Breathing circuit components for respiratory equipment

Abstract

In one embodiment, a breathing circuit component is provided, the breathing circuit component including: an inlet; an outlet; and an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the wall including a diaphragm that allows water vapor to pass through but substantially prevents liquid water and breathing gas from passing through, wherein the diaphragm has a thickness of about 35 micrometers to 45 micrometers.

Description

[0001] This application is a divisional application of Chinese patent application No. PCT / NZ2017 / 050074, National Application No. 201780043006.9, filed on June 7, 2017, entitled "Breathing Circuit Component for Breathing Equipment". Technical Field

[0002] This invention relates to respiratory circuit components for respiratory devices, and more particularly to components such as respiratory gas tubing. Such respiratory gas tubing may include inhaled or exhaled gas tubing connected between an airflow controller and a patient interface, or multiple sections of such tubing. Such respiratory circuit components may include other parts of the respiratory circuit, such as tubing connectors, tubing adapters, catheter mounts, or shorter segments of the respiratory gas tubing for connecting between the patient interface and an inhaled gas tubing for delivering inhaled gas to the patient interface. This invention stems from work relating to respiratory gas tubing of the type described in our earlier patent applications US 2001054422 and US 20090126817, the entire contents of which are hereby incorporated herein by reference. Background Technology

[0003] In breathing apparatus, gases with high relative humidity levels are supplied and returned through relatively limited breathing gas tubing. Condensation buildup on the inner walls of this tubing is a common consequence of this high humidity. In the prior art, attempts have been made to mitigate the adverse effects of condensation by reducing the condensation level or by incorporating collection points within the breathing gas tubing to drain the condensate. Condensation is typically reduced by maintaining or increasing the temperature of the airflow and / or the tubing walls to decrease condensation formation.

[0004] Our earlier application, US 2001054422, describes a breathing circuit component including an inlet, an outlet, and an enclosing wall defining a gas passage between the inlet and the outlet. At least one area of ​​the wall is formed of a breathable material that allows water vapor to pass through the gas passage while substantially preventing the passage of liquid water and breathing gases. Such a breathing circuit component may include an inspiratory or expiratory portion of the breathing circuit.

[0005] Breathing gas tubing is used in respiratory systems to deliver breathing gases between a respiratory component (such as a ventilator, high-flow therapy device, or CPAP) and the patient. The breathing gas may be heated and / or humidified before being delivered to the patient to mimic the transformation that occurs when air enters the respiratory system. Breathing gas tubing in the form of inhalation gas tubing can deliver heated and / or humidified breathing gas directly to the patient interface, or in some cases, an additional (usually shorter) breathing gas tubing may be located between the inhalation gas tubing and the patient interface. The additional breathing gas tubing may be insulated and / or heated to reduce condensation formation within the breathing gas tubing. Breathable breathing gas tubing also prevents condensation formation within the breathing gas tubing. As used herein, the term "breathable" generally refers to a material that is permeable or highly permeable to water vapor and substantially impermeable to liquid water and large volumes of gas. As used herein, "breathable material" generally refers to a material that is highly permeable to water vapor and substantially impermeable to liquid water and large volumes of gas. In some embodiments, the breathable material may have a density greater than or equal to 500 g / m³. 2 Water vapor permeability over 24 hours (or around that value), measured according to the modified specification ASTM E 96-66 B, where: T 水 = 30°C; T 空气 = 21°C, relative humidity = 60%, air flow rate = 2 m / s (using the positive cup method). Permeability can be greater than 750 g / m³. 2 / 24 h, greater than 1000 g / m 2 / 24h, greater than 1500 g / m 2 / 24 h, greater than 2000 g / m 2 / 24 h, up to 3000 g / m 2 / 24 h, or greater than or equal to approximately 1900 g / m 2 / 24 h. Therefore, in some embodiments, the gas impermeability of the breathable material can be less than 200 ml*mm / m² / day / atmospheric pressure. The gas can be air, and the term "air" should be understood to mean a breathable gas consisting primarily of a combination of oxygen and nitrogen, with water vapor specifically excluded. Breathing circuit components and / or circuits suitable for use in this specification may conform to standards ASTM E 96-66 B, ISO 811, and / or EN ISO 9237.

[0006] The goal is to provide breathing circuit components that are as easy to use, as inconspicuous as possible, and as comfortable and reliable as possible. Gaining patient acceptance and satisfaction with multiple components of a breathing device can be challenging. It has been shown that patients who accept and are satisfied with a breathing device are more likely to continue using it and thus reliably receive the necessary treatment.

[0007] Breathing circuit components made of such breathable materials may have reduced durability and may be easily damaged by end users.

[0008] Undesirable noises can also occur during the use of existing breathing gas tubing, especially when it is moved, kinked, or bent. Such movement can cause a 'hissing' type of noise, which is undesirable. This is particularly relevant when the breathing gas tubing is being used by a relatively active, spontaneously breathing patient. Summary of the Invention

[0009] One object of the present invention is to provide a breathing circuit component that will at least partially improve upon the above, or at least provide a useful option for the public and / or medical professionals.

[0010] An alternative objective of at least one aspect of the invention is to provide a breathable breathing gas conduit that is more durable and / or produces less "rustling" noise during use.

[0011] According to a first aspect of the present invention, a breathing circuit component is provided, the breathing circuit component comprising:

[0012] Entrance;

[0013] exit;

[0014] And an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the wall comprising a membrane that allows water vapor to pass through but substantially prevents liquid water and breathing gases from passing through, wherein

[0015] The thickness of the diaphragm is approximately 35 to 45 micrometers.

[0016] In some embodiments, the thickness of the diaphragm is about 37 micrometers to 43 micrometers, or about 39 micrometers to 40 micrometers, or about 40 micrometers.

[0017] The diaphragm may contain a hydrophilic polyester material. In one example, the diaphragm is made of material marketed under the trademark Sympatex.

[0018] The breathing circuit component may be a breathing gas conduit, such as an inhalation or exhalation gas conduit, or a shorter section of such a breathing gas conduit. The breathing circuit component may include, for example, a conduit connector, a conduit adapter, or a tubing mount.

[0019] In an example of a breathing gas conduit, the conduit may include at least one helically wound polymer strip or band, a portion or all of which includes a diaphragm, with the corresponding edges of adjacent turns of the strip abutting or overlapping and bonded together to form an enclosing wall. Lateral reinforcements to prevent crushing may be provided, comprising helical reinforcing ribs disposed between adjacent turns of the strip or band at the abutting or overlapping edges. The pitch of the helical reinforcing ribs may range from about 3.5 mm to 5.5 mm, about 4.1 mm to 4.8 mm, and about 3.8 mm to 5.2 mm. In one embodiment, the pitch of the helical reinforcing rib may be about 4.5 mm. The width of the reinforcing rib may be between 1 mm and 3 mm, and in one example, about 2 mm. The height of the reinforcing rib may be between 0.5 mm and 2 mm, and in one example, about 1 mm. The reinforcing rib may comprise a thermoplastic material and is made of a polyester-based polymer material. Both the conduit wall and the reinforcing rib may comprise a polyester-based polymer, which improves the bonding between the conduit wall and the reinforcing rib. The reinforcing ribs can be made from a material sold under the trade name Arnitel® EM550. The polymer used for the reinforcing ribs can be mixed with pigments.

[0020] In another example, the lateral reinforcement may include a series of annular reinforcing ribs or bars distributed along the length of the breathing gas conduit.

[0021] The ratio of the reinforcing rib pitch to the diaphragm wall thickness in the breathing gas conduit can range from 1:0.0080 to 1:0.0128, from 1:0.0080 to 1:0.0118, and in one embodiment, it is 1:0.0088. Based on these ratios and the non-limiting values ​​provided above for the reinforcing rib pitch, the diaphragm wall thickness can be between 35 micrometers and 45 micrometers, 37 micrometers and 43 micrometers, 39 micrometers and 40 micrometers, or 40 micrometers.

[0022] In some instances, the length of the gas passage between the inlet and outlet can range from approximately 310 mm to 410 mm. The length of the gas passage between the inlet and outlet can be approximately 370 mm, and is typically in the range of 360 mm to 380 mm.

[0023] The inner diameter of the breathing gas conduit can be in the range of 10 mm to 15 mm, or 11.4 mm to 12.2 mm, and in one example it is 11.8 mm.

[0024] Breathing gas tubing may include longitudinal reinforcements to resist tension on the breathing gas tubing.

[0025] The breathing gas conduit may include a heating wire extending along, through, or wound around a gas passage. The heating wire may, for example, be embedded in a spiral reinforcing rib or ribbed structure. More than one heating wire may be provided.

[0026] A breathing gas conduit may include a sensing wire extending along, through, or wound around a gas passage. The sensing wire may, for example, be embedded in a helical reinforcing rib or ribbed structure. More than one sensing wire may be provided. The breathing gas conduit may also include one or more sensors in communication with one or more sensing wires.

[0027] Breathing circuit components can have walls formed entirely of diaphragms.

