Nasal cannulae, conduits and fixation systems

Abstract

To provide a component for a medical system, for conveying gas to and / or from a patient.SOLUTION: A medical breathing tube comprises 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 utilized.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to components for medical systems that deliver gases to and / or from a patient. In one detailed aspect, the present disclosure relates to conduits, and more particularly to respiratory tubing used in the inspiratory limb, expiratory limb, and / or combined respiratory limb of a respiratory system. In another aspect, the present disclosure relates to nasal cannulas and conduits that form part of a respiratory system. In another aspect, the present disclosure relates to nasal cannulas that form part of a respiratory system. In another aspect, the present disclosure relates to one or more systems for positioning a patient interface, such as a cannula, in an operative position for and / or relative to a user. [Background technology]

[0002] In assisted breathing, respiratory gases are supplied to the patient through a flexible respiratory tube. Gases exhaled by the patient can be delivered through a similar respiratory tube or exhaled into the patient's environment. Gases are typically administered to the patient through a user interface, which may also include a dedicated short respiratory tube connecting the interface to the supply tube. Each respiratory tube is ideally lightweight, resistant to kinking or pinching, and flexible to ensure adequate performance and patient comfort.

[0003] Typically, breathing tube sizes range from about 10 mm to about 25 mm internal diameter bore (including both neonatal and adult applications). Dedicated user interface tubes are thinner, and may have an internal diameter of about 2 mm for neonatal applications. The small size of the dedicated user interface breathing tube reduces its obscurity and reduces the weight it places on the patient's face. The breathing tube is preferably flexible for easy bending, which can improve patient comfort and ultimately increase patient compliance with treatment.

[0004] In medical applications such as assisted breathing, the gas inhaled by the patient is preferably delivered at about body temperature (usually 33°C to 37°C) and at a high relative humidity (generally near saturation). In other medical applications, such as continuous positive airway pressure (CPAP) systems or positive pressure ventilation systems that provide positive pressure respiratory gas to patients suffering from obstructive sleep apnea (OSA), the respiratory gas may be heated and / or humidified to various levels to improve user comfort, or may be delivered without heating or humidification.

[0005] Similar tubing may also be used to provide insufflation gas for laparoscopic surgery. Such insufflation tubes would also ideally be lightweight, resistant to kinking or pinching, and similarly flexible, so as to minimize obstruction and encumbrance within the operating room. The insufflation gas (typically CO2, but may be other gases or gas mixtures) may also be humidified.

[0006] Additionally, gases provided to a patient may be provided via nasal cannulae, with the flexibility of the associated tubing being an important consideration, particularly in the infant or neonatal setting. Increasing the flexibility of the tubing that delivers gases to the patient's cannulae promotes increased comfort and, consequently, increased compliance with such gas delivery therapy.

[0007] Additionally, it would be advantageous to provide an alternative or improved system for positioning an interface or determining the operational position of an interface, such as a nasal cannula, which may further facilitate improved compliance with gas delivery therapy.

[0008] References to patents, other external documents, or other sources of information may be made herein for the purpose of generally providing a context for discussing the features of the present disclosure. Unless specifically stated otherwise, the reference to such external documents should not be construed as an admission that such documents or sources of information are prior art in any jurisdiction or form part of the common general knowledge in the art.

[0009] Further aspects and advantages of the present disclosure will become apparent from the ensuing description, which is given by way of example only. Summary of the Invention [Means for solving the problem]

[0010] It is an object of the present disclosure to provide components and / or methods of manufacturing components that may go some way to at least ameliorating the above, or at least provide a useful option for the public or medical professionals.

[0011] In a first aspect, the present disclosure broadly resides in a method for manufacturing medical tubing, the method including the steps of providing an inner form and extruding a tubular body around the inner form, the tubular body defining a lumen enclosing the inner form.

[0012] Preferably, the method comprises: i) applying a vacuum within (or to) the lumen, whereby the vacuum draws the tubular body radially inward of the lumen and an outermost perimeter defined by the inner form, the outermost perimeter of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; or ii) applying stretch (or expansion) to at least a portion or region of the tubular body enclosing the inner form, whereby upon release of the stretch (or expansion), the stretched (or expanded) portion or region of the tubular body returns (or is allowed to retract) radially inward of an outermost perimeter defined by the lumen and the inner form, the outermost perimeter defining a plurality of alternating peaks and valleys along the length of the tubular body; or iii) A combination of i) and ii) Further includes:

[0013] Preferably the tubular body is provided by extrusion or by forcing material through a die head.

[0014] Preferably, the tubular body is extruded around an inner form and a reduced pressure is applied in such a way that the inner surface of the tubular body becomes at least partially adhered or bonded to at least a portion of the inner form, preferably this reduced pressure is the difference between the pressure in the lumen and the pressure surrounding the tubular body, more preferably the pressure inside (or supplied to) the lumen is less than the pressure surrounding (or the pressure surrounding) the tubular body is greater than the pressure inside (or supplied to) the lumen.

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

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

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

[0018] Preferably the lumen is subjected to a reduced pressure as it exits the extrusion die head.

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

[0020] Preferably the tubular body so formed is corrugated.

[0021] Preferably, the peaks of the corrugated tubular body so formed are defined by the outermost periphery of the inner form.

[0022] Preferably, the valleys of the corrugated tubular body so formed are defined by inwardly drawn portions of the tubular body drawn inward between one or more inner forms.

[0023] Preferably the inner form is a framework or internal support structure that provides support for the tubular body.

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

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

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

[0027] Preferably the inner form provides or supports a lumen within the tube so formed.

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

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

[0030] Preferably, the inner mold is a spirally wound element (or member) having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, or about 1.1 mm to about 1.3 mm. More preferably, the pitch between adjacent turns is about 1 mm to about 1.5 mm.

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

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

[0033] Preferably the inner form is made from a medical grade material, preferably medical grade stainless steel.

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

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

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

[0037] Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

[0038] Preferably, the ratio of the pitch of the inner mold to the outer diameter (for example, the outermost diameter) of the inner mold is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0039] Preferably, the ratio of the inner mold diameter (eg, the diameter of the actual inner mold element or member) to the outer diameter (eg, the outermost diameter) of the inner mold is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably the ratio is 0.06.

[0040] Preferably, the ratio of corrugation depth to external (ie, outer) tube diameter is from about 0.05 to about 0.09.

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

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

[0043] Preferably, the tubular body is one or a combination of (and preferably extruded from) one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or any one or more of breathable polyamides, more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, even more preferably a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

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

[0046] Preferably the inner mould is electrically conductive and preferably the inner mould is an electrically driven heater.

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

[0048] Preferably the tube further comprises a heater, more preferably an electrically powered heater (such as an electrically heated wire or circuit).

[0049] Preferably, the tubular body so formed has flexibility as defined by passing the Increase in Flow Resistance with Bending test according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0050] Preferably the medical tubing is a respiratory tube.

[0051] Preferably the inner form is made up of one or more individual components.

[0052] Preferably, the inner form comprises one or more components.

[0053] Preferably the tube comprises one or more inner forms. In a second aspect, the invention broadly relates to a method for manufacturing a tube comprising: a tubular body defining a lumen extending between open terminal ends of the body; an inner form enclosed within the lumen and providing support for the tubular body, the outermost periphery of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; It can be said that the medical tube comprises:

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

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

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

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

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

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

[0060] Preferably, the inner form is one or a combination of a helical spring or spirally wound element, a spirally wound framework or spirally wound rib, an annular disc, a ring, or a plurality of individual supports interconnected or interconnectable by one or more connecting links.

[0061] Preferably, the inner form supports a tubular body defining a lumen therein.

[0062] Preferably the inner form is a framework or internal support structure that provides support for the tubular body.

[0063] Preferably, the tubular body is substantially unsupported from the inner form at the roots and is supported by the inner form at the peaks.

[0064] Preferably the wall of the tubular body is suspended between adjacent peaks.

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

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

[0067] Preferably the inner form is a spiral wound rib or ribbed element.

[0068] Preferably the inner form is a helical element or member.

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

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

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

[0072] Preferably the inner form is made from a medical grade material, preferably medical grade stainless steel.

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

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

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

[0076] Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

[0077] Preferably, the ratio of the pitch of the inner mold to the outer diameter (for example, the outermost diameter) of the inner mold is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0078] Preferably, the ratio of the inner mold diameter (eg, the diameter of the actual inner mold element or member) to the outer diameter (eg, the outermost diameter) of the inner mold is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0079] Preferably, the ratio of corrugation depth to external (ie, outer) tube diameter is from about 0.05 to about 0.09.

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

[0081] Preferably, the tubular body is (and preferably is extruded from) one or a combination of thermoplastic elastomers, polypropylene-based elastomers, liquid silicone rubber (LSR), or breathable thermoplastic polyurethanes, or breathable polyamides; more preferably, the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0082] Preferably, the inner form is a plurality of rings spaced longitudinally along the lumen.

[0083] Preferably the ring is toroidal or annular.

[0084] Preferably the inner form is one or more individual elements connected together.

[0085] Preferably, the inner form includes a plurality of reinforcing ribs regularly spaced along the lumen.

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

[0087] Preferably, one turn of the helical stiffening wire comprises one complete turn around the lumen of the tube.

[0088] Preferably, one turn of the helical reinforcing wire comprises wire disposed between adjacent peaks of the inner form.

[0089] Preferably the tubular body is flexible as defined by passing the Increase in Flow Resistance with Bending test according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0090] Preferably, the terminal end of the tube is integral with nasal prongs that are configured to be inserted into a user's nostrils as a nasal interface for delivering breathing gas to the user.

[0091] Preferably, the inner mold is a mesh.

[0092] Preferably the inner form is a conductor suitable for heating or sensing the properties of the gas within the tube.

[0093] Preferably the inner mould is electrically conductive and preferably the inner mould is an electrically driven heater.

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

[0095] Preferably the tube further comprises a heater, more preferably an electrically powered heater (such as an electrically heated wire or circuit).

[0096] Preferably the tube is a breathing tube.

[0097] Preferably the inner form is made up of one or more individual components.

[0098] Preferably, the inner form comprises one or more components.

[0099] Preferably the tube comprises one or more inner forms.

[0100] In a third aspect, the present invention broadly comprises: at least one nasal prong having one or more gas outlets configured to be inserted into the user's nostrils and one or more gas inlets fluidly connected to the one or more gas outlets; one or more corrugated gas delivery tubes, the tube including a tubular body defining a lumen and an inner form enclosed within the lumen, the inner form providing support for the tubular body, the outermost periphery of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; 1. A nasal cannula device comprising: It may comprise a nasal cannula device in which one or more gas inlets in the nasal prongs are integrally formed with the terminal end of the tube, whereby the tube lumen is fluidly connected to one or more gas outlets in the nasal prongs.

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

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

[0103] The nasal cannula preferably has a substantially planar or flat or contoured backing adapted to rest on the user's face, preferably as a stabilizer for the prongs in the user's nares.

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

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

[0106] Preferably, the cannula includes a pair of nasal prongs, each of which may be integrally formed with, or attached (or attachable) to, or connected (or connectable) to, the terminal end of a pair of one or more gas delivery tubes.

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

[0108] Preferably, the cannula device is formed from any one or more of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides; more preferably, the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

[0110] Preferably, the nasal prongs of each nasal cannula are positioned adjacent to one another with the respective delivery tubes extending in opposite directions away from the nasal prongs.

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

[0112] Preferably the tube is a breathing tube.

[0113] Preferably the tube is as defined by the first or second aspect, for example the tube is produced by a method as defined by the first aspect or is a tube as defined by the second aspect.

[0114] In a fifth aspect, the invention broadly relates to a method of manufacturing a nasal cannula, the method comprising: providing an inner form; extruding a tubular body around the inner form, the tubular body defining a lumen surrounding the inner form, and attaching a nasal cannula thereto; It can be said that the method comprises the steps of:

[0115] Preferably, the method comprises: i) applying a vacuum within (or to) the lumen, whereby the vacuum draws the tubular body radially inward of the lumen and an outermost perimeter defined by the inner form, the outermost perimeter of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; or ii) applying stretch (or expansion) to at least a portion or region of the tubular body enclosing the inner form, whereby upon release of the stretch (or expansion), the stretched (or expanded) portion or region of the tubular body returns (or is allowed to retract) radially inward of an outermost perimeter defined by the lumen and the inner form, the outermost perimeter defining a plurality of alternating peaks and valleys along the length of the tubular body; or iii) A combination of i) and ii) Further includes:

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

[0117] Preferably the tubular body so formed is a tube as defined by the method of the first aspect or as defined by the tube of the second aspect.

[0118] The terminal end of the tube, preferably so formed by the tubular body, is placed in a mold or form for molding or shaping the nasal cannula, the mold or form is preferably closed, and the nasal cannula is overmolded or shaped onto that or some terminal end of the tube.

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

[0120] Preferably, the nasal cannula is molded from any one or more of one or a combination of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides; more preferably, the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, one or more liquid silicone rubbers, or breathable thermoplastic elastomers, for example, styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

[0122] Preferably, a nasal cannula mold is provided which is capable of receiving the terminal end of the tube so formed by manufacturing the tubular body, so that when the molding equipment is operated, the nasal cannula is molded, a portion of which is overmolded onto the terminal end of the tube.

[0123] The nasal cannula device, preferably made by a nasal cannula, is in fluid communication with the terminal end of the tube so formed by the manufacture of the tubular body.

[0124] In a sixth aspect, the present invention broadly relates to a fastening system for a user interface and / or user interface tubing, comprising: a skin patch defining an anchoring area, the skin patch having a user side and an interface side, the user side of the skin patch configured to stick or adhere to the skin of a user; a fixation patch, at least a portion of which is configured to extend over the user interface and / or associated user interface tubing and is secured to the user interface side of the skin patch to secure the user interface to the user; Including, The fixation patch and skin patch may be said to comprise a fixation system configured such that when the fixation system is applied to a patient with a suitable or compatible user interface, the fixation patch can be contained within or surrounded by the fixation area of ​​the skin patch.

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

[0126] Preferably, the fixation patch is shaped or otherwise configured to accommodate the geometric or other characteristics of the user interface and / or associated user interface tubing.

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

[0128] Preferably, the fastening patch has a pair of wings located at one end of the patch, which wings are configured to be fastened to the skin patch on either side of the user interface and / or associated user interface tubing.

[0129] Preferably the fixation patch has tube end wings that extend or are adapted to extend under the user interface tubing and to secure to the skin patch.

[0130] Preferably, the user side of the skin patch has a skin-friendly adhesive (eg, a hydrocolloid) that affixes or adheres the skin patch to the user's skin.

[0131] Preferably, the skin patch has a surface area sufficient to distribute the pressure or adhesive force of application across the skin of the user.

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

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

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

[0135] Preferably the fixation system is adapted for use with an infant or newborn.

[0136] Preferably the fixation system is configured for use with a nasal cannula as defined by the third aspect.

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

[0138] In a seventh aspect, the present invention may broadly be said to comprise a fastening system for a user interface and / or user interface tubing including a two-part releasable attachment or coupling device, the device including a skin patch and a user interface patch: the skin patch has a patient side and an interface side, the patient side of the skin patch being attachable to the skin of a user (e.g., by adhesive, typically a skin-friendly adhesive such as a hydrocolloid), the interface side of the skin patch being provided with a first part of a two-part releasable attachment or coupling system; and the user interface patch having an interface side and a patient side, the patient side of the user interface patch being provided with a complimentary second part of a two-part releasable attachment or coupling system; The interface side of the user interface patch may be attachable to or coupled to the user interface and / or associated user interface tubing, e.g., by adhesive, or may be formed as part of the user interface, or may be provided as the backside of the user interface on which the second part of a two-part system is provided.

[0139] Preferably, the interface side of the skin patch has one of the hooks or loops, and the second part of the second patch has the other of the hooks or loops, so that the first and second parts (and patches) are releasably attachable or connectable to one another.

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

[0141] Preferably the user interface patch is installable or attached or attachable or coupled to or with the user interface.

[0142] Preferably the user interface patch is integral with or forms part of the user interface.

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

[0144] Preferably, the first part of the two-part releasable attachment or connection system is adhered or adhereable to the user interface side of the skin patch by a suitable adhesive.

[0145] Preferably, the user side of the skin patch has a skin-friendly adhesive (eg, a hydrocolloid) that affixes or adheres the skin patch to the user's skin.

[0146] Preferably, the skin patch has a surface area sufficient to distribute the pressure or adhesive force of application across the skin of the user.

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

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

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

[0150] Preferably the fixation system is adapted for use with an infant or newborn.

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

[0152] Preferably the fixation system is adapted for use with a tube as defined by the first and / or second aspect.

[0153] Preferably, a fixation patch as defined above is applied or applicable over the user interface and is adhered or adhereable to the skin patch to provide further fixation.

[0154] Preferably, the first part of the two-part releasable attachment or connection system includes a substrate that is secured to or for securing to the skin patch.

[0155] Preferably, the substrate portion includes at least one slit or at least one slot, the slit or slot separating the substrate portion into areas.

[0156] Preferably, the substrate portion includes a plurality of slits or slots or both which together divide the substrate portion into a serpentine body.

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

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

[0159] Preferably, a plurality of the slits or slots are curved, and the curved slits or slots are arranged substantially parallel.

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

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

[0162] Preferably the substrate portion is divided into sections by spiral slits or slots.

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

[0164] Preferably, the centre of the concentric circles is approximately at the centre of the substrate portion.

