shape, but may have other shapes.

The pad includes a first part 553 of a two-part releasable attachment system 551. In some embodiments, the structure of the skin patch is that the first part 553 of the releasable attachment system includes a substrate and a plurality of fasteners (having active hooks, active loops or other elements) arranged across the area of the substrate. The substrate is fixed to the body of the skin patch. In some embodiments, the substrate is fixed by an adhesive or fixed by direct bonding during the formation of the skin patch.

In some embodiments, the substrate has an area smaller than the skin patch and is positioned on the skin patch so that it does not reach any edge of the skin patch. In this way, the substrate edge extends from the edge of the skin patch around the perimeter of the substrate. Patch

In some embodiments, the substrate of the first component of the two-component releasable attachment system is flexible so that the substrate plane can be bent to conform to a surface that curves in one direction. However, the substrate is typically not also stretchable to conform to surfaces that curve in two orthogonal directions. However, the backing of the skin patch can be stretchable and can conform to surfaces that curve in more than one direction, such as to conform to the contours of the patient's body while being worn.

According to some embodiments, this difficulty can be alleviated by providing a first component 553 of a two-part releasable attachment system in a form wherein the base portion is divided into multiple regions by at least one slit or at least one slot, so that different parts of the base portion can bend independently, so that the overall form of the base portion can be deformed to substantially match a surface that is curved in two directions. This is the case even if the base portion only bends in one direction at its individual locations.

The example of this form is illustrated in Figure 36B to Figure 36R. The pad profile of the skin patch is illustrated in Figure 36A. This configuration is particularly useful for the type of shape in which compound bending is the biggest problem, and this type is a shape in which two or more bends of the substrate are more likely to interact. Typically these shapes are fat, short, fat, short and fat, or short and fat and not thin. For example, this type of shape will have a short perimeter relative to the area. If it is concave or the perimeter is hollow, then consider the virtual perimeter, which is the shortest enclosed path outside the shape, and these shapes will have a small ratio of the square of the length of this virtual perimeter to the area of the shape. A circle has the lowest ratio of about 12.6:1, a square has a ratio of about 16:1, and a 2-to-1 rectangle has a ratio of 18:1. Although more elongated shapes have higher ratios, for example, a 5-to-1 rectangle has a perimeter squared to area ratio of 29:1. In some embodiments, the improvements described with reference to Figures 36B-36R are preferably used for patch shapes having a ratio of the shortest enclosing perimeter length squared to the perimeter interior area of less than 25. In other embodiments, the improvements described with reference to Figures 36B-36R are preferably used for releasably attachable base portions having a ratio of the shortest enclosing perimeter length squared to the base covering area of less than 25.

As with the variations of Figures 36A-36R, the substrate may be formed as multiple non-continuous components, but the preferred form of the substrate is a single continuous component.

In some embodiments, the releasably attachable base portion covers substantially the entire area of the skin patch 550. In other embodiments, the base portion covers substantially a majority of the area of the skin patch, such as 50% or more, 60% or more, 70% or more, or 80% or more of the skin patch area.

Referring to FIG. 36A , in some 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 sharp corners. Rounded or radiused corners or curved edges are less likely to be lifted than sharp corners. In a plurality of 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 extending into the extension 3600.

In the specific embodiment of Figure 36B, 36F, 36G and 36H, the substrate portion will not extend completely into the edge of the skin patch 550. Around at least a portion of the edge, a narrow section is maintained between the edge of the skin patch and the edge of the substrate. This narrow section can extend around the entire periphery of the substrate. In some embodiments, such as in the embodiment of Figure 36B, this section between the edge of the skin patch 550 and the edge of the substrate can be wider than other positions in certain positions. For example, in Figure 36B, a wider section 3615 is provided to be positioned away from the end of the nose. This provides attachment at a section closer to the nose, but allows the user to release the releasable fastener by starting to tear away at a section farther from the nose. Other examples of Figures 36C to 36R may provide substrate sizes and positioning configurations 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.

The size of other specific embodiments also may not extend to the skin patch edge. Roughly, in the embodiment of Figure 36B to 36R, the base portion comprises a crouching overall shape, which occupies a high percentage of the inner area of the stretched periphery (the shortest path surrounding the shape). In brief, the base portion is formed into a body, but may also be formed by a few bodies (for example two bodies) of a plurality of closely interwoven bodies, such as Figure 36R. Inside this body, the base is divided into multiple parts and/or elongated shapes by at least one slot or slit, so that the adjacent parts (or sub-parts) of the base are opposite across the slot, slit or gap. Depending on the configuration of the slots, slits or gaps (or multiple slots, slits or gaps), the substrate allows the underlying skin patch to stretch in one or more directions in addition to bending or forming into compound curves. Several notable features and characteristics will then be described with reference to different substrate portions and configurations.

In each case, certain aspects of an embodiment are described. Different variations can be constructed using these aspects. The aspects of one embodiment can be easily combined with the aspects of other embodiments. The configuration of the slits or grooves can be oriented in other directions, or can be mirrored or reversed.

The substrate 3603 of Figure 36B is generally serpentine. The substrate has an 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 formed into a series of swing loops divided by slits 3306. 3306 can be perpendicular to a line between the ends 3304 and 3305 or angled at some other angle. For example, the slits 3306 can be angled so 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 serpentine shape may provide a shortest uncut path between the first end of the base portion and the second end of the base portion that is at least twice the actual linear distance between these locations.

The meandering series of slits provide interlaced portions of the meandering path, and the interlaced portions can bend in different directions to allow the substrate to conform to the underlying composite curved surface. For example, the curved portion 3307 can bend independently of the straight portion 3308, and the outer surface of the skin patch pad is allowed to bend and bulge in two orthogonal directions.

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

The base of Figure 36C is generally similar to the base of Figure 36B. The base 3309 shown completely covers the skin patch. One end fills the first end 3304 of the skin patch, and 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 so that the winding body extends between the two ends 3304 and 3305. The base illustrated in Figure 36C has substantially the same elastic properties as the base of Figure 36B.

The base portion of FIG. 36D has substantially the same structure as the base portion of FIG. 36C , but the base portion 3311 of FIG. 36D includes a slit 3312 that is farther from the nose tip 3304 at the upper end than at the lower end, while the slit 3310 of the base portion of FIG. 36C is closer to the nose tip 3304 at the upper end than at the lower end.

Other similar meandering shapes are provided by the base portion 3313 of Figure 36G and the base portion 3318 of Figure 36H. In these cases, narrow slots are provided along the base portion longitudinally to respectively separate the base portion into a series of adjacent islands 3321 and 3322. Slots 3318 and 3319 are wider than the slits of the aforementioned embodiments. A series of narrow bridges 3323 and 3324 are respectively joined between 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.

In the embodiment of FIG. 36G, the slot 3319 is oriented substantially orthogonal to a line between the skin patch ends 3304 and 3305. In FIG. 36H, similar to FIG. 36C, the slot 3320 is oriented with its upper end closer to the nose end 3304 than the 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 can be less than 0.2 or less than 0.1 of the average slot length.

Other serpentine embodiments are described below with reference to FIGS. 36M , 36O , and 36E .

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

In the configuration of the 36B, 36C, 36D, and 36F to 36H figures, slotting or slits are substantially parallel orientations to each other. In the configuration of the 36E figure, a series of slits 3329 and 3330 are extending at opposite sides of the base portion. In the present embodiment, the first group of slits 3329 is oriented with non-parallel angles relative to the second group of slits 3330. More specifically, in this specific embodiment, the upper end of slit 3329 is farther away from the end 3304 of the skin patch than the lower end, and the upper end of slotting 3330 is closer to the end 3304 of the skin patch than the lower end. In some embodiments, slits 3329 and 3330 pass through the midline of the base portion (the midline extending from end 3304 to end 3305) such that there is no straight path between ends 3304 and 3305. Slits 3329 and 3330 form a herringbone pattern.

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 base portion 3331 substantially covers the entire surface of the skin patch and is divided by an irregular slit configuration. For example, a slit 3333 extends from an edge adjacent end 3304 in a roughly S-shaped manner, producing a series of interleaved fingers from either side of the base portion 3331. A second slit 3333 extends from an edge of the base adjacent end 3305 of the skin patch. This slit form includes a corner or a dog leg, and is divided into a cross slit 3335 at a cross point 3334. The slits 3332 and 3333 divide the area of the base portion 3331 into multiple zones or sections of approximately equal width, with interlaced fingers and long joints. In this embodiment, the slits are mostly integrated into the base portion 3331 and are only connected to the edge of the base portion 3331 at two locations.

Similar configurations of interleaved fingers are evident in the base portion 3336 of FIG. 36J and the base portion 3337 of FIG. 36R. In the base portion 3336 of FIG. 35J, a single narrow slot 3337 of small width extends longitudinally along the base portion in a serpentine path from one edge of the base adjacent end 305 to the adjacent edge 3304. In this embodiment, the single slot 3337 hits the edge of the base portion 3336 at only one location. The slot 3337 divides the base portion 3336 into two large portions, each of which includes a series of fingers 3338 and 3339. The fingers 3338 and 3339 are interleaved. The location of the slot 3337 and the direction of the long leg of the bend 3341 allow the fingers 3338 and 3339 to be oriented in a direction that is transverse to but at an angle to a line between the ends 3304 and 3305.

In another embodiment illustrated in FIG. 36R , a single meandering slot 3342 extends from the upper edge of slot 3337 to the lower edge of slot 3337. Slot 3342 extends in a meandering path including a straight portion 3343 and a bend 3344. This divides slot 3337 into two transversely 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 interdigitated fingers are oriented substantially parallel to a line extending between ends 3304 and 3305.

Another embodiment including a single slot or slit is illustrated in FIG. 36K. In this embodiment, a single slit 3346 extends in a generally spiral configuration from the edge position adjacent end 3305 to a position generally centered on base portion 3347. Spiral slit 3346 divides base portion 3347 into a single continuous spiral of base material. In some embodiments, multiple spiral slits begin at different locations around the periphery of base portion 3347, dividing the base portion into multiple interlaced base material spirals.

The embodiment of Fig. 36Q includes a substantially continuous curved slit, compared to the embodiments of Figs. 36B to 36J and 36R which primarily utilize straight slits, although there are curved portions in some cases. Figs. 36K to 36P illustrate other base portion embodiments with curved slits.

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 case. Some of the slits 3350 are reached from the edges of the base portions 3348 and 3349.

Other slots 3351 begin and end inside the bodies of base portions 3348 and 3349. For example, in base portion 3348, slits 3351 each describe an arc greater than 315 degrees but less than 360 degrees, creating circular and annular portions inside base portion 3348 that are connected to other portions of base portion 3348 via narrow bridges. Slits 3351 in base portion 3349 operate in a similar manner to create circular and annular portions connected via narrow bridges.

In FIG. 36K , the arrangement of slits 3350 and 3351 and in particular the bridges between the portions divided by the slits provide a serpentine path of continuous uncut material between the ends 3305 and 3304 of the base portion and the center 3352 of the base portion. In FIG. 36L , the arrangement of curved slits 3350 and substantially circular slits 3351 provide substantially aligned bridges, providing a more straight path between at least one end 3305 of the base portion and the center 3352 of the base portion.