[0028] The breathing circuit component can resist stretching forces of up to about 30 Newtons and / or at least 15 to 30 Newtons in the longitudinal direction (i.e., in the direction of the longitudinal axis of the gas passage) without permanent deformation. In another embodiment of the invention, the breathing circuit resists stretching forces of up to about 25 Newtons in the longitudinal direction.

[0029] The breathing circuit component can withstand a force of up to about 15 Newtons and / or at least 10 to 15 Newtons applied in the lateral direction (i.e., in the direction transverse to the longitudinal axis of the gas passage) without breaking. In another embodiment of the invention, the breathing circuit component resists a force of about 13 Newtons applied in the lateral direction.

[0030] In another aspect of the invention, the breathing circuit component may include an inlet, an outlet; and an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the wall including a diaphragm that allows water vapor to pass through but substantially prevents liquid water and breathing gas from passing through; wherein the breathing circuit component resists a stretching force of up to about 30 Newtons in the longitudinal direction (i.e., in the direction of the longitudinal axis of the gas passage) without permanent deformation.

[0031] The breathing circuit component can resist a stretching force of at least 15 to 30 Newtons in the longitudinal direction (i.e., in the direction of the longitudinal axis of the gas passage) without permanent deformation. In another embodiment of the invention, the breathing circuit component resists a stretching force of up to about 25 Newtons in the longitudinal direction.

[0032] In another aspect of the invention, the breathing circuit component may include an inlet, an outlet, and an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the wall including a diaphragm that allows water vapor to pass through but substantially prevents liquid water and breathing gas from passing through, wherein the breathing circuit component resists a force of up to about 15 N applied in a lateral direction (i.e., in a direction transverse to the longitudinal axis of the gas passage) without breaking.

[0033] The breathing circuit component can withstand a force of 10 to 15 Newtons applied in the lateral direction (i.e., in the direction transverse to the longitudinal axis of the gas passage) without breaking. In another embodiment of the invention, the breathing circuit component resists a force of approximately 13 Newtons applied in the lateral direction.

[0034] The breathing circuit may also include reinforcing elements, such as reinforcing ribs or stiffeners, which support and reinforce the enclosing wall, wherein the breathing circuit component resists forces of up to about 15 Newtons applied in the lateral direction (i.e., in the direction transverse to the longitudinal axis of the gas passage) without the breathing circuit component being delaminated, which would cause the reinforcing element to separate from the enclosing wall.

[0035] The enclosing wall of the breathing circuit component can define a gas passage, which is entirely composed of a breathable diaphragm.

[0036] In another aspect of the invention, a breathing gas conduit for a breathing device is provided, the breathing gas conduit comprising: an inlet; an outlet; and an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the wall comprising a diaphragm that allows water vapor to pass through but substantially prevents liquid water and breathing gas from passing through; wherein the thickness of the diaphragm is about 35 micrometers to 45 micrometers.

[0037] The thickness of the diaphragm can be approximately 37 to 43 micrometers, 39 to 40 micrometers, or 40 micrometers.

[0038] In one aspect of the invention, a breathing gas conduit for a breathing device is provided, the breathing gas conduit comprising: an inlet; an outlet; an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the wall comprising a diaphragm that allows water vapor to pass through but substantially prevents liquid water and breathing gas from passing through, the diaphragm having a certain diaphragm wall thickness; and reinforcing ribs or stiffeners spirally wound on the enclosing wall, the reinforcing ribs having a reinforcing rib pitch being the distance between adjacent turns of the reinforcing rib; wherein the ratio of the reinforcing rib pitch to the diaphragm wall thickness of the breathing gas conduit is in the range of 1:0.0080 to 1:0.0128.

[0039] The ratio of the reinforcing rib pitch to the diaphragm thickness can be in the range of 1:0.0080 to 1:0.0118 and / or 1:0.0088.

[0040] In another aspect of the invention, a breathing gas conduit kit for a breathing device is provided, the kit comprising: a breathing gas conduit having an inlet, an outlet, and an enclosing wall defining a gas passage between the inlet and the outlet; a conduit connector configured to connect to the inlet or the outlet; and a breathing circuit component of the various embodiments described above, wherein the breathing circuit component is configured to connect to the breathing gas conduit via the conduit connector.

[0041] The breathing gas tubing kit may also include a patient interface, which is any of the following:

[0042] a) A full-face mask, which includes a mask frame and padding configured to seal around the patient's nose and mouth;

[0043] b) A face mask, comprising a mask frame and a pad configured to seal around the patient's mouth;

[0044] c) A nasal mask, which includes a mask frame and a soft pad configured to seal around the patient's nose.

[0045] d) A nasal cannula having one or more pins for insertion into a patient's nostril;

[0046] e) A nasal mask, comprising one or more nasal pillows configured to seal against the patient's nose; and

[0047] f) A hybrid mask comprising a combination of a nose pillow / insert and a mouth seal.

[0048] g) Endotracheal tubes; and

[0049] h) Tracheostomy interface.

[0050] The breathing gas duct kit may also include a humidification chamber configured to humidify the breathing gas.

[0051] In another aspect of the invention, a breathing device is provided for delivering a breathable gas stream to a patient, the breathing device comprising: a humidifier configured to humidify a breathable gas stream received from a gas source; and a breathing circuit component as described above, the breathing circuit component being configured to be in fluid communication with the humidifier.

[0052] The breathing device may also include a blower configured to generate a flow of breathable gas.

[0053] The breathing system may also include an inhalation gas conduit configured to connect the humidifier to the breathing circuit components. The inhalation gas conduit may also include a heater element configured to heat the gas flowing through it.

[0054] The breathing device may also include a patient interface configured to be in fluid communication with breathing circuit components to deliver breathable gas to or from a patient. The patient interface may be any of the following:

[0055] a) A full-face mask, which includes a mask frame and padding configured to seal around the patient's nose and mouth;

[0056] b) A face mask, comprising a mask frame and a pad configured to seal around the patient's mouth;

[0057] c) A nasal mask, which includes a mask frame and a soft pad configured to seal around the patient's nose.

[0058] d) A nasal cannula having one or more pins for insertion into a patient's nostril;

[0059] e) A nasal mask, comprising one or more nasal pillows configured to seal against the patient's nose; and

[0060] f) A hybrid mask comprising a combination of a nose pillow / insert and a mouth seal.

[0061] g) Endotracheal tubes; and

[0062] h) Tracheostomy interface.

[0063] In another aspect of the invention, a breathing circuit component kit is provided, the kit comprising:

[0064] a) The breathing circuit components as described above; and

[0065] b) Patient interface.

[0066] The patient interface can be any of the following:

[0067] a) A full-face mask, which includes a mask frame and padding configured to seal around the patient's nose and mouth;

[0068] b) A face mask, comprising a mask frame and a pad configured to seal around the patient's mouth;

[0069] c) A nasal mask, which includes a mask frame and a soft pad configured to seal around the patient's nose.

[0070] d) A nasal cannula having one or more pins for insertion into a patient's nostril;

[0071] e) A nasal mask, which includes one or more nasal pillows configured to seal against the patient's nose;

[0072] f) A hybrid mask comprising a combination of a nose pillow / insert and a mouth seal;

[0073] g) Endotracheal tubes; and

[0074] h) Tracheostomy interface.

[0075] The breathing circuit component kit may also include any one or more of the following:

[0076] a) A lanyard, which is configured to be attached to or near the first end of the breathing circuit component;

[0077] b) A pipe connector configured to connect a first end of the breathing circuit component to an inhalation gas duct;

[0078] c) An inhalation gas conduit configured to deliver inhaled gas to the patient interface via the breathing circuit component;

[0079] d) A humidifier configured to humidify breathing gases before delivering those gases to the patient interface; and / or

[0080] e) A gas source configured to supply an inhaled gas flow to the patient interface via the breathing circuit component.

[0081] The intake duct may include a heating element configured to heat the gas as it flows along the intake duct.

[0082] At least the humidifier and the gas source can be integrated, so that the humidifier and the gas source are housed in a single housing.

[0083] Throughout this specification and claims, it should be understood that a material that allows water vapor to pass through but substantially impermeable to liquid water and breathable gases can be described as a "breathable" material. A material can be breathable due to its composition, physical structure, or a combination thereof. As used herein, the term "breathable" generally refers to a material that is highly permeable to water vapor and substantially impermeable to liquid water and large volumes of gas. As used herein, "breathable material" generally refers to a material that is highly permeable to water vapor and substantially impermeable to liquid water and large volumes of gas. In some embodiments, the breathable material may have a density greater than or equal to 500 g / m³. 2 Water vapor permeability over 24 hours (or around that value), measured according to the modified specification ASTM E 96-66 B, where: T 水 = 30°C; T 空气 = 21°C, relative humidity = 60%, air flow rate = 2 m / s (using the positive cup method). Permeability can be greater than 750 g / m³. 2 / 24 h, greater than 1000 g / m 2 / 24 h, greater than 1500 g / m 2 / 24 h, greater than 2000 g / m 2 / 24 h, up to 3000 g / m 2 / 24 h, or greater than or equal to approximately 1900 g / m 2 / 24h. Therefore, in some embodiments, the gas impermeability of the breathable material can be less than 200 ml*mm / m² / day / atmospheric pressure. The gas can be air, and the term "air" should be understood to mean a breathable gas consisting primarily of a combination of oxygen and nitrogen, with water vapor specifically excluded. Typically, breathing circuit components and / or circuits suitable for use in this specification may conform to standards ASTM E 96-66 B, ISO 811, and / or EN ISO 9237.

