JP6921916B2 - Patient interface and methods for forming the patient interface - Google Patents

Description

2 (B) Mutual reference to related applications This application is filed on November 15, 2013, US Provisional Application No. 61 / 904,974, and filed on April 30, 2013, US Provisional Application No. 61 /. 817,674, US Provisional Application No. 61 / 823,192 filed on May 14, 2013, US Provisional Application No. 61 / 823,353 filed on May 14, 2013, 2013 6 Claims the interests of US Provisional Application No. 61 / 837,521 filed on 20th May and US Provisional Application 61 / 839,916 filed on 27th June 2013. This application claims the interests of Australian Provisional Application No. 2013900132 filed on January 16, 2013 and Australian Provisional Application No. 2013900168 filed on January 18, 2013. This application claims the benefit of New Zealand Application No. 605907 filed on 16 January 2103. Each of the previously referenced applications is incorporated herein by reference in its entirety.

3 (C) Background of technology 3.1 (1) Field of technology This technology relates to one or more of diagnosis, treatment, and improvement of respiratory diseases, and procedures for preventing respiratory diseases. Regarding. In particular, the present technology relates to medical devices for treating respiratory diseases and preventing respiratory diseases and the use of such medical devices.

3.2 (2) Description of related technology The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airways.

The airways contain a series of bifurcations, which become thinner, shorter, and more as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, which allows oxygen to move from the air into the venous blood and carbon dioxide to the outside. The trachea divides into the left and right main bronchioles, which in turn eventually divide into the terminal bronchioles. The bronchi form the induced airways and are not involved in gas exchange. Further division of the airways results in respiratory bronchioles and ultimately alveoli. The alveolar region of the lung is where gas exchange takes place and is referred to as the respiratory region.

There is a series of respiratory illnesses.

Obstructive sleep apnea (OSA), a form of sleep apnea (SDB), is characterized by obstruction of the upper airways during sleep. It results from a combination of an abnormally small upper airway and the usual loss of muscle tone in the area of the tongue, soft palate, and posterior pharyngeal wall during sleep. Depending on the medical condition, the affected patient generally stops breathing 200-300 times per night for a duration of 30-120 seconds. This often causes excessive daytime somnolence, as well as cardiovascular disease and brain damage. The syndrome is a common illness, especially in middle-aged and older obese men, but affected individuals may be unaware of the problem. For this, refer to Patent Document 1 (Sullivan).

Cheyne-Stokes Respiration (CSR) is a respiratory controller disorder in patients with a rhythmic alternating cycle of increased and decreased ventilation that causes repeated deoxygenation and reoxygenation of arterial blood. CSR is considered detrimental due to recurrent hypoxia. In some patients, CSR is associated with repeated arousal from sleep, causing severe sleep disturbances, increased sympathetic activity, and increased afterload. For this, refer to Patent Document 2 (Berthon-Jones).

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

Chronic obstructive pulmonary disease (COPD) includes any group of lower respiratory tract diseases that share certain characteristics. These features include increased resistance to air movement, a long expiratory phase of breathing, and a loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco 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 reduce muscle function either directly through an intrinsic muscle lesion or indirectly through a neuromuscular lesion. Some NMD patients are characterized by progressive muscular dysfunction leading to loss of gait, wheelchair restraint, dysphagia, respiratory weakness, and ultimately death from respiratory failure. Neuromuscular disease can be divided into rapidly progressive and slowly progressive. That is, (i) rapidly progressive disease: characterized by muscular dysfunction that worsens over months and results in death within years (eg, myotonic dystrophy (ALS) and Duchenne muscularity in teens). Muscular dystrophy (DMD)); (ii) Variable or slowly progressive disease: characterized by muscular dystrophy that worsens over the years and slightly reduces life expectancy (eg, muscular dystrophy, facial scapulohumeral arm) Muscular dystrophy and myotonic dystrophy). Symptoms of respiratory failure in NMD include increasing general weakness, dysphagia, dyspnea on exertion and rest, fatigue, drowsiness, headache on waking, and difficulty concentrating and emotional changes.