Another serial embodiment is illustrated in Figures 36N to 36P. In this serial, base portions 3353, 3354, 3355 and 3356 are each divided by a series of narrow curved slots, each slot extending from the upper edge or the lower edge of the base portion into the interior of the base portion body. The slots in each base portion 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 of the width of the base portion, but not completely across the width of the base portion. For example, the slots extend across greater than 70%, greater than 80% or greater than 90% of the width of the base portion. The slots may have radiused corners at the closed end.

In the arrangement of FIG. 36M, the series of 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. The base portion is thus divided into generally serpentine lengths. In this embodiment, the curvature of each base slot is such that the upper and lower ends of each slot are further from the end 3304 than the middle thereof.

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 so that the upper and lower ends of each slot are farther away from the first end 3304 of the skin patch than the middle thereof.

Figure 360 illustrates another embodiment similar to the embodiment of Figure 36N. In Figure 360, curved slots 3362 and 3363 extend from the lower edge and upper edge of the base portion respectively. Slotted series 3362 intersects with slotted series 3363 to form a continuous path that meanders or spirals along the base portion. In the embodiment of Figure 360, the upper and lower ends of each curved slot are farther away from the first end 3304 of the skin patch than the middle portion.

Another variation is illustrated in Figure 36P. In this embodiment, the curved slots 3364 extend from the same edge of the base portion. They can extend from the upper edge or the lower edge. The curved slots 3364 are all arranged in a parallel configuration. The upper and lower ends of the curved slots are farther away from the first end 3304 of the skin patch than the middle thereof.

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

Skin patch 650 defines a fixation footprint for attachment to a patient, having a similar configuration to the previous fixation embodiment corresponding to skin patch 550. The user side of skin patch 650 is configured to attach to or adhere to the user's skin.

The fixing patch 660 extends over the user interface and/or the associated user interface tube and is bonded to the skin patch 650 to fix the user interface to the patient. The fixing patch 660 and the skin patch 650 are assembled so that the fixing patch can be contained in or bounded by the fixing footprint of the skin patch when the fixing system is applied to the patient with an appropriate or compatible user interface. The fixing patch 660 is contained within the fixing footprint of the skin patch 650 to reduce the possibility of unnecessary contact with the patient's skin and potential irritation. Ideally, the skin patch 650 has the same or larger surface area as the fixing patch 660.

As for the embodiment where the interface includes a two-part releasable attachment to a skin patch, in this embodiment including a fastening patch 660, the skin patch 650 is provided with a coupling system component for releasably coupling the fastening patch 660. For example, the skin patch 650 may include one component of a two-part mechanical fastener system across its surface or a portion of its surface, and the fastening patch 660 has another component of the fastening system.

In this way, the size of the skin patch can reduce the possibility of the adhesive tape or any additional tape extending onto the user's skin. It is preferred to avoid or reduce the application, or repeated application and removal of adhesives to the user's skin. This embodiment advantageously reduces the repeated application of adhesives or adhesive tapes to the user's skin to install and position the user interface to the operating position. Adhesive tape or other skin adhesive patches (when repeatedly applied and removed) are particularly problematic for infants. Problems include, but are not limited to, skin irritation from 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 from repeated application and removal of skin patches or tapes in order to position or reposition the interface to the user. Repositioning or adjustments may be required when therapeutic treatments are repeated (i.e., changing from one type of treatment to another and then back again). Therefore, preferably, the embodiments provide a system for placing or positioning a user interface to a user while still reducing the possibility of problems associated with adhesive tape adhering to the user's skin.

It is important to understand that there are multiple disadvantages and problems associated with repositioning interfaces, particularly infant interfaces. These include "lion noses," superficial abrasions, or skin allergies from the traditional tape technique of applying a user interface (e.g., nasal cannula) to the user. Such problems also occur when the user cycles between different treatment options, traditionally followed by removal of the helmet or tape or user interface, and then installation of a new device and user interface or interface positioning helmet or other headgear. Therefore, providing a fixation system that is in a ready-to-receive mode of receiving the user interface when applied to the user is a major step toward reducing one of the problems that the user has previously had to deal with. Again, improved ease of installation is an added benefit in terms of both complexity and time and effort for the caregiver (e.g., nurse).

The fixed patch can be shaped or otherwise configured to correspond to the geometry or other features of the user interface and/or the associated user interface tube. The illustrated fixed patch has multiple wings 661 to correspond to the user interface tube and increase the contact area of the fixed patch 660 exposed to the skin patch 650. The fixed patches illustrated in Figures 22 and 23 each have a pair of wings disposed at one end of the patch. The wings 661 are configured to fix the skin patch on either side of the user interface and/or the associated user interface tube and reduce the possibility of 660 bulging around the interface and/or the tube.

The fixing patch 661 illustrated in FIG. 22 also has a tube end wing 661. The tube end wing 661 is assembled to extend under the user interface tube and fixed to the skin patch 650 to link the end of the fixing patch 660.

The second embodiment of the fixing 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 configured to attach the user interface to the patient's face, particularly adjacent to the user's upper lips and/or cheeks. The fixing system illustrated is suitable for neonatal use.

The user side of the skin patch 550, 650 preferably has a skin-sensitive adhesive (such as a hydrophilic colloid) to adhere the patch to the user's skin, allowing the application of each fixing system to cause as little irritation as possible. The skin patch 550, 650 preferably has sufficient surface area to distribute the adhesive force and interface retention force over a sufficient area of the user's face to reduce the accumulation of local pressure.

The fixing system illustrated in the figure is particularly configured to receive and/or fix the previously disclosed nasal cannula and the associated tube. The tube can extend from one or both sides of the user's face. In addition, the fixing system can be configured so that the user interface is fixed to the skin patch by a two-part removable attachment or connection configuration and a fixing patch over the interface and/or tube.

Although the present disclosure has been described with respect to certain embodiments, other embodiments that are apparent to those skilled in the art also fall within the scope of the present disclosure. Thus, many variations and modifications may be made without departing from the spirit and scope of the present disclosure. For example, multiple components may be repositioned as desired. Furthermore, not all features, aspects, and advantages are required to practice the present disclosure. Therefore, the scope of the present disclosure is intended to be limited only by the scope of the following patent application.

It should be understood that the various embodiments described above and with reference to 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 fixing system of the present invention, or can be used in combination with other retaining systems or interchangeably. In addition, the anatomically shaped fork of the present invention can be combined with the aforementioned tube or interface or fixing system embodiment, or can be used in combination with other tubes or interfaces or fixing systems or interchangeably. The aforementioned multiple embodiments are particularly excellent in combination. Preferred Features

