Nasal cannula, conduit and fixation system

Abstract

The present invention provides a medical breathing tube comprising a tubular body that defines a lumen extending between the open ends of the body, and an inner mold enclosed within the lumen and serving as a support for the tubular body. [Solution] The inner mold may be a coated and sealed inner mold, the coating of which secures the inner mold to the tubular body. The inner mold may simultaneously or separately provide a series of alternating peaks and valleys (e.g., waveforms) of the tubular body. A patient interface (such as a mask or nasal cannula) can be connected to such tubing. A system for securing the patient interface in a working position may also be available.

Description

Technical Field

[0001] The present disclosure generally relates to components for medical systems that carry gas to and / or from a patient. In one particular aspect, the present disclosure relates to conduits, and more particularly, to breathing tubes used in the inspiratory limb, expiratory limb, and / or composite breathing limb of a respiratory system. In another aspect, the present disclosure relates to nasal cannulas and conduits that form part of a respiratory system. In another aspect, the present disclosure relates to nasal cannulas that form part of a respiratory system. In another aspect, the present disclosure relates to one or more systems for positioning a patient interface, such as a cannula, in an operating position for and / or against a user.

Background Art

[0002] In assisted respiration, breathing gas is supplied to a patient via a flexible breathing tube. The gas exhaled by the patient can be sent via a similar breathing tube or exhaled around the patient. The gas is typically administered to the patient via a user interface, which may also include a dedicated short breathing tube that connects the interface to a supply tube. Each breathing tube is ideally lightweight, resistant to kinking or constriction, and flexible so as to ensure sufficient performance and comfort for the patient.

[0003] Typically, the size of the breathing tube ranges from an internal diameter hole of about 10 mm to about 25 mm (including applications for both neonates and adults). The dedicated user interface tube is thinner and can have an internal diameter of about 2 mm in neonatal applications. The dedicated user interface breathing tube is less obtrusive due to its small size and reduces the weight on the patient's face. The breathing tube preferably has flexibility so as to bend easily, thereby improving patient comfort and, in turn, increasing patient treatment compliance.

[0004] In medical applications such as assisted breathing, the gas inhaled by the patient is preferably delivered at around body temperature (usually 33°C to 37°C) and with high relative humidity (generally near 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 levels to improve user comfort, or it may be supplied without heating or humidification.

[0005] Similar tubing can also be used to supply inhaled gas during laparoscopic surgery. Such inhaled tubing is ideally lightweight, resistant to kinking or tightening, and exhibits similar flexibility, so as not to obstruct or obstruct the operating room. The inhaled gas (typically CO2, but may be other gases or mixtures) can also be humidified.

[0006] Furthermore, the gas delivered to the patient may be delivered via a nasal cannula. The flexibility of the associated tubing is an important consideration, especially in infant or neonatal settings. Improving the flexibility of the tubing that delivers the gas to the patient's cannula promotes improved comfort and, consequently, improved compliance with such gas delivery therapy.

[0007] Furthermore, providing alternative or improved interface positioning or operational positioning systems for interfaces such as nasal cannulas may be advantageous. Such alternative or improved systems may further enhance compliance with gas delivery therapy.

[0008] This specification references patent specifications, other external documents, or other sources of information, for the purpose of generally providing a context for considering the features of this disclosure. Unless specifically stated otherwise, references to such external documents should not be construed as acknowledging that such documents or sources of information constitute prior art in any jurisdiction or form part of the common general knowledge in the art.

[0009] Further aspects and advantages of this disclosure will become apparent from the following description, which is provided merely as an example. [Overview of the project] [Means for solving the problem]

[0010] The purpose of this disclosure is to provide components and / or methods for manufacturing components that can be used to some extent to improve at least the above, or that can provide at least a useful option to the public or healthcare professionals.

[0011] In a first embodiment, the disclosure relates to a method for manufacturing a medical tubing, the method comprising the steps of providing an inner mold, and extruding a tubular body around the inner mold, thereby defining a lumen in which the tubular body encloses the inner mold.

[0012] Preferably, this method is i) A step of applying a depressurization within (or relative to) a lumen, wherein the depressurization draws a tubular body radially inward around the outermost circumference defined by the lumen and the inner mold, so that the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body, or ii) A step of extending (or stretching) at least a portion or region of a tubular body enclosing an inner mold, wherein when the extension (or stretching) is released, the extended portion or region of the tubular body returns (or becomes capable of being retracted) so as to be drawn radially inward toward the outermost circumference defined by the lumen and the inner mold, and the outermost circumference defines a plurality of alternating peaks and valleys along the length of the tubular body, or iii) Combinations of i) and ii) It also includes.

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

[0014] Preferably, the tubular body is pushed out around the inner mold, and a reduction in pressure is applied in such a manner that the inner surface of the tubular body is at least partially attached to or bonded to at least a portion of the inner mold, preferably the reduction in pressure being the difference between the pressure in the lumen and the pressure around the tubular body, more preferably the pressure inside (or supplied to) the lumen is less than the pressure around the tubular body (or the pressure around the tubular body is greater than the pressure inside (or supplied to) the lumen).

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

[0016] Preferably, the reduced pressure is applied to or adjacent to the lumen components.

[0017] Preferably, the reduced pressure is applied to or adjacent to the die head.

[0018] Preferably, the lumens undergo a depressurization process as they exit the extrusion die head.

[0019] Preferably, the tubular body and the inner mold are co-extruded.

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

[0021] Preferably, the peaks of the corrugated tubular body formed in this manner are defined by the outermost circumference of the inner mold.

[0022] Preferably, the valleys of the corrugated tubular body formed in this manner are defined by inwardly retracted portions of the tubular body, which are retracted inward between one or more inner molds.

[0023] Preferably, the inner mold is a framework or internal support structure that supports the tubular body.

[0024] Preferably, the internal mold is of a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0025] Preferably, the inner mold is a mesh.

[0026] Preferably, the inner mold is one or a combination of a helically wound spring or helical element, helical framework or helical rib, an annular disk, a ring, or a plurality of individual supports interconnected or interconnected by one or more connecting links.

[0027] Preferably, the inner mold supports or is supporting the lumen inside the tube formed as such.

[0028] Preferably, the inner mold is a helical element or member.

[0029] Preferably, the inner mold has a pitch that varies along the length (or section) of the tube.

[0030] Preferably, the inner mold is a helical element (or member) having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, 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.

[0031] Preferably, the inner mold has an outermost diameter of about 1.6 mm to about 4.6 mm, or about 1.7 to about 4.5, or about 1.8 to about 4.4, or about 1.9 to about 4.3, or about 2 to about 4.2, or about 2.1 to about 4.1, or about 2.2 to about 4, or about 2.3 to about 3.9, or about 2.4 to about 3.8, or about 2.5 to about 3.7, or about 2.6 to about 3.6, or about 2.7 to about 3.5, or about 2.8 to about 3.4, or about 2.9 to about 3.3, or about 3 mm to about 3.2 mm.

[0032] Preferably, the inner mold is a helical element, which has a diameter of about 0.05 mm to 0.3 mm, or about 0.06 to 0.29 mm, or about 0.07 to 0.28 mm, or about 0.08 to 0.27 mm, or about 0.09 to 0.26 mm, or about 0.1 to 0.25 mm, or about 0.11 to 0.24 mm, or about 0.12 to 0.23 mm, or about 0.13 to 0.24 mm, or about 0.14 to 0.23 mm, or about 0.15 to 0.22 mm, or about 0.16 to 0.24 mm, or about 0.17 to 0.23 mm, or about 0.18 to 0.22 mm, or about 0.19 mm to 0.21 mm. Preferably, it has a diameter of about 0.1 mm to 1.5 mm.

[0033] Preferably, the inner mold is made of medical-grade material, preferably medical-grade stainless steel.

[0034] Preferably, the tubular body has a wall thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm. Preferably, the wall thickness is approximately 0.1 mm to approximately 0.2 mm.

[0035] Preferably, the tubular body has an internal diameter (e.g., lumens) of approximately 1.5 mm to 4.5 mm, or approximately 1.6 to 4.4 mm, or approximately 1.7 to 4.3 mm, or approximately 1.8 to 4.2 mm, or approximately 1.9 to 4.1 mm, or approximately 2 to 4 mm, or approximately 2.1 to 3.9 mm, or approximately 2.2 to 3.8 mm, or approximately 2.3 to 3.7 mm, or approximately 2.4 to 3.6 mm, or approximately 2.5 to 3.5 mm, or approximately 2.6 to 3.4 mm, or approximately 2.7 to 3.3 mm, or approximately 2.8 to 3.2 mm, or approximately 2.9 mm to 3.1 mm.

[0036] Preferably, the tubular body has an outer diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm. Preferably, it has an outer diameter of approximately 3 mm to 5 mm.

[0037] Preferably, the tubular body is corrugated, and this corrugation has a depth of approximately 0.1 mm to approximately 0.5 mm.

[0038] Preferably, the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0039] Preferably, the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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 0.06.

[0040] Preferably, the ratio of the waveform depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09.

[0041] Preferably, the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0042] Preferably, the tubular body is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0043] Preferably, the tubular body is any one or more of the following (preferably extruded therefrom): one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides; more preferably, the polymer is a polymer of the thermoplastic elastomer family, including but not limited to polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, such as styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, the polymer has 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.

[0044] Preferably, the tubular body is a breathable tube, or is formed from or made of one or more breathable materials such as breathable thermoplastic polyurethane or breathable polyamides.

[0045] Preferably, the reduced pressure is applied while the tubular body is in a molten, semi-molten, or uncured state, preferably the reduced pressure is about 0 to about -2 bar (absolute), more preferably about 0 to about -1 bar (absolute), even more preferably up to about -0.9 bar (absolute), and even more preferably such reduced pressure is the pressure difference between the inside of the lumen and the area surrounding the tubular body.

[0046] Preferably, the internal mold is conductive, and preferably, the internal mold is an electrically driven heater.

[0047] Preferably, the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0048] Preferably, the tube further includes a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0049] Preferably, the tubular body formed in this manner has flexibility as defined by passing a test of increased flow resistance due to bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0050] Preferably, medical tubing is a breathing tube.

[0051] Preferably, the internal mold is composed of one or more individual components.

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

[0053] Preferably, the tube includes one or more inner molds. In a second embodiment, the present invention broadly applies to: A tubular body comprising a body that defines a lumen extending between the opening ends of the body, An inner mold enclosed within the lumen and supporting the tubular body, wherein the outermost circumference of the inner mold defines multiple peaks and valleys arranged alternately along the length of the tubular body, and It could be said that it consists of medical tubing containing [the specified material].

[0054] Preferably, the tubular body is an extruded tube.

[0055] Preferably, the tubular body is a continuous tube.

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

[0057] Preferably, the peaks of the corrugated tubular body are defined by the outermost circumference of the inner mold.

[0058] Preferably, the valleys of the corrugated tubular body are defined by portions of the tubular body that are drawn inward between the inner molds.

[0059] Preferably, the internal mold is of a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0060] Preferably, the internal mold is one or a combination of several individual supports that are interconnected or connectable by a coil spring or helical element, a helical frame or helical rib, annular disc, a ring, or one or more connecting links.

[0061] Preferably, the inner mold supports a tubular body that defines a lumen inside.

[0062] Preferably, the inner mold is a framework or internal support structure that supports the tubular body.

[0063] Preferably, the tubular body is not substantially supported by the inner mold in the valleys, but is supported by the inner mold in the peaks.

[0064] Preferably, the walls of the tubular body are suspended between adjacent mountains.

[0065] Preferably, the tubular body is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0066] Preferably, the tubular body is a breathable tube, or is formed from or made of one or more breathable materials such as breathable thermoplastic polyurethane or breathable polyamides.

[0067] Preferably, the inner mold is a helical rib or a ribbed element.

[0068] Preferably, the internal mold is a helical element or member.

[0069] Preferably, the inner mold has a pitch that varies along the length (or section) of the tube. Preferably, the inner mold is a helical winding element having a pitch between adjacent windings of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9 mm, or about 0.6 to about 1.8 mm, or about 0.7 to about 1.7 mm, or about 0.8 to about 1.6 mm, or about 0.9 to about 1.5 mm, or about 1 to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the pitch between adjacent windings is about 1 mm to about 1.5 mm.

[0070] Preferably, the inner mold has an outermost diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm.

[0071] Preferably, the inner mold is a helical element, which has a diameter of about 0.05 mm to 0.3 mm, or about 0.06 to 0.29 mm, or about 0.07 to 0.28 mm, or about 0.08 to 0.27 mm, or about 0.09 to 0.26 mm, or about 0.1 to 0.25 mm, or about 0.11 to 0.24 mm, or about 0.12 to 0.23 mm, or about 0.13 to 0.24 mm, or about 0.14 to 0.23 mm, or about 0.15 to 0.22 mm, or about 0.16 to 0.24 mm, or about 0.17 to 0.23 mm, or about 0.18 to 0.22 mm, or about 0.19 mm to 0.21 mm. Preferably, it has a diameter of about 0.1 mm to 1.5 mm.

[0072] Preferably, the inner mold is made of medical-grade material, preferably medical-grade stainless steel.

[0073] Preferably, the tubular body has a wall thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm. Preferably, the wall thickness is approximately 0.1 mm to approximately 0.2 mm.

[0074] Preferably, the tubular body has an internal diameter of approximately 1.5 mm to approximately 4.5 mm, or approximately 1.6 to approximately 4.4 mm, or approximately 1.7 to approximately 4.3 mm, or approximately 1.8 to approximately 4.2 mm, or approximately 1.9 to approximately 4.1 mm, or approximately 2 to approximately 4 mm, or approximately 2.1 to approximately 3.9 mm, or approximately 2.2 to approximately 3.8 mm, or approximately 2.3 to approximately 3.7 mm, or approximately 2.4 to approximately 3.6 mm, or approximately 2.5 to approximately 3.5 mm, or approximately 2.6 to approximately 3.4 mm, or approximately 2.7 to approximately 3.3 mm, or approximately 2.8 to approximately 3.2 mm, or approximately 2.9 mm to approximately 3.1 mm.

[0075] Preferably, the tubular body has an outer diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm. Preferably, it has an outer diameter of approximately 3 mm to 5 mm.

[0076] Preferably, the tubular body is corrugated, and this corrugation has a depth of approximately 0.1 mm to approximately 0.5 mm.

[0077] Preferably, the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0078] Preferably, the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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 0.06.

[0079] Preferably, the ratio of the waveform depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09.

[0080] Preferably, the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0081] Preferably, the tubular body is one or a combination of thermoplastic elastomers, polypropylene-based elastomers, liquid silicone rubber (LSR), or breathable thermoplastic polyurethanes or breathable polyamides (preferably extruded therefrom), and more preferably the polymer is a polymer of the thermoplastic elastomer family, such as polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and even more preferably a polymer of 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.

[0082] Preferably, the inner mold consists of multiple rings spaced apart longitudinally along the lumen.

[0083] Preferably, the ring is toroidal or annular in shape.

[0084] Preferably, the internal mold is one or more individual elements connected to one another.

[0085] Preferably, the internal mold includes a plurality of reinforcing ribs regularly spaced apart along the lumen.

[0086] Preferably, each reinforcing rib includes one turn of a helical reinforcing wire.

[0087] Preferably, one turn of the helical reinforcing wire includes a complete one-turn around the lumen of the tube.

[0088] Preferably, one turn of the helical reinforcing wire includes a wire positioned between adjacent peaks of the inner mold.

[0089] Preferably, the tubular body has flexibility as defined by passing a test of increased flow resistance due to bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0090] Preferably, the end of the tube is integrated with a nasal prong, which is configured to be inserted into the user's nostril as a nasal interface for delivering respiratory gas to the user.

[0091] Preferably, the inner mold is mesh.

[0092] Preferably, the inner wire is suitable for heating the gas inside the tube or for detecting the characteristics of the gas.

[0093] Preferably, the internal mold is conductive, and preferably, the internal mold is an electrically driven heater.

[0094] Preferably, the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0095] Preferably, the tube further includes a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0096] Preferably, the tube is a breathing tube.

[0097] Preferably, the internal mold is composed of one or more individual components.

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

[0099] Preferably, the tube includes one or more inner molds.

[0100] In a third embodiment, the present invention broadly applies to: A nasal prong having one or more gas outlets configured to be inserted into the user's nostrils, and one or more gas inlets fluidly connected to one or more gas outlets, A corrugated gas delivery tube of one or more gases, the tube comprising a tubular body defining a lumen and an inner mold enclosed within the lumen, the inner mold supporting the tubular body, and the outermost circumference of the inner mold defining a plurality of alternating peaks and valleys along the length of the tubular body, In a nasal cannula device including, It can also be said that the nasal cannula device consists of a nasal cannula in which one or more gas inlets of the nasal prongs are integrally formed with the end of the tube, thereby fluidly connecting the tube lumen to one or more gas outlets of the nasal prongs.

[0101] Preferably, the nasal prongs are shaped to substantially conform anatomically to the inside of the user's nose or nostrils.

[0102] Preferably, the nasal prongs are curved to avoid the user's septum, or are otherwise shaped or constructed.

[0103] Preferably, the nasal cannula has a substantially planar, flattened, or irregularly shaped backing material configured to rest on the user's face, preferably as a stabilizing material for the prongs in the user's nostrils.

[0104] Preferably, one or more ribs extend between the front surface of the backing material and the cannula, the ribs providing a contact surface for a tape or other suitable retainer used to fasten or attach the cannula to the user's face, preferably the tape includes an adhesive portion or is an adhesive tape or contact adhesive tape.

[0105] Preferably, the two nasal prongs are integrally formed with a single corrugated delivery tube.

[0106] Preferably, the cannula includes a pair of nasal prongs, each prong being integrally formed with, or attached to (or attachable to), or connected to (or connectable to) the terminus of a pair of one or more gas delivery tubes.

[0107] Preferably, the cannula device is formed from a polymer, such as a thermoplastic polymer, preferably one or more polymers suitable for medical respiratory tubes.

[0108] Preferably, the cannula device is formed of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides, and more preferably the polymer is a polymer of a family of thermoplastic elastomers, such as polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and even more preferably a polymer of 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.

[0109] In a fourth embodiment, the present invention may be said to broadly consist of a user interface including a pair of nasal cannulas as defined in the third embodiment.

[0110] Preferably, the nasal prongs of each nasal cannula are positioned adjacent to each other, and the respective delivery tubes extend in opposite directions away from the nasal prongs.

[0111] Preferably, the system further includes a harness that extends between and connects the nasal cannulas.

[0112] Preferably, the tube is a breathing tube.

[0113] Preferably, the tube is as defined in the first or second embodiment, for example, the tube is manufactured by the method defined in the first embodiment or is a tube as defined in the second embodiment.

[0114] In a fifth embodiment, the present invention broadly relates to a method for manufacturing a nasal cannula, The steps include providing an internal mold, Steps include pushing a tubular body out around an inner mold, defining a lumen in which the tubular body surrounds the inner mold, and attaching a nasal cannula to it. It could also be said that it consists of methods that include

[0115] Preferably, this method is i) A step of applying a depressurization within (or relative to) a lumen, wherein the depressurization draws a tubular body radially inward around the outermost circumference defined by the lumen and the inner mold, so that the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body, or ii) A step of extending (or stretching) at least a portion or region of a tubular body enclosing an inner mold, wherein when the extension (or stretching) is released, the extended portion or region of the tubular body returns (or becomes capable of being retracted) so as to be drawn radially inward toward the outermost circumference defined by the lumen and the inner mold, and the outermost circumference defines a plurality of alternating peaks and valleys along the length of the tubular body, or iii) Combinations of i) and ii) It also includes.

[0116] Preferably, this method includes the step of overmolding nasal prongs onto the end portion of the tubular body.

[0117] Preferably, the tubular body formed in this manner is a tube as defined by the method of the first embodiment or as defined by the tube of the second embodiment.

[0118] Preferably, the end of the tube thus formed by the tubular body is placed in a mold or form for molding or shaping the nasal cannula, preferably the mold or form is closed, and the nasal cannula is overmolded or shaped on its or a part of the end of the tube.

[0119] Preferably, the nasal cannula is made of a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes.

[0120] Preferably, the nasal cannula is molded from one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides, and more preferably the polymer is a polymer of 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.

[0121] Preferably, the tubular body is a breathable tube, or is formed from or made of one or more breathable materials such as breathable thermoplastic polyurethane or breathable polyamides.

[0122] Preferably, a nasal cannula mold is provided, which is capable of receiving the end portion of a tube formed in that manner by the manufacture of a tubular body, and so when the molding equipment is operated, the nasal cannula is molded, with a portion of it being overmolded onto the end portion of the tube.

[0123] Preferably, a nasal cannula device is made by a nasal cannula, and the end of the tube formed in this way by the manufacturing of a tubular body is in fluid communication with the device.

[0124] In a sixth embodiment, the present invention broadly relates to a fixed system for user interfaces and / or user interface tubing, A skin patch that defines a fixed area, having a user side and an interface side, wherein the user side of the skin patch is configured to adhere to or bond with the user's skin, A fixation patch wherein at least a portion of the fixation patch is configured to extend over and cover the user interface and / or associated user interface tubing, and is fixed to the user interface side of the skin patch, thereby fixing the user interface to the user. Includes, The fixation system may also be described as comprising a fixation patch and a skin patch, configured such that when the fixation system is applied to a patient along with a suitable or compatible user interface, the fixation patch may be included within or surrounded by the fixation area of ​​the skin patch.

[0125] Preferably, the surface area of ​​the skin patch is the same as or larger than the surface area of ​​the fixation patch.

[0126] Preferably, the fixed patch is shaped to conform to the geometric or other features of the user interface and / or associated user interface tubing, or otherwise configured.

[0127] Preferably, the fixing patch has at least one wing.

[0128] Preferably, the fixation patch has a pair of wings positioned at one end of the patch, and these wings are configured to be fixed to the skin patch on both sides of the user interface and / or associated user interface tubing.

[0129] Preferably, the fixation patch has a tube end wing, which is configured to extend under the user interface tubing, or to be made to extend under it, and to adhere to the skin patch.

[0130] Preferably, the user side of the skin patch has a skin-friendly adhesive (e.g., a hydrophilic colloid) that attaches or adheres the skin patch to the user's skin.

[0131] Preferably, the skin patch has a surface area large enough to distribute the pressure or adhesive force of the patch across the user's skin.

[0132] Preferably, the skin patch is configured to adhere to or stick to the user's face.

[0133] Preferably, the skin patch is configured to adhere to or be attached to the user's face adjacent to the user's upper lip and / or cheek.

[0134] Preferably, the fixation system is configured to receive and / or secure the nasal cannula and / or associated tubing, the tubing extending from one or both sides of the user's face.

[0135] Preferably, the restraint system is configured for use with infants or neonates.

[0136] Preferably, the fixation system is configured for use with a nasal cannula as defined in the third embodiment.

[0137] Preferably, the fixing system is configured for use with a tube as defined by either the first and / or second embodiment.

[0138] In a seventh embodiment, the present invention may be broadly said to consist of a fixing system for a user interface and / or user interface tubing, including a two-part, releasable mounting or coupling device, the device including a skin patch and a user interface patch: The skin patch has a patient side and an interface side, the patient side of the skin patch is attachable to the user's skin (e.g., by adhesive, generally a skin-friendly adhesive such as a hydrophilic colloid), and the interface side of the skin patch is provided with a first component of a two-part detachable attachment or coupling system, and The user interface patch has an interface side and a patient side, and the patient side of the user interface patch is provided with a complementary second component of a two-part detachable mounting or coupling system. The interface side of the user interface patch may be attached to or connected to the user interface and / or associated user interface tubing, for example by adhesive, or formed as part of the user interface, or provided as the back surface of a user interface on which the second part of a two-part system is provided.

[0139] Preferably, the interface side of the skin patch has either a hook or a loop, and the second part of the second patch has the other hook or loop, so that the first and second parts (and patches) can be removably attached to or connected to each other.

[0140] Preferably, the first patch is plaqueable and / or attachable to the skin of the user's face.

[0141] Preferably, the user interface patch is installable, attachable, or connectable to the user interface.

[0142] Preferably, the user interface patch is formed integrally with the user interface or forms a part thereof.

[0143] Preferably, the first component of a two-part releasable attachment or coupling system on the skin patch occupies about 90%, or about 85%, or about 75%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or less than 10% of the interface side of the skin patch.

[0144] Preferably, the first component of a two-part, releasable mounting or coupling system is bonded or can be bonded to the user interface side of the skin patch with a suitable adhesive.

[0145] Preferably, the user side of the skin patch has a skin-friendly adhesive (e.g., a hydrophilic colloid) that attaches or adheres the skin patch to the user's skin.

[0146] Preferably, the skin patch has a surface area large enough to distribute the pressure or adhesive force of the patch across the user's skin.