Chest wall disease is a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the thorax. Diseases are usually characterized by restrictive disorders and share long-term hypercapnia respiratory failure. Scoliosis and / or posterior scoliosis can cause severe respiratory failure. Symptoms of respiratory failure include dyspnea on exertion, peripheral edema, orthopnea, recurrent pulmonary infections, headache on waking, fatigue, poor sleep quality, and loss of appetite.

Other than that, healthy individuals may make good use of systems and devices to prevent the development of respiratory illness.

3.2.1 System One known product used to treat SDB is the S9 Sleep Therapy System manufactured by ResMed.

3.2.2 Treatment Nose continuous positive airway pressure (CPAP) treatment has been used to treat obstructive sleep apnea (OSA). The premise is that continuous positive airway pressure can act as a pneumatic sprint and prevent upper airway obstruction by pushing the soft palate and tongue forward away from the posterior oropharyngeal wall.

Non-invasive ventilation (NIV) has been used to treat OHS, COPD, MD, and chest wall disease.

3.2.3 Patient Interface Applying a predetermined amount of positive pressure air to the entrance of the patient's airway is facilitated by the use of a patient interface such as a nasal mask, full face mask, nasal pillow, or nasal cradle mask. A full-face mask includes a mask having at least one seal forming portion covering the nostrils and the mouth or at least a plurality of seal forming portions individually covering the nostrils and the mouth. A range of patient interface devices are known, many of which are very noticeable, aesthetically unpleasant, poorly fitted, especially when worn for extended periods of time or when the patient is unfamiliar with the system. It suffers from one or more things that are difficult and unpleasant to use. Masks designed for aviators, as part of personal protective equipment, or only for the administration of anesthetics may be acceptable in their initial use, but nevertheless. It is unpleasant and undesirable to wear over a long period of time, for example during sleep.

3.2.3.1 Seal forming structure The patient interface generally includes a seal forming structure.

One type of seal forming structure extends over the outer periphery of the patient interface and is applied to the user's face when a force is applied to the patient interface with the seal forming structure butt-engaged with the user's face. It is designed to seal against it. The seal forming structure may include an air-filled cushion or a fluid-filled cushion, or a molded or formed surface of an elastic seal element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is not proper, there will be a gap between the seal-forming structure and the face, and the patient interface will be pressed against the face to achieve the seal. More power is needed.

Other types of seal forming structures incorporate a flap seal of thin material located over the outer circumference of the mask to provide a self-sealing effect on the user's face when positive pressure is applied into the mask. If the fit between the face and the mask is not good, as in traditional style seal forming structures, more force may be required to perform the seal, or the mask may leak. be. Also, if the shape of the seal forming structure does not match the shape of the patient, the seal forming structure may break or buckle during use, which causes leakage.

Other forms of seal-forming structures may use adhesives to perform the seal. Some patients may find it inconvenient to constantly apply and remove the adhesive on their face.

A series of patient interface seal structure technologies are disclosed in the following patent applications transferred to Resmed Limited, namely Patent Document 3, Patent Document 4, and Patent Document 5.

3.2.3.2 Positioning Stabilization The seal-forming structure of the patient interface used for positive pressure air therapy is exposed to the corresponding force of air pressure that interferes with the seal. Therefore, various techniques have been used to position the seal forming structure and maintain it in a seal relationship with the appropriate part of the face.

One technique is the use of adhesives. For this, refer to Patent Document 6, for example.

Another technique is the use of one or more straps and stabilizing harnesses. Many such harnesses suffer from one or more of unsuitable, bulky, uncomfortable, and difficult to use.