SP1. A corrugated medical tube comprises: a tubular body, the body defining a lumen extending between open ends of the body, and an inner molded part enclosing the interior of the lumen and supporting the tubular body, an outermost periphery of the inner molded part defining a plurality of staggered wave crests and wave troughs along a length of the tubular body. SP2. A tube as claimed in claim aspect SP1, wherein the tubular body is an extruded tube. SP3. A tube as claimed in claim aspect SP1 or SP2, wherein the tubular body is a continuous tube. SP4. A tube as claimed in any one of claim aspects SP1 to SP3, wherein the tubular body is a continuous extruded tube. SP5. A tube as claimed in any one of claim aspects SP1 to SP4, wherein the wave crests of the corrugated tubular body are defined by the outermost periphery of the inner molded part. SP6. A tube as claimed in any one of claims SP1 to SP5, wherein the trough of the corrugated tubular body is defined by the inward withdrawal of the inner molded part, by the inwardly withdrawn portion of the tubular body. SP7. A tube as claimed in any one of claims SP1 to SP6, wherein the inner molded part is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths. SP8. A tube as claimed in any one of claims SP1 to SP7, wherein the inner molded part is a helical spring or a helical winding element, a helical winding skeleton or a helical winding rib, an annular disc, a ring, or one or a combination of multiple separate support members interconnected or interconnectable by one or more connecting rods. SP9. A tube as claimed in any one of claims SP1 to SP8, wherein the inner molded part is a support for the tubular body defining a lumen therein. SP10. A tube as claimed in any one of claims SP1 to SP9, wherein the inner molded part is a skeleton or internal support structure supporting the tubular body. SP11. A tube as claimed in any one of claims SP5 to SP10, wherein the tubular body is substantially not supported by the inner molded part at the troughs but is supported by the inner molded part at the crests. SP12. A tube as claimed in any one of claims SP5 to SP11, wherein the wall of the tubular body is suspended between adjacent crests. SP13. A tube as claimed in any one of claims 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. A tube as claimed in any one of claims SP1 to SP13, 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. SP15. A tube as claimed in any one of claims SP1 to SP14, wherein the inner molded part is a spirally wound rib, or rib element. SP16. A tube as claimed in any of claim aspects SP1 to SP15, wherein the inner molded part is a spirally 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. SP17. A tube as claimed in any one of claim aspects SP1 to SP16, wherein the inner molded 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 one of claims SP1 to SP17, wherein the inner molded part 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 0.1 1 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 as claimed in claim aspect SP18, wherein the inner molded part is a medical grade material, preferably a medical grade stainless steel. SP20. A tube as claimed in any one of claim aspects 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 one of claim aspects SP1 to SP20, wherein the tubular body has an inner 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 one of claim aspects 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. A tube as claimed in any one of claims SP1 to SP22, wherein the tubular body is (preferably extruded from) a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber (LSR), a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer. The family of plastic 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 one of claims SP1 to SP24, wherein the inner mold is a plurality of rings spaced longitudinally along the lumen. SP25. A tube as claimed in claim SP24, wherein the shape of the rings is a complex surface or a ring. SP26. A tube as claimed in any one of claims SP1 to SP25, wherein the inner molded part is one or more separate components linked to each other. SP27. A tube as claimed in any one of claims SP1 to SP26, wherein the inner molded part is a plurality of reinforcing ribs regularly spaced along the lumen. SP28. A tube as claimed in claim SP27, wherein each reinforcing rib comprises one turn of a helical reinforcing wire. SP29. A tube as claimed in claim SP28, wherein one turn of the helical reinforcing wire comprises one complete revolution around the lumen. SP30. A tube as claimed in claim SP28, wherein one turn of the helical reinforcing wire comprises the wire located between adjacent wave crests of the inner molded part. SP31. A tube as claimed in any of claims SP1 to SP30, wherein the tubular body is defined as flexible by passing a test of increase in flow resistance with bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000). SP32. A tube as claimed in any of claims SP1 to SP31, wherein one end of the tube is integrated with a nasal prong, the nasal prong being suitable for insertion into a user's nostril as a nasal interface for delivering breathing gas to a user. SP33. A tube as claimed in any of claims SP1 to SP32, wherein the internal molded part is a screen. SP34. A tube as claimed in any of claims SP1 to SP33, wherein the internal molded part is a wire suitable for heating or sensing a property of a gas inside the tube. SP35. A tube as claimed in any one of claims SP1 to SP34, wherein the internal molded part is electrically conductive, preferably the internal molded part is an electric heater. SP36. A tube as claimed in any one of claims SP1 to SP35, wherein the internal molded part comprises an electrically conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor). SP37. A tube as claimed in any one of claims SP1 to SP36, wherein the tube further comprises a heater, preferably an electric heater (such as a heater wire or heater circuit). SP38. A tube as claimed in any one of claims SP1 to SP37, wherein the tube is a breathing tube. SP39. A tube as claimed in any one of claims SP1 to SP38, wherein the ratio of the spacing of the inner mold to the outer diameter of the inner mold (e.g., the outermost diameter) 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. SP40. A tube as claimed in any one of claims SP1 to SP38, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or component) to the outer diameter of the inner mold (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 the ratio is 0.06. SP41. A tube as claimed in any one of claims SP1 to SP38, wherein the ratio of the corrugation depth to the outer (i.e., external) tube diameter is about 0.05 to about 0.09. SP42. A tube as claimed in any one of claims SP1 to SP38, wherein the physical properties of the tubular body result in the tube having desired flexibility and/or structural support. SPM11. A method of manufacturing a medical tube, the method comprising: providing an inner mold protruding from a tubular body encasing the inner mold, the tubular body defining a lumen surrounding the inner mold. SPM12. A method as claimed in claim aspect SPM11, further comprising: i) applying a decompression to (or to) the interior of a tubular cavity so that the decompression draws the tubular body radially inward in the tubular cavity or at an outermost periphery defined by the inner mold, the outermost periphery of the inner mold defining a plurality of alternating peaks and valleys along a length of the tubular body, or ii) applying an extension (or stretching) to at least a portion or a region of the tubular body surrounding the inner mold, so that the release of the extension (or stretching) returns (or allows) the extended (or stretched) portion or region of the tubular body to be radially drawn inward in the tubular cavity or at an outermost periphery defined by the inner mold, 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. A method as claimed in claim aspect SPM11 or SPM12, wherein the tubular body is provided by extrusion or by extruding a material from a die. SPM14. A method as claimed in any one of claim aspects SPM11 to SPM13, wherein the tubular body is extruded around the inner mold, and the reduced pressure is applied in a manner that allows an inner surface of the tubular body to become at least partially attached or connected to at least a portion of the inner mold, preferably the reduced pressure difference between the pressure inside the lumen and the pressure surrounding the tubular body, and more preferably 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)). SPM15. A method as claimed in any one of claims SPM11 to SPM15, wherein the tubular body is a single-walled body. SPM16. A method as claimed in any one of claims SPM11 to SPM16, wherein the reduced pressure is applied at or adjacent to the formation of the lumen. SPM17. A method as claimed in claim SPM14, wherein the reduced pressure is applied at or adjacent to a die. SPM18. A method as claimed in claim SPM14, wherein the lumen experiences the reduced pressure when leaving an extrusion die. SPM19. A method as claimed in any one of claims SPM11 to SPM18, wherein the tubular body and the inner mold are co-extruded. SPM110. A method as claimed in any one of claims SPM11 to SPM18, wherein the tubular body so formed is corrugated. SPM111. A method as claimed in any one of claims SPM11 to SPM110, wherein the wave crests of the corrugated tubular body so formed are defined by the outermost periphery of the inner mold. SPM112. A method as claimed in any one of claims SPM11 to SPM111, wherein the wave troughs of the corrugated tubular body so formed are defined by an inwardly drawn portion of the tubular body drawn inwardly between the inner molds. SPM113. A method as claimed in any one of claims SPM11 to SPM112, wherein the inner mold is a skeleton or internal support structure that supports the tubular body. SPM114. A method as claimed in any one of claims SPM11 to SPM113, wherein the internal molded part is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths. SPM115. A method as claimed in any one of claims SPM11 to SPM113, wherein the internal molded part is a screen. SPM116. A method as claimed in any one of claims SPM11 to SPM113, wherein the internal molded part is a coil spring or a coiled element, a coiled frame or a coiled rib, an annular disc, a ring, or one or a combination of multiple separate support members interconnected or interconnectable by one or more connecting rods. SPM117. A method as claimed in any one of claims SPM11 to SPM117, wherein the inner mold is supportive or supports the lumen inside the tube so formed. SPM118. A method as claimed in any one of claims SPM11 to SPM113 or SPM117, wherein the inner mold is a spirally 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. A method as claimed in any one of claim aspects SPM11 to SPM113 or SPM117, wherein the inner mold 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. A method as claimed in any one of claim aspects SPM118 or SPM119, wherein the inner molded part 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 A linear diameter of 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 as claimed in claim SPM120, wherein the inner mold is a medical grade material, preferably a medical grade stainless steel. SPM122. A method as claimed in any one of claims SPM11 to SPM121, 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. SPM123. A method as claimed in any one of claims SPM11 to SPM122, wherein the tubular body has an inner 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. A method as claimed in any one of claims 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. A method as claimed in any one of claims 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. A method as claimed in any one of claims SPM11 to SPM125, wherein the tubular body is (preferably extruded from) a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as Thermoplastic elastomer family, 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. A method as claimed in any one of claims SPM11 to SPM126, wherein the tubular body is a breathable tube, or is made of a breathable material, such as breathable thermoplastic polyurethanes (classes) or breathable polyamides. SPM128. A method as claimed in any one of claims SPM11 to SPM127, wherein the decompression is applied when the tubular body is in a molten state, or a semi-molten state, or a state that has not yet hardened, preferably the decompression 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 decompression is a pressure difference between the inner side of the lumen and the surrounding area of the tubular body. SPM129. A method as claimed in any one of claims SPM11 to SPM128, wherein the inner mold is conductive, preferably the inner mold is an electric heater. SPM130. A method as claimed in any one of claims SPM11 to SPM129, wherein the inner molded part comprises an electrically conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor). SPM131. A method as claimed in any one of claims SPM11 to SPM130, wherein the tube further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit). SPM132. A method as claimed in any one of claims SPM11 to SPM131, wherein the tubular body is defined as flexible by passing a test for increase in flow resistance with bending according to ISO 5367:2000 (E) (4th edition, June 1, 2000). SPM133. A method as claimed in any one of claims SPM11 to SPM132, wherein the medical tube is a breathing tube. SPM134. A tube as claimed in any one of claims SPM11 to SPM133, wherein the ratio of the spacing of the inner mold to the outer diameter (e.g., the outermost diameter) of the inner mold 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. SPM135. A tube as claimed in any one of claims SPM11 to SPM134, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter of the inner mold (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 the ratio is 0.06. SPM136. A tube as claimed in any one of claims 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 one of claims SPM11 to SPM136, wherein the physical properties of the tubular body result in the tube having a desired flexibility and/or structural support. SP21. A medical tube comprises: a tubular body, the body defining a lumen extending between open ends of the body, an inner molded part enclosing the interior of the lumen and supporting the tubular body, and a coating encapsulating the inner molded part, the coating securing the inner molded part to the tubular body. SP22. A medical tube as claimed in claim aspect SP21, wherein the coating and the tubular body are welded along the tube. SP23. A medical tube as claimed in claim aspect SP21 or SP22, wherein the coating and the tubular body are welded at separate locations along the tube. SP24. A medical tube as claimed in claim aspect SP22, wherein the coating and the tubular body are welded substantially continuously along the longitudinal direction of the tube. SP25. A medical tube as claimed in any one of claims SP21 to SP24, wherein the outermost periphery of the inner mold defines a plurality of alternating peaks and valleys along a length of the tubular body. SP26. A tube as claimed in claim SP25, wherein the peaks of the corrugated tubular body are defined by the outermost periphery of the inner mold. SP27. A tube as claimed in claim SP25 or SP26, wherein the corrugated tubular body is defined by an inwardly drawn portion of the tubular body drawn inwardly between the inner molds. SP28. A tube as claimed in any one of claims SP21 to SP27, wherein the inner mold is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths. SP29. A tube as claimed in any one of claims SP21 to SP28, wherein the inner molded part is a helical spring or a helical wound element, a helical wound skeleton or a helical wound rib, an annular disc, a ring, or one or a combination of a plurality of separate supports interconnected or interconnectable by one or more connecting rods. SP210. A tube as claimed in any one of claims SP21 to SP29, wherein the inner molded part supports the tubular body and defines the lumen therein. SP211. A tube as claimed in any one of claims SP21 to SP210, wherein the inner molded part is a skeleton or internal support structure supporting the tubular body. SP212. A tube as claimed in any one of claims SP25 to SP27, wherein the tubular body is substantially unsupported by the troughs from the inner molded part and is supported by the inner molded part at the crests. SP213. A tube as claimed in any one of claims SP25 to SP27, wherein the walls of the tubular body are suspended between adjacent crests. SP214. A tube as claimed in any one of claims 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 use in medical breathing tubes. SP215. A tube as claimed in any one of claims SP21 to SP214, wherein the inner molded part is a helically wound rib, or rib element. SP216. A tube as claimed in any one of claims SP21 to SP215, wherein the inner molded part is a helically wound strip, the coating encapsulating the strip. SP217. A tube as claimed in any one of claims SP21 to SP216, wherein the inner molded part is a helically wound wire, the coating encapsulating the wire. SP218. A tube as claimed in any one of claims SP21 to SP217, wherein the coating provides a surface to be joined to the tubular body. SP219. A tube as claimed in any of claim aspects SP21 to SP218, wherein the inner molded part is a spirally 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. SP220. A tube as claimed in any one of claim aspects SP21 to SP219, wherein the inner molded 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. SP221. A tube as claimed in any one of claims SP21 to SP220, wherein the inner molded part 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. A tube as claimed in any one of claims SP21 to SP221, wherein the inner molded part is a medical grade material, preferably a medical grade stainless steel. SP223. A tube as claimed in any one of claim aspects 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 one of claim aspects SP21 to SP223, wherein the tubular body has an inner 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 one of claim aspects 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. A tube as claimed in any one of claims SP21 to SP225, wherein the tubular body is (preferably extruded from) one or a combination of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide; more preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic The invention relates to a polymer of the family of thermoplastic elastomers, 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. SP227. A tube as claimed in any one of claims SP21 to SP226, wherein the inner mold is a plurality of rings spaced longitudinally along the lumen. SP228. A tube as claimed in claim SP227, wherein the shapes of the rings are complex curved or toroidal. SP229. A tube as claimed in any one of claims SP21 to SP228, wherein the inner molded part is one or more separate elements linked to each other. SP230. A tube as claimed in any one of claims SP21 to SP229, wherein the inner molded part is a plurality of reinforcing ribs regularly spaced along the lumen. SP231. A tube as claimed in claim SP230, wherein each reinforcing rib comprises one turn of a helical reinforcing wire. SP232. A tube as claimed in claim SP231, wherein one turn of the helical reinforcing wire comprises one complete revolution around the lumen. SP233. A tube as claimed in claim SP231, wherein one turn of the helical reinforcing wire comprises the wire located between adjacent wave crests of the inner molded part. SP234. A tube as claimed in any of claims SP2 to SP233, wherein the tubular body is defined as flexible by passing a test of increase in flow resistance with bending in accordance with ISO 5367:2000 (E) (4th edition, June 1, 2000). SP235. A tube as claimed in any of claims SP21 to SP234, wherein one end of the tube is integrated with a nasal prong, the nasal prong being adapted to be inserted into a user's nostril as a nasal interface for delivering respiratory gas to a user. SP236. A tube as claimed in any of claims SP21 to SP235, wherein the internal molded part is a screen. SP237. A tube as claimed in any one of claims SP21 to SP236, wherein the internal molded part is a wire suitable for heating or sensing the properties of the gas inside the tube. SP238. A tube as claimed in any one of claims SP21 to SP237, wherein the internal molded part is conductive, preferably the internal molded part is an electric heater. SP239. A tube as claimed in any one of claims SP21 to SP238, wherein the internal molded part comprises a conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor). SP240. A tube as claimed in any one of claims SP21 to SP239, wherein the tube further comprises a heater, preferably an electric heater (such as a heater wire or a heater circuit). SP241. A tube as claimed in any one of claims SP21 to SP240, wherein the tube is a heating tube. SP242. A tube as claimed in any one of claims SP21 to SP241, wherein the ratio of the spacing of the inner molded part to the outer diameter (e.g., the outermost diameter) of the inner molded part 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. SP243. A tube as claimed in any of claims SP21 to SP242, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter of the inner mold (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, the ratio is 0.06. SP244. A tube as claimed in any of claims 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 claims SP21 to SP244, wherein the physical properties of the tubular body result in the tube having a desired flexibility and/or structural support. STM21. A method for manufacturing a medical tube, the method comprising: providing an inner molded part enclosed in a coating, and providing a tubular body covering the inner molded part, the tubular body defining a lumen surrounding the inner molded part, the tubular body being arranged to cover the inner molded part so that the coating is connected to an inner surface of the tubular body, wherein the inner molded part remains enclosed. STM22. A method as claimed in claim STM21, wherein the step of providing an inner molded part comprises providing an elongated molded part enclosed in a coating suitable for application to a medical tube, and manufacturing a supporting inner molded part for a medical tube from the coated elongated molded part. STM23. A method as claimed in claim STM22, wherein the uncoated elongated member is immersed in a bath of coating material to apply the encapsulating coating. STM24. A method as claimed in claim STM23, wherein the bath contains a molten polymer level at a temperature greater than about 150°C. STM25. A method as claimed in any one of claims STM22 to STM24, wherein the inner member is made by spirally winding the elongated member into a spiral form. STM26. A method as claimed in any one of claims 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 one of claim aspects STM21 to STM26, comprising: a) applying a decompression to (or to) the interior of the tubular cavity so that the decompression draws the tubular body radially inward, or b) applying an extension (or stretch) to at least a portion or a region of the tubular body surrounding the inner molded part so that the release of the extension (or stretch) returns (or allows) the extended (or stretched) portion or region of the tubular body to be radially drawn inward, or c) a combination of a) and b). STM28. A method as claimed in claim STM27, wherein the tubular body is radially drawn inwardly at the lumen or at the outermost periphery defined by the inner mold, the outermost periphery of the inner mold defining a plurality of alternating peaks and valleys along a length of the tubular body to form a corrugated tube. STM29. A method as claimed in any one of claims STM2 to STM28, wherein the tubular body is provided by extrusion or by extruding a material from a die. STM210. A method as claimed in any one of claim aspects STM21 to STM29, wherein the tubular body is extruded around the inner mold, and the reduced pressure is applied in a manner that allows an inner surface of the tubular body to become at least partially attached or connected to at least a portion of the inner mold, preferably the reduced pressure difference between the pressure within the lumen and the pressure surrounding the tubular body, more preferably 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)). STM211. A method as claimed in any one of claims STM21 to STM211, wherein the tubular body is provided around the inner mold at a temperature such that the coating is bonded to at least a portion of the tubular body. STM212. A method as claimed in claim STM211 or STM212, wherein the tubular body is provided around the inner mold at a temperature that allows the coating to fuse to the inner mold. STM213. A method as claimed in claim STM211 or STM212, wherein the tubular body is at least partially fused to the coating. STM214. A method as claimed in any one of claims STM21 to STM213, wherein the tubular body is a single-walled body. STM215. A method as claimed in any one of claims STM21 to STM214, wherein a reduced pressure is applied to or adjacent to the formation of the lumen. STM216. A method as claimed in claim STM215, wherein the reduced pressure is applied to or adjacent to a die. STM217. A method as claimed in claim STM216, wherein the lumen experiences the reduced pressure when exiting an extrusion die. STM218. A method as claimed in any one of claims STM21 to STM217, wherein the tubular body is extruded simultaneously with the manufacture of the inner part from the elongated part. STM219. A