[0165] Preferably, the slits or slots divide the substrate portion into a plurality of islands, each connected to one or more adjacent islands by thin bridges.

[0166] Preferably the substrate portion is divided into portions by an S-shaped slit.

[0167] Preferably the substrate portion is divided into portions by a T-shaped slit.

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

[0169] Preferably, for a boundary that defines the shortest path around the perimeter of the substrate, the substrate portion spans at least 80% of the area within the boundary.

[0170] In an eighth aspect, the present invention broadly comprises: providing an inner mold encapsulated in a coating; providing a tubular body around the inner form, the tubular body defining a lumen enclosing the inner form; 1. A method of manufacturing medical tubing, comprising: The method may comprise providing a tubular body around the inner former such that the coating and the inner surface of the tubular body bond together, leaving the inner former enclosed.

[0171] Preferably, the step of providing an inner form comprises: providing an elongated form encapsulated in a coating suitable for application in medical tubing; producing an inner mold from the coated elongated mold to support the medical tubing; Includes:

[0172] The encapsulating coating is applied by immersing a preferably uncoated elongated former into a bath of coating material.

[0173] Preferably, the bath contains a molten polymer grade at a temperature above about 150°C.

[0174] Preferably, the inner mould is manufactured by spirally winding an elongated mould into a helical shape.

[0175] Preferably the method comprises: providing an uncoated elongated mold; encapsulating the elongated form in a coating suitable for application in medical tubing; Further includes:

[0176] Preferably the method comprises: i) applying a vacuum within (or to) the lumen, whereby the vacuum draws the tubular body radially inward; or ii) applying a stretch (or extension) to at least a portion or region of the tubular body that encloses the inner former, whereby upon release of the stretch (or extension), the stretched (or extended) portion or region of the tubular body returns (or is allowed to retract) radially inward; or iii) or a combination of i) and ii) Further includes:

[0177] Preferably, the tubular body is drawn radially inward of an outermost periphery defined by the lumen and the inner form, the outermost periphery defining a plurality of alternating peaks and valleys along the length of the tubular body to form a corrugated tube.

[0178] Preferably the tubular body is provided by extrusion or by forcing material through a die head.

[0179] Preferably, the tubular body is extruded around an inner form and a reduced pressure is applied in a manner that allows the inner surface of the tubular body to become at least partially adhered or bonded to at least a portion of the coating, and preferably, the reduced pressure creates a difference between the pressure in the lumen and the pressure surrounding the tubular body, more preferably the pressure inside (or supplied to) the lumen is less than the pressure surrounding (or the pressure surrounding) the tubular body is greater than the pressure inside (or supplied to) the lumen.

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

[0181] Preferably, the tubular body is provided around the inner former at a temperature that fuses the coating and the inner former together.

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

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

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

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

[0186] Preferably the lumen is subjected to a reduced pressure as it exits the extrusion die head.

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

[0188] Preferably the tubular body so formed is corrugated (which may be axially corrugated or helically corrugated).

[0189] Preferably, the peaks of the corrugated tubular body so formed are defined by the outermost periphery of the inner form.

[0190] Preferably, the valleys of the corrugated tubular body so formed are defined by inwardly drawn portions of the tubular body drawn inward between one or more inner forms.

[0191] Preferably the inner form is a framework or internal support structure that provides support for the tubular body.

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

[0193] Preferably the inner mould is one or a combination of a helical spring or spirally wound element, a spirally wound framework or spirally wound rib, an annular disc, a ring or a plurality of individual supports interconnected or interconnectable by one or more connecting links.

[0194] Preferably the inner form provides or supports a lumen within the tube so formed.

[0195] Preferably the inner form is a helical element or member.

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

[0197] Preferably, the inner mold includes a spirally wound element (or member) having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, or about 1.1 mm to about 1.3 mm. More preferably, the pitch between adjacent turns is about 1 mm to about 1.5 mm.

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

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

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

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

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

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

[0204] Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

[0205] Preferably, the ratio of the pitch of the inner mold to the outer diameter (for example, the outermost diameter) of the inner mold is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0206] Preferably, the ratio of the inner mold diameter (eg, the diameter of the actual inner mold element or member) to the outer diameter (eg, the outermost diameter) of the inner mold is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0207] Preferably, the ratio of corrugation depth to external (ie, outer) tube diameter is from about 0.05 to about 0.09.

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

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

[0210] Preferably, the tubular body is one or a combination of (preferably extruded from) any one or more of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes; more preferably, the polymer may be a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

[0212] Preferably the inner mould is electrically conductive and preferably the inner mould is an electrically driven heater.

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

[0214] Preferably the tube further comprises a heater, more preferably an electrically powered heater (such as an electrically heated wire or circuit).

[0215] Preferably, the tubular body so formed has flexibility as defined by passing the Increase in Flow Resistance with Bending test according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0216] Preferably the medical tubing is a respiratory tube.

[0217] Preferably the inner form is made up of one or more individual components.

[0218] Preferably, the inner form comprises one or more components.

[0219] Preferably the tube comprises one or more inner forms.

[0220] In a ninth aspect, the invention broadly relates to a method for manufacturing medical tubing, comprising: i) providing an inner form; ii) providing a tubular body around the inner former, the tubular body defining a lumen enclosing the inner former, and applying a vacuum within (or to) the lumen or applying stretching (or expansion) to at least a portion or region of the tubular body enclosing the inner former; or iii) or a combination of i) and ii) It can be said that the method comprises the steps of:

[0221] Preferably, a greater vacuum or greater stretching (or extension) or a combination of both is applied, such that as the greater vacuum is applied or the extension (or extension) is released, or both, the tubular body is drawn radially inward of the lumen along the length of the tubular body and the outermost periphery defined by the inner form, which in turn defines a plurality of alternating peaks and valleys.

[0222] Preferably, the inner former is encapsulated in the coating and the tubular body is provided around the inner former such that the coating and the inner surface of the tubular body bond together, while the inner former remains encapsulated.

[0223] In a tenth aspect, the present invention broadly comprises: The medical tubing may be said to comprise a tubular body defining a lumen extending between open terminal ends of the body, an inner form enclosed within the lumen and providing support for the tubular body, and a coating encapsulating the inner form and securing the inner form to the tubular body.

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

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

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

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

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

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

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

[0231] Preferably, the inner form is one or a combination of a helical spring or spirally wound element, a spirally wound framework or spirally wound rib, an annular disc, a ring, or a plurality of individual supports interconnected or interconnectable by one or more connecting links.

[0232] Preferably, the inner form supports a tubular body defining a lumen therein.

[0233] Preferably the inner form is a helical element or member.

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

[0235] Preferably the inner form is a framework or internal support structure that provides support for the tubular body.

[0236] Preferably, the tubular body is substantially unsupported from the inner form at the roots and is supported by the inner form at the peaks.

[0237] Preferably the wall of the tubular body is suspended between adjacent peaks.

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

[0239] Preferably the inner form is a spiral wound rib or ribbed element.

[0240] Preferably the inner form is a spiral wound strip and the coating encapsulates the strip.

[0241] Preferably the inner form is a spirally wound metal wire, with the coating encapsulating the wire.

[0242] Preferably, the coating provides a surface that readily bonds with the tubular body.

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

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

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

[0246] Preferably the inner form is made from a medical grade material, preferably medical grade stainless steel.

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

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

[0249] Preferably, the tubular body is corrugated, the corrugations having a depth of about 0.1 mm to about 0.5 mm.

[0250] Preferably, the ratio of the pitch of the inner mold to the outer diameter (for example, the outermost diameter) of the inner mold is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0251] Preferably, the ratio of the inner mold diameter (eg, the diameter of the actual inner mold element or member) to the outer diameter (eg, the outermost diameter) of the inner mold is about 0.02 to about 0.10, more preferably about 0.05 to about 0.07, and most preferably 0.06.

[0252] Preferably, the ratio of corrugation depth to external (ie, outer) tube diameter is from about 0.05 to about 0.09.

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

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

[0255] Preferably, the tubular body is (and preferably is extruded from) one or a combination of a thermoplastic elastomer, a polypropylene-based elastomer, one or more liquid silicone rubbers, or breathable thermoplastic polyurethanes; more preferably, the polymer is a polymer such as, but not limited to, polyolefins, a thermoplastic elastomer, or a breathable thermoplastic elastomer, for example, a styrenic block copolymer, a copolyester elastomer, or a thermoplastic elastomer family such as a thermoplastic polyolefin elastomer or a thermoplastic polyurethane elastomer; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0256] Preferably, the inner form is a plurality of rings spaced longitudinally along the lumen.

[0257] Preferably the ring is toroidal or annular.

[0258] Preferably the inner form is one or more individual elements connected together.

[0259] Preferably, the inner form includes a plurality of reinforcing ribs regularly spaced along the lumen.

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

[0261] Preferably, one turn of the helical stiffening wire comprises one complete turn around the lumen of the tube.

[0262] Preferably, one turn of the helical reinforcing wire comprises wire disposed between adjacent peaks of the inner form.

[0263] Preferably the tubular body is flexible as defined by passing the Increase in Flow Resistance with Bending test according to ISO 5367:2000(E) (4th edition, June 1, 2000).

[0264] Preferably, the terminal end of the tube is integral with nasal prongs that are configured to be inserted into a user's nostrils as a nasal interface for delivering breathing gas to the user.

[0265] Preferably, the inner mold is a mesh.

[0266] Preferably the inner form is a conductor suitable for heating or sensing the properties of the gas within the tube.

[0267] Preferably the inner mould is electrically conductive and preferably the inner mould is an electrically driven heater.

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

[0269] Preferably the tube further comprises a heater, more preferably an electrically powered heater (such as an electrically heated wire or circuit).

[0270] Preferably the tube is a breathing tube.

[0271] Preferably the inner form is made up of one or more individual components.

[0272] Preferably, the inner form comprises one or more components.

[0273] Preferably the tube comprises one or more inner forms.

[0274] In an eleventh aspect, the present invention broadly comprises: It may be said to comprise a medical tube including a tubular body defining a lumen extending between open terminal ends of the body, and an inner form enclosed within the lumen and providing support for the tubular body.

[0275] Preferably, the outermost periphery of the inner form defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0276] Preferably, the inner former is encapsulated in a coating which secures the inner former to the tubular body.

[0277] In a twelfth aspect, the present invention broadly comprises: At least one nasal prong having one or more gas outlets configured to be inserted into a user's nostrils and one or more gas inlets fluidly connected to the one or more gas outlets, the prongs shaped to follow the anatomical curvature of the user's nostrils. It may be said that the nasal cannula device comprises:

[0278] Preferably, the nasal prongs are shaped to avoid contact with the user's septum at the bottom of the user's nose.

[0279] Preferably, the nasal prongs are shaped to avoid contact with the internal structures of the user's nose.

[0280] Preferably, the nasal prongs are shaped so that one or more flows of breathing gas through one or more gas outlets are substantially aligned with the upper airway of the user.

[0281] Preferably, the nasal prongs are shaped to extend generally upwardly and backwardly into the user's nostrils, the nasal prongs having a curvature that includes at least two inflection points.

[0282] Preferably, the nasal prongs define a lumen extending between one or more gas inlets and one or more gas outlets, the shape of the lumen varying from generally circular at the one or more gas inlets to generally elliptical at the one or more gas outlets.

[0283] Preferably, the prongs are shaped to maximize the cross-sectional area of ​​the lumen.

[0284] Preferably, the interface further includes a support that extends along the user's upper lip.

[0285] Preferably, the interface includes two nasal prongs symmetrically spaced about the user's sagittal plane, the prongs extending inwardly below the user's nose from a base on a common support positioned along the user's upper lip.

[0286] Preferably, the nasal prongs extend from the support towards the user's septum, curve upwardly and backward around the corners of the user's nares and into the user's nares, each prong extending along a generally oblique backward trajectory and passing through two medial-lateral inflection points that direct one or more gas outlets relative to the user's upper airway passages.

[0287] Preferably, the prongs may have a contoured trajectory that conforms to the anatomical shape of the user's nostrils. More preferably, i) in a first portion (or phase) of such prongs, the trajectory moves horizontally toward the midline of the face, ii) in a second portion (or phase) of the prongs, the trajectory curves upward toward the crown of the head directly into the nostrils, iii) in a third portion (or phase) of the prongs, the trajectory wraps back up to follow the anatomical curvature of the nostrils and into the head, and iv) in a fourth portion (or phase), the trajectory slopes horizontally toward the center of the cannula, aligning the outlet with the user's upper airway.

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

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

[0290] Preferably, the nasal cannula further includes a contoured backing or facial pad configured to rest against the user's face.

[0291] Preferably, the backing or face pad is pre-formed to a contoured curve that substantially conforms to the face or upper lip area of ​​the user.

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

[0293] In a thirteenth aspect, the present invention broadly relates to a method for producing a method for manufacturing a semiconductor device comprising: at least one nasal prong having one or more gases outlets configured to be inserted into the user's nostrils and one or more gases inlets fluidly connected to the one or more gases outlets; 1. A nasal cannula device comprising one or more gas delivery tubes, the tube including a tubular body defining a lumen, and an inner form enclosed within the lumen, the inner form providing support for the tubular body, It may comprise a nasal cannula device in which one or more gas inlets in the nasal prongs are integrally formed with the terminal end of the tube, whereby the tube lumen is fluidly connected to one or more gas outlets in the nasal prongs.

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

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

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

[0297] The nasal cannula preferably has a contoured backing or face pad configured to rest against the user's face, preferably as a stabilizer for the prongs in the user's nostrils.

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

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

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

[0301] Preferably, the cannula device is formed from any one or more of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, breathable polyester elastomers, or breathable thermoplastic elastomers, e.g., styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, breathable polyester elastomers, and even more preferably a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

[0303] In a fourteenth aspect, the present invention may broadly be said to consist in a user interface including a pair of nasal prongs as defined by the thirteenth aspect.

[0304] Preferably, in such a user interface, the nasal prongs are positioned adjacent to one another with the respective delivery tubes extending in opposite directions away from the nasal prongs.

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

[0306] Preferably the tube is a breathing tube.

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

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

[0309] In a fifteenth aspect, the present invention broadly comprises: at least one nasal prong having a gas outlet configured to be inserted into a nostril of a user and a gas inlet fluidly connected to the gas outlet; The nasal cannula device may be said to comprise: At least one nasal prong includes a backing material configured to rest on the face of a user, with a lip extending around at least a portion of the periphery of a rear surface of the backing material, the rear surface configured to receive or retain a user interface patch such that, in use, the user interface patch can be releasably attachable or connectable to or with a skin patch adhered to the face of a user.

[0310] Preferably the lip is a barrier.

[0311] Preferably the lip is deformable.

[0312] Preferably, the lip extends around at least the periphery of an area substantially adjacent the prong associated with the backing material.

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

[0314] Preferably, one or more individual lips are adjacent to or join or overlap the lip portion.

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

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

[0317] Preferably, the backing is a substantially planar or flat or contoured (such as a pre-formed curved) backing adapted to rest against the face of a user.

[0318] Preferably, the backing material acts as a stabilizer for the prong(s) in the user's nostril(s).

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

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

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

[0322] A user interface patch receivable or retainable on the rear surface of the backing (or backing component), preferably as defined by any one of the above aspects.

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

[0324] Preferably, the at least one or more lips include at least one outer peripheral lip portion and at least one inner peripheral lip portion, each of said lips being provided for contact with the face of a user.

[0325] Preferably the gas inlet of the cannula is in fluid communication with or in connection with a tube as defined in any one of the above aspects.

[0326] In a sixteenth aspect, the invention may be broadly said to comprise a portion of a releasable fastener including a substrate portion supporting mechanical fasteners distributed over a surface thereof, the substrate portion being flexible but substantially inextensible, the substrate portion being divided into a plurality of regions by at least one slit or at least one slot such that separate divided portions of the substrate can bend independently to substantially conform to a complex curved surface underlying the substrate.

[0327] Preferably, the substrate portion includes a plurality of slits or slots or both which together divide the substrate portion into a serpentine body.

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

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

[0330] Preferably, a plurality of the slits or slots are curved, and the curved slits or slots are arranged substantially parallel.

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

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

[0333] Preferably the substrate portion is divided into sections by spiral slits or slots.

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

[0335] Preferably, the centre of the concentric circles is approximately at the centre of the substrate portion.

[0336] Preferably, the slits or slots divide the substrate portion into a plurality of islands, each connected to one or more adjacent islands by thin bridges.

[0337] Preferably the substrate portion is divided into portions by an S-shaped slit.

[0338] Preferably the substrate portion is divided into portions by a T-shaped slit.

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

[0340] Preferably, for a boundary that defines the shortest path around the perimeter of the substrate, the substrate portion spans at least 80% of the area within the boundary.

[0341] In a sixteenth aspect, the invention may broadly be said to consist of a user interface assembly, the assembly comprising: a fastening system for the user interface and / or components associated with the user interface (e.g., tubes or tubing, etc.); a tube connected to the user interface that provides at least a portion of a breathing circuit to a user of the interface; Including, The fastening system includes a two-part releasable attachment (or coupling) device, which comprises: a skin patch and a user interface patch; the skin patch having a patient side and an interface side; The patient side of the skin patch is attachable to the skin of a user (e.g., by adhesive, typically a skin-friendly adhesive such as a hydrocolloid); the interface side of the skin patch is provided with a first part of a two-part releasable attachment or coupling system; and the user interface patch having an interface side and a patient side; a patient side of the user interface patch is provided with a complimentary second part of a two-part releasable attachment or coupling system; the interface side of the user interface patch is attachable (or connectable) to a user interface and / or a component associated with the user interface (e.g., a tube or tubing); and The tube is The device includes a tubular body defining a lumen extending between open terminal ends of the body, an inner form enclosed within the lumen and providing support for the tubular body, and a coating encapsulating the inner form and securing the inner form to the tubular body.