Hard elements, also known as "rigidisers," have been used with expandable headgear. One known issue is that a rigidizer that is non-removably attached (eg, laminated or sewn) to a large area of expandable material limits the stretchable length of the material and thus the elastic properties of the entire headgear. Associated with the fact that it affects. Another issue concerns the cleaning of headgear, which requires cleaning of both the rigidizer and the expandable material together as they are non-removably attached to each other.

3.2.3.3 Vent Technology Some forms of the patient interface system may include vents to allow the outflow of exhaled carbon dioxide. Many such vents are noisy. Other vents may block during use, resulting in inadequate spillage. Some vents may disturb the sleep of the patient's bed partner, for example by noise or focused airflow. Some vents cannot be cleaned properly and must be discarded after they are blocked. Some vents have been used for short durations, i.e. less than 3 months, and are therefore vulnerable to avoid cleaning or frequent cleaning and to encourage more frequent replacement of vents. Manufactured from materials. Resmed Limited has developed many improved mask venting technologies. For this, refer to Patent Document 7, Patent Document 8, Patent Document 9, Patent Document 10, and Patent Document 11.

The sound pressure level values of various objects are listed below.

3.2.3.4 Nose pillow technology One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Other nasal pillows or nasal puffs are the subject of Patent Document 12 (Trimble and others) assigned to Puritan Bennett Corporation.

Resmed Limited has the following products that incorporate nasal pillows: SWIFT ™ nasal pillow mask, SWIFT II ™ nasal pillow mask, SWIFT LT ™ nasal pillow mask, SWIFT FX ™ nose pillow mask, And we have manufactured LIBERTY full face masks. The following patent applications transferred to Resmed Limited, namely National Patent Document 13 (which describes aspects of the ResMed SWIFT ™ nose pillow mask, among others), Patent Document 11 (among others, ResMed SWIFT LT nose) Aspects of pillow masks are described), Patent Document 14 and Patent Document 15 (among others, the aspects of ResMed LIBERTY ™ full face masks are described), Patent Document 16 (among others, ResMed SWIFT FX ™). Describes aspects of the nasal pillow mask) describes the nasal pillow mask.

3.2.4 PAP device Positive pressure air is generally supplied to the patient's airways by a PAP device such as a motor driven blower. The blower outlet is connected to the patient interface described above via a flexible delivery conduit.

3.2.5 Mandibular Repositioning The Mandibular Repositioning Device (MRD) is one of the treatment options for sleep apnea. This device is a custom adjustable oral device available from a dentist that holds the mandible in an anterior position during sleep. This mechanical protrusion widens the space behind the tongue, exerting tension on the pharyngeal wall, reducing airway collapse and reducing palatal vibration.

U.S. Pat. No. 4,944,310 U.S. Pat. No. 6,532,959 International Publication No. 1998 / 004,310 Pamphlet International Publication No. 2006/074, 513 Pamphlet International Publication No. 2010 / 135,785 Pamphlet U.S. Patent Application No. 2010/0000534 International Publication No. 1998 / 034,665 Pamphlet International Publication No. 2000 / 078,381 Pamphlet U.S. Pat. No. 6,581,594 U.S. Patent Application No. 2009/0050156 U.S. Patent Application No. 2009/0044808 U.S. Pat. No. 4,782,832 International Publication No. 2004/073 Pamphlet International Publication No. 2005/063,328 Pamphlet International Publication No. 2006/130, 903 Pamphlet International Publication No. 2009 / 052,560 Pamphlet

4 (D) Brief Overview of Technology This technology diagnoses, improves, and treats respiratory diseases with one or more of comfort, cost, effectiveness, ease of use, and increased manufacturability. , Or directed towards providing medical devices used in prevention.

One aspect of the art relates to devices used in the diagnosis, amelioration, treatment, or prevention of respiratory diseases.

Other aspects of the technique relate to methods used in the diagnosis, amelioration, treatment, or prevention of respiratory diseases.