[0084] For example, the length of the gas passage between the inlet and outlet can be in the range of approximately 310 mm to 410 mm, or 360 mm to 380 mm, and in one instance is 370 mm.

[0085] Those skilled in the art will recognize that the term "respiratory system" as used herein can refer to any system suitable for delivering breathing gases to a patient, such as, but not limited to, oxygen, carbon dioxide, air, and / or any combination of breathing gases suitable for delivery to a patient. Similarly, it should be recognized that the patient may be receiving any type of therapy, such as, but not limited to, high-flow therapy (HFT), such as nasal high-flow therapy (NHFT), for the treatment of obstructive sleep apnea (OSA), invasive ventilation (INV), or non-invasive ventilation (NIV).

[0086] Such a respiratory system may include one or more respiratory components, which may refer to, but are not limited to, a gas source, an airflow generator, a humidification device, a humidification chamber, or medical tubing.

[0087] As used herein, breathing gas conduits may refer to gas conduits, such as, but not limited to, inhalation gas conduits, exhalation gas conduits, or interface gas conduits connecting breathing components to the patient interface.

[0088] As described herein, a gas source can refer to a device that supplies one or more gases to a respiratory system so that the gases can be delivered to a patient. The gas source can be, for example, but not limited to, ambient air, a wall source, or a gas canister. Those skilled in the art will further recognize that an airflow generator, as described herein, can refer to any device suitable for delivering airflow to a respiratory system, such as, but not limited to, ventilators, blowers, air compressors, etc. In some cases, the airflow generator can be integrated with a humidification device. In some cases, the gas source can be located remotely from the respiratory system, which includes a suitable gas inlet port configured for connection to a remote gas source.

[0089] Further aspects of the invention should be considered in light of all its novel aspects, which will become apparent from the following description.

[0090] Unless the context clearly requires otherwise, the words “including”, “contains”, etc., throughout this specification shall be understood to have an inclusive meaning (as opposed to an exclusive or exhaustive meaning), that is, to mean “including but not limited to”.

[0091] While the invention has been described by way of example and with reference to its possible embodiments, it should be understood that modifications or improvements can be made to the invention without departing from its scope. The invention can also be broadly described as existing in the parts, elements, and features individually or collectively mentioned or indicated in the specification of this application, and in any or all combinations of two or more of said parts, elements, or features. Furthermore, where specific parts or the whole of the invention with known equivalents are mentioned, such equivalents are incorporated herein as if described separately.

[0092] Any discussion of the prior art throughout this specification should in no way be construed as an admission that such prior art is widely known or forms part of common general knowledge in the art. Attached Figure Description

[0093] A preferred embodiment of the invention will now be described with reference to the accompanying drawings, in which:

[0094] Figure 1 This is a schematic cross-sectional view of a single-walled breathing gas conduit constructed and operated according to an embodiment of the present invention, which is formed by applying reinforcing ribs to an overlapping spirally wound thin film layer forming the conduit wall;

[0095] Figure 2 It is used to form Figure 1 A plan view of the breathing gas duct forming device;

[0096] Figure 3 This is a perspective view of a breathing gas conduit constructed and operated according to an embodiment of the present invention;

[0097] Figure 4 yes Figure 3 A side view of the breathing gas duct;

[0098] Figure 5 yes Figure 3 and Figure 4 A schematic cross-sectional view of the wall of the breathing gas duct;

[0099] Figure 6 This is a perspective view of a short breathing gas conduit constructed and operated according to an embodiment of the present invention, the short breathing gas conduit being connected between an inhalation gas conduit and a patient interface including a nasal cannula;

[0100] Figure 7 This is a front view of another patient interface, showing... Figure 6 Short breathing tubes;

[0101] Figure 8This is a perspective view of a short breathing gas conduit constructed and operated according to another embodiment of the present invention, the short breathing gas conduit being connected between an inhaled breathing gas conduit and a patient interface including a tracheostomy interface.

[0102] Figure 9 This is a cross-sectional view of a breathing gas conduit according to an embodiment of the present invention;

[0103] Figure 10 It is a cross-sectional view of a segment of the wall of a breathing gas conduit according to one possible construction;

[0104] Figure 11 This is a cross-sectional front view of a coaxial breathing circuit incorporating a breathing gas conduit, constructed and operated according to yet another embodiment of the present invention.

[0105] Figure 12 yes Figure 11 A side front view of a partial cross-section of the coaxial breathing circuit;

[0106] Figure 13 This is a schematic cross-sectional view of a branch for a breathing circuit according to yet another variation of the invention;

[0107] Figure 14 This is a schematic cross-sectional view of a catheter mounting component incorporating the breathing circuit components of the present invention;

[0108] Figure 15 It is a graph showing the acoustic test results between a breathing gas conduit constructed and operated according to an embodiment of the present invention and a breathing gas conduit known in the art;

[0109] Figure 16 This is a plan view of a breathing gas conduit according to an embodiment of the present invention, which is installed for testing on a sound test bench;

[0110] Figure 17 This is a side view of a breathing gas conduit constructed and operated according to an embodiment of the present invention, the breathing gas conduit being connected between a patient interface and a blower / humidifier unit; and

[0111] Figure 18A and Figure 18B This is a schematic cross-sectional view of different configurations of a single-walled breathing gas conduit and spiral reinforcing ribs constructed and operated according to another embodiment of the present invention. Detailed Implementation

[0112] According to the present invention, a breathing circuit component is provided, at least a portion of which comprises a breathable material. The breathing circuit component may include a breathing gas conduit, such as an entire inhalation or exhalation gas conduit, or a shorter length or portion of the conduit. "Short" means shorter than the inhalation or exhalation gas conduit. For example, the length of the gas passage between the inlet and outlet may range from about 310 mm to 410 mm, or from about 360 mm to 380 mm, and in one embodiment is 370 mm.

[0113] In one embodiment, the breathing circuit component may include a short breathing gas tubing, one end of which is configured to connect to a patient interface. The breathing circuit component may include a mask adapter configured to connect between the patient interface and the breathing gas tubing. The other end of the short breathing gas tubing may include or be provided with a tubing connector for connecting to the gas tubing. Therefore, the breathing circuit component can be packaged and sold as a component or kit including the tubing connector, the short breathing gas tubing, and the patient interface (optionally including a lanyard and / or mask connector). The patient interface may include any of the following:

[0114] a) A full-face mask, which includes a mask frame and padding configured to seal around the patient's nose and mouth;

[0115] b) A face mask, comprising a mask frame and a pad configured to seal around the patient's mouth;

[0116] c) A nasal mask, which includes a mask frame and a soft pad configured to seal around the patient's nose.

[0117] d) A nasal cannula having one or more pins for insertion into a patient's nostril;

[0118] e) A nasal mask, which includes one or more nasal pillows configured to seal against the patient's nose;

[0119] f) A hybrid mask comprising a combination of a nose pillow / insert and a mouth seal;

[0120] g) Endotracheal tubes; and

[0121] h) Tracheostomy interface.

[0122] In an alternative embodiment, the breathing circuit component may include a tubing connector or adapter to which a breathing gas conduit (such as an inhalation or exhalation gas conduit) may be connected.

[0123] The breathing circuit component may primarily include an inlet, an outlet, and an enclosing wall defining a gas passage between the inlet and the outlet. At least one section of the wall includes a diaphragm made of a breathable material. The breathing circuit component can be configured to allow water vapor to pass through while substantially preventing the passage of liquid water and breathing gases.

[0124] As used herein, the term "breathable" generally refers to a material that is highly permeable to water vapor and substantially impermeable to liquid water and large volumes of gas. As used herein, "breathable material" generally refers to a material that is highly permeable to water vapor and substantially impermeable to liquid water and large volumes of gas. In some embodiments, the breathable material may have a density greater than or equal to 500 g / m³. 2 The water vapor permeability over 24 hours (or around that value), measured according to the modified specification ASTM E96-66 B, where: T 水 = 30°C; T 空气 = 21°C, relative humidity = 60%, air flow rate = 2 m / s (using the positive cup method). Permeability can be greater than 750 g / m³. 2 / 24 h, greater than 1000 g / m 2 / 24 h, greater than 1500 g / m 2 / 24 h, greater than 2000 g / m 2 / 24 h, up to 3000 g / m 2 / 24 h, or greater than or equal to approximately 1900 g / m 2 / 24 h. Therefore, in some embodiments, the gas impermeability of the breathable material can be less than 200 ml*mm / m² / day / atmospheric pressure. The gas can be air, and the term "air" should be understood to mean a breathable gas consisting primarily of a combination of oxygen and nitrogen, with water vapor specifically excluded. Typically, breathing circuit components and / or circuits suitable for use in this specification can conform to standards ASTM E 96-66 B, ISO 811, and / or EN ISO 9237.