[0342] Preferably the interface is a nasal cannula.

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

[0344] Preferably the interface includes a fastening system.

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

[0346] Preferably, the interface is a nasal cannula device including at least one nasal prong having a gases outlet configured to be inserted into a user's nostril and a gases inlet fluidly connected to the gases outlet, the at least one nasal prong including a backing material configured to rest on a user's face, wherein a lip extends around at least a portion of the periphery of a rear surface of the backing material, the rear surface configured to receive or retain a user interface patch such that, in use, the user interface patch may be releasably attachable or connectable to a skin patch adhered to the user's face or to such a skin patch.

[0347] Preferably the lip is a barrier.

[0348] Preferably the lip is deformable.

[0349] Preferably, the lip extends around at least the periphery of an area substantially adjacent the prong associated with the backing material.

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

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

[0352] Preferably, one or more individual lips are adjacent to or join or overlap the lip portion.

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

[0354] Preferably, the backing is a substantially planar or flat or contoured (such as a pre-formed curved) backing adapted to rest against the face of a user.

[0355] Preferably, the backing material acts as a stabilizer for the prong(s) in the user's nostril(s).

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

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

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

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

[0360] The term "comprising" as used in this specification and claims means "consisting at least in part of." When interpreting each statement in this specification and claims that includes the term "comprising," there may be other features than the one or more preceded by this term. Related terms such as "comprise" and "comprises" should be interpreted in the same way.

[0361] The present disclosure may also be broadly described as consisting in any combination of parts, elements, features and / or descriptions of disclosures referenced or indicated in the specification of this application, individually or collectively, and any two or more of said parts, elements, features or descriptions of disclosures, and where reference is made herein to a particular integer that is known to be equivalent in the art to which the present disclosure pertains, such known equivalent is deemed to be incorporated herein by reference as if individually set forth.

[0362] The present disclosure is set forth above and also contemplates constructions thereof, the following of which are provided by way of example only.

[0363] These and other features, aspects, and advantages of the present disclosure will now be described with reference to the drawings of preferred embodiments, which are intended to illustrate, but not to limit, the present disclosure, and in which: [Brief explanation of the drawings]

[0364] [Figure 1] FIG. 1 is a side view of a corrugated medical tubing showing one end of the tubing in cross section depicting the configuration of the tubular body around an inner former. [Figure 2] FIG. 1 is a side view of a medical tubing shown in cross section with the tubular body cut away to reveal a continuous helical inner form. [Figure 3A] FIG. 1 is a side view of a medical tube shown in cross section with the tubular body cut away to reveal multiple individual rings corresponding to discrete inner forms. [Figure 3B] FIG. 1 is a side view of a medical tubing shown in cross section illustrating a sandwich wall construction around an inner former. [Figure 3C] FIG. 10 is a side view of a further embodiment in which the inner form is embedded in the wall. [Figure 3D] FIG. 10 is a side view of a further embodiment in which the tubular body is heat shrunk onto an inner former. [Figure 3E] FIG. 10 is a side view of a further alternative embodiment in which an inner mold serves to hold the tubular body in a desired shape. [Figure 4] 1 is a schematic diagram of a medical tubing molding machine, the machine including a hopper, a feed screw, and a die head. [Figure 5] FIG. 1 is a schematic diagram of a die head used to form reinforced medical tubing. [Figure 6] FIG. 1 is a perspective view of a nasal interface incorporating a pair of reinforced medical tubing, each coupled to a nasal prong. [Figure 7] FIG. 7 is a perspective view of the nasal interface of FIG. 6 incorporating a backing material component for stabilizing the interface in place and receiving headgear attachments. [Figure 8] FIG. 8 is a front view of the nasal interface of FIG. 7. [Figure 9] FIG. 8 is a top view of the nasal interface of FIG. 7. [Figure 10] FIG. 8 is a side view of the nasal interface of FIG. 7. [Figure 11] FIG. 8 is a front view of the nasal interface of FIG. 7 shown in cross section. [Figure 12] FIG. 8 is a perspective view of the nasal interface of FIG. 7 in place on an infant's head. [Figure 13] FIG. 1 is a perspective view of a nasal interface incorporating a pair of reinforced medical tubing each coupled to a nasal prong, where each nasal prong is secured to a harness including a plurality of ribs and a pair of headgear attachments. [Figure 14]FIG. 1 is a perspective view of a nasal interface incorporating a pair of reinforced medical tubing each coupled to a nasal prong, each nasal prong secured to a harness including a plurality of ribs. [Figure 15] 10 shows a nasal cannula positioned in an operative position on a user's face, the cannula being positioned according to an embodiment of the seventh aspect. [Figure 16] FIG. 16 is a side view of the nasal cannula device of FIG. 15. [Figure 17] 10 shows an embodiment according to a seventh aspect and its constituent assembly parts. [Figure 18] 10 shows a nasal cannula positioned in an operative position on a user's face, the cannula being positioned according to an embodiment of the sixth aspect. [Figure 19] FIG. 19 is a side view of the nasal cannula device of FIG. 18. [Figure 20] FIG. 10 shows an exploded perspective view of an embodiment according to a sixth aspect and its constituent assembly parts. [Figure 21] The relevant layers of an embodiment according to the sixth aspect are shown from right to left (user not shown). [Figure 22] 10 illustrates an embodiment of a fixing patch according to the sixth aspect. [Figure 23] 10 illustrates another or alternative embodiment of the fixation patch according to the sixth aspect. [Figure 24A] FIG. 1 is an enlarged perspective view of a cross-section of medical tubing with the corrugated tubular body cut away to reveal the coated spiral inner form. [Figure 24B] FIG. 1 is an enlarged perspective view of a cross-section of medical tubing with the smooth tubular body cut away to reveal the coated spiral inner form. [Figure 25A] FIG. 1 is a schematic front view of a pair of nasal prongs showing the shape of the prongs and inner lumen. [Figure 25B] FIG. 1 is a schematic side view of a pair of nasal prongs showing the shape of the prongs and inner lumen. [Figure 25C] FIG. 1 is a schematic front view of a pair of inverted nasal prongs showing the shape of the prongs and inner lumen. [Figure 25D] FIG. 1 is a schematic perspective view of a pair of inverted nasal prongs showing the shape of the prongs and inner lumen. [Figure 26A] FIG. 10 is a perspective view of a nasal interface having a curved backing material component. [Figure 26B] FIG. 10 is a front view of a nasal interface having a curved backing material component. [Figure 26C] FIG. 10 is a top view of a nasal interface having a curved backing material component. [Figure 26D] FIG. 10 is a rear view of a nasal interface having a curved backing material component. [Figure 27A] FIG. 17D is a close-up view of the nasal prongs shown in FIG. 17D. [Figure 27B] FIG. 17D is a close-up view of the nasal prongs shown in FIG. 17C. [Figure 28] 10 shows a nasal cannula device in use with a backing component that includes a lip. [Figure 29] 10 shows a nasal cannula device in use with a backing component that includes a lip. [Figure 30] FIG. 1 is a front perspective view of a nasal cannula device having a backing component that includes a lip. [Figure 31] FIG. 10 is a rear perspective view of a nasal cannula device having a backing component including a lip. [Figure 32] FIG. 1 is a top rear perspective view of a nasal cannula device having a backing component including a lip and a user interface patch on a rear surface of the backing component. [Figure 33] 33 is a cross-sectional view through the nasal cannula device of FIG. 32 when the user interface patch is coupled with the skin patch. [Figure 34] FIG. 34 is a side rear perspective view of the nasal cannula device of FIGS. 30-33. [Figure 35] FIG. 35 is a rear view of the alternative nasal cannula device of FIGS. 28-34 illustrating a series of split lips. [Figure 36A]1 illustrates an exemplary configuration of a skin patch according to some embodiments. [Figure 36B] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36C] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36D] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36E] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36F] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36G] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36H] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36I] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36J] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36K] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36L] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36M] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36N] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36O] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36P] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36Q] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. [Figure 36R] 36B illustrates various embodiments of fastener substrate portions secured to the skin patch of FIG. 36A. DETAILED DESCRIPTION OF THE INVENTION

[0365] Medical tubing (i.e., respiratory tubing) is subject to various constraints. Some of the constraints may be performance-driven characteristics such as weight, flexibility, and flow rate. Other constraints may be required by regulatory agencies and must be met before the tubing can be used in medical applications. Required constraints may include an assessment of the structural integrity of the tubing and the biocompatibility or sterility (for hygiene purposes) of the tubing components. One such constraint is the flow resistance caused by kinks, which may be defined by the relevant tests provided in ISO 5367:2000(E) (4th Edition, June 1, 2000).

[0366] Biocompatibility of materials, such as materials that may interact with or come into contact with respiratory gases or other fluids, but do not leach or impart materials to respiratory gases or other fluids that may be consumed or ingested by the user or patient, can be useful. Sterility can also be useful to help ensure no, or minimal, if any, transfer or disease to the user or patient.

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

[0368] Application-specific configurations of medical tubing can be complex and limit the associated design process. Additionally, strict regulations regarding component use often restrict medical professionals to strict adherence to component guidelines and instructions.

[0369] Tubing A medical tubing 100 is shown generally in FIG. 1. In a first embodiment, the medical tubing 100 is corrugated. However, the tubing may also be made or manufactured with a smooth outer surface (e.g., FIG. 24B) or a substantially smooth inner surface (e.g., FIGS. 3B, 3C). In one illustrated embodiment, the tubing 100 includes a tubular body 102. The body 102 defines a lumen 107 extending between open ends of the body 102. An inner form 110 is enclosed within the lumen 107. The inner form provides support for the tubular body. The outermost periphery of the inner form defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0370] The illustrated tube 100 has a corrugated profile including a plurality of peaks 104 and valleys 105. The peaks 104 and valleys 105 extend around the circumference of the tube 100 and alternate along the tubular body 102 (or its wall) (i.e., in a direction generally parallel to the longitudinal axis 101 of the tube 100).

[0371] The tubular body 102 defines a lumen 107 extending between the terminal ends of the tube 100. In medical applications, the passage of gas through the tube 100 is limited to the lumen 107, with the tubular body 102 defining the outer boundary of that passageway. The tube 100 preferably has an opening disposed adjacent either terminal end. Ideally, the opening is disposed generally coaxially with the lumen (i.e., aligned with the longitudinal axis 101 in the illustrated embodiment) to reduce flow disturbances within the tube 100.

[0372] The illustrated tube 100 also includes an inner former 110 over, around, or surrounding the tubular body 102. The tubular body 102 encloses the inner former 110 within the lumen of the tube 100. The inner former 110 provides a framework that defines the overall shape and contributes to the structural properties of the tube 100. Preferably, the interior surface or interior faces of the tubular body 102 are secured to the inner former 110. The tubular body 102 and inner mold 110 may be secured together by either press-fitting the tubular body 102 onto the inner mold 110 (e.g., FIG. 3D), by applying the tubular body 102 onto the inner mold in a molten, semi-molten, or uncured state, thereby fusing and bonding (or bonding) the inner surface of the tubular body 102 to the inner mold 110 (e.g., FIG. 3C), or even by providing a tubular body having at least an inner wall layer and an outer wall layer with the inner mold sandwiched therebetween (e.g., FIG. 3B).

[0373] The inner form 110 preferably defines a scaffolding substructure that is disposed about the longitudinal axis 101 of the tube 100 and supports the tubular body 102. The tubular body 102 is disposed over the inner form 110, with the corrugations in the tubular body 102 reflecting the structure of the reinforcing scaffold provided by the inner form 110. The peaks 104 of the tube corrugations correspond to the reinforcing ribs (i.e., the shape of the inner form 110) that support the tubular body 102. The valleys 105 of the tube corrugations are preferably unsupported sections of the tubular body 102 that are suspended between adjacent reinforcing ribs.

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

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

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

[0377] The inner form may have an outer coating as shown in the cross-section of the tube in Figures 24A and 24B. The coating shown in Figures 24A and 24B is about 35 microns thick, and the tube wall is about 150 microns thick. The coating 1111 completely encapsulates the inner form 1110. In an alternative form, it may also be advantageous to partially coat the inner form, such as with discrete coated sections over the length of the inner form 1110.

[0378] A coating on the inner form 1110 may be applied to increase the strength of the bond it forms with the tubular body 1102, to improve biocompatibility or sterility within the tube, and / or to isolate the inner form from the contents of the tube (thereby preventing corrosion of the inner form, etc.). Preferably, the coating is thin enough so that it does not negatively affect the mechanical properties of the inner form, such as reducing its elasticity or flexibility.

[0379] The tube in Figure 3B is a generally sandwich structure, made by inserting a thin-walled polymer tube into the center of an inner former, such as a coil spring. This assembly is then passed through a crosshead tubing extrusion die, which extrudes a molten, similarly thin-walled polymer tube over the outside of the assembly. The molten outer tube is brought into contact with the inner tube by drawdown of the extruded melt and / or by a pressure differential, which may be a vacuum applied between the two layers, or a positive pressure applied to the inside of the inner tube or the outside of the outer tube, or any combination thereof. The molten outer tube contacts the inner tube, creating a bond between them, which, after cooling, results in a tube consisting of the inner and outer walls of the tubular body. The inner former (e.g., a coil spring wire reinforcement) remains sandwiched between the two wall layers.

[0380] Such tubing may be formed with fairly smooth bores, resulting in low flow resistance, while the outer wall layer of the tubing is corrugated, promoting flexibility of the tubular body. The inner former is mechanically held in place by a sandwich effect. Therefore, a pre-coated inner former may not be necessary to achieve this adhesion to the tubing wall, although this option exists. The tubing may be two thin layers of tubing of similar material bonded together with an inner former (e.g., a spring) held in place away from the gas path. This provides a highly flexible, yet strong, crush- and kink-resistant tube. Mechanically holding the spring in place helps maintain the integrity of the tubing structure under axial stress, and the absence of the spring in the gas path reduces biocompatibility or sterility requirements for the inner former component.

[0381] The tube in Figure 3C is a generally embedded structure. The tube in this embodiment is made by passing an inner former (such as a coil spring) through a crosshead extrusion die, thereby extruding a polymer tube (tubular body) over the outside of the inner former (e.g., spring). Using a drawdown speed that achieves a drawdown in combination with either an internal vacuum or external positive pressure (or both), the polymer is sucked between the coils of the inner former (e.g., spring) to the point where the inner former is enclosed and mechanically locked in place. The tubular body formed is generally corrugated in shape (flexible), and a pre-coated inner former is not required to achieve adhesion, although this option exists. The tubular body is at a temperature sufficient to allow the tubular body to come into contact with itself and self-fuse from the heat of extrusion when the inner former is enclosed. In this regard, a fusion line or region is designated W in Figure 3C.

[0382] The tube in Figure 3D is a generally heat-shrunk structure. The tube is made by placing an inner former (e.g., a coil spring) into a length of tubular body formed from thin-walled, heat-shrinkable tubing (or energy). Heat (or appropriate energy to cause material shrinkage) is then applied, causing the tubular body to shrink and fit snugly against the inner former (e.g., spring), and corrugations are formed in the open spaces along the wall between successive wall sections supported by the inner former. This results in a corrugated tube with inner (e.g., wire) reinforcement. The corrugations provide good flexibility. If the interior or inner surface of the tubular body is pre-coated with a suitable adhesive, the inner former and tube wall can be further adhered or joined to one another.

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

[0384] Some advantages of coating the inner mold with a suitable material include: - The inner form is more firmly fixed to the tubular body, improving the overall strength and durability of the tube. - Strengthening of the tubular body, increasing its resistance to swelling and degradation caused by exposure to chemicals. - The coating provides a biocompatible (or sterile) barrier or layer of material around the former itself, thereby expanding the range of acceptable materials that can be used on the former, thereby improving biocompatibility or sterility (and also allowing the former to be colored, improving aesthetics and / or product recognition). - The inner form is protected from the contents of the tube (thereby reducing corrosion and / or other degradation of the inner form).

[0385] Coating the inner former with a suitable material can help reduce any tendency of the inner former to separate from the tubular body when the bond is stressed, such as can occur when certain materials swell from exposure to certain chemicals (such as oils, alcohols and / or detergents) or when breathable materials are exposed to water vapor or aqueous solutions.

[0386] In various embodiments (e.g., FIGS. 1, 2, 3, 24A, and 24B), the inner former supports the tubular body and resists narrowing and constriction of the tube lumen. The tubular body is advantageously formed from, formed of, or includes a suitable polymer, such as a thermoplastic elastomer, a propylene-based elastomer, liquid silicone rubber (LSR), a breathable thermoplastic polyurethane, or a breathable polyamide. The polymer may be, but is not limited to, a polyolefin, a thermoplastic elastomer, or a breathable thermoplastic elastomer, such as a polymer from the thermoplastic elastomer family, e.g., a styrenic block copolymer, a copolyester elastomer, or a thermoplastic polyolefin elastomer or a thermoplastic polyurethane elastomer, or a breathable polyamide. Forming the tubular body using a breathable material may also be utilized, thereby providing the added benefit of breathability to such medical tubing or circuits. Particularly suitable polymeric materials are those having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90. Such materials may also be used in the fabrication of nasal cannula devices as described in more detail below.