[0147] Preferably, the skin patch is configured to adhere to or stick to the user's face.

[0148] Preferably, the skin patch is configured to adhere to or be attached to the user's face adjacent to the user's upper lip and / or cheek.

[0149] Preferably, the fixation system is configured to receive and / or fix the nasal cannula and associated tubing, the tubing extending from one or both sides of the user's face.

[0150] Preferably, the restraint system is configured for use with infants or neonates.

[0151] Preferably, the fixation system is configured for use with a nasal cannula as defined by any one of claims 3 or more.

[0152] Preferably, the fixing system is configured for use with the tubing as defined in the first and / or second embodiment.

[0153] Preferably, the fixation patch as defined above is applied over or can be applied to the user interface and is fixed to or can be fixed to the skin patch, providing further fixation.

[0154] Preferably, the first component of a two-part, releasable mounting or coupling system includes a base material that is fixed to or for fixing to a skin patch.

[0155] Preferably, the base material portion includes at least one slit or at least one slot, and the slit or slot separates the base material portion into a range.

[0156] Preferably, the base material portion includes a plurality of slits or slots, or both, that divide the base material portion into a meandering body.

[0157] Preferably, the slits and / or slots are arranged in the substrate such that a first set of at least one pair of slits or slots extends from one edge of the substrate into the substrate, and a second set of slits or slots extends from the other edge of the substrate into the substrate, and the slits or slots of one set are arranged alternately with the slits or slots of the other set, so that the path along the portion of the substrate from one end to the other without intersecting the slits or slots must follow a zigzag or meandering path that is significantly longer than a straight line between those ends.

[0158] Preferably, some of the multiple slits or slots are curved.

[0159] Preferably, multiple slits or slots are curved, and the curved slits or slots are arranged substantially parallel to each other.

[0160] Preferably, the slits or slots are arranged in a herringbone pattern extending from the edge of the base material portion.

[0161] Preferably, the substrate is divided into portions separated by serpentine slits or slots.

[0162] Preferably, the base material portion is divided into parts by spiral-shaped slits or slots.

[0163] Preferably, the base material is divided into smaller portions by slits or slots arranged substantially concentrically.

[0164] Preferably, the center of the concentric circles is approximately in the center of the base material.

[0165] Preferably, the slits or slots divide the base material into multiple islands, each of which is connected to one or more adjacent islands by thin bridges.

[0166] Preferably, the base material portion is divided into parts by an S-shaped slit.

[0167] Preferably, the base material portion is divided into parts by a T-shaped slit.

[0168] Preferably, the base material portion covers at least 70% of the area of ​​the skin patch.

[0169] Preferably, with respect to the boundary defining the shortest path surrounding the substrate, the substrate portion covers at least 80% of the area within the boundary.

[0170] In the eighth embodiment, the present invention is broadly, A step of providing an inner mold sealed in a coating, A step of providing a tubular body around an inner mold, wherein the tubular body defines a lumen that surrounds the inner mold. A method for manufacturing medical tubing, including The method can also be described as one in which a tubular body is provided around an inner mold, thereby integrally bonding the coating and the inner surface of the tubular body, while the inner mold remains sealed.

[0171] Preferably, the step of providing an internal mold is: A step of providing an elongated mold enclosed in a coating suitable for application in medical tubing, The steps include manufacturing an inner mold that will support a medical tube from a coated elongated mold, and Includes.

[0172] Preferably, an uncoated elongated mold is immersed in a coating material bath and the encapsulation coating is applied.

[0173] Preferably, the bath contains a molten polymer grade at a temperature of over approximately 150°C.

[0174] Preferably, the inner mold is manufactured by winding a long, narrow mold in a spiral shape to form a helical mold.

[0175] Preferably, the method is A step of providing an uncoated elongated mold, A step of encapsulating an elongated mold in a coating suitable for application in medical tubing, and It also includes.

[0176] Preferably, the method is i) A step of applying a reduced pressure within (or relative to) the lumen, wherein the reduced pressure pulls the tubular body radially inward, or ii) A step of extending (or stretching) at least one portion or region of a tubular body enclosing an inner mold, wherein when the extension (or stretching) is released, the extended (or stretched) portion or region of the tubular body returns to (or becomes capable of being retracted) radially inward, or iii) or a combination of i) and ii) It also includes.

[0177] Preferably, the tubular body is drawn radially inward around the outermost circumference defined by the lumen and the internal mold, and the outermost circumference defines a number of alternating peaks and valleys along the length of the tubular body to form a corrugated tube.

[0178] Preferably, the tubular body is provided by extrusion or by extruding the material from a die head.

[0179] Preferably, the tubular body is pushed out around the inner mold, and a reduction in pressure is applied in such a manner that the inner surface of the tubular body adheres or binds at least partially to at least a portion of the coating, preferably by creating a pressure difference between the pressure in the lumen and the pressure around the tubular body, more preferably the pressure inside (or supplied to) the lumen is less than the pressure around the tubular body (or the pressure around the tubular body is greater than the pressure inside (or supplied to) the lumen).

[0180] Preferably, the tubular body is provided around the inner mold at a temperature that bonds the coating to at least a portion of the tubular body.

[0181] Preferably, the tubular body is provided around the inner mold at a temperature that fuses the coating with the inner mold.

[0182] Preferably, the tubular body is fused with the coating, at least partially.

[0183] Preferably, the tubular body is a single-walled body.

[0184] Preferably, the reduced pressure is applied to or adjacent to the lumen components.

[0185] Preferably, the reduced pressure is applied to or adjacent to the die head.

[0186] Preferably, the lumens undergo a depressurization process as they exit the extrusion die head.

[0187] Preferably, the tubular body is extruded simultaneously with the manufacturing of the inner mold from the elongated mold.

[0188] Preferably, the tubular body formed in this manner is corrugated (it may be an axially corrugated or helical corrugated).

[0189] Preferably, the peaks of the corrugated tubular body formed in this manner are defined by the outermost circumference of the inner mold.

[0190] Preferably, the valleys of the corrugated tubular body formed in this manner are defined by inwardly retracted portions of the tubular body, which are retracted inward between one or more inner molds.

[0191] Preferably, the inner mold is a framework or internal support structure that supports the tubular body.

[0192] Preferably, the internal mold is of a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0193] Preferably, one or a combination of multiple individual supports connected to each other or connectable by an internal coil spring or helical element, a helical frame or helical rib, annular disc, a ring, or one or more connecting links.

[0194] Preferably, the inner mold supports or is supporting the lumen inside the tube thus formed.

[0195] Preferably, the internal mold is a helical element or member.

[0196] Preferably, the inner mold has a pitch that varies along the length (or section) of the tube.

[0197] Preferably, the inner mold includes helical elements (or members) having adjacent winding pitches of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9 mm, or about 0.6 to about 1.8 mm, or about 0.7 to about 1.7 mm, or about 0.8 to about 1.6 mm, or about 0.9 to about 1.5 mm, or about 1 to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the adjacent winding pitch is about 1 mm to about 1.5 mm.

[0198] Preferably, the inner mold has an outermost diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm.

[0199] Preferably, the inner mold is a helical element, which has a diameter of about 0.05 mm to 0.3 mm, or about 0.06 to 0.29 mm, or about 0.07 to 0.28 mm, or about 0.08 to 0.27 mm, or about 0.09 to 0.26 mm, or about 0.1 to 0.25 mm, or about 0.11 to 0.24 mm, or about 0.12 to 0.23 mm, or about 0.13 to 0.24 mm, or about 0.14 to 0.23 mm, or about 0.15 to 0.22 mm, or about 0.16 to 0.24 mm, or about 0.17 to 0.23 mm, or about 0.18 to 0.22 mm, or about 0.19 mm to 0.21 mm.

[0200] Preferably, the inner mold is made of medical-grade material, preferably a suitable material, preferably polymer-grade or medical-grade stainless steel coated with stainless steel.

[0201] Preferably, the tubular body has a wall thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm. Preferably, the wall thickness is approximately 0.1 mm to approximately 0.2 mm.

[0202] Preferably, the tubular body has an internal (e.g., lumen) diameter of approximately 1.5 mm to 4.5 mm, or approximately 1.6 to 4.4 mm, or approximately 1.7 to 4.3 mm, or approximately 1.8 to 4.2 mm, or approximately 1.9 to 4.1 mm, or approximately 2 to 4 mm, or approximately 2.1 to 3.9 mm, or approximately 2.2 to 3.8 mm, or approximately 2.3 to 3.7 mm, or approximately 2.4 to 3.6 mm, or approximately 2.5 to 3.5 mm, or approximately 2.6 to 3.4 mm, or approximately 2.7 to 3.3 mm, or approximately 2.8 to 3.2 mm, or approximately 2.9 mm to 3.1 mm.

[0203] Preferably, the tubular body has an outer diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm. Preferably, it has an outer diameter of approximately 3 mm to 5 mm.

[0204] Preferably, the tubular body is corrugated, and this corrugation has a depth of approximately 0.1 mm to approximately 0.5 mm.

[0205] Preferably, the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0206] Preferably, the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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 0.06.

[0207] Preferably, the ratio of the waveform depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09.

[0208] Preferably, the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0209] Preferably, the tubular body is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0210] Preferably, the tubular body is any one or more of (preferably extruded from) one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, and more preferably the polymer is a polymer of the thermoplastic elastomer family, such as polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and even more preferably a polymer of 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.

[0211] Preferably, the reduced pressure is applied while the tubular body is in a molten, semi-molten, or uncured state, preferably the reduced pressure is about 0 to about -2 bar (absolute), more preferably about 0 to about -1 bar (absolute), even more preferably up to about -0.9 bar (absolute), and even more preferably such reduced pressure is the pressure difference between the inside of the lumen and the area surrounding the tubular body.

[0212] Preferably, the internal mold is conductive, and preferably, the internal mold is an electrically driven heater.

[0213] Preferably, the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0214] Preferably, the tube further includes a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0215] Preferably, the tubular body formed in this manner has flexibility as defined by passing a test of increased flow resistance due to bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0216] Preferably, medical tubing is a breathing tube.

[0217] Preferably, the internal mold is composed of one or more individual components.

[0218] Preferably, the internal mold includes one or more components.

[0219] Preferably, the tube includes one or more inner molds.

[0220] In a ninth embodiment, the present invention broadly relates to a method for manufacturing medical tubing, i) Steps of providing an internal mold, ii) Providing a tubular body around an inner mold, wherein the tubular body defines a lumen surrounding the inner mold and applies reduced pressure to (or relative to) the lumen, or extending (or stretching) at least a portion or region of the tubular body surrounding the inner mold, iii) or a combination of i) and ii) It could also be said that it consists of methods that include

[0221] Preferably, by applying a greater depressurization, a greater extension (or stretching), or a combination thereof, when a greater depressurization is applied, or when the extension (or stretching) is released, or both, the tubular body is drawn radially inward along the length of the tubular body and the outermost circumference defined by the inner mold, and then the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys.

[0222] Preferably, the inner mold is enclosed in the coating, and the tubular body is provided around the inner mold so that the coating and the inner surface of the tubular body are integrally bonded, with the inner mold remaining enclosed.

[0223] In a tenth embodiment, the present invention broadly relates to, It could also be said that the medical tube comprises a tubular body defining a lumen extending between the open ends of the body, an inner mold enclosed within the lumen and supporting the tubular body, and a coating that encloses the inner mold and fixes the inner mold to the tubular body.

[0224] Preferably, the coating and the tubular body are fused together along the tube.

[0225] Preferably, the coating and the tubular body are fused together at discrete positions along the tube.

[0226] Preferably, the coating and the tubular body are fused substantially continuously along the length of the tube.

[0227] Preferably, the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0228] Preferably, the peaks of the corrugated tubular body are defined by the outermost circumference of the inner mold.

[0229] Preferably, the valleys of the corrugated tubular body are defined by portions of the tubular body that are drawn inward between the inner molds.

[0230] Preferably, the internal mold is of a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0231] Preferably, the internal mold is one or a combination of several individual supports that are interconnected or connectable by a coil spring or helical element, a helical frame or helical rib, annular disc, a ring, or one or more connecting links.

[0232] Preferably, the inner mold supports a tubular body that defines a lumen inside.

[0233] Preferably, the internal mold is a helical element or member.

[0234] Preferably, the inner mold has a pitch that varies along the length (or section) of the tube.

[0235] Preferably, the inner mold is a framework or internal support structure that supports the tubular body.

[0236] Preferably, the tubular body is not substantially supported by the inner mold in the valleys, but is supported by the inner mold in the peaks.

[0237] Preferably, the walls of the tubular body are suspended between adjacent mountains.

[0238] Preferably, the tubular body is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0239] Preferably, the inner mold is a helical rib or a ribbed element.

[0240] Preferably, the inner mold is a helical strip, and the coating encloses the strip.

[0241] Preferably, the inner mold is a helical-wound metal wire, and the coating encloses the wire.

[0242] Preferably, the coating provides a surface that readily adheres to the tubular body.

[0243] Preferably, the inner mold is a helical element (or member) having a pitch between adjacent windings of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9 mm, or about 0.6 to about 1.8 mm, or about 0.7 to about 1.7 mm, or about 0.8 to about 1.6 mm, or about 0.9 to about 1.5 mm, or about 1 to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the pitch between adjacent windings is about 1 mm to about 1.5 mm.

[0244] Preferably, the inner mold has an outermost diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm.

[0245] Preferably, the inner mold is a helical element, which has a diameter of about 0.05 mm to 0.3 mm, or about 0.06 to 0.29 mm, or about 0.07 to 0.28 mm, or about 0.08 to 0.27 mm, or about 0.09 to 0.26 mm, or about 0.1 to 0.25 mm, or about 0.11 to 0.24 mm, or about 0.12 to 0.23 mm, or about 0.13 to 0.24 mm, or about 0.14 to 0.23 mm, or about 0.15 to 0.22 mm, or about 0.16 to 0.24 mm, or about 0.17 to 0.23 mm, or about 0.18 to 0.22 mm, or about 0.19 mm to 0.21 mm. Preferably, it has a diameter of about 0.1 mm to 1.5 mm.

[0246] Preferably, the inner mold is made of medical-grade material, preferably medical-grade stainless steel.

[0247] Preferably, the tubular body has a (wall) thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm. Preferably, the wall thickness is approximately 0.1 mm to approximately 0.2 mm.

[0248] Preferably, the tubular body has an internal diameter (e.g., lumens) of about 1.5 mm to about 4.5 mm, or about 1.6 to about 4.4 mm, or about 1.7 to about 4.3 mm, or about 1.8 to about 4.2 mm, or about 1.9 to about 4.1 mm, or about 2 to about 4 mm, or about 2.1 to about 3.9 mm, or about 2.2 to about 3.8 mm, or about 2.3 to about 3.7 mm, or about 2.4 to about 3.6 mm, or about 2.5 to about 3.5 mm, or about 2.6 to about 3.4 mm, or about 2.7 to about 3.3 mm, or about 2.8 to about 3.2 mm, or about 2.9 mm to about 3.1 mm. Preferably, it has an external (or outer) diameter of about 3 mm to about 5 mm.

[0249] Preferably, the tubular body is corrugated, and this corrugation has a depth of approximately 0.1 mm to approximately 0.5 mm.

[0250] Preferably, the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0251] Preferably, the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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 0.06.

[0252] Preferably, the ratio of the waveform depth to the outer (i.e., outer) tube diameter is about 0.05 to about 0.09.

[0253] Preferably, the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0254] Preferably, the tubular body has an outer diameter of approximately 1.6 mm to 4.6 mm, or approximately 1.7 to 4.5 mm, or approximately 1.8 to 4.4 mm, or approximately 1.9 to 4.3 mm, or approximately 2 to 4.2 mm, or approximately 2.1 to 4.1 mm, or approximately 2.2 to 4 mm, or approximately 2.3 to 3.9 mm, or approximately 2.4 to 3.8 mm, or approximately 2.5 to 3.7 mm, or approximately 2.6 to 3.6 mm, or approximately 2.7 to 3.5 mm, or approximately 2.8 to 3.4 mm, or approximately 2.9 to 3.3 mm, or approximately 3 mm to 3.2 mm.

[0255] Preferably, the tubular body is one or a combination of thermoplastic elastomers, polypropylene-based elastomers, one or more liquid silicone rubbers, or breathable thermoplastic polyurethanes (preferably extruded therefrom), and more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrene-based block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and even more preferably a polymer of 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.

[0256] Preferably, the inner mold consists of multiple rings spaced apart longitudinally along the lumen.

[0257] Preferably, the ring is toroidal or annular in shape.

[0258] Preferably, the internal mold is one or more individual elements connected to one another.

[0259] Preferably, the internal mold includes a plurality of reinforcing ribs regularly spaced apart along the lumen.

[0260] Preferably, each reinforcing rib includes one turn of a helical reinforcing wire.

[0261] Preferably, one turn of the helical reinforcing wire includes a complete one-turn around the lumen of the tube.

[0262] Preferably, one turn of the helical reinforcing wire includes a wire positioned between adjacent peaks of the inner mold.

[0263] Preferably, the tubular body has flexibility as defined by passing a test of increased flow resistance due to bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0264] Preferably, the end of the tube is integrated with a nasal prong, which is configured to be inserted into the user's nostril as a nasal interface for delivering respiratory gas to the user.

[0265] Preferably, the inner mold is mesh.

[0266] Preferably, the inner wire is suitable for heating the gas inside the tube or for detecting the characteristics of the gas.

[0267] Preferably, the internal mold is conductive, and preferably, the internal mold is an electrically driven heater.

[0268] Preferably, the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0269] Preferably, the tube further includes a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0270] Preferably, the tube is a breathing tube.

[0271] Preferably, the internal mold is composed of one or more individual components.

[0272] Preferably, the internal mold includes one or more components.

[0273] Preferably, the tube includes one or more inner molds.

[0274] In the eleventh embodiment, the present invention is broadly described as follows: It can also be said that the medical tube consists of a tubular body comprising a body that defines a lumen extending between the open ends of the body, and an inner mold enclosed within the lumen and serving as a support for the tubular body.

[0275] Preferably, the outermost periphery of the inner mold defines a plurality of ridges and valleys arranged alternately along the length of the tubular body.

[0276] Preferably, the inner mold is encapsulated in a coating, and the coating fixes the inner mold to the tubular body.

[0277] In a twelfth aspect, the present invention broadly at least one nasal prong having one or more gas outlets configured to be inserted into a user's nostril and one or more gas inlets fluidly connected to the one or more gas outlets, the prong being shaped to conform to the anatomical curvature of the user's nostril may be said to consist of a nasal cannula device including.

[0278] Preferably, the nasal prong is shaped to avoid contact with the user's septum at the lower part of the user's nose.

[0279] Preferably, the nasal prong is shaped to avoid contact with the internal structure of the user's nose.

[0280] Preferably, the nasal prong is shaped such that the flow of one or more respiratory gases through the one or more gas outlets is substantially aligned with the user's upper airway.

[0281] Preferably, the nasal prong is shaped to extend substantially upward and rearward within the user's nostril, and the nasal prong has a curvature including at least two inflection points.

[0282] Preferably, the nasal prong defines a lumen extending between the one or more gas inlets and the one or more gas outlets, and the shape of the lumen changes from a substantially circular shape at the one or more gas inlets to a substantially elliptical shape at the one or more gas outlets.

[0283] Preferably, the prong is shaped to maximize the cross-sectional area of the lumen.

[0284] Preferably, the interface further includes a support extending along the upper lip of the user.

[0285] Preferably, the interface includes two nasal prongs symmetrically spaced with respect to the sagittal plane of the user, and these prongs extend inwardly below the user's nose from a base on a common support disposed along the upper lip of the user.

[0286] Preferably, the nasal prong extends from the support toward the septum of the user, curves upwardly and rearwardly around the corner of the user's external nostril and into the user's nostril, each prong extends along a generally inclined rearward trajectory, and passes through two medial-lateral inflection points that determine the orientation of one or more gas outlets with respect to the upper airway passage of the user.

[0287] Preferably, the prong may have a non-uniform trajectory that conforms to the anatomical shape of the user's external nostril. More preferably, i) in a first portion (or phase) of such a prong, the trajectory moves horizontally toward the midline of the face, ii) in a second portion (or phase) of the prong, the trajectory curves upwardly toward the vertex directly into the external nostril, iii) in a third portion (or phase) of the prong, the trajectory winds back into the head following the anatomical curve of the external nostril, and iv) in a fourth portion (or phase), the trajectory slopes horizontally toward the center of the cannula so that the outlet is aligned with the upper airway of the user.

[0288] Preferably, the prong has a cross-section that varies along a central trajectory. For example, the cross-section may be generally circular at the base of the trajectory (i.e., in the region of the first portion) and become generally elliptical toward the end of the trajectory or prong (e.g., in the region of the fourth portion).

[0289] Preferably, the cross-sectional diameter generally decreases along the trajectory from the first portion (or phase) to the end of the fourth portion (or phase).

[0290] Preferably, the nasal cannula further includes a backing material or facet pad with a modified contour that is configured to rest on the user's face.

[0291] Preferably, the backing material or face pad is pre-molded to have a curved contour that substantially conforms to the user's face or upper lip area.

[0292] Preferably, each prong is capable of receiving an independent flow from the gas supply source.

[0293] In the 13th embodiment, the present invention broadly applies to: A nasal prong having at least one gas outlet configured to be inserted into the user's nostril, and one or more gas inlets fluidly connected to the gas outlet, A nasal cannula device comprising one or more gas delivery tubes, the tube including a tubular body defining a lumen and an inner mold enclosed within the lumen, the inner mold supporting the tubular body, It can also be said that the nasal cannula device consists of a nasal cannula in which one or more gas inlets of the nasal prongs are integrally formed with the end of the tube, thereby fluidly connecting the tube lumen to one or more gas outlets of the nasal prongs.

[0294] Preferably, the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0295] Preferably, the prongs are shaped to conform to the anatomical curvature of the user's nostrils.

[0296] Preferably, the nasal prongs are curved to avoid the user's septum, or are otherwise shaped or constructed.

[0297] Preferably, the nasal cannula has a contoured backing material or facet pad configured to rest on the user's face, preferably as a stabilizing material for the prongs in the user's nostrils.

[0298] Preferably, one or more ribs extend between the front surface of the backing material or facial pad and the cannula, the ribs providing a contact surface for a tape or other suitable retainer used to fasten or attach the cannula to the user's face, preferably the tape includes an adhesive portion or is an adhesive tape or contact adhesive tape.

[0299] Preferably, the two nasal prongs are integrally formed with a single corrugated delivery tube.

[0300] Preferably, the cannula device is formed from liquid silicone rubber or polymer, such as a thermoplastic polymer, preferably one or more polymers suitable for medical respiratory tubes.

[0301] Preferably, the cannula device is formed of one or more of any one or more of the following: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes. More preferably, the polymer is a polymer such as, but is not limited to, polyolefins, thermoplastic elastomers, breathable polyester elastomers, or breathable thermoplastic elastomers, such as styrene-based block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, or breathable polyester elastomers. Even more preferably, the polymer may have 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.

[0302] Preferably, such a cannula may be used in combination with a tube as defined by any one of the embodiments described above.

[0303] In a 14th aspect, the invention may broadly be said to consist of a user interface including a pair of nasal cannulas as defined by the 13th aspect.

[0304] Preferably, in such a user interface, the nasal prongs are arranged adjacent to each other and each delivery tube extends in an opposite direction away from the nasal prong.

[0305] Preferably, such a user interface further includes a harness that extends between and couples the nasal cannulas.

[0306] Preferably the tubes are breathing tubes.

[0307] Preferably, in such a user interface, the tubes are as defined by any one of the above aspects.

[0308] Preferably, in such a user interface, the prongs are glued or otherwise adhered to the tubes.

[0309] In a 15th aspect, the invention may broadly consist of a nasal cannula device including at least one nasal prong configured to be inserted into a user's nostril and a gas inlet fluidly connected to the gas outlet, wherein the at least one nasal prong includes a backing material configured to rest on the user's face, where a lip extends around at least a portion of the perimeter of the rear surface of the backing material and the rear surface is configured to receive or hold a user interface patch, and thus during use the user interface patch may be removably attached or connected to a skin patch affixed to the user's face or such a skin patch. Preferably the lip is a barrier wall.

[0310] Preferably the lip is a barrier wall.

[0311] Preferably, the lip is deformable.

[0312] Preferably, the lip extends at least around the area substantially adjacent to the prongs related to the backing material.

[0313] Preferably, the lip is a series of one or more individual lips.

[0314] Preferably, one or more individual lips are adjacent to, joined to, or overlapping with the lip portion.

[0315] Preferably, the lip is an endless lip that extends around the rear surface of the backing material.

[0316] Preferably, during use, the lip substantially forms a fluid seal or fluid barrier between the rear surface of the backing material and the cannula-facing surface of the user interface patch.