[0125] The thickness of the diaphragm can be from about 35 micrometers to 45 micrometers. In one embodiment, the breathing circuit component resists a stretching force of up to 30 N and at least in the range of 20 N to 30 N in the longitudinal direction (i.e., in the direction of the longitudinal axis of the gas passage) without permanent deformation. In one embodiment of the invention, the breathing circuit component resists a stretching force of about 25 N in the longitudinal direction. In one embodiment, the breathing circuit component resists a longitudinal tensile force of up to 55 N and at least between 45 N and 55 N before breaking along the longitudinal axis of the component. In one embodiment of the invention, the breathing circuit component resists a longitudinal tensile force between 49 N and 54 N, and in one embodiment about 52 N. In one embodiment, the breathing circuit component resists a force applied in the lateral direction (i.e., in the direction transverse to the longitudinal axis of the gas passage) in the range of 11.5 N to 13.5 N, in one embodiment in the range of 12 N to 13 N, and in one embodiment about 12.5 N without breaking (e.g., due to puncture or delamination).

[0126] In examples of breathing circuit components including diaphragms reinforced and / or supported by helical reinforcing ribs or ribs, a delamination test is performed by applying force to the diaphragm in a lateral direction until the diaphragm breaks or "delaminates" from the reinforcing ribs. The applied force is applied laterally by forcing a probe into the diaphragm a predetermined distance. During the test, the peak force is displayed by a force gauge that is part of the test apparatus. If the obtained force exceeds a predetermined set value, indicating that yielding in the breathable membrane has occurred before any delamination, the test passes.

[0127] The breathing gas conduit may include at least one helically wound polymer strip or band, a portion or all of which forms a diaphragm, with the corresponding edges of adjacent turns of the strip abutting or overlapping and bonding to form an enclosing wall. The breathing gas conduit may include lateral reinforcements to resist deformation of the conduit, such as helical reinforcing ribs disposed between adjacent turns of the strip at the abutting or overlapping edges, or a series of annular reinforcing ribs or ribs distributed along the length of the conduit. The reinforcing ribs may be formed of a thermoplastic material, such as, but not limited to, polyester-based polymers. Both the strip or band and the reinforcing ribs may be made of polyester-based polymers, which improves the bonding between them. The reinforcing ribs may be made of a material sold under the trade name Arnitel® EM550.

[0128] Breathing gas tubing may further or alternatively include longitudinal reinforcements to resist tension on the breathing gas tubing.

[0129] See Figure 1An example method for manufacturing a single-walled breathing gas conduit is shown, comprising a breathing circuit component including a breathing gas conduit 1. This method may be particularly suitable for thin-walled conduits. A membrane 6 is arranged in a spiral or helical shape such that the edge portions of adjacent layers overlap, forming the wall of the breathing gas conduit 1. A reinforcing element, comprising a polymer reinforcing rib 3, is inserted between the overlapping edges of adjacent loops of the membrane 6. This reinforcing element combines with the overlapping portion of the membrane 6 to seal the joint between loops and form a continuous breathing gas conduit 1. A seam is formed between the edge 5 of the first layer of the membrane 6 and the edge 7 of the second adjacent layer of the membrane 6, which is laid on top of the reinforcing rib when the polymer reinforcing rib 3 melts. Because the overlapping layers of the membrane are very thin, they follow the contour of the reinforcing rib 3 very closely, resulting in a smooth inner conduit wall. Figure 18A In another embodiment of the invention shown, the reinforcing ribs 3 are not inserted between the overlapping edges of adjacent loops of the membrane 6, but are disposed on both layers. More specifically, the membrane 6 is first arranged in a spiral or helical shape such that the edge portions of adjacent layers overlap. Then, the reinforcing ribs 3 of polymer material are disposed on the overlapping edges of the membrane 6 to form a breathing gas circuit.

[0130] like Figure 1 As is evident, the reinforcing rib 3 has a softened 'D' shape or semicircle, with the flat side of the 'D' located on the inside. This particular shape ensures that the inner surface of the wall of the breathing gas conduit 1 is substantially flat, thereby minimizing flow resistance. The reinforcing rib 3 can be extruded as a circle (i.e., the die of the extrusion device can have a circular cross-section) and inserted between / on the overlapping edges of the film 6. When the reinforcing rib 3 is helically drawn into / on the film structure 6 and after cooling, the reinforcing rib typically acquires its 'D' shape or semicircle. Those skilled in the art will recognize that the shape of the reinforcing rib 3 is not limited to this particular shape, but any suitable profile shape can be used, such as, but not limited to, circular, elliptical, "pill-shaped," and variations of the D shape. Figure 18B These different shapes / variations of the reinforcing ribs are shown.

[0131] Those skilled in the art will further recognize that, although Figure 1The breathing gas circuit 1 is formed as a single helix or spiral shape, but any other suitable configuration is possible. For example, but not limited to, the breathing gas circuit 1 can be formed as a double helix structure of the membrane 6 and include two reinforcing ribs. In addition and / or alternatively, the breathing gas circuit 1 can include one or more heating wires or sensing wires. These wires can be disposed within and / or outside the gas channel formed by the wall of the breathing gas circuit 1. In another embodiment, one or more wires can be combined in the reinforcing ribs. In another embodiment where the breathing gas circuit is formed as a double helix structure, each reinforcing rib can include a single wire.

[0132] It will also be further appreciated that, in all the different variations and / or configurations provided above and below in this specification, the spiral reinforcing rib is provided as a reinforcing member / reinforcing element that is not part of the wall and / or diaphragm.

[0133] In examples where the breathing circuit component is a breathing gas tubing, this tubing can take various forms, but typically includes a breathable diaphragm that defines a passage for water vapor flow. Water vapor is allowed to diffuse through the diaphragm wall before it has a chance to condense into liquid water within the breathing gas tubing. This prevents condensation buildup on the inside of the breathing gas tubing, eliminating the need for a condensate collector in the breathing gas tubing or for clinician intervention to remove condensate from the breathing gas tubing. When the breathing gas tubing is connected to a patient interface, preventing condensation buildup on the inside of the breathing gas tubing also prevents, or at least reduces, the formation of condensate in the patient interface or on the patient's skin.

[0134] A breathable or partially breathable membrane that allows water vapor to pass through can constitute all or part of a breathing circuit component. Therefore, water vapor can only diffuse from a selected portion of the airflow passage defined by the breathing circuit component.

[0135] The diaphragm may be supported or partially supported and / or reinforced by one or more ribs or stiffeners spirally wound inside or outside the diaphragm. The stiffeners may be made of metal or polymer, or a combination of both. The stiffeners may include one or more conductive elements for heating the conduit and / or connecting to one or more sensors. Sensors for determining gas properties (such as temperature, flow rate, humidity, gas concentration, or pressure) may be embedded in the stiffeners or diaphragm of the breathing gas conduit, or may be provided at or connected to one or both ends of the breathing gas conduit.

[0136] Figure 2 Examples of forming equipment suitable for manufacturing breathing circuit components, such as breathing gas conduits according to the above embodiments of the present invention, are shown.

[0137] The device includes a forming unit 15 having a plurality of rotating rods arranged around a central support rod. These rotating rods extend from and are rotated by a gearbox within a machined positioning block 16. These rotating rods follow a helical path at least in the pipe forming zone. The pitch angle of these rotating rods relative to the support rod controls the pitch angle of the formed breathing gas pipe.

[0138] The breathing gas conduit formed on the forming device is rotated by the movement of a rotating rod and advanced in the direction of arrow 17. The advancing speed of the forming device is selected relative to the rotational speed such that the pitch of the strip or helix laid onto the forming device 15 is slightly smaller than the width of the strip, so that adjacent turns overlap tightly. The first extruder 18 extrudes a strip 19 of thin-film polymer material. The strip 19 is deposited on the forming device in a helical manner under the action of the forming device 15. The pitch of the helix of the strip 19 is slightly smaller than the width of the strip 19. The helical deposition of the strip 19 forms the wall 20 of the breathing gas conduit. The second extruder 21 extrudes reinforcing ribs 22 of polymer material. The molten reinforcing ribs 22 are deposited between the overlapping portions of adjacent turns of the strip 19 and are sufficiently heated to weld to the strip of the strip 19. Applying molten reinforcing ribs between the overlapping layers of the strip can improve the weld quality because the two layers of the strip to be welded are in physical contact with the molten reinforcing ribs. The quality of the surface finish of the inner surface of the breathing gas duct is important because a rough inner surface can impede gas flow and cause more condensate to accumulate in the duct. The above-described construction technique is particularly suitable for ducts made of membrane. During manufacturing, the membrane can conform to the shape of the raised ribs of the applied molten reinforcing ribs 22. By very tightly overlapping and wrapping the membrane onto and around the reinforcing ribs, the membrane maintains a smooth inner surface on the final duct product, such as... Figure 1 As shown. It is desirable that the strip is at least laterally flexible enough to conform to the contour of the reinforcing rib along its overlapping portion, such that the overlapping strip can meet or substantially meet the strip exposed from below at the edge of the reinforcing rib.

