JP2020203098A - Gas washout vent for patient interface - Google Patents

Abstract

To provide medical devices used in the diagnosis, amelioration, treatment or prevention of respiratory disorders, having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.SOLUTION: The invention provides a gas washout vent, and a patient interface with the gas washout vent, configured to allow patient-exhaled CO2 to flow to an exterior of the plenum chamber to minimize rebreathing of exhaled CO2 by the patient. The gas washout vent includes: at least one outlet orifice 3402; a diffusing member 3406 at least partly covering the outlet orifice; and a blocking member 3408 having an air-impermeable material, the blocking member preventing gas exiting from the outlet orifice from flowing straight through the diffusing member.SELECTED DRAWING: Figure 4

Description

The art relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related diseases. The technology also relates to medical devices or devices and their use.

1.2.1 Human respiratory system and its diseases The respiratory system of the body promotes gas exchange. The nose and mouth form the entrance to the patient's airways.

The airways contain a series of branch canals, which become narrower, shorter, and numerous as they go deeper into the lungs. The main function of the lungs is gas exchange, where oxygen enters the venous blood from the air and carbon dioxide is carried out. The trachea is divided into the left and right main bronchioles, which further branch to the terminal bronchioles. The bronchi make up the induced airways and are not involved in gas exchange. Further division of the airways results in respiratory bronchioles and eventually alveoli. The vesicular area of the lung where gas exchange takes place is called the respiratory area. See John B. West, "Respiratory Physiology," Lippincott Williams & Wilkins, 9th Edition, 2011.

There is a series of respiratory illnesses. Certain diseases can be characterized by specific events such as apnea, hypoventilation and hyperventilation.

Obstructive sleep apnea (OSA) is a type of sleep apnea disorder (SDB) characterized by events involving closure or obstruction of the upper airways during sleep. This is the result of a combination of an abnormally small upper airway and a normal loss of muscle tone in the area of the tongue, a normal loss of the soft palate and posterior pharyngeal wall during sleep. Under these conditions, affected patients typically stop breathing for 30 to 120 seconds, and in some cases 200 to 300 respiratory arrests overnight. Excessive drowsiness often occurs during the day, which can cause cardiovascular disease and brain damage. The syndrome is a disorder that is especially common in overweight middle-aged men, but affected individuals may be unaware of the problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Cheyne-Stokes breathing (CSR) is another form of sleep apnea disorder. CSR is a disorder of the patient's respiratory regulator, in which alternating and rhythmic breathing tapering, known as the CSR cycle. The characteristic of CSR is that arterial blood is repeatedly deoxygenated and reoxygenated. Due to recurrent hypoxia, CSR can be detrimental. In some patients, CSR is associated with repetitive arousal during sleep, which results in severe sleep disorders, exacerbation of sympathetic nervous system activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Verson-Jones).

Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during awakening in the absence of a known cause of hypopnea. Symptoms include dyspnea, headache when waking up and excessive daytime sleepiness.

Chronic obstructive pulmonary disease (COPD) includes any group of lower respiratory tract diseases with common characteristics. This includes increased resistance to air movement, prolonged expiratory phase of respiration and decreased normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD develops with constant smoking (first risk factor), occupational exposure, air pollution and genetic factors. Symptoms include dyspnea on exertion, chronic cough and sputum production.

Neuromuscular disease (NMD) is a broad term that includes many diseases and illnesses that impair muscle function directly through intrinsic muscle lesions or indirectly through nerve lesions. Some NMD patients are characterized by progressive muscular disorders leading to loss of gait, are wheelchair-bound, have dysphagia, develop respiratory weakness and eventually die of respiratory failure. Neuromuscular disease can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disease is characterized by months of muscle dysfunction and death within a few years (eg, muscle atrophy). Sexual lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) Variable or slowly progressive disease: characterized by exacerbations over several years and a slight reduction in life expectancy (eg, life expectancy) Extremity band, facial scapulohumeral muscular dystrophy and myotonic dystrophy). Symptomatology of respiratory failure in NMD includes progressive generalized weakness, dysphagia, dyspnea on exertion and rest, fatigue, drowsiness, headache when waking up, difficulty concentrating and difficulty changing mood.

Chest wall disease is a group of thoracic deformities that lead to inadequate connections between the respiratory muscles and the rib cage. The disease is usually characterized by restrictive disorders and may have long-term hypercapnia respiratory failure. Scoliosis and / or posterior scoliosis can develop severe respiratory failure. Symptomatology of respiratory failure includes: dyspnea on exertion, peripheral edema, orthopnea, recurrent pulmonary infections, headache on waking, fatigue, poor sleep quality and loss of appetite.

Various treatments have been performed to treat or ameliorate such conditions. On the other side, healthy individuals can take advantage of such treatments to prevent the development of respiratory illness. However, these have many drawbacks.

1.2.2 Treatment Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The hypothesis is that continuous positive airway pressure acts as an air splint, pushing the soft palate and tongue forward and away from the posterior pharyngeal wall to prevent obstruction of the upper airway. Treatment of OSA with CPAP therapy is voluntary, if the patient has one or more of the devices that provide such treatments are uncomfortable, difficult to use, expensive and aesthetically unattractive. You do not have to choose this treatment.

Invasive ventilation (NIV) ventilates the patient through the upper respiratory tract by performing some or all of the breathing work to help the patient breathe well and / or maintain adequate oxygen levels in the body. Provide assistance. Ventilation assistance is provided via the patient's interface. NIV has been used in the treatment of CSR, OHS, COPD, MD and chest wall diseases. In some forms, the comfort and effectiveness of these treatments can be improved.

Invasive ventilation (IV) provides ventilation assistance to patients who can no longer breathe effectively on their own and is provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

1.2.3 Diagnosis and Treatment Systems These treatments are provided by treatment systems or devices. The system and equipment can also be used to diagnose the condition without it.

The treatment system consists of a respiratory pressure treatment device (RPT device) device, an air circuit, a humidifier, a patient interface and data management.

1.2.3.1 Patient Interface A patient interface can be used to interface a breathing device to its wearer, for example by providing airflow to the airway entrance. Air flow is provided via a nose cover / or a mask to the mouth, a tube to the mouth or a tracheal opening tube to the patient's trachea. Depending on the treatment applied, the patient interface may form a seal, eg, the part of the patient's face, at a pressure sufficiently different from the ambient pressure so that the treatment is effective, eg about 10 cmH ₂ O with respect to the ambient pressure. The gas is sent out at the positive pressure of. In other forms, such as oxygen delivery, in positive pressure of about 10 cm H 2 _O, a seal can be supplied to the gas of the airway may not be included in the patient interface.

There are various challenges in designing the patient interface. The face has a complex three-dimensional shape. The size and shape of the nose varies considerably from individual to individual. The head contains bone, cartilage and soft tissue, and different areas of the face react differently to mechanical forces. The jaw or mandible may move in relation to other bones in the skull. The entire head may move during respiratory treatment.

Due to these conundrums, some masks are obstructive, aesthetically unpleasant, costly, inadequately worn, suffer from one or more difficulties in use, and wear out after long-term use. Or it is unpleasant if the patient is unfamiliar with the system. For example, masks designed specifically for aviators, masks designed as part of personal protective devices (eg, filter masks), SCUBA masks, or masks for anesthetic administration can withstand the original application, It is unpleasantly unpleasant to wear it for a long period of time, for example several hours. This discomfort leads to reduced patient compliance with the treatment. This is especially true if you have to wear a mask while you sleep.

As long as the patient follows the treatment, CPAP treatment is particularly effective in treating certain respiratory disorders. If the mask is unpleasant or difficult to use, the patient may not follow treatment. Patients are often advised to wash their masks on a regular basis, so if the masks are difficult to clean (eg, difficult to assemble or disassemble), the patient may not wash their masks, which is Affects patient compliance.

Masks for other applications (eg, aviators) may not be suitable for sleep apnea, but masks designed for sleep apnea may be suitable for other applications. Absent.

For these reasons, patient interfaces for the delivery of CPAP during sleep are a unique area.

1.2.3.1.1 Seal forming part The patient interface includes a seal forming part. Since it comes into direct contact with the patient's face, the shape and morphology of the seal forming area can directly affect the effectiveness and comfort of the patient interface.

The patient interface is partly characterized by the design intent of where the seal forming portion hits the face in use. In one form of patient interface, the seal forming portion can have two quasi-parts that correspond to the left and right nostrils, respectively. In one form of patient interface, the seal forming portion may be a single element that surrounds both nostrils during use. Such a single element may be designed to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of the patient interface, the seal forming portion may consist of elements surrounding the area of the mouth in use, for example forming a seal on the lower lip area of the face. In one form of the patient interface, the seal forming portion may consist of a single element surrounding both nostril and mouth portions in use. These different types of patient interfaces are known by the various names given by their manufacturers and include nasal masks, whole face masks, nasal pillows, nasal sprays and nasal ridge masks.

Effective seal-forming areas in one area of the patient's face may not be suitable for another area due to differences in the shape, structure, variability and sensitive areas of the patient's face. For example, an underwater eyeglass sticker covering the patient's forehead is not suitable for use on the patient's nose.

Suitable for a variety of different facial shapes and sizes, it is possible to design a seal forming part for mass production, such as one comfortable and effective design. One or both must be fitted to form the seal until there is an inconsistency between the shape of the patient's face and the seal forming part of the mass-produced patient interface.

One type of seal forming part extends near the periphery of the patient interface so that the seal forming part is about to engage the patient's face and seals against the patient's face when force is applied to the patient interface. Intended for. The seal forming portion can include a cushion filled with air or liquid, or a molded or formed surface of an elastic seal element made of an elastomer such as rubber. In this type of seal formation, if the fit is not appropriate, there is a gap between the seal formation and the face, which requires additional force on the patient interface against the face to form the seal.

