TW202045216A - A nasal cannula, conduit and securement system - Google Patents

Abstract

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

Description

Nasal cannula, catheter and fixation system Invention field

This disclosure generally relates to components of a medical system for delivering gas to and from a patient. In a specific aspect, this disclosure relates to catheters, more specifically, breathing tubes used for inhalation, exhalation and/or combined breathing limbs of the respiratory system. In another specific aspect, the disclosure relates to nasal cannulas and catheters that form part of the respiratory system. In another specific aspect, the disclosure relates to a nasal cannula that forms part of the respiratory system. In another specific aspect, the disclosure relates to positioning a patient interface such as a sleeve in an operating position for a user.

Background of the invention

In assisted breathing, breathing gas is supplied to the patient through a flexible breathing tube. The gas exhaled by the patient can be conducted through a similar breathing tube or out of the patient environment. The gas is typically administered to the patient via a user interface, and a short dedicated breathing tube may also be included to couple the interface and the breathing tube. The breath management of each root is thought to be light, resistant to kinking or pinching, but also flexible to ensure sufficient efficiency and comfort for the patient.

The size of the breathing tube is typically within about 10 mm to about 25 mm Part diameter boring (covering neonatal and adult use). The dedicated user interface tube can be smaller, with an internal diameter of approximately 2 mm for newborns. The small size of the dedicated user interface breathing tube makes it visually less invasive and reduces the weight on the patient's face. The breathing tube is preferably flexible, making it easy to bend and improving the comfort of the patient, which in turn improves the patient's compliance with the treatment.

For medical applications such as assisted breathing, the gas inhaled by the patient is preferably delivered at close to body temperature (usually 33°C to 37°C) and with relatively high humidity (usually close to saturation). In other medical applications, such as continuous positive pressure breathing assist (CPAP) systems or positive pressure ventilation systems to provide positive pressure breathing gas to patients suffering from obstructive sleep apnea (OSA), the breathing gas can be heated and/or Humidified to varying degrees to improve user comfort, or supplied without heating or humidification.

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

In addition, the gas supplied to the patient can be supplied through the nasal cannula. Especially in the case of babies and newborns, the flexibility of the connected tubes becomes an important consideration. Improving the flexibility of the tube that supplies the gas to the patient cannula helps to improve the comfort, and as a result, improves the compliance of the gas delivery process.

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

The patent specification, other external documents, or other information sources have been explained in the specification, usually to provide a context for discussing the characteristics of the disclosure. Unless otherwise specifically stated, the mention of these external documents is not an admission that these documents or other information are derived from prior art or constitute part of the common knowledge of the art industry in any case.

The other aspects and advantages disclosed in this article will be more apparent from the detailed description section below, which is only an example.

Summary of the invention

The purpose of this disclosure is to provide a component or a method of manufacturing a component that has made several improvements at least in relation to the foregoing description or will provide useful choices for the public or medical practitioners.

In the first aspect, this disclosure broadly includes a method for manufacturing a medical tube, the method includes providing an inner profile, extruding a tubular body of the inner profile, and the tubular system defines and surrounds the interior One of the lumen of the profile.

Preferably, the method further includes:

i) Applying a reduced pressure to (or to) the inside of the lumen, so that the reduced pressure draws the tubular body radially inward from the lumen or the outermost periphery defined by the inner profile. The outermost periphery defines a plurality of alternating peaks and valleys along a length of the tubular body, or

ii) applying an extension (or stretching) to at least a part or a region of the tubular body surrounding the inner profile, so that the release of the extension (or stretching) extends (or stretches) the tubular body Part or area returned (or permitted) in the management The cavity or the outermost periphery defined by the inner profile is drawn radially inward, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body, or

iii) A combination of one of i) and ii).

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

Preferably, the tubular body is extruded around the inner profile, and the manner of applying pressure allows an inner surface of the tubular body to become at least partly attached or connected to at least a part of the inner profile, preferably the tube The pressure difference between the pressure in the cavity and the pressure surrounding the tubular body. More preferably, the pressure inside the lumen (provided to the lumen) is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than The pressure inside the lumen (provided to the lumen).

Preferably the tubular body is a single-walled body.

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

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

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

Preferably, the tubular body and the inner profile are co-extruded.

Preferably, the tubular body thus formed is corrugated.

Preferably, the wave crests of the corrugated body formed in this way are defined by the outermost periphery of the inner profile.

Preferably, the wave troughs of the corrugated tubular body formed in this way are formed by the inwardly drawn portions of the tubular body that are drawn inwardly between the inner profiles Defined.

Preferably, the internal profile is a skeleton or internal support structure that supports the tubular body.

Preferably, the internal profile has a continuous length, one or a series of semi-continuous lengths, or a series of separate lengths.

Preferably the inner profile is a screen.

Preferably, the internal profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring, or are interconnected by one or more connecting rods or can be mutually connected. One or a combination of multiple separate supports connected.

Preferably, the inner profile is supportive or supports the lumen inside the tube thus formed.

Preferably, the inner profile is supported or supported by the lumen inside the tube thus formed.

Preferably, the inner profile is a spiral element or component.

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

Preferably, the inner profile is a spirally wound element (or member) having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about A pitch between adjacent turns of 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the distance between adjacent turns is about 1 mm to about 1.5 mm.

Preferably, the inner profile has a thickness of about 1.6 mm to about 4.6 mm, Or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to About 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or One of the outermost diameters of about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

Preferably, the inner profile is a spirally wound element having a thickness of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 Mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 Mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm One diameter. It preferably has a diameter of about 0.1 mm to about 1.5 mm.

Preferably, the internal profile is a medical grade material, preferably a medical grade stainless steel.

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

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

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

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

Preferably, the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

Preferably the diameter of the inner profile (e.g. the actual inner profile element (Or the diameter of the member) to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably the ratio is 0.06.

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

Preferably, the characteristics of the tubular body make it necessary for the tube to have the desired flexibility and/or structural support.

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

Preferably the tubular system is (preferably extruded from it) thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane , Or one or a combination of breathable polyamides; more preferably, the polymer may be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as a family of thermoplastic elastomers, such as styrene blocks Copolymer, copolymer elastomer, or thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; even more preferably having from about 30 to about 90, or from about 30 to about 80, or from 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 Shaw A polymer.

Preferably, the tubular body is an air-permeable tube or is made of an air-permeable material, such as air-permeable thermoplastic polyurethane or air-permeable polyamide.

Preferably, the reduced pressure is applied when the tubular system is in a molten state, or a semi-molten state, or an unhardened state, preferably the reduced pressure is from about 0 to about -2 Pa (absolute), more preferably It is about 0 to about -1 Pa (absolute), and even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably this pressure reduction is the inside of the lumen and around the tubular body Pressure difference in one of the zones.

Preferably, the internal profile is conductive, and preferably the internal profile is an electric heater.

Preferably, the internal molded part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

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

Preferably, the tubular system is defined as flexibility by passing a test according to ISO 5367: 2000(E) (fourth edition, June 1, 2000) that the flow resistance increases with bending.

Preferably, the medical tube is a breathing tube.

Preferably the inner profile contains one or more separate components.

Preferably the inner profile contains one or more components.

Preferably the tube contains one or more internal profiles. In the second aspect, it can be said that the present invention broadly consists of a medical tube, which includes:

A tubular body defining a lumen extending between the open terminals of the body, and

An inner profile that surrounds the inside of the lumen and supports the tubular body, and the outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

Preferably, the tubular body is an extruded tube.

Preferably, the tubular body is a continuous tube.

Preferably, the tubular body is a continuous extruded tube.

Preferably, the wave crests of the corrugated tubular body are defined by the outermost periphery of the inner profile.

Preferably the bellows body system is bounded by an inward extraction portion of the tubular body that is drawn inwardly between the internal profiles.

Preferably, the internal profile has a continuous length, one or a series of semi-continuous lengths, or a series of separate lengths.

Preferably, the internal profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring, or are interconnected by one or more connecting rods or can be mutually connected. One or a combination of multiple separate supports connected.

Preferably, the inner profile supports the tubular body to define the lumen inside.

Preferably, the internal profile is a skeleton or internal support structure supporting the tubular body.

Preferably, the tubular body is substantially not supported by the trough from the inner profile but is tied to the crest and supported by the inner profile.

Preferably, the wall of the tubular body is suspended between adjacent wave crests.

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

Preferably, the tubular body is a gas-permeable tube, or from or from a permeable tube Gas-permeable materials such as air-permeable thermoplastic polyurethane or air-permeable polyamides.

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

Preferably, the inner profile is a spiral element or component.

Preferably the inner profile has a pitch that varies along a length (or section) of the tube. Preferably, the inner profile is a spirally wound element having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or A pitch between adjacent turns of about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the distance between adjacent turns is about 1 mm to about 1.5 mm.

Preferably, the inner shape has a thickness of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 Mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 Mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

Preferably, the inner profile is a spirally wound element having a thickness of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 Mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 Mm, or a diameter of about 0.19 mm to about 0.21 mm. It preferably has a diameter of about 0.1 mm to about 1.5 mm.

Preferably, the internal profile is a medical grade material, preferably a medical grade stainless steel.

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

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

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

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

Preferably, the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

Preferably the ratio of the diameter of the inner profile (for example, the diameter of the actual inner profile element or component) to the outer diameter (for example the outermost diameter) of the inner profile is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, the best ratio is 0.06.

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

Preferably, the characteristics of the tubular body make it necessary for the tube to have the desired flexibility and/or structural support.

Preferably the tubular system is (preferably extruded from it) thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane , Or one or a combination of breathable polyamides; more preferably, the polymer may be such as but not limited to polyolefin, thermoplastic elastomer, or breathable thermoplastic elastomer Such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having from 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 of Shore A polymer.

Preferably, the inner profile is a plurality of rings spaced longitudinally along the lumen.

Preferably, the shape of the rings is toric or ring.

Preferably the inner profile is one or more separate elements linked to each other.

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

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

Preferably, one turn of the spiral reinforcement wire includes a complete turn around the lumen.

Preferably, one turn of the spiral reinforcement wire includes the wire located between adjacent crests of the inner profile.

Preferably, the tubular system is defined as flexibility by passing a test according to ISO 5367: 2000(E) (fourth edition, June 1, 2000) that the flow resistance increases with bending.

Preferably, a terminal of the tube is integrated with a nasal prong, and the nasal prong is adapted to be inserted into a user's nostril to deliver breathing gas to a user's nasal interface.

Preferably the inner profile is a screen.

Preferably, the internal profile is a wire suitable for heating or sensing the properties of the gas inside the tube.

Preferably, the internal profile is conductive, and preferably the internal profile is an electric heater.

Preferably, the internal molded part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

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

Preferably the tube is a breathing tube.

Preferably the inner profile contains one or more separate components.

Preferably the inner profile contains one or more components.

Preferably the tube contains one or more internal profiles.

In the third aspect, the present invention can be described as broadly composed of a nasal cannula configuration including:

At least one nasal prong having an air outlet adapted to be inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, and

A corrugated gas delivery tube, the tube includes a tubular body defining a lumen and an inner profile surrounding the lumen, the inner profile supporting the tubular body, and an outermost periphery of the inner profile defining an edge Multiple alternating peaks and valleys of one length of the tubular body,

The air inlet of the nasal prong is integrally formed with a terminal of the tube, so that the tube cavity is fluidly connected to the air outlet of the nasal prong.

Preferably, the nasal prongs are shaped to follow the shape substantially anatomically Inside the nose or nostril of a user.

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

Preferably, the nasal cannula has a substantially flat or flat or contoured backing that is assembled to rest on a user's face, preferably as a stabilizing member of the prong on a user's nostril.

Preferably one or more ribs extend between a front face of the backing and the sleeve, the ribs provide a thin strap or other suitable fixation used to buckle or attach the sleeve to a user's face One of the contact surfaces of the part, preferably the thin strip includes an adhesive part or is an adhesive tape or a contact adhesive tape.

Preferably the dinasal prongs are integrally formed with a single corrugated delivery tube.

Preferably, the sleeve includes a pair of nasal prongs, each prong is integrally formed with a terminal of a pair of gas delivery tubes, or can be attached (or attached) or connected (or can be connected) to the terminal .

Preferably, the sleeve configuration is made of a polymer such as a thermoplastic polymer, preferably a polymer or multiple polymers suitable for medical breathing tubes.

Preferably, the sleeve configuration is made of thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide. Any one or more of one or a combination; more preferably, the polymer may be such as, but not limited to, polyolefin, thermoplastic elastomer, or breathable thermoplastic elastomer such as a family of thermoplastic elastomers, such as styrene inlay Segment copolymer, copolymer elasticity Body, or thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; even more preferably having 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 of Shore A polymer .

In the fourth aspect, it can be said that the present invention broadly includes a user interface including a pair of nasal cannulas as defined by the third aspect.

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

Preferably, it further includes a wire harness that extends and couples between the nasal cannula.

Preferably the tube is a breathing tube.

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

In the fifth aspect, it can be said that the present invention broadly includes a method for manufacturing a nasal cannula, which includes:

Provide an internal model,

A tubular body is extruded to cover the inner profile, the tubular body defines a lumen surrounding the inner profile, and a nasal cannula is attached to it.

Preferably, the method further includes:

i) Applying a reduced pressure to (or to) the inside of the lumen, so that the reduced pressure draws the tubular body radially inward from the lumen or the outermost periphery defined by the inner profile. The outermost periphery defines a length along one of the tubular bodies Multiple alternating peaks and valleys of degree, or

ii) applying an extension (or stretching) to at least a part or a region of the tubular body surrounding the inner profile, so that the release of the extension (or stretching) extends (or stretches) the tubular body Part or area returns (or may permit) to be drawn radially inwardly from the outermost periphery defined by the lumen or by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body ,or

iii) A combination of one of i) and ii).

Preferably, the method includes sheathing a terminal end of the tubular body and molding a nasal prong.

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

Preferably, a terminal end of the tube thus formed by the tubular body is positioned in a mold or a mold for molding or forming a nasal cannula, preferably the mold or mold is closed, and the The nasal cannula is molded or shaped to cover the or a terminal end of the tube.

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

Preferably, the formed nasal cannula is made of thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide Any one or more of the amines or a combination is made; more preferably the polymer can be such as, but not limited to, polyolefin, thermoplastic elastomer, or breathable thermoplastic elastomer such as a family of thermoplastic elastomers, such as Styrene block copolymer, copolymer Or thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; even more preferably having 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 Shore A polymer.

Preferably the tubular body is a gas-permeable tube, or is made of or made of a gas-permeable material such as gas-permeable thermoplastic polyurethane or gas-permeable polyamide.

Preferably, a nasal cannula mold is provided which can receive an end of the tube formed by the manufacture of the tubular body, so that the operation of the mold assists the molding of the nasal cannula, and a part of the nasal cannula is The end of the tube is sheathed and molded.

Preferably, the nasal cannula configuration manufactured by the nasal cannula is in fluid communication with a terminal end of the tube formed by the manufacture of the tubular body.

In the sixth aspect, it can be said that the present invention broadly includes a fixing system for a user interface and/or user interface tube, which includes:

A skin patch defines a fixed footprint, the skin patch has a user side and an interface side, the user side of the skin patch is assembled to attach or adhere to the user's skin, and

A fixed patch, at least a part of the fixed patch is assembled to extend above the user interface and/or the connected user interface tube and fixed to the user side of the skin patch to fix the user interface to The user,

The fixing patch and the skin patch are assembled to serve as the fixing system When applied to the patient with a suitable or compatible user interface, the fixing patch can be contained in or bounded by the fixed footprint of the skin patch.

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

Preferably, the fixing patch is formed or otherwise assembled to adapt to the geometry or other characteristics of the user interface and/or the connected user interface tube.

Preferably, the fixing patch has at least one wing.

Preferably, the fixing patch has a pair of wings arranged at one end of the patch, and the wings are assembled to be fixed to a user interface and/or any side of the connected user interface tube Of the skin patch.

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

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

Preferably, the skin patch has a surface with sufficient area so that the surface distributes the attachment or adhesion pressure across the user's skin.

Preferably, the skin patch is assembled to attach or stick to a user's face.

Preferably, the skin patch is assembled to attach or adhere to a user's face, particularly adjacent to the user's upper lip and/or cheek.

Preferably, the fixing system is assembled to receive and/or fix a A nasal cannula and/or connected tube that extends from one or both sides of a user's face.

Preferably, the fixation system is assembled for a baby or newborn.

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

Preferably, the fixing system is configured to define a tube such as by the first and/or second orientation.

In the seventh aspect, it can be said that the present invention broadly includes a fixing system for a user interface and/or user interface tube, including a two-part releasable attachment or connection configuration, the configuration including a skin sticker 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 skin of a user (for example, by an adhesive, which is usually a skin-sensitive adhesive such as a hydrophilic colloid), The interface side of the skin patch is provided with the first part of a two-part releasable attachment or connection system, and

The user interface patch has an interface side and a patient side, and the patient side of the user interface patch is provided with the complementary second component of the two-part releasable attachment or connection system,

The interface side of the user interface patch can be attached or can be connected to the user interface and/or the connected user interface tube, for example by an adhesive or can be formed as a part of the user interface, or When the user interface is provided with the second component of the two-component system, it can be provided as the user interface. The back surface of the user interface.

Preferably, the interface side of the skin patch has one of a hook or a loop, and the second part of the second patch has the other of the hook or loop, so that the first and the first The two parts (and the patch) are releasably attached or connected to each other.

Preferably, the first patch can be positioned and/or attached to the facial skin of a user.

Preferably, the user interface patch can be positioned, or be attached or attachable, or be linked to or with a user interface.

Preferably, the user interface patch is integrally formed with a user interface or forms a part of the user interface.

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

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

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

Preferably, the skin patch has a surface with sufficient area so that the surface spreads the attachment pressure or adhesion across the user's skin.

Preferably the skin patch is assembled to attach or adhere to a The user's face.

Preferably, the skin patch is assembled to attach or adhere to a user's face adjacent to the user's upper lip and/or cheek.

Preferably, the fixation system is configured to receive and/or fix a nasal cannula and a connected tube, the tube extending from one or both sides of a user's face.

Preferably, the fixation system is assembled for a baby or newborn.

Preferably, the fixation system is configured for a nasal cannula such as defined by any one or more of the third aspect.

Preferably, the fixing system is configured to define a tube such as by the first and/or second orientation.

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

Preferably, the first component of the two-part releasable attachment or linking system includes a base that is fixed to or used to be fixed to the skin patch.

Preferably, the base portion includes at least one slit or at least one slot, with the base portion area separated by the slit or slot.

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

Preferably, the slits and/or slots are arranged on the base body so that the first set of at least one set of slits or slots is from an edge of the base body Extends into the base, and a second set of slits or slots extends into the base from the other edge of the base, the slits or slots of one set are the same as those of the other set The grooves intersect so that a path of the slits or notches along the base portion from one end to the other end without crossing a set follows a zigzag or serpentine path that is longer than a straight line between the two ends.

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

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

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

Preferably, the base system is divided into open parts by a serpentine slit or slot.

Preferably, the base part is divided into a plurality of parts by a spiral slit or slot.

Preferably, the base portion is divided into sub-sections by slits or slots arranged in substantially concentric circles.

Preferably, the isocentric circle is centered on approximately the center of the base portion.

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

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

Preferably, the base part is divided into a plurality of parts by a T-shaped slit.

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

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

In the eighth aspect, it can be said that the present invention broadly includes a method of manufacturing a medical tube, which includes:

Provide an internal part encapsulated in a coating layer, and

Provide a tubular body covering the inner profile,

The tubular system defines a lumen that surrounds the inner profile, and the tubular system is arranged to enclose the inner profile so that the coating layer and an inner surface of the tubular body are joined together, wherein the inner profile maintains Encapsulated.

Preferably, the step of providing an internal mold includes:

Provide an elongated member enclosed in a coating suitable for application to a medical tube, and

From the coated elongated part, one of the supporting internal parts for a medical tube is manufactured.

Preferably, the uncoated elongated member is immersed in a coating material bath to apply the encapsulating coating layer.

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

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

Preferably, the method further includes:

Provide an uncoated elongated part,

Encapsulating the elongated member is suitable for application to a coating layer of a medical tube.

Preferably, the method further includes:

i) applying a reduced pressure to (or to) the inside of the lumen, so that the reduced pressure draws the tubular body radially inward, or

ii) applying an extension (or stretching) to at least a part or a region of the tubular body surrounding the inner profile, so that the release of the extension (or stretching) extends (or stretches) the tubular body Part or area returns (or permits) radial inward extraction, or

iii) A combination of one of i) and ii).

Preferably the tubular body is drawn radially inward from the lumen or the outermost periphery defined by the inner profile, and the outermost periphery of the inner profile defines a plurality of alternating peaks along a length of the tubular body And peaks and valleys to form a bellows.

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

Preferably, the tubular body is extruded around the inner profile, and the manner of applying pressure allows an inner surface of the tubular body to become at least partly attached or connected to at least a part of the inner profile, preferably the tube The pressure difference between the pressure in the cavity and the pressure surrounding the tubular body. More preferably, the pressure inside the lumen (provided to the lumen) is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than The pressure inside the lumen (provided to the lumen).

Preferably, the tubular body surrounds the inner profile and is provided at a temperature such that the coating layer is connected to at least a part of the tubular body.

Preferably, the tubular system surrounds the internal profile to permit the The coating layer is welded to the inner profile at a temperature.

Preferably the tubular present system is at least partially fused with the coating layer.

Preferably the tubular body is a single-walled body.

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

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

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

Preferably the tubular system is extruded simultaneously with the manufacture of the inner profile from the elongated profile.

Preferably, the tubular body thus formed is corrugated (may be axial or spiral corrugation).

Preferably, the wave crests of the corrugated tubular body thus formed are defined by the outermost periphery of the inner profile.

Preferably, the wave troughs of the corrugated tubular body thus formed are defined by the inward extraction portions of the tubular body that are drawn inwardly between the inner profiles.

Preferably, the internal profile is a skeleton or internal support structure that supports the tubular body.

Preferably, the internal profile has a continuous length, one or a series of semi-continuous lengths, or a series of separate lengths.

Preferably, the internal profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring, or are interconnected by one or more connecting rods or can be mutually connected. One or a combination of multiple separate supports connected.

Preferably, the inner profile is supportive or supports the lumen inside the tube thus formed.

Preferably, the inner profile is a spiral element or component.

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

Preferably, the inner profile is a spirally wound element (or member) having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about A pitch between adjacent turns of 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the distance between adjacent turns is about 1 mm to about 1.5 mm.

Preferably, the inner shape has a thickness of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 Mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 Mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

Preferably, the inner profile is a spirally wound element having a thickness of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 Mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 Mm, or a diameter of about 0.19 mm to about 0.21 mm.

Preferably, the internal profile is a medical grade material, preferably a medical grade stainless steel coated with a suitable material, preferably a polymer grade or a stainless steel.

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

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

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

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

Preferably, the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

Preferably the ratio of the diameter of the inner profile (for example, the diameter of the actual inner profile element or component) to the outer diameter (for example the outermost diameter) of the inner profile is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, the best ratio is 0.06.

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

Preferably, the characteristics of the tubular body make it necessary for the tube to have the desired flexibility and/or structural support.

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

Preferably the tubular system is (preferably extruded from it) thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester One or a combination of elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide; more preferably, the polymer may be such as but not limited to polyolefin, thermoplastic elastomer, or breathable Thermoplastic elastomers, such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having from 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 A polymer of Shore A of about 60, or about 70, or about 80, or about 90.

Preferably, the tubular body is an air-permeable tube or is made of an air-permeable material, such as air-permeable thermoplastic polyurethane or air-permeable polyamide.

Preferably, the reduced pressure is applied when the tubular system is in a molten state, or a semi-molten state, or an unhardened state, preferably the reduced pressure is from about 0 to about -2 Pa (absolute), more preferably It is about 0 to about -1 Pa (absolute), and even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably this pressure reduction is the inside of the lumen and around the tubular body Pressure difference in one of the zones.

Preferably, the internal profile is conductive, and preferably the internal profile is an electric heater.