[0139] In addition to bonding the membrane to fused reinforcing ribs between adjacent overlapping layers, other active fusion techniques can be applied. Active methods may include, for example, hot air welding, hot roller welding, or radio frequency welding.

[0140] It should be understood that the above-described breathing gas conduit and manufacturing method are provided as examples of thin-walled conduit types to which the present invention can be applied. These examples were chosen to illustrate many possible variations and are not intended to be limiting in any way. Many further variations will be presented to those skilled in the art. While some embodiments of the invention have been described, and these embodiments convey specific advantages over other embodiments, other combinations may prove commercially useful.

[0141] Appendix Figure 1 , 5 Figures 1 and 13 show small gaps or spaces between the overlapping portions of the stiffeners and the strip. It should be understood that these spaces are presented merely for illustrative purposes to distinguish the stiffeners from the overlapping layers in the figures. In practice, the overlapping layers conform to and integrate with the stiffeners without forming large gaps or air bubbles.

[0142] See Figures 3 to 5 The diagram shows a breathing circuit component including a breathing gas conduit 1, the breathing circuit component including a diaphragm defining a conduit wall 6 formed by adjacent membrane layers 5, 7, wherein each layer 5, 7 is bonded to the next layer via a helical reinforcing rib 3.

[0143] See Figures 6 to 8 Various embodiments of a breathing circuit component according to the present invention are illustrated. In these embodiments, the breathing circuit component includes a relatively short section of breathing gas conduit 1 connecting the patient interface P and the inhalation gas conduit 1, which may or may not be heated. This short section of breathing gas conduit 1 is shorter than the inhalation gas conduit 1.

[0144] refer to Figure 6 The patient interface P includes nose pins held on the patient's head by a suitable headband H. In the example shown, these nose pins are non-sealing and do not essentially seal against the patient's nostrils. (Reference) Figure 7 The same breathing gas circuit 1 is shown, but this circuit is used with a different patient interface P. The patient interface P includes a nasal pin held on the patient's head by a suitable ear hook E. Reference Figure 8 The patient interface P includes a tracheostomy interface held on the patient's neck by a suitable neck strap S. The upper end of the inhaled gas tubing I and the associated tubing connector C are attached to the patient's neck by a suitable lanyard L.

[0145] refer to Figures 6 to 8 The short-length breathing gas tubing 1 may include an unheated, flexible section of the tubing positioned proximal to the patient to reduce twisting or pulling on the patient interface P and to minimize potential heating problems or overheating near the patient. To reduce condensation formation in the unheated breathing gas tubing 1, the tubing 1 is permeable and has the features described above. Figures 1 to 5 The aforementioned vapor permeability properties.

[0146] The advantage of providing this shorter breathable breathing gas tubing 1 is that most of the moisture in the gas is delivered to the patient, so while condensation is reduced, moisture loss through the breathable walls of the short breathing gas tubing 1 is relatively low. It is envisioned that this short breathing gas tubing 1 be used in conjunction with any longer breathing gas tubing to deliver heated and humidified gas to the patient.

[0147] Neck straps or lanyards are available. Figure 6 A lanyard L is shown. The lanyard L can be connected to the inhalation gas tubing I, or to the connection between the inhalation gas tubing I and the breathing circuit components. A buckle may be provided with the lanyard L to adjust its length. The purpose of the lanyard is to support a portion of the weight of the inhalation gas tubing I, preventing this weight from pulling on the nasal cannula assembly. This helps prevent the prongs from interfering with the sensitive lining of the nasal passage and allows the patient interface to remain properly positioned on the face.

[0148] The described strap or lanyard L can be used with any patient interface that supplies gas to a patient; for example, it can be used with a nasal mask or face mask, or with a tracheostomy accessory or connector. When used with such an interface, the strap or lanyard L supports the weight of one or more breathing gas tubes that supply gas to a face mask, connector, or tubing, and helps reduce tension on the face mask, connector, or tubing.

[0149] See Figure 7 It is possible to provide nasal cannula attachments to hold the nasal cannula assembly on the patient's face. Figure 7 The attachment device is in the form of ear hooks E, which are attached to the straps of the face mounting portion of the nasal cannula assembly.

[0150] The ear hook E extends from the face mount to around the patient's ear and provides rigid anchoring when using a non-elastic material. The ear hook E can be made of a thin, round cord with its end embedded in plastic, and it can be adjustable. The plastic end of the ear hook E is inserted into a specially designed cavity in the strap, allowing for length adjustment for a comfortable yet secure fit.

[0151] Figure 8 A patient interface P is shown, comprising a tracheostomy interface using a neck strap or lanyard L. The tracheostomy interface includes a tracheostomy connector TC attached to a tracheostomy mount TM, which extends through a hole in the patient's neck into a tracheostomy tube (not shown) and subsequently into the patient's airway. This tracheostomy interface provides a direct connection between a breathing circuit component, including a relatively short breathing gas tubing 1, and a breathing supply received through a longer inhaled gas tubing I.

[0152] Excessive weight on the tracheostomy tube can lead to excessive movement of the tube, increasing the risk of complications such as displacement or re-insertion of the tracheostomy tube, granulation tissue formation, or, more seriously, stoma erosion. To eliminate or reduce these problems, a tether or sling L can be attached to the inhalation gas tubing I or the breathing gas tubing 1, or to an additional connector (which can, for example, connect the breathing gas tubing 1 to the inhalation gas tubing I). The tether or sling L transfers the weight of tubing 1, I, and the tracheostomy connector TC from the tracheostomy tube or fitting TM, distributing it across the patient's neck, thus minimizing the load applied directly to the tracheostomy tube or fitting TM. The tether or sling L can be adjustable, allowing its length to be varied to suit the patient's needs.

[0153] See Figure 9 In one embodiment of the present invention, the breathable breathing circuit component including the breathing gas conduit 1 is formed as one or more longitudinal strips 8, 9 having a breathable diaphragm as part of its wall 6.

[0154] A suitable material for breathable membranes is a hydrophilic polyester block copolymer formed into a uniform flat film. Examples of such membranes are sold under the trademark SYMPATEX®. This material is particularly suitable for the production of films.

[0155] Other variations are Figure 13 The figure depicts the flexible wall diaphragm of the breathing gas conduit, which is reinforced to provide resistance to lateral crushing and longitudinal stretching of the breathing gas conduit.

[0156] See Figure 11 and Figure 12 This illustrates another aspect of the invention, including a breathing circuit component of the breathing gas conduit according to the invention being provided as an inner conduit configured as a coaxial conduit, such that exhaled gas and inhaled gas each flow in one of the inner conduit or the space between the inner conduit and the outer conduit, and in use, water vapor, rather than liquid water, is delivered from the exhaled gas passage to the inhaled gas passage. The water vapor from the exhaled gas humidifies the inhaled gas, thereby providing a passive gas humidification system.

[0157] In another embodiment, the breathing circuit component according to the invention may include a catheter mounting member. (See reference...) Figure 14 The application of the present invention in catheter mounting components is described.

[0158] Alternatively, one or more longitudinal sections (lengths) of the breathing gas conduit may be formed of a breathable material, or the insulating zone of the conduit wall may be formed of that material. The embodiments described herein may be preferred because they are readily manufactured and can be achieved through continuous stitching, gluing, or welding, through co-extrusion, or by using materials according to… Figure 2 The example device is wound onto the forming device for linear manufacturing.

[0159] See Figure 10 and Figure 13 Spiral, helical, or longitudinal internal (or external) reinforcing members or a series of annular reinforcing members may be provided on the outer (or inner) side of the tubular diaphragm to provide support. These supporting members may be formed, for example, of polymeric plastic materials, such as those used in the walls (not the ventilated areas) of breathing gas conduits, or alternatively, may be, for example, wire supports, such as drawn steel wire, or formed of a combination of materials such as polymeric materials and embedded metal elements.

[0160] Figure 10 The breathing gas conduit shown can be formed using any of many methods. For example, the tubular diaphragm can be supplied as a continuous conduit. Alternatively, it can be supplied as a strip. When supplied as an extruded strip, the diaphragm can be spirally wound onto a forming device. A helical support rib, provided in a semi-molten state, is then laid over the overlapping portion between adjacent turns. Heat from the helical support rib causes two adjacent strips to bond together with the rib, forming a flexible, elastic conduit once cooled.

[0161] An embodiment of a breathing gas conduit including longitudinal reinforcement is shown in Figure 13 The embodiment utilizes longitudinal reinforcing threads extending parallel to the pipe axis. Alternatively and / or alternatively, a mesh sheath can also be used as a longitudinal reinforcement.