One aspect of the technique is a patient interface having a seal-forming structure that is removable for cleaning. The hope of the technology is to provide a patient interface that is lighter than the prior art patient interface, less noticeable than the prior art patient interface, and quieter in use than the prior art patient interface. be. It is also desirable to provide a patient interface that is intuitive for the patient to understand when connecting the mask components prior to the start of treatment and is easy to adjust and wear for treatment.

One aspect of one embodiment of the present technology is a patient interface having a seal forming structure that can be positioned in place on the patient interface via a hard-to-hard connection. Another aspect of one embodiment of the technique is a patient interface seal forming structure that can be removed for cleaning without requiring separation of the headgear portion of the patient interface.

One embodiment of the present art is a patient interface comprising a seal forming structure, a plenum chamber, and a connection, the seal forming structure and the plenum chamber being formed from a relatively flexible material and also. The connection is made of a relatively hard material. In one form, the connection can be detachably connected to the frame of the patient interface via, for example, snapping, toggle, or bistability. In one form, the connection is insert molded into the plenum chamber.

Another aspect of one embodiment of the technique is adapted to match the intended peripheral shape of the wearer (ie, the patient) and to fit closely to the intended wearer's face. A patient interface that is molded or otherwise configured with a well-defined perimeter shape.

One aspect of one embodiment of the technique is the method of manufacturing the patient interface described herein. The hope of this technology is to provide a manufacturing method that is less complex than traditional methods of manufacturing patient interfaces to improve manufacturing efficiency, uses less raw materials, and requires less assembly time by the operator. That is.

Another aspect of the technique is intended for a patient interface for delivering a predetermined amount of pressurized air or respiratory gas to the entrance of a patient's airways. The patient interface may include a cushion member including a holding structure, a seal forming structure irremovably connected to the holding structure, and a frame member, in which the holding structure and the frame member repeatedly reciprocate each other. Detachable, the gas chamber is formed, at least in part, by the engagement of the cushion member with the frame member, and increased air pressure within the cushion member increases the sealing force between the seal forming structure and the frame member. ..

One aspect of one embodiment of the technique is a method of manufacturing a patient interface.

Another aspect of the technique is intended for a patient interface for delivering pressurized gas to a patient to treat sleep apnea. The patient interface is a seal forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nasal holes of the patient are integrally formed, and the plenum chamber includes a plenum connection region to form a seal. Formed integrally with the frame, a seal-forming structure configured to seal the structure below the bridge of the nose over the lower perimeter of the patient's nose, and a frame that can be releasably attached to the plenum connection area. The connection port may be provided with a gas delivery tube that is irremovably coupled to the frame at the connection port. The gas delivery tube is a spiral coil composed of a plurality of adjacent coils, each of which is a spiral coil. A spiral coil, which is separated by width and has an outer surface that defines the coil diameter, and a plurality of coils that are coaxial with the spiral coil and are attached to the spiral coil between adjacent coils among a plurality of adjacent coils. Provided with a web of material having at least one fold extending radially outward between adjacent coils of the adjacent coils, wherein the at least one fold is defined by a predetermined fold line. You may.