Preferably, the internal molded part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

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

Preferably, the tubular system formed in this way is passed according to ISO 5367: 2000(E) (Fourth Edition, June 1, 2000) The test of increasing flow resistance with bending is defined as flexibility.

Preferably, the medical tube is a breathing tube.

Preferably the inner profile contains one or more separate components.

Preferably the inner profile contains one or more components.

Preferably the piping system contains one or more internal profiles.

In the ninth aspect, it can be said that the present invention broadly includes a method of manufacturing a medical tube, which includes:

i) Provide an internal part,

ii) Providing a tubular body covering the inner profile, the tubular body defining a lumen enclosing the inner profile, and applying a reduced pressure to (or to) the interior of the lumen, or applying an extension (or Stretch) to enclose at least a part or a region of the tubular body of the inner profile, or

iii) A combination of i) and ii).

It is preferable to apply a greater reduced pressure or a greater extension (or stretching) or a combination of the two along the length of the tubular body and an outermost periphery defined by the inner profile. The radially inward extraction of the lumen, when the greater reduced pressure is applied or the extension (or stretching) is released or both, the outermost periphery of the inner profile defines a plurality of alternating peaks and valleys .

Preferably, the inner profile is enclosed in a coating layer, and the tubular system is provided to cover the inner profile so that the coating layer is connected to an inner surface of the tubular body, wherein the inner profile The system remains encapsulated.

In the tenth aspect, it can be said that the present invention broadly includes a medical tube including:

A tubular body, the system defines a lumen extending between the open terminals of the body, and an inner part that surrounds the lumen and supports the tubular body, and encloses a coating of the inner part The coating layer fixes the inner profile to the tubular body.

Preferably the coating layer and the tubular system are welded along the tube.

Preferably, the coating layer and the tubular system are welded along the tube at separate positions.

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

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

Preferably, the wave crests of the corrugated tubular body are defined by the outermost periphery of the inner profile.

Preferably the bellows body system is bounded by an inward extraction portion of the tubular body that is drawn inwardly between the internal profiles.

Preferably, the internal profile has a continuous length, one or a series of semi-continuous lengths, or a series of separate lengths.

Preferably, the internal profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring, or are interconnected by one or more connecting rods or can be mutually connected. One or a combination of multiple separate supports connected.

Preferably, the inner profile supports the tubular body to define the lumen inside.

Preferably, the inner profile is a spiral element or component.

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

Preferably, the internal profile is a skeleton or internal support structure supporting the tubular body.

Preferably, the tubular body is substantially not supported by the trough from the inner profile but is tied to the crest and supported by the inner profile.

Preferably, the wall of the tubular body is suspended between adjacent wave crests.

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

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

Preferably, the inner profile is a spirally wound strip, and the coating layer encapsulates the strip.

Preferably, the inner profile is a spirally wound wire, and the coating encapsulates the wire.

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

Preferably, the inner profile is a spirally wound element (or member) having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about A pitch between adjacent turns of 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm. More preferably, the distance between adjacent turns is about 1 mm to about 1.5 mm.

Preferably, the inner profile has a thickness of about 1.6 mm to about 4.6 mm, Or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to About 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or One of the outermost diameters of about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

Preferably, the inner profile is a spirally wound element having a thickness of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 Mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 Mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm One diameter. It preferably has a diameter of about 0.1 mm to about 1.5 mm.

Preferably, the internal profile is a medical grade material, preferably a medical grade stainless steel.

Preferably, the tubular body has a diameter of about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm , Or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 mm, Or one (wall) thickness of about 0.14 mm to about 0.16 mm. The thickness is preferably one (wall) of about 0.1 mm to about 0.2 mm.

Preferably, the tubular body has a size of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm , Or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm To about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm, one of the internal diameters (or lumen). Preferably have an outer (or outer) diameter of about 3 mm to about 5 mm

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

Preferably, the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the ratio is about 0.20 to about 0.35, and even more preferably the ratio is about 0.28 or about 0.29.

Preferably the ratio of the diameter of the inner profile (for example, the diameter of the actual inner profile element or component) to the outer diameter (for example the outermost diameter) of the inner profile is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, the best ratio is 0.06.

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

Preferably, the characteristics of the tubular body make it necessary for the tube to have the desired flexibility and/or structural support.

Preferably, the tubular body has a size of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm , Or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm To about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

Preferably the tubular system is (preferably extruded from it) thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane , Or one or a combination of breathable polyamides; more preferably, the polymer may be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as a family of thermoplastic elastomers, such as styrene blocks Copolymer, copolymer elastomer, or thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; even more preferably having from about 30 to about 90, or from about 30 to about 80, or from 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 Shaw A polymer.

Preferably, the inner profile is a plurality of rings spaced longitudinally along the lumen.

Preferably, the shape of the rings is toric or ring.

Preferably the inner profile is one or more separate elements linked to each other.

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

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

Preferably, one turn of the spiral reinforcement wire includes a complete turn around the lumen.

Preferably, one turn of the spiral reinforcement wire includes the wire located between adjacent crests of the inner profile.

Preferably, the tubular system is defined as flexibility by passing a test according to ISO 5367: 2000(E) (fourth edition, June 1, 2000) that the flow resistance increases with bending.

Preferably, a terminal of the tube is integrated with a nasal prong, and the nasal prong is adapted to be inserted into a user's nostril to deliver breathing gas to a user's nasal interface.

Preferably the inner profile is a screen.

Preferably, the internal profile is a wire suitable for heating or sensing the properties of the gas inside the tube.

Preferably, the internal profile is conductive, and preferably the internal profile is an electric heater.

Preferably, the internal molded part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

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

Preferably the tube is a breathing tube.

Preferably the inner profile contains one or more separate components.

Preferably the inner profile contains one or more components.

Preferably the tube contains one or more internal profiles.

In the eleventh aspect, it can be said that the present invention broadly includes a medical tube including:

A tubular body defines a lumen extending between the open terminals of the body, and is enclosed in the lumen and supports an internal part of the tubular body.

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

Preferably, the inner profile is enclosed in a coating layer that fixes the inner profile to the tubular body.

In the twelfth aspect, it can be said that the present invention broadly includes a nasal cannula configuration including:

At least one nasal prong, the prong having an air outlet suitable for being inserted into a user's nostril and an air inlet fluidly connected to the air outlet, the or each prong is shaped to conform to the user's nostril The anatomical curvature.

Preferably the nasal prongs are shaped to avoid contact with the user's nasal septum at the base of the user's nose.

Preferably the nasal prongs are shaped to avoid contact with the internal structure of a user's nose.

Preferably, the nasal prongs are shaped to substantially align the flow of breathing gas flowing through the air outlet with the upper respiratory tract of a user.

Preferably, the nasal prongs are shaped to extend substantially upward and backward into a user’s nostrils, and the nasal prongs have a curvature including at least two reflections. Break point.

Preferably, the nasal prong defines a lumen extending between the air inlet and the air outlet, and the shape of the lumen is changed from a substantially circular shape at the air inlet to a substantially elliptical shape at the air outlet.

Preferably the prong is shaped to maximize the cross-sectional area of the lumen.

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

Preferably, the interface includes dinasal prongs spaced symmetrically about the sagittal plane of a user, and the prongs are attached to a common support provided along the upper lip of a user from a base. Extend in the direction below the user's nose.

Preferably, the nasal prongs extend from the support body toward the user’s nasal septum, and surround a user’s nostril corners to bend upwards and backwards into the user’s nostrils. The upwardly inclined rear track extends, and by orienting the air outlet relative to the second mid-outer inflection point of the upper airway of the user.

Preferably, the prongs have a shaped track that matches the anatomical shape of the user's nostrils. More preferably, i) in the first part (or stage) of the prong, the track moves horizontally toward the midline of the face; ii) in the second part (or stage) of the prong ), the track is curved upwards directly into the nostril toward the crown of the head; iii) in a third part (or stage) of the prong, the track rolls backward following the anatomical curvature of the nostril Into the head; and iv) in a fourth part (or stage), the track is directed into the casing The heart is tilted horizontally to align the outlet and the upper airway of a user.

Preferably the prongs have a cross section that changes along the central track. For example, the cross-section may be substantially circular at the base of the track (that is, the area in the first part), and become substantially elliptical toward the end of the track or the fork (for example, the area in the fourth part).

Preferably, the cross-sectional area is substantially reduced along the track from the first section (or stage) to the end of the fourth section (or stage).

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

Preferably, the backing or facial liner is pre-shaped to be substantially curved to match a contour shape of a user's face or upper lip area.

Preferably, each prong can receive an independent flow from a gas source.

In the thirteenth aspect, it can be said that the present invention broadly includes a nasal cannula configuration including:

At least one nasal prong having an air outlet adapted to be inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, and

A gas delivery tube, the tube including a tubular body defining a lumen and an inner profile surrounding the lumen, the inner profile supporting the tubular body,

The air inlet of the nasal prong is integrally formed with a terminal end of the tube, so that the lumen of the tube is fluidly connected to the air outlet of the nasal prong.

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

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

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

Preferably, the nasal cannula has a contoured backing or facial cushion that is assembled to rest on a user's face, preferably as a stabilizing member of the prong on a user's nostril.

Preferably one or more ribs extend between a front surface of the backing or facial cushion and the sleeve, the ribs provide a thin strap or are used to buckle or attach the sleeve to a user's face One of the other suitable fixing elements of the contact surface, preferably the thin strip contains an adhesive part or is an adhesive tape or a contact adhesive tape.

Preferably the dinasal prongs are integrally formed with a single corrugated delivery tube.

Preferably, the sleeve configuration is made of a liquid silicone rubber or a polymer such as a thermoplastic polymer, preferably a polymer or multiple polymers suitable for medical breathing tubes.

Preferably, the sleeve configuration is made of thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide. Any one or more of one or a combination; more preferably, the polymer may be such as, but not limited to, polyolefin, thermoplastic elastomer, or breathable thermoplastic elastomer such as a family of thermoplastic elastomers, such as styrene inlay Segment copolymer, copolymer elastomer, or thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; It is even more preferable to have 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 of the Xiaoer A polymer.

Preferably, this sleeve can be used in combination with the tube defined in any of the above-mentioned faces.

In the fourteenth aspect, it can be said that the present invention broadly includes a user interface including a pair of nasal sleeves as defined in the thirteenth aspect.

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

Preferably, the user interface further includes a wire harness that extends and couples between the nasal cannula.

Preferably the tube is a breathing tube.

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

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

In the fifteenth aspect, it can be said that the present invention broadly includes a nasal cannula configuration including:

At least one nasal prong having an air outlet adapted to be inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, the at least one nasal prong comprising a backing, and the backing is It is assembled to rest on a user’s face with a lip extending around the circumference of a back surface of the backing At least part of the side, the rear surface is configured to receive or retain a user interface patch, so that in use, the user interface patch can be releasably attached or connected to or attached to A skin patch on the user's face.

Preferably the lip is a barrier.

Preferably the lip is deformable.

Preferably, the lip extends at least partially to enclose the periphery substantially adjacent to a region of a prong connected to the backing.

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

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

Preferably, the lip is a circulating lip extending around the periphery of the back surface of the backing.

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

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

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

Preferably, the at least one prong head extends from the at least one nasal prong head in a lateral direction away from a user's nasal septum.

Preferably, the casing is further defined by any of the aforementioned aspects.

Preferably, the sleeve can be operated as the fixing system defined in any of the aforementioned aspects.

Preferably, the user interface patch can be received or held on the back surface of the backing (or backing component) as defined in any of the aforementioned faces.

Preferably at least the (etc.) lip is water repellent.

Preferably, at least the lip(s) includes at least one outer peripheral lip and at least one inner peripheral lip, each of which is arranged to contact a user's face.

Preferably, the air inlet of the sleeve is fluidly connected with the tube as defined in any of the aforementioned faces.

In the sixteenth aspect, it can be said that the present invention broadly includes a part of a releasable fixing element, which includes a base part supporting a dispersed mechanical fastener across its surface, the base part being flexible but Substantially non-stretchable, the base body is divided into a plurality of regions by at least one slit or at least one slot, so that by independent bending of the different divisions of the base body, the base body can substantially follow the shape Square compound curved surface.

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

Preferably the slits and/or grooves are arranged on the base such that at least one of the first set of slits or grooves extends into the base from an edge of the base, and the slits or grooves A second set extends into the base from the other edge of the base, and the slits or slots of one set are intersected with the slits or slots of the other set so as to extend along the base from one end to The other end does not cross a set of these slits or grooves one path is to follow the ratio of two A jagged or serpentine path with a long straight line between the ends.

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

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

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

Preferably, the base system is divided into open parts by a serpentine slit or slot.

Preferably, the base part is divided into a plurality of parts by a spiral slit or slot.

Preferably, the base portion is divided into sub-sections by slits or slots arranged in substantially concentric circles.

Preferably, the isocentric circle is centered on approximately the center of the base portion.

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

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

Preferably, the base part is divided into a plurality of parts by a T-shaped slit.

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

Preferably, a boundary surrounding the shortest path around the periphery of the base is defined, and the base portion covers at least 80% of the internal area of the boundary.

In the seventeenth aspect, it can be said that the present invention broadly includes a use The user interface assembly includes:

A fixing system for the user interface and/or a component (such as a tube or pipe) connected to the user interface, and

Connected to the user interface to provide at least a part of a breathing circuit to a tube of a user of the interface,

The fixing system includes a two-part releasable attachment (or connection) configuration, and the configuration includes:

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 skin of a user (for example, by means of an adhesive, usually a skin sensitive adhesive such as a hydrocolloid),

The interface side of the skin patch is provided with the first part of a two-part releasable attachment or connection system, and

The user interface patch has an interface side and a patient side,

The patient side of the user interface patch is provided with the complementary second component of the two-part releasable attachment or connection system,

The interface side of the user interface patch can be attached (or can be connected) to the user interface and/or the component (such as a tube or tube) connected to the user interface, and

The piping system includes:

A tubular body defining a lumen extending between the open terminals of the body,

An inner part surrounding the lumen and supporting the tubular body, and

A coating layer that encapsulates the inner profile, and the coating fixes the inner profile to the tubular body.

Preferably the interface is a nasal cannula.

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

Preferably, the interface includes a fixing system.

Preferably, the tube is a medical breathing tube.

Preferably, the interface is a nasal cannula configuration including: at least one nasal prong having an air outlet suitable for being inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, the at least A nasal prong includes a backing that is assembled to rest on a user's face, wherein a lip extends over at least a part of the periphery of a back surface of the backing, and the back surface is It is assembled to receive or retain a user interface patch so that in use, the user interface patch can be releasably attached or connected to or attached to a skin of a user's face Patch.

Preferably the lip is a barrier.

Preferably the lip is deformable.

Preferably, the lip extends at least partially to enclose the periphery substantially adjacent to a region of a prong connected to the backing.

Preferably, the lip is a circulating lip extending around the periphery of the back surface of the backing.

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

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

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

Preferably, the backing is a substantially flat or flat or contoured (such as a pre-shaped curve) backing that is assembled to rest on a user's face.

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

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

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

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

It should be understood that the multiple embodiments of the aforementioned user interface assembly can be combined as described herein to manage applications.

The terms used in the specification and the scope of the patent application include meaning "at least part of the composition". When interpreting each statement included in the term in the specification and the scope of the patent application, features other than the term or prefix can also be presented. Related terms such as "include" and "include" must be interpreted in the same way.

The disclosure herein can also be said to broadly include the individual or collective components, elements, and features mentioned or indicated in the description of the case and/or the statement of the disclosure, and any two of the disclosed components, elements, features, or statements Any one or all combinations of one or more, and when specific integers are mentioned here and there are related art-known equivalents disclosed herein, these known equivalents are deemed to be incorporated herein as if individually stated .

This article reveals the composition that includes the previous and subsequent examples.

100, 200, 301, 401, 1100: medical tube

101, 201: vertical axis

102, 202, 1102: tubular body

104, 204: crest

105, 205: trough

106: Fork

107, 415, 507, 607, 2011: lumen

110, 210, 302, 1110: internal parts

310: Extruder

312: Hopper

313: Feed Screw

314: Rotary Drive

315: Extruder outlet

317: Die

320: side port

321: Vacuum Port

325: Constriction

340: Air Wipe Takeover

400: nasal interface, user interface

402: Nasal Prong

403, 503, 603: backing, wiring harness

405: Coupling

404: Shell

406, 506, 606: fork

410, 510, 610: user side

411: Orifice

500, 600: fixed system

501, 601: Tube

550, 650: skin patch

551: Two-part releasable attachment or link configuration

552: User Interface Patch

553: The first part

660: fixed patch

661: Tube End Wing

1111: coating

1130-1135: Ellipse

1400: nose interface

1401: tube

1402: Nasal Prong

1406: Facial Pad

1411: Forkhead air outlet

1415: base

1420: scan line, track

2000: Nasal cannula configuration, nasal cannula

2001: Nose prong

2002: vent

2003: air intake

2004: Backing

2005: lips

2006: back surface

2007: User interface patch

2008: skin patch

2009: hook

2010: Ring

3304: first end

3305: second end

3306, 3310, 3312, 3329, 3330, 3332, 3333, 3335, 3346, 3350, 3351: slit

3307, 3344: Recurve

3308, 3343: Straight

3309, 3311, 3313, 3318, 3325, 3331, 3336, 3337, 3347, 3348, 3349, 3353-3356, 3359: base part

3319, 3320, 3327, 3337, 3342, 3350, 3351, 3357, 3358, 3360-3364: slotted

3321, 3322, 3326: Island

3323, 3324, 3328: bridge

3335: Cross slit

3338, 3339, 3345: refers to

3340: feet

3344: return end

3346: spiral slit

3350: curved slit

3352: Center

3361-3364: curved slotting

3550: skin patch

3600: Extension

3602: oval or oval body

3603: matrix

3615: Wider section

W: Welding line, welding area

These and other features, aspects and advantages disclosed herein will now be described with reference to the drawings of preferred embodiments, which are intended to illustrate but not limit the disclosure herein, and in the accompanying drawings:

Figure 1 is a side view of a corrugated medical tube. One end of the tube is shown in a cross-sectional view to illustrate the configuration of a tubular body that covers the inner profile.

Figure 2 is a side view of the medical tube. The tubular body is cut out and shown in cross-section to illustrate the continuous spiral inner profile.

Figure 3A is a side view of the medical tube. The tubular body is cut out and shown in a cross-sectional view to illustrate the multiple independent rings representing the discrete internal profile.

Figure 3B is a side view of the medical tube. The tubular body is cut to show a cross-sectional view to illustrate the structure of the sandwich wall covering the inner part.

Figure 3C is a side view of yet another embodiment, where the internal profile is embedded in the wall.

Figure 3D is a side view of another embodiment, where the tube-shaped system heats and shrinks to wrap around the inner profile.

Figure 3E is a side view of yet another embodiment, where the internal profile is manipulated to keep the tubular body in the desired form.

Figure 4 is a schematic representation of the equipment used to form the medical tube. The equipment includes a hopper, a feed screw, and a die.

Figure 5 is a schematic representation of a die used to form a reinforced medical tube.

Figure 6 is a perspective view of a nasal interface combining a pair of reinforced medical tubes each coupled to a nasal prong.

Figure 7 is a perspective view of the nose interface of Figure 6 combined with a back component to stabilize the interface and receive a helmet attachment.

Figure 8 is a front view of the nose interface of Figure 7.

Figure 9 is a top view of the nose interface of Figure 7.

Figure 10 is a side view of the nose interface of Figure 7.

Figure 11 is a cross-sectional view showing the front view of the nose interface of Figure 7;

Figure 12 is a perspective view of the nasal interface of Figure 7 positioned on the baby's head.

Figure 13 is a perspective view of a nasal interface combining a pair of reinforced medical tubes each coupled to a nasal prong, wherein the individual nasal prongs are fixed to a harness including a plurality of ribs and a pair of helmet attachments.

Figure 14 is a perspective view of a nasal interface combining a pair of reinforced medical tubes each coupled to a nasal prong, each nasal prong is fixed to a wire harness including a plurality of ribs.

Figure 15 shows the nasal cannula positioned in an operating position on the user's face, the cannula being positioned according to an embodiment of the seventh aspect.

Figure 16 is a side view of the nasal cannula configuration of Figure 15.

Figure 17 shows an embodiment according to the seventh aspect and its assembly components.

Figure 18 shows the nasal cannula positioned in an operating position on the user's face, the cannula being positioned according to an embodiment of the sixth aspect.

Figure 19 is a side view of the nasal cannula configuration of Figure 18.

Figure 20 shows an exploded perspective view of an embodiment and its constituent assembly components according to the sixth aspect.

Figure 21 shows the relative layers from right to left (the user is not shown in the figure) according to an embodiment of the sixth aspect.

Figure 22 shows an embodiment of a fixed patch based on the sixth aspect.

Figure 23 shows another or alternative embodiment of the fixed patch according to the sixth aspect.

Figure 24A is a close-up perspective view of the cut-away medical tube, with the corrugated tube body cut to expose the coated spiral inner profile.

Figure 24B is a close-up perspective view of a medical tube that has been dissected. The smooth tubular body has been cut to expose the coated spiral inner profile.

Figure 25A is a schematic front view of a pair of nasal prongs, illustrating the shape of the prongs and the internal lumen.

Figure 25B is a schematic side view of a pair of nasal prongs, illustrating the shape of the prongs and the internal lumen.

Figure 25C is a schematic front view of a pair of reverse nasal prongs, illustrating the shape of the prongs and the internal lumen.

Figure 25D is a schematic perspective view of a pair of reverse nasal prongs, illustrating the shape of the prongs and the internal lumen.

Figure 26A is a perspective view of a nasal interface with a curved backing component.

Figure 26B is a front view of a nose interface with a curved backing assembly.

Figure 26C is a top view of the nose interface with curved backing components.

Figure 26D is a rear view of the nose interface with a curved backing component.

Figure 27A is a close-up view of the nasal prongs illustrated in Figure 17D.

Figure 27B is a close-up view of the nasal prongs illustrated in Figure 17C.

Figures 28 and 29 show a nasal cannula configuration in use with a backing component including a lip.

Figure 30 is a perspective view before configuration of a nasal cannula with a backing component including a lip.

Figure 31 is a perspective view of the nasal cannula with a backing component including a lip after configuration.

Figure 32 is a top rear perspective view of a nasal cannula configuration with a backing component including a lip and a user interface patch on the back of the backing component.

Figure 33 is a cross-sectional view of the nasal cannula configuration of Figure 32 when the user interface patch is connected to the skin patch.

Figure 34 is a rear perspective view of the nose cannula configuration of Figures 30 to 33.

Figure 35 is a rear view of another nasal cannula configuration of Figures 28 to 34, illustrating a series of segmented lips.

Figure 36A illustrates an outline drawing of a skin patch according to several embodiments.

Figures 36B to 36R illustrate various embodiments of the base portion of a fixing member for fixing to the skin patch of Figure 36A.

Detailed description of the preferred embodiment

Medical tubes (also known as breathing tubes) have several restrictions. Some of these limitations may be due to performance reasons, such as weight, flexibility, and flow characteristics. Other restrictions may be controlled by regulatory authorities, and the tube must be used for medical purposes. Meet the regulations first. Manipulation restrictions may include evaluating the structural integrity of the tube and the biocompatibility or sterility (for hygiene purposes) of the tube components. One of the limitations is the flow resistance induced by bending, which can be defined in accordance with the relevant tests proposed by ISO 5367: 2000(E) (Fourth Edition, June 1, 2000).

The biocompatibility of the material is useful, for example, the material can interact or contact with breathing gas or other fluids, and it will not leak out or produce materials that may be consumed or ingested by the user or patient to breathing gas or other fluids . Sterility can also be used to assist with no or minimal (if any) transfer or disease to the user or patient.

Therefore, a number of standards must be considered during the design and testing of medical tubes, reflecting the variety of tubes available in the medical field. The special requirements and details of different medical procedures and applications have also contributed to the availability of a variety of medical tubes. The characteristics of different medical applications indicate that tubes that are particularly suitable for specific procedures may not meet different medical application standards.