Another type of seal forming section includes a flap seal made of a thin material located near the periphery of the mask, which self-seals against the patient's face when positive pressure is applied inside the mask. Poor fit between the face and the mask, as in previous types of seal forming portions, requires additional force to form the seal or leaks from the mask. In addition, if the shape of the seal forming portion does not match that of the patient, it may wrinkle or bend during use, resulting in leakage.

Another type of seal forming portion can include a mating element, such as insertion into the nostril, which some patients find unpleasant.

Another form of the seal forming portion uses an adhesive to achieve the seal. Some patients find it inconvenient to constantly apply adhesive to the face and remove it.

The following patent applications assigned to ResMed Limited disclose various patient interface seal forming techniques: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennet. Another nasal pillow or nasal spray is the subject of US Special 4,782,832 (Trimble et al.), Which was transferred to Puritan-Bennet Corporation.

ResMed Limited was prepared the following products incorporating nasal spray: SWIFT ^TM (TM) nasal pillow mask, ^SWIFT TM II nasal pillows mask, ^SWIFT TM LT nasal pillows mask, ^SWIFT TM FX nasal pillow mask and MIRAGE LIBERTY ^TM (Registered trademark) Full face mask. The following patent application transferred to ResMed describes an example of a nasal pillow mask: International Patent Application WO 2004 / 073,778 (particularly describing the characteristics of RedMed Limited SWIFT ^TM nasal pillow), US Patent Application 2009 / 0044808 (particularly describing the characteristics of the ResMed Limited SWIFT ^TM LT nose pillow); international patent applications WO2005 / 063,328 and WO2006 / 130,903 (particularly describing the characteristics of the ResMed Limited MIRAGE LIBERTY ^TM full-face mask); WO2009 / 052,560 (In particular, the characteristics of ResMed Limited SWIFT ^TM FX nose pillow are described).

1.2.3.1.2 Positioning and Stabilization The seal forming part of the patient interface used for positive pressure air therapy is affected by the force of air pressure to collapse the seal. In this way, various techniques have been used to position the seal forming portion and maintain a sealing relationship with an appropriate portion of the face.

One technique is the use of adhesives. See, for example, US patent application US2010 / 00534. However, the use of adhesives can be unpleasant for some patients.

Another technique is the use of one or more straps and / or stabilizing straps. Many of these sashes suffer from the problems of one or more incompatibility, bulkiness, discomfort and awkwardness in use.

1.2.3.1.3 Vent Technology Some forms of patient interface systems may include vents for cleaning exhaled carbon dioxide. This vent can create a gas flow from the interior space of the patient interface, eg, to the plenum chamber, to the outside of the patient interface, eg to the atmosphere. The vent contains an orifice, through which gas passes during use of the mask. Many of these vents are noisy. Other vents block during use, resulting in inadequate cleaning. Some vents interfere with the sleep of patient 1000's bed partner 1100 due to noise or airflow focusing.

ResMed Limited has developed a number of improved mask venting technologies. See International Patent Application WO 1998 / 034,665; International Patent Application WO2000 / 078,381; US Patent 6,581,594; US Patent Application US2009 / 0050156; National Patent Application 2009/0044808.

(* Only one sample is measured by the test method specified in ISO3744 in CRAP mode at 10 cmH2O) Sound pressures of various objects are listed below.

1.2.3.2 Respiratory Pressure Therapy (RPT) Devices Air pressure generators are known for a variety of applications, such as industrial scale ventilation systems. However, medical air pressure generators have specific requirements that are not met by more general purpose air pressure generators such as reliability, size and weight. In addition, devices designed for medical use suffer from one or more drawbacks in comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost and reliability.

An example of a special requirement for some RPT devices is acoustic noise.

One known RPT device used for the treatment of sleep apnea disorders is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators such as the RedMed StellaTM series of adult and pediatric ventilators are invasive and non-invasively dependent on a variety of patients treating a number of conditions, including but not limited to NMD, OHS and COPD. Can provide support for breathing.

ResMed Elisee ^TM (TM) 150 ventilator and ResMed VSIII ^TM (R) ventilator, suitable for an adult or pediatric patient to treat a number of conditions, to provide support for invasion and noninvasive dependent ventilation Can be done. These ventilators provide volumetric and barometric respiration with single or double limb circuits. The RPT device typically consists of a pressure generator such as a motor driven blower or compressed gas reservoir and is configured to supply air flow to the patient's airways. In some cases, positive pressure can supply airflow to the patient's airways. The outlet of the RPT device is connected to the patient interface described above via an air circuit.

1.2.3.3 Humidifier If the air flow is sent without humidification, the airways may become dry. When using a humidifier with the RPT device and patient interface, a humidified gas is generated, which minimizes nasal mucosal dryness and increases patient airway comfort. In cooler climates, warm air is much more comfortable than cold air when it hits the face widely in and around the patient interface. A variety of artificial humidifiers and systems are known, but they may not meet the special requirements of medical humidifiers.

Typically, while the patient is sleeping or resting (eg in a hospital), a medical humidifier is used if necessary to increase the humidity and / or temperature of the air stream relative to the ambient air. The medical humidifier placed near the bed may be small. The medical humidifier may be configured to simply humidify and / or heat the air stream supplied to the patient without humidifying and / or heating around the patient. For example, room-based systems (eg, saunas, air conditioners or evaporative coolers) can also humidify the air that the patient breathes, but these systems will humidify and / or heat the entire room and are resident. May cause discomfort to the person. In addition, medical humidifiers have stricter safety restrictions than industrial humidifiers.

Many medical humidifiers are known, but they can suffer from one or more drawbacks. Some medical humidifiers provide inadequate humidification, and some are difficult or inconvenient for the patient to use.

The technology provides medical devices with one or more improved comfort, cost, effectiveness, ease of use and manufacturability used for the diagnosis, amelioration, treatment or prevention of respiratory diseases. There is.

A first aspect of the present invention relates to a device used for diagnosing, ameliorating, treating or preventing respiratory diseases.

Another aspect of the technique relates to methods used in the diagnosis, amelioration, treatment or prevention of respiratory diseases.

One aspect of this technique is to provide a method and / or device for improving the patient's respiratory treatment compliance.

One embodiment of the present technology includes at least one outlet orifice; a diffusion member covering the outlet orifice; and a block member having an air impervious member, wherein the gas exiting the outlet orifice passes through the diffusion member as it is. To prevent it from flowing.

Another aspect of one embodiment of the technique comprises a patient for at least one patient's nasal inlet and a sealed delivery of air flow to the patient's airway entrance at continuous positive pressure with respect to ambient pressure. in the interface, wherein the patient interface, the patient is asleep, through the patient's breathing cycle, the during use sleep disordered breathing to maintain a high therapeutic pressures in the range of about 4 cmH 2 _O of about 30 cm H 2 _O from ambient air pressure Improved, the patient interface is: with a sealing structure configured to seal around the patient's airway entrance; sealing at the area surrounding the patient's airway entrance and sealing contact while maintaining therapeutic pressure at the patient's airway entrance. A positioning and stabilization structure that maintains the structure; a plenum chamber that is configured to be pressurized to a pressure above atmospheric pressure during use; CO ₂ exhaled by the patient flows out of the plenum chamber, causing the patient to A gas cleaning vent that minimizes rebreathing of CO ₂ and the gas cleaning vent comprises at least one outlet orifice; a diffusion member that at least partially covers the outlet orifice; an air impervious member. The block member includes a block member, which prevents the gas exiting the outlet orifice from flowing directly to the diffusion member.

In an embodiment, (a) the diffuser and block member are configured to direct gas exiting the outlet orifice from the diffuser member outward in a direction different from the outlet orifice; (b) the diffuser member is a diffuser member. Provides a flow path parallel to the surface of the block member in contact with; (c) the diffuser is a porous material; (d) the diffuser is an open cell foam; (e) the diffuser is fibrous. (F) The block member is fixed to the diffuser along the surface of the block member in contact with the diffuser; (g) the surface of the diffuser is opposite the outlet orifice with respect to the thickness of the diffuser. (H) The patient interface further includes multiple outlet orifices; (i) the diffuser covers each of the outlet orifices; (j) the axis defined at the center of the orifif is the diffuser. Not perpendicular to the nearest surface of the; (k) the air impervious material is a flexible material; (l) the air impermeable material is a rigid material; (m) the patient interface , Further including a channel configured to drain the liquid from the outlet orifice; (n) the orifice is within the channel; (o) the channel has a V-shaped or U-shaped cross section; (p. ) The orifice is in a leg of a V-shaped or U-shaped cross section; (q) the block member includes a hole configured to divert the gas exiting the orifice; (r) The hole comprises multiple directions of the hole configured to direct the gas in multiple directions; (s) the diffuser and the block member are detachably attached to the plenum chamber; (t) the orifice The orifice is sized to provide virtually all pressure drops of gas passing through the wash vent and diffuser when therapeutic pressure is applied; (u) the orifice creates choke flow at therapeutic pressure; and / or (V) The orifice produces choke flow when the therapeutic pressure is about 4 cmH ₂ O.

Another aspect of one embodiment of the present disclosure, for a patient to improve sleep disorders during sleep, through the patient's breathing cycle, the therapeutic pressure above ambient pressure in the range of about 4 cmH 2 _O of about 30 cm H 2 _O A gas wash vent for a patient interface configured to maintain, the gas wash vent with at least one outlet orifice; with a diffuser covering the outlet orifice; and a block member with an air impervious material. Including, the block member prevents the gas exiting the outlet orifice from passing through the diffuser member as it is.