method as claimed in any one of claims STM21 to STM218, wherein the tubular body so formed is corrugated. STM220. A method as claimed in claim STM219, wherein the wave crests of the corrugated tubular body so formed are defined by the outermost periphery of the inner mold. STM221. A method as claimed in claim STM29 or STM220, wherein the wave troughs of the corrugated tubular body so formed are defined by an inwardly drawn portion of the tubular body drawn inwardly between the inner mold. STM222. A method as claimed in any one of claims STM21 to STM221, wherein the inner mold is a skeleton or internal support structure that supports the tubular body. STM223. A method as claimed in any one of claims STM21 to STM222, wherein the inner molded part is a continuous length, one or a series of semi-continuous lengths, or a series of separated lengths. STM224. A method as claimed in any one of claims STM21 to STM223, wherein the inner molded part is a helical spring or a helical wound element, a helical wound skeleton or a helical wound rib, an annular disc, a ring, or one or a combination of multiple separate support members interconnected or interconnectable by one or more connecting rods. STM225. A method as claimed in any one of claims STM21 to STM224, wherein the inner molded part is supportive or supports the tubular cavity inside the tube so formed. STM226. A method as claimed in any of claim aspects STM21 to STM225, wherein the inner molded part is a spirally 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. STM227. A method as claimed in any one of claim aspects STM21 to STM226, wherein the inner mold 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. STM228. A method as claimed in any one of claims STM21 to STM227, wherein the inner molded part 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 A diameter of 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. A method as claimed in any one of claims STM21 to STM228, wherein the inner mold is a medical grade material, preferably a medical grade stainless steel coated with a suitable material, preferably a polymer grade or a stainless steel. STM230. A method as claimed in any one of claim aspects 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 as claimed in any one of claim aspects STM21 to STM230, wherein the tubular body has an inner 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 as claimed in any one of claim aspects STM21 to STM231, 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. A method as claimed in any one of claims 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. A method as claimed in any one of claims STM21 to STM233, wherein the tubular body is (preferably extruded from) a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as Thermoplastic elastomer family, 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. A method as claimed in any one of claims STM21 to STM234, wherein the decompression is applied when the tubular body is in a molten state, or a semi-molten state, or a state that has not yet hardened, preferably the decompression 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 decompression is a pressure difference between the inner side of the lumen and the surrounding area of the tubular body. STM236. A method as claimed in any one of claims STM21 to STM235, wherein the inner mold is conductive, preferably the inner mold is an electric heater. STM237. A method as claimed in any one of claims STM21 to STM236, wherein the internal molded part comprises an electrically conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor). STM238. A method as claimed in any one of claims STM21 to STM237, wherein the tube further comprises a heater, preferably an electric heater (such as a heater wire or heater circuit). STM239. A method as claimed in any one of claims STM21 to STM238, wherein the tubular body is defined as flexible by passing a test for increase in flow resistance with bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000). STM240. A method as claimed in any one of claims STM21 to STM239, wherein the medical tube is a breathing tube. STM241. A method as claimed in any one of claims STM21 to STM240, wherein the tube is formed by co-extruding at least one spiral reinforcement together with a tubular body having a continuous wall. STM242. A method as claimed in claim STM241, wherein a vacuum is applied to a lumen region of the extruded tubular body so that the continuous wall forms a ripple around the inner mold. STM243. A method as claimed in claim STM241 or STM242, wherein the extruded continuous wall is a single wall. STM244. A method as claimed in any one of claims STM21 to STM243, wherein the ratio of the spacing of the inner mold to the outer diameter of the inner mold (e.g., the outermost diameter) is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and more preferably the ratio is about 0.28 or about 0.29. STM245. A method as claimed in any one of claims STM21 to STM244, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or component) to the outer diameter of the inner mold (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. STM246. A method as claimed in any one of claims STM21 to STM245, wherein the ratio of the corrugation depth to the outer (i.e., external) tube diameter is about 0.05 to about 0.09. STM247. A method as claimed in any one of claims STM21 to STM246, wherein the physical properties of the tubular body result in the tube having desired flexibility and/or structural support. ST31. A medical tube comprising: a tubular body defining a lumen extending between open ends of the body, and an inner molded part enclosed within the lumen and supporting the tubular body. ST32. A tube as claimed in claim ST31, wherein the outermost periphery of the inner molded part defines a plurality of alternating peaks and valleys along a length of the tubular body. ST33. A tube as claimed in claim aspect ST31 or ST32, wherein the inner molded part is enclosed in a coating, the coating securing the inner molded part to the tubular body. STM31. A method of manufacturing a medical tube, the method comprising: providing an inner molded part, providing a tubular body enclosing the inner molded part, the tubular body defining a lumen enclosing the inner molded part, and i) applying a decompression to (or to) the interior of the lumen, or ii) applying an extension (or stretching) to at least a portion or region of the tubular body enclosing the inner molded part, or iii) a combination of i) and ii). STM32. A method as claimed in claim STM31, wherein a greater pressure reduction or a greater extension (or stretch) or a combination of the two is applied along the length of the tubular body and an outermost periphery defined by the inner molded part to draw the tubular body radially inward toward the lumen, and when the greater pressure reduction is applied or the extension (or stretch) is released or both, the outermost periphery of the inner molded part defines a plurality of alternating peaks and valleys. STM33. A method as claimed in claim STM31 or STM32, wherein the inner molded part is enclosed in a coating, the tubular body is provided to sheath the inner molded part so that the coating is connected to an inner surface of the tubular body, and the inner molded part 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 configured to attach to or adhere to the user's skin, and a fixation patch, at least a portion of which is configured to extend over the user interface and/or the associated user interface tube and to be 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 configured so that the fixation patch can be contained in or demarcated by the fixation footprint of the skin patch when the fixation system is applied to a patient with an appropriate or compatible user interface. TA2. A fixing system as claimed in claim aspect TA1, wherein the skin patch has the same or a larger surface area as the fixing patch. TA3. A fixing system as claimed in claim aspect TA1 or TA2, wherein the fixing patch is formed or otherwise configured to correspond to the geometry or other features of the user interface and/or the connected user interface tube. TA4. A fixing system as claimed in any of claim aspects TA1 to TA3, wherein the fixing patch has at least one wing. TA5. A fixing system as claimed in any of claim aspects TA1 to TA4, wherein the fixing patch has a pair of wings disposed at one end of the patch, the wings being configured to be fixed to the skin patch on either side of a user interface and/or a connected user interface tube. TA6. A fixing system as claimed in any of claim aspects TA1 to TA5, wherein the fixing patch has a tube end wing that is assembled to extend or be used to extend under the user interface tube and be fixed to the skin patch. TA7. A fixing system as claimed in any of claim aspects TA1 to TA6, wherein the user side of the skin patch has a skin-sensitive adhesive (such as a hydrophilic colloid) that attaches or adheres the skin patch to the skin of a user. TA8. A fixing system as claimed in any of claim aspects TA1 to TA7, wherein the skin patch has a surface of sufficient area so that the surface distributes the attachment or adhesive force pressure across the skin of the user. TA9. A fixing system as claimed in any one of claim aspects TA1 to TA8, wherein the skin patch is configured to be attached or adhered to the face of a user. TA10. A fixing system as claimed in any one of claim aspects TA1 to TA9, wherein the skin patch is configured to be attached or adhered to the face of a user, particularly adjacent to the lip and/or cheek of the user. TA11. A fixing system as claimed in any one of claim aspects TA1 to TA10, wherein the fixing system is configured to receive and/or fix a nasal cannula and/or associated tube extending from one or both sides of a user's face. TA12. A fixing system as claimed in any one of claim aspects TA1 to TA11, wherein the fixing system is configured for use on an infant or newborn. TA13. A fixing system as claimed in any one of claim aspects TA1 to TA12, wherein the fixing system is configured for use with a set of pipes as defined by any one or more of COM1-COM17, or COMM11-COMM19, or COM21-COM216. TA14. A fixing system as claimed in any one of claim aspects TA1 to TA13, wherein the fixing system is configured for use with a pipe as defined by any one or more of SP1-SP38, or SP21-SP241, or ST31-ST33. COM1. A nasal cannula configuration comprising: at least one nasal prong 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 inner molded part enclosing the interior of the lumen, the inner molded part supporting the tubular body, an outermost periphery of the inner molded part defining a plurality of alternating peaks and valleys along a length of the tubular body, wherein the inlet of the nasal prong is integrally formed with a terminal end of the tube such that the lumen is fluidly connected to the outlet of the nasal prong. COM2. A nasal cannula as claimed in claim aspect COM1, wherein the nasal prong is formed to substantially anatomically conform to the interior of a user's nose or nostril. COM3. A nasal cannula as claimed in claim aspect COM1 or COM2, wherein the nasal prongs are curved or otherwise shaped or configured to avoid a user's nasal septum. COM4. A nasal cannula as claimed in any of claim aspects COM1 to COM3, wherein the nasal cannula has a substantially planar or flat or contoured backing configured to rest on a user's face, preferably as a stabilizer for the prongs in a user's nostrils. COM5. A nasal cannula as claimed in claim aspect COM4, wherein one or more ribs extend between a front face of the backing and the cannula, the ribs providing a contact surface for a tape or other suitable fastener for snapping or attaching the cannula to a user's face, preferably the tape comprising an adhesive portion or being an adhesive tape or a contact adhesive tape. COM6. A nasal cannula as claimed in any one of claims COM1 to COM5, wherein two nasal prongs are integrally formed with a single corrugated delivery tube. COM7. A nasal cannula as claimed in any one of claims COM1 to COM6, wherein the cannula comprises a pair of nasal prongs, each prong being integrally formed with one end of a pair of gas delivery tubes, or being attachable (or attachable) or connectable (or connectable) to the end. COM8. A nasal cannula as claimed in any one of claims COM1 to COM7, wherein the cannula is made of a polymer such as a thermoplastic polymer, preferably a polymer or polymers suitable for medical breathing tubes. COM9. A nasal cannula as claimed in any one of claims COM1 to COM8, wherein the cannula is made of any one or more of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; preferably, the polymer may be, for example, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as thermoplastics. A family of thermoplastic elastomers, 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. COM10. A user interface comprising a pair of nasal cannulas as claimed in any one of claim aspects COM1 to COM9. COM11. A user interface as claimed in claim aspect COM3, wherein the nasal prongs of each nasal cannula are arranged adjacent to each other and the individual delivery tubes extend in opposite directions away from the nasal prongs. COM12. A user interface as claimed in claim aspect COM4, further comprising a wiring harness extending and coupling between the nasal cannula. COM13. A nasal cannula as claimed in any one of claim aspects COM1 to COM12, wherein the tube is a breathing tube. COM14. A nasal cannula as claimed in any one of claim aspects COM1 to COM13, wherein the tube is as defined in any one or more of SP1-SP38, or SP21-SP241, or ST31-ST33. COM15. A nasal cannula as claimed in any one of claims COM1 to COM14, wherein the tube is connected to the air inlet of the nasal prong (or prong) from one side of the cannula (e.g., the left side or the right side). COM16. A nasal cannula as claimed in any one of claims COM1 to COM14, wherein the tube is connected to the air inlet of the nasal prong (or prong) from both sides of the cannula (e.g., both the left side and the right side). COM17. A nasal cannula as claimed in any one of claims COM1 to COM16, wherein the cannula is an infant (or newborn) nasal cannula. COMM11. A method for manufacturing a nasal cannula, the method comprising: providing an inner mold, extruding a tubular body to cover the inner mold, the tubular body defining a lumen surrounding the inner mold, and attaching a nasal cannula thereto. COMM12. A method as claimed in claim aspect COMM11, further comprising: i) applying a decompression to (or to) the interior of a tubular cavity so that the decompression draws the tubular body radially inward in the tubular cavity or at an outermost periphery defined by the inner mold, the outermost periphery of the inner mold defining a plurality of alternating peaks and valleys along a length of the tubular body, or ii) applying an extension (or stretching) to at least a portion or a region of the tubular body surrounding the inner mold so that the release of the extension (or stretching) returns (or allows) the extended (or stretched) portion or region of the tubular body to be radially inwardly drawn in the tubular cavity or at an outermost periphery defined by the inner mold, 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. A method as claimed in claim aspect COMM11 or COMM12, wherein the method comprises molding a nasal prong around one end of the tubular body. COMM14. A method as claimed in any one of claims COMM11 to COMM13, wherein one end of the tube so formed by the tubular body is positioned in a mold or a mold for molding or forming a nasal cannula, preferably the mold or mold is closed, and the nasal cannula is molded or formed around the one or one end of the tube. COMM15. A method as claimed in any one of claims COMM11 to COMM14, wherein the nasal cannula is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes. COMM16. A method as claimed in any one of claims COMM11 to COMM15, wherein the nasal cannula is made of any one or more of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as Thermoplastic elastomer family, 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. COMM17. A method as claimed in any one of claims 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 one of claims COMM11 to COMM17, wherein a nasal cannula mold is provided, the mold being capable of receiving one end of the tube formed by the manufacture of the tubular body, such that operation of the mold assists in molding the nasal cannula, a portion of the nasal cannula being molded by enveloping the tube end. COMM19. A method as claimed in any one of claims COMM11 to COMM18, wherein 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. COM21. A nasal cannula configuration comprising: at least one nasal prong 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 comprising a tubular body defining a lumen and an inner molded part enclosing the interior of the lumen, the inner molded part supporting the tubular body, wherein the air inlet of the nasal prong is integrally formed with a terminal end of the tube such that the tube lumen is fluidly connected to the air outlet of the nasal prong. COM22. A nasal cannula as claimed in claim aspect COM21, wherein an outermost periphery of the inner molded part defines a plurality of alternating peaks and valleys along a length of the tubular body. COM23. A nasal cannula as claimed in claim aspect COM21 or COM22, wherein the prong is shaped to follow the anatomical curvature of a user's nostril. COM24. A nasal cannula as claimed in any one of claims COM21 to COM23, wherein the nasal prongs are curved or otherwise shaped or configured to avoid a user's nasal septum. COM25. A nasal cannula as claimed in any one of claims COM21 to COM24, wherein the nasal cannula has a contoured backing or facial liner configured to rest on a user's face, preferably as a stabilizer for the prongs in a user's nostrils. COM26. A nasal cannula as claimed in claim aspect COM25, wherein one or more ribs extend between a front face of the backing or facial pad and the cannula, the ribs providing a contact surface for a tape or other suitable fastener for fastening or attaching the cannula to a user's face, preferably the tape comprising an adhesive portion or being an adhesive tape or a contact adhesive tape. COM27. A nasal cannula as claimed in any of claim aspects COM21 to COM26, wherein the two nasal prongs are integrally formed with a single corrugated delivery tube. COM28. A nasal cannula as claimed in any of claim aspects COM21 to COM27, wherein the cannula is configured to be made of a liquid silicone rubber or a polymer such as a thermoplastic polymer, preferably a polymer or polymers suitable for medical breathing tubes. COM29. A nasal cannula as claimed in any of claim aspects COM21 to COM28, wherein the cannula is configured to be made of any one or more of a thermoplastic elastomer, a propylene-based elastomer, a thermoplastic breathable polyester elastomer, a liquid silicone rubber, a breathable thermoplastic polyurethane, or a breathable polyamide, or a combination thereof; preferably, the polymer may be, for example, but not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer such as a thermoplastic elastomer. A family of plastic elastomers, 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. COM210. A user interface comprising a pair of nasal cannulas as claimed in any one of claim aspects COM221 to COM29. COM211. A user interface as claimed in claim aspect COM210, wherein the nasal prongs are arranged adjacent to each other and the individual delivery tubes extend in opposite directions away from the nasal prongs. COM212. A user interface as claimed in claim aspect COM211, further comprising a wiring harness extending and coupling between the nasal cannulas. COM213. A nasal cannula as claimed in any one of claim aspects COM21 to COM212, wherein the tube is a breathing tube. COM214. A nasal cannula as claimed in any one of claim aspects COM21 to COM213, wherein the tube is as defined in any one or more of SP1-SP38, or SP21-SP241, or ST31-ST33. COM215. A nasal cannula as claimed in any one of claims COM21 to COM24, wherein the tube is manufactured by a method as defined in any one or more of SPM11-SPM133, or STM21-STM243, or STM31-STM33. COM216. A nasal cannula as claimed in any one of claims COM21 to COM215, wherein the prong is glued or otherwise adhered to the tube. PWL1. A nasal cannula configuration comprising: at least one nasal prong having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly coupled to the air outlet, the at least one nasal prong comprising a backing configured to rest on a user's face, wherein a lip extends over 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 so that, in use, the user interface patch can be releasably attached or coupled to or with a skin patch attached to a user's face. PWL2. A nasal cannula as claimed in claim aspect PWL1, wherein the lip is a barrier. PWL3. A nasal cannula as claimed in claim aspect PWL1 or PWL2, wherein the lip is deformable. PWL4. A nasal cannula as claimed in any of claims PWL1 to PWL3, wherein the lip extends at least partially around the periphery of a region substantially adjacent to a prong coupled to the backing. PWL5. A nasal cannula as claimed in any of claims PWL1 to PWL3, wherein the lip is a series of one or more separate lips. PWL6. A nasal cannula as claimed in claim PWL5, wherein the one or more separate lips are adjacent, or contiguous, or overlapping lips. PWL7. A nasal cannula as claimed in any of claims PWL1 to PWL6, wherein the lip is a circumferential lip extending around the periphery of the rear surface of the backing. PWL8. A nasal cannula as claimed in any one of claims PWL1 to PWL7, wherein in use, the lip substantially forms a fluid (or liquid) seal, or a fluid (or liquid) barrier, between the rear surface of the backing and a cannula-facing surface of the user interface patch. PWL9. A nasal cannula as claimed in any one of claims PWL1 to PWL8, wherein the backing is a substantially planar or flat or contoured (such as a preformed curve) backing configured to rest on the face of a user. PWL10. A nasal cannula as claimed in any one of claims PWL1 to PWL9, wherein the backing assists in acting as a stabilizer for the prong(s) in the nostril(s) of a user. PWL11. A nasal cannula as claimed in any of claims PWL1 to PWL10, wherein the at least one prong extends outwardly from the at least one nasal prong, away from a user's nasal septum. PWL12. A nasal cannula as claimed in any of claims 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 claims PWL1 to PWL12, wherein the cannula can be operated by the fixation system as defined by any one or more of TA1-TA14. PWL14. A nasal cannula as claimed in any one of claims PWL1 to PWL13, wherein the user interface patch is receivable or retainable 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 one of claims PWL1 to PWL14, wherein the air inlet of the cannula is fluidly connected to or with the tube as defined by any one or more of SP1-SP38, SPM11-SPM133, SP21-SP241, STM21-STM243, ST31-ST33, STM31-STM33. PWL16. A nasal cannula as claimed in any one of claims PWL1 to PWL15, wherein at least the lip(s) are hydrophobic. PWL17. A nasal cannula as claimed in any of claims PWL1 to PWL16, wherein at least the lip(s) include at least one outer peripheral lip and at least one inner peripheral lip, each of the lips 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 a plurality of zones by at least one slit or at least one slot so that the base can substantially conform to an underlying composite curved surface by independent bending of different sections of the base. WP2. A fixing system as claimed in claim aspect WP1, wherein the base portion includes a plurality of slits or slots or both, which together divide the base portion into a winding body. WP3. A fixing system as claimed in claim aspect WP2, wherein the slits and/or slots are arranged in the base so that a first set of at least one set of slits or slots extends into the base from one edge of the base, and a second set of slits or slots extends into the base from another edge of the base, and the slits or slots of one set are interlaced with the slits or slots of another set so that a path along the base portion from one end to the other end without crossing the slits or slots of one set follows a saw-like or winding path that is much longer than a straight line between the two ends. WP4. A fastening system as claimed in any one of claims WP1 to WP3, wherein one of the plurality of slits or slots is curved. WP5. A fastening system as claimed in any one of claims WP1 to WP3, wherein a plurality of the slits or slots are curved and the curved slits or slots are arranged substantially in parallel. WP6. A fastening system as claimed in any one of claims WP1 to WP3, wherein the slits or slots are arranged in a herringbone pattern extending from the edge of the base portion. WP7. A fastening system as claimed in claim WP1, wherein the base is divided into separate portions by a serpentine slit or slot. WP8. A fixing system as claimed in claim aspect WP1, wherein the base portion is divided into a plurality of portions by a spiral slit or groove. WP9. A fixing system as claimed in claim aspect WP1, wherein the base portion is divided into subdivided portions by slits or grooves arranged as substantially concentric circles. WP10. A fixing system as claimed in claim aspect WP9, wherein the concentric circles are centered approximately on the center of the base portion. WP11. A fixing system as claimed in claim aspect WP1, wherein the slits or grooves divide the base portion into a plurality of islands, each island being connected to an adjacent island or islands by a narrow bridge. WP12. A fixing system as claimed in claim aspect WP1, wherein the base portion is divided into a plurality of portions by an S-shaped slit. WP13. A fixing system as claimed in claim aspect WP1, wherein the base portion is divided into a plurality of portions by a T-shaped slit. WP14. A fixing system as claimed in any one of claims WP1 to WP13, wherein the base portion covers at least 70% of the area of the skin patch. WP15. A fixing system as claimed in any one of claims WP1 to WP14, wherein for a boundary defining the shortest path around the periphery of the base, the base portion covers at least 80% of the area inside the boundary. WP16. A fixation system as claimed in any of claims WP1 to WP15, wherein the system can be used in combination with a fixation system of TA1-TA14, or a sleeve of COM1-COM17, or a sleeve of PWL1-PWL17, or any one or more of a tube of SP1-SP38, or SP21-SP241, or ST31-ST33. 