The configuration of medical tubes limited to specific applications complicates and restricts the design process of the connection. In addition, strict regulations on the use of components often restrict medical practitioners from strictly complying with component guidelines and instructions.

tube

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

The tube 100 shown in the figure has a corrugated contour shape and includes a plurality of wave crests 104 and wave troughs 105. The wave crests 104 and wave troughs 105 surround the circumference of the tube 100 and extend staggeredly along the tubular body 102 (or its wall surface) (that is, in a direction substantially parallel to the longitudinal axis 101 of the tube 100).

The tubular body 102 defines a lumen 107 extending between the two terminal ends of the tube 100. For medical purposes, the gas passage tube 100 is restricted to the lumen 107, and the tubular body 102 defines the outer boundary of the passage. The tube 100 preferably has an opening adjacent to the terminal. Ideally, the opening is arranged to be substantially coaxial with the lumen (that is, aligned with the longitudinal axis 101 in this embodiment) to reduce flow interference inside the tube 100.

The illustrated tube 100 also includes a tubular body 102 provided with an inner profile 110 that is sheathed, surrounded or surrounded. The tubular body 102 encloses the inner profile 110 inside the lumen of the tube 100. The inner profile 110 provides a skeleton that defines the general shape and contributes to the structural characteristics of the tube 100. Preferably, the inner surface or inner surface of the tubular body 102 is fixed to the inner profile 110. By shrinking and nesting the tubular body 102 to the inner profile 110 (for example, Figure 3D), the tubular body 102 is applied to cover the inner profile in a molten, semi-molten or even unhardened state, so that the inner surface of the tubular body 102 Fuse and join (or bond) to the inner profile 110 (e.g., Figure 3C), or even provide a tubular body having at least one inner wall layer and an outer wall layer and the inner profile is sandwiched between the two layers (e.g. 3B Figure), the tubular body 102 and the inner profile 110 can be fixed together.

The inner profile 110 preferably defines a skeleton base structure, is provided with a longitudinal axis 101 surrounding the tube 100 and supports the tubular body 102. The tubular body 102 is arranged to cover the inner profile 110, and the corrugations of the tubular body 102 reflect the structure of the reinforced skeleton provided by the inner profile 110. The wave peak 104 of the pipe corrugation corresponds to the reinforcing rib supporting the tubular body 102 (that is, the shape of the inner profile 110). The trough 105 of the pipe corrugation is preferably an unsupported section of the tubular body 102, which is suspended between adjacent reinforcing ribs.

The inner shape 110, such as illustrated in Figures 1, 2, 3-3D, 24A, and 24B, includes a continuous spiral frame with a spiral spring structure. The skeleton generates the spiral corrugations of the tubular body 102, which can be seen in the left part of the first figure. In this specific embodiment, the inner profile 110 is continuously fixed to the tubular body 102 at the crest 104 of the corrugation. The tubular body 102 follows the contour shape of the inner profile 110, and wraps and sleeves each reinforcing rib. In this embodiment, the contact interface between each reinforcing rib and the tubular body 102 may exceed half of the peripheral surface of the rib.

Fig. 3 illustrates another embodiment of the medical tube 200. In this embodiment, the inner profile 210 includes a plurality of rings along the longitudinal axis 201 of the tube 200. Each ring 210 provides peripheral reinforcement ribs that coincide with the wave crests 204 of the tubular body 202. The individual rings constitute the reinforcing skeleton of the inner profile 210 illustrated in this example. Accordingly, the tube 200 has peripheral corrugations, with separate wave crests 204 and wave troughs 205 extending along the tube 200 around the longitudinal axis 201. When the tube is twisted (that is, when a torsion force is applied), adjacent loops can be chained to counter the narrowing of the lumen. The rings may be formed by gaskets or discs with apertures to allow flow therethrough. Preferably the rings are toric surfaces or Ring.

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

The inner molded part may have an outer coating layer, as illustrated in the cross-sectional tube in Figures 24A and 24B. 24A and 24B illustrate the coating thickness of about 35 microns and the tube wall thickness of about 150 microns. The coating layer 1111 completely encapsulates the inner profile 1110. In another form, the inner profile can also be partially coated, such as covering the longitudinally divided sections of the inner profile 1110.

The inner profile 1110 can be coated to increase the bond strength formed by the tubular body 1102, improve the biocompatibility or sterility inside the tube, and/or separate the inner profile from the contents of the tube (such as preventing the inner Corrosion of the profile). Preferably, the coating layer is thin enough so that it will not negatively affect the mechanical properties of the inner profile, such as reduced elasticity or flexibility.

The tube shown in Figure 3B is usually a sandwich composition. The tube is made of a thin-walled polymer tube inserted into the center of the inner profile, such as a coil spring. Then the assembly passes through a cross tube extrusion die, which extrudes the melt and similarly extrudes a thin-walled polymer tube to cover the outside of the assembly. Utilizing the vertical extension of the extruded melt and/or the pressure difference between the two layers applied by vacuum, or the positive pressure applied to the inside of the inner tube or the outside of the outer tube or a combination of both, the molten outer tube contacts the inner tube. The contact of the molten outer tube with the inner tube creates a connection between the two. Once cooled, the tube consisting of the inner wall and the outer wall of the tubular body remains. Internal parts (such as coil spring wire reinforcement) remain Clamped between the two walls.

The tube can be shaped to have a relatively smooth bore to provide low flow resistance, and the outer wall layer of the tube is corrugated to assist the flexibility of the tubular body. The internal profile is mechanically locked in position by the clamping effect. Therefore, a pre-coated internal profile may not be required to achieve this bonding to the tube wall, but this option exists. The tube can be two thin layers bonded by similar materials, and the inner profile (such as a spring) is locked and positioned away from the gas path. This provides extremely flexible but strong rolling and kink resistant pipes. The mechanical locking spring is positioned to help maintain the integrity of the tube structure under axial stress, and the spring is not in the gas path to reduce the biocompatibility or sterility requirements of the internal profile components.

The tube in Figure 3C is roughly an embedded structure. The method of manufacturing the tube in this embodiment is that the inner profile (such as a coil spring) is extruded through a cross extrusion die, and the polymer tube (tubular body) is extruded to cover the exterior of the inner profile (such as a spring). Using drag speed to achieve drawdown, combined with internal vacuum or external positive pressure (or both), the polymer is drawn between the coils of the internal profile (such as a spring) until the internal profile is enclosed and mechanically locked in position. The formed tubular body is usually corrugated (flexible) and does not require a pre-coated internal profile to achieve bonding, but this option exists. The tubular body has a high enough temperature. Once the inner profile is sheathed, the tubular body will contact itself and be welded by the extrusion heat. In this regard, the weld line or weld zone is shown as W in Figure 3C.

The tube in Figure 3D usually has a heat-shrinkable structure. After placing an inner profile (such as a coil spring) inside the tubular body in the longitudinal direction, the wall is thin and the tube is made by heat shrinkable tube or energy forming. Then apply heat (or suitable to cause the material The contraction energy) causes the tubular body to contract and adhere closely to the inner profile (such as a spring), and the open space along the wall between the subsequent wall sections supported by the inner profile shrinks to cause the formation of corrugations. In this way, a corrugated tube reinforced with an internal profile (such as a metal wire) remains. The corrugation results in good flexibility. If the inner surface or inner surface of the tubular body is pre-coated with a suitable adhesive, the inner profile and the tube wall will be further attached or connected to each other.

The tube in Figure 3E is of yet another form. The tubular body may be formed (e.g., formed by extrusion) and then pulled or dragged through the inner shape 110 or its interior. Therefore, the inner profile 110 can substantially surround the tubular body (that is, the inner profile becomes a profile outside the tubular body). For example, refer to Figure 3E. The inner profile 110 functions to support or maintain the tubular body 102 in a desired form, shape, or configuration. As with several other embodiments described herein, the inner profile 110 functions to define a series of alternating crests and troughs, and the perimeter of the inner profile defines troughs 105. The crest 104 between the supported sections (by the inner mold 110) is not directly supported by the inner mold 110. The advantage of this structure and configuration is to further reduce the need for pre-coating the inner part 110 for reasons of biocompatibility or sterility (such as hygiene), but the inner part 110 can be pre-coated to reduce corrosion Or other effects from the environment.

Several advantages of coating the inner parts with appropriate materials include:

-Improve the overall strength and durability of the tube by more firmly fixing the inner profile to the tubular body.

-Strengthen the tubular body to improve the resistance to swelling and degradation caused by exposure to chemicals.

-Improve production by increasing the allowable range of materials that can be used for internal parts Material compatibility or sterility, because the coating layer provides a biocompatibility (or sterility) barrier or material layer surrounding the inner shape itself (it is also permitted that the inner shape is colored to improve aesthetics and/or Product identification).

-Protect the inner part from contacting the contents of the tube (to reduce corrosion or other degradation of the inner part).

Coating the inner profile with a suitable material can alleviate the tendency of the inner profile to separate from the tubular body when the connection is stressed. For example, it occurs when some materials are exposed to certain chemicals (such as oils, alcohols and/or detergents). ) While swelling, or when the breathable material is exposed to water vapor or aqueous solutions.

In various embodiments (such as Figures 1, 2, 3, 24A, and 24), the inner profile supports the tubular body and resists the constriction and contraction of the lumen. The tubular body can advantageously be made or composed of the following materials or contain suitable polymers, such as thermoplastic elastomers, propylene-based elastomers, liquid silicone rubber (LSR), breathable thermoplastic polyurethane, or breathable Polyamide. The polymer may be such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic poly Urethane elastomer, or breathable polyamide. The use of breathable materials to make the tubular body can also be used to provide the additional advantage of the breathability of such medical tubes or circuits. Particularly suitable polymer materials are those having from about 30 to about 90, or from about 30 to about 80, or from about 30 to about 70, or from about 30 to about 60, or from about 30 to about 50, or from 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 Xiaoer A. This material can also be used to form a nasal cannula configuration, which will be described later.

The tubular body can be made or composed of the following materials or contain a variety of thermoplastic polyurethane, thermoplastic polyester elastomer or liquid silicone rubber (LSR), including breathable grades. The excellently selected material grade has favorable mechanical properties (such as durability, tear resistance and high elasticity) and optionally, provides good transparency to detect water accumulation inside the tube.

The coating layer may be made of the same material or different materials from the tubular body. Excellently, the coating layer 1111 and the tubular body 1102 are chemically compatible, so that the coating layer 1111 and the tubular body 1102 can be welded together to form a joint between the inner profile 1110 and the tubular body 1102. The inner profile may be made from other suitable polymers that are chemically compatible with the material of the tubular body 1102. In one form, the coating layer 1111 may be a gas impermeable material (even if the tubular body 1102 is gas permeable), so that the inner profile 1110 is isolated from any moisture in the lumen. Excellently, both the tubular body and the coating layer can be made or composed of the following materials or include durable thermoplastic polyurethanes (TPU). When the tubular system is made or composed of the following materials or contains thermoplastic polyurethane, the coating layer can also be made or composed of the following materials or contains multiple polymers. Excellently, the polymer grade selected for the coating layer is strong and has good abrasion resistance to allow the inner profile to be manipulated (such as rolled into a spiral) after coating.

In addition, the tubular body can be extruded or formed in other ways so that the wall has a minimum thickness to reduce the weight of the tube and further improve the flexibility of the tube. The inner profile 110 may be made of an elastic material such as a suitable metal or polymer for further bending.

Excellently, the minimum wall thickness of the tubular body helps improve the performance of the tube flexibility. In addition, this advantage comes from a tube made of gas permeable material. The gas permeability of such a medical tube is improved by a reduced or minimum wall thickness. This combination of reduced or minimum wall thickness and the use of breathable materials is particularly excellent when used as part of a medical breathing circuit or system.

The structure of the tube increases the extensibility by adding auxiliary length to the tubular body suspended in the troughs between the reinforcing ribs of the inner profile 110.

As shown in Fig. 3E of the alternative embodiment, the extension of the tubular body is provided by adding an auxiliary length to the tubular body suspended between the wave crests formed by the inner profile 110.

The additional auxiliary length of the wall makes the distance between the inner profiles undulate, so that the tube can be stretched longitudinally without the lumen being significantly narrowed. The additional auxiliary length allows the pipe to expand and contract in the longitudinal direction with minimal tensile or compression deformation or stress crimping or straightening of the pipe wall.

The flexibility of the pipe can also be improved by allowing the distance between adjacent reinforcing ribs to be changed around the circumference of the pipe in response to bending. The rib spacing is changed around the tube, allowing the internal profile to expand and contract on opposite sides of the tube at the same time to respond to the bending of the lumen, without pinching or kinking the tube and still satisfying ISO 5367:2000(E) (Fourth Edition, 2000) June 1) defined flexibility requirements.

In addition, the inner profile can be conductive. The conductive inner profile can assist in a number of optional additional features used in the operation or use of such tubes. For example, the inner profile may be (or may contain) an electric heater. For example, the inner profile may include one or more components.

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

In some embodiments, the tube may include a heater such as an electric heater (eg heater wire, heater circuit, etc.).

Setting up heating or heaters can help maintain the humidity of the gas passing through the pipe and other related components. Heating can also alleviate the problem of "water dripping on the outside". The sensor is excellently assisted in providing a data feedback system, assisting the connected heater control system or information feedback to the user monitor or monitoring system.

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

In yet another aspect of the present invention, one or more inner moldings 110 may be provided. In this way, a double helix shape or other configuration of the internal shape can be provided to support the pipe, but the flexibility and extensibility of the structural pipe can be maintained.

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

The tube can be used for adults and newborns, but it is well suited for the newborn interface, and the dedicated tube is the smallest. For example, the neonatal interface tube according to the illustrated structure may have an inner diameter (or lumen diameter) of a tubular body of about 1.5 mm to about 4.5 mm, an outer diameter of about 1.6 mm to about 4.6 mm, and about 0.05 A wall thickness of about 0.25 mm to about 0.25 mm. Preferably the inner diameter is about 2.4 mm to about 3 mm, and the outer diameter is about 2.6 mm to about 3.4 mm, and the wall thickness is about 0.1 mm to about 0.2 mm.

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

The outer diameter of the tubular body may be about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm , Or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm To about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm. The outer diameter can be about 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6mm, 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 , 4.3 mm, 4.4 mm, 4.5 mm, or 4.6 mm. It is preferably about 3 mm to about 5 mm.

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

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

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

In an embodiment of the present invention, the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, preferably the ratio is about 0.20 to about 0.35, and more Preferably, the ratio is about 0.28 or about 0.29.

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

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

Also, another embodiment may require the physical properties of the tubular body to require the tube to have the desired flexibility and/or structural support.

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

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

The outer diameter of the inner profile (such as the spiral skeleton) may be about 1.7 mm to about 4.4 mm, or about 1.8 mm to about 4.3 mm, or about 1.9 mm To about 4.2 mm, or about 2.0 mm to about 4.1 mm, or about 2.1 mm to about 4.0 mm, or about 2.2 mm to about 3.9 mm, or about 2.3 mm to about 3.8 mm, or about 2.4 mm to about 3.7 mm, Or about 2.5 mm to about 3.6 mm, or about 2.6 mm to about 3.5 mm, or about 2.7 mm to about 3.4 mm, or about 2.8 mm to about 3.3 mm, or about 2.9 mm to about 3.2 mm. The outer diameter of the spiral skeleton can be about 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, or 4.4 mm.

The diameter of the inner part (or the wire used to form the skeleton) can be about 0.05 mm to about 0.30 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm , Or about 0.09 mm to about 0.26 mm, or about 0.10 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.22 mm, or about 0.14 mm To about 0.21 mm, or about 0.15 mm to about 0.20 mm, or about 0.16 mm to about 0.19 mm. The diameter of the wire used to form the skeleton can be about 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, or 0.30 mm. It is preferably about 0.1 mm to about 0.4 mm.

The distance between internal parts (e.g. spiral skeleton) can be about 0.40 millimeters M to about 1.80 mm, or about 0.45 mm to about 1.75 mm, or about 0.50 mm to about 1.70 mm, or about 0.55 mm to about 1.65 mm, or about 0.60 mm to about 1.60 mm, or about 0.65 mm to about 1.55 mm , Or about 0.70 mm to about 1.50 mm, or about 0.75 mm to about 1.45 mm, or about 0.80 mm to about 1.40 mm, or about 0.85 mm to about 1.35 mm, or about 0.90 mm to about 1.30 mm, or about 0.95 mm To about 1.25 mm, or about 1.00 mm to about 1.2 mm, or about 1.05 mm to about 1.15 mm. The distance between the spiral skeletons can be about 0.40 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.6 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.95 mm, 1.0 mm, 1.05 mm, 1.1 Mm, 1.15 mm, 1.2 mm, 1.25 mm, 1.3 mm, 1.35 mm, 1.4 mm, 1.45 mm, 1.5 mm, 1.55 mm, 1.6 mm, 1.65 mm, 1.7 mm, 1.75 mm, or 1.8 mm. It is preferably about 1 mm to about 1.5 mm.

In various forms of the present invention, the inner profile can be provided to a tubular body with variable or variable pitch. In this way, once the inner profile becomes a part of the tube, the distance between the inner profile can be a variable pitch. Varying spacing can have special advantages, including increased areas of strength/support or flexibility. Such a system can also be used to support even thinner-walled tubular bodies.

In yet another embodiment, the varying pitch allows the density of the internal profile to vary per unit tube length. This configuration is useful when the inner profile or parts of the inner profile are provided as a heating source or sensor for the gas flowing through the lumen.

The inner profile 110 may include a single continuous turn or multiple turns of wire linked end-to-end to form a spiral skeleton, element or rib. In addition, internal parts can be Contains multiple separate rings. Multiple rings can be linked along the longitudinal direction of the tube. Metal wires, elongated polymers, or other suitable couplings (including multiple wires or elongated polymers) can extend along the lumen to link multiple loops. Multiple links can be separated around the periphery of the rings.

For neonatal use, the tube has an alternative to transparent polyvinyl chloride (PVC) tubing that is typically used to support and supply breathing gas to the nasal cannula. Preferably, the user interface is independently supported by the interface tube (such as a dedicated skin pad), so that the movement of the tube is not restricted and the tube is more flexible.

Tube manufacturing method

In addition to the foregoing description, the medical tube can be manufactured by arranging a tubular body to cover the inner part (or in another embodiment, the inner part is used to cover the tubular body). The tubular body defines a lumen and substantially surrounds the inner profile. In one embodiment, during manufacturing, reduced pressure may be applied to the inner (or to) lumen such that the reduced pressure drags the tubular body and the outermost periphery defined by the inner profile radially inward. The outermost periphery of the inner profile can define a plurality of staggered crests and troughs along the longitudinal direction of the tubular body. The tube can also be made with a smooth surface, as shown in Figure 24B. In another embodiment, during manufacturing, elongation (or stretching) can be applied to a portion or a region of the tubular body surrounding the inner profile, so that the elongation (or stretching) returns (or allows) the extension of the tubular body The (or stretched) part or area drags the lumen and the outermost periphery defined by the inner profile radially inward, and the outermost periphery can define a plurality of interlaced peaks and troughs along the longitudinal direction of the tubular body.

In yet another embodiment, the combination of applying reduced pressure to the lumen and elongation (or stretching) to the tubular body can be an embodiment of the manufacture of the tube.

Figures 4 and 5 illustrate the manufacturing equipment for reinforced medical tubes. Exemplify The illustrated equipment includes an extruder 310 and a coupled die 317. The raw material (typically thermoplastic beads, but any other form of raw material used as a master batch) is fed into the extruder, where it is heated, pressurized or passed through a die 317 to form a medical tube 301, such as the tubular body discussed above. Then the tube 301 advances through the air wiper tube 340 where the air passes through the tube 301 to cool the tubular body.

A device that clamps or applies elongation (or stretching) to the tubular body can be used. In this way, the tubular body is allowed to stretch to enclose or surround the inner profile, and then when it releases the extension (or from the stretched condition) to the clamping relationship with the inner profile, it assumes the outermost periphery defined by the inner profile shape.

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

The raw material of the tubular body is fed into a hopper 312 installed at the top, for example. The hopper 312 allows the raw material to enter the barrel of the extruder 310 through the hopper under the action of gravity or another suitable feeder system. The feed screw 313 is enclosed in the barrel of the extruder and feeds the material along the barrel toward the die 317. The feed screw 313 is coupled to the rotation drive 314 to rotate the screw around the longitudinal axis.

The material is heated to a molten state or a semi-molten state inside the barrel. When the raw material advances along the barrel, the barrel can be actively heated or friction generates heat, which can melt the material enough.

Appropriate extruders for the manufacture of medical tubes are supplied by Welex. The Wiley extruder is equipped with 30 to 40 mm diameter screws, and typically 12 Up to 16 mm annular die with 0.5 to 1.0 mm gap has been found to be suitable for rapid manufacturing of low-cost tubes. Similar extrusion machines are made by Kuhne (Germany), AXON Plastic Machinery (Sweden), AMUT (Italy), and Battenfeld (Germany and China), For example.

In order to assist the co-extrusion of the tube assembly, the tubular body material may be fed into the die 317 tangentially. When the inner profile advances through the die 317, the tubular body can be extruded to cover the inner profile, and the molten or semi-melted tubular body is laid on the inner profile. The tubular body melted during cooling is preferably adhered to the inner molded part to firmly fix the components of the tubular body together.

In this specific embodiment, the die 317 (illustrated in FIG. 5) is suitable for disposing a barrel orthogonal to the extruder 310, and has a side port 320 adjacent to the air outlet 315 of the extruder. The molten or semi-molten material leaving the extruder 310 is fed into the side port 320 of the die 317 and released into the peripheral compartment. The peripheral compartment exits from a nozzle 325, through which the inner profile 302 is stretched. The pressure generated by the extruder 310 forces the material to surround the inner profile 302 through the narrowed portion 325, so that the tubular body 301 directly squeezes the inner profile. It is preferable that the inner profile continuously advances through the die 317 at a substantially constant rate (but the advance rate can be adjusted to change the thickness of the tubular body along the line at a constant extrusion rate).

Suction is applied to the inside of the die through the vacuum port 321. Suction reduces the internal pressure of the tube cavity after extrusion, causing the molten or semi-melted tubular body to be drawn on the inner profile to form corrugations on the inner surface of the tube. Preferably, the tubular body from the extrusion process is still glued enough to cover the inner profile.

The application of reduced pressure inside the tubular body or the lumen can be, for example, by applying vacuum or reduced pressure to the lumen channel. In addition, decompression can be relative decompression or Comparing decompression. For example, the pressure surrounding the tubular body can be increased so that the pressure inside the tube is relatively lower than the pressure around the tubular body. In this way, the tubular body experiences a pressure difference and encourages the tubular body to be pulled (or pushed) radially inward. The pressure inside the lumen and outside the tubular body can therefore be any suitable pressure so that the lumen has a lower pressure than around the tubular body. Therefore, the inner surface of the lumen is pulled or pushed (by means of a pressure difference) to contact the inner profile, and form or have the outermost peripheral shape of the inner profile in the embodiment illustrated in Figures 1, 2, 3, and 24A. Part of the tubular body may not be supported by the inner profile, but can be drawn in more radially inward than the outermost peripheral surface of the inner profile, which emphasizes the shape defined by the inner profile.

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

For example, coating a metal wire with a suitable polymer grade involves drawing the wire through a molten polymer bath at a temperature of more than 150°C, but for example, it can be more than 180°C or about 200°C (enough for the polymer melt to coat the interior The temperature of the surface of the part). When the coating layer is sufficiently cooled, the wire can be made into an inner shape. The inner profile can be manufactured by winding the coated wire helically around a mandrel.

In other examples, the inner profile may be applied to the inner profile by dipping through a bath containing polymer or applying polymer to the inner profile through an extrusion die. Coated or encapsulated.

Other applications

It is expected that this embodiment will find other medical applications that are particularly suitable. For example, it involves applications that are expected to be lightweight and highly flexible, and have sufficient resistance to rolling, pinching and kinking. It also includes the delivery limbs and exhaust limbs of surgical humidification systems, including the use of breathable medical Tube is the best use.

user interface

The tube can be combined with a user interface, such as a nasal cannula to deliver breathing gas to the user. The nasal interface combined with the tube is illustrated in Figs. 6-12. The illustrated interface 400 includes a pair of nasal prongs 402. Each prong 402 is coupled to a terminal of the tube 401. The other end of the tube 401 can be coupled to a supply catheter to interconnect the prong 402 to the breathing system. The tube 401 may be coupled to individual supply conduits, or otherwise combined (for example, by a Y-shaped coupling or other suitable connections such as a manifold) to form a single joint of the supply conduit and assist in delivering breathing gas to the interface 400. An embodiment of the user interface 400 is illustrated in Figure 12 as being worn by a baby.