In the embodiments, (a) the apex of at least one bend may define the bend diameter, and (b) the coil diameter is approximately equal to the bend diameter when the gas delivery tube is in the neutral state. In the neutral state, adjacent coils may be separated from each other, and (c) the gas delivery tube is in three different states, that is, the gas delivery tube has a neutral length, and the gas delivery tube is the gas delivery tube. One of an extended state in which the gas delivery tube is extended to a stretch length longer than the neutral length along the longitudinal axis and a compressed state in which the gas delivery tube is compressed to a compression length shorter than the neutral length along the longitudinal axis. (D) The web of material may include at least one bend extending radially outward along at least one longitudinal portion of the gas delivery tube (e). The material web may have an angle of inclination that increases from the spiral coil to the apex of at least one bend when the gas delivery tube is in the neutral state, and (f) the material web may have a predetermined bend line. It may have an asymmetric cross-sectional shape in the vicinity, (g) predetermined bending lines may be evenly spaced between adjacent coils of a plurality of adjacent coils, and (h) a plurality of adjacent coils. The width of the coils separating adjacent coils may be approximately equal to the width of the spiral coil when the gas delivery tube is in the neutral state, (i) the spiral coil is at least one bend in the web of material. It may occupy a larger proportion of the surface area of the gas delivery tube, (j) the outer portion of the spiral coil may have a rounded outer shape, and (k) the spiral coil may be thicker than the web of material. (L) The web of material may have a substantially uniform thickness, and (m) the spiral coil comprises a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU). The web of material may and / or the web of material may comprise a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU), and (n) the gas delivery tube may be insert-molded into a frame into the gas delivery tube. It may be non-removably coupled to the frame at the connection port by (o) the web and spiral coil of material may be coupled to form a uniform, continuous inner surface of the gas delivery tube (o). p) At least one bend extends radially outward between every other coil of the plurality of adjacent coils. The seal forming structure may include (q) a recess for receiving the top of the patient's nose, and (r) the adaptation region may be located above the recess, said adaptation. The region is thinner and more flexible than the rest of the seal-forming structure, (s) said seal-forming structure may comprise foam, gel, and / or low durometer silicone. t) The seal-forming structure may vary in thickness at a predetermined position around the nasal opening, and (u) the seal-forming structure is a pair extending symmetrically around the nasal opening. Each protruding end may be configured to seal against the patient's facial area where the nasal wing connects to the patient's face, (v) said seal forming structure. A pair of projecting end support portions corresponding to each projecting end and structured to support each projecting end may be provided, and at least a part of the pair of projecting end support portions is formed with a seal. It may extend into the gas chamber defined by the structure, (w) the lower part of the seal forming structure is concave in a relaxed state to seal against the patient's upper lip and follow the curvature of the patient's upper lip. It may be and / or (x) the seal forming structure is to prevent the seal forming structure from collapsing when it is engaged with the patient's nose to form a pneumatic seal. May be provided with a double wall cushion.

Another aspect of the technique is intended for a patient interface for delivering pressurized gas to a patient to treat sleep apnea. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, and the plenum chamber includes a plenum connection area and a seal-forming structure. A seal-forming structure configured to seal the body below the bridge of the nose over the lower perimeter of the patient's nose and a frame that can be releasably attached to the plenum connection area, wherein the frame is the first. A frame and a pair of rigidiser arms comprising the second material, wherein the second material is different from the first material, may include a pair of rigidizer arms. The frame and the pair of rigidizers are non-removably connected.

In an embodiment, (a) the first material may be relatively elastically flexible than the second material, and (b) the frame may be paired with rigidizer arms to form a mechanical connection. It may be overmolded, (c) the mechanical connection may include an encapsulating portion extending from each of the pair of rigidizer arms overmolded by the material of the frame, and (d) the encapsulating portion may be a hook. It may have a portion of the bend, (e) the first material may be used to be integrally bonded to the second material, and (f) the first material is a thermoplastic polypropylene elastomer. The second material may be a thermoplastic polymer, (g) the thermoplastic polymer may be polypropylene (PP), and (h) the first material is a fiber-reinforced composite. It may be a polypropylene material, the second material may be polypropylene, and (i) each of the pair of rigidizer arms is configured to hold the pocket-like end of the strap of the positioning stabilization structure. Each of the pair of rigidizer arms may include a protruding end, the protruding end may be near the frame, (j) the first material may not be expandable, and each of the pair of rigidizer arms may be as compared to the other plane. It may be structured to be more flexible in a plane substantially parallel to the patient's Frankfort horizontal plane, and (k) each of the rigidizer arms has a body that is curved to roughly follow the patient's cheek shape. It may be provided with a connection that is configured to connect to the frame, the connection being located at the distal end of the rigidizer arm, (l) the connection with at least one protrusion. The seal-forming structure may include a recess for receiving the top of the patient's nose. Often, (n) the adaptation region may be located above the recess, the adaptation region is thinner and more flexible than the rest of the seal forming structure, and (o) the seal forming structure. The body may comprise foam, gel, and / or low molecular weight silicone, and (p) the seal-forming structure may vary in thickness at a predetermined location around the nasal opening. (Q) The seal-forming structure may include a pair of protruding ends that extend symmetrically around the nasal opening, with each protruding end in the patient's facial region where the nasal wings connect to the patient's face. It may be configured to seal against (r). The seal forming structure may include a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end, and the pair of protruding end supporting portions may be provided. , At least in part may extend into the gas chamber defined by the seal forming structure, (s) the lower portion of the seal forming structure seals against the patient's upper lip and the curvature of the patient's upper lip. It may be concave in a relaxed state to comply with, and / or (t) the seal forming structure is a seal forming structure when the seal forming structure is engaged with the patient's nose to form a pneumatic seal. A double wall cushion may be provided to prevent the body from collapsing.