[0162] exist Figure 13In this embodiment, the breathing gas conduit includes a breathable polymer inner wall 350. A helical reinforcing rib 353 is fused or adhered to the breathable inner wall 350. A plurality of reinforcing threads 351, extending along the length of this wall and spaced apart around the outer surface of the breathing gas conduit, are parallel to each other and aligned parallel to the longitudinal axis of the breathing gas conduit. The threads 351 are supported on the helical reinforcing rib 353 and span the space between the turns of the helical reinforcing rib 353. In this embodiment, it is important to select the reinforcing threads 351 (material, size, and number) such that the threads 351 are sufficiently rigid to resist buckling under the instantaneous drop in internal pressure that can be expected during the patient's breathing. Unrestrained or excessive buckling of the threads 351 can cause the conduit to axially contract to unacceptable levels. The axial threads 351 can be woven or braided fibers, stretched or extruded monofilaments, or other equivalent forms.

[0163] Figure 13 The embodiments provide a breathing circuit component that can form all or part of a breathing circuit, which is reinforced by helical reinforcing ribs 353 to prevent crushing and by axial threads 351 to resist longitudinal extension. These threads prevent direct contact between the user and the surface of the breathing circuit component, thereby reducing the risk of punctures, etc.

[0164] When a breathing circuit component includes a breathing gas expiratory conduit that forms or is part of an expiratory branch of the breathing circuit, the purpose of one or more permeable zones in the conduit wall is to allow water vapor to diffuse from, for example, the expiratory branch of the breathing circuit along a path independent of any specific exhaust location (if any exhaust location is provided). This eliminates the buildup of condensate within the expiratory branch by drying the humidifying gas as it flows through it. This further reduces the humidity of the gas reaching auxiliary equipment (such as filters, ventilators, etc.), thereby reducing the risk of condensate buildup and improving operational performance.

[0165] According to another aspect of the invention, such as Figure 11 and Figure 12 As illustrated, a breathing circuit component in the form of a breathing gas conduit incorporating one or more longitudinal strips of a breathable diaphragm can be further integrated into a coaxial breathing circuit as a passive humidification device. See especially... Figure 11 In the cross-section of the diagram, the coaxial breathing circuit may include an outer conduit 11 and an inner conduit 10. For heat transfer reasons, the inner conduit 10 carries the inspiratory airflow within its space 12. The expiratory airflow is carried by the space 13 between the inner conduit 10 and the outer conduit 11. This airflow configuration is respectively... Figure 12Arrows 20 and 19 indicate this. It should be recognized that an alternative airflow configuration can be provided, in which case arrows 19 and 20 are reversed. Alternatively, the inhalation airflow can be carried by the outermost radial space 13, and the exhalation airflow by the innermost space 12.

[0166] The inner conduit 10 is formed having one or more longitudinal strips 6, 7 of breathable diaphragms in its wall 1, or alternatively, the wall 1 is formed entirely of breathable diaphragms, as previously referenced. Figure 9 , Figure 10 and Figure 11 Therefore, the humidity in the exhalation airflow space 13 can pass through sections A and B of the breathable diaphragm to humidify the inhalation airflow in the inhalation airflow space 12.

[0167] The breathable membrane acts on the relative partial pressure of water vapor, so by utilizing the flow in the counter-current arrangement, it is possible to achieve essentially passive humidification of the intake flow.

[0168] See Figure 12 , indicating that includes Figure 11 The diagram depicts a breathing circuit configuration for a coaxial breathing gas conduit. In this circuit, the breathing gas conduit has a patient-end connector 15 and a ventilator-end connector 16, which has an inspiratory port 17 and an expiratory port 18. Inspiratory backflow 20 and expiratory backflow 19 are indicated.

[0169] The sensor can be located, for example, in the patient-side connector 15, to detect, for example, a short circuit indicating a leak in the internal piping.

[0170] In addition to reducing or eliminating condensation formation within the inner pipe 10 or outer pipe 11, and to maintain the gas flowing through the breathing gas duct at a substantially uniform temperature, a heater device, such as a resistance heating wire, may be disposed within the inner or outer pipe, within the gas space 12 or 13, or within the pipe wall itself. Alternatively, the heating wire may also serve as a reinforcing support within or outside the inner pipe 10. Figure 12 (The spiral 25 in the middle), which is the same as the coaxial pipe.

[0171] Another breathing circuit component to which this invention can be applied is a catheter mount. The catheter mount connects the patient docking component (such as a mouthpiece, nasal mask, or endotracheal tube) to the two branches of the breathing circuit. This connection to the two branches of the breathing circuit is typically accomplished via a Y-connector. During the patient's inspiratory and expiratory cycles, the two branches of the breathing circuit each have different functions, one serving as the inspiratory conduit and the other as the expiratory conduit. The catheter mount serves a dual purpose, delivering both inhaled and exhaled air. Therefore, the catheter mount may have significant disadvantages.

[0172] The catheter mounting component of the present invention is combined with Figure 14 Depicted in the image. The catheter mounting fitting engages the Y-shaped connector at the ventilator end. The internal conduit 455 extends coaxially with the external conduit 456. At its patient end, the internal conduit 455 is supported on an internal conduit connector 457, which in turn is supported from the patient end connector 459 via a support strut 458. The other end of the internal conduit 455 is supported on an internal conduit connector 460, which forms part of the ventilator end connector 461.

[0173] exist Figure 14 In the duct installation, the ventilator end inner duct connector 460 communicates with the intake duct connector 462. The outer duct 456 is entirely formed of breathable material and may also include lateral reinforcements (spiral reinforcement 467) and longitudinal reinforcements (axially oriented threads 490) on its outer side. When based on previous information... Figure 2 When constructed in the manner described, the spiral reinforcing ribs 467 are laid on the overlapping portions between continuous turns of the extrusion belt, which helps the overlapping portions to integrate with the anti-damage reinforcement.

[0174] Therefore, in use, according to Figure 14 The catheter mount has an inspiratory flow entering it, as indicated by arrow 470. The inspiratory flow passes through the inner tubing, exits through the patient-end connector 459, and reaches the patient, as indicated by arrow 471. During exhalation, whether assisted or not, the exhaled air passes through connector 459 and enters the space surrounding the inner tubing 455, as indicated by arrow 472. As indicated by arrow 473, this air passes along the inside of the wall of the outer tubing 456, and then exits through the expiratory tubing connector 463 of the ventilation connector 461, as indicated by arrow 474. Water vapor can pass through the water vapor permeable portion of the outer tubing 456 as it passes through the catheter mount within the space between the inner tubing 455 and the outer wall 456. Except for any reinforcing ribs, the entire length of the outer tubing 456 is permeable. In this way, although the exhaled air may experience a certain degree of temperature drop as it passes through the duct fitting and reaches the exhalation tubing connector 463, this temperature drop is accompanied by a decrease in humidity due to water vapor passing through the breathable diaphragm of the outer tubing. Therefore, the relative humidity of the exhaled airflow is reduced, and the rain out effect is also diminished.

[0175] According to the invention, a breathing circuit component, such as a breathing gas conduit 1 (e.g., as referenced) Figures 3 to 5As shown, this stems from work already conducted with the aim of providing improved breathing circuit components, particularly improved breathing gas tubing for breathing devices. In one embodiment, the breathing circuit component is a relatively short breathing gas tubing configured to connect at one end to a patient interface and at the other end to an inhalation gas tubing that forms part of the breathing circuit. Both ends of this relatively short breathing gas tubing may be provided with or include connectors for connecting to the patient interface and the inhalation gas tubing.

[0176] The breathing circuit component may include a breathing gas conduit configured to form any part of the breathing circuit, and thus may include all or part of a breathing gas inhalation conduit for delivering breathable gas to a patient from a device for inhalation via a suitable patient interface, or may include all or part of a breathing gas expiration conduit for delivering exhaled gas from a patient interface. The patient interface may be any interface configured to deliver breathing gas to a patient and may include any of the following:

[0177] a) A full-face mask, which includes a mask frame and padding configured to seal around the patient's nose and mouth;

[0178] b) A face mask, comprising a mask frame and a pad configured to seal around the patient's mouth;

[0179] c) A nasal mask, which includes a mask frame and a soft pad configured to seal around the patient's nose.

[0180] d) A nasal cannula having one or more pins for insertion into a patient's nostril;

[0181] e) A nasal mask, which includes one or more nasal pillows configured to seal against the patient's nose;

[0182] f) A hybrid mask comprising a combination of a nose pillow / insert and a mouth seal;

[0183] i) the endotracheal tube; and

[0184] j) Tracheostomy interface.

[0185] In other embodiments, the breathing circuit component may include a connector or adapter for connection to the inhaled or exhaled gas tubing as described above. Such an adapter may be configured to connect one end of the inhaled or exhaled gas tubing to another component of a respiratory therapy or treatment device. In one embodiment, the breathing circuit component includes a relatively short section between a patient interface at one end of the breathing gas tubing and an inhaled gas tubing at the other end.