1. A medical breathing tube, comprising: a tubular body, the body defining a lumen extending between open ends of the body, an inner molded part surrounding the interior of the lumen and supporting the tubular body, and a coating enveloping the inner molded part, the coating securing the inner molded part to the tubular body. 2. A medical tube as claimed in claim 1, wherein the coating and the tubular body are plastically welded to each other along the tube. 3. A medical tube as claimed in claim 1 or 2, wherein an outermost periphery of the inner mold defines a plurality of alternating peaks and valleys along a length of the tubular body. 4. A tube as claimed in any one of claim 1 to 3, wherein the peaks of the corrugated tubular body are defined by the outermost periphery of the inner mold. 5. A tube as claimed in any one of claim aspects 1 to 4, wherein the inner molded part is a helical spring or a helical wound element, a helical wound skeleton or a helical wound rib, an annular disc, a ring, or one or a combination of a plurality of separate support members interconnected or interconnectable by one or more connecting rods. 6. A tube as claimed in any one of claim aspects 1 to 5, wherein the tubular body is substantially not supported by the inner molded part at the wave troughs but is supported by the inner molded part at the wave crests. 7. A tube as claimed in any one of claims 1 to 6, 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. 8. A tube as claimed in any one of claims 1 to 7, wherein the inner molded part is a spirally wound metal wire, and the coating encapsulates the wire. 9. A tube as claimed in any one of claims 1 to 8, wherein the coating provides a surface that is easily connected to the tubular body. 10. A medical breathing tube comprising: a tubular body defining a lumen extending between open ends of the body, and an inner molded part enclosing the interior of the lumen and supporting the tubular body, an outermost periphery of the inner molded part defining a plurality of alternating peaks and valleys along a length of the tubular body. 11. A tube as claimed in claim 10, wherein the tubular body is an extruded tube. 12. A tube as claimed in claim 10 or 11, wherein the tubular body is a continuous tube. 13. A tube as claimed in any one of claim 10 to 12, wherein the peaks of the corrugated tubular body are defined by the outermost periphery of the inner molded part. 14. A tube as claimed in any one of claim aspects 10 to 13, wherein the inner molded part is a helical spring or a helical wound element, a helical wound skeleton or a helical wound rib, an annular disc, a ring, or one or a combination of a plurality of separate support members interconnected or interconnectable by one or more connecting rods. 15. A tube as claimed in any one of claim aspects 10 to 14, wherein the tubular body is substantially not supported by the inner molded part at the wave troughs but is supported by the inner molded part at the wave crests. 16. A tube as claimed in any one of claim aspects 10 to 15, 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. 17. A medical breathing tube, comprising: a tubular body, the body defining a lumen extending between open ends of the body, and an inner molded part surrounding the interior of the lumen and supporting the tubular body. 18. A tube as claimed in claim aspect 17, wherein the inner molded part is enclosed in a coating, the coating securing the inner molded part to the tubular body. 19. A medical tube as claimed in claim 17 or 18, wherein the coating and the tubular body are plastically welded to each other along the tube. 20. A medical tube as claimed in any of claim 17 to 19, wherein the coating and the tubular body are welded at separate locations along the tube. 21. A medical tube as claimed in any of claim 17 to 19, wherein the coating and the tubular body are welded substantially continuously along the longitudinal direction of the tube. 22. A medical tube as claimed in any of claim 17 to 21, wherein an outermost periphery of the inner mold defines a plurality of alternating peaks and valleys along a length of the tubular body. 23. A medical tube as claimed in any one of claim aspects 17 to 22, wherein an outermost periphery of the inner mold 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 one of claim aspects 22 or 23, wherein the peaks of the tubular body are defined by the outermost periphery of the inner mold. 25. A tube as claimed in any one of claim aspects 22 to 24, wherein the valleys of the tubular body are defined by inwardly drawn portions of the tubular body drawn inwardly between the inner mold. 26. A tube as claimed in any one of claim aspects 17 to 25, wherein the inner mold is a continuous length, one or a series of semi-continuous lengths, or a series of separate lengths. 27. A tube as claimed in any one of claim aspects 17 to 26, wherein the inner molded part is one or a combination of a helical spring or a helical wound element, a helical wound frame or a helical wound rib, annular disc, ring, or a plurality of separate support members interconnected or interconnectable by one or more connecting rods. 28. A tube as claimed in any one of claim aspects 17 to 27, wherein the inner molded part supports the tubular body that defines the lumen internally. 29. A tube as claimed in any one of claim aspects 17 to 28, wherein the inner molded part is a frame or internal support structure that supports the tubular body. 30. A tube as claimed in any one of claim aspects 17 to 29, wherein the tubular body is not substantially supported by the inner molded part at the wave troughs but is supported by the inner molded part at the wave crests. 31. A tube as claimed in any one of claim aspects 17 to 30, wherein the walls of the tubular body are suspended between adjacent wave crests. 32. A tube as claimed in any one of claim aspects 17 to 31, wherein the tubular body is a breathable tube, or is made of a breathable material, (e.g., breathable thermoplastic polyurethane(s) or breathable polyamides). 33. A tube as claimed in any one of claim aspects 17 to 32, wherein the inner molded part is a helically wound rib, or rib element. 34. A tube as claimed in any one of claims 17 to 33, wherein the inner molded member is a helically wound metal wire and the coating encapsulates the wire. 35. A tube as claimed in any one of claims 17 to 34, wherein the coating provides a surface to which the tubular body can be attached. 36. A tube as claimed in any one of claims 17 to 35, wherein the inner molded member has a spacing that varies along a length (or segment) of the tube. 37. A tube as claimed in any one of claims 17 to 36, wherein the inner molded member is a helically wound element having a spacing between adjacent turns of about 1 mm to about 1.5 mm. 38. The tube as claimed in any one of claims 17 to 37, wherein the inner molded member is a spirally wound element having a diameter of about 0.1 mm to about 0.4 mm. 39. The tube as claimed in any one of claims 17 to 38, wherein the tubular body has a wall thickness of about 0.1 mm to about 0.2 mm. 40. The tube as claimed in any one of claims 17 to 39, wherein the tubular body has an outer diameter of about 3 mm to about 5 mm. 41. The tube as claimed in any one 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 one of claim aspects 17 to 41, wherein the tubular body is flexible as defined by a test of increase in resistance to flow with bending in accordance with ISO 5367:2000 (E) (4th edition, June 1, 2000). 43. A tube as claimed in any one of claim aspects 17 to 42, wherein one end of the tube is integral with a nasal prong adapted to be inserted into a nostril of a user as a nasal interface for delivering respiratory gases to a user. 44. A tube as claimed in any one of claim aspects 17 to 43, wherein the internal molding is a wire adapted to heat or sense a property of a gas within the tube. 45. A tube as claimed in any one of claims 17 to 44, wherein the inner molded part is electrically conductive, preferably the inner molded part is an electric heater. 46. A tube as claimed in any one of claims 17 to 45, wherein the inner molded part comprises an electrically conductive component or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor). 47. A tube as claimed in any one of claims 17 to 46, wherein the tube further comprises a heater, or an electric heater (such as a heater wire or heater circuit). 48. A tube as claimed in any one of claims 17 to 47, wherein the inner molded part is composed of one or more separate components. 49. A tube as claimed in any one of claim aspects 17 to 48, wherein the inner molded part comprises one or more separate components. 50. A tube as claimed in any one of claim aspects 17 to 49, wherein the tube comprises one or more inner molded parts. 51. A tube as claimed in any one of claim aspects 17 to 50, wherein the ratio of the spacing of the inner molded part to the outer diameter (e.g., outermost diameter) of the inner molded part is about 0.10 to about 0.50. 52. A tube as claimed in any one of claim aspects 17 to 51, wherein the ratio is about 0.20 to about 0.35. 53. A tube as claimed in any one of claim aspects 17 to 52, wherein the ratio is about 0.28. 54. A tube as claimed in any one of claim aspects 17 to 53, wherein the ratio is about 0.29. 55. A tube as claimed in any one of claim aspects 17 to 54, wherein the diameter of the inner molded part (e.g., the actual inner molded part element or component) 56. A tube as claimed in any one of claim aspects 17 to 55, wherein the ratio is about 0.05 to about 0.07. 57. A tube as claimed in any one of claim aspects 17 to 56, wherein the ratio is about 0.06. 58. A tube as claimed in any one of claim aspects 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 one of claim aspects 17 to 58, wherein the physical properties of the tubular body result in the tube having the desired flexibility and/or structural support. 60. A nasal cannula configuration comprising: at least one nasal prong having an air outlet adapted for insertion into a user's nares and an air inlet fluidly coupled to the air outlet, the or each prong being shaped to follow the anatomical curvature of a user's nares. 61. A nasal cannula as claimed in claim aspect 60, wherein the nasal prong is shaped to avoid contacting the user's nasal septum at the base of a user's nose. 62. A nasal cannula as claimed in claim aspect 60 or 61, wherein the nasal prong is shaped to avoid contacting the internal structure of a user's nose. 63. A nasal cannula as claimed in either of claim aspects 60 or 62, wherein the nasal prong is shaped to substantially align the flow of respiratory gas passing through the air outlet with the upper airway of a user. 64. A nasal cannula as claimed in any of claim aspects 60 or 63, wherein the nasal prong is shaped to extend generally upwardly and rearwardly into a user's nostril, the nasal prong having a curvature including at least two inflection points. 65. A nasal cannula as claimed in any of claim aspects 60 or 64, wherein the nasal prong defines a lumen extending between the air inlet and the air outlet, the lumen shape 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 aspect 65, wherein the prong is shaped to maximize the cross-sectional area of the lumen. 67. A nasal cannula as claimed in any of claim aspects 60 or 66, wherein the cannula further comprises a support extending along the upper lip of a user. 68. A nasal cannula as claimed in any of claim aspects 60 or 67, wherein the cannula comprises two nasal prongs symmetrically spaced about a user's sagittal plane, the prongs extending inwardly from a base under the user's nose on a common support disposed along the user's upper lip. 69. A nasal cannula as claimed in claim aspect 68, wherein the prongs extend from the support toward the user's nasal septum and curve upward and backward around the corner of a user's nostril into the user's nostril, each prong extending along a generally inclined posterior trajectory and through two mediolateral inflection points that orient the air outlet relative to the user's upper airway. 70. A nasal cannula as claimed in any one of claim aspects 60 or 69, wherein the or each prong has a shaped track that matches the anatomical shape of the user's nostril. 71. A nasal cannula as claimed in claim aspect 70, wherein in a first portion (or stage) of the or each prong, the track moves horizontally toward the midline of the face; in a second portion (or stage) of the prong, the track curves upward directly into the nostril toward the crown of the head; in a third portion (or stage) of the prong, the track rolls back into the head following the anatomical curvature of the nostril; and in a fourth portion (or stage), the track tilts horizontally toward the center of the cannula to align the outflow port with the upper airway of a user. 72. A nasal cannula as claimed in any one of claim aspects 60 or 71, wherein the or each prong has a cross-section that varies along the central track. 73. A nasal cannula as claimed in any one of claim aspects 60 or 72, wherein the cross-sectional area substantially decreases along the track from the first portion (or stage) to the end of the fourth portion (or stage). 74. A nasal cannula as claimed in any one of claim aspects 60 or 73, wherein the nasal cannula further comprises a contoured backing or facial cushion configured to rest on a user's face. 75. The nasal cannula as claimed in claim 74, wherein the back or face pad is preformed to be substantially curved to match a contour of a user's face or upper lip region. 76. The nasal cannula as claimed in either claim 60 or 75, wherein each prong is adapted to receive an independent flow from a gas source. 77. A fixation system for a user interface and/or a component (e.g., such as a tube or pipe) associated with the user interface, the fixation system comprising a two-part releasable attachment (or connection) arrangement, the arrangement 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 the skin of a user (e.g., by an adhesive, typically a skin-sensitive adhesive such as a hydrophilic colloid), the interface side of the skin patch being provided with the first part 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 the complementary second component of the two-component releasable attachment or connection system, the interface side of the user interface patch being attachable (or connectable) to the user interface and/or the component (e.g., a tube or pipe) associated with the user interface. 78. The system as claimed in claim aspect 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. The system as claimed in claim aspect 77 or 78, wherein the first patch is positionable and/or attachable to the facial skin of a user. 80. A system as claimed in any one of claim aspects 77 to 79, wherein the user interface patch is positionable, or attached or attachable, or linked to or with a user interface. 81. A system as claimed in any one of claim aspects 77 to 80, wherein the user interface patch is integrally formed with a user interface or forms a part of the user interface. 82. A system as claimed in any one of claim aspects 77 to 81, wherein the two-part releasable attachment or linking 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 one of claims 77 to 82, wherein the first component of the two-component releasable attachment or coupling system is bonded or bondable to the user interface side of the skin patch. 84. A system as claimed in any one 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) that attaches or adheres the skin patch to a user's skin. 85. A system as claimed in any one of claims 77 to 84, wherein the skin patch has a surface of sufficient area such that the surface distributes the attachment pressure or adhesive force across the user's skin. 86. The system as claimed in any one of claims 77 to 85, wherein the skin patch is configured to be attached or adhered to a user's face. 87. The system as claimed in any one of claims 77 to 86, wherein the skin patch is configured to be attached or adhered to a user's face adjacent to the user's lip and/or cheek. 88. The system as claimed in any one of claims 77 to 87, wherein the securement system is configured to receive and/or secure a nasal cannula and associated tubing that extends from one or both sides of a user's face. 89. The system as claimed in any one of claims 77 to 88, wherein the securement system is configured for use on an infant or newborn. 90. The system as claimed in any one of claim aspects 77 to 89, wherein the component coupled to the interface is a medical breathing tube. 91. The system as claimed in claim aspect 90, wherein the medical breathing tube is as defined in any one or more of claim aspects 1 to 59. 92. The system as claimed in any one of claim aspects 77 to 91, wherein the user interface is a nasal cannula. 93. The system as claimed in claim aspect 83, wherein the nasal cannula is as defined in any one or more of claim aspects 60 to 76. 94. The system as claimed in any one of claim aspects 77 to 93, wherein the first component of the two-component releasable attachment or connection system comprises a substrate that is secured to or used to secure to the skin patch. 95. The fastening system as claimed in claim 94, wherein the base portion includes at least one slit or at least one slot, with regions of the base portion separated by the slit or slot. 96. The fastening system as claimed in claim 95, wherein the base portion includes a plurality of slits or slots or both, which together divide the base portion into a serpentine body. 97. A fastening system as claimed in claim 95, wherein the slits and/or slots are arranged in the substrate so that a first set of at least one set of slits or slots extends into the substrate from one edge of the substrate, and a second set of slits or slots extends into the substrate from another edge of the substrate, and the slits or slots of one set are interleaved with the slits or slots of another set so that a path along the substrate portion from one end to the other without crossing the slits or slots of one set follows a saw-like or serpentine path that is longer than a straight line between the two ends. 98. A fastening system as claimed in any one of claim 95 to 97, wherein one of the slits or slots is curved. 99. A fastening system as claimed in any one of claim aspects 95 to 88, wherein the plurality of slits or slots are curved and the curved slits or slots are arranged substantially in parallel. 100. A fastening system as claimed in any one of claim aspects 96 to 88, wherein the slits or slots are arranged in a herringbone pattern extending from the edge of the base portion. 101. A fastening system as claimed in claim aspect 95, wherein the base portion is divided into separate portions by a serpentine slit or slot. 102. A fastening system as claimed in claim aspect 95, wherein the base portion is divided into a plurality of portions by a spiral slit or slot. 103. The fastening system as claimed in claim aspect 95, wherein the base portion is divided into subdivided portions by slits or slots arranged as substantially concentric circles. 104. The fastening system as claimed in claim aspect 103, wherein the concentric circles are centered approximately on the center of the base portion. 105. The fastening system as claimed in claim aspect 95, wherein the slits or slots divide the base portion into a plurality of islands, each island being connected to an adjacent island or islands by a narrow bridge. 106. The fastening system as claimed in claim aspect 95, wherein the base portion is divided into a plurality of portions by an S-shaped slit. 107. The fastening system as claimed in claim 95, wherein the base portion is divided into a plurality of portions by a T-shaped slit. 108. The fastening system as claimed in any one of claim 94 to 107, wherein the base portion covers at least 70% of the area of the skin patch. 109. The fastening system as claimed in any one of claim 100 to 108, wherein the base portion covers at least 80% of the area inside a boundary defining the shortest path around the periphery of the base. 110. A user interface assembly comprising: a securing system for the user interface and/or a component (e.g., such as a tube or pipe) coupled to the user interface, and a tube coupled to the user interface to provide at least a portion of a breathing circuit to a user of the interface, wherein the securing system comprises a two-part releasable attachment (or connection) arrangement 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 the skin of a user (e.g., by an adhesive, typically a skin-sensitive adhesive such as a hydrophilic colloid), the interface side of the skin patch being provided with the first part of a two-part releasable attachment or connection system, and The user interface patch has an interface side and a patient side, the patient side of the user interface patch is provided with the complementary second component of the two-component releasable attachment or connection system, the interface side of the user interface patch is attachable (or connectable) to the user interface and/or the component (e.g., a tube or tube) associated with the user interface, and wherein the tube comprises: a tubular body defining a lumen extending between open ends of the body, an inner mold member surrounding the interior of the lumen and supporting the tubular body, and a coating encapsulating the inner mold member, the coating securing the inner mold member to the tubular body. 111. The interface as claimed in claim aspect 110, wherein the interface is a nasal cannula. 112. The interface as claimed in claim 110 or 111, wherein the interface comprises one or a pair of nasal prongs. 113. The interface as claimed in claim 112, wherein the interface comprises a securing system as defined in any one or more of claim 77 to 109. 114. The interface as claimed in any one of claim 110 to 113, wherein the tube is a medical breathing tube. 115. The interface as claimed in claim 114, wherein the tube is as defined in any one or more of claim 1 to 59. 116. An interface as claimed in any one of claim aspects 110 to 115, wherein the interface is a nasal cannula configuration comprising: at least one nasal prong having an air outlet adapted for insertion into a user's nostril and an air inlet fluidly coupled to the air outlet, the at least one nasal prong comprising a backing configured to rest on a user's face, wherein a lip extends over at least a portion of the periphery of a rear surface of the backing configured to receive or retain a user interface patch, such that in use, the user interface patch can be releasably attached or coupled to or with a skin patch attached to a user's face. 117. An interface as claimed in claim aspect 116, wherein the lip is a barrier. 118. The interface as claimed in claim 116 or 117, wherein the lip is deformable. 119. The interface as claimed in any of claim 116 to 118, wherein the lip extends to at least partially encompass the periphery of a region substantially adjacent to a prong coupled to the backing. 120. The interface as claimed in any of claim 116 to 119, wherein the lip is a loop lip extending to encompass the periphery of the rear surface of the backing. 121. The interface as claimed in any of claim 116 to 120, wherein the lip is a series of one or more separate lips. 122. The interface as claimed in claim 121, wherein the one or more separate lips are adjacent, or contiguous, or overlapping lip portions. 123. An interface as claimed in any one of claim aspects 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 a sleeve-facing surface of the user interface patch. 124. An interface as claimed in any one of claim aspects 116 to 123, wherein the backing is a substantially planar or flat or contoured (e.g., pre-formed curve) backing configured to rest on the face of a user. 125. An interface as claimed in any one of claim aspects 116 to 124, wherein the backing assists in acting as a stabilizer for the prong(s) in the nostril(s) of a user. 126. An interface as claimed in any one of claims 116 to 125, wherein the at least one backing extends laterally from the at least one nasal prong away from a user's nasal septum. 127. An interface as claimed in any one of claims 116 to 126, wherein at least the lip(s) are water repellent. 128. An interface as claimed in any one of claims 116 to 127, wherein at least the lip(s) include at least one outer peripheral lip and at least one inner peripheral lip, each of the lips being configured to contact a user's face.