Each prong 402 defines a lumen extending between the user end 410 and the tube end 415 of the prong 402. The tube end 415 of the prong 402 is coupled to 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 combined with the orifice 411 for this project. The orifice 411 can be arranged concentrically with the terminal end of the fork 402, so that the flow out of the fork 402 is rarely disturbed. The tube end of the prong 402 can be shaped like an anatomical shape and/or closely follow the shape of the user's nostrils, and the terminal end of the prong 402 (that is, the end that joins the orifice 411) is for example bent away from the nasal septum to reduce irritation may.

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

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

The fork 402 preferably maintains a separate relationship. In this embodiment, the backing or harness 403 is coupled to the dinasal prong 402. The backing 403 preferably maintains the prongs 402 in a fixed and spaced relationship. Different interface 400 sizes can be manufactured to adapt to changes in the distance between the noses.

The illustrated backing 403 also includes a housing 404 that substantially surrounds or captures at least a portion of the tube end 415 of the prong 402. The housing 404 is combined with a coupling 405 to attach the helmet to fix the interface 400 in position. On both sides of the tube 401, a pair of fork brackets 406 protrude outward from the backing 403. The fork frame 406 increases the contact area between the interface 400 and the patient, disperses the holding force of the interface over a larger area, and reduces the pressure applied to the user's face.

The user side of the backing 403 and the fork frame 406 (that is, the side facing away from the user's face) can be contoured to reflect the expected anatomy. The backing 403 and the fork frame 406 can also be made from flexible materials to allow the structure to adapt to a specific personal face.

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

The shell 404 can be ribbed between the front of the fork frame 406 and the portion of the shell 404 connecting the fork 402 and the interface tube 401, as illustrated in FIGS. 12 and 13. When fixing the interface 400 to the user, the ribs increase the useful interface contact area of the medical tape. The ribs can also increase the torsional stiffness of the fork frame and help stabilize the position of the fork head 402.

The fork 402, the backing 403 and the fork frame 406 are preferably made of a suitable polymer. Preferably, individual sleeves (such as the prong 402 and the tube 401) are made by a sleeve molding process in which the prong 402 covers the outside of the tube 401. The sleeve molding process usually involves inserting one end of the pre-formed tube 401 into a suitable mold, while the material used to make the prongs is injected into the outside of the tube inside the mold to retain the tube 401. Excellently, the fork head 402, the backing 403, and the fork frame 406 are made by a single sleeve molding process to form a fully integrated interface.

The configuration or design of the fork head can take various forms. In a preferred embodiment, the prongs and/or sleeves molded with a conveying tube can be described in US Patent Publication No. 2010/0192957, which is incorporated herein by reference in its entirety.

Fork head

The geometry of another preferred form of the nasal prongs is illustrated in Figures 25A to 25D. The combination of a common base support pad and a face support pad is illustrated in Figures 26A to 26D, and a close-up is shown in Figures 27A and 27B. The numbering characteristics of the prongs illustrated in these figures are marked with the previous figures (6th to 6th to Figure 13) presents similar numbers with the same features (but prefixed to identify specific embodiments).

The geometric shapes of the prongs 1402 in Figures 25A to 25D are illustrated by using scan lines 1420 to indicate prongs orbits, and ellipses 1130 to 1135 to indicate the shape and direction of the lumen inside the respective prongs in specific orbits. Each prong 1402 follows a scanning path, which is shaped to follow the anatomical geometry/curvature/contour shape of the user's nostrils. The prongs are molded or shaped to follow the anatomical shape and curvature of the user's nostrils. Excellently, the prongs maximize the gap between the prongs and the internal structures of the nostrils by anatomically matching the nostril path.

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

In the following, the geometric shape of the prong head will be illustrated by fixing the interface on the user's face during use. The interface is configured such that the prong 1402 is approximately symmetrically arranged around the sagittal plane of the user. Each prong extends from a base 1415 of a common support that extends along the upper lip of the user. The prong 1402 is spaced from the support body to avoid the nasal septum. The distance between the prongs 1402 at the base 1415 is selected to show the maximum gap between the prongs and the user's nasal septum (at the base of the nose) according to the size range of the face corresponding to each interface (ie, the specific interface size).

The initial stages of each fork track 1420 before the base 1415 are represented by ellipses 1130 and 1131 (first stage). During this phase, the prongs essentially extend coaxially with the individual breathing tubes. The scanning path of the two tracks 1420 is roughly along the upper lip of the user, extending from both sides of the sagittal plane toward the nasal septum. Fork head 1402 With respect to the upper lip of the user, the scan passes slightly backwards or behind the curve (toward the user's coronal plane), as illustrated by the rotation of the lumen (represented by the change in direction of ellipses 1130, 1131, and 1132). The internal flow path defined by the shape of the lumen remains circular during this stage.

From the base 1415, each prong 1402 scans upward or upward (away from the transverse plane) toward the user's head, and the prong 1402 scans backward or backward (toward the user's coronal plane) relative to the user's upper lip. Between the ellipses 1131 and 1133 (the second stage), the lumen of the prong head smoothly transitions along the upper lip of the user from a generally mid-outer direction to a mainly inclined rearward direction, guiding the gas to flow to the upper back of the user's head. During this phase, the prong lumen shrinks slightly into an oval shape to use the available space inside the nostril.

In the third stage (between ellipses 1133 and 1134), the prongs continue to follow the inclined rear track toward the upper back of the user's head (away from the transverse plane and toward the coronal plane), smoothly reducing the inclination rate (above the prong track 1420) The composition causes the lumen to move away from the transverse plane). During this phase, the prong 1402 has negligible convergence (or mid-lateral component) towards the sagittal plane. During this stage, the lumen of the forkhead shrinks further and becomes more elliptical.

In the final stage (between ellipses 1134 and 1135), the prong 1402 continues to follow the inclined posterior orbit, slightly converging toward the sagittal plane. The outside convergence of the prong 1402 starts at the beginning (or slightly before) the fourth stage of the adjacent ellipse 1134, and illustrates the reflex point of the track. Adjacent to the last ellipse 1135, there is a second reflex point to reduce the convergence of the fork head, and the fork head outlet 1411 is oriented backward (towards the coronal plane), with a slight mid-lateral component facing the sagittal plane (refer to Figure 25B) The direction of the final ellipse 1135).

During the fourth stage, the inclination rate of the fork head track 1420 continues to decrease until the individual track 1420 is substantially parallel to the transverse plane of the fork head air outlet 1411 (represented by an ellipse 1135). The middle and outer sides of the adjacent last ellipse 1135 prong track 1420 are adjusted up and down, and the prong air outlet 1411 is positioned to be substantially aligned with the upper airway passage to reduce soft tissue irritation caused by exhaled breathing gas. The lumen of the fork head at the air outlet 1411 is elliptical, and the major axis of the ellipse is arranged on a substantially transverse plane. The air outlet 1411 guides the breathing gas upward or upward toward the top of the user's head (away from the lateral surface) and backward or backward (toward the user's coronal surface).

Figures 13, 14 and 25 to 27 illustrate the shape of the prong 1402 (both track and lumen) to avoid contact with the user's nasal septum area, thereby reducing the risk of tissue injury in this area. By aligning the air outlet of the forkhead with the upper respiratory tract of the user, the forkhead improves the comfort and efficacy of the user. The shape of the lumen maximizes the longitudinal cross-sectional area of the prongs, and uses the anatomically available space of the patient's nostrils to minimize flow resistance. The prong tube cavity has a shape that avoids sealing the user's nostrils.

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

Such anatomical prongs may have shaped tracks that match the anatomical shape of the user's nostrils. In the first part (or stage) of this prong, the track moves horizontally towards the midline of the face. In the second part (or stage) of the prong, the track bends upwards directly into the nostrils towards the top of the head. In the third part (or stage) of the prong, the track follows the anatomical curvature of the nostril and enters the inside of the head. And in the fourth part (or Stage), the track is inclined horizontally toward the center of the sleeve to align the outflow port with the user's upper airway.

This anatomical prong has a cross section that changes along the central track. For example, the cross-section is generally circular at the base of the track and becomes generally elliptical toward the end of the track or the fork. In addition, the diameter of the cross-section is roughly reduced from the first part (or stage) to the end of the fourth part (or stage) along the track.

The prongs are preferably made of soft flexible materials to further reduce the trauma to the soft tissues of the nostrils. An example of a potential material is biocompatible thermoplastic elastomer or liquid silicone rubber (LSR).

The nasal interface 1400 combined with the prong 1402 is illustrated in FIGS. 26A to 26D, 27A, and 27. The interface includes a nasal prong 1402, a common support extending along the patient’s upper lip below the nose and supporting the nasal prong 1402, a pair of prongs or facial cushions 1406, and an integral tube 1401, all of which are roughly centered on the sagittal plane Symmetrically spaced. The interface is formed as an integral or unified component, and the tube 1401 is directly connected to the base 1415 of the nasal prong 1402. The open distal end of each integral tube 1401 is configured to receive a suitable breathing tube (such as tube 100). The breathing tube may be attached or fixed to the interface tube 1401 in other ways. The facial pad 1406 is anatomically shaped with distribution and scaled curvatures to reflect the facial geometry of the intended user. The anatomical shape of the face pad 1406 allows the interface to match the user's face at a predetermined position, where the contour of the face pad 1406 matches the user's facial contour. The pre-shaped facial pad 1406 compensates for the anatomical nasal prong 1402, improves the placement of the nasal prong 1402 and retains the accuracy and speed inside the user's nostrils.

Pre-formed or contoured face pad 1406 to the user's face Features, reducing the pressure applied to the patient's face by any holding mechanism (adhesive tape, helmet or other devices). This reduces the possibility of compression pain. The anatomical shape of the face pad 1406 promotes the engagement, which enhances the stability of the interface 1400 and the nasal prong 1402, thereby improving comfort and therapeutic efficacy.

In yet another embodiment, a nasal cannula configuration 2000 is proposed, including at least one nasal prong 2001, the or each prong 2001 has an air outlet 2002 adapted to be inserted into the user's nostril, and a fluid communication with the air outlet 2002 Air intake 2003. The at least one nasal prong 2001 includes a backing 2004 that is assembled to rest on the patient's face, and where the lip portion 2005 extends around at least a part of the periphery of the back surface 2006 of the backing 2004. The backing 2004 is assembled to receive or retain the user interface patch 2007. In use, the user interface patch 2007 can be releasably attached or connected to the skin patch 2008 or can be fixed to the user's face.

Lips

The lip 2005 generally serves as a barrier, providing a seal, such as a fluid seal. However, it should be understood that setting the lip 2005 as a physical barrier, not necessarily a fluid seal, is sufficient to prevent most fluids (such as nasal or oral mucus, or breast milk or fluid used to wash the user’s face) from leaking under the backing 2004 Leak to the back surface 2006.

Excellently, the lip 2005 operates to prevent most of the fluid from leaking to the rear surface 2006 under the backing 2004. Otherwise, such leakage will damage the adhesion or connection between the user interface patch 2007 and the user's face or the skin patch 2008 applied to the user's face. This kind of tandem patch provides a fixed system for positioning the nasal cannula relative to the user’s nostril, or assists in positioning the nasal cannula at a relatively high level. Optimal location or positioning. In addition, the fluid leakage becomes clogged on the interface facing surface of the user interface patch 2007 or the skin patch; the surface of the patch becomes odorous or slimy and unhealthy. Such damage should be avoided as much as possible, unpleasant to the user or caregiver, or even the ability of the nasal cannula to be maintained in a better position. Providing such a lip 2005 around the rear surface 2006 of the backing 2004 attempts to minimize one or more of these harmful effects.

According to this embodiment, the lip 2005 can be deformed. For example, the lips 2005 may be shaped so that part of the lips contact the user's face, or the skin patch 2008 may be bendable or flexible. In this way, when pressure is applied to the lip 2005, such as when pressure is applied by the bonding force between the user interface patch 2007 and the skin patch 2008, the lip 2008 can be allowed to deform to more effectively follow the shape of the contact. The surface can improve the possibility of more effective fluid sealing or fluid barrier.

The lip portion 2005 may extend at least around the periphery (or part of the periphery) of the backing 2004, for example, around a region substantially adjacent to the connected prongs. For example, the lip 2005 is configured to block most of the flow system from the back of the backing in the mouth and nose area of the user. In other words, nasal mucus leaving the nostril of the user’s nose or saliva leaving the user’s mouth may drip back to the backing of the nasal cannula (depending on the position of the user’s head), or even milk from the baby’s mouth during breastfeeding The leakage then drips to the area surrounding the nasal cannula configuration 2000. In addition, the baby or user's facial wash may produce fluid drips to the area surrounding the nasal cannula 2000.

All of these fluids (and others that are not necessarily the foregoing) may affect the effectiveness of the fixation patch system used to fix or position the sleeve to the user's face. Also, the negative effects of the fixation system patch being clogged with odor or mucus The influence is not expected.

Accordingly, in one embodiment, a lip portion 2005 is preferably provided to surround the back surface 2006 of the backing 2004 and extend from the prong 2001 or the user's nostril to at least this area outside of it. In this case, the lip 2005 may not extend completely around the periphery of the backing.

In other embodiments, the lip may be formed from a series of smaller or segmented lips, which may or may not be adjacent to each other to help form barriers or seals. For example, as shown in FIG. 35, a series of segmented lips may be provided, which together surround part or all of the back surface 2006 of the backing 2004. The lip 2005 may be produced or formed by a series of one or more separate lips, such as shown in FIG. 35. Furthermore, these segmented lips may be adjacent to, adjoining, or even overlapping each other when forming the lip 2005.

In this way, the lips can jointly form a barrier or seal against fluid invasion.

It should be understood that the lip 2005 can be configured to extend completely around the periphery of the backing. In this case, the lip 2005 will be a circular endless lip.

The lips can be formed (or treated to) water repellent properties or attributes, thereby further assisting in reducing liquid passage through the lip barrier.

The part of the lips that contacts the user's skin may be spoon-shaped. For example, the lips may have a contoured shape to effectively provide a pair of parallel spaced apart lips, an outer peripheral lip and an inner peripheral lip as a whole. In this way, a set of lips each contact the user's skin to assist in providing a liquid barrier or seal. It must also be understood that a series of parallel lips can be used.

As mentioned above, the backing 2004 can be substantially flat or flat or even A backing with contours (such as the pre-curved curves shown in Figures 28-34) is assembled to rest on the user's face. The backing 2004 can generally extend from the at least one nasal prong 2001 to the outside, away from the user's nasal septum. The backing 2004 can assist in the operation as a stabilizing member of the nasal prong 2001 in the user's nostrils. In this regard, such a backing 2004 may include various rib features described in other embodiments.

It should also be understood that the nasal cannula configuration 2000 of this embodiment may have a pair of nasal prongs 2001 to be inserted into the user's nostril, and each prong 2001 has an adjacent or connected backing 2004. When a pair of prongs 2001 are provided, the prongs can be independent of each other, or a wire harness can be used to join the prong structures together to provide additional stability, as previously described in other embodiments.

The sleeve 2000 of this embodiment may additionally include the features of the fluid-connected (or integrally formed) tubes 100, 200, 400, 1100 as described herein, and/or may use the user interface patch and skin as described herein The fixation system 500, 600 of the patch, and/or permits fluid communication of the air inlet to the reinforced medical tube 100, 200 as described herein. Furthermore, it must be understood that the nasal prong 2001 can be any of the prong shapes or configurations described above, including the anatomical prongs referred to in Figures 25A-27B.

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

Figures 28 and 29 show a nasal cannula configuration 2000 with a backing 2004 attached to a skin patch 2008 fixed to the user's face. The lip 2005 is shown in contact with the skin patch 2008, thereby providing a fluid barrier, otherwise fluid may leak to the underside of the backing 2004 and the rear surface 2006 of the fixed position of the user interface patch 2007. As shown in the figure, the user interface patch 2007 is located on the inner side of the lip 2005.

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

As shown in FIGS. 31 and 34, the rear surface 2006 is initially not provided with a user interface patch, that is, the rear surface 2006 is configured to receive or fix the user interface patch 2007. Such a user interface patch 2007 can be connected to the back surface 2006 by an adhesive or other suitable connection. Once the patch is in place, it is ready to attach to or receive the skin patch.

In one form, the user interface patch may be a part of a two-part connection system, such as a loop of a hook and loop system. In this case, the surface of the skin patch 2008 facing the interface will include hooks that can engage the loops of the user interface patch. With reference to Fig. 32, the user interface patch with loops fixed on the back surface 2006 is exemplified and prepared to be connected to the hook of the skin patch.

Figure 33 shows a cross-sectional view of the sleeve 2000 through which the hook 2009 with the skin patch engages the loop 2010 of the user interface patch. It is also shown that the lumen 2011 or the gas passage allows the gas inlet of the gas supply sleeve to be delivered to the gas outlet 2002 of the nasal prong 2001.

Fixed system

The fixing system for fixing the user interface and/or the user interface tube to the patient is illustrated in Figs. 15-17. The fixation system 500 is shown as supporting a nasal cannula on the baby's face.

Advantageously, the system provides a substantially faster and modified or simplified installation user interface for user positioning. In addition, these effects also promote the use of other user interfaces or the removal of user interfaces from the user when the user is cycling between different treatments (such as gas therapy such as continuous positive pressure breathing aid (CPAP) or high flow applications). Improve or simplify.

Some user interfaces are specially configured to interact with or respond to the system of the described embodiment. In addition, the unmodified user interface can be adapted to the described embodiments and can be easily located, and the installation process involves very little time.

In many embodiments provided by the fixing system, such a system allows the interface to be quickly positioned to the user, and can provide a reliable positioning of the interface.

An easy-to-locate user interface is particularly useful for users. The provision of a system allows a caregiver (such as a nurse) to apply the fixation system with one hand, which is particularly advantageous when the user of the interface is a baby.

In addition, in another embodiment, the fixing system provides a first level fixing of the user interface to the user. For example, this first level fixation can be as shown in Figures 15-17. When the user requires additional or higher security for user interface positioning or fixation, the second level of interface fixation can be used. Such additional layers can be applied by applying patches from above, such as using patch 660. The patch 660 can be an adhesive patch and can be installed on the user interface and/or the top of the tube and adhered to a part of the skin patch 550.

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

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

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

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

The two-part releasable attachment or connection configuration 551 may include hook and loop materials (such as Velcro), a magnet or an array of magnets arranged on individual patches with appropriately arranged holes, and an adhesive configuration, Act when two patches are pressure bonded or coupled with another suitable release paper. The interface side of the skin patch 550 may have one of the hook or loop material, and the patient side of the user interface patch 552 may have the other of the hook or loop material, so that the skin patch and the user interface patch are Releasably attach or link to each other.

When referring to hook and loop materials, it means any one of a wide variety of regional mechanical fasteners. For example, the Velcro product range includes hook and loop products, where the hook assembly includes upright nylon hooks (shaped as cut loops through the woven backing sheet) that engage any complementary loop stack material. The Velcro product range also includes raised hook products, which are typically smaller in size and match the "pile" Non-woven fiber backing material. These hook materials are designed to work with a range of loop bases, and in some cases, these hook materials are also used as loop bases. Other similar systems include the Dual-Lock re-opening and closing fastener system from 3M in St. Paul, Minnesota, USA. The common feature of these refoldable fastener systems is to engage any contact part between the two parts of the system. Since there are multiple connectors scattered throughout the product area, precise alignment of individual connectors is not required. A wide range of releasable fastener systems in the art can be used in releasable attachment systems to provide releasable attachment between the skin patch and the user interface.

The two-part releasable attachment or connection system can be attached to the interface side of the skin patch with an appropriate adhesive, and occupy up to 100% or less than about 90%, or about 85%, or about the surface area of the interface side of the skin patch. 75%, or about 60%, or about 50%, or about 40%, or about 30%, or about 20%, or about 10%.

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

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

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

Patch

In some embodiments, the base of the first component of the two-part releasable attachment system is flexible, so that the plane of the base can be bent to follow a curved surface in one direction. However, the substrate is typically not a surface that can also be stretched to follow the curve in two orthogonal directions. However, the pad of the skin patch can be a surface that can be stretched and can be bent in more than one direction, such as can be worn on the contour of the patient's body.

According to several embodiments, this difficulty can be alleviated by providing a first part 553 of a two-part releasable attachment system in the form of a base part formed by at least one slit or at least one slot. Divided into multiple zones, so that different parts of the base body can be bent independently, so the overall form of the base body can be deformed to substantially match the two-directional curved surface. This is the case even if the base portion is bent in only one direction at its individual positions.

Examples of this form are illustrated in Figures 36B to 36R. The contour of the pad of the skin patch is illustrated in Figure 36A. This configuration is especially useful for the shape type where compound bending is the biggest problem. This type is a shape where two or more bends of the matrix are easier to interact. Typically these shapes are fat, short, fat, short and fat or short and fat but not elongated. For example, the shape of this type will have a short perimeter relative to the area. If the surface is concave or the periphery is hollow, consider the virtual periphery, which is the shortest enclosing path outside the shape, and the shapes will have a small ratio of the square of the virtual periphery length to the area of the shape. A circle has the lowest ratio of about 12.6:1, and a square has Approximately 16:1 ratio, 2 to 1 rectangle has a ratio of 18:1. Although a more slender shape has a higher ratio, for example, a 5 to 1 rectangle has a perimeter square to area ratio of 29:1. In some embodiments, the improvements described with reference to Figures 36B to 36R are excellently applied to a patch shape having a ratio of the shortest enclosing peripheral length square to the peripheral internal area less than 25. In other embodiments, the improvements described with reference to FIGS. 36B to 36R are excellently applied to the releasable attachment base portion having the shortest surrounding peripheral length square to the base coverage area ratio of less than 25.

Like the variation of Figures 36A-36R, the base can be formed as a plurality of non-continuous parts, but the preferred form of the base is a single continuous part.

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

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

In the specific embodiment shown in Figures 36B, 36F, 36G, and 36H, the base portion does not extend into the edge of the skin patch 550 completely. Surrounding at least a part of the edge, the narrow section is maintained between the edge of the skin patch and the edge of the substrate. This narrow section can extend around the entire periphery of the base. In some embodiments, such as the embodiment in FIG. 36B, the section between the edge of the skin patch 550 and the edge of the substrate may be wider in some locations than in other locations. For example, in Figure 36B, the wider section 3615 is intended to be positioned at the end away from the nose. This provides attachment to the section closer to the nose, but allows the user to start tearing off at the section farther from the nose to release the releasable fastener. For other examples of Figures 36C to 36R, the size and positioning configuration of the substrate on the skin patch can be provided. For example, in each case, the example configuration can be constructed to a smaller area of the skin patch and positioned closer to the nose of the skin patch.

The size of other specific embodiments may not extend to the edge of the skin patch. Generally, in the embodiment of FIGS. 36B to 36R, the base portion includes a crouched overall shape, occupying a high percentage of the internal area of the stretched periphery (the shortest path surrounding the shape). Generally speaking, the base body is shaped as one body, but it can also be formed by a small number of closely intertwined bodies (for example, two bodies), such as in Figure 36R. Inside the body, the base system is divided into multiple parts and/or elongated shapes by at least one slot or slot, so that adjacent parts (or sub-parts) of the base body are opposite across the slot, slot or gap. . Depending on the configuration of the slots, slots or gaps (or multiple slots, slots or gaps), the matrix allows the underlying skin patch to stretch in one or more directions in addition to being bent or shaped into a compound curve. Then, referring to different base parts and configurations, several eye-catching features and characteristics will be described.