[0186] In one instance, this breathing gas tubing is directly connected between the patient interface and the blower / humidifier unit, such as... Figure 17 As shown. The breathing gas tubing may include an intermediate section, which is a relatively short section of the breathing gas tubing located between a patient interface (such as a nasal cannula) and a tubing or tubing connector, the tubing connector being used to connect to another section of the breathing gas tubing extending from the blower-humidifier unit. Figure 17 An example of such a blower-humidifier unit is shown, manufactured and sold by the applicant under the trade name AIRVO. This unit includes a fan or blower configured to generate a gas flow. In one example, an oxygen source may be connected to the blower unit to supplement the ambient air pumped by the fan or blower. In another example, the fan or blower may simply draw in and pump ambient air without providing any other source of breathable gas. The fan or blower is connected to a humidifier that heats water to produce water vapor, which is mixed with the gas flow to humidify the gas. The humidifier typically includes a humidifier chamber and a heating plate.

[0187] refer to Figures 3 to 5 The breathing gas conduit 1 is formed by a spirally wound or spirally coiled strip of vapor permeable to the diaphragm 6, which is supported at the overlapping edge by spiral support ribs or reinforcing ribs 3.

[0188] The thickness of the vapor permeable membrane 6 is about 40 micrometers, and / or may fall within the range of about 35 to 45 micrometers. The vapor permeable membrane 6 may be non-porous.

[0189] When there is a temperature difference between the inside and outside of the breathing gas duct 1, water vapor contained in the duct 1 or in the gas flowing through the duct permeates the gaps in the diaphragm 6, causing the water vapor to flow in the direction from the "warm side" to the "cold side" of the duct 1, that is, to flow radially outward from the airflow channel defined by the diaphragm 6.

[0190] The diaphragm 6 is designed to prevent viruses / microorganisms from entering the airflow channel inside the respiratory gas duct 1 through the diaphragm 6.

[0191] The diaphragm 6 of the breathing gas conduit 1 is supported by spirally wound support ribs 3, which are:

[0192] - Made of semi-rigid plastic.

[0193] - To prevent or resist the breathing gas tube 1 from being folded or crushed.

[0194] - The pitch is approximately 4.5 mm.

[0195] In some instances, colored pigments can be added to the diaphragm 6 and / or ribs to color the pipe in the desired way. For example, white pigment can be added to the spiral ribs to achieve a “whiter,” cleaner appearance.

[0196] In another example, the length of the modified breathing gas tubing 1 described above can be assembled with a tubing end connector at one end and a patient interface at the opposite patient end. The tubing end connector can be connected to an additional breathing gas tubing for connection to a blower / humidifier, which may or may not be breathable and / or may or may not be heated. For example, the additional breathing gas tubing may be an inhalation gas tubing. The patient interface can include any suitable interface as described above.

[0197] The length of the breathing gas tubing can be longer than that of existing art arrangements. For example, the breathing gas tubing of the aforementioned nasal cannula device can be increased from approximately 320 mm in existing art arrangements to approximately 370 mm, or to a length falling within the range of approximately 360 mm to 380 mm. This additional length of the breathing gas tubing can improve patient fit and / or maintain substantially similar thermal performance to existing art tubing. The length of the modified breathing gas tubing can be adjusted to further regulate patient fit and / or vapor permissibility. For example, a suitable modified breathing gas tubing length can fall within the range of approximately 310 mm to 410 mm. This can improve patient fit and / or maintain substantially similar thermal performance to existing art breathing gas tubing.

[0198] The thicker diaphragm is more rigid than existing breathing gas tubing (which can be approximately 25 µm in some instances), and therefore more self-supporting. Consequently, the diaphragm is less likely to tear, rupture, or become stuck in the machine during the spiral winding process to form the breathing gas tubing. Therefore, it has a lower chance of being discarded during manufacturing compared to existing breathing gas tubing.

[0199] In use, the increased thickness of the diaphragm improves its strength, and thus its durability, as well as the strength and durability of the entire breathing gas tubing. Therefore, the diaphragm is less likely to tear, perforate, or rupture if improperly handled or gripped by a user, clinician, or inexperienced installer. Consistent with tests described later in the instructions, the increased wall thickness of the breathing gas tubing increases the longitudinal force required to break the tubing along its longitudinal axis and increases the lateral force required to break the tubing substantially transversely to its longitudinal axis.

[0200] A thicker diaphragm is more rigid, thus producing less of a "rustling" noise when bent or wrinkled. This rustling noise from existing breathing tubing has been shown to be particularly bothersome to patients, especially when they are trying to rest or sleep. Surprisingly, it has been discovered that a thicker diaphragm can reduce this noise without adding extra weight or reducing the flexibility of the breathing tubing, thus avoiding patient objections.

[0201] In the above examples, the diaphragm or mesh is formed of a breathable material with a diaphragm wall thickness tolerance of 40 µm ± 5 µm.

[0202] In one instance, the pitch of the spirally wound diaphragm and ribs forming the breathing gas conduit is about 4.5 mm, and / or may fall within the range of about 3.8 mm to 5.2 mm.

[0203] According to the present invention, the ratio of the reinforcing rib pitch to the diaphragm wall thickness in the breathing gas conduit 1 is in the range of 1:0.0080 to 1:0.0128. In one embodiment of the present invention, this ratio is in the range of 1:0.0080 to 1:0.0118. In another embodiment of the present invention, this ratio is 1:0.0088.

[0204] The above relationship between diaphragm wall thickness and pitch can provide an optimal balance of at least the following characteristics:

[0205] • Pipe strength (in both lateral and longitudinal directions)

[0206] • The "hissing" noise from the pipes

[0207] • Pipe flexibility / rigidity

[0208] • Materials used in pipe production

[0209] • Pipe weight

[0210] • Vapor permissibility (especially due to the amount of membrane exposed surface area)

[0211] It should be recognized that the parameters of the breathing gas conduit can be adjusted to change the properties of the breathing gas conduit as desired. For example:

[0212] A large diaphragm wall thickness relative to the pitch can lead to:

[0213] • Increased pipe strength

[0214] • Reduced "rustling" noise

[0215] • Reduced pipe flexibility

[0216] • The steam permissibility of the pipeline decreases (due to increased diaphragm wall thickness).

[0217] • Increased pipe weight (due to thicker diaphragm walls)

[0218] Conversely, a smaller diaphragm wall thickness relative to the pitch can lead to:

[0219] •Intensity decreases

[0220] • The "rustling" noise increased.

[0221] • Increased pipe flexibility (i.e., allowing the pipe to fold over itself and / or create flow restriction).

[0222] • Increased vapor permissibility (due to reduced membrane wall thickness)

[0223] • Reduced pipe weight (due to thinner diaphragm walls)

[0224] A large pitch relative to the diaphragm wall thickness can lead to:

[0225] • Reduced pipe strength

[0226] • Increased “rustling” noise (i.e., the increased span of the diaphragm material between the ribs allows for a larger “rustling” sound).

[0227] • Increased pipe flexibility (i.e., allowing the pipe to fold over itself and / or create flow restriction).

[0228] • The amount of material required to form the pipe is reduced (due to the increased number of turns of the spiral winding).

[0229] • Increased vapor permissibility (due to increased exposed surface area of ​​the diaphragm)

[0230] • Reduced pipe weight (due to reduced material usage)

[0231] Conversely, a smaller pitch relative to the diaphragm wall thickness can lead to:

[0232] •Increased strength

[0233] • Reduced "rustling" noise

[0234] • Reduced pipe flexibility

[0235] • The amount of material required to form the pipe increases (due to the increased number of turns of the spiral winding).

[0236] • Increased pipe weight (due to increased material usage)

[0237] • Vapor permissibility decreases (due to reduced surface area exposed by the diaphragm)

[0238] The 40 µm diaphragm is thicker and therefore more rigid than existing breathing gas conduits (typically with a diaphragm thickness of about 25 micrometers). Because the diaphragm is more rigid, it may require less structural support from helical ribs or reinforcing ribs. Therefore, the pitch of the ribs can be increased (i.e., extended) to reduce the structural support provided by the ribs. Increasing the rib pitch can then advantageously require a less rigid plastic material and will increase the exposed surface area of ​​the diaphragm, thereby improving the flexibility and / or permeability of the conduit.

[0239] Conversely, the pitch of the spiral ribs or reinforcing ribs can be reduced to provide additional support for the pipe.

[0240] For example, a suitable pipe pitch can fall within the range of approximately 3.8 mm to 5.2 mm, and in one instance it can be 4.5 mm.

[0241] The breathing gas conduit 1 according to the present invention also exhibits a significantly increased resistance to permanent deformation, such that the force required for permanent deformation is much higher than that required for breathing gas conduits using prior art. Permanent deformation can occur across a small portion of the conduit or along its entire length. Permanent deformation may also occur during use or during manufacturing due to the breathing gas conduit being caught, gripped, pulled, etc.