In an embodiment, (a) the diffuser and block member are configured to direct gas exiting the outlet orifice from the diffuser member outward in a direction different from the outlet orifice; (b) the diffuser member is a diffuser member. Provides a flow path parallel to the surface of the block member in contact with; (c) the diffuser is a porous material; (d) the diffuser is an open cell foam; (e) the diffuser is fibrous. (F) The block member is fixed to the diffuser along the surface of the block member in contact with the diffuser; (g) the surface of the block member is opposite the outlet orifice with respect to the thickness of the diffuser. (H) The gas cleaning vent further comprises a plurality of outlet orifices; (i) The diffusion member covers each of the plurality of outlet orifices; (j) The axis defined at the center of the orifif diffuses. Not perpendicular to the nearest surface of the member; (k) the air impervious material is a flexible material; (l) the air impermeable material is a rigid material; (m) the patient interface Further includes a channel configured to drain the liquid from the outlet orifice; (n) the orifice is within the channel; (o) the channel has a V-shaped or U-shaped cross section; p) The orifice is in a leg with a V-shaped or U-shaped cross section; (q) the block member includes a hole configured to divert the gas exiting the orifice; (r). The hole includes multiple directions of the hole configured to direct the gas in multiple directions; (s) the diffusion member and the block member are detachably attached to a gas cleaning vent; (t) the The orifice is sized to provide virtually all pressure drops of gas passing through the wash vent and diffuser when therapeutic pressure is applied; (u) the orifice creates choke flow at therapeutic pressure; and / Or (v) The orifice produces choke flow when the treatment pressure is about 4 cmH ₂ O.

Another aspect of one embodiment of the present disclosure, for a patient to improve sleep disorders during sleep, through the patient's breathing cycle, the therapeutic pressure above ambient pressure in the range of about 4 cmH 2 _O of about 30 cm H 2 _O A gas wash vent for a patient interface configured to maintain, said gas wash vent: with at least one outlet orifice defining a first axis; with a diffuser covering the outlet orifice; airless. With a block member having a penetrating material; the block member prevents gas exiting the outlet orifice from passing through the diffuser member as is, and has at least one hole through the block member, the hole demarcating a second axis. The first axis and the second axis are not aligned or parallel here.

In an embodiment, (a) the first axis and the second axis form an angle of 15 to 75 degrees; (b) the first axis and the second axis form an angle of 30 to 60 degrees. (C) The gas cleaning vent comprises a plurality of outlet orifices and a plurality of holes; (d) At least one outlet orifice is formed through the thickness of the material and the first axis is of the material. It forms a normal and sharp angle to the surface; the acute angle is 15 to 75 degrees; and / or (e) the acute angle is 30 to 60 degrees.

Of course, the aspects form the quasi-modes of the invention. In addition, the quasi-modes and / or modes can be combined in various ways to constitute additional or quasi-modes of the art.

Other features of the technology will be apparent in light of the information contained in the detailed description, abstracts, drawings and claims below.

3.1 Treatment system The technology is not limited and is illustrated by examples, where the same reference numbers refer to the same elements in the numbers in the accompanying drawings:

FIG. 1A shows a system comprising a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow, receiving positive pressure air from the RPT device 4000. The air from the RPT device is humidified in the humidifier 5000 and supplied to the patient 1000 through the air circuit 4170. Bed partner 1100 is also shown. FIG. 1B shows a system comprising a patient 1000 wearing a patient interface 3000 in the form of a nasal mask, receiving positive pressure air from the RPT device 4000. The air from the RPT device is humidified in the humidifier 5000 and supplied to the patient 1000 through the air circuit 4170. FIG. 1C shows a system comprising a patient 1000 wearing a patient interface 3000 in the form of a full face mask, which receives positive pressure air from the RPT device 4000. The air from the RPT device is humidified in the humidifier 5000 and supplied to the patient 1000 through the air circuit 4170. FIG. 1D shows 1000 patients undergoing a polysomnography (PSG). 3.2 Respiratory system and facial anatomy FIG. 2A shows an overview of the human respiratory system including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sac, heart and diaphragm. FIG. 2B provides an overview of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilage, alar cartilage, nose, upper lip, lower lip, larynx, hard palate, soft palate, mesopharynx, tongue, epiglottis, vocal cord folds, esophagus and trachea. Shown. FIG. 2C is a front view of some features of body surface anatomy including upper lip, upper red lip, lower red lip, lower lip, mouth width, endocantion, ala of nose, horay line and kaylion. Further up, down, radial inside and radial outside are shown. FIG. 2D shows some features of body surface anatomy including the glabellar, serion, pronazareth, subnasal point, upper lip, lower lip, splatmenton, nasal ridge, ala crest point, upper ear base point, lower ear base point. It is a side view of the head. Also shown are upward and downward and forward and backward directions. FIG. 2E is a further side view of the head. Frankfort horizontal and nasolabial folds have also been identified. The frontal surface is also shown. FIG. 2F is a bottom view of the nose showing some identified features including the nasolabial fold, lower lip, upper red lip, nostril, lower nose point, ear canal, pronazareth, main axis and sagittal plane of the nostril. Is. FIG. 2G is a side view of the features of the surface of the nose. FIG. 2H shows the subcutaneous structure of the nose including lateral cartilage, septum cartilage, large nasal ala cartilage, small nasal ala cartilage, sesamoid cartilage, nasal bone, epithelium, adipose tissue, maxillary frontal process and fibrous adipose tissue. FIG. 2I shows the medial anatomy of the nose about a few millimeters from the sagittal plane, especially the septal cartilage and medial leg of the alar cartilage. FIG. 2J is a front view of the bones of the head including the frontal nose and cheekbones. The turbinates are shown as the maxilla and mandible. FIG. 2K shows a side view of the contour of the surface of the head along with some muscles. The following bones are shown: frontal bone, butterfly bone, nasal bone, cheekbone, maxilla, mandible, crown of the skull, temporal and occipital bones. A chin uplift is shown. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle and trapezius muscle. FIG. 2L shows an anterolateral view of the nose. 3.3 Patient interface FIG. 3A shows a patient interface in the form of a nasal mask according to one embodiment of the technique. FIG. 3B shows the patient interface in the form of a full face mask, depicting various curved areas of the seal forming structure, such as the dome area, saddle area, edge cushion surface and holes in the cushion surface. There is. FIG. 3C is a cross section cut along line 3C-3C of FIG. 3B, showing an exemplary outline of the contour of the seal forming structure. FIG. 3D shows a bag cushion of a full face mask, which has a torus surface and depicts a saddle area and a dome area. FIG. 3E is a cross section cut along line 3E-3E of FIG. 3D, showing an exemplary outline of the contour of the bag cushion. FIG. 3F is a drawing of a swivel table and a related cylindrical region according to one embodiment of the present technology. FIG. 3G is a drawing of an example of the saddle area. FIG. 3H depicts an example of a negative curve and a positive curve that are combined to form the contour of the saddle region. FIG. 3I depicts an example of a dome region. FIG. 3J depicts an example of a plurality of negative curves that are combined to form the contour of the dome region. FIG. 4 depicts the orifice and the diffusion and block members that form part of the gas wash vent. FIG. 5 depicts the diffusion member and the block member forming a part of the gas cleaning vent, and the hole is in the block member. FIG. 6 is an exploded view of an orifice, a diffusion member forming a part of a gas cleaning vent formed in an annular shape around a central hole, and a block member. FIG. 7 is a simplified diagram of an orifice, a diffusion member forming a part of a gas cleaning vent formed in an annular shape around a central hole, and a block member. FIG. 8 is a drawing of a cross-sectional view taken along the line 8-8 of FIG. FIG. 9A depicts a partial view of an elbow with a gas wash vent with one ring-shaped outlet. FIG. 9B depicts an axial view of the orifice in the gas wash vent of FIG. 9B. FIG. 9C is a depiction of a cross section seen through the plane of the drawing of FIG. 9B, which is equivalent to the plane cut by 9C-9C in FIG. 9B. FIG. 10A depicts an elbow with a ball and socket joint and a gas wash vent. FIG. 10B is an exploded view of the elbow of FIG. 10A. FIG. 10C is a side view of the elbow. FIG. 10D depicts a cross-sectional view taken along the line 10D-10D of FIG. 10C.

Before discussing the technique in more detail, it should be understood that the technique is not limited to the particular embodiments described herein. It should also be understood that the terminology used in this disclosure is intended to describe only the particular embodiments discussed herein and is not intended to be limiting.

The following description is provided for various embodiments that share one or more properties and / or features. It should be understood that one or more features of any one embodiment can be combined with one or more features of the other embodiment or other embodiment. Moreover, a single feature or combination of features of any embodiment can constitute a further embodiment.

4.1 Treatment In one form, the technique comprises a method of treating respiratory disorders consisting of the steps of applying positive pressure to the airway entrance of patient 1000.

In certain embodiments of the technique, positive pressure air is supplied to the nasal passages through one or both nostrils of the patient.

In certain embodiments of the technique, mouth breathing is restricted, prohibited or prevented.

4.2 Treatment system In one form, the technique comprises an instrument or device for treating a respiratory disease. The device or device includes an RPT device 4000 that supplies the patient 1000 with pressurized air via an air circuit 4170 to the patient interface 3000.

4.3 Patient Interface The non-invasive patient interface 3000 according to one aspect of the technique has the following functional aspects: connecting to a seal forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300 and an air circuit 4170. One form of connection port 3600 for. In some cases, functional aspects may be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. During use, the seal forming structure 3100 is arranged so as to surround the patient's airway entrance so that the air supply to the airway is positive pressure.

4.3.1 Seal forming structure In one embodiment of the present technology, the seal forming structure 3100 can provide a seal forming surface and further provide a cushioning function.