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

The base 3603 in Figure 36B is substantially serpentine. The base has an end adjacent to the first end 3304 of the skin patch and a second end adjacent to or facing the second end 3305 of the skin patch. The base system is formed into a series of swing loops divided by slits 3306. 3306 can be perpendicular to a line between ends 3304 and 3305 or angled at some other angle. For example, the slits 3306 may include 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 vice versa, the lower end of each slit is closer to the first end 3304 than the upper end of each slit . There may be at least three slits, at least four slits, or at least five slits. The serpentine shape can provide the shortest uncut path between the first end of the base portion and the second end of the base portion at least twice the actual linear distance between these positions.

The serpentine-shaped slit series provide the staggered part of the meandering path, and the staggered part can be bent in different directions to make the matrix follow the shape of the compound curved surface. For example, the curved portion 3307 can be bent independently from the straight portion 3308, and the outer surface of the skin patch pad is allowed to bend and protrude in two orthogonal directions.

The serpentine shape of the base 3603 includes curved or radiused corners. Bent or radiused corners are less prone to lift up due to accidental contact than sharp corners. Similar modifications can be made to any of the embodiments illustrated in FIGS. 36B to 36R.

The base of Figure 36C is broadly similar to the base of Figure 36B. The base 3309 shown in the figure completely covers the skin patch. One end fills the first end 3304 of the skin patch, and the other end reaches the other end 3305 of the skin patch. A series of staggered slits 3310 reach the staggered edge of the base portion, so that the serpentine body extends between the two ends 3304 and 3305. The base portion illustrated in Fig. 36C has substantially the same flexibility characteristics as the base portion of Fig. 36B.

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

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

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

Other serpentine embodiments will be described below with reference to Figures 36M, 36O, and 36E.

Another matrix configuration including a series of islands connected by bridges is illustrated in Figure 36F. In this embodiment, the base portion 3325 includes an island 3326 and a slot 3327. Bridge 3328 connects the islands. In the illustrated form, the bridge in Figure 36F is positioned along the center line between ends 3304 and 3305. This configuration can be described as having a central member and a string extending from both sides of the member Column leaf department. In this embodiment, the slots 3327 extend inwardly from each edge at equal intervals. The slots are oriented as a line between the substantially vertical ends 3304 and 3305. Slots 3327 extend inward from the edges on opposite sides of the alignment axis. In addition, the slots 3327 can be staggered. As in FIGS. 36H and 36B to 36D, the slot 3327 may be oriented at a non-orthogonal angle relative to the line between the ends 3304 and 3305.

In the configurations of Figures 36B, 36C, 36D, and 36F to 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 are extended on opposite sides of the base portion. In this embodiment, the first set of slits 3329 is oriented at a non-parallel angle relative to the second set of slits 3330. More specifically, in this embodiment, the upper end of the slit 3329 is farther from the end 3304 of the skin patch than the lower end, and the upper end of the slot 3330 is closer to the end 3304 of the skin patch than the lower end. In some embodiments, the slits 3329 and 3330 pass through the center line of the base portion (extending from the end 3304 to the center line of the end 3305), so that there is no straight path between the ends 3304 and 3305. The slits 3329 and 3330 form a herring bone pattern.

The embodiments described in Figures 36B to 36H are generally regular patterns. Figure 36I illustrates an embodiment with a relatively irregular pattern. In this embodiment, the base portion 3331 substantially covers the entire surface of the skin patch and is divided by an irregular slit arrangement. For example, the slit 3333 extends from an adjacent end 3304 in an approximately S-shape, and interleaved tandem fingers are generated from either side of the base portion 3331. The second slit 3333 extends from an edge of the adjacent end 3305 of the base of the skin patch. This slit form includes a corner or a dog leg, and is divided into a cross slit 3335 at the intersection 3334. The slits 3332 and 3333 divide the area of the base portion 3331 into multiple regions or sections of approximately equal width, with interdigitating fingers and long joints. In this embodiment, most of the slits are integrated into the base portion 3331, and are only connected to the edges of the base portion 3331 at two positions.

The similar arrangement of the interleaved fingers is evident in the base 3336 in Figure 36J and the base 3337 in Figure 36R. In the base 3336 of FIG. 35J, a single narrow slot 3337 with a small width extends from an edge of the adjacent end 305 of the base in a serpentine path along the longitudinal direction of the base to the adjacent edge 3304. In this embodiment, the single slot 3337 only hits the edge of the base portion 3336 at one position. The slot 3337 divides the base portion 3336 into two parts, each including a series of fingers 3338 and 3339. Refers to the intersection of 3338 and 3339 lines. The position of the slot 3337 and the direction of the long leg of the bent portion 3341 allow the fingers 3338 and 3339 to be oriented along the direction that crosses but at an angle between the ends 3304 and 3305.

In another embodiment illustrated in FIG. 36R, a single serpentine slot 3342 extends from the upper edge of the slot 3337 to the lower edge of the slot 3337. The slot 3342 is extended on a serpentine path including a straight portion 3343 and a curved portion 3344. In this way, the slot 3337 is divided into two transversely divided parts, each including an elongated finger 3345. The fingers of one part intersect with the fingers of the other. In this embodiment, the interdigitated fingers are substantially aligned with a line extending between the parallel ends 3304 and 3305.

Another embodiment including a single slot or slit is illustrated in Figure 36K. In this embodiment, the single slit 3346 extends in a substantially spiral configuration from the adjacent end 3305 of the edge position to a position substantially centered on the base portion 3347 and ends. The spiral slit 3346 divides the base portion 3347 into a single continuous spiral base material. In some embodiments, the multiple spiral slits start at different positions around the periphery of the base portion 3347, dividing the base portion into a plurality of intersecting spirals of base material.

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

In the embodiment of FIGS. 36K and 36L, the base portions 3348 and 3349 are divided by a plurality of curved slits 3350 which are arranged substantially in a series of concentric circles in each example. Some slits 3350 reach from the edges of the base 3348 and 3349.

The other slots 3351 start and end in the bases 3348 and 3349 inside the body. For example, in the base portion 3348, the slits 3351 each draw an arc greater than 315 degrees but less than 360 degrees, forming a circular and ring-shaped portion inside the base portion 3348, which is connected to other parts of the base portion 3348 through narrow bridges. The slits 3351 in the base portion 3349 operate in a similar manner to produce circular and ring-shaped portions connected by narrow bridges.

In Figure 36K, the arrangement of the slits 3350 and 3351 and, in particular, the bridges between the parts divided by the slits make the continuous uncut material formed between the ends 3305 and 3304 of the base and the center 3352 of the base Winding path. In Figure 36L, the arrangement of the curved slits 3350 and the substantially circular slits 3351 makes the bridges substantially aligned, so that a straighter path is provided between at least one end 3305 of the base and the center 3352 of the base.

Another serial embodiment is illustrated in FIGS. 36N to 36P. In this series, the base portions 3353, 3354, 3355, and 3356 are respectively divided by a series of narrow curved slots, and each slot extends from the upper edge or the lower edge of the base portion into the interior of the base body. The lines on each base body are arranged in parallel. in In some embodiments, the interval between the curved slots is substantially the same along the longitudinal direction of the base portion. In some embodiments, the slot extends across most of the width of the base, but not entirely across the width of the base. For example, the slot extends across more than 70%, more than 80%, or more than 90% of the width of the base portion. The slot can have a radiused corner at the closed end.

In the configuration of Figure 36M, the series of slots extend from alternate sides of the base portion, the slots 3357 and 3358 extend from the upper edge of the base portion, and the slots 3359 and 3360 extend from the lower edge of the base portion. In this way, the base portion is divided into substantially serpentine lengths. In this embodiment, the bend of each base body slot is such that the upper end and the lower end of each slot are farther away from the end 3304 than the middle part.

In the embodiment of Figure 36N, all four curved slots 3361 extend from the same edge of the base portion. This shape is like a comb, with a series of fingers extending from the same direction of a single back bone. As for Embodiment 36N, in this example, the slots are curved so that the upper and lower ends of the slots are farther away from the first end 3304 of the skin patch than the middle portion.

Figure 36O illustrates yet another embodiment similar to that of Figure 36N. In Figure 36O, curved slots 3362 and 3363 extend from the lower edge and the upper edge of the base portion, respectively. The slotted series 3362 is interleaved with the slotted series 3363 to form a continuous path that is serpentine or spiral along the base. In the embodiment of FIG. 36O, the upper end and the lower end of each curved slot are farther away from the first end 3304 of the skin patch than the middle part.

Another change is illustrated in Figure 36P. In this embodiment, the curved slot 3364 will extend from the same edge of the base portion. Can extend from the upper or lower edge. The curved slots 3364 are all arranged in a parallel configuration. Bend open The upper and lower ends of the groove are farther away from the first end 3304 of the skin patch than the middle part.

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

The skin patch 650 defines a fixed footprint attached to the patient, and has a configuration similar to the skin patch 550 in the previous fixed embodiment. The user side of the skin patch 650 is assembled to attach or adhere to the user's skin.

The fixing patch 660 extends over the user interface and/or the connected user interface tube and is adhered to the skin patch 650 to fix the user interface to the patient. The fixation patch 660 and the skin patch 650 are assembled to allow the fixation patch to be contained in or fixed by the skin patch when the fixation system is applied to the patient with a suitable or compatible user interface The world drawn by footprints. The fixed patch 660 is accommodated inside the fixed footprint of the skin patch 650, which can reduce the possibility of unnecessary contact with the patient's skin and potential irritation. Ideally, the skin patch 650 has the same or larger surface area as the fixed patch 660.

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

In this way, the size of the skin patch can reduce the possibility of tape application or the possibility of any additional tape extending to the user's skin. It is better to avoid or reduce the application, or to repeatedly apply and remove the adhesive to the user's skin. This embodiment advantageously reduces repeated application of adhesive or adhesive tape to the user's skin to install and position the user interface to the operating position. Adhesive tape or other skin adhesive patches (when applied and removed repeatedly) are particularly problematic for babies. Problems include but are not limited to adhesive chemicals (or adhesive removal chemicals such as solvents) or tape chemicals (for example due to skin sensitivity) causing skin irritation, repeated application and removal in order to locate or reposition the interface to the user Skin patches or tapes cause damage to the user's skin. When the therapeutic treatment is repeated (that is, from one type of treatment to another, and then repeated), repositioning or adjustment may be required. Therefore, excellently, the described embodiment proposes a system for positioning or positioning the user interface for the user while still reducing the possibility of the adhesive tape attaching to the user's skin and connecting.

It is necessary to understand that the repositioning interface, especially for infants, has many shortcomings and problems associated with it. Including "lion nose", epidermal abrasions, or skin irritation from the traditional application of user interface (such as nasal cannula) to the user's tape application technique. This problem also occurs when the user goes back and forth between different treatment options. Traditionally, the helmet or tape or user interface is removed, and then new equipment and helmets or other helmets for user interface or interface positioning are installed. Therefore, proposing a ready-to-receive mode in which a fixed system receives a user interface when it is applied to a user is a major progress towards reducing the problems that the user has to face. Moreover, in terms of complexity and the time and effort of caregivers (such as nurses), improving the ease of installation is an additional benefit.

The fixed patch can be shaped or assembled in other ways to adapt to the geometry or other characteristics of the user interface and/or the connected user interface tube. The exemplified fixing patch has multiple wings 661 to adapt to the user interface tube and increase the contact area of the fixing patch 660 exposed to the skin patch 650. The fixed patches illustrated in Figures 22 and 23 each have a pair of wings arranged at one end of the patch. The wings 661 are assembled to fix the skin patch on either side of the user interface and/or the connected user interface tube, and reduce the possibility of 660 bulging around the interface and/or tube.

The fixing patch 661 illustrated in FIG. 22 also has tube end wings 661. The tube end wings 661 are assembled to extend below the user interface tube and are fixed to the skin patch 650 to link and fix the end of the patch 660.

The second embodiment of the fixing system can be used to fix the tube to any part of the patient's body. The embodiments illustrated in Figures 15 to 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 fixed system illustrated is suitable for neonatal use.

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

The fixation system illustrated in the figure is specifically configured to receive and/or fix the previously disclosed nasal cannula and the associated tube. The tube can extend from one or both sides of the user's face. In addition, the fixing system can be combined so that the user interface is attached or connected by a two-part detachable configuration and the interface The fixing patch above the surface and/or tube is fixed to the skin patch.

Although the disclosure herein has been described in terms of certain embodiments, other embodiments that are clearly known to those skilled in the art also fall within the scope of the disclosure herein. In this way, many changes and modifications can be made without departing from the essence and scope disclosed in this article. For example, multiple components can be repositioned as desired. In addition, not all the features, aspects, and advantages are required to implement the disclosure herein. Therefore, the scope disclosed in this article is intended to be limited only by the scope of the following patent applications.

It should be understood that multiple embodiments described above and with reference to the drawings can be combined with each other to achieve desired or advantageous results. For example, the tube can be connected to the sleeve attached to the present invention, or can be used in combination with other sleeves not specifically described here. In the same way, the sleeve of the present invention can be used in combination with the fixing system of the present invention, or can be used in combination with other holding systems or used interchangeably. In addition, the anatomical shape prongs of the present invention can be combined with the aforementioned tube or interface or fixing system, or can be used in combination with other tubes or interfaces or fixing systems or used interchangeably. The combination of the foregoing multiple embodiments is particularly excellent.

Preferred features

SP1. A corrugated medical tube comprising: a tubular body, the system defines a lumen extending between the open terminals of the body, and an internal part surrounding the lumen and supporting the tubular body, along the A length of the tubular body defines an outermost periphery of a plurality of interlaced wave crests and wave troughs of the inner profile.

SP2. The tube claimed by SP1 as requested, wherein the tubular body is an extruded tube.

SP3. If the tube claimed by SP1 or SP2 is requested, the tubular body It is a coiled tube.

SP4. The tube claimed in any one of the requested aspects SP1 to SP3, wherein the tubular body is a continuous extruded tube.

SP5. The tube claimed in any one of the requested aspects SP1 to SP4, wherein the wave crest of the corrugated tubular body is defined by the outermost periphery of the inner profile.

SP6. The tube claimed in any one of the requested aspects SP1 to SP5, wherein the trough of the corrugated tubular body is drawn inwardly of the inner profile and defined by the drawn inwardly portion of the tubular body.

SP7. The tube claimed in any one of the request modes SP1 to SP6, wherein the inner shape is a continuous length, one or a series of semi-continuous lengths, or a series of divided lengths.

SP8. The tube claimed in any one of the requested aspects SP1 to SP7, wherein the inner profile is a spiral spring or a spirally wound element, a spirally wound skeleton or a spirally wound rib, an annular disc, a ring , Or one or a combination of a plurality of separate supports interconnected by one or more connecting rods or interconnectable.

SP9. The tube claimed in any one of the requested aspects SP1 to SP8, wherein the inner profile is a support for the tubular body defining a lumen inside.

SP10. The tube claimed in any one of the requested aspects SP1 to SP9, wherein the internal profile is a skeleton or internal support structure supporting the tubular body.

SP11. The tube claimed in any one of the requested aspects SP5 to SP10, wherein the tubular body is substantially not supported by the inner shape member in the troughs but is supported by the inner shape member in the wave crests.

SP12. The tube claimed in any one of the requested aspects SP5 to SP11, wherein the wall of the tubular body is suspended between adjacent wave crests.

SP13. The tube claimed in any one of the requested aspects SP5 to SP12, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably suitable for medical breathing tubes polymer.

SP14. The tube claimed by any one of SP1 to SP13 as requested, wherein the tubular body is a gas-permeable tube or is made of a gas-permeable material, such as gas-permeable thermoplastic polyurethane (type) or gas-permeable Sex polyamides.

SP15. The tube claimed in any one of the requested aspects SP1 to SP14, wherein the inner profile is a spirally wound rib or a rib element.

SP16. The tube claimed in any one of the requested aspects SP1 to SP15, wherein the inner profile is a spirally wound element having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm To about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm One space between adjacent turns.

SP17. The tube claimed in any one of the requested aspects SP1 to SP16, wherein the inner profile has a length of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or About 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about One of the outermost diameters of 3 mm to about 3.2 mm.

SP18. If any of the claims from SP1 to SP17 is requested, where The inner profile is a spirally wound element having a thickness of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or About 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm diameter .

SP19. The tube claimed by SP18 as requested, wherein the inner part is a medical grade material, preferably a medical grade stainless steel.

SP20. The tube claimed in any one of the requested aspects SP1 to SP19, wherein the tubular body has about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 Mm, or a thickness of about 0.14 mm to about 0.16 mm.

SP21. The tube claimed in any one of the requested aspects SP1 to SP20, wherein the tubular body has about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 Mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm M to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.

SP22. The tube claimed in any one of the requested aspects SP1 to SP21, wherein the tubular body has about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 Mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 An external diameter of one millimeter to about 3.2 millimeters.

SP23. The tube claimed by any one of SP1 to SP22 as requested, wherein the tubular system is (preferably extruded from) thermoplastic elastomer, propylene-based elastomer, and thermoplastic breathable polyester Elastomer, liquid silicone rubber (LSR), breathable thermoplastic polyurethane, or breathable polyamide one or a combination; more preferably, the polymer may be such as, but not limited to, polyolefin, thermoplastic elastomer , Or breathable thermoplastic elastomers, such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having 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 of the polymer of Shore A.

SP24. The tube claimed in any one of the requested aspects SP1 to SP24, wherein the inner profile is a plurality of rings spaced longitudinally along the lumen.

SP25. For the tube claimed by SP24, the shape of the rings is toric or ring.

SP26. The tube claimed in any one of the request modes SP1 to SP25, wherein the inner profile is one or more separate elements linked to each other.

SP27. The tube claimed in any one of the requested aspects SP1 to SP26, wherein the inner profile is a plurality of reinforcing ribs regularly spaced along the lumen.

SP28. The tube claimed by SP27 as requested, wherein each reinforcing rib includes one turn of a spiral reinforcing wire.

SP29. The tube claimed by SP28 in the requested aspect, wherein one turn of the spiral reinforcement wire includes a complete turn around the lumen.

SP30. The tube claimed by SP28 in the requested aspect, wherein one turn of the spirally reinforced wire includes the wire located between the adjacent wave crests of the inner profile.

SP31. For a tube claimed by any one of SP1 to SP30, the tubular system is subject to flow resistance according to ISO 5367: 2000(E) (Fourth Edition, June 1, 2000) The added test is defined as flexibility.

SP32. The tube claimed in any one of the requested aspects SP1 to SP31, wherein a terminal of the tube is integrated with a nasal prong, and the nasal prong is suitable for being inserted into a user's nostril for delivering breathing gas to A nasal interface for one user.

SP33. The tube claimed by any one of SP1 to SP32 as requested, wherein the inner profile is a screen.

SP34. Such as the management of any of the claims from SP1 to SP33, where The inner profile is a wire suitable for heating or sensing the properties of the gas inside the tube.

SP35. The tube claimed in any one of the requested aspects SP1 to SP34, wherein the inner shape is conductive, and preferably the inner shape is an electric heater.

SP36. The tube claimed in any one of the request modes SP1 to SP35, wherein the inner part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

SP37. The tube claimed in any one of the requested modes SP1 to SP36, wherein the tube system further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

SP38. The tube claimed by any one of SP1 to SP37 as requested, wherein the tube is a breathing tube.

SP39. The tube claimed in any one of the requested aspects SP1 to SP38, wherein the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the The ratio is about 0.20 to about 0.35, and more preferably, the ratio is about 0.28 or about 0.29.

SP40. The tube claimed in any one of the requested aspects SP1 to SP38, wherein the ratio of the diameter of the inner profile (for example, the diameter of the actual inner profile element or component) to the outer diameter (for example, the outermost diameter) of the inner profile It is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably the ratio is 0.06.

SP41. The tube claimed in any one of the requested aspects SP1 to SP38, wherein the ratio of the corrugation depth to the outer (ie, outer) tube diameter is about 0.05 to about 0.09.

SP42. The tube claimed in any one of the requested aspects SP1 to SP38, wherein the physical properties of the tubular body make the tube have the desired flexibility and/ Or structural support.

SPM11. A method of manufacturing a medical tube, the method comprising: providing an inner profile protruding from a tubular body enclosing the inner profile, the tubular system defining a lumen surrounding the inner profile.

SPM12. If the method claimed by SPM11 is requested, it further includes:

i) Applying a reduced pressure to (or to) the inside of the lumen, so that the reduced pressure draws the tubular body radially inward from the lumen or the outermost periphery defined by the inner profile. The outermost periphery defines a plurality of alternating peaks and valleys along a length of the tubular body, or

ii) applying an extension (or stretching) to at least a part or a region of the tubular body surrounding the inner profile, so that the release of the extension (or stretching) extends (or stretches) the tubular body Part or area returns (or may permit) to be drawn radially inwardly from the outermost periphery defined by the lumen or by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body ,or

iii) A combination of one of i) and ii).

SPM13. The method claimed by SPM11 or SPM12 as requested, wherein the tubular system is provided by extrusion or by extruding a material from a die.

SPM14. The method claimed by any one of SPM11 to SPM13 in the request mode, wherein the tubular body is extruded around the inner profile, and the pressure reduction is applied in a manner that allows an inner surface of the tubular body to become at least partially attached or Connected to at least a part of the internal profile, preferably the pressure difference between the pressure in the lumen and the pressure surrounding the tubular body, more preferably the lumen (raising The pressure supplied to the lumen is lower than the pressure surrounding the tubular body (or the pressure surrounding the tubular body is greater than the pressure inside the lumen (provided to the lumen)).

SPM15. The method claimed in any one of the requested aspects SPM11 to SPM15, wherein the tubular body is a single-walled body.

SPM16. The method claimed in any one of the requested aspects SPM11 to SPM16, wherein the reduced pressure is applied to or adjacent to the formation of the lumen.

SPM17. The method claimed by SPM14 in the requested aspect, wherein the reduced pressure is applied to or adjacent to a die.

SPM18. The method claimed by SPM14 as requested, in which the lumen experiences the decompression when exiting from an extrusion die.

SPM19. The method claimed in any one of SPM11 to SPM18 as requested, wherein the tubular body and the inner profile are co-extruded.

SPM110. The method claimed in any one of the requested aspects SPM11 to SPM18, wherein the tubular body thus formed is corrugated.

SPM111. The method claimed in any one of the requested aspects SPM11 to SPM110, wherein the wave crests of the corrugated tubular body thus formed are defined by the outermost periphery of the inner profile.

SPM112. The method claimed in any one of the requested aspects SPM11 to SPM111, wherein the troughs of the corrugated tubular body thus formed are formed by the inward extraction portion of the tubular body that is drawn inwardly between the internal shapes Define.

SPM113. The method claimed in any one of the requested aspects SPM11 to SPM112, wherein the internal profile is a skeleton or internal support structure supporting the tubular body.

SPM114. The method claimed in any one of the requested aspects SPM11 to SPM113, wherein the internal profile is a continuous length, one or a series of semi-continuous lengths, or a series of divided lengths.

SPM115. The method claimed by any one of SPM11 to SPM113 in the request mode, wherein the inner profile is a screen.

SPM116. The method claimed in any one of the requested aspects SPM11 to SPM113, wherein the internal profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring , Or one or a combination of a plurality of separate supports interconnected by one or more connecting rods or interconnectable.

SPM117. The method claimed in any one of the requested aspects SPM11 to SPM117, wherein the internal profile is supportive or supports the lumen inside the tube thus formed.

SPM118. The method claimed in any one of SPM11 to SPM113 or SPM117 in the requested aspect, wherein the inner profile is a spirally wound element having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 The distance between adjacent turns in millimeters.

SPM119. The method claimed in any one of SPM11 to SPM113 or SPM117 as requested, wherein the inner profile has a thickness of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm , Or about 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to About 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or The outermost diameter is one of about 2.9 mm to about 3.3 mm, or about 3 mm to about 3.2 mm.

SPM120. The method claimed in any one of the requested aspects SPM118 or SPM119, wherein the inner profile is a spirally wound element having a size of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or About 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about A diameter of 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm.

SPM121. The method proposed by SPM120 as requested, wherein the internal profile is a medical grade material, preferably a medical grade stainless steel.

SPM122. The method claimed in any one of the requested aspects SPM11 to SPM121, wherein the tubular body has about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 Mm, or a thickness of about 0.14 mm to about 0.16 mm.