[0317] Preferably, the backing material is a substantially planar, flattened, or irregularly shaped (such as a pre-formed curved surface) backing material configured to rest on the user's face.

[0318] Preferably, the backing material acts as a stabilizer for one or more prongs in one or more nostrils of the user.

[0319] Preferably, at least one backing material extends laterally outward from at least one nasal prong, away from the user's septum.

[0320] Preferably, the cannula is further defined by any one of the above embodiments.

[0321] Preferably, the cannula functions in conjunction with the fixation system as described in the above embodiment.

[0322] Preferably, a user interface patch that is receivable or retainable on the rear surface of a backing material (or backing material component) as defined by any one of the above embodiments.

[0323] Preferably, at least one or more lips are hydrophobic.

[0324] Preferably, at least one or more lips include at least one outer circumferential lip portion and at least one inner circumferential lip portion, each of which is provided for contact with the user's face.

[0325] Preferably, the gas inlet of the cannula is fluidly connected to or to a tube as defined in any one of the embodiments described above.

[0326] In a sixteenth embodiment, the present invention may be said to consist more broadly of a part of a releasable fastener including a base material portion supporting mechanical fasteners dispersed across its surface, wherein the base material portion is flexible but substantially non-stretchable, and the base material portion is divided into a plurality of ranges by at least one slit or at least one slot, so that the divided separate portions of the base material can bend independently so that the base material can substantially conform to a complex curved surface on the underside.

[0327] Preferably, the base material portion includes a plurality of slits or slots, or both, that divide the base material portion into a meandering body.

[0328] Preferably, the slits and / or slots are arranged in the substrate such that a first set of at least one pair of slits or slots extends from one edge of the substrate into the substrate, and a second set of slits or slots extends from the other edge of the substrate into the substrate, and the slits or slots of one set are arranged alternately with the slits or slots of the other set, so that the path along the portion of the substrate from one end to the other without intersecting the slits or slots must follow a zigzag or meandering path that is significantly longer than a straight line between those ends.

[0329] Preferably, some of the multiple slits or slots are curved.

[0330] Preferably, multiple slits or slots are curved, and the curved slits or slots are arranged substantially parallel to each other.

[0331] Preferably, the slits or slots are arranged in a herringbone pattern extending from the edge of the base material portion.

[0332] Preferably, the substrate is divided into portions separated by serpentine slits or slots.

[0333] Preferably, the base material portion is divided into parts by spiral-shaped slits or slots.

[0334] Preferably, the base material is divided into smaller portions by slits or slots arranged substantially concentrically.

[0335] Preferably, the center of the concentric circles is approximately in the center of the base material.

[0336] Preferably, the slits or slots divide the base material into multiple islands, each of which is connected to one or more adjacent islands by thin bridges.

[0337] Preferably, the base material portion is divided into parts by an S-shaped slit.

[0338] Preferably, the base material portion is divided into parts by a T-shaped slit.

[0339] Preferably, the base material portion covers at least 70% of the area of ​​the skin patch.

[0340] Preferably, with respect to the boundary defining the shortest path surrounding the substrate, the substrate portion covers at least 80% of the area within the boundary.

[0341] In a sixteenth embodiment, the present invention may be said to broadly consist of a user interface assembly, the assembly being: A fixing system for the user interface and / or components related to the user interface (e.g., tubes or tubing), A tube connected to the user interface provides the user of the interface with at least a portion of the breathing circuit. Includes, The fixing system includes a two-part, releasable mounting (or coupling) device, which is Including 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 can be attached to the user's skin (for example, with an adhesive, generally a skin-friendly adhesive such as a hydrophilic colloid), On the interface side of the skin patch, a first component of a two-part type detachable mounting or coupling system is provided, The user interface patch has an interface side and a patient side. The patient side of the user interface patch is provided with a complementary second component of a two-part, detachable mounting or coupling system. The interface side of the user interface patch is attachable to (or connectable to) the user interface and / or components associated with the user interface (e.g., tubes or tubing), and The tube is The device comprises a tubular body defining a lumen extending between the open ends of the body, an inner mold enclosed within the lumen and supporting the tubular body, and a coating enclosing the inner mold and fixing the inner mold to the tubular body.

[0342] Preferably, the interface is a nasal cannula.

[0343] Preferably, the interface includes one or a pair of nasal prongs.

[0344] Preferably, the interface includes a fixed system.

[0345] Preferably, the tube is a medical respiratory tube.

[0346] Preferably, the interface is a nasal cannula device including at least one nasal prong having a gas outlet configured to be inserted into the user's nostril and a gas inlet fluidly coupled to the gas outlet, the at least one nasal prong including a backing material configured to rest on the user's face, the backing material having a lip extending around at least a portion of the periphery of the posterior surface of the backing material, the posterior surface configured to receive or hold a user interface patch, and thus, during use, the user interface patch can be removably attached to or coupled to a skin patch fixed to the user's face.

[0347] Preferably, the lip is a barrier wall.

[0348] Preferably, the lip is deformable.

[0349] Preferably, the lip extends at least around the area substantially adjacent to the prongs related to the backing material.

[0350] Preferably, the lip is an endless lip that extends around the rear surface of the backing material.

[0351] Preferably, the lip is a series of one or more individual lips.

[0352] Preferably, one or more individual lips are adjacent to, joined to, or overlapping with the lip portion.

[0353] Preferably, during use, the lip substantially forms a fluid (e.g., liquid) seal or fluid barrier between the rear surface of the backing material and the cannula-facing surface of the user interface patch.

[0354] Preferably, the backing material is a substantially planar, flattened, or irregularly shaped (such as a pre-formed curved surface) backing material configured to rest on the user's face.

[0355] Preferably, the backing material acts as a stabilizer for one or more prongs in one or more nostrils of the user.

[0356] Preferably, at least one backing material extends laterally outward from at least one nasal prong, away from the user's septum.

[0357] It should be understood that the various embodiments of the tube described above may be used in combination with a user interface or nasal cannula, such as those described herein.

[0358] It should be understood that the various embodiments of the fixing system described above may be used in combination with a user interface or nasal cannula, such as those described herein.

[0359] It should be understood that various embodiments of the user interface assembly described herein may be used in combination with the tubes also described herein.

[0360] The term "comprising" as used herein and in the claims means "consisting of at least a portion of." When interpreting each statement herein and in the claims that contains the term "comprising," there may be other features that precede this term. Related terms such as "comprise" and "comprises" should be interpreted similarly.

[0361] The Disclosure may also be said to be more broadly contained, individually or collectively, in the parts, elements and features and / or descriptions of the Disclosure that are referenced or indicated in the Specification of this Application, and in any combination of any two or more such parts, elements, features or descriptions of the Disclosure, and where the Disclosure refers to any particular integer that is known to be an equivalent in the relevant art, such known equivalent is incorporated herein by reference as being individually described.

[0362] This disclosure is as stated above, and the structure provided below as an example is also assumed.

[0363] Herein, the above and other features, aspects and advantages of the present disclosure will be described with reference to the drawings of preferred embodiments, which are intended to illustrate and not limit the present disclosure, and which are as follows: [Brief explanation of the drawing]

[0364] [Figure 1] This is a side view of a corrugated medical tube, showing a cross-section of one end of the tube to illustrate the structure of the tubular body surrounding the inner mold. [Figure 2] This is a side view of a medical tube shown in cross-section, with a notch in the tubular body revealing a continuous spiral inner shape. [Figure 3A] This is a side view of a medical tube shown in cross-section, with the tubular body notched to reveal multiple independent rings corresponding to discrete internal molds. [Figure 3B] This is a side view of a medical tube, shown in cross-section to illustrate the sandwich wall structure around the inner mold. [Figure 3C] A side view, showing a further embodiment in which the internal mold is embedded in the wall. [Figure 3D] This is a side view of a further embodiment in which the tubular body has been heat-shrunk on an internal mold. [Figure 3E] A side view shows a further alternative embodiment in which the internal mold works to hold the tubular body in the desired mold. [Figure 4] This is a schematic diagram of a medical tubing molding machine, which includes a hopper, feed screw, and die head. [Figure 5] This is a schematic diagram of a die head used for molding reinforced medical tubing. [Figure 6] This is a perspective view of a nasal interface incorporating a pair of reinforced medical tubes, each connected to a nasal prong. [Figure 7] Figure 6 is a perspective view of the nose interface, which incorporates backing material components to stabilize the interface in place and to accept the headgear attachment. [Figure 8] Figure 7 is a front view of the nasal interface. [Figure 9] Figure 7 is a top view of the nasal interface. [Figure 10] Figure 7 is a side view of the nasal interface. [Figure 11] This is a front view of the nasal interface shown in cross-section in Figure 7. [Figure 12] Figure 7 is a perspective view of the nasal interface positioned appropriately on the infant's head. [Figure 13] This is a perspective view of a nasal interface incorporating a pair of reinforced medical tubes, each connected to a nasal prong, which is then secured to a harness that includes multiple ribs and a pair of headgear attachments. [Figure 14]This is a perspective view of a nasal interface incorporating a pair of reinforced medical tubes, each connected to a nasal prong, which is secured to a harness containing multiple ribs. [Figure 15] The image shows a nasal cannula positioned in the working position on the user's face, with the cannula positioned according to an embodiment of the seventh aspect. [Figure 16] Figure 15 is a side view of the nasal cannula device. [Figure 17] An embodiment relating to the seventh aspect and its constituent assembly components are shown. [Figure 18] The image shows a nasal cannula positioned in the working position on the user's face, with the cannula positioned according to an embodiment of the sixth aspect. [Figure 19] Figure 18 is a side view of the nasal cannula device. [Figure 20] An exploded perspective view of an embodiment relating to the sixth aspect and its constituent assembly parts are shown. [Figure 21] The relevant layers of the embodiment according to the sixth aspect are shown from right to left (the user is not shown). [Figure 22] An example of an embodiment of the fixing patch according to the sixth aspect is provided. [Figure 23] Another or alternative embodiment of the fixing patch according to the sixth aspect is illustrated below. [Figure 24A] This is a magnified perspective view of a cross-section of a medical tube, showing a notch in the corrugated tubular body revealing the coated spiral inner mold. [Figure 24B] This is a magnified perspective view of a cross-section of a medical tube, showing a notch in the smooth tubular body revealing the coated spiral inner shape. [Figure 25A] This is a schematic front view of a pair of nasal prongs showing the shape of the prongs and internal lumen. [Figure 25B] This is a schematic side view of a pair of nasal prongs showing the shape of the prongs and internal lumen. [Figure 25C] This is a schematic front view of a pair of inverted nasal prongs showing the shape of the prongs and internal lumen. [Figure 25D] This is a schematic perspective view of a pair of inverted nasal prongs showing the shape of the prongs and internal lumen. [Figure 26A] This is a perspective view of a nose interface having a curved backing material component. [Figure 26B] This is a front view of a nose interface having a curved backing material component. [Figure 26C] This is a top view of a nose interface having a curved backing material component. [Figure 26D] This is a rear view of a nose interface having a curved backing material component. [Figure 27A] Figure 17D is a magnified view of the nasal prongs. [Figure 27B] Figure 17C is a magnified view of the nasal prongs shown. [Figure 28] This shows a nasal cannula device used with backing material components, including the lip. [Figure 29] This shows a nasal cannula device used with backing material components, including the lip. [Figure 30] This is a front perspective view of a nasal cannula device having backing material components including a lip. [Figure 31] This is a rear perspective view of a nasal cannula device having backing material components including a lip. [Figure 32] This is a top and rear perspective view of a nasal cannula device having a backing material component including a lip, and a user interface patch on the rear surface of the backing material component. [Figure 33] Figure 32 is a cross-sectional view through the nasal cannula device when the user interface patch is connected to the skin patch. [Figure 34] Figures 30 to 33 are side and rear perspective views of the nasal cannula device. [Figure 35] Figures 28-34 are rear views of alternative nasal cannula devices illustrating a series of segmented lips. [Figure 36A]The outline of a skin patch according to one embodiment is illustrated. [Figure 36B] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36C] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36D] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36E] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36F] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36G] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36H] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36I] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36J] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36K] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36L] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36M] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36N] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36O] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36P] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36Q] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Figure 36R] Figure 36A illustrates various embodiments of the fastener base material portion that is fixed to the skin patch. [Modes for carrying out the invention]

[0365] Medical tubing (i.e., breathing tubes) is subject to various constraints. Some constraints may be performance-driven characteristics such as weight, flexibility, and flow rate. Other constraints may be required by regulatory authorities and must be complied with in order for the tubing to be used in medical applications. Required constraints may include evaluation of the structural integrity of the tubing and the biocompatibility or sterility (for hygienic purposes) of the tubing components. One such constraint is the flow resistance caused by bending, which can be defined by the relevant tests provided in ISO 5367:2000(E) (4th edition, June 1, 2000).

[0366] Biocompatibility of materials, such as materials that can interact with or come into contact with respiratory gases or other fluids, and that do not leach or impart to respiratory gases or other fluids that the user or patient may consume or ingest, may be useful. Sterility may also be useful in ensuring that there is no or minimal transfer of disease to the user or patient.

[0367] Therefore, numerous criteria are considered in the design and testing of medical tubing, which are reflected in the diversity of tubing available in the medical field. The specialized requirements and characteristics of various medical procedures and applications can also contribute to the diversity of available medical tubing. The specificity of various medical applications means that tubing particularly suitable for a particular procedure may not meet the criteria for a different medical application.

[0368] Medical tubing with application-specific configurations can be complex and restrict the associated design process. Furthermore, strict regulations regarding the use of components often restrict healthcare professionals to strictly adhere to component guidelines and instructions.

[0369] Tubing A medical tube 100 is schematically shown in Figure 1. In a first embodiment, the medical tube 100 is corrugated. However, the tube may also be fabricated or manufactured to have a smooth outer surface (e.g., Figure 24B) or a substantially smooth inner surface (e.g., Figures 3B, 3C). In one exemplary embodiment, the tube 100 includes a tubular body 102. The body 102 defines a lumen 107 extending between the open ends of the body 102. An inner mold 110 is enclosed within the lumen 107. The inner mold provides support for the tubular body. The outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0370] The illustrated tube 100 has a corrugated shape including a number of peaks 104 and valleys 105. The peaks 104 and valleys 105 extend along the circumference of the tube 100 and are arranged alternately along the tubular body 102 (or its wall) (i.e., in a direction substantially parallel to the longitudinal axis 101 of the tube 100).

[0371] The tubular body 102 defines a lumen 107 extending between the ends of the tube 100. In medical applications, the passage of gas through the tube 100 is limited to the lumen 107, and the tubular body 102 defines the outer boundary of that passage. The tube 100 preferably has an opening located adjacent to each end. Ideally, this opening is positioned substantially coaxially with the lumen (i.e., aligned with the longitudinal axis 101 in the illustrated embodiment) to reduce turbulence in the flow within the tube 100.

[0372] The illustrated tube 100 also includes an inner mold 110, the tubular body 102 is positioned to cover, around, or enclose it. The tubular body 102 encloses the inner mold 110 within the lumen of the tube 100. The inner mold 110 provides a framework that defines the overall shape and contributes to the structural characteristics of the tube 100. Preferably, the inner surface or inner surface of the tubular body 102 is fixed to the inner mold 110. The tubular body 102 and the inner mold 110 can be fixed together by: crimping the tubular body 102 onto the inner mold 110 (for example, Figure 3D); applying the tubular body 102 onto the inner mold in a molten, semi-molten, or uncured state, thereby fusing and bonding (or binding) the inner surface of the tubular body 102 with the inner mold 110 (for example, Figure 3C); or by providing a tubular body having at least an inner wall layer and an outer wall layer, with the inner mold sandwiched between them (for example, Figure 3B).

[0373] The inner mold 110 preferably defines a substructure that forms a framework, which is arranged around the longitudinal axis 101 of the tube 100 and supports the tubular body 102. The tubular body 102 is positioned to cover the inner mold 110, and the corrugations in the tubular body 102 reflect the structure of the reinforcing framework provided by the inner mold 110. The peaks 104 of the tube's corrugations correspond to the reinforcing ribs (i.e., the shape of the inner mold 110) that support the tubular body 102. The valleys 105 of the tube's corrugations preferably represent unsupported sections of the tubular body 102 that are suspended between adjacent reinforcing ribs.

[0374] The internal mold 110, as illustrated in Figures 1, 2, 3B-3D, 24A, and 24B, includes a continuous helical framework having a structure similar to that of a coil spring. This framework gives the tubular body 102 a helical corrugation, which can be seen in the left portion of Figure 1. In the illustrated embodiment, the internal mold 110 is continuously fixed to the tubular body 102 at the peaks 104 of the corrugation. The tubular body 102 conforms to the contour of the internal mold 110 and wraps around each reinforcing rib. In the illustrated embodiment, the contact surface between each reinforcing rib and the tubular body 102 may exceed half of the circumferential surface of the rib.

[0375] Figure 3 illustrates another embodiment of the medical tube 200. In this embodiment, the inner mold 210 includes a plurality of rings spaced apart along the longitudinal axis 201 of the tube 200. Each ring 210 provides a circumferential reinforcing rib positioned to coincide with the peaks 204 of the tubular body 202. The individual rings constitute the reinforcing framework of the illustrated inner mold 210. Thus, the tube 200 has a circumferential corrugation with discrete peaks 204 and valleys 205 extending along the tube 200 around the longitudinal axis 201. Adjacent rings may be joined together to resist lumen narrowing when the tube is twisted (i.e., when a torsional force is applied). The rings may be formed from washers or disks with holes for flow to pass through. Preferably, the rings are toroidal or annular.

[0376] Another embodiment of the tube 1100 is shown in Figure 24B. The tube 1100 has a similar structure to the corrugated tube 100 shown in Figure 1 and includes a tubular body 1102 and an inner mold 1110. However, the tubular body 1102 of the tube 1100 shown in Figure 24B defines a smooth or non-corrugated or uncorrugated outer wall.

[0377] The inner mold may have an outer coating as shown in the cross-sectional tubes of Figures 24A and 24B. The coating shown in Figures 24A and 24B is approximately 35 microns thick, and the tube wall is approximately 150 microns thick. The coating 1111 completely encloses the inner mold 1110. In an alternative configuration, it may also be advantageous to partially coat the inner mold, such as by discrete coating sections over the length of the inner mold 1110.

[0378] The inner mold 1110 may be coated to increase the strength of the bond formed with the tubular body 1102, improve biocompatibility or sterility within the tube, and / or isolate the inner mold from the contents of the tube (thus preventing corrosion of the inner mold, etc.). Preferably, the coating is sufficiently thin so as not to negatively affect the mechanical properties of the inner mold, such as reducing its elasticity or flexibility.

[0379] The tube in Figure 3B has a roughly sandwich structure, which is fabricated by inserting a thin-walled polymer tube into the center of an inner mold, such as a coil spring. When this assembly is passed through a crosshead tubing extrusion die, a molten and similarly thin-walled polymer tube is extruded, covering the outside of the assembly. The drawdown of the extruded molten material and / or the vacuum applied between the two layers, or a pressure difference which may be a positive pressure applied inside the inner tube or outside the outer tube, or a combination of all of these, brings the molten outer tube into contact with the inner tube. The contact of the molten outer tube with the inner tube creates a bond between them, which, after cooling, results in a tube consisting of an inner wall and an outer wall of a tubular body. The inner mold (e.g., a coil spring wire reinforcement) remains sandwiched between the two wall layers.

[0380] The tube may be formed to have fairly smooth holes, thereby providing low flow resistance, while the outer wall layer of the tube is corrugated to promote the flexibility of the tubular body. The inner mold is mechanically fixed in place by a sandwich effect. Therefore, a pre-coated inner mold may not be necessary to achieve this adhesion to the tube wall, although this option exists. The tube may also consist of two thin layers of tubing made of similar material bonded integrally with an inner mold (e.g., a spring) fixed in place away from the gas path. This provides a tube that is extremely flexible, yet strong, and resistant to crushing and kinking. Mechanically fixing the spring in place promotes the maintenance of the integrity of the tubing structure under axial stress, and the absence of the spring in the gas path reduces the biocompatibility or sterility requirements of the inner mold components.

[0381] The tube in Figure 3C is a substantially embedded structure. The tube in this embodiment is manufactured by passing an inner mold (such as a coil spring) through a crosshead extrusion die, thereby covering the outside of the inner mold (e.g., a spring) and extruding a polymer tube (tubular body). By using a take-up rate that achieves drawdown in combination with either internal vacuum or external positive pressure (or both), the polymer is drawn between the coils of the inner mold (e.g., a spring) until the inner mold is enclosed and mechanically fixed in place. The formed tubular body has a substantially corrugated shape (flexibility), and a pre-coated inner mold is not required to achieve bonding, although this option exists. The tubular body is at a temperature sufficient to self-fuse from the heat of extrusion by contacting itself once the inner mold is surrounded. In this regard, in Figure 3C, the fusion line or fusion region is indicated as W.

[0382] The tube in Figure 3D is a substantially heat-shrinkable structure. The tube is made by placing an inner mold (e.g., a coil spring) inside a tubular body of a certain length formed from thin-walled, heat-shrinkable tubing (or energy). When heat (or energy appropriate to cause the material to shrink) is then applied, the tubular body shrinks and adheres tightly to the inner mold (e.g., the spring), and in the spaces along the walls between subsequent wall sections supported by the inner mold, the shrinkage creates a corrugated shape. This results in a corrugated tube with inner mold (e.g., wire) reinforcement. The corrugation provides good flexibility. If the inner surface or inner surface of the tubular body is pre-coated with a suitable adhesive, the inner mold and the tube walls can be further bonded or connected to each other.

[0383] The tube in Figure 3E is a further alternative embodiment. A tubular body can be formed (e.g., by extrusion) and then passed through or pulled into the inner mold 110. Thus, the inner mold 110 can substantially surround the tubular body (i.e., the inner mold is outside the tubular body). See, for example, Figure 3E. The inner mold 110 serves to support or hold the tubular body 102 in a desired shape, form, or configuration. As with some of the other embodiments described herein, the inner mold 110 serves to define a series of alternating peaks and valleys, with the perimeter of the inner mold defining the valleys 105. Regions of the peaks 104 between the sections supported (by the inner mold 110) are not directly supported by the inner mold 110. The advantage of this structure and configuration is that the need to pre-coat the inner mold 110 for biocompatibility or sterility (e.g., hygienic) reasons is further reduced; however, such mold 110 may be pre-coated to reduce corrosion or other effects from environmental conditions.

[0384] Some advantages of coating the inner mold with a suitable material include: - The inner mold is securely fixed by the tubular body, which improves the overall strength and durability of the tube. - Increased resistance to swelling and degradation caused by exposure to chemicals, and strengthening of the tubular body. - The coating provides a biocompatible (or sterile) barrier or layer of material around the inner mold itself, thus broadening the range of acceptable materials that can be used for the inner mold, thereby improving biocompatibility or sterility (and also allowing the inner mold to be colored, enhancing aesthetics and / or product recognition). - The inner mold is protected from the contents of the tube (therefore reducing corrosion and / or other decomposition of the inner mold).

[0385] Coating the inner mold with a suitable material can help mitigate any tendency for the inner mold to separate from the tubular body when the bonding area is subjected to stress, such as when certain materials swell from exposure to certain chemicals (such as oils, alcohols, and / or cleaning agents), or when breathable materials are exposed to water vapor or aqueous solutions.

[0386] In various embodiments (e.g., Figures 1, 2, 3, 24A, and 24B), the inner mold supports the tubular body and resists narrowing and shrinkage of the tube lumen. The tubular body is advantageously formed from, formed with, or comprising a suitable polymer, such as a thermoplastic elastomer, a propylene-based elastomer, liquid silicone rubber (LSR), a breathable thermoplastic polyurethane, or a breathable polyamide. The polymer may be, but is not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, such as the thermoplastic elastomer family, such as styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, or breathable polyamides. Formation of the tubular body using a breathable material may also be utilized, thereby providing such medical tubing or circuit with the further advantage of breathability. Particularly preferred 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 fabricate nasal cannula devices, as will be described in more detail below.

[0387] The tubular body may be formed from, or contain, various thermoplastic polyurethanes, thermoplastic polyester elastomers, or liquid silicone rubber (LSR), including permeable grades. Advantageously, the selected material grade may have beneficial mechanical properties (such as durability, tear resistance, and high elasticity) and, optionally, good transparency to allow detection of any water accumulation within the tube.