Another aspect of the technique is intended for a patient interface for delivering pressurized gas to a patient to treat sleep apnea. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nasal passages of the patient are integrally formed, and the plenum chamber includes a plenum connection area, and the seal-forming structure is formed. Formed integrally with the frame, a seal-forming structure configured to seal the body below the bridge of the nose over the lower perimeter of the patient's nose, and a frame that can be releasably attached to the plenum connection area. It may include a connecting port and at least one vent for draining exhaled breath, the vent being irremovably connected to the frame, the at least one vent interlacing with plastic fibers. It is formed from a cloth formed by letting the cloth have a pore ratio of a predetermined size.

In an embodiment, (a) at least one vent may comprise two vents that are irremovably connected to the frame on either side of the connection port, and (b) the two vents may have a first air velocity. A first vent having a first vent and a second vent having a second air velocity different from the first air velocity may be provided. (C) The first air velocity and the second air velocity are The average air velocity of the first air velocity and the second air velocity may be selected to be within a predetermined range, and (d) the first air velocity and / or the second air velocity is the second air velocity. It may be obtained by heating a part of the first vent and / or the second vent to a pore ratio of a predetermined size, respectively, and (e) the plastic fiber is polypropylene, woven polypropylene material, polycarbonate, nylon. , And may be formed from a thermoplastic polymer from any one from the group consisting of polyethylene, (f) at least one vent is overmolded, co-injection molded, and two-shot (2K) injection molded. Any one from the group consisting of may be non-removably connected to the frame by molecular attachment, (g) at least one vent may have a semicircular or D-shape, (h). The seal-forming structure may include a recess for receiving the top of the patient's nose, and (i) the adaptation region may be located above the recess, where the adaptation region is the seal-forming structure. It is thinner and more flexible than the rest of the seal-forming structure, (j) the seal-forming structure may comprise foam, gel, and / or low durometer silicone, and (k) the seal-forming structure. May vary in thickness at a predetermined position around the nasal opening. (L) The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening. Each protruding end may be configured to seal the patient's facial area where the nasal wings connect to the patient's face, and (m) the seal forming structure corresponds to each protruding end. A pair of projecting end support portions structured to support each projecting end portion may be provided, and the pair of projecting end support portions may be provided with a gas defined by a seal forming structure at least in part. It may extend into the chamber, and (n) the lower portion of the seal forming structure may be sealed to the patient's upper lip and may be relaxed and concave to follow the curvature of the patient's upper lip, and / Alternatively, (o) a seal forming structure May be provided with a double wall cushion to prevent the seal forming structure from collapsing when the seal forming structure is engaged with the patient's nose to form a pneumatic seal.