SPM123. Any one of SPM11 to SPM122 as requested The method of the method, wherein the tubular body has a diameter of about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 Mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 Mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.

SPM124. The method claimed in any one of the requested aspects SPM11 to SPM123, wherein the tubular body has about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 Mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 An external diameter of one millimeter to about 3.2 millimeters.

SPM125. The method claimed by any one of SPM11 to SPM124 as requested, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably suitable for medical breathing tubes polymer.

SPM126. The method claimed by any one of SPM11 to SPM125 as requested, wherein the tubular system is (preferably extruded from) thermoplastic elastomer, propylene-based elastomer, and thermoplastic breathable polyester Elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide One or a combination; more preferably, the polymer may be such as, but not limited to, polyolefin, thermoplastic elastomer, or breathable thermoplastic elastomer such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers , Or thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; even more preferably having 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 Shore A polymer.

SPM127. The method claimed by any one of SPM11 to SPM126 as requested, wherein the tubular body is a gas-permeable tube, or is made of a gas-permeable material, such as gas-permeable thermoplastic polyurethane (like) or gas-permeable Sex polyamides.

SPM128. The method claimed in any one of SPM11 to SPM127 in the requested state, wherein the reduced pressure is applied when the tubular main system is in a molten state, or a semi-molten state, or an unhardened state, preferably the reduced pressure system It is about 0 to about -2 Pa (absolute), more preferably about 0 to about -1 Pa (absolute), even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably The pressure reduction is the pressure difference between the inner side of the lumen and the surrounding area of the tubular body.

SPM129. The method claimed in any one of the requested aspects SPM11 to SPM128, wherein the internal profile is electrically conductive, preferably the internal profile is an electric heater.

SPM130. The method claimed in any one of the requested aspects SPM11 to SPM129, wherein the internal mold includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

SPM131. The method claimed in any one of the requested aspects SPM11 to SPM130, wherein the pipe system further comprises a heater, preferably an electric heater (such as a heater wire or heater circuit).

SPM132. The method proposed by any one of SPM11 to SPM131 as requested, in which the tubular system adopts flow resistance according to ISO 5367:2000(E) (fourth edition, June 1, 2000) The added test is defined as flexibility.

SPM133. The method claimed in any one of SPM11 to SPM132 in the request mode, wherein the medical tube is a breathing tube.

SPM134. The tube claimed by any one of SPM11 to SPM133 in the requested aspect, wherein the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the The ratio is about 0.20 to about 0.35, and more preferably, the ratio is about 0.28 or about 0.29.

SPM135. The tube claimed by any one of SPM11 to SPM134 in the requested aspect, wherein the ratio of the diameter of the inner part (for example, the diameter of the actual inner part element or component) to the outer diameter (for example, the outermost diameter) of the inner part It is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably the ratio is 0.06.

SPM136. The tube claimed in any one of the requested aspects SPM11 to SPM135, wherein the ratio of the corrugation depth to the outer (ie, outer) tube diameter is about 0.05 to about 0.09.

SPM137. The tube claimed in any one of SPM11 to SPM136 as requested, wherein the physical properties of the tubular body make the tube required to have the desired flexibility and/or structural support.

SP21. A medical tube system includes: a tubular body, the system defines a lumen extending between the open terminals of the body, and an internal part that surrounds the lumen and supports the tubular body, and a package A coating layer of the inner profile is sealed, and the coating layer fixes the inner profile to the tubular body.

SP22. The medical tube claimed by SP21 as requested, wherein the coating layer and the tubular system are welded along the tube.

SP23. The medical tube claimed by SP21 or SP22, in which the coating layer and the tubular system are welded along the tube at a separate position.

SP24. The medical tube claimed by SP22 as requested, wherein the coating layer and the tubular system are substantially continuously welded along the longitudinal direction of the tube.

SP25. The medical tube claimed in any one of the requested aspects SP21 to SP24, wherein the outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

SP26. The tube claimed by SP25 as requested, wherein the wave crests of the bellows body are defined by the outermost periphery of the inner profile.

SP27. The tube claimed by SP25 or SP26, in which the bellows system is defined by the inward extraction part of the tubular body drawn inwardly between the internal shapes.

SP28. The tube claimed in any one of the requested modes SP21 to SP27, wherein the inner profile is a continuous length, one or a series of semi-continuous lengths, or a series of separate lengths.

SP29. The tube claimed in any one of the requested aspects SP21 to SP28, wherein the inner profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring , Or borrow one or more One or a combination of a plurality of separate supports that are interconnected or interconnectable by knot links.

SP210. The tube claimed in any one of the requested aspects SP21 to SP29, wherein the inner profile supports the tubular body to define the lumen inside.

SP211. The tube claimed in any one of the requested aspects SP21 to SP210, wherein the internal profile is a skeleton or internal support structure supporting the tubular body.

SP212. The tube claimed in any one of the requested aspects SP25 to SP27, wherein the tubular body is substantially not supported by the trough from the inner profile but is tied to the crest by the inner profile.

SP213. The tube claimed in any one of the requested aspects SP25 to SP27, wherein the wall of the tubular body is suspended between adjacent wave crests.

SP214. The tube claimed by any one of SP21 to SP213 as requested, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably suitable for medical breathing tubes polymer.

SP215. The tube claimed in any one of the requested aspects SP21 to SP214, wherein the inner profile is a spirally wound rib or a rib element.

SP216. The tube claimed in any one of the requested aspects SP21 to SP215, wherein the inner profile is a spirally wound strip, and the coating layer encapsulates the strip.

SP217. The tube claimed in any one of the request modes SP21 to SP216, wherein the inner profile is a spirally wound wire, and the coating layer encloses the wire.

SP218. The tube claimed in any one of the requested aspects SP21 to SP217, wherein the coating layer provides a surface to be joined with the tubular body.

SP219. If any one of SP21 to SP218 is requested to be managed, Wherein the inner part is a spirally wound element having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm to about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 A pitch between adjacent turns of about 1 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm.

SP220. The tube claimed in any one of the requested aspects SP21 to SP219, wherein the inner profile has a length of about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or About 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about One of the outermost diameters of 3 mm to about 3.2 mm.

SP221. The tube claimed in any one of the requested aspects SP21 to SP220, wherein the inner profile is a spirally wound element having a size of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or About 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about A diameter of 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 mm.

SP222. The tube claimed in any one of SP21 to SP221 as requested, wherein the inner part is a medical grade material, preferably a medical grade stainless steel.

SP223. The tube claimed in any one of the requested aspects SP21 to SP222, wherein the tubular body has about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 Mm, or a thickness of about 0.14 mm to about 0.16 mm.

SP224. The tube claimed in any one of the requested aspects SP21 to SP223, wherein the tubular body has about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to about 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 Mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 An internal diameter of one millimeter to about 3.1 millimeters.

SP225. The tube claimed in any one of the requested aspects SP21 to SP224, wherein the tubular body has about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, Or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to Approximately 3.3 mm, or an external diameter of approximately 3 mm to approximately 3.2 mm.

SP226. The tube claimed by any one of SP21 to SP225 as requested, wherein the tubular system is (preferably extruded from) thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester One or a combination of elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide; more preferably, the polymer may be such as but not limited to polyolefin, thermoplastic elastomer, or breathable Thermoplastic elastomers, such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having from 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 A polymer of Shore A of about 60, or about 70, or about 80, or about 90.

SP227. The tube claimed in any one of the requested aspects SP21 to SP226, wherein the inner profile is a plurality of rings spaced apart longitudinally along the lumen.

SP228. For the tube claimed by SP227, the shape of the rings is toric or ring.

SP229. The tube claimed in any one of the request modes SP21 to SP228, wherein the inner profile is one or more separate elements linked to each other.

SP230. The tube claimed in any one of the requested aspects SP21 to SP229, wherein the inner profile is a plurality of reinforcing ribs regularly spaced along the lumen.

SP231. The tube claimed by SP230 as requested, wherein each reinforcing rib includes one turn of a spiral reinforcing wire.

SP232. The tube claimed by SP231 as requested, wherein one turn of the spiral reinforcement wire includes a complete turn around the lumen.

SP233. The tube claimed by SP231 as requested, wherein one turn of the spirally reinforced wire includes the wire located between adjacent crests of the inner profile.

SP234. For a tube claimed by any one of SP2 to SP233, the tubular system has flow resistance according to ISO 5367: 2000(E) (Fourth Edition, June 1, 2000). The added test is defined as flexibility.

SP235. The tube claimed by any one of SP21 to SP234 as requested, wherein a terminal of the tube is integrated with a nasal prong, and the nasal prong is suitable for being inserted into a user's nostril as a delivery of breathing gas to A nasal interface for one user.

SP236. The tube claimed by any one of SP21 to SP235 as requested, wherein the inner profile is a screen.

SP237. The tube claimed in any one of SP21 to SP236 as requested, wherein the inner profile is a wire suitable for heating or sensing the properties of the gas inside the tube.

SP238. The tube claimed by any one of SP21 to SP237 in the request mode, wherein the inner shape is conductive, and preferably the inner shape is an electric heater.

SP239. The tube claimed in any one of the request modes SP21 to SP238, wherein the inner part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

SP240. The tube claimed in any one of the request modes SP21 to SP239, wherein the tube system further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

SP241. The tube claimed by any one of SP21 to SP240 as requested, wherein the tube is a heating tube.

SP242. As claimed in any one of the requested aspects SP21 to SP241, wherein the ratio of the distance between the inner profile to the outer diameter (for example, the outermost diameter) of the inner profile is about 0.10 to about 0.50, more preferably the The ratio is about 0.20 to about 0.35, and more preferably, the ratio is about 0.28 or about 0.29.

SP243. The tube claimed in any one of the requested aspects SP21 to SP242, wherein the ratio of the diameter of the inner profile (for example, the diameter of the actual inner profile element or component) to the outer diameter (for example, the outermost diameter) of the inner profile It is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably the ratio is 0.06.

SP244. The pipe claimed in any one of the requested aspects SP21 to SP243, wherein the ratio of the corrugation depth to the outer (ie, outer) pipe diameter is about 0.05 to about 0.09.

SP245. The tube claimed in any one of the requested aspects SP21 to SP244, wherein the physical properties of the tubular body make the tube have the desired flexibility and/or structural support.

STM21. A method of manufacturing a medical tube, the method comprising: providing an inner profile encapsulated in a coating layer, and providing a tubular body enclosing the inner profile, the tubular system defining and surrounding the A lumen of the inner profile, the tubular system is arranged to cover the inner profile so that the coating layer is connected with an inner surface of the tubular body, wherein the inner profile maintains Encapsulated.

STM22. The method claimed by STM21 in the requested aspect, wherein the step of providing an internal part comprises providing an elongated part enclosed in a coating layer suitable for application to a medical tube, and from the coating The covered slender part is manufactured for one of a medical tube to support the inner part.

STM23. The method claimed in the request aspect STM22, wherein the uncoated elongated member is immersed in a coating material bath to apply the encapsulating coating layer.

STM24. The method claimed by STM23 as requested, wherein the bath contains a molten polymer grade at a temperature higher than about 150°C.

STM25. The method claimed in any one of the requested aspects STM22 to STM24, wherein the inner profile is manufactured by spirally winding the elongate profile into a spiral form.

STM26. The method claimed in any one of STM22 to STM25 as requested, which comprises: providing an uncoated elongated part, encapsulating the elongated part suitable for application to one of the medical tubes Floor.

STM27. If the method claimed by any one of STM21 to STM26 in the request aspect, it includes:

a) applying a reduced pressure to (or to) the inside of the lumen, so that the reduced pressure draws the tubular body radially inward, or

b) applying an extension (or stretching) to at least a part or a region of the tubular body surrounding the inner profile, so that the release of the extension (or stretching) extends (or stretches) the tubular body Part or area returns (or permits) radial inward extraction, or

c) A combination of one of a) and b).

STM28. The method claimed by STM27 in the requested aspect, wherein the tubular system is drawn radially inward from the lumen or the outermost periphery defined by the inner profile, and the outermost periphery of the inner profile is defined along the tube A plurality of alternating peaks and valleys of one length of the body form a corrugated tube.

STM29. The method claimed in any one of the requested aspects STM2 to STM28, wherein the tubular system is provided by extrusion or by extruding a material from a die.

STM210. The method claimed by any one of STM21 to STM29 in the requested aspect, wherein the tubular body is extruded around the inner profile, and the way of applying pressure allows one of the inner surfaces of the tubular body to become at least partially attached or Connected to at least a part of the inner profile, preferably the pressure difference between the pressure in the lumen and the pressure surrounding the tubular body, more preferably the pressure inside the lumen (provided to the lumen) is lower than the surrounding pressure The pressure of the tubular body (or the pressure surrounding the tubular body is greater than the pressure inside the lumen (provided to the lumen)).

STM211. The method claimed in any one of the requested aspects STM21 to STM211, wherein the tubular body is provided around the inner profile at a temperature so that the coating layer is connected to at least a part of the tubular body.

STM212. The method claimed by STM211 or STM212 in the requested aspect, wherein the tubular system surrounds the inner profile and provides at a temperature that allows the coating to be welded to the inner profile.

STM213. The method claimed by STM211 or STM212 in the requested aspect, wherein the tubular system is at least partially fused with the coating layer.

STM214. Any claim from STM21 to STM213 as requested The method, wherein the tubular body is a single-walled body.

STM215. The method claimed in any one of the requested aspects STM21 to STM214, wherein a reduced pressure is applied to or adjacent to the formation of the lumen.

STM216. The method claimed by STM215 in the requested aspect, wherein the reduced pressure is applied to or adjacent to a die.

STM217. The method claimed by request aspect STM216, wherein the lumen experiences the decompression when exiting from an extrusion die.

STM218. The method claimed in any one of the requested aspects STM21 to STM217, wherein the tubular system is extruded simultaneously with the manufacture of the inner profile from the elongated profile.

STM219. The method claimed in any one of the requested aspects STM21 to STM218, wherein the tubular body thus formed is corrugated.

STM220. The method claimed by STM219 in the requested aspect, wherein the wave crests of the corrugated tubular body thus formed are defined by the outermost periphery of the inner profile.

STM221. The method claimed in the request aspect STM29 or STM220, wherein the troughs of the corrugated tubular body thus formed are defined by the inwardly drawn portions of the tubular body drawn inwardly between the internal shapes.

STM222. The method claimed in any one of the requested aspects STM21 to STM221, wherein the internal profile is a skeleton or internal support structure that supports the tubular body.

STM223. The method claimed in any one of the requested aspects STM21 to STM222, wherein the internal profile is a continuous length, one or a series of semi-continuous lengths, or a series of divided lengths.

STM224. The method claimed in any one of the requested aspects STM21 to STM223, wherein the internal profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring , Or one or a combination of a plurality of separate supports interconnected by one or more connecting rods or interconnectable.

STM225. The method claimed in any one of the requested aspects STM21 to STM224, wherein the internal profile is supportive or supports the lumen inside the tube thus formed.

STM226. The method claimed in any one of the requested aspects STM21 to STM225, wherein the inner profile is a spirally wound element having a thickness of about 0.4 mm to about 2 mm, or about 0.5 mm to about 1.9 mm, or about 0.6 mm To about 1.8 mm, or about 0.7 mm to about 1.7 mm, or about 0.8 mm to about 1.6 mm, or about 0.9 mm to about 1.5 mm, or about 1 mm to about 1.4 mm, or about 1.1 mm to about 1.3 mm One space between adjacent turns.

STM227. The method claimed in any one of the requested aspects STM21 to STM226, wherein the inner profile has about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or About 1.9 mm to about 4.3 mm, or about 2 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about One of the outermost diameters of 3 mm to about 3.2 mm.

STM228. Any one of STM21 to STM227 as requested The method of the invention, wherein the inner mold is a spirally wound element, the element has a thickness of about 0.05 mm to about 0.3 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.1 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.24 mm, or about 0.14 mm to about 0.23 mm, or about 0.15 mm to about 0.22 mm, or about 0.16 mm to about 0.24 mm, or about 0.17 mm to about 0.23 mm, or about 0.18 mm to about 0.22 mm, or about 0.19 mm to about 0.21 A diameter in millimeters.

STM229. The method claimed in any one of STM21 to STM228 in the requested aspect, wherein the internal profile is a medical grade material, preferably coated with a suitable material, preferably a polymer grade or a stainless steel Of a medical grade stainless steel.

STM230. The method claimed in any one of the requested aspects STM21 to STM229, wherein the tubular body has about 0.05 mm to about 0.25 mm, or about 0.06 mm to about 0.24 mm, or about 0.07 mm to about 0.23 mm, or about 0.08 mm to about 0.22 mm, or about 0.09 mm to about 0.21 mm, or about 0.1 mm to about 0.2 mm, or about 0.11 mm to about 0.19 mm, or about 0.12 mm to about 0.18 mm, or about 0.13 mm to about 0.17 Mm, or a thickness of about 0.14 mm to about 0.16 mm.

STM231. The method claimed in any one of the requested aspects STM21 to STM230, wherein the tubular body has about 1.5 mm to about 4.5 mm, or about 1.6 mm to about 4.4 mm, or about 1.7 mm to about 4.3 mm, or about 1.8 mm to about 4.2 mm, or about 1.9 mm to about 4.1 mm, or about 2.0 mm to About 4.0 mm, or about 2.1 mm to about 3.9 mm, or about 2.2 mm to about 3.8 mm, or about 2.3 mm to about 3.7 mm, or about 2.4 mm to about 3.6 mm, or about 2.5 mm to about 3.5 mm, or An internal diameter of about 2.6 mm to about 3.4 mm, or about 2.7 mm to about 3.3 mm, or about 2.8 mm to about 3.2 mm, or about 2.9 mm to about 3.1 mm.

STM232. The method claimed in any one of the requested aspects STM21 to STM231, wherein the tubular body has about 1.6 mm to about 4.6 mm, or about 1.7 mm to about 4.5 mm, or about 1.8 mm to about 4.4 mm, or about 1.9 mm to about 4.3 mm, or about 2.0 mm to about 4.2 mm, or about 2.1 mm to about 4.1 mm, or about 2.2 mm to about 4.0 mm, or about 2.3 mm to about 3.9 mm, or about 2.4 mm to about 3.8 Mm, or about 2.5 mm to about 3.7 mm, or about 2.6 mm to about 3.6 mm, or about 2.7 mm to about 3.5 mm, or about 2.8 mm to about 3.4 mm, or about 2.9 mm to about 3.3 mm, or about 3 An external diameter of one millimeter to about 3.2 millimeters.

STM233. The method claimed in any one of STM21 to STM232 in the requested aspect, wherein the tubular body is a polymer (preferably extruded from a polymer), such as a thermoplastic polymer, preferably suitable for medical breathing tubes polymer.

STM234. The method claimed in any one of STM21 to STM233 as requested, wherein the tubular system is (preferably extruded from it) thermoplastic elastomer, propylene-based elastomer, and thermoplastic breathable polyester One or a combination of elastomer, liquid silicone rubber, breathable thermoplastic polyurethane, or breathable polyamide; more preferably, the polymer may be such as but not limited to polyolefin, thermoplastic elastomer, or breathable Thermoplastic elastomers such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or Thermoplastic polyolefin elastomer, or thermoplastic polyurethane elastomer; even more preferably having about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or A polymer of Shore A of about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

STM235. The method claimed in any one of STM21 to STM234 in the requested state, wherein the reduced pressure is applied when the tubular main system is in a molten state, or a semi-molten state, or an unhardened state, preferably the reduced pressure system It is about 0 to about -2 Pa (absolute), more preferably about 0 to about -1 Pa (absolute), even more preferably about 0 to about -0.9 Pa (absolute), and even more preferably The pressure reduction is the pressure difference between the inner side of the lumen and the surrounding area of the tubular body.

STM236. The method claimed in any one of STM21 to STM235 in the requested mode, wherein the internal profile is electrically conductive, preferably the internal profile is an electric heater.

STM237. The method claimed in any one of the requested aspects STM21 to STM236, wherein the internal profile includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

STM238. The method claimed in any one of the requested aspects STM21 to STM237, wherein the pipe system further comprises a heater, more preferably an electric heater (such as a heater wire or heater circuit).

STM239. The method claimed by any one of STM21 to STM238 in the request mode, wherein the tubular system adopts the flow resistance according to ISO 5367:2000(E) (fourth edition, June 1, 2000) The added test is defined as flexibility.

STM240. The method claimed in any one of the requested aspects STM21 to STM239, wherein the medical tube is a breathing tube.

STM241. The method claimed in any one of the requested aspects STM21 to STM240, wherein the pipe system is formed by co-extruding at least one spiral reinforcement member and the same tubular body, the tubular body having a continuous wall.

STM242. The method claimed by STM241 in the requested aspect, wherein a vacuum is applied to a lumen area of the extruded tubular body so that the continuous wall forms a corrugation surrounding the inner profile.

STM243. The method claimed by STM241 or STM242, in which the continuous wall to be extruded is a single wall.

STM244. The method claimed in any one of the requested aspects STM21 to STM243, wherein the ratio of the distance between the inner profile to the outer diameter of the inner profile (for example, the outermost diameter) is about 0.10 to about 0.50, more preferably the The ratio is about 0.20 to about 0.35, and more preferably, the ratio is about 0.28 or about 0.29.

STM245. The method claimed in any one of the requested aspects STM21 to STM244, wherein the ratio of the diameter of the inner part (for example, the diameter of the actual inner part element or component) to the outer diameter (for example, the outermost diameter) of the inner part It 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.

STM246. The method claimed in any one of the requested aspects STM21 to STM245, wherein the ratio of the corrugation depth to the outer (that is, outer) tube diameter is about 0.05 to about 0.09.

STM247. The method claimed in any one of STM21 to STM246 in the requested aspect, wherein the physical properties of the tubular body contribute to the requirement that the tube has a desired The flexibility and/or structural support.

ST31. A medical tube, comprising: a tubular body defining a lumen extending between the open terminals of the body, and an internal part enclosed in the lumen and supporting the tubular body.

ST32. The tube claimed by ST31 in the requested aspect, wherein the outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

ST33. The tube claimed in ST31 or ST32 in the requested aspect, wherein the inner profile is enclosed in a coating layer that fixes the inner profile to the tubular body.

STM31. A method of manufacturing a medical tube, the method comprising:

Providing an inner profile, providing a tubular body covering the inner profile, the tubular body defining a lumen enclosing the inner profile, and i) applying a reduced pressure to (or) the interior of the lumen, Or ii) applying an extension (or stretching) to at least a part or a region of the tubular body enclosing the inner profile, or iii) a combination of i) and ii).

STM32. The method claimed by STM31 in the requested aspect, in which a greater pressure reduction or a greater extension (or stretching) or a combination of the two is applied along the tubular body and the outermost one defined by the inner profile A length of the periphery draws the tubular body radially inwardly of the lumen. When the greater reduced pressure is applied or the extension (or stretching) is released or both, the outermost part of the inner profile The periphery defines multiple alternating peaks and valleys.

STM33. The method claimed by STM31 or STM32 as requested, wherein the internal part is enclosed in a coating layer, and the tubular system provides sheathing The inner profile makes the coating layer and an inner surface of the tubular body joined together, wherein the inner profile remains enclosed.

TA1. A fixing system for a user interface and/or user interface tube, which includes:

A skin patch defines a fixed footprint, the skin patch has a user side and an interface side, the user side of the skin patch is assembled to be attached or adhered to the user's skin, and a fixed patch At least a part of the fixing patch is assembled to extend over the user interface and/or the connected user interface tube and be fixed to the user side of the skin patch to fix the user interface to the user , The fixation patch and the skin patch are assembled to allow the fixation patch to be contained in or by the skin patch when the fixation system is applied to the patient with a suitable or compatible user interface Fix the boundaries drawn by footprints.

TA2. The fixation system claimed by TA1 in the requested aspect, wherein the skin patch has the same or a larger surface area as the fixation patch.

TA3. The fixing system claimed by TA1 or TA2 as requested, wherein the fixing patch is formed or otherwise assembled to adapt to the geometry of the user interface and/or the connected user interface tube or other feature.

TA4. The fixation system claimed by any one of TA1 to TA3 in the requested aspect, wherein the fixation patch has at least one wing.