[0388] The coating may be formed from the same material as the tubular body or from a different material. Advantageously, the coating 1111 may be chemically compatible with the tubular body 1102, allowing the coating 1111 and the tubular body 1102 to fuse together to form a bond that connects the inner mold 1110 to the tubular body 1102. The inner mold may be made from a suitable polymer of another material that is chemically compatible with the material of the tubular body 1102. In one embodiment, the coating 1111 may be made of an impermeable material (even if the tubular body 1102 is made of an impermeable material), thereby isolating the inner mold 1110 from any moisture in the lumen of the tube. Advantageously, both the tubular body and the coating may be made of, formed from, or contain durable thermoplastic polyurethanes (TPUs). If the tubular body is made of, formed from, or contains thermoplastic polyurethane, the coating may be made from, formed from, or contain various polymers. Advantageously, the polymer grade selected for the coating is tough and has good abrasion resistance, allowing for internal mold manipulation (such as spiral winding) after coating.

[0389] Furthermore, the tubular body can be formed by extruding or other means to minimize the wall thickness in order to lighten the tube and further improve its flexibility. The inner mold 110 can be manufactured from an elastic material that is suitable for further bending, such as a suitable metal or polymer.

[0390] Advantageously, embodiments of tubular bodies with minimal wall thickness help to promote improved tubular flexibility. Furthermore, such properties are beneficial for tubes formed from breathable materials, as the reduced or minimal wall thickness promotes breathability in such medical tubing. Such a combination of reduced or minimal wall thickness and the use of breathable materials can be particularly advantageous when used as part of a medical breathing circuit or system.

[0391] In this tube structure, the additional length of the suspended tubular body in the valleys between the reinforcing ribs of the inner mold 110 accumulates, increasing its extensibility.

[0392] As shown in Figure 3E of an alternative embodiment, extensibility is provided by the additional length of the suspended tubular body in the peaks between the valleys formed by the inner mold 110 acting on the tubular body.

[0393] The additional length of the wall allows for variations in the pitch of the internal mold, thus enabling the tube to be stretched and compressed longitudinally without significantly reducing the lumen. By shortening or straightening the additional length, the tube can be stretched and compressed longitudinally while minimizing tensile or compressive deformation or stress on the tube wall itself.

[0394] The flexibility of the tube can also be improved by varying the spacing between adjacent reinforcing ribs around the circumference of the tube to adapt to bending. When the rib spacing is varied circumferentially, the internal mold can expand and contract simultaneously on both sides of the tube in response to lumen bending, without tightening or kinking of the tube, while still satisfying the flexibility requirements defined by ISO 5367:2000(E) (4th edition, June 1, 2000).

[0395] In addition, the inner mold may be conductive. A conductive inner mold can facilitate a number of optional additional features for the operation or use of such tube. For example, the inner mold may be (or include) an electrically driven heater. For example, the inner mold may consist of one or more components.

[0396] In another embodiment, the internal mold may include one or more conductive members, electrically driven heaters, or sensors (e.g., flow sensors, temperature sensors, humidity sensors, pressure sensors, etc.).

[0397] In some embodiments, the tube may include a heater, such as an electrically driven heater (e.g., a heating wire, a heating circuit, etc.).

[0398] Heating or the provision of a heater can help maintain the humidity of one or more gases passing through the tube and other related components. Heating can also mitigate problems associated with "rainout." Providing sensors can, advantageously, help provide information feedback to an information feedback system or a user monitor or monitoring system that assists the associated heater control system.

[0399] It should also be understood that an internal mold 110 with a variable or changing pitch along the length of the tubular body may be provided.

[0400] In yet another aspect of the present invention, one or more inner molds 110 may be provided. In this way, a double-helix shaped inner mold or other configuration can be provided for supporting a tube, but while maintaining the flexibility and extensibility of such constituent tube.

[0401] As described above, and as shown, for example, in Figures 1-3E, Figure 24A, or Figure 24B, the medical tubing structures are particularly applicable to user interfaces where the interface is connected to the respiratory system by a short, dedicated length tube. The flexibility and extensibility of the tubing can compensate for patient movement, while the internal mold 110 resists narrowing of the gas lumen (e.g., tightening, kinking, and crushing) caused by forces resulting from this movement.

[0402] While tubing can be used for both adult and neonatal applications, it is well suited for neonatal interfaces where dedicated tubing is minimal. For example, a neonatal interface tube according to the exemplified structure may have an internal diameter (or lumen diameter) of approximately 1.5 mm to 4.5 mm, an external diameter of approximately 1.6 mm to 4.6 mm, and a wall thickness of approximately 0.05 mm to 0.25 mm. Preferably, the internal diameter is approximately 2.4 mm to 3 mm, the external diameter is approximately 2.6 mm to 3.4 mm, and the wall thickness is approximately 0.1 mm to 0.2 mm.

[0403] The internal diameter (or lumen diameter) of the tubular body may be approximately 1.5 mm to 4.5 mm, or approximately 1.6 mm to 4.4 mm, or approximately 1.7 mm to 4.3 mm, or approximately 1.8 mm to 4.2 mm, or approximately 1.9 mm to 4.1 mm, or approximately 2.0 mm to 4.0 mm, or approximately 2.1 mm to 3.9 mm, or approximately 2.2 mm to 3.8 mm, or approximately 2.3 mm to 3.7 mm, or approximately 2.4 mm to 3.6 mm, or approximately 2.5 mm to 3.5 mm, or approximately 2.6 mm to 3.4 mm, or approximately 2.7 mm to 3.3 mm, or approximately 2.8 mm to 3.2 mm, or approximately 2.9 mm to 3.1 mm. The internal diameter (or lumen diameter) may be approximately 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, or 4.5mm.

[0404] The outer diameter of the tubular body may be approximately 1.6 mm to 4.6 mm, or approximately 1.7 mm to 4.5 mm, or approximately 1.8 mm to 4.4 mm, or approximately 1.9 mm to 4.3 mm, or approximately 2.0 mm to 4.2 mm, or approximately 2.1 mm to 4.1 mm, or approximately 2.2 mm to 4.0 mm, or approximately 2.3 mm to 3.9 mm, or approximately 2.4 mm to 3.8 mm, or approximately 2.5 mm to 3.7 mm, or approximately 2.6 mm to 3.6 mm, or approximately 2.7 mm to 3.5 mm, or approximately 2.8 mm to 3.4 mm, or approximately 2.9 mm to 3.3 mm. The outer diameter may be approximately 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3.0mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4.0mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, or 4.6mm. Preferably, it is approximately 3mm to 5mm.

[0405] The wall thickness of the tubular body may be approximately 0.05 mm to 0.25 mm, or approximately 0.06 mm to 0.24 mm, or approximately 0.07 mm to 0.23 mm, or approximately 0.08 mm to 0.22 mm, or approximately 0.09 mm to 0.21 mm, or approximately 0.10 mm to 0.20 mm, or approximately 0.11 mm to 0.19 mm, or approximately 0.12 mm to 0.18 mm, or approximately 0.13 mm to 0.17 mm, or approximately 0.14 mm to 0.16 mm. The wall thickness may be approximately 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, or 0.25 mm. Preferably, it is approximately 0.1 mm to approximately 0.2 mm.

[0406] The tubular body may have a wave depth of approximately 0.1 mm to approximately 0.5 mm.

[0407] The waveform depth can be defined by the distance between the point of minimum radius from the longitudinal axis (centerline) of the tubular body and the point of maximum radius from the longitudinal axis (centerline) of the tubular body.

[0408] In one embodiment of the present invention, the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0409] In another embodiment, the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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 0.06.

[0410] In yet another embodiment, the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is approximately 0.05 to approximately 0.09.

[0411] Furthermore, in another embodiment, the physical properties of the tubular body may be required to contribute to the desired flexibility and / or structural support required for the tube.

[0412] This size of tubing is viable for dedicated neonatal applications because, despite its limited gas flow lumen, it can meet the maximum inspiratory flow requirements for newborns. The small and lightweight tubing reduces pressure on the infant's face and makes the interface less noticeable. The tubing's flexibility and weight increase user comfort and simplify the placement and adjustment of the interface by the physician.

[0413] The inner mold is preferably made from stainless steel wire, most preferably grade 302, 304, or 316, or other suitably elastic material having appropriate biocompatible or sterile properties, which can be wound around a helical frame of a suitable size that supports the tubular body. Ideally, the outer diameter of the helical frame is about 1.7 mm to about 4.4 mm, while the wire used to make the frame may have a diameter of about 0.05 mm to about 0.3 mm. The pitch of the helical frame is preferably about 0.4 mm to about 1.8 mm to provide the desired tubular flexibility, but may be about 1 mm to about 1.5 mm. Preferably, the outer diameter of the helical frame 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 pitch of the helical frame is about 0.8 mm to about 1.4 mm.

[0414] The outer diameter of the inner mold (e.g., a spiral frame) may be approximately 1.7 mm to 4.4 mm, or approximately 1.8 mm to 4.3 mm, or approximately 1.9 mm to 4.2 mm, or approximately 2.0 mm to 4.1 mm, or approximately 2.1 mm to 4.0 mm, or approximately 2.2 mm to 3.9 mm, or approximately 2.3 mm to 3.8 mm, or approximately 2.4 mm to 3.7 mm, or approximately 2.5 mm to 3.6 mm, or approximately 2.6 mm to 3.5 mm, or approximately 2.7 mm to 3.4 mm, or approximately 2.8 mm to 3.3 mm, or approximately 2.9 mm to 3.2 mm. The outer diameter of the spiral framework may be approximately 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

[0415] The diameter of the inner mold (for example, the wire used to make the framework) may be approximately 0.05 mm to 0.30 mm, or approximately 0.06 mm to 0.29 mm, or approximately 0.07 mm to 0.28 mm, or approximately 0.08 mm to 0.27 mm, or approximately 0.09 mm to 0.26 mm, or approximately 0.10 mm to 0.25 mm, or approximately 0.11 mm to 0.24 mm, or approximately 0.12 mm to 0.23 mm, or approximately 0.13 mm to 0.22 mm, or approximately 0.14 mm to 0.21 mm, or approximately 0.15 mm to 0.20 mm, or approximately 0.16 mm to 0.19 mm. The diameter of the wire used to construct the framework may be approximately 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, or 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, or 0.30 mm. Preferably, it is approximately 0.1 mm to approximately 0.4 mm.

[0416] The pitch of the internal mold (for example, a spiral frame) may be approximately 0.40 mm to 1.80 mm, or approximately 0.45 mm to 1.75 mm, or approximately 0.50 mm to 1.70 mm, or approximately 0.55 mm to 1.65 mm, or approximately 0.60 mm to 1.60 mm, or approximately 0.65 mm to 1.55 mm, or approximately 0.70 mm to 1.50 mm, or approximately 0.75 mm to 1.45 mm, or approximately 0.80 mm to 1.40 mm, or approximately 0.85 mm to 1.35 mm, or approximately 0.90 mm to 1.30 mm, or approximately 0.95 mm to 1.25 mm, or approximately 1.00 mm to 1.2 mm, or approximately 1.05 mm to 1.15 mm. The pitch of the spiral framework may be approximately 0.40 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.6 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.95 mm, 1.0 mm, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm, 1.3 mm, 1.35 mm, 1.4 mm, 1.45 mm, 1.5 mm, 1.55 mm, 1.6 mm, 1.65 mm, 1.7 mm, 1.75 mm, or 1.8 mm. Preferably, it is approximately 1 mm to approximately 1.5 mm.

[0417] In various embodiments of the present invention, the inner mold may be provided in a tubular body having a variable or changing pitch. Thus, the pitch of the inner mold may be a pitch that changes once it becomes part of the constituent tube. The changing pitch may have certain advantages, including an increase in the area of ​​strength / support or flexibility. Such a system may also be useful for supporting even thinner tubular bodies.

[0418] In yet another embodiment, the varying pitch makes it possible to change the density of the inner mold per unit length of the tube. Such a structure may be useful when the inner mold or components of the inner mold are provided for a gas passing through a lumen, or as a heat source or sensor for such a gas.

[0419] The inner mold 110 may include a single continuous winding of wire, or multiple windings joined together with ends attached, to form a helical framework, element, or rib. Alternatively, the inner mold may include multiple individual rings. The rings may be joined longitudinally along the tube. Wires, elongated polymers, or other suitable connectives (including multiple wires or elongated polymers) may extend along the lumen of the tube and join the rings. Multiple links may be spaced apart around the circumference of the rings.

[0420] For neonatal applications, the tubing provides an alternative to the transparent PVC tubing typically used for supporting nasal cannulas and supplying respiratory gases. Preferably, the user interface is supported independently of the interface tubing (e.g., a dedicated skin pad) so that the tubing can be more bent without restricting its movement.

[0421] Tubing manufacturing method In addition to the foregoing, medical tubing can be manufactured by providing a tubular body around an inner mold (or, in an alternative embodiment, by an inner mold around a tubular body). The tubular body generally defines a lumen enclosing the inner mold. During manufacturing, in one embodiment, a vacuum may be applied into (or relative to) the lumen, thereby drawing the tubular body radially inward around the outermost perimeter defined by the lumen and the inner mold. The outermost perimeter of the inner mold defines a series of alternating peaks and valleys along the length of the tubular body. The tubing may also be manufactured with a smooth outer surface as shown in Figure 24B. In another embodiment, during manufacturing, at least a portion or region of the tubular body enclosing the inner mold may be stretched (or elongated), so that when the stretching (or elongation) is released, the stretched (or elongated) portion or region of the tubular body returns (or becomes capable of being retracted) so that it is drawn back (or can be drawn back) radially inward toward the outermost circumference defined by the lumen and the inner mold, so that the outermost circumference defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0422] In yet another embodiment, the manufacturing of the tube may involve a combination of both applying reduced pressure to the lumen and stretching (or elongating) the tubular body.

[0423] Equipment for manufacturing reinforced medical tubing is illustrated in Figures 4 and 5. The illustrated equipment includes an extruder 310 and an associated die head 317. Raw materials (typically thermoplastic beads, but may be any other form of raw materials as a masterbatch) are fed into the extruder, where they are heated, pressed or passed through the die head 317 to form a tubular body of a medical tube 301, such as the tube discussed above. The tube 301 then passes through an air wipe 340, where compressed air is supplied over the tube 301 to cool the tubular body.

[0424] An apparatus can be used to grasp or extend (or lengthen) the tubular body. In this way, the tubular body is stretched over or around the inner mold, and then when the stretch (or lengthened state) is released, it becomes gripped by the inner mold and thus takes the shape of the outermost circumference defined by the inner mold.

[0425] Materials that may be used to form the tubular body include, as discussed above, thermoplastic elastomers, propylene-based elastomers, thermoplastic breathable polyester elastomers, liquid silicone rubber (LSR), and breathable thermoplastic polyurethanes, or breathable polyamides, for example, those with a Shore A of about 30 to about 90.

[0426] The raw material for the tubular body is fed, for example, into a hopper 312 mounted on top. The hopper 312 flows the raw material into the barrel of the extruder 310 under the influence of gravity or another suitable feeding system. A feed screw 313 is built into the extruder barrel and advances the material along the barrel to the die head 317. The feed screw 313 is connected to a rotary drive mechanism 314, which rotates the screw around its longitudinal shaft.

[0427] The material is heated to a molten or semi-molten state inside the barrel. The barrel may be actively heated, or the friction generated as the material moves along the barrel may be sufficient to melt the material.

[0428] Extruders suitable for the manufacture of medical tubing are supplied by Welex. Welex extruders, equipped with a screw with a diameter of 30-40 mm and an annular die head of 12-16 mm with a typical spacing of 0.5-1.0 mm, have been found to be suitable for high-speed production of low-cost tubing. Similar extruders are offered, for example, by American Kuhne (Germany), AXON AB Plastics Machinery (Sweden), AMUT (Italy), and Battenfeld (Germany and China).

[0429] To facilitate co-extrusion of the tube components, the raw material for the tubular body can be supplied tangentially to the die head 317. Next, as the inner mold moves through the die head 317, the tubular body is extruded onto the inner mold, and the molten or semi-molten tubular body can spread and cover the inner mold. The molten tubular body preferably adheres to the inner mold as it cools, fixing the tube components together.

[0430] In the exemplary embodiment, the die head 317 (shown in Figure 5) is configured to be positioned perpendicular to the barrel of the extruder 310, with its side port 320 positioned 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 head 317 and discharged into the outer periphery chamber. After exiting the outer periphery chamber, it enters the nozzle 325, through which the inner mold 302 is drawn. The pressure generated by the extruder 310 pushes the material around the inner mold 302 into the constriction 325, thereby directly extruding the tubular body 301 over the inner mold. Preferably, the inner mold advances continuously through the die head 317 at a substantially constant speed (however, the advance speed may be adjusted to vary the thickness along the tubular body at a constant extrusion rate).

[0431] Suction is applied to the inside of the die head through the vacuum port 321. The suction reduces the pressure in the lumen of the extruded tube, thereby drawing the molten or semi-molten tubular body around the inner mold and creating a corrugated surface on the outer surface of the tube. Preferably, the material of the tubular body adheres to the inner mold because it still retains sufficient tackiness from the extrusion process.

[0432] Depressurization within or relative to the lumen of the tubular body may be performed, for example, by applying vacuum pressure or depressurization to the lumen passage. Alternatively, the depressurization may be a relatively or comparatively reduced pressure. For example, the pressure around the tubular body may be increased such that the pressure inside the lumen is then lower than the pressure around the tubular body. In this way, the tubular body is subjected to a pressure difference that promotes it to be drawn (or pushed) radially inward. Thus, the pressure inside the lumen and outside the tubular body may be any suitable pressure such that the pressure inside the lumen is relatively lower than the pressure around the tubular body. Consequently, the inner surface of the lumen is then drawn (by the pressure difference) or pushed inward and comes into contact with the inner mold, thereby forming or taking the shape of the outermost perimeter of the inner mold in the embodiments shown in Figures 1, 2, 3 and 24A. Part of the tubular body may not be supported by the inner mold and may be drawn further radially inward than the outermost perimeter of the inner mold, thereby further emphasizing the shape defined by the inner mold.

[0433] If the inner mold is coated (for example, as used in the tubes in Figures 24A and 24B), the coating may need to be shielded from any excessive heat sources to avoid damage. In one detailed embodiment, the inner mold may be manufactured from a metal wire formed from medical-grade stainless steel (however, non-medical-grade materials with a biocompatible layer or an encapsulation coating that provides a sterile and corrosion-blocking wall may also be used). The wire can be encapsulated in a suitable coating by passing the wire through a material bath. The high temperature of the coating material in the bath can also partially sterilize the wire by killing any biological contaminants.

[0434] For example, coating a wire with a suitable polymer grade may involve passing the wire through a molten polymer bath at a temperature above 150°C, but may also be, for example, above 180°C or about 200°C (a temperature sufficient to coat the surface of the inner mold with the molten polymer). Once the coating has cooled sufficiently, the wire can be processed into an inner mold. The inner mold may be processed by winding the coated wire in a spiral around a mandrel.

[0435] In other examples, the inner mold may be coated or sealed by immersion in a polymer-containing bath or by an extrusion die head that applies the polymer to the inner mold.

[0436] Other applications It is anticipated that other medical applications in which this embodiment is particularly suitable may be found. For example, applications involving medical tubing that is lightweight and highly flexible, and has sufficient resistance to crushing, tightening, and kinking, may also include delivery and discharge rims of surgical humidification systems, as well as applications in which the use of breathable medical tubing is preferred.

[0437] User Interface The tube may be incorporated into a user interface for delivering respiratory gases to the user, such as a nasal cannula. Nasal interfaces incorporating the tube are shown in Figures 6 to 12. An illustrated interface 400 includes a pair of nasal prongs 402. Each prong 402 is connected to the end of the tube 401. The other end of the tube 401 is connected to a supply conduit, and the prongs 402 can be interconnected with the respiratory system. The tube 401 may be connected to individual supply conduits or may be joined together (e.g., by a Y-connector or other suitable connector, e.g., a manifold) to form a single connection with the supply conduits, facilitating the delivery of respiratory gases to the interface 400. An embodiment of the user interface 400 is shown fitted to an infant in Figure 12.

[0438] Each prong 402 defines a lumen extending between the user end 410 and the tubing end 415 of the prong 402. The tubing end 415 of the prong 402 connects the prong 402 to the interface tube 401. The user end 410 of the prong 402 is configured to deliver breathing gas to the user's nostrils and for this purpose incorporates an opening 411. The opening 411 may be concentric with the end of the prong 402 so as to minimize turbulence in the flow leaving the prong 402. The tubing end of the prong 402 can be anatomically shaped and / or closely matched to the user's nostril, and the end of the prong 402 (i.e., the end incorporating the opening 411) may be curved away from the septum so as to reduce the possibility of causing irritation, for example.

[0439] The user end 410 and tube end 415 of the prong 402 are connected by an arc-shaped elbow fitting. In the illustrated embodiment, the user end 410 and tube end 415 are positioned substantially perpendicularly, and the elbow fitting passes through approximately 90°. Advantageously, in one embodiment, the elbow fitting has a smooth transition between adjacent sections of the prong 402 (corresponding to a larger radius of curvature), which can minimize flow turbulence within the prong 402.

[0440] The interface tube 401 is connected to the tube end 415 of the prong 402. Preferably, the prong 402 is overmolded onto the tube 401 to provide an integrated component. In the exemplary embodiment, the tube end section 415 of the tube 401 and the prong 402 are arranged concentrically with the prong 402 that extends around the tube 401. Preferably, a large portion of the tube end section 415 is formed to cover the tube 401, thereby increasing the contact area and reinforcing the joint between the prong 402 and the tube 401.

[0441] The prongs 402 are preferably kept in a spaced-out relationship. In the illustrated embodiment, a backing material or harness 403 is connected to both prongs 402. The backing material 403 preferably holds the prongs 402 in a spaced-out relationship. Different sizes of interface 400 can be produced to accommodate variations in the spacing between the noses.

[0442] The illustrated backing material 403 also includes a housing 404 that generally encloses or captures at least a portion of the tubular end 415 of the prong 402. The housing 404 incorporates a coupling 405 that can be used to secure a headgear for holding the interface 400 in place. A pair of outriggers 406 project outward from the backing material 403 on both sides of the tube 401. The outriggers 406 increase the contact surface between the interface 400 and the patient, which distributes the force holding the interface over a larger area, thereby reducing the pressure applied to the user's face.

[0443] The contours of the user-facing side (i.e., the side that rests on the user's face) of the backing material 403 and outrigger 406 may be determined to reflect the expected anatomical structure. The backing material 403 and outrigger 406 may also be formed from a flexible material to adapt the structure to the face of a particular individual.

[0444] The outrigger may include a portion that allows the user (or caregiver) to more easily detach or peel the outrigger 106 from the user's skin or skin patch. Such a tab may improve the ease of application / removal of the interface from the user.

[0445] The housing 404 may incorporate a ribbed section between the front of the outrigger 406 and the portion of the housing 404 that connects to the prongs 402 and interface tube 401 (as shown in Figures 12 and 13). The ribbed section increases the interface contact surface available for adhesion of medical tape material when securing the interface 400 to the user. The ribbed section also increases the torsional rigidity of the outrigger, which helps stabilize the position of the prongs 402.

[0446] The prongs 402, backing material 403, and outriggers 406 are preferably manufactured from a suitable polymer. Preferably, individual cannulas (e.g., prongs 402 and tube 401) are manufactured by overmolding the prongs 402 around the outer surface of the tube 401. The overmolding method generally involves inserting the end of a pre-formed tube 401 into a suitable mold and injecting the material used to manufacture the prongs into the mold around the outer surface of the tube while keeping the tube 401 immobile. Advantageously, both prongs 402, backing material 403, and outriggers 406 are processed in a single overmolding step, forming a complete, integrated interface.

[0447] The configuration or design of the prongs can take various forms. In one preferred embodiment, the prongs and / or cannula, which are overmolded together with the delivery tube, may be as described in U.S. Patent Application Publication No. 2010 / 0192957, which is incorporated herein by reference as a whole.

[0448] Prong Another preferred geometric shape of the nasal prongs is schematically shown in Figures 25A–25D, shown in combination with a common base support and facet support pad in Figures 26A–26D, and shown in enlarged views in Figures 27A and 27B. The enumerated features of the prongs shown in these figures are identified by the same reference numerals as the same features present in previous figures (Figures 6–13) (however, prefixes are added to distinguish specific embodiments).

[0449] The geometric shapes of the prongs 1402 in Figures 25A to 25D are shown by sweep lines 1420 representing the prong trajectory and ellipses 1130 to 1135 representing the shape and orientation of the lumen within each prong at a particular trajectory. Each prong 1402 follows a sweep path whose shape is determined according to the anatomical geometric shape / curvature / contour of the user's nostril. The prongs are molded or shaped according to the anatomical shape and curvature of the user's nostril. Advantageously, the prongs can maximize the gap between the prongs and the internal structure of the external nostril by anatomically matching the path of the external nostril.

[0450] In one preferred form, the prongs are pre-molded or pre-formed according to the anatomical shape of the nostril, as opposed to prongs made of a material that can conform to the anatomical shape of the nostril.