The seal forming structure 3100 according to the present technology can be constructed of a soft, flexible and elastic material such as silicon.

In one form, the seal-forming portion of the non-invasive patient interface 3000 comprises a pair of nasal sprays or nasal pillows, each nasal spray or nasal pillow constructed to form a seal with each nostril of the patient's nose. And placed.

Nose pillows according to aspects of the technique include: a cranial cone, at least a portion of which forms a seal on the underside of the patient's nose, legs, a flexible portion of the cranial cone bottom and a cranial cone. Connect to the leg. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible area adjacent to the base of the leg. The flexible area acts in unison to act as a universal joint structure, corresponding to both displacement and angular relative motion of the structure in which the head cone and nasal pillow are connected. For example, the crowned cone can be axially displaced towards the structure to which the legs are connected.

In one form, the non-invasive patient interface 3000 comprises a seal forming portion that forms a seal on the upper lip portion of the patient's face, which is the lip superior, during use.

In one form, the non-invasive patient interface 3000 comprises a seal forming portion that forms a seal on the jaw portion of the patient's face during use.

4.3.2 Plenum Chamber The Plenum Chamber 3200 has a perimeter 3210 (see Figure 3c) that is shaped to complement the surface of the average human facial contour in the area where the seal is formed during use. Have. During use, the peripheral edge 3220 of the plenum chamber 3200 (see FIG. 3c) is positioned close to the adjacent surface of the face. The actual contact with the face is made by the seal forming structure 3100. The seal forming structure 3100 can extend to the entire periphery 3210 of the plenum chamber 3200 during use.

4.3.3 Positioning and stabilization structure 3300
The seal forming portion 3100 of the patient interface 3000 of the present technology is held in the sealing position during use by the positioning and stabilizing structure 3300.

In one embodiment of the technique, the positioning and stabilizing structure 3300 is configured to be suitable for wear by a sleeping patient. In one embodiment, the positioning and stabilizing structure 3300 has a thin or cross-sectional thickness to reduce the volume of the grasped or actual instrument. In one embodiment, the positioning and stabilizing structure 3300 has at least one strap having a rectangular cross section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

In one embodiment of the technique, the positioning and stabilizing structure 3300 includes a strap made of a laminate of a patient contact layer of fabric, an inner layer of foam and an outer layer of fabric. In one form, the foam is porous to allow moisture (eg, sweat) to permeate the strap. In one form, the outer layer of the fabric comprises a loop material to engage the material portion of the hook.

In certain embodiments of the technique, the positioning and stabilizing structure 3300 comprises an extensible, eg, elastically stretchable strap. For example, the strap is configured to stretch during use, pulling in the cushion and directing force into sealing contact with the patient's facial area. In an embodiment, the strap is configured like a fixture.

In certain embodiments of the technique, the positioning and stabilizing structure 3300 comprises bendable, eg, non-rigid straps. The advantage of this aspect is that the patient is more comfortable lying down during sleep.

4.3.4 Vent In one form, the patient interface 3000 includes a vent 3400 connected and arranged to wash the exhaled carbon dioxide and is therefore also referred to as a gas wash vent.

One form of vent 3400 according to the present invention includes and describes a plurality of orifices 3402, such as, for example, about 20 to about 80 orifices, or about 40 to about 60 orifices, or about 45 to about 55 orifices. Includes each of the whole integrals of.

The vent 3400 can be placed in the plenum chamber 3200. As an alternative, the vent 3400 can be placed in a separate structure 3500, such as a swivel (see FIG. 3a).

FIG. 4 illustrates a cross section of some orifices 3402. The orifice 3402 is exemplified as a hole through the wall 3404 of the plenum chamber 3200. However, the orifice 3402 can be located at a location other than the wall 3404. For example, the orifice 3402 can be located between the separation structure 3500 and the connection port 3600 or in the portion of the air circuit 4170, preferably near the connection port 3600. The holes are illustrated with diameters shorter than the axial length of the holes. The length and / or diameter can be selected to generate the appropriate flow rate when the plenum chamber 3200 is pressurized to therapeutic pressure. The flow through the orifice 3402 is choked at therapeutic pressure (eg, 4 cmH ₂ O or higher) (eg, Mach number 1) or the flow produces a flow rate less than a pressure drop sufficient to be choked. The choked flow results in virtually all pressure drops in the vent 3400 where the orifice 3402 is generated. The arrows conceptually illustrate the direction of flow when the plenum chamber 3200 is pressurized above atmospheric pressure.

Orifice 3402 is formed through the material thickness of wall 3404. Each of the orifices 3402 defines an axis, for example, along the center of the orifice. This axis forms a normal and acute angle to the surface of the wall 3404. This angle includes any perfect field within the described range and is 15 to 75 degrees or 30 to 60 degrees. For example, this angle can be about 45 degrees.

The orifice 3402 is covered with the diffusion member 3406 so that the flow exiting the orifice 3402 affects the diffusion member 3406 and at least partially flows to the diffusion member. The diffusing member 3406 can be formed from a material such as a porous material such that the gas flows through the material but diffuses any jet or other flow formation exiting the orifice 3402. Some suitable examples of diffusing materials include non-woven fiber materials; woven fiber materials; or open cell foams. The diffusing material can be a medium similar to or the same as the filter medium. The diffusing material 3406 can reduce the perceptible noise generated by the vent 3400 during use (eg, when therapeutic pressure is applied).

An example is a diffusion member 3406 covered by a block member 3408 that prevents gas from flowing out of the orifice 3402 and passing directly through the diffusion member 3406. The block member 3408 is constructed from at least a part of an air impervious material. The air impervious material may be any suitable flexible or rigid material. For example, the air impervious material may be a hard plastic (eg, molded polycarbonate) or a flexible plastic (eg, a plastic commercially available in sheet form). The block member 3408 can be molded integrally with the diffusion member 3406 and can be molded separately but is attached to the diffusion member 3406 so that it cannot be removed, and is molded separately and in removable contact with the diffusion member 3406 or a combination thereof. .. The block member 3408 is exemplified on the opposite side of the outlet orifice 3402 with respect to the thickness of the diffusion member 3406.

The block member diverts the flow (with respect to the direction through the orifice 3402) before exiting the diffusion member 3406. The block member 3408 and / or the diffusing member 3406 is configured such that the flow exiting the orifice 3402 must flow at least a predetermined distance through the diffusing member 3406 before leaving the ambient atmosphere. The block member 3408 may also be configured to provide a particular direction and / or directionality so that the flow exiting the vent 3400 minimizes the disturbance to the wearer and / or bed partner caused by the flow. it can. For example, the block member 3408 can allow gas to pass through the diffusing member 3406 so that it is generally parallel to the surface of the block member 3408 closest to the diffusing member 3406.

In FIG. 4, the orifice 3402 and the diffuser 3406 can be arranged vertically as shown in FIG. 8, but the central axes of the respective orifices are oriented so that they are not perpendicular to the nearest surface of the diffuser 3406. ..

Channel 3410 can be applied to the outer surface of wall 3404. The channel 3410 is illustrated in a V-shaped cross section, but can be formed in any suitable cross section, such as a U-shaped cross section. Channel 3410 can be configured to drain liquid from one or more outlets of orifice 3402. Orifice 3402 can be formed in V-shaped or U-shaped legs.

FIG. 5 illustrates the configuration of an alternative block member 3408. In FIG. 5, the block member 3408 includes a hole 3412. The hole 3412 can direct the outflow of the diffusing member 3406 to the opposite side of the orifice 3402, but in a different direction. The flow path is not straight through the orifice 3402 and the diffusion member 3406. The arrows associated with holes 3412 are illustrated in parallel, but for ease of illustration only. The hole 3412 can be configured to redirect the flow in multiple directions.

Each hole 3412 is neither aligned nor parallel to the axis defined by the respective orifice 3402. Seen from the cross section of FIG. 5, any axis defined by the hole 3412 and any axis defined by the orifice 3402 form an angle. This angle includes any perfect field in the range described and is between 15 degrees 75 degrees or between 30 degrees and 60 degrees. For example, this angle is about 45 degrees.

FIG. 6-8 illustrates an alternative configuration of the vent 3400. FIG. 6 is a partially exploded view, FIG. 7 is a partially assembled view, and FIG. 8 is an example of a cross-sectional view taken along the line 8-8 of FIG. In these figures, the orifice 3402 is illustrated in a circular arrangement around the central hole 3414. This circular arrangement is illustrated to include three main rows of holes, where the two innermost circular rows are closer to each other than the outermost circular row, but of any number. A series of circles can be provided and the spaces between columns are equal. The central hole 3414 allows fluid communication between the plenum chamber 3200 and the connection port 3600, and also with the air circuit 4170. The diffuse member 3406 and the block member 3408 are also exemplified as being arranged around the central hole 3414. In this configuration, the block member 3408 is removable attached (eg, removable snap or screw attached) or fixed and attached (eg, snap attached that must be broken to permanently bond or disassemble) and diffuse member. The 3406 is fixed to or not fixed to the block member 3408 but is held by the block member 3408. As optimally shown in FIG. 7, the radial opening 3416 is provided so that the gas exits the diffuser 3406 radially outward from the central hole 3414.

9a-9c illustrate the configuration of another alternative to the vent 3400. FIG. 9a is a partial view of the flow path in one form of elbow 3418, which may be located between the separation structure 3500 and the connection port 3600 (both illustrated in FIG. 3a) and includes a vent 3400. Since this configuration hides most of the features of the vent 3400, the following description will be referred to in FIGS. 9b and 9c.