[0242] Permanent deformation of the breathing gas tubing is undesirable for at least the following reasons:

[0243] Further stretching thins the membrane material, which may lead to:

[0244] • The "rustling" noise is louder

[0245] • Decreased heat retention

[0246] • Increased risk of puncture (i.e., due to lateral forces).

[0247] Stretching further expands / increases the pitch of the helical ribs, which may result in:

[0248] • Reduced support in both lateral and longitudinal directions

[0249] • Excessive flexibility (i.e., allowing the pipe to fold over itself and / or create flow restrictions)

[0250] • The visual appeal of the pipes is reduced.

[0251] In addition, the increased wall thickness of the breathing gas conduit 1 increases the longitudinal force required to destroy the breathing gas conduit 1 along its longitudinal axis, and also increases the lateral force required to destroy the breathing gas conduit 1 substantially transversely to the longitudinal axis.

[0252] It should be recognized that, according to the present invention, one, some, or all of the properties of the above-mentioned breathing gas conduit can be changed.

[0253] The example of such a membrane described above is a membrane sold under the trademark Sympatex. It should be recognized that, after appropriate investigation and testing regarding properties such as vapor transfer, insulation, the resulting "rustling" noise, diaphragm / pipe strength, and compatibility with existing production equipment, diaphragms of similar thickness manufactured by other companies may be used as alternatives.

[0254] The improved breathing gas tubing is more durable during both manufacturing and use. Therefore, it is less prone to damage during both manufacturing and final use.

[0255] The improved breathing gas tubing also produces less "rustling" noise when bent or wrinkled. Therefore, it is expected that the improved breathing gas tubing will be more readily accepted by users. Surprisingly, it has been found that despite the thicker tubing, and thus possessing all the aforementioned properties, a suitable level of water vapor transfer has still been achieved. This is contrary to expectations in the art, which had anticipated that breathing gas tubing with such a significantly increased wall thickness would not be so successful in allowing water vapor to pass through. Therefore, by making the breathing gas tubing walls thicker, the problems of noise and low durability in prior art breathing gas tubing have been solved or at least mitigated—a completely unexpected result.

[0256] An improved breathing gas conduit according to one or more embodiments of this disclosure was tested using prior art to determine the average sound level. According to the invention, the improved breathing gas conduit has a diaphragm thickness of 40 µm, while another breathing gas conduit of prior art size has a diaphragm thickness of 25 µm.

[0257] The tests were conducted on a noise test bench. The breathing gas tubing was clamped at one end of the bench, and a stepper motor was attached to the other end. The stepper motor was actuated, causing the end of the tubing attached to it to flex towards and away from the motor. The stepper motor was actuated in cycles of approximately two seconds, moving 180 degrees forward and backward. The entire noise test bench was placed inside a sound laboratory, and noise levels were measured. Noise was measured using a sound level meter and a series of microphones positioned above and around the noise test bench. The noise generated by the stepper motor itself was consistent across all tests. Therefore, our results indicate that the tubing with a 40-micron diaphragm is quieter, regardless of the noise level of the stepper motor.

[0258] The test results are described below, and further... Figure 15 The figure shows a graph of the results of the flexible sound test 515, comparing the decibel (dB) readings 517 of the 40 µm diaphragm thickness pipe 518 and the 25 µm diaphragm thickness flexible pipe 519.

[0259] Figure 16 The noise test bench 501 described is shown. The test bench 501 includes a base plate 503, a stepper motor 505 mounted towards one end of the base plate 503, and a pipe clamp 507 also mounted on the base plate 503, spaced apart from the motor 505. For completeness, a motor control circuit system 509 and a motor power cable 511 are also shown. A pipe fitting 513 is associated with a breathing gas pipe 515 mounted on the plate 503 via the pipe clamp 507. The noise test bench 501 is further shown as being placed within a sound laboratory 519, which is equipped with a sound level measuring device 517, such as a microphone array, like the one used during testing.

[0260] Three pipes were tested at each diaphragm thickness, each pipe consisting of... Figure 15 The graphs are represented by individual bars. Each pipe was tested three times, and the average sound level was calculated for each pipe across the three tests, followed by the average sound level for each pipe's diaphragm thickness.

[0261]

[0262] These results confirm that the breathing gas tubing disclosed herein exhibits significantly and unexpectedly improved properties compared to prior art tubing, particularly a desirable reduction in noise during use. In any case, the breathing gas tubing disclosed herein is quieter in use and is therefore likely to be more acceptable to users.

[0263] Although the invention has been described with reference to specific embodiments, other embodiments that will be apparent to those skilled in the art are also within the scope of the invention. Therefore, various changes and modifications can be made without departing from the spirit and scope of the invention. For example, various components may be repositioned as needed. Furthermore, not all of these features, aspects, and advantages are essential to practicing the invention. Therefore, the scope of the invention is intended to be defined solely by the following claims.

Claims

1. A breathing circuit component, comprising: Entrance exit; And an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the enclosing wall including a membrane that allows water vapor to pass through but substantially prevents liquid water or breathing gas from passing through; The breathing circuit component resists a stretching force of up to about 30 Newtons in the longitudinal direction without permanent deformation, the longitudinal direction being the direction of the longitudinal axis of the gas passage.

2. The breathing circuit component according to claim 1, wherein the breathing circuit component resists a stretching force of at least 15 Newtons to 30 Newtons in the longitudinal direction without permanent deformation, the longitudinal direction being the direction of the longitudinal axis of the gas passage.

3. The breathing circuit component of claim 1, wherein the breathing circuit component resists a stretching force of up to about 25 Newtons in the longitudinal direction without permanent deformation, the longitudinal direction being the direction of the longitudinal axis of the gas passage.

4. The breathing circuit component according to claim 1 or 2, wherein the breathing circuit component resists a longitudinal tensile force of up to 55 N in the direction of the longitudinal axis of the gas passage before breaking.

5. The breathing circuit component according to any one of claims 1 to 2, wherein, The thickness of the diaphragm is 35 micrometers to 45 micrometers.

6. The breathing circuit component according to claim 5, wherein the thickness of the diaphragm is 37 micrometers to 43 micrometers.

7. The breathing circuit component according to claim 5, wherein the thickness of the diaphragm is 39 micrometers to 40 micrometers.

8. The breathing circuit component according to claim 5, wherein the thickness of the diaphragm is 40 micrometers.

9. The breathing circuit component according to any one of claims 1 to 2, wherein the diaphragm comprises a hydrophilic polyester material.

10. The breathing circuit component according to any one of claims 1 to 2, wherein the breathing gas conduit comprises at least one helically wound strip of polymer, a portion or all of the strip comprising the diaphragm, and the respective edges of adjacent turns of the strip abutting or overlapping and joining to form the enclosing wall.

11. A breathing circuit component, comprising: Entrance; exit; And an enclosing wall defining a gas passage between the inlet and the outlet, at least one region of the enclosing wall including a membrane that allows water vapor to pass through but substantially prevents liquid water or breathing gas from passing through; The breathing circuit component can withstand a force of up to about 15 N applied in the lateral direction without breaking, the lateral direction being the direction transverse to the longitudinal axis of the gas passage.

12. The breathing circuit component of claim 11, wherein the breathing circuit component resists a force of 10 to 15 Newtons applied in a lateral direction without breaking, the lateral direction being transverse to the longitudinal axis of the gas passage.

13. The breathing circuit component according to claim 11 or 12, wherein the breathing circuit component resists a force of about 13 Newtons applied in a lateral direction without breaking, the lateral direction being a direction transverse to the longitudinal axis of the gas passage.

14. The breathing circuit component according to claim 11 or 12, further comprising a reinforcing element that supports and reinforces the enclosure wall, wherein the breathing circuit component resists a force of up to about 15 Newtons applied in a lateral direction without delamination, which would cause the reinforcing element to separate from the enclosure wall, the lateral direction being a direction transverse to the longitudinal axis of the gas passage.

15. The breathing circuit component according to claim 14, wherein the reinforcing element is a reinforcing rib or rib.

16. The breathing circuit component according to claim 11 or 12, wherein the enclosing wall defining the gas passage is entirely composed of a breathable diaphragm.

17. The breathing circuit component according to any one of claims 11 to 12, wherein, The thickness of the diaphragm is 35 micrometers to 45 micrometers.

18. The breathing circuit component of claim 17, wherein the thickness of the diaphragm is 37 micrometers to 43 micrometers.

19. The breathing circuit component of claim 17, wherein the thickness of the diaphragm is 39 micrometers to 40 micrometers.

20. The breathing circuit component of claim 17, wherein the thickness of the diaphragm is 40 micrometers.

21. The breathing circuit component according to any one of claims 11 to 12, wherein the diaphragm comprises a hydrophilic polyester material.

22. The breathing circuit component according to any one of claims 11 to 12, wherein the breathing gas conduit comprises at least one helically wound strip of polymer, a portion or all of said strip comprising the diaphragm, and the respective edges of adjacent turns of said strip abutting or overlapping and joining to form the enclosing wall.

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