[0451] The geometric shape of the exemplary prongs is described below in relation to how the interface is held on the user's face during use. The interface is positioned such that the prongs 1402 are arranged substantially symmetrically with respect to the user's sagittal plane. Each prong extends from a base 1415 positioned on a common support that extends along the user's upper lip. The prongs 1402 are spaced apart on the support to avoid the user's septum. The spacing between the prongs 1402 at the base 1415 is selected to provide the maximum gap between the prongs and the user's septum (below the nose) for the range of facial sizes to which each interface is adapted (i.e., for a given interface size).

[0452] The initial phase of each prong trajectory 1420 prior to the base 1415 is represented by ellipses 1130 and 1131 (first phase). During this phase, the prongs extend substantially coaxially with their respective breathing tubes. Both trajectories 1420 generally sweep along paths that extend from both sides of the sagittal plane toward the septum, following the user's upper lip. Prong 1402 sweeps slightly backward or backward relative to the user's upper lip (towards the user's coronal plane), as indicated by the rotation of the lumen (represented by the change in the orientation of ellipses 1130, 1131, and 1132). The internal flow path, defined by the shape of the lumen, remains approximately circular during this phase.

[0453] From the base 1415, each prong 1402 sweeps upward or superiorly toward the top of the user's head (away from the cross-section) and backward or posteriorly toward the user's upper lip (towards the user's coronal plane). Between the ellipsoids 1131 and 1133 (second phase), the lumens of the prongs smoothly transition from a substantially medial-lateral direction along the user's upper lip to a predominantly inclined posterior direction that guides the gas flow toward the upper posterior side of the user's head. The lumens of the prongs decrease slightly during this phase and become more elliptical, taking advantage of the available space within the nostrils.

[0454] In the third phase (between ellipses 1133 and 1134), the prongs continue to move along an inclined posterior trajectory toward the upper rear of the user's head (away from the transverse plane, toward the coronal plane), where the inclination rate smoothly decreases (the lumen is pulled away from the transverse plane by the upper component of the prong trajectory 1420). During this phase, the prongs 1402 may have a negligibly small convergence toward the sagittal plane (or medial-lateral component). The prong-lumen further decreases during this phase, gradually becoming elliptical.

[0455] In the final phase (between ellipses 1134 and 1135), the prong 1402 may continue along an inclined posterior trajectory, with some medial-lateral convergence toward the sagittal plane. The medial-lateral convergence of the prong 1402 begins at the indicated trajectory inflection point, adjacent to (or slightly before) the start of the fourth phase, which is adjacent to ellipse 1134. There is a second inflection point adjacent to the final ellipse 1135, which reduces the prong's convergence and directs the prong exit 1411 backward (towards the coronal plane) with a slight medial-lateral component toward the sagittal plane (as represented by the orientation of the final ellipse 1135 in Figure 25B).

[0456] The inclination of the prong trajectories 1420 continues to decrease during the fourth phase, until each trajectory 1420 is substantially parallel to the cross-section at the prong outlet 1411 (represented by the ellipse 1135). By adjusting the medial-lateral and vertical directions of the prong trajectories 1420 adjacent to the last ellipse 1135, the prong outlet 1411 is positioned substantially aligned with the upper airway passage, reducing soft tissue irritation caused by the expelled respiratory gases. The prong lumen is elliptical at the outlet 1411, with the major axis of the ellipse positioned substantially in the cross-section. The outlet 1411 directs the respiratory gases upward or superiorly towards the top of the user's head (away from the cross-section) and backward or posteriorly (towards the user's coronal plane).

[0457] The shape of the prong 1402 shown in Figures 13, 14, and 25-27 (both trajectory and lumen) avoids contact with the user's septal area, thus reducing the risk of tissue damage in this area. This prong improves user comfort and therapeutic efficacy by aligning the prong exit with the user's upper airway. The lumen shape maximizes the cross-sectional area of ​​the prong along its length while utilizing the anatomically available space in the patient's nostril to minimize flow resistance. The prong lumen is shaped to avoid sealing the user's nostril.

[0458] Each prong may be provided with an independent gas source. In this way, when a pair of prongs are used, one prong may supply respiratory gas while the other prong supplies a medicinal gas, such as a gas used for respiratory therapy or to improve the user's respiratory condition.

[0459] Such anatomical prongs may have a modified trajectory that conforms to the anatomical shape of the user's nostrils. In the first part (or phase) of the prongs, the trajectory moves horizontally toward the midline of the face. In the second part (or phase) of the prongs, the trajectory curves upward toward the top of the head and directly into the nostrils. In the third part (or phase) of the prongs, the trajectory rewinds to enter the head, following the anatomical curvature of the nostrils. And in the fourth part (or phase), the trajectory tilts horizontally toward the center of the cannula, with the outlet aligned with the user's upper airway.

[0460] Such anatomically shaped prongs have a cross-section that changes along the central locus. For example, the cross-section is approximately circular at the base of the locus and becomes approximately elliptical towards the end of the locus or prong. Furthermore, the cross-sectional diameter generally decreases along the locus from the end of the first part (or phase) to the end of the fourth part (or phase).

[0461] The prongs are preferably made from a soft, flexible material to further reduce trauma to the soft tissues of the nostrils. Examples of possible materials include biocompatible thermoplastic elastomers or liquid silicone rubber (LSR).

[0462] A nasal interface 1400 incorporating the prongs 1402 is shown in Figures 26A–26D, 27A, and 27B. This interface includes the nasal prongs 1402 and a common support, which supports the prongs 1402, a pair of outriggers or facet pads 1406, and integrated tubing 1401, extending below the nose along the user's upper lip and spaced substantially symmetrically with respect to the sagittal plane. The interface is formed as an integral or single component in which the tubing 1401 connects directly to the base 1415 of the prongs 1402. The distal opening end of each integrated tube 1401 is configured to receive a suitable breathing tube (e.g., tube 100). The breathing tube may be bonded to the interface tubing 1401 or otherwise secured. The facet pads 1406 are anatomically shaped with a distribution and scale of curvature that reflects the geometric shape of the target user's face. The anatomical shape of the facet pad 1406 provides the interface with positive engagement with the user's face in place, and the contour of the facet pad 1406 matches the contour of the user's face. The pre-formed facet pad 1406 complements the anatomical nasal prongs 1402 by improving the accuracy and speed at which the prongs 1402 can be placed and held within the user's nostrils.

[0463] By pre-shaping or contouring the face pad 1406 to match the user's facial features, the pressure applied to the user's face by any retention mechanism (adhesive tape, headgear, or other means) is reduced. This reduces the likelihood of pressure ulcers. The positive engagement facilitated by the anatomical shape of the face pad 1406 increases the stability of the interface 1400 and prongs 1402, thereby improving the comfort and efficacy of the administered treatment.

[0464] In a further embodiment, a nasal cannula device 2000 is provided, comprising at least one nasal prong 2001, each of which has a gas outlet 2002 configured to be inserted into one (or more) nostrils of the user, and a gas inlet 2003 fluidly coupled to the gas outlet 2001. At least one nasal prong 2001 comprises a backing material 2004, configured to rest on the user's face, with a lip 2005 extending over at least a portion of the periphery of the rear surface 2006 of the backing material 2004. The rear surface 2004 is configured to receive or hold a user interface patch 2007. During use, the user interface patch 2007 may be removably attached to or connectable to, or to, a skin patch 2008 that is fixed to, or can be fixed to, the user's face.

[0465] lip Lip 2005 can generally function as a barrier and may provide a seal, such as a fluid-tight seal. However, it will be understood that providing Lip 2005 as a physical barrier and not necessarily a fluid-tight seal may be sufficient to prevent most fluids (such as nasal or oral mucus, or breast milk or fluids used to wash the user's face) from seeping from the underside of the backing material 2004 to the rear surface 2006.

[0466] Advantageously, the lip 2005 prevents most of the fluid from seeping from the underside of the backing material 2004 to the rear surface 2006. Otherwise, such seepage could impair the adhesion or connection between the user interface patch 2007 and the user's face or the skin patch 2008 applied to the user's face. Such a series of patches provides a fixation system for positioning the cannula relative to the user's nostrils or for facilitating the positioning of the nasal cannula in a preferred position or location. Such fluid seepage could clog the interface-facing surface of the user interface patch 2007 or the skin patch; such patch surfaces could then become foul-smelling, or generally slimy or unsanitary. Such problems are unpleasant for the user or their caregiver and may also affect the ability of such nasal cannula to remain in a preferred position, and should therefore be avoided wherever possible. The provision of a lip 2005 over the rear surface 2006 of the backing material 2004 is an attempt to minimize one or more of such harmful effects.

[0467] According to this embodiment, the lip 2005 may be deformable. For example, the lip 2005 may be shaped so that a portion of the lip that contacts the user's face or skin patch 2008 is bendable or flexible. This allows the lip 2008 to deform to more effectively match the shape it is in contact with when pressure is applied to the lip 2005, such as due to the engagement force between the user interface patch 2007 and the skin patch 2008, potentially increasing the likelihood of a more effective seal or fluid barrier.

[0468] Such lip 2005 may extend around (or part of) the backing material 2004, for example, around an area substantially adjacent to the associated prongs. For example, most of the fluid that the configuration of lip 2005 prevents from entering the rear surface of the backing material originates in the user's nasal or oral area. That is, nasal mucus coming out of one or more nostrils of the user's nose, or oral mucus coming out of the user's mouth, may drip back towards the backing material of the cannula (depending on the user's head position), or breast milk leaking from the mouth of a nursing infant may then drip onto the area surrounding the nasal cannula device 2000. Furthermore, splashing of water on the face of the infant or user may generate fluid that drips onto the area around or surrounding the cannula 2000.

[0469] Any such fluid (and other fluids not necessarily mentioned above) can affect the effectiveness of the fixation patch system used to secure or position the cannula to the user's face. Furthermore, negative effects resulting from foul odor or clogging of the fixation system patch with mucus (or slime) are undesirable.

[0470] Accordingly, in one embodiment, the priority is to provide a lip 2005 on the rear surface 2006 of the backing material 2004, extending at least from a region near or adjacent to the prongs 2001 or the user's nostrils to a region laterally away from there. In such an example, the lip 2005 may not extend around the entire perimeter of the backing material.

[0471] In other embodiments, the lip may be formed from a series of small or segmented lip portions that are joined together or not joined together to facilitate the formation of a barrier wall or seal. For example, as shown in Figure 35, a series of segmented lips may be provided that extend integrally, partially or entirely, around the rear surface 2006 of the backing material 2004. The lip 2005 may be provided or formed from a series of one or more individual lips as shown in Figure 35. Furthermore, such segmented lip portions may be adjacent to each other, joined together, or even overlapping each other in forming the lip 2005.

[0472] In this way, the lip can form a barrier or seal against the ingress of fluid.

[0473] However, it will be understood that Lip 2005 can be supplied to extend around the entire circumference of the backing material. In such a case, Lip 2005 can become an endless lip.

[0474] These lips may be formed (or treated to be) hydrophobic in nature or properties, thereby further promoting the reduction of liquid passing through the lip barrier.

[0475] The lip portion that comes into contact with the user's skin may be spoon-shaped. For example, the lip may have an external shape that effectively provides a pair of parallel, spaced-apart lips, an outer lip, and an inner lip as a whole. In this way, each of the pair of lips comes into contact with the user's skin, promoting the provision of a more effective barrier or seal against liquids. It will also be understood that a series of parallel lips may be utilized.

[0476] As previously stated, the backing material 2004 may take the form of a substantially planar, flattened, or even irregularly shaped backing material (such as a pre-formed curved surface as shown in Figures 28 to 34) configured to rest on the user's face. The backing material 2004 may generally extend laterally outward from at least one nasal prong 2001, away from the user's septum. Such backing material 2004 may serve to function as a stabilizer for one or more prongs 2001 in one or more nostrils of the user. In this regard, such backing material 2004 may include various rib features as described in other embodiments.

[0477] It will also be understood that the nasal cannula 2000 of this embodiment may have a pair of prongs 2001 for insertion into the user's nostrils, each prong 2001 having an adjacent or related backing material 2004. If a pair of prongs 2001 is provided, the prongs may be independent of each other, or, as described above in other embodiments, the prongs may be structurally connected to each other using a harness for further stability.

[0478] The cannula 2000 of this embodiment may further include various features of fluid-connected (or integrally formed) tubing 100, 200, 400, 1100 as described herein, and / or utilize user interface patch and skin patch fixation systems 500, 600 as described herein, and / or fluid-connect the gas inlet to the reinforced medical tubing 100, 200 as described herein. Furthermore, it will be understood that the prong 2001 may have any of the prong shapes or configurations described herein, including anatomically shaped prongs as referenced in Figures 25A to 27B.

[0479] One embodiment of the nasal cannula 2000 is shown in Figures 28 to 34.

[0480] Figures 28 and 29 show a cannula device 2000 having a backing material 2004 connected to a skin patch 2008 fixed to the user's face. A lip 2005 in contact with the skin patch 2008 is shown, thereby providing a barrier against fluids that, in the absence of such a barrier, could leak to the underside of the backing material 2004 and to the rear surface 2006 holding the user interface patch 2007. As shown, the user interface patch 2007 is located inside the lip 2005.

[0481] Figures 30 to 34 show the nasal cannula 2000 in more detail.

[0482] As shown in Figures 31 and 34, the rear surface 2006 may initially be provided without a user interface patch, i.e., the surface 2006 is configured to receive or hold a user interface patch 2007. Such a user interface patch 2007 may be bonded to the rear surface 2006 by an adhesive or other suitable bond. Once the patch is positioned in place, it is ready to bond to or receive a skin patch.

[0483] In one embodiment, the user interface patch may be one component of a two-part coupling system, such as the loop of a hook-and-loop system. In such an example, the interface-facing surface of the skin patch 2008 may consist of a hook that can engage with the loop of the user interface patch. See Figure 32, which shows the rear surface 2006 holding the user interface patch with the loop, ready to connect the hook of the skin patch.

[0484] Figure 33 shows a cross-section of the cannula 2000 through which the hook 2009 of the skin patch engages with the loop 2010 of the user interface patch. Also shown is the lumen 2011 or gas passage path for the gas supplied to the gas inlet of the cannula and delivered to the gas outlet 2002 of the prong 2001.

[0485] Fixed system Fixation systems for securing the user interface and / or user interface tubing to the patient are shown in Figures 15–17. An example of a fixation system 500 supporting a nasal cannula on the face of an infant is shown.

[0486] Advantageously, this system generally provides faster and improved or simplified ease of installation of the user interface to the user's operational position. Furthermore, these advantages may also contribute to improved or simplified ease of application of alternative user interfaces or removal of user interfaces from the user when the user is periodically administered various therapies (such as gas therapy, e.g., CPAP or high-flow application).

[0487] A certain type of user interface may be specifically provided through interaction with or adaptation of the system in the described embodiments. Alternatively, a non-modified user interface can be adapted by the described embodiments and positioned relatively easily and with minimal installation time.

[0488] In various embodiments provided by a fixed system, such a system can provide rapid positioning of the interface for the user, as well as reliable positioning of the interface.

[0489] The ability for users to easily position the user interface is particularly useful. Providing a system that allows caregivers (e.g., nurses) to apply the fixing system with one hand or without assistance is especially advantageous when the user of the interface is an infant.

[0490] In addition, in another embodiment, the fixation system provides the user with a first level of fixation of the user interface. For example, such first level of fixation may be as shown in Figures 15 to 17. If the user requires additional or enhanced security regarding the positioning or fixation of the user interface, a second level of interface fixation can be utilized. Such additional levels may include the application of an overpatch, such as one provided by patch 660. Such patch 660 may be an adhesive patch that is set up by being placed over the user interface and / or tubing and can adhere to a portion of the skin patch 550.

[0491] The fixing system 500 includes a two-part, releasable mounting or coupling device 551. The releasable coupling device 551 functions between a pair of patches, each fixed to a patient and user interface.

[0492] The first patch is a skin patch 550 that is adhered to or otherwise attached to the patient's skin. The skin patch has a user side that faces the user's skin and an interface side that faces the user interface. The user side of the skin patch 550 can be attached to the user's skin with a skin-friendly adhesive such as a hydrophilic colloid. The user interface side of the skin patch is provided with a first component 553 of a two-part releaseable attachment or coupling system 551.

[0493] The second patch is a 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 positioned adjacent to the skin patch when the system 500 is engaged. A complementary second component 553 of the two-part releasable attachment or coupling system is fixed to the patient side of the user interface patch 552, so that the respective components of the two-part releasable attachment or coupling system 551 can be easily engaged when the patches 550 and 552 are assembled together. The interface side of the user interface patch 552 is fixed to the user interface. The user interface patch may be integrated with the user interface, or preferably bonded to it.

[0494] A portion or corner of the user interface patch 552 may include an area that does not adhere to the skin patch 550. The schematic purpose of this is to provide an area (or tab) that can be easily grasped by the user or caregiver to remove or pull the interface away from the skin patch. For example, the backing material 2004 may also include such a corner area.

[0495] The two-part, releasable attachment or coupling device 551 may include a hook-and-loop material (such as Velcro), magnets or magnetic arrays with suitably arranged poles placed on each patch, an adhesive device that activates when the patches are biased toward each other, or another suitable releasable coupling mechanism. The interface side of the skin patch 550 may have one of the hook-and-loop materials, and the patient side of the user interface patch 552 may have the other of the hook-and-loop material, thereby enabling the skin patch and the user interface patch to be releasably attached to or coupled to each other.

[0496] When referring to hook-and-loop materials, it means any one of a wide variety of faceted mechanical fasteners. For example, the Velcro® product range includes hook-and-loop products in which the hook components consist of upright nylon hooks (formed as cut loops through a woven backing web) that engage with any complementary loop pile material. The Velcro® range also includes extruded hook products, typically smaller in size, which engage with "fluffy" non-woven fiber backing materials. These hook materials are designed to work with a wide range of loop substrates, and in some cases, these hook materials also function as loop substrates. Another similar system is the Dual-Lock® recloseable fastener system from 3M in St. Paul, Minnesota, USA. A common feature of these recloseable fastener systems is that any portion of the contact between the two parts of the system engages. Because numerous connectors are distributed across the entire surface of the product, it is not necessary to precisely align the individual connectors. In a detachable mounting system, a wide range of detachable fastener systems within this field can be used to provide a detachable mounting between the skin patch and the user interface.

[0497] The first component of a two-part, releasable mounting or coupling system may be bonded to the user interface side of the skin patch with a suitable adhesive, and may occupy up to 100% or less than about 90%, or about 85%, or about 75%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or about 10% of the interface-side surface area of ​​the skin patch.

[0498] According to some embodiments, the skin patch 550 is a substantially flat pad having a thickness that is significantly smaller than either its width or its length. In some embodiments, the shape of the pad is generally oval, but it may take other shapes.

[0499] The pad includes a first component 553 of a two-part releasable attachment system 551. In some embodiments, the skin patch structure is such that the first component 553 of the releasable attachment system includes a substrate and a number of fastener elements (including effective hooks, effective loops, or other elements) provided across the entire surface of the substrate. The substrate is fixed to the body of the skin patch. In some embodiments, the substrate is fixed by adhesive or by direct bonding during the formation of the skin patch.

[0500] In some embodiments, the substrate is smaller in area than the skin patch and is positioned on the skin patch so as not to reach any of its edges. In this way, the edges of the substrate extend from the edges of the skin patch all around its perimeter.

[0501] patch In some embodiments, the base material of the first component of a two-part removable mounting system is flexible, and therefore the plane of the base material can bend to conform to a surface curved in one direction. However, the base material is typically also inelastic and cannot conform to a surface curved in two orthogonal directions. However, a pad may have elasticity and shape conformability to a surface curved in two or more directions, such as when it is required to conform to the contour of the placement site on a patient.

[0502] According to some embodiments, this difficulty is mitigated by providing a first part 553 of a two-part releaseable attachment such that the base material is divided into regions by at least one slit or at least one slot, so that various parts of the base material can bend independently, allowing the overall shape of the base material to deform to substantially coincide with a bidirectionally curved surface. This may also apply if the base material is curved in only one direction at any individual location of the base material.

[0503] Examples of such shapes are shown in Figures 36B to 36R. The outer shape of the skin patch pad is shown in Figure 36A. This configuration is particularly useful for shapes where complex curvatures are most problematic, such as shapes where two or more bends are likely to intersect in the substrate. Typically, such shapes are rather thick, squat, bulky, short and thick, or short and bulky, rather than elongated. For example, this type of shape has a short perimeter relative to its area. If such a shape has a recess or depression around its perimeter, considering a virtual perimeter which is the shortest path enclosing the outside of the shape, this shape may exhibit a small ratio of the area of ​​the shape to the square of the length of this virtual perimeter. For example, the smallest ratio is shown by a circle with a ratio of approximately 12.6:1, a square has a ratio of approximately 16:1, and a rectangle with a ratio of 2:1 has a ratio of 18:1. The more elongated the shape, the larger the ratio; for example, a rectangle with a ratio of 5:1 has a ratio of 29:1 for the area to the square of the perimeter. In some embodiments, the improvements described in relation to Figures 36B to 36R are advantageously used for patch shapes where the ratio of the square length of the shortest enclosing perimeter to the area of ​​the inner perimeter is less than 25. In other embodiments, the improvements described in relation to Figures 36B to 36R are advantageously used for removable mounting substrate portions where the ratio of the square length of the shortest enclosing perimeter to the area occupied by the substrate is less than 25.

[0504] The substrate may be formed as multiple separate parts as shown in the modified examples in Figures 36A to 36R; however, the preferred form is a single continuous part for the substrate.

[0505] In some embodiments, the removable attachment substrate portion extends substantially over the entire area of ​​the skin patch 550. In other embodiments, the substrate portion extends over most of the area of ​​the skin patch, for example, 50% or more, 60% or more, 70% or more, or 80% or more of the area of ​​the skin patch.

[0506] Referring to Figure 36A, in some embodiments, the skin patch 550 includes a substantially elliptical or oval body 3602 having a small lateral extension 3600 at one end. In preferred embodiments, this shape does not have sharp corners. Rounded or curved corners or edges make it less likely to accidentally curl up compared to when there are sharp corners. In many exemplary embodiments of the fastener base material, the fastener base material includes an overall shape that generally matches the overall shape of the skin patch 550, including extending to the extended portion 3600.

[0507] In the embodiments illustrated in Figures 36B, 36F, 36G, and 36H, the substrate portion does not extend completely to the edge of the skin patch 550. A narrow area remains between the edge of the skin patch and the edge of the substrate around at least a portion of the edge. This narrow area extends around the entire perimeter of the substrate. In some embodiments, such as the embodiment in 36B, this area between the edge of the skin patch 550 and the edge of the substrate may be wider in some places than in others. For example, in Figure 36B, an extended area 3615 is provided at the end intended to be positioned away from the nose. This provides attachment retention in the area closer to the nose, but allows the user to begin prying to release the release fastener in the area further away from the nose. Similar configurations regarding the size and position of the substrate relative to the skin patch may be provided in other examples in Figures 36C–36R. For example, in any case, the configuration of this example can be made to cover a smaller area of ​​the skin patch and positioned closer to the nasal end of the skin patch.

[0508] Other embodiments illustrated may also be sized so as not to extend to the edges of the skin patch. Generally, in the embodiments of Figures 36B–36R, the base material portion includes a stocky overall shape that occupies a large proportion of the area within the stretched perimeter (the shortest path enclosing its shape). Generally, the base material portion is formed as a single body, but it may also be formed of a few bodies (e.g., two bodies) that are closely spaced and alternating, as in Figure 36R. Within the range of these bodies, the base material is divided into multiple parts and / or elongated shapes by at least one slot of the slit, so that adjacent parts (or small parts) of the base material portion are on opposite sides of the slit, slot, or gap. Depending on the arrangement of the slots, slits, gaps (or multiple slots, slits, or gaps), the base material may be able to stretch in one or more directions, in addition to the skin patch underneath curving or forming a complex curved surface. Some notable features and properties are described here with reference to various base material shapes and configurations.

[0509] In each case, a specific aspect of the embodiment is described. Many variations can be created using these aspects. Aspects of one embodiment can be easily combined with aspects of other embodiments. The arrangement of the slits or slots may be oriented in other directions, or they may be placed in a mirror image or inverted.

[0510] The substrate 3603 in Figure 36B is essentially meandering. The substrate has an end adjacent to the first end 3304 of the skin patch and a second end adjacent to or facing toward the second end 3305 of the skin patch. The substrate is formed in the shape of a series of switchback loops divided by slits 3306. The slits 3306 may be oriented perpendicular to the line between ends 3304 and 3305, or at some other angle. For example, the slits 3306 may be oriented at an angle such that the upper end of each slit is closer to the first end 3304 than the lower end of each slit, or conversely, 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. This meandering shape can provide a seamless shortest path between the first end of the substrate portion and the second end of the substrate portion, which is at least twice the actual straight-line distance between these locations.