FIG. 9b is an axial view in which the cap 3422 and the diffusion member 3406 are omitted. The outlet orifice 3402 is clearly visible in this figure. Two annular rows are illustrated, each containing 40 outlet orifices 3402. The orifices are offset so that the outlet orifices 3402 in the inner and outer rows are radially aligned. In this configuration, the circular rows can be closer together. Although two columns are illustrated, any number of columns can be provided, for example one column or three columns or more. Forty outlet orifices 3402 are illustrated in each annular row, but can provide more or less orifices needed to maintain an appropriate level of gas cleaning. For example, one, five, 10, 15, 20, 25, 30, 35, 40, 45, 50 or more orifices 3402 per annular row, or a number of orifices in between can be provided.

In FIG. 9c, the annular row of orifices 3402 can be seen in cross section through the wall 3420. The wall 3420 is similar to the wall 3404, except that the wall 3420 is illustrated apart from the plenum chamber 3200; however, the wall 3420 is part of the plenum chamber 3200.

The diffusion member 3406 is exemplified as a ring shape having a rectangular cross section. The block member 3408 is exemplified as a relatively thin sheet-like ring on the side of the diffusion member 3406 opposite the orifice 3402. The block member 3408 is attached to the diffusion member 3406 by any suitable method, such as adhesive.

The cap 3422 is exemplified to cover the diffusion member 3406 and the block member 3408. The cap 3422 is in contact with the block member 3408 so that the diffusion member 3406 is pressed against the wall 3420. As an alternative, the diffuser 3406 does not have to be pressed against the wall 3420. The cap 3422 can serve as a block member, in which case the ring-shaped block member 3408 illustrated in FIG. 9c can be omitted.

The cap 3422 includes an angled annular flange 3424 that forms an annular gap 3426 away from the wall 3420. The annular flange 3424 can also be considered skirt-like or truncated cone-shaped. The annular gap 3426 provides a flow path to the surrounding atmosphere so that the flow of gas cleaning is not excessively restricted. Alternatively, one or more openings (such as radial openings 3416) are provided within the annular flange 3424 to provide a flow path to the surrounding atmosphere, thereby providing whole or part of the annular gap 3426. Can be removed.

The cap 3422 is illustrated with an annular groove 3428 combined with an annular projection 3430 that holds the cap 3422 in place. An annular projection is a continuous or annularly spaced projection to form a snap attachment that provides a twist for axial interference without minimal interference or interference with axial insertion and provides a cap 3422 for predetermined. Provide a configuration to hold in place. In FIG. 9c, the annular projection 3430 is exemplified as three annularly spaced annular projections. The lip 3432 of the annular groove 3428 can be omitted at three corresponding positions and is sized so that there is little or no interference with the cap 3422 during axial insertion. Other forms of attachment are possible. For example, a screw-type tightening arrangement is provided and the cap 3422 is held in place by adhesive or welding. Releasable tightening, such as the configuration or screw connection illustrated, allows the diffuser 3406 to be replaced if, for example, the diffuser is damaged, clogged or contaminated.

The vent 3400 is illustrated on one side of the vent in the elbow 3418 (eg, upstream with respect to the direction of exhalation), but the vent 3400 may be upstream or downstream of the bend.

10a-10c exemplify another alternative configuration of the vent 3400. The same reference number is the same as above, and therefore, description other than the following is omitted. The vent 3400 in these figures is formed around an example of a separate structure 3500 that includes a ball 3434 and a socket 3436 that are part of an elbow 3418. In the embodiment illustrated here, the ball 3434 and the socket 3436 have three degrees of freedom in rotation. However, several degrees of freedom of rotation are possible, for example one or two degrees of freedom of rotation.

As is well seen in FIG. 10d, the cap 3422 is connected to the first half 3440 located on the cap 3422 and the second half on the companion component with a snap-mount connection 3438. Six of each of the first half 3440 and the second half 3442 are provided between the radial openings 3416, three of which appear in FIG. 10a. However, more or less can be provided as needed to obtain adequate holding power and / or flow rate.

As can be clearly seen in FIG. 10c, 44 orifices 3402 equally spaced in a single annular row are illustrated. However, the number and spacing of orifices 3402 can be different. For example, a small number of orifices 3402 can be used when a low flow rate is required, and a large number of orifices 3402 can be used when a large flow rate is required. As explained above, more columns can be provided. Also, the orifices do not have to be in an annular arrangement. If the orifice is in a position other than the illustrated position, it can be placed in a grid based on Cartesian coordinates. Alternatively, the orifice 3402 need not be of any type of row and can be placed in a random or pseudo-random position.

4.3.5 Separate structure (plural)
In one embodiment, the patient interface 3000 includes at least one separate structure 3500, such as a swivel or ball and socket.

4.3.6 Connection Port The connection port 3600 allows connection to the air circuit 4170.

4.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700.

4.3.8 Anti-respiratory arrest valve In one form, the patient interface 3000 includes an anti-respiratory arrest valve.

4.3.9 ports (plural)
In one embodiment of the technique, the patient interface 3000 includes one or more ports that can access the volume within the plenum chamber 3200. In one of these forms the clinician can replenish oxygen. In one embodiment, the properties of the gas in the plenum chamber 3200, such as pressure, can be measured directly.

4.4 Glossary For the purposes of publication of the Technology, one or more of the following definitions may be applied in some form of the Technology. Alternative definitions can be applied in other forms of the art.

4.4.1 General air: In some forms of the technology, air means atmospheric air, and in other forms of the technology, air is some of the breathable gases, such as oxygenated atmospheric air. Means other combinations of.

Periphery: In certain embodiments of the art, perimeter terms mean (i) external to the treatment system or patient, and (ii) directly surrounding the treatment of the system or patient.

For example, the ambient humidity associated with a humidifier is the humidity that directly surrounds the humidifier, such as the humidity of the room in which the patient is sleeping. Such ambient humidity is different from the humidity outside the room where the patient is sleeping.

In another embodiment, the ambient pressure is the pressure directly surrounding or outside the body.

In some embodiments, the ambient noise (eg, acoustics) can be thought of as the background noise level of the patient's room, other than, for example, the noise generated by the RPT device or the noise emitted from the mask or patient interface. Ambient noise is generated from sources outside the room.

Continuous Positive Airway Pressure (CPAP) Treatment: CPAP treatment is the application of air to the airway inlet at a pressure that is continuously positive with respect to the atmosphere, and the pressure is nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance of the airway is slightly higher during inhalation and slightly lower during exhalation. In some forms, pressure fluctuates between different respiratory cycles of the patient. For example, it increases in response to the detection of signs of partial obstruction of the upper airway in the patient and decreases in the absence of signs of partial obstruction of the upper airway.

Patient: Human with or without respiratory illness.

Automatic Positive Pressure Airway Pressure (APAP) Treatment: CRAP treatment in which the treatment pressure is automatically adjusted depending on the presence or absence of SDB events, for example, from breathing to breathing, between minimum and maximum.

4.4.2 Aspects of respiratory rate cycle Apnea: By some definitions, apnea is said to occur when the flow drops below a predetermined threshold for a period of time, eg 10 seconds. Obstructive apnea is said to have occurred when air was blocked due to airway obstruction despite the patient's efforts. Central apnea is said to have occurred when the airway is open but apnea is detected due to decreased respiratory effort or when no respiratory effort is made. Mixed apnea is said to have occurred when reduced or lack of respiratory effort occurred at the same time as airway obstruction.

Respiratory rate: The rate of spontaneous breathing of a patient, usually measured by breathing per minute.

Load cycle: ratio of inhalation time, ratio of total respiration time to Ti, Tiot.

Effort (breathing): Breathing effort is said to be the work done by the spontaneous breathing of the patient trying to breathe.

Expiratory part of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

Flow restriction: Flow restriction is interpreted as a situation in the patient's respiratory function, where the result of the patient's efforts does not result in a corresponding increase in flow. When flow limitation occurs in the inspiratory portion of the respiratory cycle, it is described as inspiratory flow limitation. When flow restriction occurs in the expiratory part of the respiratory cycle, it is described as expiratory flow restriction.

Inspiratory waveform type with restricted flow:
(I) Flattened: There is an ascent, followed by a relatively flat area, followed by a descent.
(Ii) M-type: There are two local peaks, one at the front edge, one at the trailing edge, and the space between the two peaks is relatively flat.
(Iii) Chair-like: There is a single local peak, which is on the leading edge and is followed by a relatively flat area.
(Iv) Inverted chair shape: There is a relatively flat part, followed by a single local peak, which is at the trailing edge.

Decreased breathing: Preferably, decreased breathing is a decrease in flow, not a break in flow. In one form, if there is a period of subthreshold flow reduction, it is said that respiratory depression has occurred. Central apnea occurred when respiratory depression occurred due to reduced respiratory effort. In one form in adults, any of the following can be said to be respiratory depression:
(I) Patient breathing is reduced by 30% for at least 10 seconds and there is an additional 4% associated desaturation; or (ii) Patient breathing is reduced for at least 10 seconds (but less than 50%) and at least 3% There is associated desaturation or arousal.

Hyperventilation: Increased flow to levels higher than normal flow.

Inspiratory part of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is called the inspiratory part of the respiratory cycle.

Openness (airway): The degree of open airway or the degree to which the airway is open. The open airway is open. Airway patency is quantified as open at a value of (1) and obstruction at a value of zero (0).

Positive end-expiratory pressure (PEEP): A pressure above the air pressure in the lungs that is present at the end of exhalation.

Peak flow rate (Qpeak): The maximum value of the flow rate between the inspiratory parts of the respiratory air flow waveform.

Respiratory flow, air flow, patient air flow, respiratory air flow (Qr); these synonyms may be understood to refer to the estimation of respiratory flow in the RPT device. On the other hand, there is an actual respiratory flow rate "true respiratory flow rate" or "true respiratory air flow" experienced by the patient, which is usually expressed in liters per minute.