TA5. The fixing system claimed by any one of TA1 to TA4 as requested, wherein the fixing patch has a pair of wings arranged at one end of the patch, and the wings are assembled to be fixed to a user The skin patch on either side of the interface and/or the connected user interface tube.

TA6. The fixing system claimed by any one of TA1 to TA5 as requested, wherein the fixing patch has a tube end wing which is assembled to extend or is used to extend under the user interface tube And fixed to the skin patch.

TA7. The fixation system claimed by any one of TA1 to TA6 as requested, wherein the user side of the skin patch has a skin-sensitive adhesive (such as a hydrocolloid) which attaches or adheres to the skin patch To the skin of a user.

TA8. The fixation system claimed in any one of the requested aspects TA1 to TA7, wherein the skin patch has a surface with a sufficient area so that the surface disperses the attachment or adhesive force pressure across the user's skin.

TA9. The fixation system claimed in any one of TA1 to TA8 as requested, wherein the skin patch is assembled to attach or stick to a user's face.

TA10. The fixation system claimed by any one of TA1 to TA9 as requested, wherein the skin patch is assembled to be attached or adhered to the face of a user, particularly adjacent to the upper lip and/or cheek of the user .

TA11. The fixation system claimed by any one of TA1 to TA10 as requested, wherein the fixation system is configured to receive and/or fix a nasal cannula and/or a connected tube, and the tube is used from a The person’s face extends on one or both sides.

TA12. The fixation system claimed by any one of TA1 to TA11 as requested, wherein the fixation system is assembled for use with a baby or newborn.

TA13. If the fixed system of any one of TA1 to TA12 is requested The fixed system is configured for a set of pipes as defined by any one or more of COM1-COM17, or COMM11-COMM19, or COM21-COM216.

TA14. The fixing system claimed by any one of TA1 to TA13 as requested, wherein the fixing system is assembled for a tube such as SP1-SP38, or SP21-SP241, or any one of ST31-ST33 Defined by one or more.

COM1. A nasal cannula configuration comprising: at least one nasal prong having an air outlet suitable for being inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, and a corrugated A gas delivery tube comprising a tubular body defining a lumen and an inner profile surrounding the lumen, the inner profile supporting the tubular body, and an outermost periphery of the inner profile defining along the tube A plurality of alternating peaks and valleys of a length of the body, wherein the air inlet of the nasal prong is integrally formed with a terminal of the tube, so that the lumen is fluidly connected to the air outlet of the nasal prong.

COM2. The nasal cannula claimed by COM1 as requested, wherein the nasal prongs are shaped to conform to the nose or nostril of a user substantially anatomically.

COM3. The nasal cannula claimed by COM1 or COM2 as requested, wherein the nasal prongs are curved or otherwise shaped or assembled to avoid a user's nasal septum.

COM4. The nasal cannula claimed by any one of COM1 to COM3 as requested, wherein the nasal cannula has a substantially flat or flat or contoured backing that is assembled to rest on a user’s face, It is preferably used as a stabilizing member of the prong on the nostril of a user.

COM5. The nasal cannula claimed by COM4, if requested, wherein one or more ribs extend between a front surface of the backing and the cannula, and the ribs are provided with thin bands or used to fasten or attach the cannula To a contact surface of one of the other suitable fixing members of a user's face, preferably the thin strip includes an adhesive part or is an adhesive tape or a contact adhesive tape.

COM6. The nasal cannula claimed by any one of COM1 to COM5 as requested, wherein the two nasal prongs are integrally formed with a single corrugated delivery tube.

COM7. The nasal cannula claimed by any one of COM1 to COM6 as requested, wherein the cannula includes a pair of nasal prongs, each prong is integrally formed with one terminal of a pair of gas delivery tubes, or can be attached Connect (or attachable) or link (or attachable) to the terminal.

COM8. The nasal cannula claimed by any one of COM1 to COM7 as requested, wherein the cannula configuration is made of a polymer such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes Or multipolymer.

COM9. The nose cannula claimed by any one of COM1 to COM8 as requested, wherein the cannula configuration is made of thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, Breathable thermoplastic polyurethane, or breathable polyamide, any one or more of one or a combination; more preferably, the polymer can be such as, but not limited to, polyolefin, thermoplastic elastomer , Or breathable thermoplastic elastomers, such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having 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 of Shore A polymer.

COM10. A user interface comprising a pair of nasal cannulas as claimed by any one of COM1 to COM9 in the requested mode.

COM11. The user interface claimed by COM3 as requested, wherein the nasal prongs of each nasal cannula are arranged adjacent to each other and the individual delivery tubes extend away from the nasal prongs in the opposite direction.

COM12. The user interface claimed by COM4 as requested, which further includes a wiring harness that extends and couples between the nasal cannula.

COM13. The nasal cannula claimed by any one of COM1 to COM12 as requested, wherein the tube is a breathing tube.

COM14. The nasal cannula claimed by any one of COM1 to COM13 as requested, wherein the tube system is as defined in any one or more of SP1-SP38, or SP21-SP241, or ST31-ST33.

COM15. The nasal cannula claimed by any one of COM1 to COM14 as requested, wherein the tube is connected to the nasal prong (or two prongs) from one side (for example, left or right) of the cannula Breath.

COM16. The nasal cannula claimed by any one of COM1 to COM14 as requested, wherein the tube is connected to the nasal prong (or two prongs) from both sides (for example, both the left and right sides) of the cannula The air inlet.

COM17. The nasal cannula claimed by any one of COM1 to COM16 as requested, wherein the cannula is an infant (or newborn) nasal cannula.

COMM11. A method of manufacturing a nasal cannula, the method comprising: providing an inner profile, extruding a tubular body to cover the inner profile, the tube The shaped body defines a lumen surrounding the inner profile, and a nasal cannula is attached to it.

COMM12. If the method proposed by COMM11 is requested, it further includes:

i) Applying a reduced pressure to (or to) the inside of the lumen, so that the reduced pressure draws the tubular body radially inward from the lumen or the outermost periphery defined by the inner profile. The outermost periphery defines a plurality of alternating peaks and valleys along a length of the tubular body, or

ii) applying an extension (or stretching) to at least a part or a region of the tubular body surrounding the inner profile, so that the release of the extension (or stretching) extends (or stretches) the tubular body Part or area returns (or may permit) to be drawn radially inwardly from the outermost periphery defined by the lumen or by the inner profile, the outermost periphery defining a plurality of alternating peaks and valleys along a length of the tubular body ,or

iii) A combination of one of i) and ii).

COMM13. The method claimed by COMM11 or COMM12 in the request mode, wherein the method includes covering a terminal of the tubular body and molding a nasal prong.

COMM14. The method claimed in any one of the requested aspects COMM11 to COMM13, wherein a terminal of the tube so formed by the tubular body is positioned in a mold or a profile for molding or forming a nose cannula Inside, it is preferable that the mold or the molded part is closed, and the nasal cannula is sleeved over the or a terminal end of the tube to be molded or shaped.

COMM15. Any one of COMM11 to COMM14 as requested The claimed method, wherein the nasal cannula is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical breathing tubes.

COMM16. The method claimed by any one of COMM11 to COMM15 as requested, wherein the nose cannula is made of thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, breathable Any one or more of thermoplastic polyurethane or breathable polyamide or a combination thereof is made; more preferably, the polymer may be such as but not limited to polyolefin, thermoplastic elastomer, or Breathable thermoplastic elastomers, such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having 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 of the Shore A polymer.

COMM17. The method claimed by any one of COMM11 to COMM16 as requested, wherein the tubular body is a gas-permeable tube, or made of or from a gas-permeable material such as gas-permeable thermoplastic polyurethane or gas-permeable polyamide Class made.

COMM18. The method claimed by any one of COMM11 to COMM17 as requested, wherein a nose cannula mold is provided, which can receive a terminal of the tube formed by the manufacture of the tubular body, so that the operation of the mold is assisted The nasal cannula is molded, and a part of the nasal cannula is molded by the end of the tube.

COMM19. Any one of COMM11 to COMM18 as requested The claimed method, wherein the nasal cannula configuration manufactured by the nasal cannula is in fluid communication with an end of the tube formed by the manufacture of the tubular body.

COM21. A nasal cannula configuration, which includes: at least one nasal prong having an air outlet suitable for being inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, and a gas Delivery tube, the tube includes a tubular body defining a lumen and an inner profile surrounding the lumen, the inner profile supporting the tubular body, wherein the air inlet of the nasal prong is connected to the tube A terminal is integrally formed so that the tube lumen is fluidly connected to the air outlet of the nasal prong.

COM22. The nasal cannula claimed by COM21 in the requested aspect, wherein an outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

COM23. The nasal cannula claimed by COM21 or COM22 as requested, wherein the prong is shaped to conform to the anatomical curvature of a user's nostril.

COM24. The nasal cannula claimed by any one of COM21 to COM23 as requested, wherein the nasal prongs are curved or otherwise shaped or assembled to avoid a user's nasal septum.

COM25. The nasal cannula claimed by any one of COM21 to COM24 as requested, wherein the nasal cannula is configured to rest on the face of a user and one of the contoured backings or facial cushions, preferably It is used as a stabilizer for the prong to the nostril of a user.

COM26. For the nasal cannula claimed by COM25, one or more ribs extend between the front of the backing or facial cushion and the cannula, and the ribs are provided with thin straps or used to buckle or attach Connect the sleeve to a user's face One of the other suitable fixing members of the part contacts the surface, preferably the thin strip contains an adhesive part or is an adhesive tape or a contact adhesive tape.

COM27. The nasal cannula claimed by any one of COM21 to COM26 as requested, wherein the two nasal prongs are integrally formed with a single corrugated delivery tube.

COM28. The nasal cannula claimed by any one of COM21 to COM27 as requested, wherein the cannula configuration is made of a liquid silicone rubber or a polymer such as a thermoplastic polymer, preferably suitable for medical breathing The tube is one or more polymers.

COM29. The nasal sleeve claimed by any one of COM21 to COM28 as requested, wherein the sleeve configuration is made of thermoplastic elastomer, propylene-based elastomer, thermoplastic breathable polyester elastomer, liquid silicone rubber, Breathable thermoplastic polyurethane, or breathable polyamide, any one or more of one or a combination; more preferably, the polymer can be such as, but not limited to, polyolefin, thermoplastic elastomer , Or breathable thermoplastic elastomers, such as the family of thermoplastic elastomers, such as styrene block copolymers, copolymer elastomers, or thermoplastic polyolefin elastomers, or thermoplastic polyurethane elastomers; even more preferably having 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 of the polymer of Shore A.

COM210. A user interface that includes a pair of nasal cannulas claimed by any one of COM221 to COM29 as requested.

COM211. If the user interface claimed by COM210, the nasal prongs are arranged adjacent to each other and the individual delivery pipes are far away The nasal prongs extend in the opposite direction.

COM212. The user interface claimed by COM211 as requested, which further includes a wiring harness that extends and couples between the nasal cannula.

COM213. The nasal cannula claimed by any one of COM21 to COM212 as requested, wherein the tube is a breathing tube.

COM214. The nasal cannula claimed by any one of COM21 to COM213 as requested, wherein the tube system is as defined in any one or more of SP1-SP38, or SP21-SP241, or ST31-ST33.

COM215. The nasal cannula claimed by any one of COM21 to COM24 as requested, wherein the tube is manufactured by a method such as SPM11-SPM133, or STM21-STM243, or STM31-STM33. .

COM216. The nasal cannula claimed by any one of COM21 to COM215 as requested, wherein the prong is glued or otherwise adhered to the tube.

PWL1. A nasal cannula configuration comprising: at least one nasal prong having an air outlet suitable for being inserted into the nostril of a user and an air inlet fluidly connected to the air outlet, the at least one The nasal prongs include a backing that is assembled to rest on a user's face, wherein a lip extends over at least a part of the periphery of a back surface of the backing, and the back surface is It is assembled to receive or retain a user interface patch so that in use, the user interface patch can be releasably attached or connected to or attached to a skin patch on a user’s face sheet.

PWL2. The nasal cannula claimed by PWL1 as requested, wherein the lip is a barrier.

PWL3. The nasal cannula claimed by PWL1 or PWL2 as requested, wherein the lip is deformable.

PWL4. The nasal cannula as claimed in any one of the requested aspects PWL1 to PWL3, wherein the lip extends at least partially to enclose the periphery substantially adjacent to a region of a prong connected to the backing.

PWL5. The nasal cannula claimed in any one of the request modes PWL1 to PWL3, wherein the lip is a series of one or more separate lips.

PWL6. The nasal cannula claimed by PWL5 as requested, wherein the one or more divided lips are adjacent, or adjoining or overlapping lips.

PWL7. The nasal cannula claimed in any one of the requested aspects PWL1 to PWL6, wherein the lip is a circulating lip extending around the periphery of the back surface of the backing.

PWL8. The nasal cannula claimed in any one of the requested aspects PWL1 to PWL7, wherein in use, the lip substantially forms the back surface of the backing and one of the user interface patch facing the cannula surface One of the fluid (or liquid) seals, or fluid (or liquid) barriers.

PWL9. The nasal cannula claimed in any one of the requested aspects PWL1 to PWL8, wherein the backing is a substantially flat or flat or contoured (such as a preset) that is assembled to rest on a user's face Forming curve) backing.

PWL10. The nasal cannula claimed in any one of the requested aspects PWL1 to PWL9, wherein the backing assists as a stabilizer of the prong(s) in the nostril(s) of a user.

PWL11. The nasal cannula claimed in any one of the request modes PWL1 to PWL10, wherein the at least one prong extends from the at least one nasal prong in a lateral direction away from a user's nasal septum.

PWL12. The nasal cannula claimed by any one of PWL1 to PWL11 as requested, wherein the cannula is further defined by any one or more of COM1-COM17, or COMM11-COMM19, or COM21-COM216.

PWL13. The nasal cannula claimed by any one of PWL1 to PWL12 as requested, wherein the cannula can operate as the fixation system defined by any one or more of TA1-TA14.

PWL14. The nasal cannula claimed by any one of PWL1 to PWL13 as requested, wherein the user interface patch can be received or held on the backing as defined in any one or more of WP1-WP15 On the back surface.

PWL15. The nasal cannula claimed by any one of PWL1 to PWL14 as requested, wherein the air inlet of the cannula is fluidly connected to or connected to, for example, SP1-SP38, SPM11-SPM133, SP21-SP241, STM21- Any one or more of STM243, ST31-ST33, STM31-STM33 defines the tube.

PWL16. The nasal cannula claimed in any one of PWL1 to PWL15 as requested, wherein at least the (etc.) lip is water-repellent.

PWL17. The nasal cannula claimed in any one of the requested aspects PWL1 to PWL16, wherein at least the lip(s) includes at least one outer peripheral lip and at least one inner peripheral lip, and each of the lips is provided for Touch the face of a user.

WP1. A part of a releasable fixing element, which includes a base portion supporting a dispersed mechanical fastener across its surface, the base portion being flexible but substantially non-stretchable, the base portion It is divided into a plurality of areas by at least one slit or at least one slot, so that the different divisions of the substrate Independent bending, the substrate can substantially follow the shape of a composite curved surface below.

WP2. The fixing system claimed by WP1 in the requested aspect, wherein the base portion includes a plurality of slits or slots or both, which together divide the base portion into a serpentine body.

WP3. The fixing system claimed by WP2 in the requested aspect, wherein the slits and/or grooves are arranged on the base such that at least one of the first set of slits or grooves extends from an edge of the base The base, and a second set of slits or slots extends into the base from the other edge of the base, and the slits or slots in one set intersect with the slits or slots in the other set Inserting so that a path of the slits or notches along the base portion from one end to the other end without crossing a set follows a zigzag or serpentine path that is longer than a straight line between the two ends.

WP4. The fixing system claimed in any one of the requested aspects WP1 to WP3, wherein one of the plurality of slits or grooves is slit or the slit is curved.

WP5. The fixing system claimed by any one of the requested aspects WP1 to WP3, wherein a plurality of the slits or slots in the slits or slots are curved and the curved slits or slots are substantially parallel Configuration.

WP6. The fixation system claimed in any one of request aspects WP1 to WP3, wherein the slits or slots are configured to extend from the edge of the base portion into a herring bone pattern.

WP7. The fixed system claimed by WP1 as requested, wherein the base system is divided into separate parts by a serpentine slit or slot.

WP8. The fixing system claimed by WP1 as requested, wherein the base part is divided into a plurality of parts by a spiral slit or slot.

WP9. The fixing system claimed by WP1 in the requested aspect, wherein the base portion is divided into sub-sections by slits or slots arranged in substantially concentric circles.

WP10. The fixing system claimed by WP9 in the requested aspect, wherein the equicentric circle is centered around the center of the base.

WP11. The fixing system claimed by WP1 in the requested aspect, wherein the slits or grooves divide the base body into a plurality of islands, and each island is connected to an adjacent island or islands by a narrow bridge.

WP12. For the fixing system claimed by WP1, the base part is divided into multiple parts by an S-shaped slit.

WP13. The fixing system claimed by WP1 as requested, wherein the base part is divided into multiple parts by a T-shaped slit.

WP14. The fixing system claimed in any one of the requested aspects WP1 to WP13, wherein the base part covers at least 70% of the area of the skin patch.

WP15. The fixing system claimed in any one of the request aspects WP1 to WP14, wherein for a boundary defining the shortest path around the periphery of the substrate, the substrate portion covers at least 80% of the internal area of the boundary.

WP16. The fixing system claimed by any one of WP1 to WP15 as requested, wherein the system can be combined with the fixing system of TA1-TA14, or the casing of COM1-COM17, or the casing of PWL1-PWL17, or SP1-SP38 Or use any one or more of SP21-SP241 or ST31-ST33 in combination.

1. A medical breathing tube, which contains:

A tubular body defining a lumen extending between the open terminals of the body,

An inner part that surrounds the lumen and supports the tubular body, and

A coating layer that encapsulates the inner profile, and the coating fixes the inner profile to the tubular body.

2. The medical tube claimed in claim 1, wherein the coating layer and the tubular system are plastically welded to each other along the tube.

3. The medical tube claimed in item 1 or 2 of the requested aspect, wherein an outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

4. The tube claimed in any one of items 1 to 3 in the requested aspect, wherein the wave crests of the bellows body are defined by the outermost periphery of the inner profile.

5. The tube claimed in any one of items 1 to 4 of the requested aspect, wherein the inner profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc , Ring, or one or a combination of a plurality of separate supports interconnected or interconnectable by one or more connecting links.

6. The tube claimed in any one of items 1 to 5 in the requested aspect, wherein the tubular body is substantially not supported by the internal profile in the troughs but is supported by the internal profile in the crests.

7. The tube claimed in any one of items 1 to 6 as requested, wherein the tubular body is an air-permeable tube or is made of an air-permeable material, such as air-permeable thermoplastic polyurethane (like) Or breathable polyamides.

8. The tube claimed in any one of items 1 to 7 in the requested aspect, wherein the inner profile is a spirally wound metal wire, and the coating layer encapsulates the wire.

9. The tube claimed in any one of items 1 to 8 in the requested aspect, wherein the coating layer provides a surface that is easily connected to the tubular body.

10. A medical breathing tube, which contains:

A tubular body defining a lumen extending between the open terminals of the body, and

An inner profile that surrounds the interior of the lumen and supports the tubular body, and an outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

11. The tube claimed in claim 10, wherein the tubular body is an extruded tube.

12. The tube claimed in item 10 or 11 in the requested aspect, wherein the tubular body is a continuous tube.

13. The tube claimed in any one of items 10 to 12 in the request aspect, wherein the wave crests of the bellows body are defined by the outermost periphery of the inner profile.

14. The tube claimed in any one of items 10 to 13 of the requested aspect, wherein the inner profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, or an annular disc , Ring, or one or a combination of a plurality of separate supports interconnected or interconnectable by one or more connecting links.

15. The tube claimed in any one of items 10 to 14 in the requested aspect, wherein the tubular body is substantially not supported by the internal profile at the troughs but supported by the internal profile at the crests.

16. The tube claimed in any one of items 10 to 15 as requested, wherein the tubular body is an air-permeable tube or is made of an air-permeable material, such as air-permeable Thermoplastic polyurethane (type) or breathable polyamide.

17. A medical breathing tube, which contains:

A tubular body defining a lumen extending between the open terminals of the body, and

An inner part that surrounds the inside of the lumen and supports the tubular body.

18. The tube claimed in claim 17, wherein the inner profile is enclosed in a coating, and the coating fixes the inner profile to the tubular body.

19. The medical tube claimed in claim 17 or 18, wherein the coating layer and the tubular system are plastically welded to each other along the tube.

20. The medical tube claimed in any one of items 17 to 19 in the requested aspect, wherein the coating layer and the tubular system are welded at separate positions along the tube.

21. The medical tube claimed in any one of items 17 to 19 of the requested aspect, wherein the coating layer and the tubular system are welded substantially continuously along the longitudinal direction of the tube.

22. The medical tube claimed in any one of items 17 to 21 of the requested aspect, wherein an outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body.

23. The medical tube claimed in any one of items 17 to 22 of the requested aspect, wherein an outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body (ie ripple).

24. The tube claimed in any one of items 22 or 23 of the requested aspect, wherein the wave crests of the tubular body are defined by the outermost periphery of the inner profile.

25. The tube claimed in any one of items 22 to 24 of the requested aspect, wherein the troughs of the tubular body are defined by the inward extraction portions of the tubular body that are drawn inwardly between the internal shapes.

26. The tube claimed in any one of items 17 to 25 in the requested aspect, wherein the inner shape is a continuous length, one or a series of semi-continuous lengths, or a series of divided lengths.

27. The tube claimed in any one of items 17 to 26 of the requested aspect, wherein the inner profile is a spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc , Ring, or one or a combination of a plurality of separate supports interconnected or interconnectable by one or more connecting links.

28. The tube claimed in any one of items 17 to 27 in the requested aspect, wherein the inner profile supports the tubular body defining the lumen inside.

29. The tube claimed in any one of items 17 to 28 of the requested aspect, wherein the inner profile is a skeleton or an inner supporting structure supporting the tubular body.

30. The tube claimed in any one of items 17 to 29 of the requested aspect, wherein the tubular body is substantially not supported by the inner shape member in the troughs but is supported by the inner shape member in the wave crests.

31. The tube claimed in any one of items 17 to 30 in the requested aspect, wherein the wall of the tubular body is suspended between adjacent wave crests.

32. The tube claimed in any one of items 17 to 31 as requested, wherein the tubular body is a gas-permeable tube, or is made of a gas-permeable material, (for example, gas-permeable thermoplastic polyurethane (like ) Or breathable polyamide).

33. The tube claimed in any one of items 17 to 32 in the requested aspect, wherein the inner profile is a spirally wound rib or a rib element.

34. The tube claimed in any one of items 17 to 33 in the requested aspect, wherein the inner profile is a spirally wound metal wire, and the coating layer encapsulates the wire.

35. The tube claimed in any one of items 17 to 34 in the requested aspect, wherein the coating layer provides a surface that can be connected to the tubular body.

36. The tube claimed in any one of items 17 to 35 in the requested aspect, wherein the inner profile has a pitch that changes along a length (or section) of the tube.

37. The tube claimed in any one of Claims 17 to 36, wherein the inner profile is a spirally wound element with a pitch between adjacent turns of about 1 mm to about 1.5 mm.

38. The tube claimed in any one of items 17 to 37 in the requested aspect, wherein the inner profile is a spirally wound element, the element having a diameter of about 0.1 mm to about 0.4 mm.

39. The tube claimed in any one of claims 17 to 38, wherein the tubular body has a wall thickness of about 0.1 mm to about 0.2 mm.

40. The tube claimed in any one of items 17 to 39 in the requested aspect, wherein the tubular body has an outer diameter of about 3 mm to about 5 mm.

41. The tube claimed in any one of items 17 to 40 in the requested aspect, wherein the tubular body is corrugated, and the corrugations have a depth of about 0.1 mm to about 0.5 mm.

42. If the tube claimed in any one of items 17 to 41 of the request aspect, the tubular system is obtained by bending according to ISO 5367: 2000(E) (fourth edition, June 1, 2000) The test of increased flow resistance is defined as flexibility.