[0511] The series of slits in the meandering shape provide sections with alternating meandering paths, and these sections can bend in different directions so that the substrate can substantially conform to the underlying complex curved surface. For example, the loopback section 3307 can bend independently of the straight section 3308, and the outer surface of the skin patch pad can be bent to become convex in two orthogonal directions.

[0512] The meandering shape of the substrate 3603 includes curved or rounded corners. Compared to sharp corners, curved or rounded corners are less likely to bend up easily, for example, due to careless contact. Similar improvements can be made to any of the embodiments shown in Figures 36B to 36R.

[0513] The substrate portion in Figure 36C is generally similar to the substrate portion in Figure 36B. This substrate portion 3309 is shown completely covering the skin patch. One end closes the first end 3304 of the skin patch, while the other end reaches the other end 3305 of the skin patch. A series of alternating slits 3310 extend alternately from each side of the substrate portion, resulting in a meandering body extending between ends 3304 and 3305. The substrate portion shown in Figure 36C exhibits essentially the same flexural characteristics as the substrate portion in Figure 36B.

[0514] The base material portion in Figure 36D shares essentially the same structure as the base material portion in Figure 36C, except that the base material portion 3311 in Figure 36D includes a slit 3312 whose upper end is further from the nasal end 3304 than its lower end, whereas the slits 3310 of the base material portion in Figure 36C have upper ends that are closer to the nasal end 3304 than their lower ends.

[0515] Other similar meandering shapes are provided by the substrate portion 3313 in Figure 36G and the substrate portion 3318 in Figure 36H. In each of these cases, narrow slots are provided to separate the substrate portion into a series of adjacent islands 3321 and 3322 along the length of the substrate portion. Slots 3318 and 3319 are wider than the slits in the previously described embodiments. A series of narrow bridges 3323 and 3324 connect the islands 3321 and 3322, so that the patch forms a continuous meandering structure. The continuous meandering structure or single-piece structure improves the ease with which the substrate portion can be positioned on the skin patch.

[0516] In the embodiment of Figure 36G, slot 3319 is oriented substantially perpendicular to the line between the ends 3304 and 3305 of the skin patch. In Figure 36H, slots 3320 are oriented such that their upper ends are closer to the nasal end 3304 than their lower ends—similar to Figure 36C. In these embodiments, the width of each bridge 3323, 3324 is significantly shorter than the length of the slot. For example, on average, the width of the bridge portion may be less than 0.2 or less than 0.1 of the average length of the slot.

[0517] Other meandering embodiments are described below with reference to Figures 36M, 36O, and 36E.

[0518] Another configuration of the substrate, including a series of islands connected by bridges, is shown in Figure 36F. In this embodiment, the substrate portion 3325 includes islands 3326 and slots 3327. Bridges 3328 connect the islands. In the exemplary embodiment, the bridge in Figure 36F is located along the centerline between ends 3304 and 3305. This configuration can be described as having a central member from which a series of leaf portions extend on both sides. In the exemplary embodiment, the slots 3327 extend inward by an equal distance from each edge. The slots are oriented substantially perpendicular to the line between ends 3304 and 3305. The slots 3327 extend inward from the edges in a straight line on both sides of the axis. Alternatively, the slots 3327 may be staggered. As with Figures 36H and 36B-36D, the slots 3327 may be oriented at an angle other than perpendicular to the line between ends 3304 and 3305.

[0519] In the configurations of Figures 36B, 36C, 36D, and 36F-36H, the slots or slits are oriented substantially parallel to each other. In the configuration of Figure 36E, a series of slits 3329 and 3330 extend from both sides of the substrate portion. In this embodiment, the first group of slits 3329 is oriented at an angle not parallel to the second group of slits 3330. In particular, in the exemplary embodiments, the upper end of slit 3329 is further from the edge 3304 of the skin patch than its lower end, while the upper end of slot 3330 is closer to the edge 3304 than its lower end. In some embodiments, the slits 3329 and 3330 pass through the centerline of the substrate portion (the centerline extending from the edge 3304 to 3305), and therefore there is no straight path between the edge 3304 and 3305 that is not cut by the slits 3329 or 3330. Slits 3329 and 3330 form a herringbone pattern.

[0520] The embodiments described with reference to Figures 36B to 36H had essentially regular patterns. Figure 36I illustrates an embodiment having a less regular pattern. In this embodiment, the base material portion 3331 extends substantially over the entire surface of the skin patch and is divided by one or more slits of an irregular configuration. For example, slit 3333 extends in a substantially S-shape from one edge adjacent to the end 3304, creating a series of alternating fingers from both sides of the base material portion 3331. A second slit 3333 extends from the edge of the base material adjacent to the end 3305 of the skin patch. The shape of this slit includes corners or bends and divides into intersecting slits 3335 at intersection 3334. Slits 3332 and 3333 divide the extent of the base material portion 3331 into areas or sections of substantially equal width having alternating fingers and long joining portions. In this embodiment, the slits are generally located on the inside of the base material portion 3331 and are connected to the edge of the base material portion 3331 at only two points.

[0521] Similar alternating finger configurations are seen in substrate portion 3336 in Figure 36J and substrate portion 3337 in Figure 36R. In substrate portion 3336 of Figure 35J, a single narrow slot 3337 with a narrow width extends in a winding path along the length of the substrate portion to an adjacent edge 3304 from the edge of the substrate adjacent to the end 305. In this embodiment, the single slot 3337 intersects the edge of the substrate 3336 at only one point. The slot 3337 divides the substrate portion 3336 into two main parts, each containing a series of fingers 3338 and 3339, respectively. The fingers 3339 and 3338 are arranged alternately. The position of slot 3337 and the orientation of the long leg 3340 between loopback portion 3341 result in fingers 3339 and 3338 that are oriented along a direction that crosses the line between ends 3304 and 3305, but at an angle to it.

[0522] In an alternative embodiment as shown in Figure 36R, a single meandering slot 3342 extends from the upper edge to the lower edge of the substrate portion 3337. The slot 3342 extends along a meandering path that includes a straight portion 3343 and a loopback end 3344. This divides the substrate portion 3337 into two laterally separated portions, each containing at least one elongated finger 3345. The fingers of one portion alternate with one or more fingers of the other portion. In this embodiment, the alternating fingers are oriented substantially parallel to a line extending between ends 3304 and 3305.

[0523] Another embodiment, including a single slot or slit, is shown in Figure 36K. In this embodiment, a single slit 3346 extends in a substantially spiral configuration from an edge location adjacent to the end 3305 to an end location approximately in the center within the base material portion 3347. This spiral slit 3346 divides the base material portion 3347 into a single continuous spiral base material. In some embodiments, multiple spiral slits may begin at various locations around the base material portion 3347, dividing the base material into multiple alternating spiral base material sections.

[0524] The embodiment in Figure 36Q includes substantially continuously curved slits, compared to the embodiments in Figures 36B-36J and 36R, which primarily use straight slits, although they sometimes include curved portions. Figures 36K-36P show embodiments of other substrate portions having curved slits.

[0525] In the embodiments shown in Figures 36K and 36L, the base material portions 3348 and 3349 are each divided by a plurality of curved slits 3350, which in both cases are arranged essentially on a series of concentric trajectories. Parts of the slits 3350 extend from the edges of the base material portions 3348 and 3349.

[0526] Other slots 3351 begin and end within the body of the substrate portions 3348 and 3359. For example, in substrate portion 3348, each slit 3351 forms an arc greater than 315° but less than 360°, creating circular and annular portions within the substrate portion 3348, which are connected to other parts of the substrate portion 3348 via thin bridges. Slits 3351 in substrate portion 3349 function similarly, creating circular and annular portions connected by thin bridges.

[0527] In Figure 36K, the arrangement of the slits 3350 and 3351, particularly the arrangement of the bridges between the portions thus divided by the slits, is such that a continuous, uninterrupted, winding path of material is provided between the ends 3305 and 3304 of the substrate portion and to the center 3352 of the substrate portion. In contrast, in Figure 36L, the arrangement of the curved slit 3350 and the substantially circular slit 3351 is such that the bridges are substantially aligned and a more direct path is provided between at least one end 3305 of the substrate portion and the center 3352 of the substrate portion.

[0528] Another series of embodiments are shown in Figures 36N to 36P. In this series, each of the substrate portions 3353, 3354, 3355, and 3356 is divided by a series of narrow, curved slots, each extending from either the upper or lower edge of the substrate portion into the body of the substrate portion. The series of curved slots in each substrate portion are arranged in parallel. In some embodiments, the spacing between the curved slots is substantially constant along the length of the substrate portion. In some embodiments, the slots extend over most of the width of the substrate portion, but not over the entire width of the substrate portion. For example, the slots may extend over more than 70%, 80%, or 90% of the width of the substrate portion. The slots may have rounded corners at their closed ends.

[0529] In the configuration shown in Figure 36M, a series of slots extend alternately from each side of the substrate portion, with slots 3357 and 3358 extending from the upper edge of the substrate portion, and slots 3359 and 3360 extending from the lower edge of the substrate portion. This divides the substrate portion into essentially winding lengths. In this embodiment, the curvature of each substrate slot is such that the upper and lower ends of each slot are further from the end portion 3304 than the central portion.

[0530] In the embodiment of Figure 36N, all four curved slots 3361 extend from the same edge of the substrate portion. This is reminiscent of a comb, where a series of fingers extend in the same direction from a single spine. As far as Embodiment 36N is concerned, in this example the slots are curved such that their upper and lower ends are further from the first end 3304 of the skin patch than their central portion.

[0531] Figure 36O illustrates a further embodiment similar to the embodiment in Figure 36N. In Figure 36O, curved slots 3362 and 3363 extend from the lower and upper edges, respectively, of the substrate portion. Slot series 3362 is arranged alternately with slot series 3363, resulting in a meandering or spiral continuous path along the substrate portion. In the embodiment of Figure 36O, the upper and lower ends of each curved slot are closer to the first end 3304 than the central portion of each curved slot.

[0532] Another modification is shown in Figure 36P. In this embodiment, the curved slots 3364 may extend from the same edge of the base material portion. They may extend from the upper edge or from the lower edge. All the curved slots 3364 are arranged in an essentially parallel configuration. The upper and lower ends of the curved slots are closer to the first end portion 3304 than their central portion.

[0533] Another embodiment of the user interface and / or tubing fixation system is shown in Figures 18 to 23. The fixation system 600 includes a skin patch 650 and a fixation patch 660. The fixation patch 660 extends over and covers the user interface and / or tubing and adheres to the skin patch 650 to fix the interface and / or tubing to the patient.

[0534] The skin patch 650 defines the area to be attached to the patient and has a configuration similar to the corresponding skin patch 550 in the previous fixation embodiment. The user side of the skin patch 650 is configured to adhere to or bond to the user's skin.

[0535] The fixation patch 660 extends over and covers the user interface and / or associated user interface tubing, and adheres to the skin patch 650 to fix the user interface to the patient. The fixation patch 660 and the skin patch 650 are configured such that, when this fixation system is applied to the patient with a suitable or compatible user interface, the fixation patch may be within or surrounded by the fixation area of ​​the skin patch. By the fixation patch 660 being within the fixation area of ​​the skin patch 650, the possibility of unintended contact with the patient's skin and potential irritation can be reduced. Ideally, the skin patch 650 has the same or a larger surface area than the fixation patch 660.

[0536] Similar to embodiments in which the interface includes a two-part, releasable attachment to the skin patch, in this embodiment including a fixing patch 660, the skin patch 650 is provided with elements of a coupling system for releasably coupling with the fixing patch 660. For example, the skin patch 650 may include one part of a two-part mechanical fastener system across or over its surface, and the fixing patch 660 may have the other part of the fastener system.

[0537] Thus, the skin patch is sized such that it reduces the likelihood of taping or any further taping extending over the user's skin. The application of adhesive to the user's skin, or repeated application and removal, is preferably avoided or minimized. This embodiment advantageously reduces the likelihood of adhesive or adhesive tape being repeatedly applied to the user's skin to position and retain the user interface in working position. Adhesive tape or other skin adhesive patches (when repeatedly applied and removed) can cause problems, particularly with infants. Problems include, but are not limited to, skin irritation (e.g., due to skin hypersensitivity) by adhesive chemicals (or adhesive removal chemicals, solvents, etc.) or tape materials, and damage to the user's skin resulting from repeated application and removal of skin patches or tape to position or reposition the interface relative to the user. Repositioning or adjustment may be necessary when treatment is performed periodically (i.e., changing from one type of treatment to another and then back again). Therefore, advantageously, the embodiments described provide a system for positioning or locating a user interface relative to a user, and further a system for reducing the potential problems associated with adhesive tape that adheres to the user's skin.

[0538] It must be understood that numerous drawbacks and problems exist in relation to repositioning interfaces, particularly infant interfaces. These include "snub nosing," epidermal abrasions, or skin allergies resulting from conventional taping techniques for applying user interfaces (e.g., nasal cannulas) to the user. Such problems also occur when users are periodically subjected to different treatment options, and subsequently, when the headgear or tape or user interface is removed and then a new device and user interface or interface positioning headgear or other gear is installed. Therefore, providing a fixation system that is in an immediately acceptable mode when applied to the user is a useful step in reducing the problems users have faced in the past. Furthermore, improvements in ease of installation, both in terms of complexity and the time and effort required of caregivers (e.g., nurses), would be even more beneficial.

[0539] The fixation patch may be shaped or otherwise configured to adapt to the geometric or other features of the user interface and / or associated user interface tubing. An illustrated fixation patch has a plurality of wings 661, the wings 661 underpinning the user interface tubing and increasing the contact surface of the fixation patch 660 exposed to the skin patch 650. The fixation patches illustrated in Figures 22 and 23 each have a pair of wings positioned at one end of the patch. The wings 661 are configured to secure to the skin patch on both sides of the user interface and / or associated user interface tubing, reducing the possibility of the fixation patch 660 bunching up around the interface and / or tubing.

[0540] The fixation patch 661 shown in Figure 22 also has a tube end wing 661. The tube end wing 661 is configured to extend under the user interface tubing and adheres to the skin patch 650, joining the ends of the fixation patch 660.

[0541] Both embodiments of these restraint systems can be used to secure the tubing to any part of the patient's body. The embodiments shown in Figures 15–23 are configured to attach the user interface to the patient's face, particularly adjacent to the user's upper lip and / or cheek. The illustrated restraint systems are suitable for neonatal applications.

[0542] The user side of the skin patches 550 and 650 preferably has a skin-friendly adhesive (such as a hydrophilic colloid) that adheres the patch to the user's skin, so as to minimize irritation caused by the application of each fixation system. The skin patches 550 and 650 preferably have a sufficient surface area so that the adhesive and interface retention force are distributed over an appropriate area of ​​the user's face, and local pressure increases are suppressed.

[0543] The exemplary fixation system is configured, in particular, to receive and / or fix the previously disclosed nasal cannula and associated tubing. The tubing may extend from one side of the user's face or from both sides. Furthermore, the fixation system may be combined such that the user interface is fixed to a skin patch by a two-part, releasable mounting or coupling device and a fixation patch positioned over the interface and / or tubing.

[0544] While this disclosure describes specific embodiments, other embodiments that would be obvious to those skilled in the art are also within the scope of this disclosure. Therefore, various modifications and improvements can be made without departing from the spirit and scope of this disclosure. For example, the positions of various components may be changed as desired. Furthermore, not all features, embodiments, and advantages of this disclosure are necessarily required for implementation. Accordingly, the scope of this disclosure is intended to be defined solely by the following claims.

[0545] It should be understood that the various embodiments described above with reference to the figures may be used in combination to achieve desired or beneficial results. For example, the tubes described may be connected to or attached to the cannulas of the present invention, or used in combination with other cannulas not specifically described herein. Similarly, the cannulas of the present invention may be used in combination with the fixation systems of the present invention, or in combination with or interchangeably with other retention systems. Furthermore, the anatomically shaped prongs of the present invention may be implemented in combination with the tubes, interfaces, or fixation systems described above, or in combination with or interchangeably with other tubes, interfaces, or fixation systems. There may be certain advantages associated with combining the various embodiments described above.

[0546] Desirable features SP1. A corrugated medical tube comprising: a tubular body defining a lumen extending between the open ends of the body; and an inner mold enclosed within the lumen and serving as a support for the tubular body, wherein the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0547] SP2. The tube according to claim SP1, wherein the tubular body is an extruded tube.

[0548] SP3. The tube according to claim SP1 or SP2, wherein the tubular body is a continuous tube.

[0549] SP4. A tube according to any one of claims SP1 to SP3, wherein the tubular body is a continuously extruded tube.

[0550] SP5. A tube according to any one of claims SP1 to SP4, wherein the peaks of the corrugated tubular body are defined by the outermost circumference of the inner mold.

[0551] SP6. A tube according to any one of claims SP1 to SP5, wherein the valleys of the corrugated tubular body are defined by portions of the tubular body that are drawn inward between the inner molds.

[0552] SP7. A tube according to any one of claims SP1 to SP6, wherein the inner mold is a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0553] SP8. The tube according to any one of claims SP1 to SP7, wherein the internal mold is one or a combination of a plurality of individual supports that are interconnected or connectable by one or more connecting links, such as a coil spring or helical element, a helical frame or helical rib, annular disc, a ring, or one or more connecting links.

[0554] SP9. A tube according to any one of claims SP1 to SP8, wherein the internal mold supports a tubular body that defines a lumen inside.

[0555] SP10. A tube according to any one of claims SP1 to SP9, wherein the inner mold is a framework or internal support structure that supports the tubular body.

[0556] SP11. A tube according to any one of claims SP5 to SP10, wherein the tubular body is substantially not supported by the inner mold in the valleys and is supported by the inner mold in the ridges.

[0557] SP12. A tube according to any one of claims SP5 to SP11, wherein the walls of the tubular body are suspended between adjacent mountains.

[0558] SP13. The tube according to any one of claims SP5 to SP12, wherein the tubular body is a polymer, for example a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0559] SP14. The tube according to any one of claims SP1 to SP13, wherein the tubular body is a breathable tube, or is formed from or made of one or more breathable materials such as breathable thermoplastic polyurethane or breathable polyamides.

[0560] SP15. A tube according to any one of claims SP1 to SP14, wherein the internal mold is a helical rib or a ribbed element.

[0561] SP16. A tube according to any one of claims SP1 to SP15, wherein the inner mold is a helical winding element having adjacent winding pitches of approximately 0.4 mm to approximately 2 mm, or approximately 0.5 to approximately 1.9 mm, or approximately 0.6 to approximately 1.8 mm, or approximately 0.7 to approximately 1.7 mm, or approximately 0.8 to approximately 1.6 mm, or approximately 0.9 to approximately 1.5 mm, or approximately 1 to approximately 1.4 mm, or approximately 1.1 mm to approximately 1.3 mm.

[0562] SP17. A tube according to any one of claims SP1 to SP16, wherein the inner mold has an outermost diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0563] SP18. A tube according to any one of claims SP1 to SP17, wherein the inner mold is a helical element having a diameter of approximately 0.05 mm to 0.3 mm, or approximately 0.06 to 0.29 mm, or approximately 0.07 to 0.28 mm, or approximately 0.08 to 0.27 mm, or approximately 0.09 to 0.26 mm, or approximately 0.1 to 0.25 mm, or approximately 0.11 to 0.24 mm, or approximately 0.12 to 0.23 mm, or approximately 0.13 to 0.24 mm, or approximately 0.14 to 0.23 mm, or approximately 0.15 to 0.22 mm, or approximately 0.16 to 0.24 mm, or approximately 0.17 to 0.23 mm, or approximately 0.18 to 0.22 mm, or approximately 0.19 mm to 0.21 mm.

[0564] SP19. The tube according to claim SP18, wherein the inner mold is made of medical-grade material, preferably medical-grade stainless steel.

[0565] SP20. A tube according to any one of claims SP1 to SP19, wherein the tubular body has a thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm.

[0566] SP21. A tube according to any one of claims SP1 to SP20, wherein the tubular body has an internal diameter of approximately 1.5 mm to approximately 4.5 mm, or approximately 1.6 to approximately 4.4 mm, or approximately 1.7 to approximately 4.3 mm, or approximately 1.8 to approximately 4.2 mm, or approximately 1.9 to approximately 4.1 mm, or approximately 2 to approximately 4 mm, or approximately 2.1 to approximately 3.9 mm, or approximately 2.2 to approximately 3.8 mm, or approximately 2.3 to approximately 3.7 mm, or approximately 2.4 to approximately 3.6 mm, or approximately 2.5 to approximately 3.5 mm, or approximately 2.6 to approximately 3.4 mm, or approximately 2.7 to approximately 3.3 mm, or approximately 2.8 to approximately 3.2 mm, or approximately 2.9 mm to approximately 3.1 mm.

[0567] SP22. A tube according to any one of claims SP1 to SP21, wherein the tubular body has an outer diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0568] SP23. The tube according to any one of claims SP1 to SP22, wherein the tubular body is one or a combination of a thermoplastic elastomer, a polypropylene-based elastomer, liquid silicone rubber (LSR), or a breathable thermoplastic polyurethane or breathable polyamide (preferably extruded therefrom), and more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., a styrene-based block copolymer, a copolyester elastomer, or a family of thermoplastic elastomers such as a thermoplastic polyolefin elastomer or a thermoplastic polyurethane elastomer, and even more preferably a polymer of 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.

[0569] SP24. A tube according to any one of claims SP1 to SP24, wherein the internal mold is a plurality of rings spaced apart longitudinally along the lumen.

[0570] SP25. The tube according to claim SP24, wherein the ring is toroidal or annular.

[0571] SP26. A tube according to any one of claims SP1 to SP25, wherein the internal mold is one or more individual elements connected to one another.

[0572] SP27. A tube according to any one of claims SP1 to SP26, wherein the internal mold includes a number of reinforcing ribs regularly spaced apart along the lumen.

[0573] SP28. The tube according to claim SP27, wherein each reinforcing rib comprises one turn of a helical reinforcing wire.

[0574] SP29. The tube according to claim SP28, wherein one turn of the helical reinforcing wire includes a complete one turn around the lumen of the tube.

[0575] SP30. The tube according to claim SP28, wherein one turn of a helical reinforcing wire includes a wire positioned between adjacent peaks of an inner mold.

[0576] SP31. A tube according to any one of claims SP1 to SP30, wherein the tubular body has flexibility as defined by passing a test of increased flow resistance due to bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0577] SP32. The tube according to any one of claims SP1 to SP31, wherein the end of the tube is integrated with a nasal prong, and the nasal prong is configured to be inserted into the user's nostril as a nasal interface for delivering respiratory gas to the user.

[0578] SP33. A tube as described in any one of claims SP1 to SP32, wherein the inner mold is mesh.

[0579] SP34. A tube according to any one of claims SP1 to SP33, wherein the inner mold is a conductor suitable for heating the gas inside the tube or for detecting the characteristics of the gas.

[0580] SP35. A tube according to any one of claims SP1 to SP34, wherein the inner mold is conductive, and preferably the inner mold is an electrically driven heater.

[0581] SP36. A tube according to any one of claims SP1 to SP35, wherein the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0582] SP37. The tube according to any one of claims SP1 to SP36, wherein the tube further includes a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0583] SP38. A tube as described in any one of claims SP1 to SP37, wherein the tube is a breathing tube.

[0584] SP39. A tube according to any one of claims SP1 to SP38, wherein the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0585] SP40. A tube according to any one of claims SP1 to SP38, wherein the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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.

[0586] SP41. A tube according to any one of claims SP1 to SP38, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is approximately 0.05 to approximately 0.09.

[0587] SP42. A tube according to any one of claims SP1 to SP38, wherein the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0588] SPM11. A method for manufacturing medical tubing, A step of providing an inner mold; a step of extruding a tubular body around the inner mold, wherein the tubular body defines a lumen surrounding the inner mold. A method that includes this.

[0589] SPM12.i) A step of applying a depressurization within (or relative to) a lumen, wherein the depressurization draws a tubular body radially inward around the outermost circumference defined by the lumen and the inner mold, so that the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body, or ii) A step of extending (or stretching) at least a portion or region of a tubular body enclosing an inner mold, wherein when the extension (or stretching) is released, the extended portion or region of the tubular body returns (or becomes capable of being retracted) so as to be drawn radially inward toward the outermost circumference defined by the lumen and the inner mold, and the outermost circumference defines a plurality of alternating peaks and valleys along the length of the tubular body, or iii) Combinations of i) and ii) The method described in SPM11, further including the method described in SPM11.

[0590] SPM13. The method according to claim SPM11 or SPM12, wherein the tubular body is provided by extrusion or by extruding material from a die head.