Tidal volume (Vt): The amount of air that is inhaled or exhaled during normal breathing when no extra effort is made.

(Inspiratory time) (Ti): The period of the inspiratory part of the respiratory air flow waveform.

(Exhalation) Time (Te): The duration of the respiratory part of the respiratory air flow waveform.

(Total) Time (Ttot): The total period between the start of the inspiratory portion of one respiratory airflow waveform and the start of the inspiratory portion of the subsequent respiratory airflow waveform.

Typical Recent Ventilation: Ventilation values where recent values tend to cluster around it over a given time scale. That is, measurement of the central tendency of recent values of ventilation.

Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This is related to a state of flow restriction, where the level of flow may increase or even decrease slightly as the pressure difference across the upper airway increases (Sterling register behavior).

Ventilation: A measurement of the total amount of gas exchanged in the patient's respiratory system. Ventilation measurements include one or both inspiratory and expiratory airflows per unit time. In terms of volume per minute, this amount is often referred to as "minute ventilation". Ventilation is sometimes given simply as volume and is understood as volume per minute.

4.4.3 RPT device parameters Flow rate: Instantaneous volume (or mass) of air delivered per unit time. Flow rate and ventilation have the same magnitude of capacity or mass per unit time. Flow rate is measured over a much shorter period of time. In some cases, the reference to the flow rate is a reference to the scalar quantity. That is, it is an amount having only a size. In other cases, the reference to the flow rate is the reference to the vector quantity. That is, it is an quantity having both size and direction. For signed quantities, the flow rate is nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion of the patient's respiratory cycle. The flow rate is given by the symbol Q. In some cases, "flow rate" is simply shortened to "flow rate." The total flow rate Qt is the flow rate of air leaving the PAP device. The vent flow rate Qv is the flow rate of air for cleaning the gas discharged from the vent. Leakage flow rate Ql is the flow rate of leakage from the patient's interface system. Respiratory air flow rate QR is the flow rate of air received by the patient's respiratory system.

Leakage: The word leak is interpreted as an unintended flow of air. In one example, the leak results in an incomplete seal between the mask and the patient interface. In another example, the leak occurs in the swivel elbow to the surroundings.

Noise, Conductivity (Acoustic): Conducted noise as used herein refers to noise transmitted to a patient through, for example, an air circuit and a patient interface and an air passage such as air in it. In one embodiment, conduction noise is quantified by measuring the sound pressure at the end of the air circuit.

Noise, Radiation (Acoustic): Radiation noise herein refers to the noise brought to the patient by the ambient air. In one embodiment, radiated noise is quantified by measuring the sound power / pressure level of interest in question according to ISO 3744.

Noise, Vent (Acoustic): Vent noise herein refers to noise generated by the flow of air through any vent, such as a hole in a patient interface.

Pressure: The force applied to a unit area. Pressure is measured in various units such as cmH ₂ O, gf / cm ² , and hectopascals. 1 cmH ₂ O is equal to 1 g-f / cm ² and is about 0.98 hectopascals. Unless otherwise indicated, the pressure in the present specification are given in cm H 2 _O. The pressure at the patient interface is given by the symbol Pm and the therapeutic pressure indicating the target value achieved by the mask pressure Pm at the current time is given by Pt.

Sound power: Energy carried by sound waves per unit time. Sound power is proportional to the square of the sound pressure multiplied by the area of the wave surface. Sound power is usually given in decibel SWL, which is described with respect to reference power and is usually ^10-12 watts.

Sound pressure: A local deviation from ambient pressure at a given time as a result of sound waves passing through a medium. Sound pressure is usually described in SPL. That is, it is described with respect to the reference pressure and is usually 20 × 10 ^-6 pascal (Pa), which is considered to be the threshold for human hearing.

4.4.4 Ventilator terminology Adapted Servo Ventilator (ASV): A servo ventilator with variable ventilation rather than fixed target ventilation. Variable target ventilation can be learned from several characteristics of the patient, such as the patient's respiratory characteristics.

Backup rate: Ventilator parameters (typically breathing rate per minute) that determine the minimum respiratory rate that the ventilator delivers to the patient if not triggered by spontaneous breathing effort.

Cycled: End of the inspiratory phase of the ventilator. When the ventilator is providing breathing to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to have cycled to stop providing breathing.

ECAP: At the base pressure, where fluctuating pressure is applied during breathing, the ventilator produces the desired mask pressure that it attempts to achieve at a given time.

IPAP: The desired mask pressure that the ventilator seeks to achieve during the inspiratory portion of breathing.

Pressure support: A number that indicates an increase in pressure during exhalation of the ventilator, meaning the pressure difference between the maximum value during exhalation and the minimum value during exhalation (eg PS = IPAP-EPAP). In some situations pressure support means the difference that pressure support intends to achieve rather than what the ventilator actually achieves.

Servo Ventilator: A ventilator that measures patient ventilation and has target ventilation, which adjusts the level of pressure support to direct patient ventilation to target ventilation.

Spontaneous / Timed (S / T): A mode in which there is a ventilator or other device that attempts to detect the onset of breathing in a patient who breathes spontaneously. However, if the device fails to detect breathing within a given time, the device will automatically initiate delivery of the breath.

Swing: An equivalent term for pressure support.

Triggered: When the ventilator delivers air breathing to a spontaneously breathing patient, it is said to have been triggered at the beginning of the expiratory portion of the breathing cycle by patient effort.

Typical Recent Ventilation: A typical recent ventilation Vtype is a value in which recent measurements of ventilation at a given time scale tend to cluster around it. For example, a central tendency measurement of ventilation measurements in a recent history would be an appropriate value for typical recent ventilation.

Ventilator: A mechanical device that provides pressure support to the patient to perform some or all of the work of breathing.

4.4.5 Facial Anatomy Wings: External outer wall or “wing” of each nostril.

Wing: The most lateral point of the nose wing.

Wing-like curvature (or wing-like apex) point: The last point in the curvature baseline of each wing, found in the folds formed by the wing-cheek junction.

Auricle: The entire visible part of the outside of the ear.

(Nose) skeleton: The nasal skeleton consists of the nasal bone, the frontal process of the maxilla and the nasal part of the frontal bone.

(Nose) Synchondrosis Skeleton: The synchondrosis skeleton of the nose consists of medial, lateral, major and minor cartilage.

Axial column: An elongated piece of skin that divides the nostrils and runs from the front nose to the upper lip.

Axial column angle: The angle between the line that passes through the middle of the nostril opening and the line that crosses under the nose and is perpendicular to the Frankfurt horizon.

Frankfurt horizontal plane: A line extending from the bottom of the orbital margin to the left ear point. The ear point is the deepest point in the notch above the tragus of the pinna.

Glabellar: Located in soft tissue, the most protruding point on the mid-sagittal plane of the forehead.

Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the nasal ala cartilage.

Lower lip (Lablerley Inferius):

Upper lip (Labler race-Perius):

Alar cartilage: The surface of the cartilage that lies beneath the lateral nasal cartilage. Curved around the front of the nostrils. Its upper end is connected to the frontal process of the cartilage by a tough fibrous membrane containing three or four minor cartilage of the wing.

Nostrils (nostrils): A nearly elliptical opening that forms the entrance to the nasal cavity. The singular form of the nostrils is the nostrils. The nostrils are separated by the nasal septum.

Nasolabial fold or fold of the nose: A fold or crevice of the skin that runs from each side of the nose to the corner of the mouth, separating the cheeks from the upper lip.

Nose-lip angle: Crosses under the nose at an angle between the axis and the upper lip.

Lower ear base point: The lowest point of attachment of the pinna to the skin of the face.

Upper ear base point: The highest point of attachment of the pinna to the skin of the face.

Anterior nose: The most prominent point or tip of the nose, identified by a side view of the rest of the head.

Indentation under the nose: A midline groove that runs from the lower border of the nasal septum to the top of the lips in the upper lip area.

Mandibular point: Located in soft tissue, the most anterior midpoint of the jaw.

Protrusions (of the nose): The protrusions of the nose are ridges of the midline of the nose, extending from Serion to Pronazareth.

Sagittal plane: A vertical plane that runs from the front to the back and divides the human body into the right and left halves.

Selion: The most recessed point in the soft tissue that covers the area of the frontal suture.

Nasal septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

Under the wing: A point at the lower edge of the wing base, where the wing base connects to the skin of the upper lip.

Nasal spine: Located in soft tissue, at this point meets the upper lip in the mid-sagittal plane.

Splatoon: The point of maximum concaveness at the midline of the lower lip between the upper lip teeth and the soft tissue pogonion.

4.4.6 Skull Anatomy Frontal: The frontal bone contains a large vertical part, the squamous part of the frontal, corresponding to the area known as the forehead.

Mandible: The mandible forms the mandible. The chin ridge is the bony process of the jaw that forms the jaw.

Maxilla: The maxilla forms the maxilla, above the mandible and below the orbit. The maxillary frontal process projects upward on the side of the nose and forms the anterior part of its lateral boundary.

Nasal bones: The nasal bones are two small oval bones that vary in size and shape from individual to individual; they are placed side by side in the center and top of the face, and their joints form the "protrusions" of the nose.

Nasal point: The intersection of the frontal bone and the two nasal bones, a depression between the eye and the nasal process.

Occipital bone: The occipital bone is located posterior and inferior to the skull. It contains an oval opening, the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved surface behind the foramen magnum is the occipital scale.

Orbit: A bone cavity within the skull that contains the eyeball.

Parietal bone: A bone that, when combined, forms the top and sides of the skull.

Temporal bone: The temporal bone is located at the base and sides of the skull and supports a part of the face known as the temple.