[0387] The tubular body may be formed from, formed of, or include various thermoplastic polyurethanes, thermoplastic polyester elastomers, or liquid silicone rubber (LSR), including breathable grades. Advantageously, the material grade selected has beneficial mechanical properties (such as durability, tear resistance, and high modulus) and may, in some cases, provide good transparency so that any accumulation of water within the tube can be detected.

[0388] The coating may be formed from the same material as the tubular body or from a different material. Advantageously, the coating 1111 may be chemically compatible with the tubular body 1102, allowing them to be fused together to form a bond connecting the inner former 1110 to the tubular body 1102. The inner former may be fabricated from a suitable polymer of another material that is chemically compatible with the material of the tubular body 1102. In one form, the coating 1111 may be a non-breathable material (even if the tubular body 1102 is a breathable material), thereby isolating the inner former 1110 from any moisture within the lumen of the tube. Advantageously, both the tubular body and the coating may be formed from, formed of, or include durable thermoplastic polyurethanes (TPUs). If the tubular body is formed from, formed of, or includes a thermoplastic polyurethane, the coating may alternatively be formed from, formed of, or include a variety of polymers. Advantageously, the polymer grade selected for the coating is tough and has good abrasion resistance to allow manipulation of the inner mold (such as winding it into a spiral mold) after coating.

[0389] Additionally, the tubular body may be extruded or otherwise formed with a minimal wall thickness to reduce the weight of the tube and further enhance the flexible properties of the tube. The inner form 110 may be fabricated from a resilient material that accommodates additional bending, such as a suitable metal or polymer.

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

[0391] This tube construction allows for increased compliance due to the accumulation of additional length of suspended tubular body in the valleys between the reinforcing ribs of inner form 110.

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

[0393] The additional wall length allows for the pitch of the inner form to be varied, thus allowing the tube to be longitudinally stretched and compressed without significantly narrowing the lumen. The additional length can be shortened or straightened, allowing the tube to be longitudinally stretched and compressed with minimal tensile or compressive deformation or stress in the tube wall itself.

[0394] Flexibility of the tube is also improved by varying the spacing between adjacent reinforcing ribs around the circumference of the tube to accommodate bending. Varying rib spacing circumferentially allows the inner former to accommodate bending of the lumen, simultaneously extending and shortening both sides of the tube without pinching or kinking the tube, while still meeting the flexibility requirements defined by ISO 5367:2000(E) (4th Edition, June 1, 2000).

[0395] Additionally, the inner mold may be electrically conductive. A conductive inner mold may facilitate numerous optional additional features to the operation or use of such a tube. For example, the inner mold may be (or may include) an electrically powered heater. For example, the inner mold may be comprised of one or more components.

[0396] In another embodiment, the inner mold may include one or more electrically conductive members, electrically powered heaters, or sensors (eg, flow sensors, temperature sensors, humidity sensors, pressure sensors, etc.).

[0397] In some embodiments, the tube can include a heater, for example, an electrically powered heater (eg, heated wire, heated circuit, etc.).

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

[0399] It should also be understood that the inner form 110 may be provided with a variable or varying pitch along the length of the tubular body.

[0400] In yet another aspect of the invention, one or more inner forms 110 may be provided. In this manner, a double helix-shaped inner form, or other configuration, can be provided to support the tube, but maintain the flexibility and compliance of such a configuration tube.

[0401] The medical tubing constructions described above and shown, for example, in Figures 1-3E, 24A, or 24B are particularly applicable to user interfaces where the interface is connected to a respiratory system by a short, dedicated length of tubing. The flexibility and compliance of the tubing allows it to compensate for patient movement, while the inner form 110 resists narrowing (e.g., pinching, kinking, and collapsing) of the gas lumen due to forces resulting from this movement.

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

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

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

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

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

[0407] The corrugation depth may be defined by the distance between the point of smallest radius from the longitudinal axis (centerline) of the tubular body to the point of largest radius from the longitudinal axis (centerline) of the tubular body.

[0408] In one embodiment of the present invention, the ratio of the pitch of the inner mold to the outer diameter (eg, outermost diameter) of the inner mold is about 0.10 to about 0.50, more preferably about 0.20 to about 0.35, or even about 0.28 or about 0.29.

[0409] In another embodiment, the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter (e.g., the outermost diameter) of the inner mold is from about 0.02 to about 0.10, more preferably from about 0.05 to about 0.07, and most preferably 0.06.

[0410] In yet another embodiment, the ratio of corrugation depth to external (ie, outer) tube diameter is from about 0.05 to about 0.09.

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

[0412] This size of tubing is viable for dedicated neonatal applications because the neonatal maximum inspiratory flow requirements can be met despite the limited gas flow lumen. The small and lightweight tubing reduces pressure on the infant's face and makes the interface less noticeable. The flexibility and weight of the tubing increases user comfort and simplifies application and adjustment of the interface by the clinician.

[0413] The inner former is preferably fabricated from stainless steel wire, most preferably grades 302, 304, or 316, that can be wound into a helical framework of suitable size to support the tubular body, or from other suitably elastic materials with suitable biocompatible or sterility properties. Ideally, the outer diameter of the helical framework is about 1.7 mm to about 4.4 mm, while the wire used to fabricate the framework may have a diameter of about 0.05 mm to about 0.3 mm. The pitch of the helical framework is preferably about 0.4 mm to about 1.8 mm to provide the desired tubing flexibility, but may be about 1 mm to about 1.5 mm. Preferably, the outer diameter of the helical framework is about 2.4 mm to about 3.4 mm, the wire diameter is about 0.15 mm to about 0.2 mm, and the pitch of the helical framework is about 0.8 mm to about 1.4 mm.

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

[0415] The diameter of the inner mold (e.g., the wire used to make the scaffold) may be about 0.05 mm to about 0.30 mm, or about 0.06 mm to about 0.29 mm, or about 0.07 mm to about 0.28 mm, or about 0.08 mm to about 0.27 mm, or about 0.09 mm to about 0.26 mm, or about 0.10 mm to about 0.25 mm, or about 0.11 mm to about 0.24 mm, or about 0.12 mm to about 0.23 mm, or about 0.13 mm to about 0.22 mm, or about 0.14 mm to about 0.21 mm, or about 0.15 mm to about 0.20 mm, or about 0.16 mm to about 0.19 mm. The diameter of the wire used to fabricate the scaffold may 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, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, or 0.30 mm, preferably about 0.1 mm to about 0.4 mm.

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

[0417] In various aspects of the invention, the inner mold can be provided with a tubular body having a variable or varying pitch. In this manner, the pitch of the inner mold can be a varying pitch once it becomes part of the component tube. The varying pitch can have certain advantages, including increased strength / support or flexible areas. Such a system can also be useful for supporting thinner-walled tubular bodies.

[0418] In yet another embodiment, a varying pitch allows for varying density of inner molds per unit length of tubing. Such a configuration may be useful when the inner mold or parts of the inner mold serve as a heating source or sensor for or of gases passing through the lumen.

[0419] The inner form 110 may comprise a single continuous wrap of wire or multiple wraps joined end to end to form a helical framework, element, or rib. Alternatively, the inner form may comprise multiple individual rings. The rings may be joined longitudinally along the tubing. Wires, elongated polymers, or other suitable connectors (including multiple wires or elongated polymers) may extend along the lumen of the tubing and join the rings together. Multiple links may be spaced around the circumference of the ring.

[0420] For neonatal applications, the tubing provides an alternative to the clear PVC tubing typically used to support nasal cannulae and deliver respiratory gases. Preferably, the user interface is supported independently of the interface tubing (e.g., by a dedicated skin pad) to allow the tube to be more flexible without restricting tubing movement.

[0421] Tubing Manufacturing Method In addition to the foregoing, medical tubing may be manufactured by providing a tubular body around an inner form (or, in an alternative embodiment, an inner form around a tubular body). The tubular body defines a lumen that generally surrounds the inner form. During manufacture, in one embodiment, a vacuum may be applied within (or to) the lumen, which draws the tubular body radially inward of the lumen and the outermost perimeter defined by the inner form. The outermost perimeter of the inner form defines a plurality of alternating peaks and valleys along the length of the tubular body. Tubes may also be made with a smooth outer surface, as shown in FIG. 24B. In another embodiment, during manufacture, at least a portion or region of the tubular body that encloses the inner form may be stretched (or drawn) so that upon release of the stretching (or drawing), the stretched (or drawn) portion or region of the tubular body returns (or is allowed to retract) radially inward of the lumen and the outermost perimeter defined by the inner form, the outermost perimeter defining a plurality of alternating peaks and valleys along the length of the tubular body.

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

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

[0424] An instrument may be utilized to grip or stretch (or stretch) the tubular body such that the tubular body is stretched over or around the inner form and then, upon release of the stretch (or stretched state), comes into gripping relationship with the inner form, thereby assuming the shape of the outermost perimeter defined by the inner form.

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

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

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

[0428] A suitable extruder for the manufacture of medical tubing is supplied by Welex. The Welex extruder, with a 30-40 mm screw diameter and a 12-16 mm annular die head, typically with a 0.5-1.0 mm gap, has been found to be suitable for producing low-cost tubing at high speeds. Similar extruders are offered by, for example, American Kuhne (Germany), AXON AB Plastics Machinery (Sweden), AMUT (Italy), and Battenfeld (Germany and China).

[0429] To facilitate co-extrusion of the tubular components, raw material for the tubular body may be fed tangentially into the die head 317. The tubular body may then be extruded onto the inner form as it advances through the die head 317, with the molten or semi-molten tubular body spreading over the inner form. The molten tubular body preferably adheres to the inner form as it cools, securing the tubular components together.

[0430] In the illustrated embodiment, the die head 317 (shown in FIG. 5) is configured for a perpendicular orientation to the barrel of the extruder 310, with a side port 320 positioned adjacent to the extruder outlet 315. Molten or semi-molten material exiting the extruder 310 is forced into the side port 320 of the die head 317 and discharged into the peripheral chamber. Upon exiting the peripheral chamber, the material enters a nozzle 325, through which the inner mold 302 is drawn. The pressure created by the extruder 310 forces the material around the inner mold 302 and through the constriction 325, thereby extruding the tubular body 301 directly over the inner mold. Preferably, the inner mold advances continuously through the die head 317 at a substantially constant speed (although the rate of advance may be adjusted to vary the thickness along the tubular body at a constant extrusion rate).

[0431] Suction is applied to the interior of the die head through vacuum port 321. The suction reduces the pressure within the lumen of the extruded tube, causing the molten or semi-molten tubular body to be drawn around the inner former, creating corrugations on the outer surface of the tube. Preferably, the tubular body material still has enough tack from the extrusion process to adhere around the inner former.

[0432] Applying a reduced pressure within or to the lumen of the tubular body may be, for example, by applying a vacuum or reduced pressure to the lumen passageway. Alternatively, the reduced pressure may be a relative or comparatively reduced pressure. For example, the pressure surrounding the tubular body may then be increased such that the pressure within the lumen is lower compared to the pressure surrounding the tubular body. In this manner, the tubular body is subjected to a pressure differential that encourages the tubular body to be drawn (or pushed) radially inward. The pressure within the lumen and outside the tubular body may therefore be any suitable pressure such that the lumen is at a relatively lower pressure compared to the pressure surrounding the tubular body. Thus, the inner surface of the lumen is then drawn (by the pressure differential) into contact with the inner mold, thereby forming or assuming the shape of the outermost periphery of the inner mold in the embodiment shown in FIGS. 1, 2, 3, and 24A. Portions of the tubular body may not be supported by the inner mold and may be drawn further radially inward than the outermost periphery of the inner mold, thereby further accentuating the shape defined by the inner mold.

[0433] If the inner former is coated (e.g., as used in the tubing of Figures 24A and 24B), the coating may need to be shielded from any excessive heat sources to avoid damage. In one particular embodiment, the inner former may be manufactured from metal wire formed from medical-grade stainless steel (although non-medical-grade materials with a biocompatible layer or encapsulating coating that provides sterility and a corrosion barrier may also be used). The wire may be encapsulated in a suitable coating by passing the wire through a bath of the material. The high temperature of the coating material in the bath may also partially sterilize the wire by killing any biological contaminants.

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

[0435] In other examples, the inner form may be coated or encapsulated using a dipping method with a bath containing the polymer or by an extrusion die head that applies the polymer to the inner form.

[0436] Other Applications It is anticipated that the present embodiment may find other medical applications for which it is particularly suitable, for example, applications involving medical tubing that is desirably lightweight and highly flexible with sufficient resistance to crushing, pinching, and kinking, including applications where the use of breathable medical tubing is preferred, may also include the delivery and drainage rims of surgical humidification systems.

[0437] User Interface Tubes may be incorporated into a user interface, such as a nasal cannula, for delivering respiratory gas to a user. Nasal interfaces incorporating tubes are shown in FIGS. 6-12. The illustrated interface 400 includes a pair of nasal prongs 402. Each prong 402 is connected to a terminal end of a tube 401. The other end of the tube 401 may be connected to a supply conduit to interconnect the prongs 402 to a respiratory system. The tubes 401 may be connected to individual supply conduits or may alternatively merge (e.g., by a Y-fitting or other suitable connector, such as a manifold) to form a single junction with the supply conduit and facilitate delivery of respiratory gas to the interface 400. An embodiment of the user interface 400 is shown being worn on an infant in FIG. 12.

[0438] Each prong 402 defines a lumen extending between a user end 410 of the prong 402 and a tube end 415. The tube end 415 of the prong 402 connects the prong 402 to the interface tube 401. The user end 410 of the prong 402 is configured to deliver respiratory gas to the user's nares and, to this end, incorporates an opening 411. The opening 411 may be positioned concentrically with the terminal end of the prong 402, thereby minimizing flow disturbances exiting the prong 402. The tube end of the prong 402 may be anatomically shaped and / or conform closely to the user's nostril, and the terminal end of the prong 402 (i.e., the end incorporating the opening 411) may be curved away from the septum, thereby reducing the potential for irritation, for example.

[0439] The user end 410 and tube end 415 of the prong 402 are connected by an arcuate elbow joint. The user end 410 and tube end 415 are generally perpendicular in the illustrated embodiment, with the elbow joint passing through approximately 90°. Advantageously, in one form, the elbow joint has a smooth transition between adjacent sections of the prong 402 (corresponding to a larger radius of curvature), which may minimize flow disturbances within the prong 402.

[0440] The interface tube 401 is coupled to the tube end 415 of the prong 402. Preferably, the prong 402 is overmolded onto the tube 401 to provide an integrated component. In the illustrated embodiment, the tube 401 and the tube end section 415 of the prong 402 are concentrically disposed with the prong 402 extending around the tube 401. Preferably, a majority of the tube end section 415 is formed over the tube 401 to increase the contact area and strengthen the bond between the prong 402 and the tube 401.

[0441] The prongs 402 are preferably held in a spaced apart relationship. In the illustrated embodiment, a backing material or harness 403 is coupled to both prongs 402. The backing material 403 preferably holds the prongs 402 in a fixed spaced apart relationship. Different interface 400 sizes can be created to accommodate variations in nose spacing.

[0442] The illustrated backing material 403 also includes a housing 404 that generally encloses or captures at least a portion of the tube ends 415 of the prongs 402. The housing 404 incorporates a connector 405 that can be used to secure headgear to hold the interface 400 in place. A pair of outriggers 406 project outwardly from the backing material 403 on either side of the tube 401. The outriggers 406 increase the contact surface between the interface 400 and the patient, which distributes the force holding the interface over a larger area and reduces pressure on the user's face.

[0443] The user-facing surfaces (i.e., the sides that rest on the user's face) of the backing material 403 and outriggers 406 may be contoured to reflect the expected anatomy. The backing material 403 and outriggers 406 may also be formed from a flexible material to allow the structure to conform to the face of a particular individual.

[0444] The outrigger may include portions that allow the user (or caregiver) to more easily peel or rip the outrigger 106 from the user's skin or from the skin patch. Such tabs may improve the ease of application of the interface / its removal from the user.

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

[0446] Prongs 402, backing material 403, and outriggers 406 are preferably fabricated from a suitable polymer. Preferably, the individual cannulas (e.g., prongs 402 and tube 401) are fabricated by overmolding prongs 402 around the exterior surface of tube 401. The overmolding process generally involves inserting a preformed terminal end of tube 401 into a suitable mold and injecting the material used to fabricate the prongs into the mold and around the exterior surface of the tube while holding tube 401 motionless. Advantageously, both prongs 402, backing material 403, and outriggers 406 are processed in a single overmolding step, forming an integral, integrated interface.

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

[0448] Prongs Another preferred form of nasal prong geometry is shown generally in Figures 25A-25D, in combination with a common base support and facial support pad in Figures 26A-26D, and in enlarged views in Figures 27A and 27B. Listed features of the prongs shown in these figures are identified with similar reference numerals as the same features present in the previous figures (Figures 6-13) (but with prefixes to distinguish the particular embodiment).

[0449] The geometry of the prongs 1402 in Figures 25A-25D is illustrated by the sweep line 1420 representing the prong trajectory and the ellipses 1130-1135 representing the shape and orientation of the lumen within each prong at that particular trajectory. Each prong 1402 follows a sweep path that is shaped according to the anatomical geometry / curvature / contour of the user's nostril. The prongs are molded or shaped according to the anatomical shape and curvature of the user's nostril. Advantageously, the prongs may anatomically conform to the path of the nostril, thereby maximizing clearance between the prongs and the internal structures of the nostril.