[0591] SPM14. The method according to any one of claims SPM11 to SPM13, wherein a reduction in pressure is applied in such a manner that a tubular body is pushed out around an inner mold and the inner surface of the tubular body is at least partially attached to or bonded to at least a portion of the inner mold, preferably the reduction in pressure is the difference between the pressure in the lumen and the pressure around the tubular body, and more preferably the pressure inside (or supplied to) the lumen is less than the pressure around the tubular body (or the pressure around the tubular body is greater than the pressure inside (or supplied to) the lumen).

[0592] SPM15. The method according to any one of claims SPM11 to SPM15, wherein the tubular body is a single-walled body.

[0593] SPM16. The method according to any one of claims SPM11 to SPM16, wherein a reduction in pressure is applied to or adjacent to the lumen component.

[0594] SPM17. The method according to claim SPM14, wherein a reduced pressure is applied to or adjacent to the die head.

[0595] SPM18. The method according to claim SPM14, wherein the lumens undergo a depressurization as they exit the extrusion die head.

[0596] SPM19. The method according to any one of claims SPM11 to SPM18, wherein a tubular body and an inner mold are co-extruded.

[0597] SPM110. The method according to any one of claims SPM11 to SPM18, wherein the tubular body thus formed is corrugated.

[0598] SPM111. The method according to any one of claims SPM11 to SPM110, wherein the peaks of the corrugated tubular body thus formed are defined by the outermost circumference of the inner mold.

[0599] SPM112. The method according to any one of claims SPM11 to SPM111, wherein the valleys of the corrugated tubular body thus formed are defined by inwardly retracted portions of the tubular body that are retracted inward between one or more inner molds.

[0600] SPM113. The method according to any one of claims SPM11 to SPM112, wherein the internal mold is a framework or internal support structure that supports the tubular body.

[0601] SPM114. The method according to any one of claims SPM11 to SPM113, wherein the internal mold is a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0602] SPM115. The method according to any one of claims SPM11 to SPM113, wherein the internal mold is mesh.

[0603] SPM116. One or a combination of internal coil springs or helical elements, helical frameworks or helical ribs, annular discs, rings, or a plurality of individual supports connected to or connected to each other by one or more connecting links, as described in any one of claims SPM11 to SPM113.

[0604] SPM117. The method according to any one of claims SPM11 to SPM116, wherein the internal mold serves as a support for or supports a lumen inside the tube thus formed.

[0605] SPM118. The method according to any one of claims SPM111 to SPM113 or SPM117, wherein the inner mold is a helical winding element having adjacent winding pitches of approximately 0.4 mm to approximately 2 mm, or approximately 0.5 to approximately 1.9 mm, or approximately 0.6 to approximately 1.8 mm, or approximately 0.7 to approximately 1.7 mm, or approximately 0.8 to approximately 1.6 mm, or approximately 0.9 to approximately 1.5 mm, or approximately 1 to approximately 1.4 mm, or approximately 1.1 mm to approximately 1.3 mm.

[0606] SPM119. The method according to any one of claims SPM111 to SPM113 or SPM117, wherein the inner mold has an outermost diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0607] SPM120. The method according to claim SPM118 or SPM119, wherein the inner mold is a helical element having a diameter of approximately 0.05 mm to 0.3 mm, or approximately 0.06 to 0.29 mm, or approximately 0.07 to 0.28 mm, or approximately 0.08 to 0.27 mm, or approximately 0.09 to 0.26 mm, or approximately 0.1 to 0.25 mm, or approximately 0.11 to 0.24 mm, or approximately 0.12 to 0.23 mm, or approximately 0.13 to 0.24 mm, or approximately 0.14 to 0.23 mm, or approximately 0.15 to 0.22 mm, or approximately 0.16 to 0.24 mm, or approximately 0.17 to 0.23 mm, or approximately 0.18 to 0.22 mm, or approximately 0.19 mm to 0.21 mm.

[0608] SPM121. The method according to claim SPM120, wherein the inner mold is made of medical-grade material, preferably medical-grade stainless steel.

[0609] SPM122. The method according to any one of claims SPM11 to SPM121, wherein the tubular body has a thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm.

[0610] SPM123. The method according to any one of claims SPM11 to SPM122, wherein the tubular body has an internal diameter of approximately 1.5 mm to approximately 4.5 mm, or approximately 1.6 to approximately 4.4 mm, or approximately 1.7 to approximately 4.3 mm, or approximately 1.8 to approximately 4.2 mm, or approximately 1.9 to approximately 4.1 mm, or approximately 2 to approximately 4 mm, or approximately 2.1 to approximately 3.9 mm, or approximately 2.2 to approximately 3.8 mm, or approximately 2.3 to approximately 3.7 mm, or approximately 2.4 to approximately 3.6 mm, or approximately 2.5 to approximately 3.5 mm, or approximately 2.6 to approximately 3.4 mm, or approximately 2.7 to approximately 3.3 mm, or approximately 2.8 to approximately 3.2 mm, or approximately 2.9 mm to approximately 3.1 mm.

[0611] SPM124. The method according to any one of claims SPM11 to SPM123, wherein the tubular body has an outer diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0612] SPM125. The method according to any one of claims SPM11 to SPM124, wherein the tubular body is a polymer, for example a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0613] SPM126. The method according to any one of claims SPM11 to SPM125, wherein the tubular body is any one or more of a thermoplastic elastomer, a polypropylene-based elastomer, a liquid silicone rubber, or a combination of one or more breathable thermoplastic polyurethanes or breathable polyamides (preferably extruded therefrom), and more preferably the polymer is a polymer of a family of thermoplastic elastomers such as polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and more preferably a polymer of 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.

[0614] SPM127. The method according to any one of claims SPM11 to SPM126, wherein the tubular body is a breathable tube, or is formed from or made of one or more breathable materials such as breathable thermoplastic polyurethane or breathable polyamides.

[0615] SPM128. The method according to any one of claims SPM11 to SPM127, wherein a reduced pressure is applied while the tubular body is in a molten, semi-molten, or uncured state, preferably the reduced pressure is about 0 to about -2 bar (absolute), more preferably about 0 to about -1 bar (absolute), and even more preferably up to about -0.9 bar (absolute), and even more preferably such reduced pressure is the pressure difference between the inside of the lumen and the area surrounding the tubular body.

[0616] SPM129. The method according to any one of claims SPM11 to SPM128, wherein the internal mold is conductive, and preferably the internal mold is an electrically driven heater.

[0617] SPM130. The method according to any one of claims SPM11 to SPM129, wherein the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0618] SPM131. The method according to any one of claims SPM11 to SPM130, wherein the tube further comprises a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0619] SPM132. The method according to any one of claims SPM11 to SPM131, wherein the tubular body thus formed has flexibility as defined by passing a test of increased flow resistance by bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0620] SPM133. The method according to any one of claims SPM11 to SPM132, wherein the medical tubing is a breathing tube.

[0621] SPM134. A tube according to any one of claims SPM11 to SPM133, wherein the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0622] SPM135. A tube according to any one of claims SPM11 to SPM134, wherein the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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.

[0623] SPM136. A tube according to any one of claims SPM11 to SPM135, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is approximately 0.05 to approximately 0.09.

[0624] SPM137. A tube according to any one of claims SPM11 to SPM136, wherein the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0625] SP21. A medical tube comprising a tubular body defining a lumen extending between the open ends of the body, an inner mold enclosed within the lumen and supporting the tubular body, and a coating enclosing the inner mold and fixing the inner mold to the tubular body.

[0626] SP22. The medical tube according to claim SP21, wherein the coating and tubular body are fused along the tube.

[0627] SP23. The medical tube according to claim SP21 or SP22, wherein the coating and the tubular body are fused together at discrete positions along the tube.

[0628] SP24. The medical tube according to claim SP22, wherein the coating and the tubular body are fused substantially continuously along the length of the tube.

[0629] SP25. A medical tube according to any one of claims SP21 to SP24, wherein the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0630] SP26. The tube according to claim SP25, wherein the peaks of the corrugated tubular body are defined by the outermost circumference of the inner mold.

[0631] SP27. The tube according to claim SP25 or SP26, wherein the valleys of the corrugated tubular body are defined by portions of the tubular body that are drawn inward between the inner molds.

[0632] SP28. A tube according to any one of claims SP21 to SP27, wherein the inner mold is of a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0633] SP29. A tube according to any one of claims SP21 to SP28, wherein the internal mold is one or a combination of a plurality of individual supports that are interconnected or connectable by one or more connecting links, such as a coil spring or helical element, a helical frame or helical rib, annular disc, a ring, or one or more connecting links.

[0634] SP210. A tube according to any one of claims SP21 to SP29, wherein the internal mold supports a tubular body that defines a lumen inside.

[0635] SP211. A tube according to any one of claims SP21 to SP210, wherein the internal mold is a framework or internal support structure that supports the tubular body.

[0636] SP212. A tube according to any one of claims SP25 to SP27, wherein the tubular body is substantially not supported by the inner mold in the valleys and is supported by the inner mold in the peaks.

[0637] SP213. A tube according to any one of claims SP25 to SP27, wherein the walls of the tubular body are suspended between adjacent mountains.

[0638] SP214. A tube according to any one of claims SP21 to SP213, wherein the tubular body is a polymer, for example, a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0639] SP215. A tube according to any one of claims SP21 to SP214, wherein the internal mold is a helical rib or a ribbed element.

[0640] SP216. A tube according to any one of claims SP21 to SP215, wherein the inner mold is a helical strip and the coating encapsulates the strip.

[0641] SP217. A tube according to any one of claims SP21 to SP216, wherein the inner mold is a helical metal wire and the coating encloses the wire.

[0642] SP218. A tube according to any one of claims SP21 to SP217, which provides a surface on which the coating readily adheres to a tubular body.

[0643] SP219. A tube according to any one of claims SP21 to SP218, wherein the inner mold is a helical winding element having adjacent winding pitches of approximately 0.4 mm to approximately 2 mm, or approximately 0.5 to approximately 1.9 mm, or approximately 0.6 to approximately 1.8 mm, or approximately 0.7 to approximately 1.7 mm, or approximately 0.8 to approximately 1.6 mm, or approximately 0.9 to approximately 1.5 mm, or approximately 1 to approximately 1.4 mm, or approximately 1.1 mm to approximately 1.3 mm.

[0644] SP220. A tube according to any one of claims SP21 to SP219, wherein the inner mold has an outermost diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0645] SP221. A tube according to any one of claims SP21 to SP220, wherein the inner mold is a helical element having a diameter of approximately 0.05 mm to 0.3 mm, or approximately 0.06 to 0.29 mm, or approximately 0.07 to 0.28 mm, or approximately 0.08 to 0.27 mm, or approximately 0.09 to 0.26 mm, or approximately 0.1 to 0.25 mm, or approximately 0.11 to 0.24 mm, or approximately 0.12 to 0.23 mm, or approximately 0.13 to 0.24 mm, or approximately 0.14 to 0.23 mm, or approximately 0.15 to 0.22 mm, or approximately 0.16 to 0.24 mm, or approximately 0.17 to 0.23 mm, or approximately 0.18 to 0.22 mm, or approximately 0.19 mm to 0.21 mm.

[0646] SP222. A tube according to any one of claims SP21 to SP221, wherein the inner mold is made of medical-grade material, preferably medical-grade stainless steel.

[0647] SP223. A tube according to any one of claims SP21 to SP222, wherein the tubular body has a thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm.

[0648] SP224. A tube according to any one of claims SP21 to SP223, wherein the tubular body has an internal diameter of approximately 1.5 mm to approximately 4.5 mm, or approximately 1.6 to approximately 4.4 mm, or approximately 1.7 to approximately 4.3 mm, or approximately 1.8 to approximately 4.2 mm, or approximately 1.9 to approximately 4.1 mm, or approximately 2 to approximately 4 mm, or approximately 2.1 to approximately 3.9 mm, or approximately 2.2 to approximately 3.8 mm, or approximately 2.3 to approximately 3.7 mm, or approximately 2.4 to approximately 3.6 mm, or approximately 2.5 to approximately 3.5 mm, or approximately 2.6 to approximately 3.4 mm, or approximately 2.7 to approximately 3.3 mm, or approximately 2.8 to approximately 3.2 mm, or approximately 2.9 mm to approximately 3.1 mm.

[0649] SP225. A tube according to any one of claims SP21 to SP224, wherein the tubular body has an outer diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0650] SP226. The tube according to any one of claims SP21 to SP225, wherein the tubular body is one or a combination of a thermoplastic elastomer, a polypropylene-based elastomer, one or more liquid silicone rubbers, or breathable thermoplastic polyurethanes, and more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrene-based block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and even more preferably a polymer of 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.

[0651] SP227. A tube according to any one of claims SP21 to SP226, wherein the internal mold is a plurality of rings spaced apart longitudinally along the lumen.

[0652] SP228. The tube according to claim SP227, wherein the ring is toroidal or annular.

[0653] SP229. A tube according to any one of claims SP21 to SP228, wherein the internal mold is one or more individual elements connected to one another.

[0654] SP230. A tube according to any one of claims SP21 to SP229, wherein the internal mold includes a number of reinforcing ribs regularly spaced apart along the lumen.

[0655] SP231. The tube according to claim SP230, wherein each reinforcing rib comprises one turn of a helical reinforcing wire.

[0656] SP232. The tube according to claim SP231, wherein one turn of the helical reinforcing wire includes a complete one turn around the lumen of the tube.

[0657] SP233. The tube according to claim SP231, wherein one turn of a helical reinforcing wire includes a wire positioned between adjacent peaks of an inner mold.

[0658] SP234. A tube according to any one of claims SP2 to SP233, wherein the tubular body has flexibility as defined by passing a test of increased flow resistance due to bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0659] SP235. The tube according to any one of claims SP21 to SP234, wherein the end of the tube is integrated with a nasal prong, and the nasal prong is configured to be inserted into the user's nostril as a nasal interface for delivering respiratory gas to the user.

[0660] SP236. A tube as described in any one of claims SP21 to SP235, wherein the inner mold is mesh.

[0661] SP237. A tube according to any one of claims SP21 to SP236, wherein the inner mold is a conductor suitable for heating a gas inside the tube or for detecting the properties of the gas.

[0662] SP238. A tube according to any one of claims SP21 to SP237, wherein the inner mold is conductive, and preferably the inner mold is an electrically driven heater.

[0663] SP239. A tube according to any one of claims SP21 to SP238, wherein the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0664] SP240. A tube according to any one of claims SP21 to SP239, wherein the tube further comprises a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0665] SP241. A tube as described in any one of claims SP21 to SP240, wherein the tube is a breathing tube.

[0666] SP242. A tube according to any one of claims SP21 to SP241, wherein the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0667] SP243. A tube according to any one of claims SP21 to SP242, wherein the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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.

[0668] SP244. A tube according to any one of claims SP21 to SP243, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is approximately 0.05 to approximately 0.09.

[0669] SP245. A tube according to any one of claims SP21 to SP244, wherein the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0670] STM21. A method for manufacturing a medical tubing, comprising the steps of providing an inner mold enclosed in a coating, and providing a tubular body around the inner mold, wherein the tubular body defines a lumen surrounding the inner mold, the method wherein the provision of the tubular body around the inner mold causes the coating and the inner surface of the tubular body to bond integrally, and the inner mold remains enclosed.

[0671] The method according to claim STM21, wherein the step of providing an inner mold includes the steps of providing an elongated mold enclosed in a coating suitable for application in medical tubing, and manufacturing an inner mold from the coated elongated mold that will serve as a support for a medical tube.

[0672] STM23. The method according to claim STM22, wherein an uncoated elongated mold is immersed in a coating material bath and an encapsulation coating is applied.

[0673] STM24. The method according to claim STM23, wherein the bath contains a molten polymer grade at a temperature of approximately 150°C or higher.

[0674] STM25. The method according to any one of claims STM22 to STM24, wherein the inner mold is manufactured by winding an elongated mold in a spiral shape to form a helical mold.

[0675] STM26. The method according to any one of claims STM22 to STM25, comprising the steps of providing an uncoated elongated mold and encapsulating the elongated mold in a coating suitable for application in medical tubing.

[0676] STM27.a) A step of applying a reduced pressure to (or relative to) a lumen, wherein the reduced pressure pulls the tubular body radially inward, or b) A step of extending (or stretching) at least a portion or region of a tubular body enclosing an inner mold, wherein when the extension (or stretching) is released, the extended (or stretched) portion or region of the tubular body returns to (or becomes capable of being retracted) radially inward, or c) Combinations of a) and b) The method described in any one of claims STM21 to STM26, including the method described in any one of claims STM21 to STM26.

[0677] STM28. The method according to claim STM27, wherein a tubular body is drawn radially inward around the outermost circumference defined by the lumen and internal mold, and the outermost circumference defines a plurality of alternating peaks and valleys along the length of the tubular body to form a corrugated tube.

[0678] STM29. The method according to any one of claims STM21 to STM28, wherein the tubular body is provided by extrusion or by extruding material from a die head.

[0679] STM210. The method according to any one of claims STM21 to STM29, wherein a tubular body is extruded around an inner mold and a reduction in pressure is applied in such a manner that the inner surface of the tubular body is at least partially attached to or bonded to at least a portion of the coating, preferably by reducing the pressure such that a difference is created between the pressure in the lumen and the pressure around the tubular body, more preferably the pressure inside (or supplied to) the lumen is less than the pressure around the tubular body (or the pressure around the tubular body is greater than the pressure inside (or supplied to) the lumen).

[0680] STM211. The method according to any one of claims STM21 to STM210, wherein a tubular body is provided around an inner mold at a temperature that causes the coating to bond to at least a portion of the tubular body.

[0681] STM212. The method according to any one of claims STM21 to STM211, wherein a tubular body is provided around an inner mold at a temperature that fuses the coating and the inner mold.

[0682] STM213. The method according to claim STM211 or STM212, wherein the tubular body is at least partially fused with the coating.

[0683] STM214. The method according to any one of claims STM21 to STM213, wherein the tubular body is a single-walled body.

[0684] STM215. The method according to any one of claims STM21 to STM214, wherein a reduction in pressure is applied to or adjacent to the lumen component.

[0685] STM216. The method according to claim STM215, wherein a reduced pressure is applied to or adjacent to the die head.

[0686] STM217. The method according to claim STM216, wherein the lumens undergo a depressurization as they exit the extrusion die head.

[0687] STM218. The method according to any one of claims STM21 to STM217, wherein a tubular body is extruded simultaneously with the manufacture of an inner mold from an elongated mold.

[0688] STM219. The method according to any one of claims STM21 to STM218, wherein the tubular body thus formed is corrugated.

[0689] STM220. The method according to claim STM219, wherein the peaks of the corrugated tubular body thus formed are defined by the outermost circumference of the inner mold.

[0690] STM221. The method according to claim STM29 or STM220, wherein the valleys of the corrugated tubular body thus formed are defined by inwardly retracted portions of the tubular body that are retracted inward between one or more inner molds.

[0691] STM222. The method according to any one of claims STM21 to STM221, wherein the internal mold is a framework or internal support structure that supports the tubular body.

[0692] STM223. The method according to any one of claims STM21 to STM222, wherein the internal mold is a continuous length, one or a series of semi-continuous lengths, or a series of discrete lengths.

[0693] STM224. One or a combination of internal coil springs or helical elements, helical frameworks or helical ribs, annular discs, rings, or a plurality of individual supports connected to or connected to each other by one or more connecting links, as described in any one of claims STM21 to STM223.

[0694] STM225. The method according to any one of claims STM21 to STM224, wherein the internal mold supports or supports the lumen inside the tube thus formed.

[0695] The method according to any one of claims STM21 to STM225, wherein the internal mold includes helical winding elements having adjacent winding pitches of approximately 0.4 mm to approximately 2 mm, or approximately 0.5 to approximately 1.9 mm, or approximately 0.6 to approximately 1.8 mm, or approximately 0.7 to approximately 1.7 mm, or approximately 0.8 to approximately 1.6 mm, or approximately 0.9 to approximately 1.5 mm, or approximately 1 to approximately 1.4 mm, or approximately 1.1 mm to approximately 1.3 mm.

[0696] STM227. The method according to any one of claims STM21 to STM226, wherein the inner mold has an outermost diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0697] STM228. The method according to any one of claims STM21 to STM227, wherein the inner mold is a helical element having a diameter of about 0.05 mm to 0.3 mm, or about 0.06 to 0.29 mm, or about 0.07 to 0.28 mm, or about 0.08 to 0.27 mm, or about 0.09 to 0.26 mm, or about 0.1 to 0.25 mm, or about 0.11 to 0.24 mm, or about 0.12 to 0.23 mm, or about 0.13 to 0.24 mm, or about 0.14 to 0.23 mm, or about 0.15 to 0.22 mm, or about 0.16 to 0.24 mm, or about 0.17 to 0.23 mm, or about 0.18 to 0.22 mm, or about 0.19 mm to 0.21 mm.

[0698] STM229. The method according to any one of claims STM21 to STM228, wherein the inner mold is made of a medical-grade material, preferably a suitable material, preferably a polymer-grade or medical-grade stainless steel coated with stainless steel.

[0699] STM230. The method according to any one of claims STM21 to STM229, wherein the tubular body has a thickness of approximately 0.05 mm to approximately 0.25 mm, or approximately 0.06 to approximately 0.24 mm, or approximately 0.07 to approximately 0.23 mm, or approximately 0.08 to approximately 0.22 mm, or approximately 0.09 to approximately 0.21 mm, or approximately 0.1 to approximately 0.2 mm, or approximately 0.11 to approximately 0.19 mm, or approximately 0.12 to approximately 0.18 mm, or approximately 0.13 to approximately 0.17 mm, or approximately 0.14 mm to approximately 0.16 mm.

[0700] STM231. The method according to any one of claims STM21 to STM230, wherein the tubular body has an internal diameter of approximately 1.5 mm to approximately 4.5 mm, or approximately 1.6 to approximately 4.4 mm, or approximately 1.7 to approximately 4.3 mm, or approximately 1.8 to approximately 4.2 mm, or approximately 1.9 to approximately 4.1 mm, or approximately 2 to approximately 4 mm, or approximately 2.1 to approximately 3.9 mm, or approximately 2.2 to approximately 3.8 mm, or approximately 2.3 to approximately 3.7 mm, or approximately 2.4 to approximately 3.6 mm, or approximately 2.5 to approximately 3.5 mm, or approximately 2.6 to approximately 3.4 mm, or approximately 2.7 to approximately 3.3 mm, or approximately 2.8 to approximately 3.2 mm, or approximately 2.9 mm to approximately 3.1 mm.

[0701] STM232. The method according to any one of claims STM21 to STM231, wherein the tubular body has an outer diameter of approximately 1.6 mm to approximately 4.6 mm, or approximately 1.7 to approximately 4.5 mm, or approximately 1.8 to approximately 4.4 mm, or approximately 1.9 to approximately 4.3 mm, or approximately 2 to approximately 4.2 mm, or approximately 2.1 to approximately 4.1 mm, or approximately 2.2 to approximately 4 mm, or approximately 2.3 to approximately 3.9 mm, or approximately 2.4 to approximately 3.8 mm, or approximately 2.5 to approximately 3.7 mm, or approximately 2.6 to approximately 3.6 mm, or approximately 2.7 to approximately 3.5 mm, or approximately 2.8 to approximately 3.4 mm, or approximately 2.9 to approximately 3.3 mm, or approximately 3 mm to approximately 3.2 mm.

[0702] STM233. The method according to any one of claims STM21 to STM232, wherein the tubular body is a polymer, for example a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubes (preferably extruded therefrom).

[0703] STM234. The method according to any one of claims STM21 to STM233, wherein the tubular body is any one or more of (preferably extruded from) one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, and more preferably the polymer is a polymer of the thermoplastic elastomer family, such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and more preferably a polymer of 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.

[0704] STM235. The method according to any one of claims STM21 to STM234, wherein a reduced pressure is applied while the tubular body is in a molten, semi-molten, or uncured state, preferably the reduced pressure is about 0 to about -2 bar (absolute), more preferably about 0 to about -1 bar (absolute), and even more preferably up to about -0.9 bar (absolute), and even more preferably such reduced pressure is the pressure difference between the inside of the lumen and the area surrounding the tubular body.

[0705] STM236. The method according to any one of claims STM21 to STM235, wherein the mold is conductive, and preferably the mold is an electrically driven heater.

[0706] STM237. The method according to any one of claims STM21 to STM236, wherein the internal mold includes a conductive member or an electrically driven heater or sensor (such as a flow rate, temperature, humidity, or pressure sensor).

[0707] STM238. The method according to any one of claims STM21 to STM237, wherein the tube further comprises a heater, more preferably an electrically driven heater (such as a heating wire or heating circuit).

[0708] STM239. The method according to any one of claims STM21 to STM238, wherein the tubular body thus formed has flexibility as defined by passing a test of increased flow resistance by bending in accordance with ISO 5367:2000(E) (4th edition, June 1, 2000).