100,200,301,401,1100: Medical tube 101,201: Longitudinal axis 102,202,1102: Tubular body 104,204: Peak 105,205: Valley 106: Fork 107,415,507,607,2011: Lumen 110,210,302,1110: Internal molded parts 310: Extruder 312: Hopper 313: Feed screw 314: Rotary actuator 315: Extruder outlet 317: Die head 320: Side port 321: Vacuum port 325: Narrowing section 340: Air wiping tube 400: nasal interface, user interface 402: nasal fork 403,503,603: backing, wiring harness 405: coupling 404: housing 406,506,606: fork 410,510,610: user end 411: orifice 500,600: fastening system 501,601: tube 550,650: skin patch 551: two-part releasable attachment or connection arrangement 552: user interface patch 553: first part 660: fastening patch 661: tube end wing 1111: coating 1130-1135: ellipse 1400: nasal interface 1401: tube 1402: nose prong 1406: facial pad 1411: prong outlet 1415: base 1420: scan line, track 2000: nasal cannula configuration, nasal cannula 2001: nose prong 2002: outlet 2003: inlet 2004: backing 2005: lip 2006: rear surface 2007: user interface patch 2008: skin patch 2009: hook 2010: loop 3304: first end 3305: second end 3306,3310,3312,3329,3330,3332,3333,3335,3346,3350,3351: slit 3307,3344: bend 3308,3343: straight part 3309,3311,3313,3318,3325,3331,3336,3337,3347,3348,3349,3353-3356,3359: base 3319,3320,3327,3337,3342,3350,3351,3357,3358,3360-3364: slot 3321,3322,3326: island 3323,3324,3328: bridge 3335: cross slit 3338,3339,3345: finger 3340: foot 3344: bend end 3346: spiral slit 3350: curved slit 3352: center 3361-3364: curved slot 3550: skin patch 3600: extension 3602: elliptical or oval body 3603: base 3615: wider section W: weld line, weld zone