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

[0451] Exemplary prong geometries are described below in relation to how the interface is held on the user's face during use. The interface is positioned so that the prongs 1402 are positioned approximately symmetrically about the user's sagittal plane. Each prong extends from a base 1415 that is positioned on a common support that extends along the user's upper lip. The prongs 1402 are spaced apart on the support to avoid the user's septum. The spacing between the prongs 1402 at the base 1415 is selected to provide maximum clearance between the prongs and the user's septum (at the bottom of the nose) for the range of face sizes that each interface accommodates (i.e., for a particular interface size).

[0452] The initial phase of each prong trajectory 1420 prior to the base 1415 is represented by ellipses 1130 and 1131 (first phase). During this phase, the prongs extend substantially coaxially with their respective breathing tubes. Both trajectories 1420 sweep a path that generally follows the user's upper lip on either side of the sagittal plane toward the septum. The prongs 1402 sweep with a slight posterior or backward curve relative to the user's upper lip (toward the user's coronal plane), as indicated by the rotation of the lumens (represented by the changing orientation of ellipses 1130, 1131, and 1132). The internal flow path defined by the shape of the lumens remains approximately circular during this phase.

[0453] From the base 1415, each prong 1402 sweeps upward or upward toward the crown of the user's head (away from the transverse plane) and backward or posteriorly relative to the user's upper lip (toward the user's coronal plane). Between the ellipsoids 1131 and 1133 (the second phase), the prong lumens smoothly transition from a generally medial-lateral direction aligned with the user's upper lip to a primarily angled posterior direction that directs gas flow toward the top and rear of the user's head. The prong lumens decrease slightly during this phase, becoming more elliptical to take advantage of the available space within the nostrils.

[0454] In the third phase (between ellipses 1133 and 1134), the prongs continue along a sloped posterior trajectory toward the upper back of the user's head (away from the transverse plane, toward the coronal plane), where the slope rate smoothly decreases (the upward component of the prong trajectory 1420 pulls the lumen away from the transverse plane). During this phase, the prongs 1402 may have negligible convergence (or mediolateral component) toward the sagittal plane. The prong lumen further decreases during this phase, becoming increasingly elliptical.

[0455] In the final phase (between ellipses 1134 and 1135), the prongs 1402 may continue along an inclined posterior trajectory with some medial-lateral convergence toward the sagittal plane. The medial-lateral convergence of the prongs 1402 begins at the indicated trajectory inflection point at (or slightly before) the beginning of the fourth phase adjacent to ellipse 1134. A second inflection point occurs adjacent to the final ellipse 1135, decreasing the prong convergence and directing the prong exit 1411 posteriorly (toward the coronal plane) with a slight medial-lateral component toward the sagittal plane (represented by the orientation of the final ellipse 1135 in FIG. 25B ).

[0456] The slope rate of the prong trajectories 1420 continues to decrease during the fourth phase, eventually causing each trajectory 1420 to become substantially parallel to the transverse plane at the prong exit 1411 (represented by the ellipse 1135). By adjusting the medial-lateral and superior-inferior directions of the prong trajectories 1420 adjacent the final ellipse 1135, the prong exit 1411 is positioned approximately in alignment with the upper airway passageway, reducing soft tissue irritation caused by escaping respiratory gases. The prong lumen is elliptical at the exit 1411, with the major axis of the ellipse lying approximately in the transverse plane. The exit 1411 directs respiratory gases upward or up toward the top of the user's head (away from the transverse plane) and backward or posteriorly (toward the user's coronal plane).

[0457] The shape of the prong 1402 (both trajectory and lumen) shown in Figures 13, 14, and 25-27 avoids contact with the user's septal area, thus reducing the risk of tissue injury in this area. The prong improves user comfort and therapeutic efficacy by aligning the prong outlet with the user's upper airway. The lumen shape maximizes the cross-sectional area of ​​the prong along its length while taking advantage of the anatomically available space in the patient's nares to minimize flow resistance. The prong lumen has a shape that avoids sealing against the user's nares.

[0458] Each prong may be provided with an independent gas source, so that when a pair of prongs is used, one prong may provide breathing gas while the other prong provides respiratory therapy or medicinal gas, such as gas used to improve the user's respiratory system.

[0459] Such anatomical prongs may have a contoured trajectory that conforms to the anatomical shape of the user's nostrils. In a first portion (or phase) of such a prong, the trajectory moves horizontally toward the midline of the face. In a second portion (or phase) of the prong, the trajectory curves upward toward the crown of the head directly into the nostril. In a third portion (or phase) of the prong, the trajectory wraps back up into the head to follow the anatomical curvature of the nostril. And in a fourth portion (or phase), the trajectory tilts horizontally toward the center of the cannula, aligning the outlet with the user's upper airway.

[0460] Such anatomically shaped prongs have a cross-section that varies along the central trajectory. For example, the cross-section may be generally circular at the base of the trajectory and become generally elliptical toward the distal end of the trajectory or prong. Furthermore, the cross-sectional diameter generally decreases along the trajectory from the first portion (or phase) to the end of the fourth portion (or phase).

[0461] The prongs are preferably manufactured from a soft, flexible material to further reduce trauma to the soft tissue of the nostrils. One possible material is a biocompatible thermoplastic elastomer or liquid silicone rubber (LSR).

[0462] A nasal interface 1400 incorporating prongs 1402 is shown in FIGS. 26A-26D, 27A, and 27B. The interface includes nasal prongs 1402 and a common support that supports the prongs 1402, which extend below the nose and along the user's upper lip, a pair of outriggers or facial pads 1406, and integral tubing 1401, all spaced approximately symmetrically about the sagittal plane. The interface is formed as a unitary or single component, with the tubing 1401 connecting directly to the base 1415 of the prongs 1402. The open distal end of each integral tube 1401 is configured to receive a suitable respiratory tube (such as tube 100). The respiratory tube may be glued or otherwise secured to the interface tubing 1401. The facial pad 1406 is anatomically shaped with a distribution and magnitude of curvature that reflects the intended facial geometry of the user. The anatomical shape of the facial pad 1406 provides the interface with positive engagement with the user's face in place, with the contours of the facial pad 1406 conforming to the contours of the user's face. The pre-shaped facial pad 1406 complements the anatomical nasal prongs 1402 by improving the accuracy and speed with which the prongs 1402 can be placed and held within the user's nostrils.

[0463] Pre-shaping or contouring the facial pad 1406 to the facial features of the user reduces the pressure exerted on the user's face by any retention mechanism (adhesive tape, headgear, or other means), thereby reducing the likelihood of pressure sores. The positive engagement promoted by the anatomical shape of the facial pad 1406 increases the stability of the interface 1400 and prongs 1402, thus improving the comfort and efficacy of the administered treatment.

[0464] In a further embodiment, there is provided a nasal cannula device 2000 including at least one nasal prong 2001, the or each prong 2001 having a gases outlet 2002 configured to be inserted into a nostril (or nostrils) of a user, and a gases inlet 2003 fluidly connected to the gases outlet 2001. The at least one nasal prong 2001 includes a backing material 2004 configured to rest on the face of a user, and wherein a lip 2005 extends around at least a portion of the periphery of a posterior surface 2006 of the backing material 2004. The posterior surface 2004 is configured to receive or retain a user interface patch 2007. In use, the user interface patch 2007 may be releasably attachable or connectable to a skin patch 2008 that is or can be adhered to the face of a user.

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

[0466] Advantageously, the lip 2005 serves to prevent the majority of fluid from seeping from the underside of the backing material 2004 onto the rear surface 2006. Such seepage could otherwise compromise the adhesion or connection between the user interface patch 2007 and the user's face or the skin patch 2008 applied to the user's face. Such a series of patches provides a securement system for positioning the cannula relative to the user's nares or for facilitating positioning of the nasal cannula in a preferred position or location. Such fluid seepage could otherwise become clogged on the interface-facing surface of the user interface patch 2007 or skin patch; such patch surface could in turn become smelly or generally slimy or unsanitary. Such obstructions should preferably be avoided if possible, as they can be uncomfortable for the user or their caregiver, or perhaps even affect the ability of such nasal cannula to remain in its preferred position. The provision of such a lip 2005 around the rear surface 2006 of the backing material 2004 attempts to minimize one or more of these deleterious effects.

[0467] According to this embodiment, the lip 2005 may be deformable. For example, the lip 2005 may be shaped such that the portion of the lip that contacts the user's face or the skin patch 2008 is able to bend or flex. This may allow the lip 2008 to deform to more effectively conform to the shape it is contacting when pressure is applied to the lip 2005, such as by an engagement force between the user interface patch 2007 and the skin patch 2008, which may increase the likelihood of a more effective seal or fluid barrier.

[0468] Such lip 2005 may extend around at least the perimeter (or a portion of the perimeter) of the backing material 2004, for example, around the area substantially adjacent the associated prong. For example, the majority of fluids that are prevented from entering the rear surface of the backing material by the configuration of the lip 2005 originate in the nasal or oral area of ​​the user. That is, nasal mucus exiting one or more nostrils of the user's nose or oral mucus exiting the user's mouth may drip back towards the backing material of the cannula (depending on the position of the user's head), or even breast milk leaking from a nursing infant's mouth, which in turn drips into the area around the nasal cannula device 2000. Additionally, bathing of the infant or user's face may produce fluids that may drip around or into the area around the cannula 2000.

[0469] Any of these fluids (and others not necessarily mentioned above) can affect the effectiveness of the fixation patch system used to secure or position the cannula on the user's face. Additionally, the negative effects caused by a foul odor or mucus (or slime) clogging of the fixation system patch can be undesirable.

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

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

[0472] In this way, the lips may together form a barrier or seal against fluid ingress.

[0473] However, it will be appreciated that the lip 2005 may be provided to extend around the entire periphery of the backing material, in which case the lip 2005 may be an endless lip.

[0474] This or these lips may be formed with (or treated to be) hydrophobic properties or attributes, which further facilitates the reduction of liquid passing through the lip barrier.

[0475] The lip portion that contacts the user's skin may be spoon-shaped. For example, the lip may have a configuration that collectively effectively provides a pair of parallel, spaced apart lips, an outer perimeter lip, and an inner perimeter lip. In this way, each of the pair of lips contacts the user's skin, helping to provide a more effective barrier or seal against liquids. It will also be appreciated that a series of parallel lips may be utilized.

[0476] As previously mentioned, the backing material 2004 may take the form of a substantially planar or flat or even contoured backing material (such as a pre-formed curve as shown in FIGS. 28-34 ) configured to rest against the user's face. The backing material 2004 may generally extend laterally outward from the at least one nasal prong 2001, away from the user's septum. Such backing material 2004 may help to act as a stabilizer for the one or more prongs 2001 in one or more of the user's nostrils. In this regard, such backing material 2004 may include various rib features as described in other embodiments.

[0477] It will also be appreciated that the nasal cannula 2000 of this embodiment may have a pair of prongs 2001 for insertion into the user's nares, each prong 2001 having an adjacent or associated backing material 2004. When a pair of prongs 2001 is provided, the prongs may be independent of one another, or, as previously described in other embodiments, the prongs may be structurally connected to one another using a harness for additional stability.

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

[0479] One embodiment of a nasal cannula 2000 is as shown in Figures 28-34.

[0480] 28 and 29 show a cannula device 2000 having a backing material 2004 coupled to a skin patch 2008 adhered to the face of a user. A lip 2005 is shown in contact with the skin patch 2008, thereby providing a barrier to fluids that might otherwise leak under the backing material 2004 and onto the rear surface 2006 that holds the user interface patch 2007. As shown, the user interface patch 2007 is located inside the lip 2005.

[0481] 30-34 show nasal cannula 2000 in further detail.

[0482] 31 and 34, rear surface 2006 may initially be provided without a user interface patch, i.e., this surface 2006 is configured to receive or hold a user interface patch 2007. Such a user interface patch 2007 may be bonded to rear surface 2006 by adhesive or other suitable bonding, which is then ready to couple to or receive a skin patch once the patch is in place.

[0483] In one form, the user interface patch can be one part of a two-part attachment system, such as the loop of a hook and loop system. In such an example, the interface-facing surface of the skin patch 2008 can be comprised of hooks that can engage with the loops of the user interface patch. See FIG. 32, which shows the rear surface 2006 holding the user interface patch with the loops ready to connect with the hooks of the skin patch.

[0484] 33 shows a cross section through the cannula 2000 with the hooks 2009 of the skin patch engaging the loops 2010 of the user interface patch. Also shown is the lumen 2011 or gas passageway for gas that is supplied to the gas inlet of the cannula and delivered to the gas outlet 2002 of the prong 2001.

[0485] Fastening system A fastening system for securing the user interface and / or user interface tubing to a patient is shown in Figures 15 to 17. An example fastening system 500 is shown supporting a nasal cannula on an infant's face.

[0486] Advantageously, the system generally provides for faster and improved or simplified ease of placing the user interface in an operative position relative to the user. Furthermore, these advantages may also contribute to improved or simplified ease of application of alternative user interfaces or removal of the user interface from the user when cyclically administering various therapies to the user (such as application of gas therapy, e.g., CPAP or high flow).

[0487] Certain user interfaces may be specially provided for interaction with or adaptation to the system of the described embodiments, or non-modified user interfaces may be adapted by the described embodiments and positioned with relative ease and minimal time spent on the installation procedure.

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

[0489] It is particularly useful for a user to be able to easily position the user interface. Providing a system that allows a caregiver (e.g., a nurse) to apply the securement system single-handedly or unassisted is particularly advantageous, especially when the user of the interface is an infant.

[0490] Additionally, in another embodiment, the fastening system provides a first level of securement of the user interface to the user. For example, such first level of securement may be as shown in FIGS. 15-17. If the user requires additional or enhanced security in positioning or securement of the user interface, a second level of interface securement may be utilized. Such an additional level may include the application of an over-patch, such as that provided by patch 660. Such patch 660 may be an adhesive patch that may be set over the user interface and / or tubing and adhered to a portion of skin patch 550.

[0491] The fastening system 500 includes a two-part releasable attachment or coupling device 551. The releasable coupling device 551 operates between a pair of patches that are secured to the patient and user interfaces, respectively.

[0492] 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 that faces the user's skin and an interface side that faces the user interface. The user side of the skin patch 550 may be attached to the user's skin with a skin-friendly 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 coupling system 551.

[0493] The second patch is a user interface patch 552. The user interface patch 552 also has a patient side and an interface side. The patient side of the user interface patch 552 is positioned adjacent to the skin patch when the system 500 is engaged. A complimentary second part 553 of a two-part releasable attachment or connection system is secured to the patient side of the user interface patch 552, thereby facilitating engagement of the respective parts of the two-part releasable attachment or connection system 551 when the patches 550, 552 are brought together. The interface side of the user interface patch 552 is secured to the user interface. The user interface patch may be integral with the user interface or, preferably, may be adhered thereto.

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

[0495] The two-part releasable attachment or coupling device 551 may include a hook and loop material (such as Velcro™), a magnet or magnet array disposed on each patch with a suitable arrangement of magnetic poles, an adhesive device that activates when the patches are forced together, or another suitable releasable coupling mechanism. 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, thereby allowing the skin patch and user interface patch to be releasably attachable or connectable to each other.

[0496] When referring to hook-and-loop materials, it refers to any one of a wide variety of surface-type mechanical fasteners. For example, the Velcro™ product range includes hook-and-loop products in which the hook component comprises an upstanding nylon hook (formed as a cut loop through a woven backing web) that engages with any complimentary loop pile material. The Velcro™ range also includes extruded hook products, typically smaller in size, that mate with a "fluffy" nonwoven fibrous backing material. These hook materials are designed to work with a wide range of loop substrates, and in some cases, these hook materials also function as loop substrates. Other similar systems include the Dual-Lock™ recloseable fastener system from 3M of St. Paul, Minnesota, USA. A common feature of these releasable fastener systems is that they engage anywhere at the interface between the two components of the system. Because there are multiple connectors distributed over the entire surface of the product, precise alignment of the individual connectors is not required. In a releasable attachment system, a wide variety of releasable fastener systems within the art may be used to provide a releasable attachment between the skin patch and the user interface.

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

[0498] According to some embodiments, the skin patch 550 is a generally planar pad having a thickness that is significantly smaller than both its width and its length. In some embodiments, the pad is generally oval in shape, although other shapes are possible.

[0499] The pad includes a first part 553 of a two-part releasable attachment system 551. In some embodiments, the dermal patch is constructed such that the first part 553 of the releasable attachment system includes a substrate and a number of fastening elements (effectively comprising hooks, loops, or other elements) provided over the entire surface of the substrate. The substrate is secured to the body of the dermal patch. In some embodiments, the substrate is secured by an adhesive or by direct bonding during formation of the dermal patch.

[0500] In some embodiments, the substrate is smaller in area than the skin patch and is positioned on the skin patch such that it does not extend beyond any of the edges of the skin patch, thus extending the edges of the substrate from the edges of the skin patch all around the perimeter of the substrate.

[0501] patch In some embodiments, the substrate of the first part of a two-part releasable attachment system is flexible, so that the plane of the substrate can bend to conform to a surface curved in one direction. However, the substrate is typically also inextensible and cannot conform to a surface curved in two orthogonal directions. However, the pad may be extensible and conformable to a surface curved in more than two directions, such as when the pad is a skin patch pad and may be required to conform to the contours of the placement site on a patient.