Cheekbones: The face is located on the top and sides of the face and is the two cheekbones that form the cheek protrusions.
4.4.7 Anatomy of the respiratory system

Diaphragm: A sheet of muscle that stretches across the bottom of the rib cage. The diaphragm separates the thoracic cavity, including the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thorax increases and air is drawn into the lungs.

Larynx: The larynx, or larynx, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

Lungs: Respiratory organs in humans. The conduction band of the lungs includes the trachea, bronchioles, bronchioles and terminal bronchioles. Respiratory zones include respiratory bronchioles, alveolar ducts and alveoli.

Nasal cavity: The nasal cavity (or nasal fossa) is an air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by vertical fins called the nasal septum. On the nasal side, there are three horizontal growths called turbinates (singularly "concha") or turbinates. There is a nose in front of the nasal cavity, and the posterior part melts into the nasopharynx through the choana.

Pharynx: The throat is located just below (below) the nasal cavity and above the esophagus and pharynx. The pharynx is usually divided into three sections: the nasopharynx (nasopharynx) (the nasal part of the pharynx), the mesopharynx (the mesopharynx) (the oral part of the pharynx) and the pharynx (the hypopharynx).

4.4.8 Material Silicone or Silicone Elastomer: Synthetic rubber. As used herein, silicon refers to liquid silicone rubber (LSR) or compression-formed silicone rubber (CMSR). One form of commercial LSR is SILASTIC manufactured by Dow Corning (included in the product range sold under this trademark). Another company that manufactures LSR is Wacker. Unless otherwise stated, exemplary forms of LSR have Shore A (or Type A) press-fit hardness in the range of about 35-45 as measured according to ASTM D2240.

Polycarbonate: A typically clear thermoplastic polymer of bisphenol-A carbonate.

4.4.9 Patient Interface Aspect Anti-Respiratory Stop Valve (AAV): A component or subassembly of the mask system that opens to the atmosphere in a fail-safe manner reduces the risk of excessive CO ₂ rebreathing in the patient.

Elbow: A conduit that changes the direction of the air flow axis and changes the direction through the angle. In one form, the angle may be about 90 degrees. In another embodiment, the angle may be 90 degrees or less. This conduit has a nearly circular cross section. In another form, the conduit can have an elliptical or rectangular cross section.

Frame: Frame means a mask structure that withstands the load of tension between two or more connection points with headgear. The frame of the mask may have a non-confidential load resistant structure in the mask. However, some forms of mask frames may also be airtight.

Headgear: Headgear may be interpreted to mean a form of positioning and stabilizing structure designed for use on the head. Preferably, the headgear comprises a collection of one or more braces, a fixture and a stiffener configured to place and hold the patient interface in place on the patient's face for delivery of respiratory treatment. .. Some fixtures are made of a soft, flexible elastic material, such as a laminated composite of foam and woven fabric.

Membrane: preferably interpreted to mean a thin element that is not substantially resistant to bending but is resistant to stretching.

Plenum Chamber: The mask plenum chamber is interpreted to mean part of a patient interface that has a wall surrounding a capacitive space, in which this volume has air that is more pressurized than the atmosphere during use. The shell may form part of the mask plenum chamber.

Seal: The noun form (“a seal”) is interpreted to mean a structure or barrier that is intentionally resistant to the flow of air through the interface between the two surfaces. The verb form (“to seal”) is interpreted to mean resisting the flow of air.

Shell: Shell is interpreted to mean a curved, relatively thin structure with bending, tensile and compressive stiffness. For example, the curved structural wall of the mask can be a shell. In some forms, the shell may be faceted. In some cases, the shell may be airtight. In some cases, the shell does not have to be airtight.

Stiffener: Stiffener is interpreted to mean a structural component designed to increase the bending resistance of another component in at least one direction.

Brace: Brace is interpreted to mean a structural component designed to increase the compression resistance of another component in at least one direction.

Swivel: (noun) An assembly of components configured to rotate around a common axis, preferably independently, preferably under low torque. In one embodiment, the swivel may be constructed to rotate at least 360 degrees. In another embodiment, the swivel may be constructed to rotate at an angle of 360 degrees or less. When used in the context of air delivery conduits, the component subassembly preferably comprises a matched pair of cylindrical conduits. During use, there is little or no air leakage from the swivel.

Fixtures: Fixtures can be interpreted as meaning structural components designed to withstand tension.

Vent: (noun) A structure that provides a deliberate flow of air from the inside of a mask or conduit to the ambient air, for example, to clean the exhaled gas.

4.4.10 Terminology used in connection with the patient interface Curvature (at a point on the surface): At a point p on the surface, there is a normal (eg, perpendicular to the outer surface). Each surface containing the normal ('normal plane') cuts the surface and defines a curve. The curvature of the curve at p can be described as having a sign and magnitude (eg, 1 / radius of a circle in contact with the curve at p). The direction of the plane where the curve has the maximum and minimum values is called the main direction. The principal curvature at p is the curvature in the principal direction.

Curvature (of the surface): A region of the surface with a saddle shape that curves in one direction and goes up and down in a different direction is said to have a negative curvature. Areas of the surface that have a dome shape that curves similarly in the two main directions are said to have a positive curvature. A flat surface is considered to have zero curvature.

Cylindrical region: A surface region that contains a path, where each point in the area near the path has a zero curvature (or virtually zero curvature) tangent to the path and a nonzero curvature in the direction perpendicular to it.

Dome region: A set of points on the surface whose principal curvatures have the same sign, for example both positive or negative.

Edges (of the surface): Surface boundaries or limits.

Floppy: Quality of one or more of the following materials, structures or composites:
・ Immediately follow acupressure.
-When you have to support your own weight, you cannot keep its shape.
・ It is not a rigid body.
-Can be elastically stretched and bent with little effort.

The quality of being a floppy is related to orientation, so a particular material, structure or composite is a floppy in the first direction, but a second direction, such as a second direction orthogonal to the first direction. Rigid or rigid in the direction of.

Intersection of two surfaces: The path where the two surfaces meet.

Negative curvature: If the curve at p deviates from the normal (eg, concave downwards), the curvature in that direction at that point is considered negative.

Path: Path: In some embodiments of the art,'path' is a path with a mathematical-topological sense, for example, a continuous space from f (0) to f (1) on the surface. In some embodiments of the art, a'path' includes, for example, a set of points on the surface and is described as a route or course.

Patient Perspective: The orientation of the object, such as during normal use by the patient.

Planar region: A surface region where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

Positive Curvature: If the curve at p goes toward a normal (eg, concave upwards), the curvature in that direction at that point is considered positive.

Resilient: It can deform substantially elastically and, when unloaded, releases virtually all energy in a relatively short time, for example 1 second.

Mountain spine: A region of the surface where the curvature of each point in the first direction is non-zero and has the same size and sign.

Rigid: Not easily deformed by acupressure and / or by the tension or load typically encountered when setting up and maintaining the patient interface in a sealing relationship with the patient's airway entrance.

Surface Labeling: Some physical structures according to the present art can include one or more surfaces. Such surfaces can be distinguished using labels that describe the orientation, position, function or some other features of the associated surface. For example, some structures consist of one or more anterior, posterior, inner and outer surfaces. In another example, the cushion structure consists of a face-contacting (eg, outer) surface and another non-face-contacting (eg, lower or inner) surface. In another embodiment, the structure comprises a first surface and a second surface.

Semi-hard: means that it is hard enough so that it does not substantially deform under the influence of mechanical forces typically applied during respiratory pressure treatment.

Saddle region: A set of points on the surface with opposite signs, one principal curvature positive and the other negative, at each point in the set.

Surface: A set of three-dimensional points drawn with two independently varying parameters, such as a sphere, is parameterized by latitude and longitude.

4.5 Other Notes Some of the disclosures in this patent document include copyright protection matters. The copyright owner does not object to any reproduction of a patent document or disclosure of a patent as long as it appears in the patent office's patent file or record. If not listed, we reserve the copyright for anything.

Unless explicitly stated in the context, and unless a range of values is stated, each intervening value is between the upper and lower limits of the range, up to 1/10 of the lower limit unit, and its description. Any other described or intervening value in the specified range is included in the art. The upper and lower limits of these intervening ranges may be independently included in the intervening range, subject to any specifically excluded limits in the stated range, and are included within the scope of the present invention. Where the described range includes one or both limits, the technique also includes the range excluding either or both of these included limits.

Further, if one or more values are stated to be incorporated herein as part of the technique, such values may be approximated and of practical skill unless otherwise noted. It should be understood that such values are available up to any suitable significant digit to the extent that the implementation allows or requires.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technique belongs. Any method or material similar to or equivalent to that described herein can also be used in the practice or testing of the art, but a limited number of exemplary methods and materials are described herein.

If it is confirmed that a particular material will be used to build the component, a clearly alternative material with similar properties can be used as an alternative. Further, on the contrary, unless otherwise specified, any and all components described herein are understood to be manufacturable and may thus be manufactured together or separately.

It should be noted that the singular forms "a", "an" and "the" as used herein and in the appended claims include the plural unless explicitly stated in the context. Is.

All publications mentioned herein have been incorporated for reference to disclose and describe the methods and / or materials that are the subject of these publications. The publications discussed herein were provided prior to the filing date of this application for the purposes of their disclosure. None of the statements herein can be construed as the art being granted the right to precede such publications for reasons of prior invention. Furthermore, the publication date described may differ from the actual publication date, and each must be confirmed independently.

The terms "comprises" and "comprising" are interpreted in a non-exclusive manner with reference to an element, component or step, and the referenced element, component or step exists or is used or explicitly. It should be combined with other unreferenced elements, components or steps.