These and other features, aspects and advantages disclosed herein will now be described with reference to the drawings of preferred embodiments, which are intended to illustrate but not limit the disclosure herein, and in the accompanying drawings: FIG. 1 is a side view of a corrugated medical tube, one end of which is shown in cross-section to illustrate the configuration of a tubular body enclosing an inner mold. FIG. 2 is a side view of a medical tube, with the tubular body cut away and shown in cross-section to illustrate a continuous spiral inner mold. FIG. 3A is a side view of a medical tube, with the tubular body cut away and shown in cross-section to illustrate multiple independent rings representing discrete inner molds. FIG. 3B is a side view of a medical tube, with the tubular body cut away to show a cross-sectional view to illustrate a sandwich wall structure enclosing an inner mold. FIG. 3C is a side view of another embodiment, where the inner mold is embedded in the wall. FIG. 3D is a side view of another embodiment, where the tubular body is heated and shrunk to enclose the inner mold. FIG. 3E is a side view of yet another embodiment, where the inner mold is operated to maintain the tubular body in a desired form. FIG. 4 is a schematic representation of an apparatus for forming a medical tube, the apparatus including a hopper, a feed screw, and a die. FIG. 5 is a schematic representation of a die for forming a reinforced medical tube. FIG. 6 is a perspective view of a nasal interface in combination with a pair of reinforced medical tubes each coupled to a nasal prong. FIG. 7 is a perspective view of the nasal interface of FIG. 6 in combination with a back assembly to stably position the interface and receive a helmet accessory. FIG. 8 is a front view of the nasal interface of FIG. 7. FIG. 9 is a top view of the nasal interface of FIG. 7. FIG. 10 is a side view of the nasal interface of FIG. 7. FIG. 11 is a front view of the nasal interface of FIG. 7 in cross-section. FIG. 12 is a perspective view of the nasal interface of FIG. 7 positioned on a baby's head. FIG. 13 is a perspective view of a nasal interface in combination with a pair of reinforced medical tubes each coupled to a nasal prong, wherein the individual nasal prongs are secured to a harness including a plurality of ribs and a pair of helmet accessories. FIG. 14 is a perspective view of a nasal interface incorporating a pair of reinforced medical tubes each coupled to a nasal prong, each nasal prong being secured to a harness comprising a plurality of ribs. FIG. 15 shows a nasal cannula positioned in an operating position on a user's face, the cannula being positioned in accordance with an embodiment of the seventh aspect. FIG. 16 is a side view of the nasal cannula configuration of FIG. 15. FIG. 17 shows an embodiment and its component assembly components in accordance with the seventh aspect. FIG. 18 shows a nasal cannula positioned in an operating position on a user's face, the cannula being positioned in accordance with an embodiment of the sixth aspect. FIG. 19 is a side view of the nasal cannula configuration of FIG. 18. FIG. 20 shows an exploded perspective view of an embodiment and its component assembly components in accordance with the sixth aspect. FIG. 21 shows the relative layers from right to left (user not shown in the figure) in accordance with an embodiment of the sixth aspect. FIG. 22 shows an embodiment of a fixing patch according to the sixth aspect. FIG. 23 shows another or alternative embodiment of a fixing patch according to the sixth aspect. FIG. 24A is a close-up perspective view of a cut-away medical tube, with the corrugated tubular body cut away to reveal the coated spiral inner molded part. FIG. 24B is a close-up perspective view of a cut-away medical tube, with the smooth tubular body cut away to reveal the coated spiral inner molded part. FIG. 25A is a schematic front view of a pair of nasal prongs, illustrating the shape of the prongs and the inner lumen. FIG. 25B is a schematic side view of a pair of nasal prongs, illustrating the shape of the prongs and the inner lumen. FIG. 25C is a schematic front view of a pair of reverse nasal prongs, illustrating the shape of the prongs and the inner lumen. FIG. 25D is a schematic perspective view of a pair of reverse nasal prongs illustrating the shape of the prongs and the internal lumen. FIG. 26A is a perspective view of a nasal interface having a curved backing assembly. FIG. 26B is a front view of a nasal interface having a curved backing assembly. FIG. 26C is a top view of a nasal interface having a curved backing assembly. FIG. 26D is a rear view of a nasal interface having a curved backing assembly. FIG. 27A is a close-up view of the nasal prong illustrated in FIG. 17D. FIG. 27B is a close-up view of the nasal prong illustrated in FIG. 17C. FIGS. 28 and 29 show a nasal cannula configuration in use having a backing assembly including a lip. FIG. 30 is a front perspective view of a nasal cannula configuration having a backing assembly including a lip. FIG. 31 is a rear perspective view of a nasal cannula configuration having a backing assembly including a lip. FIG. 32 is a top rear perspective view of a nasal cannula configuration having a backing assembly including a lip and a user interface patch on the back of the backing assembly. FIG. 33 is a cross-sectional view through the nasal cannula configuration of FIG. 32 when the user interface patch is connected to the skin patch. FIG. 34 is a side rear perspective view of the nasal cannula configuration of FIGS. 30-33. FIG. 35 is a rear view of another nasal cannula configuration of FIGS. 28-34, illustrating a serial segmented lip. FIG. 36A illustrates an outline shape of a skin patch according to some embodiments. Figures 36B to 36R illustrate various embodiments of a base portion of a fixing member for fixing to the skin patch of Figure 36A.