[0502] According to some embodiments, this difficulty is alleviated by providing the first part 553 of the two-part releasable attachment in a manner in which the substrate portion is divided into regions by at least one slit or at least one slot such that various portions of the substrate portion can bend independently, thereby allowing the overall shape of the substrate portion to deform to substantially conform to a bidirectionally curved surface. This may be true even if the substrate portion curves in only one direction at any individual point on the substrate portion.

[0503] Examples of such shapes are shown in Figures 36B-36R. The contour of the pad of the skin patch is shown in Figure 36A. This configuration is particularly useful for shapes where compound curvatures are most problematic, shapes where two or more bends in the substrate are likely to intersect. Typically, such shapes are thick, stocky, chunky, short and thick, or short and thick, rather than elongated. For example, this type of shape has a short perimeter relative to its area. If such a shape has a recess or depression in its perimeter, considering an imaginary perimeter that is the shortest path around the outside of the shape, the shape may exhibit a small ratio of the shape's area to the square of the imaginary perimeter. For example, the smallest ratio is exhibited by a circle at about 12.6:1, a square at about 16:1, and a 2:1 rectangle at 18:1. The more elongated the shape, the larger the ratio; for example, a 5:1 rectangle has a perimeter-to-area ratio of 29:1. In some embodiments, the refinements that may be described in relation to Figures 36B-36R may be advantageously used for patch shapes where the ratio of the square of the shortest enclosing perimeter to the area inside the perimeter is less than 25. In other embodiments, the refinements that may be described in relation to Figures 36B-36R may be advantageously used for releasably attached substrate portions where the ratio of the square of the shortest enclosing perimeter to the area occupied by the substrate is less than 25.

[0504] The substrate may be formed as multiple separate pieces as in the variations of Figures 36A-36R, however the preferred form is a single continuous piece for the substrate.

[0505] In some embodiments, the releasably attached substrate portion spans substantially all of the area of ​​the skin patch 550. In other embodiments, the substrate portion spans most of the area of ​​the skin patch, such as 50% or more of the area, 60% or more of the area, 70% or more of the area, or 80% or more of the area of ​​the skin patch.

[0506] 36A , in some embodiments, the dermal patch 550 includes a generally elliptical or oval body 3602 with a small lateral extension 3600 at one end. In preferred embodiments, this shape does not have sharp corners. The rounded or rounded corners or curved edges make it less likely to accidentally roll up than if sharp corners were present. In many of the exemplary embodiments of the fastener substrate, the fastener substrate includes an overall shape that generally matches the overall shape of the dermal patch 550, including extending the extended portion 3600.

[0507] In the illustrated embodiments of Figures 36B, 36F, 36G, and 36H, portions of the substrate do not extend completely to the edge of the dermal patch 550. Around at least a portion of the edge, a narrow region remains between the edge of the dermal patch and the edge of the substrate. This narrow region extends around the entire perimeter of the substrate. In some embodiments, such as the embodiment of Figure 36B, this region between the edge of the dermal patch 550 and the edge of the substrate may be wider in some places than in other places. For example, in Figure 36B, a wider region 3615 is provided at the end intended to be placed farther from the nose. This provides retention of attachment in the region closer to the nose, but allows the user to begin peeling to release the releasable fastener in the region farther from the nose. Similar configurations for substrate size and position relative to the dermal patch may be provided in the other examples of Figures 36C-36R. For example, in each case, the configuration of this example could be made on a smaller area of ​​the dermal patch and positioned closer to the nasal end of the dermal patch.

[0508] Other illustrated embodiments may also be sized so as not to extend to the edges of the skin patch. Generally, in the embodiments of Figures 36B-36R, the substrate portion comprises a chunky overall shape that occupies a large percentage of the area within its extended perimeter (the shortest path enclosing the shape). Generally, the substrate portion is formed as a single body, but may also be formed of a small number of closely interleaved bodies (e.g., two bodies), such as in Figure 36R. Within this body, the substrate is divided into multiple portions and / or elongated shapes by at least one slot, such that adjacent portions (or subportions) of the substrate portion are positioned on opposite sides of the slit, slot, or gap. Depending on the arrangement of the slot, slit, or gap (or multiple slots, slits, or gaps), the substrate may enable the underlying skin patch to stretch in one or more directions in addition to forming a curved or compound curved surface. Some prominent features and characteristics will now be described with reference to various substrate shapes and configurations.

[0509] In each case, certain aspects of an embodiment are described. Many variations can be made using these aspects. Aspects of one embodiment can be easily combined with aspects of other embodiments. The placement of the slits or slots may be oriented in other directions, or may be mirrored or reversed.

[0510] The substrate 3603 of FIG. 36B is serpentine in nature. The substrate has an end adjacent the first end 3304 of the dermal patch and a second end adjacent or facing the second end 3305 of the dermal patch. The substrate is formed into a series of switchback loops separated by slits 3306. The slits 3306 may be oriented perpendicular to the line between the ends 3304 and 3305, or at some other angle. For example, the slots 3306 may be oriented at an angle such that the top of each slit is closer to the first end 3304 than the bottom of each slit, or conversely, such that the bottom of each slit is closer to the first end 3304 than the top of each slit. There may be at least three slits, at least four slits, or at least five slits. This serpentine shape may provide a shortest unbroken path between the first end of the substrate portion and the second end of the substrate portion that is at least twice the actual straight-line distance between these points.

[0511] A series of slits in the serpentine shape provide alternating sections of serpentine paths that can bend in different directions, allowing the substrate to substantially conform to an underlying compound curved surface. For example, the loopback sections 3307 can bend independently of the straight sections 3308, allowing the outer surface of the pad of the skin patch to bend convexly in two orthogonal directions.

[0512] The serpentine shape of substrate 3603 includes curved or rounded corners, which are less likely to curl up, for example, due to inadvertent contact, than sharp corners. Similar refinements can be made to any of the embodiments shown in Figures 36B-36R.

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

[0514] The substrate portion in FIG. 36D shares essentially the same structure as the substrate portion in FIG. 36C, except that the substrate portion 3311 in FIG. 36D includes slits 3312 whose upper ends are farther from the nose end 3304 than their lower ends, while the slits 3310 of the substrate portion in FIG. 36C have their upper ends closer to the nose end 3304 than their lower ends.

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

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

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

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

[0519] 36B, 36C, 36D, and 36F-36H, the slots or slits are oriented substantially parallel to one another. In the configuration of FIG. 36E, a series of slits 3329 and 3330 extend from opposite sides of the substrate portion. In this embodiment, a first group of slits 3329 is oriented at a non-parallel angle relative to a second group of slits 3330. Notably, in the illustrated embodiment, the slits 3329 have their top ends farther from the edge 3304 of the skin patch than their bottom ends, while the slots 3330 have their top ends closer to the edge 3304 than their bottom ends. In some embodiments, the slits 3329 and 3330 pass through the centerline of the substrate portion (the centerline extending from edge 3304 to 3305), such that there is no straight path between edges 3304 and 3305 that is not cut by a slit 3329 or 3330. The slits 3329 and 3330 form a herringbone pattern.

[0520] The embodiments described with reference to Figures 36B-36H have essentially regular patterns. Figure 36I illustrates an embodiment with a less regular pattern. In this embodiment, the substrate portion 3331 spans substantially the entire surface of the dermal patch and is divided by one or more slits in an irregular configuration. For example, slit 3333 extends from one edge adjacent end 3304 in a generally S-shape, creating a series of alternating fingers from both sides of the substrate portion 3331. A second slit 3333 extends from the edge of the substrate adjacent end 3305 of the dermal patch. This slit shape includes a corner or dogleg, and divides into an intersecting slit 3335 at intersection 3334. Slits 3332 and 3333 divide the extent of the substrate portion 3331 into regions or sections of approximately equal width with alternating fingers and long interfaces. In this embodiment, the slit is generally inside the substrate portion 3331 and connects to the edge of the substrate portion 3331 in only two places.

[0521] A similar configuration of interleaved fingers is seen in substrate portion 3336 of Figure 36J and substrate portion 3337 of Figure 36R. In substrate portion 3336 of Figure 35J, a single, narrow slot 3337 having a narrow width extends in a serpentine path from the edge of the substrate adjacent end 305 along the length of the substrate portion to the adjacent edge 3304. In this embodiment, the single slot 3337 intersects the edge of substrate 3336 at only one point. Slot 3337 divides substrate portion 3336 into two main portions, each of which contains a series of fingers 3338 and 3339, respectively. Fingers 3339 and 3338 are interleaved. The position of slot 3337 and the orientation of long leg 3340 between loopback portions 3341 result in fingers 3339 and 3338 oriented along a direction transverse to, but angled relative to, the line between ends 3304 and 3305.

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

[0523] Another embodiment including a single slot or slit is shown in FIG. 36K. In this embodiment, a single slit 3346 extends in a generally spiral configuration from an edge location adjacent end 3305 to the end at a location that is approximately central within substrate portion 3347. This spiral slit 3346 divides substrate portion 3347 into a single, continuous spiral of substrate material. In some embodiments, multiple spiral slits may begin at various locations around the periphery of substrate portion 3347, dividing the substrate portion into multiple interleaved spirals of substrate material.

[0524] The embodiment of Figure 36Q includes substantially continuously curved slits, compared to the embodiments of Figures 36B-36J and 36R, which use primarily straight slits, although some curved portions are included. Figures 36K-36P show other substrate portion embodiments with curved slits.

[0525] In the embodiments of Figures 36K and 36L, substrate portions 3348 and 3349, respectively, are each divided by a plurality of curved slits 3350, which in each case are arranged on essentially a series of concentric circular loci, some of the slits 3350 extending from the edges of the substrate portions 3348 and 3349.

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

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

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

[0529] In the configuration of Figure 36M, a series of slots extend alternatingly from each side of the substrate portion, with slots 3357 and 3358 extending from the top edge of the substrate portion and slots 3359 and 3360 extending from the bottom edge of the substrate portion. This essentially divides the substrate portion into a serpentine length. In this embodiment, the curvature of each substrate slot is such that the top and bottom ends of each slot are farther from end 3304 than the central portion.

[0530] In the embodiment of Figure 36N, all four curved slots 3361 extend from the same edge of the substrate portion. This is reminiscent of a comb, with a series of fingers extending in the same direction from a single spine. As for embodiment 36N, in this example the slots are curved so that their top and bottom ends are farther from the first end 3304 of the skin patch than their central portion.

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

[0532] Another variation is shown in Figure 36P. In this embodiment, the curved slots 3364 may extend from the same edge of the substrate portion. They may extend from the top edge or the bottom edge. The curved slots 3364 are all arranged in an essentially parallel configuration. The curved slots have their top and bottom ends closer to the first end 3304 than their central portion.

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

[0534] The skin patch 650 defines a fixation area for attachment to a patient and has a similar configuration to the corresponding skin patch 550 in the previous fixation embodiment. The user side of the skin patch 650 is configured to stick or adhere to the skin of the user.

[0535] The fastening patch 660 extends over the user interface and / or associated user interface tubing and adheres to the skin patch 650 to secure the user interface to the patient. The fastening patch 660 and skin patch 650 are configured such that the fastening patch can be contained within or surrounded by the fastening confines of the skin patch when the fastening system is applied to a patient with a suitable or compatible user interface. Having the fastening patch 660 contained within the fastening confines of the skin patch 650 can reduce the possibility of inadvertent contact with the patient's skin and potential irritation. Ideally, the skin patch 650 has a surface area the same as or larger than the fastening patch 660.

[0536] Similar to the embodiment in which the interface includes a two-part releasable attachment to the dermal patch, in this embodiment including the fastening patch 660, the dermal patch 650 is provided with an element of a connection system for releasably connecting to the fastening patch 660. For example, the dermal patch 650 may include one part of a two-part mechanical fastening system over its surface or over a portion of its surface, and the fastening patch 660 may have the other part of the fastening system.

[0537] In this manner, the skin patch is sized to reduce the likelihood that the taping, or any additional taping, will extend onto the user's skin. The application of adhesive to the user's skin, or repeated application and removal, is preferably avoided or minimized. This embodiment advantageously reduces the likelihood that adhesive or adhesive tape will be repeatedly applied to the user's skin to position and retain the user interface in an operative position. Adhesive tape or other skin-adhesive patches (when repeatedly applied and removed) can cause problems, particularly for infants. These problems include, but are not limited to, skin irritation from adhesive chemicals (or adhesive removal chemicals, solvents, etc.) or tape materials (e.g., due to skin sensitivity), and damage to the user's skin due to repeated application and removal of the skin patch or tape to position or reposition the interface on the user. Repositioning or adjustments may be necessary if a treatment regimen is cycled (i.e., changed from one type of treatment to another and then back again). Advantageously, therefore, the described embodiments provide a system for positioning or locating a user interface relative to a user that also reduces the potential for problems associated with adhering adhesive tape to the user's skin.

[0538] It should be appreciated that numerous drawbacks and problems exist associated with repositioning interfaces, particularly infant interfaces. These include "snub nosing," superficial skin abrasions, or skin allergies from traditional taping techniques for applying user interfaces (e.g., nasal cannulae) to a user. Such problems also arise during the periodic application of different treatment options to a user and the traditional subsequent removal of headgear, tape, or user interface, followed by the installation of new equipment and user interface or interface-positioning headgear or other gear. Thus, providing a fastening system that, when applied to a user, is in a ready-to-use mode to accept a user interface would be a useful step forward toward reducing the problems users have previously faced. Furthermore, improving ease of installation, both in terms of complexity and time and effort required by a caregiver (e.g., a nurse), would be even more beneficial.

[0539] The fastening patch can be shaped or otherwise configured to accommodate the geometric or other characteristics of the user interface and / or associated user interface tubing. The illustrated fastening patch has a plurality of wings 661 that accommodate the user interface tubing and increase the contact surface of the fastening patch 660 exposed to the skin patch 650. The fastening patches illustrated in Figures 22 and 23 each have a pair of wings located at one end of the patch. The wings 661 are configured to secure to the skin patch on either side of the user interface and / or associated user interface tubing, reducing the likelihood of the fastening patch 660 bunching up around the interface and / or tubing.

[0540] The fixation patch 661 shown in Figure 22 also has tube end wings 661 configured to extend underneath the user interface tubing and secure to the skin patch 650 to join the ends of the fixation patch 660 together.

[0541] Both of these fixation system embodiments can be used to secure the tubing to any part of the patient's body. The embodiment shown in Figures 15-23 is configured to attach the user interface to the patient's face, specifically adjacent the user's upper lip and / or cheek. The illustrated fixation system is adapted for neonatal applications.

[0542] The user side of the skin patch 550, 650 preferably has a skin-friendly adhesive (such as a hydrocolloid) that adheres the patch to the user's skin so that application of the respective fastening system causes as little irritation as possible. The skin patch 550, 650 preferably has a sufficient surface area so that the adhesive and interface holding forces are distributed over an appropriate area of ​​the user's face to reduce localized pressure buildup.

[0543] The illustrated fastening system is particularly configured to receive and / or secure the nasal cannulae and associated tubing disclosed above. The tubing may extend from one side or both sides of the user's face. Additionally, the fastening system may be combined such that the user interface is secured to the skin patch by a two-part releasable attachment or coupling device and a fastening patch placed over the interface and / or tubing.

[0544] Although the present disclosure has been described with reference to specific embodiments, other embodiments apparent to those skilled in the art are also within the scope of the present disclosure. Accordingly, various changes and modifications may be made without departing from the spirit and scope of the present disclosure. For example, the location of various components may be changed as desired. Moreover, not all features, aspects, and advantages are necessarily required to practice the present disclosure. Accordingly, the scope of the present disclosure is intended to be defined solely by the following claims.

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

[0546] Positive features SP1. A corrugated medical tubing comprising: a tubular body defining a lumen extending between open terminal ends of the body; and an inner form enclosed within the lumen and providing support for the tubular body, the outermost periphery of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body.

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

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

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

[0550] SP5. The tube of any one of claims SP1-SP4, wherein the peaks of the corrugated tubular body are defined by the outermost perimeter of the inner form.

[0551] SP6. The tube of any one of claims SP1-SP5, wherein the valleys of the corrugated tubular body are defined by inwardly drawn portions of the tubular body drawn inward between the inner forms.

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

[0553] SP8. A tube as defined in any one of claims SP1 to SP7, wherein the inner form is one or a combination of a helical spring or spirally wound element, a helical framework or spirally wound rib, an annular disc, a ring, or a plurality of individual supports interconnected or interconnectable by one or more connecting links.

[0554] SP9. The tube of any one of claims SP1-SP8, wherein an inner form supports a tubular body defining a lumen therein.

[0555] SP10. The tube of any one of claims SP1-SP9, wherein the inner form is a framework or internal support structure that provides support for the tubular body.

[0556] SP11. The tube of any one of claims SP5-SP10, wherein the tubular body is substantially unsupported from the inner form at the valleys and supported by the inner form at the peaks.

[0557] SP12. The tube of any one of claims SP5-SP11, wherein the wall of the tubular body is suspended between adjacent peaks.

[0558] SP13. A tube according to any one of claims SP5 to SP12, wherein the tubular body is (preferably extruded from) a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubing.

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

[0560] SP15. The tube of any one of claims SP1-SP14, wherein the inner form is a spirally wound rib or ribbed element.

[0561] SP16. The tube of any one of claims SP1 to SP15, wherein the inner form is a spirally wound element having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, or about 1.1 mm to about 1.3 mm.

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

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

[0564] SP19. The tube of claim SP18, wherein the inner form is made of a medical grade material, preferably medical grade stainless steel.