The subject matter used in the detailed description is included only for ease of reference by the reader and should not be used to limit the subject matter found within the scope of the disclosure or claims. Subject headings shall not be used to interpret the claims or the scope of the claims.

Although the techniques described herein have been described with reference to specific embodiments, it should be understood that these examples are merely exemplary of the principles and applications of the techniques. In some cases, terms and symbols may imply certain details that are not required to practice the technique. For example, the terms "first" and "second" are used unless otherwise noted, but they are not intended to indicate any order and can be used to distinguish distinctly different elements. Further, process steps in the methodology may be described or exemplified in sequence, but such an order is not required. One of ordinary skill in the art will recognize that such an order may be modified and / or their features may be performed simultaneously or synchronously.

Therefore, it should be understood that numerous modifications may be made to the exemplary embodiments and other arrangements may be devised without departing from the spirit and scope of the technique.

1000 Patient 1100 Bed Partner 3000 Patient Interface 3100 Seal Forming Structure 3200 Plenum Chamber 3210 Peripheral 3220 Peripheral Edge 3300 Structure 3400 Vent 3402 Outlet Orifice 3404 Wall 3406 Diffusion Member 3408 Block Member 3410 Channel 3412 Hole 3414 Central Hole 3416 Radial Opening 3418 Elbow 3420 Wall 3422 Cap 3424 Flange 3426 Ring Gap 3428 Ring Groove 3430 Ring 3432 Lip 3434 Ball 3436 Socket 3438 Snap Mounting Connection 3440 First Half 3442 Second Half 3500 Separation Structure 3500 At least One Separation Structure 3600 Connection Port 3700 Forehead Support 4000 RPT device 4170 Air circuit 5000 Humidifier

Claims (53)

A patient interface for the sealed delivery of a continuous positive air flow with respect to the ambient air pressure to the patient's airway entrance, including at least one patient's nasal entrance, said patient interface, wherein the patient is sleeping. in, through the patient's respiratory cycle, is configured to allow during use a treatment pressure was maintained above atmospheric pressure in the range of about 4 cmH 2 _O of about 30 cm H 2 _O to improve sleep disordered breathing, the patient interface :
With a sealing structure configured to seal around the patient's airway entrance;
With a positioning and stabilizing structure that maintains the sealing structure in sealing contact with the area surrounding the patient's airway entrance while maintaining therapeutic pressure at the patient's airway entrance;
With a plenum chamber configured to be pressurized above ambient pressure during use;
Flows to the outside of the CO ₂ is the plenum chamber the patient exhaled containing a structural gas cleaning vent to minimize to rebreathing of CO ₂ the patient exhaled, the gas cleaning vent at least 1 With two outlet orifices;
With a diffusing member that at least partially covers the outlet orifice;
A patient interface comprising a block member having an air impermeable material, wherein the block member prevents the gas exiting the outlet orifice from flowing through the diffusion member as it is. The patient interface according to claim 1, wherein the diffusion member and the block member are configured so that the gas exiting the outlet orifice is directed outward from the diffusion member in a direction different from that of the outlet orifice. The patient interface according to claim 1 or 2, wherein the diffusion member provides a flow path parallel to the surface of the block member in contact with the diffusion member. The patient interface according to any one of claims 1 to 3, wherein the diffusion member is a porous material. The patient interface according to any one of claims 1 to 3, wherein the diffusion member is an open cell foam. The patient interface according to any one of claims 1 to 3, wherein the diffusion member is a fibrous material. The patient interface according to any one of claims 1 to 6, wherein the block member is fixed to the diffusion member along the surface of the block member in contact with the diffusion member. The patient interface according to claim 7, wherein the surface of the block member opposes the outlet orifice with respect to the thickness of the diffusion member. The patient interface according to any one of claims 1 to 8, further comprising a plurality of outlet orifices. The patient interface according to claim 9, wherein the diffusion member covers each of the plurality of outlet orifices. The patient interface according to any one of claims 1 to 10, wherein the axis defined at the center of the outlet orifice is not perpendicular to the nearest surface of the diffuser. The patient interface according to any one of claims 1 to 11, wherein the air-impermeable material is a flexible material. The patient interface according to any one of claims 1 to 11, wherein the air-impermeable material is a hard material. The patient interface according to any one of claims 1 to 13, further comprising a channel configured to drain the liquid from the outlet orifice. The patient interface according to claim 14, wherein the outlet orifice is the channel. 15. The patient interface of claim 15, wherein the channel has a V-shaped or U-shaped cross section. The patient interface according to claim 16, wherein the outlet orifice is in a leg of a V-shaped or U-shaped cross section. The patient interface according to any one of claims 1 to 17, wherein the block member comprises a hole configured to redirect the gas exiting the outlet orifice. 18. The patient interface of claim 18, wherein the hole comprises a plurality of directions of the hole configured to direct the gas in a plurality of directions. The patient interface according to any one of claims 1 to 19, wherein the diffusion member and the block member are detachably attached to the plenum chamber. The patient according to any one of claims 1 to 20, wherein the outlet orifice is sized to result in substantially all pressure drops of gas through the gas wash vent and diffusion member when therapeutic pressure is applied. interface. 21. The patient interface of claim 21, wherein the outlet orifice produces choked flow at therapeutic pressure. It said exit orifice, the patient interface of claim 21, the treatment pressure results in a choked flow at about 4 cmH 2 _O. For patients to improve sleep disorders during sleep, through the patient's breathing cycle, for about 4 cmH 2 _O patient interface configured to maintain therapeutic pressure above ambient air pressure in the range of about 30 cm H 2 _O The gas cleaning vent is:
With at least one outlet orifice;
A gas comprising a diffusion member covering the outlet orifice; and a block member having an air impermeable material, wherein the block member prevents gas exiting the outlet orifice from flowing directly into the diffusion member. Cleaning vent. The gas cleaning vent according to claim 24, wherein the diffusion member and the block member are configured so that the gas exiting the outlet orifice is directed outward from the diffusion member in a direction different from that of the outlet orifice. The gas cleaning vent according to claim 24 or 25, wherein the diffusion member provides a flow path parallel to the surface of the block member in contact with the diffusion member. The gas cleaning vent according to any one of claims 24 to 26, wherein the diffusion member is a porous material. The gas cleaning vent according to any one of claims 24 to 26, wherein the diffusion member is an open cell foam. The gas cleaning vent according to any one of claims 24 to 26, wherein the diffusion member is a fibrous material. The gas cleaning vent according to any one of claims 24 to 29, wherein the block member is fixed to the diffusion member along the surface of the block member in contact with the diffusion member. 30. The gas cleaning vent according to claim 30, wherein the surface of the block member opposes the outlet orifice with respect to the thickness of the diffusion member. The gas cleaning vent according to any one of claims 24 to 31, further comprising a plurality of outlet orifices. The gas cleaning vent according to claim 32, wherein the diffusion member covers each of the plurality of outlet orifices. The gas cleaning vent according to any one of claims 24 to 33, wherein the axis defined at the center of the outlet orifice is not perpendicular to the nearest surface of the diffusion member. The gas cleaning vent according to any one of claims 24 to 34, wherein the air impervious material is a flexible material. The gas cleaning vent according to any one of claims 24 to 34, wherein the air-impervious material is a hard material. The gas cleaning vent according to any of claims 24 to 36, further comprising a channel configured to drain the liquid from the outlet orifice. The gas cleaning vent according to claim 37, wherein the outlet orifice is in the channel. 38. The gas cleaning vent according to claim 38, wherein the channel has a V-shaped or U-shaped cross section. 39. The gas cleaning vent according to claim 39, wherein the outlet orifice is in a leg of a V-shaped or U-shaped cross section. The gas cleaning vent according to any one of claims 24 to 40, wherein the block member comprises a hole configured to direct the gas exiting the outlet orifice. The gas cleaning vent according to claim 41, wherein the hole comprises a plurality of directions of the hole configured to direct the gas in a plurality of directions. The gas cleaning vent according to any one of claims 24 to 42, wherein the diffusion member and the block member are detachably attached to the gas cleaning vent. The gas according to any of claims 24 to 43, wherein the outlet orifice is sized to result in substantially all pressure drops of gas through the gas wash vent and diffusion member when therapeutic pressure is applied. Cleaning vent. The gas cleaning vent according to claim 44, wherein the outlet orifice produces a choked flow at the therapeutic pressure. It said outlet orifice, the gas cleaning vent of claim 44 wherein the treatment pressure results in a choked flow at about 4 cmH 2 _O. For patients to improve sleep disorders during sleep, through the patient's breathing cycle, for about 4 cmH 2 _O patient interface configured to maintain therapeutic pressure above ambient air pressure in the range of about 30 cm H 2 _O The gas cleaning vent is:
With at least one outlet orifice that defines the first axis;
A diffusion member covering the outlet orifice; and a block member having an air impervious material; the block member prevents gas leaving the outlet orifice from flowing directly into the diffusion member, and at least passes through the block member. Includes one hole, the hole defining a second axis
Here, the gas cleaning vent is characterized in that the first axis and the second axis are not aligned and not parallel. The gas cleaning vent according to claim 47, wherein the first shaft and the second shaft form an angle between 15 and 75 degrees. The gas cleaning vent according to claim 47, wherein the first shaft and the second shaft form an angle between 30 and 60 degrees. 47. The gas cleaning vent according to claim 47, further comprising the plurality of outlet orifices and the plurality of holes. 47. The gas cleaning vent of claim 47, wherein the at least one outlet orifice is formed through the thickness of the material and the first axis forms an acute angle with a normal to the surface of the material. The gas cleaning vent according to claim 51, wherein the acute angle is between 15 and 75 degrees. The gas cleaning vent according to claim 51, wherein the acute angle is between 30 and 60 degrees.

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