Another aspect of the technique is intended for a positioning stabilization structure for a patient interface device. The positioning stabilization structure is at least one strap and at least one rigidizer arm, wherein the at least one rigidizer arm includes a body and an extension for connecting the body to the mask frame. The positioning stabilization structure may be provided with a predetermined shape that allows at least the cured portion of at least one strap to move relative to at least one rigidizer arm, with at least one strap at least one rigidizer arm. At least one strap and at least one rigidizer arm are arranged to position each other so that the hardened portion of the strap is provided with respect to the patient's sagittal plane. It may be configured to prevent the movement of at least one rigidizer arm with respect to the mask frame in parallel planes.

In an embodiment, (a) at least one rigidizer arm may be attached to at least one strap at only one local point or region, and (b) at least one rigidizer arm may be limited to at least one strap. The area may be attached to at least one strap, (c) the limited area may be adjacent to the pocket or sleeve opening of at least one strap, and (d) at least one rigidizer arm. It may be multiaxially deformable to fit the contour of the patient's face, (e) so that at least one rigidizer arm extends from the mask frame to a position closer to the patient's cheekbones or below the cheekbones. (F) The at least one rigidizer arm may have a crescent-shaped lateral profile, and (g) the end of at least one rigidizer arm may be attached to at least one strap. Often, (h) at least one rigidizer arm is sewn, welded, glued, heat crimped, clamped, buttoned, by snapping the cover over the edges and / or by snapping to an external component. It may be attached to one strap, (i) the given shape may direct the pressure of the positioning stabilization structure to a given portion of the wearer's face, and (j) at least one rigidizer arm. Must not be stretchable and has a relative greater rigidity than at least one strap, and (k) positioning stabilization structures are symmetrically placed on both sides of the patient's face. Two or more rigidizer arms may be provided, (l) at least one rigidizer arm may be completely removable from at least one strap, and (m) at least one strap may have two pockets. Each pocket receives one rigging arm to releasably secure at least one strap to the rigging arm, and (n) at least one strap may include at least one holding means, said holding means at least. It may be provided with loops, sleeves, and / or pockets for receiving one rigidizer arm and holding at least one rigidizer arm in place, and (o) at least one rigidizer arm may be provided with at least one holding means. Often, at least one of the holding means A loop, sleeve, and / or pocket may be provided to receive and hold at least one strap in place, and (p) at least one rigidizer arm is a guide element provided on at least one strap. The (q) guide element may be a loop or sheath or passage or pocket in which at least one rigidizer arm is inserted and extends or passes through. r) The guide element may allow longitudinal expansion or contraction of at least one strap with respect to at least one rigidizer arm and / or allow almost free movement or free movement of at least one rigidizer arm with respect to at least one strap. It may be possible, (s) the extension may be configured to allow flexion of at least one rigidizer arm in a plane parallel to the patient's Frankfort horizontal plane, and (t) the extension. The portions may be approximately equal in width to the body, and (u) at least one strap is positioned stable by at least one of bending of at least one rigidizer arm, rudder lock clip, buckle connection, and hook loop connection. It does not have to be substantially elastic so that the length of the chemical structure can be adjusted, and (v) a patient with a continuous positive pressure respiratory gas flow against atmospheric pressure, including at least the entrance of the patient's nose. In a patient interface system for delivery in a sealed state at the entrance to the airway, the patient interface is used throughout the patient's respiratory cycle while the patient is asleep to improve sleep-breathing disorders, such as sleep aspiration. over, above about 4 cmH ₂ O ~ about 30 cm H ₂ O than the atmospheric pressure at the time of use, for example, is generally configured about 10cmH to maintain therapeutic pressure within ₂ O exceeds the range, the patient interface system, the previous example A positioning stabilization structure according to any one or more of them and a patient interface may be provided, the patient interface being pressurized to at least both nasal passages of the patient and a pressure above atmospheric pressure during use. A seal forming structure for supplying a pressurized gas to the patient, wherein the seal forming structure and the plenum chamber are integrally formed, the plenum chamber includes a plenum connection region, and the seal forming structure is a patient's. Sealed shape configured to seal below the bridge of the nose over the lower perimeter of the nose And adult structure, in order to minimize the rebreathing of CO ₂ exhaled by the patient, a gas outlet vent configured to allow flow to the outside of the patient interface of CO ₂ patient exhales, the plenum connection A patient interface system with a frame that can be releasably attached to the area, (w) the extension may be non-removably fixed to the mask frame, and the body may be removable from the extension. Yes, and / or (x) the extension may be integrated with the body, and the extension is removable from the mask frame.