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

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

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

[0568] SP23. The tubing of any one of claims SP1 to SP22, wherein the tubular body is (preferably extruded from) one or a combination of thermoplastic elastomer, polypropylene-based elastomer, liquid silicone rubber (LSR), or breathable thermoplastic polyurethanes, or breathable polyamides; more preferably, the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomer, or breathable thermoplastic elastomer, e.g., styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0569] SP24. The tube of any one of claims SP1-SP24, wherein the inner form is a plurality of rings spaced longitudinally along the lumen.

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

[0571] SP26. The tube of any one of claims SP1-SP25, wherein the inner form is one or more separate elements connected together.

[0572] SP27. The tubing of any one of claims SP1-SP26, wherein the inner form includes a plurality of reinforcing ribs regularly spaced along the lumen.

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

[0574] SP29. The tubing of claim SP28, wherein one turn of the helical reinforcing wire comprises one complete turn around the lumen of the tubing.

[0575] SP30. The tube of claim SP28, wherein one turn of the helical reinforcing wire comprises wire disposed between adjacent peaks of the inner form.

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

[0577] SP32. The tube of any one of claims SP1 to SP31, wherein a terminal end of the tube is integral with nasal prongs, the nasal prongs being configured to be inserted into the user's nostrils as a nasal interface for delivering respiratory gas to the user.

[0578] SP33. The tube of any one of claims SP1 to SP32, wherein the inner form is mesh.

[0579] SP34. The tube of any one of claims SP1 to SP33, wherein the inner form is a conductor suitable for heating or sensing properties of gas within the tube.

[0580] SP35. The tube of any one of claims SP1 to SP34, wherein the inner form is electrically conductive, preferably the inner form is an electrically powered heater.

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

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

[0583] SP38. The tube of any one of claims SP1 to SP37, wherein the tube is a breathing tube.

[0584] SP39. A tube according to any one of claims SP1 to SP38, wherein the ratio of the pitch of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold is from about 0.10 to about 0.50, more preferably from about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0585] SP40. A tube according to any one of claims SP1 to SP38, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter (e.g., the outermost diameter) of the inner mold is from about 0.02 to about 0.10, more preferably from about 0.05 to about 0.07, and most preferably the ratio is 0.06.

[0586] SP41. The tubing of any one of claims SP1 through SP38, wherein the ratio of corrugation depth to external (i.e., outer) tubing diameter is from about 0.05 to about 0.09.

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

[0588] SPM11. A method for manufacturing medical tubing, comprising: providing an inner form; extruding a tubular body around the inner form, the tubular body defining a lumen enclosing the inner form; A method comprising:

[0589] SPM12.i) applying a vacuum within (or to) the lumen, whereby the vacuum draws the tubular body radially inward of the lumen and of an outermost perimeter defined by the inner form, the outermost perimeter of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; or ii) applying stretch (or expansion) to at least a portion or region of the tubular body enclosing the inner form, whereby upon release of the stretch (or expansion), the stretched (or expanded) portion or region of the tubular body returns (or is allowed to retract) radially inward of an outermost perimeter defined by the lumen and the inner form, the outermost perimeter defining a plurality of alternating peaks and valleys along the length of the tubular body; or iii) A combination of i) and ii) The method of SPM11, further comprising:

[0590] SPM13. The method of claim SPM11 or SPM12, wherein the tubular body is provided by extrusion or by forcing material through a die head.

[0591] SPM14. A method according to any one of claims SPM11 to SPM13, wherein the tubular body is extruded around an inner former and a reduced pressure is applied in such a way that the inner surface of the tubular body becomes at least partially adhered or bonded to at least a portion of the inner former, preferably the reduced pressure is the difference between the pressure in the lumen and the pressure surrounding the tubular body, more preferably the pressure inside (or supplied to) the lumen is less than the pressure surrounding (or the pressure surrounding) the tubular body is greater than the pressure inside (or supplied to) the lumen.

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

[0593] SPM16. The method of any one of claims SPM11-SPM16, wherein reduced pressure is applied to or adjacent to the lumen formation.

[0594] SPM17. The method of claim SPM14, wherein a vacuum is applied at or adjacent to the die head.

[0595] SPM18. The method of claim SPM14, wherein the lumen is subjected to reduced pressure as it exits the extrusion die head.

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

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

[0598] SPM111. A method according to any one of claims SPM11 to SPM110 in which the peaks of the corrugated tubular body so formed are defined by the outermost periphery of the inner mould.

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

[0600] SPM113. The method of any one of claims SPM11 to SPM112, in which the inner form is a framework or internal support structure that provides support for the tubular body.

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

[0602] SPM115. The method of any one of claims SPM11 to SPM113, wherein the inner form is a mesh.

[0603] SPM116. Inner mould One or a combination of a helical spring or spirally wound element, a spirally wound framework or spirally wound rib, an annular disc, a ring or a plurality of individual supports interconnected or interconnectable by one or more connecting links; a method according to any one of claims SPM11 to SPM113.

[0604] SPM117. The method of any one of claims SPM11 to SPM116, in which the inner form provides or supports a lumen within the tube so formed.

[0605] SPM 118. The method of any one of claims SPM 111 to SPM 113 or SPM 117 in which the inner form is a spirally wound element having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, or about 1.1 mm to about 1.3 mm.

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

[0607] SPM 120. The method of claim SPM 118 or SPM 119, wherein the inner form is a spiral wound element, the element having a diameter of about 0.05 mm to 0.3 mm, or about 0.06 to about 0.29, or about 0.07 to about 0.28, or about 0.08 to about 0.27, or about 0.09 to about 0.26, or about 0.1 to about 0.25, or about 0.11 to about 0.24, or about 0.12 to about 0.23, or about 0.13 to about 0.24, or about 0.14 to about 0.23, or about 0.15 to about 0.22, or about 0.16 to about 0.24, or about 0.17 to about 0.23, or about 0.18 to about 0.22, or about 0.19 mm to about 0.21 mm.

[0608] SPM121. The method of claim SPM120, wherein the inner form is made of a medical grade material, preferably medical grade stainless steel.

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

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

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

[0612] SPM125. A method according to any one of claims SPM11 to SPM124, wherein the tubular body is (preferably extruded from) a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubing.

[0613] SPM 126. The method of any one of claims SPM 11 to SPM 125 wherein the tubular body is one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or any one or more combinations of breathable polyamides, more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, for example, styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, even more preferably a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0614] SPM127. A method according to any one of claims SPM11 to SPM126 in which the tubular body is a breathable tube or is formed of or from one or more breathable materials such as breathable thermoplastic polyurethanes or breathable polyamides.

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

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

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

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

[0619] SPM132. A method according to any one of claims SPM11 to SPM131, in which the tubular body so formed has flexibility as defined by passing the test for increase in flow resistance with bending according to ISO 5367:2000(E) (4th edition, 1 June 2000).

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

[0621] SPM134. A tube according to any one of claims SPM11 to SPM133, wherein the ratio of the pitch of the inner mould to the outer diameter (e.g. the outermost diameter) of the inner mould is from about 0.10 to about 0.50, more preferably from about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0622] SPM135. A tube according to any one of claims SPM11 to SPM134, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter (e.g., the outermost diameter) of the inner mold is from about 0.02 to about 0.10, more preferably from about 0.05 to about 0.07, and most preferably the ratio is 0.06.

[0623] SPM136. The tubing of any one of claims SPM11 to SPM135, wherein the ratio of corrugation depth to external (i.e., outer) tubing diameter is from about 0.05 to about 0.09.

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

[0625] SP21. A medical tubing comprising a tubular body defining a lumen extending between open terminal ends of the body, an inner former enclosed within the lumen and providing support for the tubular body, and a coating encapsulating the inner former and securing the inner former to the tubular body.

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

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

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

[0629] SP25. The medical tubing of any one of claims SP21-SP24, wherein the outermost periphery of the inner form defines a plurality of alternating peaks and valleys along the length of the tubular body.

[0630] SP26. The tube of claim SP25, wherein the peaks of the corrugated tubular body are defined by the outermost perimeter of the inner form.

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

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

[0633] SP29. A tube according to any one of claims SP21 to SP28, wherein the inner form is one or a combination of a helical spring or spirally wound element, a spirally wound framework or spirally wound rib, an annular disc, a ring, or a plurality of individual supports interconnected or interconnectable by one or more connecting links.

[0634] SP210. The tube of any one of claims SP21-SP29, wherein an inner form supports a tubular body defining a lumen therein.

[0635] SP211. The tube of any one of claims SP21 to SP210, wherein the inner form is a framework or internal support structure that provides support for the tubular body.

[0636] SP212. The tube of any one of claims SP25-SP27, wherein the tubular body is substantially unsupported from the inner form at the valleys and supported by the inner form at the peaks.

[0637] SP213. A tube according to any one of claims SP25 to SP27, wherein the wall of the tubular body is suspended between adjacent peaks.

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

[0639] SP215. The tube of any one of claims SP21 through SP214, wherein the inner form is a spirally wound rib or ribbed element.

[0640] SP216. The tube of any one of claims SP21 to SP215, wherein the inner form is a spirally wound strip and the coating encapsulates the strip.

[0641] SP217. The tubing of any one of claims SP21 through SP216, wherein the inner form is a spirally wound metal wire and the coating encapsulates the wire.

[0642] SP218. The tubing of any one of claims SP21 through SP217, wherein the coating provides a surface that readily bonds with the tubular body.

[0643] SP219. A tube according to any one of claims SP21 to SP218, wherein the inner form is a spirally wound element having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, or about 1.1 mm to about 1.3 mm.

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

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

[0646] SP222. The tubing of any one of claims SP21 to SP221, wherein the inner form is made of a medical grade material, preferably medical grade stainless steel.

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

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

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

[0650] SP226. A tube according to any one of claims SP21 to SP225, wherein the tubular body is one or a combination of (preferably extruded from) a thermoplastic elastomer, a polypropylene-based elastomer, one or more liquid silicone rubbers, or breathable thermoplastic polyurethanes, more preferably wherein the polymer is a polymer such as, but not limited to, polyolefins, a thermoplastic elastomer, or a breathable thermoplastic elastomer, e.g., a styrenic block copolymer, a copolyester elastomer, or a thermoplastic elastomer family such as a thermoplastic polyolefin elastomer or a thermoplastic polyurethane elastomer, even more preferably a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0651] SP227. The tubing of any one of claims SP21 through SP226, wherein the inner form is a plurality of rings spaced longitudinally along the lumen.

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

[0653] SP229. The tube of any one of claims SP21 through SP228, wherein the inner form is one or more separate elements connected together.

[0654] SP230. The tubing of any one of claims SP21 through SP229, wherein the inner form includes a plurality of reinforcing ribs regularly spaced along the lumen.

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

[0656] SP232. The tubing of claim SP231, wherein one turn of the helical reinforcing wire comprises one complete turn around the lumen of the tubing.

[0657] SP233. The tube of claim SP231, wherein one turn of the helical reinforcing wire comprises wire disposed between adjacent peaks of the inner form.

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

[0659] SP235. A tube as defined in any one of claims SP21 to SP234, wherein a terminal end of the tube is integral with nasal prongs, the nasal prongs being configured to be inserted into the user's nostrils as a nasal interface for delivering respiratory gas to the user.

[0660] SP236. The tube of any one of claims SP21 to SP235, wherein the inner form is mesh.

[0661] SP237. A tube as defined in any one of claims SP21 to SP236, wherein the inner form is a conductor suitable for heating or sensing properties of gas within the tube.

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

[0663] SP239. A tube as defined in any one of claims SP21 to SP238, wherein the inner form includes an electrically conductive member or an electrically powered heater or sensor (such as a flow or temperature or humidity or pressure sensor).

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

[0665] SP241. The tube of any one of claims SP21 to SP240, wherein the tube is a respiratory tube.

[0666] SP242. A tube according to any one of claims SP21 to SP241, wherein the ratio of the pitch of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold is from about 0.10 to about 0.50, more preferably from about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0667] SP243. A tube according to any one of claims SP21 to SP242, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter (e.g., the outermost diameter) of the inner mold is from about 0.02 to about 0.10, more preferably from about 0.05 to about 0.07, and most preferably the ratio is 0.06.

[0668] SP244. The tubing of any one of claims SP21 through SP243, wherein the ratio of corrugation depth to external (i.e., outer) tubing diameter is from about 0.05 to about 0.09.

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

[0670] STM21. A method of manufacturing medical tubing, comprising the steps of providing an inner former encapsulated in a coating; and providing a tubular body around the inner former, the tubular body defining a lumen enclosing the inner former, wherein the tubular body is provided around the inner former such that the coating and the inner surface of the tubular body bond together and the inner former remains encapsulated.

[0671] STM22. The method of claim STM21, wherein the step of providing an inner form includes the steps of providing an elongated form encapsulated in a coating suitable for application in medical tubing, and fabricating an inner form that provides a support for the medical tubing from the coated elongated form.

[0672] STM23. The method of claim STM22, in which the encapsulating coating is applied by immersing an uncoated elongated mold in a bath of coating material.

[0673] STM24. The method of claim STM23, wherein the bath comprises a molten polymer grade at a temperature above about 150°C.

[0674] STM25. The method of any one of claims STM22-STM24, wherein the inner mold is produced by spirally winding an elongated mold into a helical shape.

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

[0676] STM27.a) applying a vacuum within (or to) the lumen, whereby the vacuum draws the tubular body radially inward; or b) applying a stretch (or extension) to at least a portion or region of the tubular body that encloses the inner former, whereby upon release of the stretch (or extension), the stretched (or extended) portion or region of the tubular body returns (or is allowed to retract) radially inward; or c) a combination of a) and b) The method of any one of claims STM21 to STM26, comprising:

[0677] STM28. The method of claim STM27, wherein the tubular body is drawn radially inward of an outermost perimeter defined by the lumen and the inner form, the outermost perimeter defining a plurality of alternating peaks and valleys along the length of the tubular body to form a corrugated tube.

[0678] STM29. The method of any one of claims STM21-STM28, wherein the tubular body is provided by extrusion or by forcing material through a die head.

[0679] STM210. A method according to any one of claims STM21 to STM29, wherein the tubular body is extruded around an inner former and a reduced pressure is applied in such a way that the inner surface of the tubular body becomes at least partially adhered or bonded to at least a portion of the coating, preferably such that the reduced pressure creates a difference between the pressure in the lumen and the pressure around the tubular body, more preferably such that the pressure inside (or supplied to) the lumen is less than the pressure around (or the pressure around) the tubular body is greater than the pressure inside (or supplied to) the lumen.

[0680] STM211. The method of any one of claims STM21-STM210, wherein the tubular body is provided around the inner former at a temperature that bonds at least a portion of the coating to the tubular body.

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

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

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

[0684] STM215. The method of any one of claims STM21-STM214, wherein a reduced pressure is applied to or adjacent to the lumen formation.

[0685] STM216. The method of claim STM215, wherein a vacuum is applied at or adjacent to the die head.

[0686] STM217. The method of claim STM216, wherein the lumen is subjected to reduced pressure as it exits the extrusion die head.

[0687] STM218. The method of any one of claims STM21-STM217, wherein the tubular body is extruded simultaneously with the formation of the inner mold from the elongated mold.

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

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

[0690] STM221. The method of claim STM29 or STM220, wherein the valleys of the corrugated tubular body so formed are defined by inwardly drawn portions of the tubular body drawn inward between one or more inner forms.

[0691] STM222. The method of any one of claims STM21-STM221, wherein the inner form is a framework or internal support structure that provides support for the tubular body.

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

[0693] STM224. Inner Form One or a combination of a helical spring or spirally wound element, a spirally wound framework or spirally wound rib, an annular disc, a ring, or a plurality of individual supports interconnected or interconnectable by one or more connecting links, and the method of any one of claims STM21 to STM223.

[0694] STM225. The method of any one of claims STM21-STM224, wherein the inner form provides or supports a lumen within the tube so formed.

[0695] STM226. The method of any one of claims STM21 to STM225, wherein the inner mold comprises a spirally wound element having a pitch between adjacent turns of about 0.4 mm to about 2 mm, or about 0.5 to about 1.9, or about 0.6 to about 1.8, or about 0.7 to about 1.7, or about 0.8 to about 1.6, or about 0.9 to about 1.5, or about 1 to about 1.4, or about 1.1 mm to about 1.3 mm.

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

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

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

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

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

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

[0702] STM233. The method of any one of claims STM21 to STM232, wherein the tubular body is (preferably extruded from) a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubing.

[0703] STM234. The method of any one of claims STM21-STM233 wherein the tubular body is one or a combination of (preferably extruded from) any one or more of: one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes; more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers; even more preferably, a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

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

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

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

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

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

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

[0711] STM242. The method of claim STM241, in which a vacuum is applied to the lumen region of the extruded tubular body, whereby a continuous wall forms a corrugation around the inner form.

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

[0713] STM244. A tube according to any one of claims STM21 to STM243, wherein the ratio of the pitch of the inner mold to the outer diameter (e.g., outermost diameter) of the inner mold is from about 0.10 to about 0.50, more preferably from about 0.20 to about 0.35, and even more preferably about 0.28 or about 0.29.

[0714] STM245. A tube as defined in any one of claims STM21 to STM244, wherein the ratio of the inner mold diameter (e.g., the diameter of the actual inner mold element or member) to the outer diameter (e.g., the outermost diameter) of the inner mold is from about 0.02 to about 0.10, more preferably from about 0.05 to about 0.07, and most preferably the ratio is 0.06.