[0709] STM240. The method according to any one of claims STM21 to STM239, wherein the medical tubing is a breathing tube.

[0710] STM241. The method according to any one of claims STM21 to STM240, wherein the tube is formed by co-extruding at least one helical reinforcing element together with a tubular body, and the tubular body has a continuous wall.

[0711] STM242. The method according to claim STM241, wherein a vacuum is applied to the lumen region of an extruded tubular body, thereby causing a continuous wall to form a corrugated shape around an inner mold.

[0712] STM243. The method according to claim STM241 or STM242, wherein the continuous wall being extruded is a single wall.

[0713] STM244. A tube according to any one of claims STM21 to STM243, wherein the ratio of the pitch 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 about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0714] A tube according to any one of claims STM21 to STM244, wherein the ratio of the inner diameter (e.g., the diameter of the actual inner element or member) 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.

[0715] STM246. A tube according to any one of claims STM21 to STM245, wherein the ratio of the corrugation depth to the outer (i.e., outer) tube diameter is approximately 0.05 to approximately 0.09.

[0716] STM247. A tube according to any one of claims STM21 to STM246, wherein the properties of the tubular body contribute to the desired flexibility and / or structural support required for the tube.

[0717] ST31. A medical tube comprising a tubular body defining a lumen extending between the open ends of the body, and an inner mold enclosed within the lumen and serving as a support for the tubular body.

[0718] ST32. The tube according to claim ST31, wherein the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0719] ST33. The tube according to claim ST31 or ST32, wherein the inner mold is sealed in a coating, and the coating fixes the inner mold to the tubular body.

[0720] STM31. A method for manufacturing medical tubing, A method comprising the steps of providing an inner mold, providing a tubular body around the inner mold, wherein the tubular body defines a lumen enclosing the inner mold, and i) applying a reduced pressure within (or relative to) the lumen, or ii) applying extension (or stretching) to at least a portion or region of the tubular body enclosing the inner mold, or iii) a combination of i) and ii).

[0721] STM32. The method according to claim STM31, wherein when a greater depressurization or greater extension (or stretching) or a combination thereof is applied, when a greater depressurization is applied or when the extension (or stretching) is released or both, the tubular body is drawn radially inward around the outermost circumference defined by the lumen and inner mold along the length of the tubular body, and the outermost circumference of the inner mold then defines a plurality of alternating peaks and valleys.

[0722] STM33. The method according to claim STM31 or STM32, wherein an inner mold is encapsulated in a coating, and a tubular body is provided around the inner mold so that the coating and the inner surface of the tubular body are integrally bonded, and the inner mold remains encapsulated.

[0723] TA1. A fixed system for user interface and / or user interface tubing, A fixation system comprising: a skin patch defining a fixation area, having a user side and an interface side, wherein the user side of the skin patch is configured to be attached to or adhered to the user's skin; and a fixation patch, wherein at least a portion of the fixation patch is configured to extend over and cover the user interface and / or associated user interface tubing, and fixes the user interface to the user by being fixed to the user interface side of the skin patch, wherein the fixation patch and the skin patch are configured such that when the fixation system is applied to a patient together with a suitable or compatible user interface, the fixation patch may be within or surrounded by the fixation area of ​​the skin patch.

[0724] TA2. The fixation system according to claim TA1, wherein the surface area of ​​the skin patch is equal to or greater than the surface area of ​​the fixation patch.

[0725] TA3. The fixing system according to claim TA1 or TA2, wherein the fixing patch is shaped to conform to the geometric or other features of the user interface and / or associated user interface tubing, or otherwise configured.

[0726] TA4. A fastening system according to any one of claims TA1 to TA3, wherein the fastening patch has at least one wing.

[0727] TA5. The fixation system according to any one of claims TA1 to TA4, wherein the fixation patch has a pair of wings positioned at one end of the patch, and these wings are configured to be fixed to the skin patch on both sides of the user interface and / or associated user interface tubing.

[0728] TA6. The fixation system according to any one of claims TA1 to TA5, wherein the fixation patch has a tube end wing, and the tube end wing is configured to extend or be made to extend to the underside of the user interface tubing and to be fixed to the skin patch.

[0729] TA7. The fixation system according to any one of claims TA1 to TA6, wherein the user side of the skin patch has a skin-friendly adhesive (e.g., a hydrophilic colloid) for attaching or bonding the skin patch to the user's skin.

[0730] TA8. The fastening system according to any one of claims TA1 to TA7, wherein the skin patch has a surface area sufficient to distribute the pressure or adhesive force of the fastening over the user's skin.

[0731] TA9. A fixation system according to any one of claims TA1 to TA8, wherein a skin patch is configured to adhere to or be attached to the face of the user.

[0732] TA10. The fixation system according to any one of claims TA1 to TA9, wherein the skin patch is configured to adhere to or be attached to the user's face adjacent to the user's upper lip and / or cheek.

[0733] TA11. A fixation system according to any one of claims TA1 to TA10, wherein the fixation system is configured to receive and / or fix a nasal cannula and / or associated tubing, the tubing extending from one or both sides of the user's face.

[0734] TA12. A restraint system according to any one of claims TA1 to TA11, wherein the restraint system is configured for use with an infant or neonatal.

[0735] TA13. The fixing system according to any one of claims TA1 to TA12, wherein the fixing system is configured to be used with a cannula as further defined by one or more of the following claims: COM1 to COM17, COMM11 to COMM19, or COM21 to COM216.

[0736] TA14. The fastening system according to any one of claims TA1 to TA13, wherein the fastening system is configured to be used with a tube as defined by any one or more of claims SP1 to SP38, SP21 to SP241, or ST31 to ST33.

[0737] COM1. A nasal cannula device comprising at least one nasal prong having one or more gas outlets configured to be inserted into the nostrils of a user, and one or more gas inlets fluidly connected to one or more gas outlets; and one or more corrugated gas delivery tubes, the tube comprising a tubular body defining a lumen, and an inner mold enclosed within the lumen, the inner mold supporting the tubular body, and the outermost circumference of the inner mold defining a plurality of alternating peaks and valleys along the length of the tubular body, wherein one or more gas inlets of the nasal prongs are integrally formed with the end of the tube, thereby fluidly connecting the tube lumen to one or more gas outlets of the nasal prongs.

[0738] COM2. The nasal cannula according to claim COM1, wherein the nasal prongs are shaped to substantially conform to the anatomical interior of the user's nose or nostrils.

[0739] COM3. The nasal cannula according to claim COM1 or COM2, wherein the nasal prongs are curved to avoid the user's septum, or are otherwise shaped or constructed.

[0740] COM4. A nasal cannula according to any one of claims COM1 to COM3, wherein the nasal cannula has a substantially planar, flattened, or irregularly shaped backing material configured to rest on the user's face as a stabilizing material for the prongs in the user's nostrils.

[0741] COM5. The nasal cannula according to claim COM4, ​​wherein one or more ribs extend between the front surface of the backing material and the cannula, the ribs providing contact surfaces for a tape or other suitable retainer used to fasten or attach the cannula to the user's face, preferably the tape including an adhesive portion or being an adhesive tape or contact adhesive tape.

[0742] COM6. A nasal cannula according to any one of claims COM1 to COM5, wherein two nasal prongs are integrally formed with a single waveform delivery tube.

[0743] COM7. A nasal cannula according to any one of claims COM1 to COM6, wherein the cannula comprises a pair of nasal prongs, each prong being integrally formed with, or attached to (or attachable to), or connected to (or connectable to) the terminus of a pair of one or more gas delivery tubes.

[0744] COM8. A nasal cannula according to any one of claims COM1 to COM7, wherein the cannula device is formed of a polymer, for example, a thermoplastic polymer, preferably one or more polymers suitable for medical respiratory tubes.

[0745] COM9. A nasal cannula according to any one of claims COM1 to COM8, wherein the cannula device is formed of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides, and more preferably the polymer is a polymer of the thermoplastic elastomer family, such as polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and more preferably a polymer of 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.

[0746] COM10. A user interface comprising a pair of nasal cannulas as described in any one of claims COM1 to COM9.

[0747] COM11. The user interface according to claim COM3, wherein the nasal prongs of each nasal cannula are positioned adjacent to each other, and each delivery tube extends in opposite directions away from the nasal prongs.

[0748] COM12. A user interface according to claim COM4, ​​further comprising a harness, wherein the harness extends between and connects nasal cannulas.

[0749] COM13. A nasal cannula as described in any one of claims COM1 to COM12, wherein the tube is a breathing tube.

[0750] COM14. A nasal cannula according to any one of claims COM1 to COM13, wherein the tube is defined by one or more of SP1 to SP38, SP21 to SP241, or ST31 to ST33.

[0751] COM15. A nasal cannula as described in any one of claims COM1 to COM14, wherein a tube is connected from one end of the cannula (e.g., left or right) to the gas inlet of the nasal prong (or both prongs).

[0752] COM16. A nasal cannula as described in any one of claims COM1 to COM14, wherein the tubing is connected to the gas inlet of the nasal prongs from both sides of the cannula (e.g., both the left and right sides).

[0753] COM17. A nasal cannula as described in any one of claims COM1 to COM16, wherein the cannula is a nasal cannula for an infant (or neonatal).

[0754] COMM11. A method for manufacturing a nasal cannula, comprising the steps of: providing an inner mold; extruding a tubular body around the inner mold, thereby defining a lumen in which the tubular body surrounds the inner mold; and attaching a nasal cannula thereto.

[0755] COMM12.i) A step of applying a depressurization within (or relative to) a lumen, wherein the depressurization draws a tubular body radially inward around the outermost circumference defined by the lumen and the inner mold, so that the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body, or ii) A step of extending (or stretching) at least a portion or region of a tubular body enclosing an inner mold, wherein when the extension (or stretching) is released, the extended portion or region of the tubular body returns (or becomes capable of being retracted) so as to be drawn radially inward toward the outermost circumference defined by the lumen and the inner mold, and the outermost circumference defines a plurality of alternating peaks and valleys along the length of the tubular body, or iii) Combinations of i) and ii) The method described in COMM11, further including the method described in COMM11.

[0756] COMM13. The method according to claim COMM11 or COMM12, comprising the step of overmolding nasal prongs onto the end of a tubular body.

[0757] COMM14. The method according to any one of claims COMM11 to COMM13, wherein the end of a tube thus formed by a tubular body is placed in a mold or form for molding or shaping a nasal cannula, preferably the mold or form is closed, and the nasal cannula is overmolded or shaped on its or a certain end of the tube.

[0758] COMM15. The method according to any one of claims COMM11 to COMM14, wherein the nasal cannula is a polymer, for example, a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

[0759] COMM16. The method according to any one of claims COMM11 to COMM15, wherein the nasal cannula is molded from any one or more of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides, and more preferably the polymer is a polymer of the thermoplastic elastomer family, such as polyolefins, thermoplastic elastomers, one or more liquid silicone rubbers, or breathable thermoplastic elastomers, for example, styrene-based block copolymers, copolyester elastomers, or thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, and more preferably a polymer of 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.

[0760] COMM17. The method according to any one of claims COMM11 to COMM16, wherein the tubular body is a breathable tube, or is formed from or made of one or more breathable materials such as breathable thermoplastic polyurethane or breathable polyamides.

[0761] COMM18. A nasal cannula mold is provided, which is capable of receiving the end portion of a tube formed in the manufacture of a tubular body, and so when the molding equipment is put into operation, a nasal cannula is molded, with a portion of it being overmolded onto the end portion of the tube, according to any one of claims COMM11 to COMM17.

[0762] COMM19. The method according to any one of claims COMM11 to COMM18, wherein a nasal cannula device, fabricated by a nasal cannula, is in fluid communication with the end of a tube formed in that manner by the manufacture of a tubular body.

[0763] COM21. A nasal cannula device comprising at least one nasal prong having one or more gas outlets configured to be inserted into the nostrils of a user, and one or more gas inlets fluidly connected to one or more gas outlets, and one or more gas delivery tubes comprising a tubular body defining a lumen, and an inner mold enclosed within the lumen, which serves as a support for the tubular body, wherein one or more gas inlets of the nasal prongs are integrally formed with the end of the tube, thereby fluidly connecting the tube lumen to one or more gas outlets of the nasal prongs.

[0764] COM22. The nasal cannula according to claim COM21, wherein the outermost circumference of the inner mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0765] COM23. A nasal cannula according to claim COM21 or COM22, wherein the prongs are shaped to conform to the anatomical curvature of the user's nostrils.

[0766] COM24. A nasal cannula according to any one of claims COM21 to COM23, wherein the nasal prongs are curved to avoid the user's septum, or are otherwise shaped or constructed.

[0767] COM25. A nasal cannula according to any one of claims COM21 to COM24, wherein the nasal cannula has a contoured backing material or facet pad configured to rest on the user's face, preferably as a stabilizing material for the prongs in the user's nostrils.

[0768] COM26. A nasal cannula according to claim COM25, wherein one or more ribs extend between the front surface of the backing material or facial pads and the cannula, the ribs providing a contact surface for a tape or other suitable retainer used to fasten or attach the cannula to the user's face, preferably the tape including an adhesive portion or being an adhesive tape or contact adhesive tape.

[0769] COM27. A nasal cannula according to any one of claims COM21 to COM26, wherein two nasal prongs are integrally formed with a single waveform delivery tube.

[0770] COM28. A nasal cannula according to any one of claims COM21 to COM27, wherein the cannula device is formed of liquid silicone rubber or a polymer, such as a thermoplastic polymer, preferably one or more polymers suitable for medical respiratory tubes.

[0771] COM29. A nasal cannula according to any one of claims COM21 to COM28, wherein the cannula device is formed of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, and more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, breathable polyester elastomers, or breathable thermoplastic elastomers, e.g., styrene-based block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, breathable polyester elastomers, and more preferably a polymer of 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.

[0772] COM210. A user interface comprising a pair of nasal cannulas as described in any one of claims COM221 to COM29.

[0773] COM211. The user interface according to claim COM210, wherein the nasal prongs are arranged adjacent to each other, and each delivery tube extends in opposite directions away from the nasal prongs.

[0774] COM212. User interface according to claim COM211, further comprising a harness, wherein the harness extends between and connects nasal cannulas.

[0775] COM213. A nasal cannula as described in any one of claims COM21 to COM212, wherein the tube is a breathing tube.

[0776] COM214. A nasal cannula according to any one of claims COM21 to COM213, wherein the tube is defined by one or more of SP1 to SP38, SP21 to SP241, or ST31 to ST33.

[0777] COM215. A nasal cannula according to any one of claims COM21 to COM24, wherein the tube is manufactured in a manner defined by one or more of the following: SPM11 to SPM133, STM21 to STM243, or STM31 to STM33.

[0778] COM216. A nasal cannula as described in any one of claims COM21 to COM215, wherein the prongs are glued to the tube or otherwise attached.

[0779] PWL1. A nasal cannula device comprising at least one nasal prong having a gas outlet configured to be inserted into the nostril of a user and a gas inlet fluidly coupled to the gas outlet, wherein at least one nasal prong comprises a backing material, and the backing material is configured to rest on the user's face, wherein a lip extends around at least a portion of the periphery of the posterior surface of the backing material, and the posterior surface is configured to receive or hold a user interface patch, so that during use, the user interface patch can be detachably attached to or coupled to a skin patch fixed to the user's face.

[0780] PWL2. A nasal cannula as described in claim PWL1, wherein the lip is a barrier.

[0781] PWL3. A nasal cannula according to claim PWL1 or PWL2, wherein the lip is deformable.

[0782] PWL4. A nasal cannula according to any one of claims PWL1 to PWL3, wherein the lip extends at least around an area substantially adjacent to the prongs relating to the backing material.

[0783] A nasal cannula as described in any one of claims PWL1 to PWL3, wherein the PWL5 lip is a series of one or more individual lip.

[0784] PWL6. The nasal cannula according to claim PWL5, wherein one or more individual lips are adjacent to, joined to, or overlap with the lip portion.

[0785] PWL7. A nasal cannula according to any one of claims PWL1 to PWL6, wherein the lip is an endless lip extending around the posterior surface of the backing material.

[0786] PWL8. A nasal cannula according to any one of claims PWL1 to PWL7, wherein, when in use, the lip forms a substantially fluid (or liquid) seal or fluid (or liquid) barrier between the rear surface of the backing material and the cannula-facing surface of the user interface patch.

[0787] PWL9. A nasal cannula according to any one of claims PWL1 to PWL8, wherein the backing material is substantially planar, flat, or irregularly shaped (such as a pre-formed curved surface) backing material configured to rest on the user's face.

[0788] PWL10. A nasal cannula according to any one of claims PWL1 to PWL9, wherein the backing material acts as a stabilizer for one or more prongs in one or more nostrils of the user.

[0789] PWL11. A nasal cannula according to any one of claims PWL1 to PWL10, wherein at least one backing material extends laterally laterally from at least one nasal prong, away from the user's septum.

[0790] PWL12. A nasal cannula according to any one of claims PWL1 to PWL11, wherein the cannula is further defined by one or more of the following: COM1 to COM17, COMM11 to COMM19, or COM21 to COM216.

[0791] PWL13. A nasal cannula according to any one of claims PWL1 to PWL12, wherein the cannula functions with a fixation system as defined by any one or more of claims TA1 to TA14.

[0792] A user interface patch that is receivable or retainable on the posterior surface of the backing material as defined by one or more of the claims PWL14.WP1 to WP15, and a nasal cannula as described in any one of the claims PWL1 to PWL13.

[0793] A nasal cannula according to any one of claims PWL1 to PWL14, wherein the gas inlet of the cannula is connected to or fluidly connected to a tube as defined by any one or more of the following: SP1 to SP38, SPM11 to SPM133, SP21 to SP241, STM21 to STM243, ST31 to ST33, STM31 to STM33.

[0794] PWL16. The interface according to any one of claims PWL1 to PWL15, wherein at least one or more lips are hydrophobic.

[0795] PWL17. The interface according to any one of claims PWL1 to PWL16, wherein at least one or more lips comprise at least one outer circumferential lip portion and at least one inner circumferential lip portion, each of which is provided for contact with the user's face.

[0796] WP1. A portion of a releaseable fastener includes a base material portion supporting mechanical fasteners dispersed across its surface, the base material portion being flexible but substantially non-stretchable, and the base material portion being divided into multiple sections by at least one slit or at least one slot, so that the divided and separate sections of the base material can bend independently, thereby allowing the base material to substantially conform to a complex curved surface on the underside.

[0797] WP2. The fixing system according to WP1, wherein the base material portion includes a plurality of slits or slots, or both, that divide the base material portion into a serpentine body.

[0798] WP3. The fastening system according to claim WP2, wherein the slits and / or slots are arranged in a substrate such that a first set of at least one pair of slits or slots extends from one edge of the substrate into the substrate, and a second set of slits or slots extends from the other edge of the substrate into the substrate, and the slits or slots of one set are arranged alternately with the slits or slots of the other set, so that the path along the portion of the substrate from one end to the other without intersecting the slits or slots follows a zigzag or meandering path that is significantly longer than a straight line between those ends.

[0799] WP4. A fastening system according to any one of claims WP1 to WP3, wherein one of the multiple slits or slots is curved.

[0800] WP5. A fastening system according to any one of claims WP1 to WP3, wherein multiple slits or slots are curved, and the curved slits or slots are arranged substantially parallel to each other.

[0801] WP6. A fastening system according to any one of claims WP1 to WP3, wherein the slits or slots are arranged in a herringbone pattern extending from the edge of the substrate portion.

[0802] WP7. The fixing system according to claim WP1, wherein the substrate is divided into portions separated by serpentine slits or slots.

[0803] WP8. The fixing system according to claim WP1, wherein the base material portion is divided into parts by spiral-shaped slits or slots.

[0804] WP9. The fixing system according to claim WP1, wherein the base material is divided into smaller parts by slits or slots arranged substantially concentrically.

[0805] WP10. The fixing system described in claim WP9, wherein the center of the concentric circles is approximately at the center of the base material.

[0806] WP11. The fastening system according to claim WP1, wherein slits or slots divide a substrate portion into multiple islands, each of which is connected to one or more adjacent islands by thin bridges.

[0807] WP12. The fixing system according to claim WP1, wherein the base material is divided into parts by an S-shaped slit.

[0808] WP13. The fixing system according to claim WP1, wherein the base material is divided into parts by a T-shaped slit.

[0809] WP14. The fixation system according to any one of claims WP1 to WP13, wherein the base material portion covers at least 70% of the area of ​​the skin patch.

[0810] WP15. A fixing system according to any one of claims WP1 to WP14, wherein the substrate portion covers at least 80% of the area within the boundary defining the shortest path surrounding the substrate.

[0811] WP16. A fixation system according to any one of claims WP1 to WP15, which can be used in conjunction with any one or more of the fixation systems TA1 to TA14, or the cannulas COM1 to COM17, or the cannulas PWL1 to PWL17, or the tubes SP1 to SP38, SP21 to SP241, or ST31 to ST33.

Claims

1. A nasal cannula assembly for delivering respiratory gas to the user, A pair of nasal prongs for insertion into a patient's nostrils, wherein each nasal prong of the pair defines a prong lumen extending between the user end and the tube end of each nasal prong, A pair of tubes, each tube supplying breathing gas to its respective nasal prong, each tube connected to the tube end of its respective nasal prong and including a tubular body defining a tube lumen, the tube lumen extending between the open ends of the tubular body, and an inner mold supporting the tubular body, the pair of tubes, A pair of face-contact pads, each of which extends laterally outward from its respective nasal prong, and each of which includes a rear surface, A fixing system associated with each rear surface, Including skin patches and user interface patches, The skin patch has a patient side and an interface side, the patient side of the skin patch is attachable to the user's skin with an adhesive, and the interface side of the skin patch is provided with a first fastener element. The user interface patch has a patient side and an interface side, the patient side of the user interface patch has a complementary second fastener element, and the interface side of the user interface patch is attached to the rear surface of each facet pad. The aforementioned fixed system includes, A nasal cannula assembly in which the first fastener element and the second fastener element are removably attached to attach the nasal cannula assembly to a patient.

2. The nasal cannula assembly according to claim 1, wherein each tube and each tube end of the nasal prong are arranged concentrically, and the nasal prongs extend around the tube.

3. The nasal cannula assembly according to claim 1 or 2, wherein the user end and the tube end of each prong are connected by an arc-shaped elbow joint end.

4. A nasal cannula assembly according to any one of claims 1 to 3, further comprising a harness connected to a pair of nasal prongs for holding the nasal prongs in a spaced-out relationship.

5. The nasal cannula assembly according to any one of claims 1 to 4, wherein each nasal prong is supplied with gas from its own separate tube.

6. The nasal cannula assembly according to any one of claims 1 to 5, wherein each nasal prong is shaped to extend generally upward and backward into the user's nostril.

7. The nasal cannula assembly according to any one of claims 1 to 6, wherein the internal mold defines a plurality of alternating peaks and valleys along the length of the tubular body.

8. The nasal cannula assembly according to any one of claims 1 to 7, wherein the tubular body is corrugated.

9. The nasal cannula assembly according to any one of claims 1 to 8, wherein the internal mold is a helical element.

10. The nasal cannula assembly according to claim 9, wherein the helical element is a helical metal wire.

11. The nasal cannula assembly according to claim 9 or 10, wherein the helical elements have a pitch between adjacent windings of about 0.4 mm to about 2 mm.

12. The tubular body is arranged around the inner mold, as described in any one of claims 1 to 11, for the nasal cannula assembly according to any one of claims 1 to 11.

13. The nasal cannula assembly according to any one of claims 1 to 12, wherein the first fastener element of the skin patch has one of a hook and one of a loop, and the second fastener element of the user interface patch has the other of a hook and one of a loop.

14. The nasal cannula assembly according to claim 13, wherein the skin patch includes a hook that can engage with the loop of the user interface patch.

15. The nasal cannula assembly according to any one of claims 1 to 14, wherein the skin patch includes a substantially oval-shaped body.

16. The nasal cannula assembly according to any one of claims 1 to 15, wherein the first fastener element includes a base material portion, the base material portion supports the first fastener element, and the base material portion is flexible but substantially non-stretchable.

17. The nasal cannula assembly according to claim 16, wherein the base material portion is divided by slots.

18. The tubular body is made of silicone, as described in any one of claims 1 to 17.

19. The nasal cannula assembly according to any one of claims 1 to 18, wherein the face-contacting pad is formed of a flexible material.

20. The nasal cannula assembly according to any one of claims 1 to 19, wherein the tubes are joined by a connector to form a single joint with a gas supply conduit.

21. The nasal cannula assembly according to any one of claims 1 to 20, wherein the skin patch includes a broad area without a substrate, and the broad area is positioned laterally away from the user's nose to facilitate the removal of the skin patch.

22. The nasal cannula assembly according to any one of claims 1 to 21, wherein the adhesive is a skin-friendly adhesive.

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