43. The tube claimed in any one of items 17 to 42 of the request aspect, wherein one end of the tube is integrated with a nasal prong, and the nasal prong is suitable for insertion The inside of a user's nostril serves as a nasal interface for delivering breathing gas to a user.

44. The tube claimed in any one of items 17 to 43 in the requested aspect, wherein the inner profile is a wire suitable for heating or sensing the properties of the gas inside the tube.

45. The tube claimed in any one of items 17 to 44 of the requested aspect, wherein the inner profile is conductive, and preferably the inner profile is an electric heater.

46. The tube claimed in any one of items 17 to 45 of the requested aspect, wherein the inner part includes a conductive member or an electric heater or a sensor (such as a flow or temperature or humidity or pressure sensor).

47. The tube claimed in any one of items 17 to 46 in the requested aspect, wherein the tube system further includes a heater or an electric heater (for example, a heater wire or a heater circuit).

48. The tube claimed in any one of items 17 to 47 of the requested aspect, wherein the inner part is composed of one or more separate components.

49. The tube claimed in any one of items 17 to 48 of the requested aspect, wherein the inner part contains one or more separate components.

50. The tube claimed in any one of items 17 to 49 of the requested aspect, wherein the tube system includes one or more internal shapes.

51. The tube claimed in any one of items 17 to 50 of the requested aspect, wherein the ratio of the distance between the inner shapes to the outer diameter (for example, the outermost diameter) of the inner shapes is about 0.10 to about 0.50.

52. The tube claimed in any one of items 17 to 51 of the request aspect, wherein the ratio is about 0.20 to about 0.35.

53. The tube claimed by any one of items 17 to 52 of the request aspect, wherein the ratio is about 0.28.

54. The tube claimed by any one of items 17 to 53, wherein the ratio is about 0.29.

55. The tube claimed in any one of items 17 to 54 in the requested aspect, wherein the diameter of the inner profile (for example, the diameter of the actual inner profile element or component) is relative to the outer diameter of the inner profile (for example, the outermost diameter) The ratio is about 0.02 to about 0.10.

56. The tube claimed in any one of items 17 to 55 of the request aspect, wherein the ratio is about 0.05 to about 0.07.

57. The tube claimed by any one of items 17 to 56 of the request aspect, wherein the ratio is about 0.06.

58. The tube claimed in any one of items 17 to 57 of the requested aspect, wherein the ratio of the corrugation depth to the outer (ie, outer) tube diameter is about 0.05 to about 0.09.

59. The tube claimed in any one of items 17 to 58 of the requested aspect, wherein the physical properties of the tubular body cause the tube to have the desired flexibility and/or structural support.

60. A nasal cannula configuration, which includes:

At least one nasal prong, the prong having an air outlet suitable for being inserted into a user's nostril and an air inlet fluidly connected to the air outlet, the or each prong is shaped to conform to the user's nostril The anatomical curvature.

61. The nasal cannula claimed in claim 60, wherein the nasal prongs are shaped to avoid contact with the user's nasal septum at the base of the user's nose.

62. The nasal cannula claimed in item 60 or 61 of the request form, wherein the nasal prong is Shaped to avoid contact with the internal structure of a user's nose.

63. The nasal cannula claimed in any one of Item 60 or 62 of the requested aspect, wherein the nasal prongs are shaped to substantially align the flow of breathing gas flowing through the air outlet with the upper airway of a user.

64. The nasal cannula claimed in any one of item 60 or 63 of the requested aspect, wherein the nasal prong is shaped to extend substantially upward and backward into a user's nostril, and the nasal prong has a curvature including Include at least two reflex points.

65. The nasal cannula claimed in any one of Item 60 or 64 of the requested aspect, wherein the nasal prong defines a lumen extending between the air inlet and the air outlet, and the shape of the lumen follows The substantially circular shape of the air inlet is changed to the substantially elliptical shape of the air outlet.

66. The nasal cannula claimed in claim 65, wherein the prong is shaped to maximize the cross-sectional area of the lumen.

67. The nasal cannula claimed in any one of Item 60 or 66 in the request aspect, wherein the cannula further comprises a support extending along the upper lip of a user.

68. The nasal cannula claimed in any one of item 60 or 67 of the request aspect, wherein the cannula comprises two nasal prongs spaced symmetrically about the sagittal plane of a user, the prongs The head is attached to a common support provided along the upper lip of a user and extends from a base in the direction below the user's nose.

69. The nasal cannula claimed in claim 68, wherein the prongs extend from the support body toward the user’s nasal septum, and surround a corner of the user’s nostril, bend upward and backward into the For the user's nostrils, each prong extends along a substantially inclined rear track, and the air outlet is oriented relative to the second middle and outer inflection point of the user's upper airway.

70. The nasal cannula claimed in any one of Claims 60 or 69, wherein the or each prong has a shaped track that matches the anatomical shape of the user's nostrils.

71. The nasal cannula claimed in claim 70, wherein in the first part (or stage) of one of the or each prong, the track moves horizontally toward the midline of the face; In the second part (or stage) of the head, the track is curved upward directly into the nostril toward the crown of the head; in the third part (or stage) of the prong, the track follows the nostril The anatomical curvature is rolled back into the head; and in a fourth part (or stage), the track is horizontally inclined toward the center of the sleeve to align the outflow port with the upper airway of a user.

72. The nasal cannula claimed in any one of item 60 or 71 of the request aspect, wherein the or each prong has a cross section that changes along the central track.

73. The nasal cannula claimed in any one of item 60 or 72 of the requested aspect, wherein the cross-sectional area is approximately along the track from the first part (or stage) to the end of the fourth part (or stage) Up to zoom out.

74. The nasal cannula claimed in any one of item 60 or 73 of the requested aspect, wherein the nasal cannula further comprises a nasal cannula that is configured to rest on a user's face and one has a contoured backing or facial cushion .

75. The nasal cannula claimed in claim 74, wherein the backing or facial cushion is pre-shaped to be substantially curved to match a contour shape of a user's face or upper lip area.

76. The nasal cannula claimed in any one of Item 60 or 75 of the request aspect, wherein each prong can receive an independent flow from a gas source.

77. A fixing system for a user interface and/or a component (such as a tube or pipe) connected to the user interface, the fixing system comprising a two-part releasable attachment (or connection) Configuration, the configuration system includes:

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 skin of a user (for example, by means of an adhesive, usually a skin sensitive adhesive such as a hydrocolloid),

The interface side of the skin patch is provided with the first part of a two-part releasable attachment or connection system, and

The user interface patch has an interface side and a patient side,

The patient side of the user interface patch is provided with the complementary second component of the two-part releasable attachment or connection system,

The interface side of the user interface patch can be attached (or can be connected) to the user interface and/or the component (such as a tube or tube) connected to the user interface.

78. The system claimed in claim 77, wherein the interface side of the skin patch has one of a hook or a loop, and the second component of the second patch has one of the hook or loop The other enables the first and second components (and patches) to be releasably attached or connected to each other.

79. If the system of claim 77 or 78 is requested, the first patch is It can be positioned and/or attached to a user's facial skin.

80. The system claimed in any one of items 77 to 79 of the requested aspect, wherein the user interface patch is positionable, attached or attachable, or linked to or connected to a user interface.

81. The system claimed in any one of items 77 to 80 of the requested aspect, wherein the user interface patch is integrally formed with a user interface or forms a part of the user interface.

82. The system claimed in any one of items 77 to 81 of the requested aspect, wherein the two-part releasable attachment or linking system on the skin patch occupies less than the interface side of the skin patch About 90%.

83. The system claimed in any one of items 77 to 82 of the requested aspect, wherein the first component of the two-part releasable attachment or connection system is bonded or bondable to the skin patch User interface side.

84. The system claimed in any one of items 77 to 83 of the request aspect, wherein the user side of the skin patch has a skin sensitive adhesive that attaches or adheres the skin patch to the skin of a user Agents (such as, for example, hydrocolloids).

85. The system claimed in any one of items 77 to 84 of the requested aspect, wherein the skin patch has a surface with sufficient area so that the surface disperses the attachment pressure or adhesion across the user's skin.

86. The system claimed in any one of items 77 to 85 of the requested aspect, wherein the skin patch is assembled to be attached or glued to a user's face.

87. The system claimed in any one of items 77 to 86 of the request aspect, wherein the skin patch is assembled to be attached or glued to the face of a user adjacent The upper lip and/or cheek of the user.

88. The system claimed in any one of items 77 to 87 of the requested aspect, wherein the fixing system is configured to receive and/or fix a nasal cannula and a connected tube, the tube being from a user Extend one or both sides of the face.

89. The system claimed in any one of items 77 to 88 of the request aspect, wherein the fixing system is configured for an infant or newborn.

90. The system claimed in any one of items 77 to 89 of the request aspect, wherein the component connected with the interface is a medical breathing tube.

91. The system claimed in item 90 of the request, wherein the medical breathing tube is as defined in any one or more of items 1 to 59 in the request.

92. The system claimed in any one of items 77 to 91 of the request aspect, wherein the user interface is a nasal cannula.

93. The system claimed in item 83 of the request, wherein the nasal cannula is defined as any one or more of items 60 to 76 in the request.

94. The system claimed in any one of items 77 to 93 of the requested aspect, wherein the first component of the two-part releasable attachment or connection system includes being fixed to or used to be fixed to the skin patch One of the substrates.

95. The fixing system claimed in claim 94, wherein the base portion includes at least one slit or at least one slot, and the base portion area is separated by the slit or the slot.

96. The fixing system claimed in claim 95, wherein the base portion includes a plurality of slits or slots or both, which together divide the base portion into a serpentine body.

97. If the fixed system claimed in item 95 is requested, the slits and/ Or the slots are arranged in the base such that at least one of the first set of slots or slots extends from one edge of the base into the base, and the second set of slots or slots extends from the other of the base. One edge extends into the base, and the slits or slots in one set are intersected with the slits or slots in the other set, so that along the base portion from one end to the other end without crossing the set of A path of equal slits or grooves follows a zigzag or serpentine path that is longer than a straight line between the two ends.

98. The fixing system claimed in any one of items 95 to 97 of the request aspect, wherein one of the plurality of slits or grooves is slit or grooved as a curve.

99. The fixing system claimed in any one of items 95 to 88 of the requested aspect, wherein the plurality of slits or slots are curved and the curved slits or slots are arranged substantially in parallel.

100. The fixation system claimed in any one of items 96 to 88 of the requested aspect, wherein the slits or grooves are configured to extend from the edge of the base portion into a herring bone pattern.

101. The fixed system claimed in claim 95, wherein the base system is divided into divided parts by a serpentine slit or slot.

102. The fixing system claimed in claim 95, wherein the base part is divided into a plurality of parts by a spiral slit or groove.

103. The fixing system claimed in claim 95, wherein the base part is divided into the detailed parts by slits or slots arranged in substantially concentric circles.

104. The fixing system claimed in claim 103, wherein the equicentric circle is centered around the center of the base.

105. If the fixed system claimed in item 95 is requested, the slits Or slotting divides the base portion into multiple islands, and each island is connected to one or more adjacent islands by a narrow bridge.

106. The fixing system claimed in item 95 of the request aspect, wherein the base part is divided into a plurality of parts by an S-shaped slit.

107. The fixing system claimed in claim 95, wherein the base body is divided into multiple parts by a T-shaped slit.

108. The fixation system claimed in any one of items 94 to 107 in the requested aspect, wherein the base portion covers at least 70% of the area of the skin patch.

109. The fixing system claimed in any one of items 100 to 108 of the requested aspect, wherein for a boundary defining the shortest path around the periphery of the base, the base portion covers at least 80% of the internal area of the boundary.

110. A user interface assembly, which includes:

A fixing system for the user interface and/or a component (such as a tube or pipe) connected to the user interface, and

Connected to the user interface to provide at least a part of a breathing circuit to a tube of a user of the interface,

The fixing system includes a two-part releasable attachment (or connection) configuration, and the configuration includes:

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 skin of a user (for example, by means of an adhesive, usually a skin sensitive adhesive such as a hydrocolloid),

The interface side of the skin patch is provided with one or two The component type releasably attaches or connects the first component of the system, and

The user interface patch has an interface side and a patient side,

The patient side of the user interface patch is provided with the complementary second component of the two-part releasable attachment or connection system,

The interface side of the user interface patch can be attached (or can be connected) to the user interface and/or the component (such as a tube or tube) connected to the user interface, and

The piping system includes:

A tubular body defining a lumen extending between the open terminals of the body,

An inner part that surrounds the lumen and supports the tubular body, and

A coating layer that encapsulates the inner profile, and the coating fixes the inner profile to the tubular body.

111. The interface of claim 110, in which the interface is a nasal cannula.

112. The interface of claim 110 or 111 of the request aspect, wherein the interface includes one or a pair of nasal prongs.

113. The interface claimed in item 112 of the request aspect, wherein the interface includes a fixed system as defined in any one or more of items 77 to 109 in the request aspect.

114. If the interface of any one of claims 110 to 113 is requested, its The middle tube is a medical breathing tube.

115. The interface of claim 114 of the request aspect, wherein the management is as defined in any one or more of items 1 to 59 of the request aspect.

116. The interface claimed by any one of items 110 to 115 in the request aspect, wherein the interface is a nasal cannula configuration including:

At least one nasal prong having an air outlet suitable for being inserted into the nostril of a user and an air inlet fluidly connected to the air outlet,

The at least one nasal prong includes a backing that is assembled to rest on the face of a user,

One of the lip extends to cover at least a part of the periphery of a rear surface of the backing, and the rear surface is configured to receive or retain a user interface patch,

In use, the user interface patch can be releasably attached or connected to or attached to a skin patch of a user's face.

117. The interface of claim 116, in which the lip is a barrier.

118. The interface claimed in item 116 or 117 of the request aspect, wherein the lip is deformable.

119. The interface claimed in any one of Claims 116 to 118, wherein the lip extension at least partially covers the periphery substantially adjacent to a region of a prong connected to the backing.

120. The interface claimed in any one of items 116 to 119 of the requested aspect, wherein the lip is a circulating lip extending around the periphery of the back surface of the backing.

121. If the interface of any one of the claims 116 to 120 is requested, its The middle lip is a series of one or more separate lips.

122. The interface claimed in item 121 of the request aspect, wherein the one or more separate lips are adjacent, or adjoining or overlapping lips.

123. The interface claimed in any one of items 116 to 122 of the requested aspect, wherein in use, the lip substantially forms the back surface of the backing and one of the user interface patches facing the sleeve surface One of the fluid (or liquid) seals, or fluid barriers.

124. The interface claimed in any one of items 116 to 123 of the requested aspect, wherein the backing is configured to rest on a user’s face that is substantially flat or flat or contoured (such as pre-shaped Curve) backing.

125. The interface claimed in any one of items 116 to 124 in the requested aspect, wherein the backing assists as a stabilizer of the prong(s) in the nostril(s) of a user.

126. The interface claimed in any one of items 116 to 125 of the requested aspect, wherein the at least one backing is away from the nasal septum of a user and extends outward from the at least one prong.

127. The interface claimed in any one of items 116 to 126 of the request, wherein at least the (etc.) lip system is water-repellent.

128. The interface claimed in any one of items 116 to 127 of the requested aspect, wherein at least the lip(s) includes at least one outer peripheral lip and at least one inner peripheral lip, each of which is for contact The face of the person.

100: medical tube

101: vertical axis

102: Tubular body

104: Crest

105: trough

107: Lumen

110: internal parts

Claims (32)

A nasal cannula configuration, which includes: At least one nasal prong, the or each prong has an air outlet adapted to be inserted into the nostril (or nostrils) of a user, and an air inlet in fluid communication with the air outlet, wherein each air inlet The port is to supply gas from a separate gas supply pipe, Each nasal prong includes a connected backing that is assembled to rest on the user’s face, Wherein the backing extends from the at least one nasal prong to the outside, away from the user's nasal septum, each backing includes a back surface, and the back surface is assembled to receive or retain a user interface patch In use, the user interface patch can be releasably attached or connected to or with a skin patch that can be attached or connected to the user’s face. The user interface patch The patch and the skin patch provide a fixation system, and Wherein, in use, the user interface patch and the skin patch are attached or connected to fix the connected backing on the user's face, and the connected backing includes the connection to the air intake Port of the gas supply pipe. Such as the nasal cannula configuration of claim 1, wherein the nasal cannula configuration includes a pair of nasal prongs. Such as the nasal cannula configuration of claim 1, wherein the nasal cannula configuration includes a pair of separate gas supply tubes, and each nasal prong is provided with a separate The gas supply pipe is in fluid communication. Such as the nasal cannula configuration of claim 1, wherein a first nasal prong is provided with a gas supply from a first gas supply tube, and the first gas supply tube extends substantially on a first portion of the user's face. Side, and a second nasal prong is provided with a gas supply from a second gas supply tube, the second gas supply substantially extending on a second side of the user’s face, And/or wherein the gas supply pipe(s) extend from one or both sides of the nasal cannula. Such as the nasal cannula configuration of claim 1, wherein at least a part of the gas supply tube(s) extends across one or both sides of the user's face. For example, the nasal cannula configuration of claim 1, wherein the nasal cannula configuration includes a pair of backings, each backing is connected to a separate nasal prong, and each backing includes a back surface, the back surface being a set It is equipped to receive or retain a user interface patch. In use, the user interface patch is releasably attached or connected to or connected with a skin patch, the skin patch can be Attached or linked to a user’s face, And/or wherein at least a part of the gas supply pipe(s) is provided on a front surface of the backing. Such as the nasal cannula configuration of claim 1, wherein the gas supply pipe or each gas supply pipe is permanently connected to the air inlet of the nasal prong. For example, the nasal cannula configuration of claim 1, wherein the separate gas supply pipe or each separate gas supply pipe is integrally formed with the air inlet of the nasal prong, and the gas supply pipe is provided for the inlet of the nasal prong. Breath. Such as the nasal cannula configuration of claim 1, wherein one of the skin patches is used by the user The interface side has one of a two-part releasable connection system, such as one of a hook or a loop, and a skin patch side of the user interface patch has one of the two-part releasable connection system The other, such as the other of the hook or the loop, enables the skin patch and the user interface patch to be releasably attached or connected to each other. Such as the nasal cannula configuration of claim 1, wherein the skin patch can be positioned and/or attached to the facial skin of a user. For example, the nasal cannula configuration of claim 1, wherein the user interface patch is positionable, or attached or attachable, or is connected to or connected to a user interface, and/or wherein the user interface patch The sheet is integrally formed with a user interface or forms a part of the user interface. For example, the nasal cannula configuration of claim 1, wherein the fixing system is configured to receive and/or fix the nasal cannula and the associated gas supply tube, and the tube is from one side or both of the user's face Side extension. Such as the nasal cannula configuration of claim 1, wherein the skin patch includes one of a two-part releasable connection system by at least one slit, or at least one slot, or The combination of at least one slit and at least one slot is divided into a plurality of regions, so that a part of the two-part releasable connection system can substantially conform to a lower surface. Such as the nasal cannula configuration of claim 1, wherein each of the gas supply pipes is a tubular body, the tubular body defines a lumen extending between the open ends of the tubular body, and an internal part is enclosed in the tube Inside the cavity and supporting the tubular body, and a coating layer encapsulates the inner molded part, the coating layer The inner profile is fixed to a wall of the tubular body. Such as the nasal cannula configuration of claim 1, wherein the air outlet of each nasal prong is suitable for insertion into the nostril of a user, and the backing is assembled to rest on the face of a user, and one of the lips Extending at least a part of the periphery of a rear surface of the backing, the rear surface is configured to receive or retain the user interface patch so that in use, the user interface patch is releasable Attached or linked to or with the skin patch, which is attached to the user's face. Such as the nasal cannula configuration of claim 15, wherein the lip is one or a combination of the following: (a) A barrier; (b) Deformable; (c) Extend at least substantially adjacent to the periphery of a region of the prongs connected to the backing; (d) An endless lip extending around the periphery of the back surface of the backing; (e) A series of one or more separate lips; (f) In use, the lip substantially forms a fluid seal, or fluid barrier, between the rear surface of the backing and a facing surface of the user interface patch; (g) Water repellent; (h) It includes at least one outer peripheral lip and at least one inner peripheral lip, each of which is for contacting a user's face. Such as the nasal cannula configuration of claim 16, wherein the one or more separate lips are Adjacent, or adjoining, or overlapping lips. Such as the nasal cannula configuration of claim 15, wherein the backing is a substantially flat or flat or contoured backing assembled to rest on a user's face, and/or wherein the backing is auxiliary As a stabilizer of the prong(s) in the nostril(s) of a user. Such as the nasal cannula configuration of claim 14, wherein the tubular body is an extruded tube, and/or wherein the tubular body is formed as a continuous tube. Such as the nasal cannula configuration of claim 14, wherein the inner profile is enclosed in a coating layer that fixes the inner profile to the tubular body. Such as the nasal cannula configuration of claim 14, wherein the coating and the tubular system are one or a combination of the following: (a) Plastic welding along the tube; (b) Welding along the pipe at a separate position; (c) Welding substantially continuously along one length of the tube. Such as the nasal cannula configuration of claim 14, wherein the outermost periphery of the inner profile defines a plurality of alternating peaks and valleys along a length of the tubular body. For example, the nasal cannula configuration of claim 22, wherein the wave peaks of the tubular body are defined by the outermost periphery of the inner profile, and/or the troughs of the tubular body are directed between the inner profile The internally extracted tubular body is bounded by an inward extraction portion. Such as the nasal cannula configuration of claim 14, wherein the internal profile is one or a combination of the following: (a) A continuous length, one or a series of semi-continuous lengths, or a series Column separation length; (b) A spiral spring or a spirally wound element, a spirally wound frame or a spirally wound rib, an annular disc, a ring, or interconnected or interconnectable by one or more connecting links One or a combination of multiple separate supports; (c) supporting the tubular body and defining the lumen inside; (d) A skeleton or internal support structure supporting the tubular body; (e) A spirally wound rib, or rib element; (f) A spirally wound metal wire, the coating encapsulating the wire; (g) Have a pitch that changes along a length (or section) of the tube; (h) A spirally wound element has a pitch between adjacent turns of about 1 mm to about 1.5 mm; (i) A spirally wound element having a diameter of about 0.1 mm to about 0.4 mm; (j) A wire suitable for heating or sensing the properties of the gas inside the tube; (k) It is conductive or an electric heater. Such as the nasal cannula configuration of claim 14, wherein the internal profile includes one or a combination of the following: (a) One or more conductive members, electric heaters, sensors, flow or temperature or humidity or pressure sensors; (b) One or more separate components; (c) One or more components. For example, the nasal cannula configuration of claim 14, wherein the tubular body is substantially not supported by the inner profile in the troughs but is supported by the inner profile in the crests, and/or wherein the tubular body is a breathable The breathable tube is either made of a breathable material or made of a breathable material. For example, the nasal sleeve configuration of claim 26, wherein the breathable material is breathable thermoplastic polyurethane (s) or breathable polyamide (s) ). Such as the nasal cannula configuration of claim 14, wherein the wall of the tubular body is suspended between adjacent wave crests. The nasal cannula configuration of claim 14, wherein the coating layer provides a surface that can be connected with the tubular body. Such as the nasal cannula configuration of claim 14, wherein the tubular body is/has one or a combination of the following: (a) have a wall thickness of about 0.1 mm to about 0.2 mm; (b) Have an outer diameter of about 3 mm to about 5 mm; (c) is corrugated, and corrugations have a depth of about 0.1 mm to about 0.5 mm; (d) It is defined as flexible by passing the test according to ISO 5367: 2000(E) (fourth edition, June 1, 2000) that the flow resistance increases with bending. Such as the nasal cannula configuration of claim 14, wherein one end of the gas supply pipe It is integrated with the nasal prongs, and the nasal prongs are suitable for being inserted into a user's nostril as a nasal interface for delivering breathing gas to a user. For example, the nasal cannula configuration of claim 14, wherein the gas supply pipe further includes one or more of the following: a heater, an electric heater, a heater wire, a heater circuit, and/or one or more Internal parts.

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