[0715] STM246. The tubing of any one of claims STM21 through STM245, wherein the ratio of corrugation depth to external (i.e., outer) tubing diameter is from about 0.05 to about 0.09.

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

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

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

[0719] ST33. The tube of claim ST31 or ST32, wherein the inner form is encapsulated in a coating, the coating securing the inner form to the tubular body.

[0720] STM31. A method for manufacturing medical tubing, comprising: 1. A method comprising the steps of: providing an inner form; providing a tubular body around the inner form, the tubular body defining a lumen enclosing the inner form; and i) applying a reduced pressure within (or to) the lumen; or ii) applying stretching (or expansion) to at least a portion or region of the tubular body enclosing the inner form; or iii) a combination of i) and ii).

[0721] STM32. The method of claim STM31, wherein a greater vacuum or a greater stretch (or distension) or a combination of both is applied such that upon application of the greater vacuum or upon release of the stretch (or distension), or both, the tubular body is drawn radially inward of the lumen along the length of the tubular body and of the outermost periphery defined by the inner form, and the outermost periphery of the inner form then defines a plurality of alternating peaks and valleys.

[0722] STM33. The method of claim STM31 or STM32, wherein the inner former is encapsulated in a coating and a tubular body is provided around the inner former such that the coating and the inner surface of the tubular body are bonded together and the inner former remains encapsulated.

[0723] TA1. A fastening system for a user interface and / or user interface tubing, comprising: 1. A fastening system including: a skin patch having a user side and an interface side, the skin patch defining a fastening area, the user side of the skin patch configured to be affixed or adhered to the skin of a user; and a fastening patch configured such that at least a portion of the fastening patch extends over the user interface and / or associated user interface tubing and is secured to the user interface side of the skin patch to secure the user interface to a user, wherein the fastening patch and the skin patch are configured such that the fastening patch can be contained within or surrounded by the fastening area of ​​the skin patch when the fastening system is applied to a patient along with a suitable or compatible user interface.

[0724] TA2. The anchoring system of claim TA1, wherein the surface area of ​​the skin patch is the same as or greater than the surface area of ​​the anchoring patch.

[0725] TA3. A fixation system as defined in claim TA1 or TA2 wherein the fixation patch is shaped or otherwise configured to accommodate geometric or other characteristics of the user interface and / or associated user interface tubing.

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

[0727] TA5. The fixation system of any one of claims TA1-TA4, wherein the fixation patch has a pair of wings disposed at one end of the patch, the wings configured to be fixed to the skin patch on either side of the user interface and / or associated user interface tubing.

[0728] TA6. The fixation system of any one of claims TA1-TA5, wherein the fixation patch has tube end wings that extend or are configured to extend under the user interface tubing and to adhere to the skin patch.

[0729] TA7. An anchoring system as described in any one of claims TA1-TA6, wherein the user side of the skin patch has a skin-friendly adhesive (e.g., hydrocolloid, etc.) that affixes or adheres the skin patch to the user's skin.

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

[0731] TA9. The fastening system of any one of claims TA1-TA8, wherein the skin patch is configured to stick or adhere to the face of the user.

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

[0733] TA11. A retention system as defined in any one of claims TA1 to TA10, wherein the retention system is configured to receive and / or secure nasal cannulae and / or associated tubing, the tubing extending from one or both sides of the user's face.

[0734] TA12. The securement system of any one of claims TA1 to TA11, wherein the securement system is configured for use with an infant or newborn.

[0735] TA13. The fixation system of any one of claims TA1-TA12, wherein the fixation system is configured for use with a cannula as further defined by any one or more of COM1-COM17, or COMM11-COMM19, or COM21-COM216.

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

[0737] COM1. A nasal cannula device comprising: at least one nasal prong having one or more gases outlets configured to be inserted into a user's nares and one or more gases inlets fluidly connected to the one or more gases outlets; and one or more corrugated gas delivery tubes, the tube including a tubular body defining a lumen and an inner form enclosed within the lumen, the inner form providing support for the tubular body, the outermost periphery of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; wherein the one or more gases inlets of the nasal prongs are integrally formed with a terminal end of the tube, whereby the tube lumen is fluidly connected to the one or more gases outlets of the nasal prongs.

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

[0739] COM3. A nasal cannula as defined in claim COM1 or COM2, wherein the nasal prongs are curved or otherwise shaped or configured to avoid the user's septum.

[0740] COM4. The nasal cannula of any one of claims COM1-COM3, wherein the nasal cannula has a substantially planar, flattened, or contoured backing configured to rest on the user's face, preferably as a stabilizer for the prongs in the user's nostrils.

[0741] COM5. A nasal cannula as claimed in claim COM4, ​​wherein one or more ribs extend between the front surface of the backing material and the cannula, the ribs providing a contact surface for tape or other suitable retaining device used to fasten or adhere the cannula to the user's face, preferably the tape including an adhesive portion or being an adhesive tape or contact adhesive tape.

[0742] COM6. A nasal cannula as defined in any one of claims COM1-COM5, wherein the two nasal prongs are integrally formed with a single corrugated delivery tube.

[0743] COM7. A nasal cannula as defined in any one of claims COM1 to COM6, wherein the cannula includes a pair of nasal prongs, each of which may be integrally formed with, attached (or attachable) to, or connected (or connectable) to a terminal end of a pair of one or more gas delivery tubes.

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

[0745] COM9. The nasal cannula of any one of claims COM1 to COM8, wherein the cannula device is formed from one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or any one or more combinations of breathable polyamides, more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, or breathable thermoplastic elastomers, e.g., styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, even more preferably a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0746] COM10. A user interface including a pair of nasal cannulas according to any one of claims COM1-COM9.

[0747] COM11. The user interface of claim COM3, wherein the nasal prongs of each nasal cannula are positioned adjacent to one another and the respective delivery tubes extend in opposite directions away from the nasal prongs.

[0748] COM12. The user interface of claim COM4 further including a harness, the harness extending between and connecting the nasal cannulas.

[0749] COM13. The nasal cannula of any one of claims COM1 to COM12, wherein the tube is a respiratory tube.

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

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

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

[0753] COM17. A nasal cannula according to any one of claims COM1 to COM16, wherein the cannula is a nasal cannula for an inant (or newborn).

[0754] COMM11. A method of manufacturing a nasal cannula, the method comprising the steps of providing an inner form, extruding a tubular body around the inner form, the tubular body defining a lumen enclosing the inner form, and attaching the nasal cannula thereto.

[0755] COMM12.i) applying a vacuum within (or to) the lumen, whereby the vacuum draws the tubular body radially inward of the lumen and an outermost perimeter defined by the inner form, the outermost perimeter of the inner form defining a plurality of alternating peaks and valleys along the length of the tubular body; or ii) applying stretch (or expansion) to at least a portion or region of the tubular body enclosing the inner form, whereby upon release of the stretch (or expansion), the stretched (or expanded) portion or region of the tubular body returns (or is allowed to retract) radially inward of an outermost perimeter defined by the lumen and the inner form, the outermost perimeter defining a plurality of alternating peaks and valleys along the length of the tubular body; or iii) A combination of i) and ii) The method of COMM11, further comprising:

[0756] COMM13. The method of claim COMM11 or COMM12, including the step of overmolding nasal prongs onto the terminal end of the tubular body.

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

[0758] COMM15. The method of any one of claims COMM11-COMM14, wherein the nasal cannula is a polymer, such as a thermoplastic polymer, preferably a polymer suitable for medical respiratory tubing.

[0759] COMM 16. The method of any one of claims COMM 11 -COMM 15, wherein the nasal cannula is molded from any one or more one or combination of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, or breathable polyamides, more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomer, one or more liquid silicone rubbers, or a breathable thermoplastic elastomer, for example, a styrenic block copolymer, a copolyester elastomer, or a thermoplastic elastomer family such as a thermoplastic polyolefin elastomer or a thermoplastic polyurethane elastomer, even more preferably a polymer with a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

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

[0761] COMM18. The method of any one of claims COMM11-COMM17, wherein a nasal cannula mold is provided, the mold capable of receiving the terminal end of the tube so formed by manufacturing the tubular body, such that upon operating the molding equipment, a nasal cannula is molded, a portion of which is overmolded onto the terminal end of the tube.

[0762] COMM19. The method of any one of claims COMM11-COMM18, wherein the nasal cannula device produced by the nasal cannula is in fluid communication with the terminal end of the tube so formed by manufacturing the tubular body.

[0763] COM21. A nasal cannula device comprising: at least one nasal prong configured to be inserted into a user's nares, the at least one nasal prong having one or more gases outlets and one or more gases inlets fluidly connected to the one or more gases outlets; and one or more gases delivery tubes, the tube including a tubular body defining a lumen and an inner form enclosed within the lumen, the inner form providing support for the tubular body; wherein the one or more gases inlets of the nasal prongs are integrally formed with a terminal end of the tube, whereby the tube lumen is fluidly connected to the one or more gases outlets of the nasal prongs.

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

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

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

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

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

[0769] COM27. A nasal cannula as defined in any one of claims COM21-COM26, wherein the two nasal prongs are integrally formed with a single corrugated delivery tube.

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

[0771] COM29. The nasal cannula of any one of claims COM21 to COM28, wherein the cannula device is formed from one or a combination of any one or more of one or more thermoplastic elastomers, one or more polypropylene-based elastomers, one or more liquid silicone rubbers, or one or more breathable thermoplastic polyurethanes, more preferably the polymer is a polymer such as, but not limited to, polyolefins, thermoplastic elastomers, breathable polyester elastomers, or breathable thermoplastic elastomers, e.g., styrenic block copolymers, copolyester elastomers, or thermoplastic elastomer families such as thermoplastic polyolefin elastomers or thermoplastic polyurethane elastomers, breathable polyester elastomers, even more preferably a polymer having a Shore A of about 30 to about 90, or about 30 to about 80, or about 30 to about 70, or about 30 to about 60, or about 30 to about 50, or about 30 to about 40, or about 30, or about 40, or about 50, or about 60, or about 70, or about 80, or about 90.

[0772] COM210. A user interface including a pair of nasal cannulas according to any one of claims COM221 through COM29.

[0773] COM211. The user interface of claim COM210, wherein the nasal prongs are positioned adjacent to one another and the respective delivery tubes extend in opposite directions away from the nasal prongs.

[0774] COM212. The user interface of claim COM211 further including a harness, the harness extending between and connecting the nasal cannulas.

[0775] COM213. The nasal cannula of any one of claims COM21-COM212, wherein the tube is a respiratory tube.

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

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

[0778] COM216. The nasal cannula of any one of claims COM21 through COM215, wherein the prongs are glued or otherwise attached to the tubing.

[0779] PWL1. A nasal cannula device including at least one nasal prong having a gases outlet configured to be inserted into a user's nostril and a gases inlet fluidly connected to the gases outlet, the at least one nasal prong including a backing material, the backing material configured to rest on a user's face, wherein a lip extends around at least a portion of the periphery of a posterior surface of the backing material, the posterior surface configured to receive or retain a user interface patch such that, in use, the user interface patch may be releasably attachable or connectable to or with a skin patch adhered to the user's face.

[0780] PWL2. The nasal cannula of claim PWL1, wherein the lip is a blocking wall.

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

[0782] PWL4. A nasal cannula as defined in any one of claims PWL1-PWL3, wherein the lip extends around at least an area substantially adjacent the prong associated with the backing material.

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

[0784] PWL6. A nasal cannula as defined in claim PWL5, wherein one or more individual lips are adjacent to, or join or overlap the lip portion.

[0785] PWL7. A nasal cannula as defined in any one of claims PWL1-PWL6, wherein the lip is an endless lip extending around the periphery of the rear surface of the backing material.

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

[0787] PWL9. A nasal cannula as defined in any one of claims PWL1-PWL8, wherein the backing material is a substantially planar, flat, or contoured (e.g., pre-formed, curved) backing material configured to rest against the user's face.

[0788] PWL10. A nasal cannula as defined in any one of claims PWL1-PWL9, wherein the backing material acts as a stabilizer for the prong(s) in the user's nostril(s).

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

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

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

[0792] PWL14. A user interface patch receivable or retainable on the rear surface of a backing material as defined by any one or more of claims PWL1 to PWL15. A nasal cannula as defined in any one of claims PWL1 to PWL13.

[0793] PWL15. A nasal cannula as defined in any one of claims PWL1 to PWL14, wherein the gas inlet of the cannula is in fluid communication with or in connection with a tube as defined by any one or more of SP1 to SP38, SPM11 to SPM133, SP21 to SP241, STM21 to STM243, ST31 to ST33, STM31 to STM33.

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

[0795] PWL17. An interface as defined in any one of claims PWL1-PWL16, wherein at least one or more lips include at least one outer peripheral lip portion and at least one inner peripheral lip portion, each of said lips being provided for contact with a user's face.

[0796] WP1. A portion of a releasable fastener includes a substrate portion supporting mechanical fasteners dispersed across its surface, the substrate portion being flexible but substantially inextensible, the substrate portion being divided into multiple areas by at least one slit or at least one slot such that the separate divided portions of the substrate can bend independently to substantially conform to a complex curved surface beneath the substrate.

[0797] WP2. The fastening system of WP1, wherein the substrate portion includes a plurality of slits or slots or both that together divide the substrate portion into a serpentine body.

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

[0799] WP4. The fastening system of any one of claims WP1-WP3, wherein a slit or slot of the plurality of slits or slots is curved.

[0800] WP5. A fastening system as defined in any one of claims WP1-WP3, wherein a plurality of the slits or slots are curved, and the curved slits or slots are arranged substantially parallel.

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

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

[0803] WP8. The fastening system of claim WP1, wherein the substrate portion is divided into portions by a spiral slit or slot.

[0804] WP9. The fastening system of claim WP1, wherein the substrate portion is divided into smaller portions by slits or slots arranged substantially concentrically.

[0805] WP10. The fastening system of claim WP9, wherein the center of the concentric circles is approximately at the center of the substrate portion.

[0806] WP11. The fastening system of claim WP1, wherein slits or slots divide the substrate portion into a plurality of islands, each connected to one or more adjacent islands by thin bridges.

[0807] WP12. The fastening system of claim WP1, wherein the substrate portion is divided into portions by an S-shaped slit.

[0808] WP13. The fastening system of claim WP1, wherein the substrate portion is divided into portions by a T-shaped slit.

[0809] WP14. The fastening system of any one of claims WP1 to WP13, wherein the substrate portion covers at least 70% of the area of ​​the skin patch.

[0810] WP15. A fastening system as defined in any one of claims WP1 to WP14, wherein the substrate portion extends at least 80% of the way within a boundary that defines a shortest path around the perimeter of the substrate.

[0811] WP16. A fixation system according to any one of claims WP1 to WP15, wherein the system may be used in conjunction with any one or more of the fixation systems TA1 to TA14, or the cannulas COM1 to COM17, or the cannulas PWL1 to PWL17, or the tubes SP1 to SP38, or SP21 to SP241, or ST31 to ST33.

Claims

1. 1. A skin patch as part of a fastening system for a user interface, comprising: a patient side and an interface side; a patient side of the skin patch is attachable to the skin of a user, and an interface side of the skin patch is provided with a first part of a two-part releasable attachment system, the first part being configured to be releasably connectable to a second part of the two-part releasable attachment system; the first part of the two-part releasable attachment system includes a substrate portion that is attached to the skin patch; the base portion has a first end and a second end that are opposed to each other in a longitudinal direction of the base portion, and a first edge and a second edge that extend between the first end and the second end and are opposed to each other in a direction perpendicular to the longitudinal direction; the substrate portion supports mechanical fasteners dispersed across its surface; the substrate portion is flexible but inextensible; The substrate portion is divided into a plurality of areas by at least one slit, Thus, the separate divided portions of the base material portion can bend independently, allowing the base material portion to conform to an underlying complex curved surface; the slits are arranged on the substrate portion such that a first set of at least one slit extends from the first edge of the substrate portion into the substrate portion and a second set of slits extends from the second edge of the substrate portion into the substrate portion, such that a path along the substrate portion from the first end to the second end without intersecting the slits is longer than a straight line extending from the first end to the second end; Skin patch.

2. The skin patch of claim 1 , wherein the two-part releasable attachment system comprises one of a hook and a loop.

3. The skin patch of claim 1 or 2, wherein the slits are curved.

4. The skin patch of claim 3 , wherein a plurality of the slits are curved, and the curved slits are arranged in parallel.

5. The skin patch of claim 1 or 2, wherein the slits are arranged in a herringbone pattern extending from the edge of the substrate portion.

6. The skin patch of claim 1 , wherein the substrate portion is divided into portions separated by serpentine slits.

7. The skin patch of claim 1 , wherein the substrate portion is divided into smaller portions by concentrically arranged slits.

8. The skin patch of claim 7 , wherein the centers of the concentric circles are approximately at the center of the substrate portion.

9. The skin patch of claim 1 , wherein the slits divide the substrate portion into a plurality of islands, each connected to one or more adjacent islands by bridges.

10. The skin patch of claim 1 , wherein the substrate portion is divided into portions by an S-shaped slit.

11. The skin patch of claim 1 , wherein the substrate portion is divided into portions by a T-shaped slit.

12. The skin patch of claim 1 , wherein the substrate portion covers at least 70% of the area of ​​the skin patch.

13. The skin patch of claim 1 , wherein the substrate portion extends at least 80% of the area within a boundary that defines a shortest path around the periphery of the substrate portion.

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