100: Medical tube

101: Vertical axis

102: Tubular body

104: Peak

105: Trough

107: Lumen

110: Internal molded parts

Claims (15)

A component of a fixing system for a user interface and/or user interface tube, wherein the component includes a base portion fixed to or used to fix to a skin patch, the base portion supports a decentralized mechanical fastener across its surface, the base portion is flexible but substantially non-stretchable, and the base portion is divided into multiple zones by at least one slit or at least one groove, so that by independent bending of different divided portions of the base, the base can substantially conform to an underlying composite curved surface. A component of a fixing system as claimed in claim 1, wherein the base portion comprises a meandering body. A component of a fixing system as claimed in claim 2, wherein the slits and/or grooves are arranged on the substrate so that a first set of at least one set of slits or grooves extends into the substrate from one edge of the substrate, and a second set of slits or grooves extends into the substrate from another edge of the substrate, and the slits or grooves of one set are interlaced with the slits or grooves of another set so that a path along the substrate from one end to the other end without crossing the slits or grooves needs to follow a saw-like or winding path that is much longer than a straight line between the two ends. A component of a fixing system as claimed in any one of claims 1 to 3, wherein one of the plurality of slits or slots is curved. A component of a fixing system as claimed in claim 1 or 2, wherein a plurality of said slits or slots are curved and said curved slits or slots are arranged substantially in parallel. A component of a fixing system as claimed in claim 1 or 2, wherein the slits or slots are configured to extend into a herringbone pattern from the edge of the base portion. A component of a fixing system as claimed in claim 1, wherein the base is divided into separate parts by a meandering slit or groove. A component of a fixing system as claimed in claim 1, wherein the base portion is divided into multiple parts by a spiral slit or groove. A component of a fixing system as claimed in claim 1, wherein the base portion is divided into subdivided portions by slits or grooves arranged in substantially concentric circles. As a component of a fixing system as claimed in claim 9, wherein the concentric circles are centered approximately at the center of the base portion. A component of a fixing system as claimed in claim 1, wherein the slits or grooves divide the base portion into a plurality of islands, each island being connected to one or more adjacent islands by a narrow bridge. A component of a fixing system as claimed in claim 1, wherein the base portion is divided into multiple parts by an S-shaped slit. A component of a fixing system as claimed in claim 1, wherein the base portion is divided into multiple parts by a T-shaped slit. A component of a fixing system as claimed in any one of claims 1 to 13, wherein the base portion covers at least 70% of the area of the skin patch. A component of a fixing system as claimed in any one of claims 1 to 14, wherein the base portion covers at least 80% of the area within a boundary defining the shortest path around the periphery of the base.

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