Another aspect of the technique is intended for a cushioning member for a patient interface for delivering a predetermined amount of pressurized air or respiratory gas to the entrance of a patient's airway. The cushion member is an integral part of a holding structure for repetitive engagement with and disengagement from the frame member, and a nasal opening and plenum chamber for supplying pressurized gas to both nasal passages of the patient. A sealed seal-forming structure formed such that the seal-forming structure seals below the nasal bridge over the lower perimeter of the patient's nose, with the seal-forming structure and plenum chamber removed from the holding structure. A second material may include a seal forming structure that is impossibly connected, the seal forming structure is formed from a first material, and the holding structure has a second mechanical property different from that of the first material. Formed from a material, the second material is harder than the first material, and the increased air pressure in the cushion member enhances the sealing force between the seal forming structure and the frame member.

In the embodiments, (a) the first material may be silicone, the second material may be silicone with a higher durometer than the first material, and (b) the cushion member may be retained. A plenum chamber located between the structure and the seal forming structure may be provided, (c) the cushion member may include a frame member formed from a second material, and (d) a first. The material may allow the seal-forming structure to easily adapt to finger pressure, and the second material may prevent the holding structure from easily adapting to finger pressure. (E) The seal-forming structure. The body may include a recess to receive the apex of the patient's nose, (f) the adaptation region may be located above the depression, and the adaptation region is the rest of the seal forming structure. (G) The seal-forming structure may comprise foam, gel, and / or low durometer silicone, and (h) the seal-forming structure may comprise the nose. The thickness may vary at a predetermined position around the opening, and (i) the seal forming structure may include a pair of protruding ends that extend symmetrically around the nasal opening. The protruding end may be configured to seal against the patient's facial area where the nasal wings connect to the patient's face. (J) The seal forming structure corresponds to each protruding end and each protruding end. A pair of protruding end support portions structured to support the portions may be provided, the pair of protruding end supporting portions extending at least in part into a gas chamber defined by a seal forming structure. It may be present, and (k) the lower part of the seal forming structure may be concave in a relaxed state so as to seal against the patient's upper lip and follow the curvature of the patient's upper lip, and (l) the seal forming structure. May be provided with a double wall cushion to prevent the seal forming structure from collapsing when the seal forming structure is engaged with the patient's nose to form a pneumatic seal, and / or ( m) In a patient interface for delivering a continuous positive respiratory gas flow to atmospheric pressure to at least the entrance to the patient's airway, including the entrance to the patient's nose, the patient interface is sleep breathing. Configured to maintain therapeutic pressure within _{approximately 4 cmH 2} O to approximately 30 cmH ₂ O above atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep to ameliorate the disorder And the patient interface is any one of the previous examples. A cushioning member and a positioning stabilization structure to maintain therapeutic pressure at least at the entrance to the patient's nasal airway while maintaining seal contact with the cushioning member at least in contact with the area surrounding the patient's nasal airway entrance. a plenum chamber which is pressurized at a pressure above atmospheric pressure during use, to minimize the rebreathing of CO ₂ exhaled by the patient, the flow to the outside of the patient interface of CO ₂ patient exhales Patient interface with outflow vents configured to tolerate.

Another aspect of the technique is intended for a patient interface for delivering respiratory gas to a patient. The patient interface is a seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nostrils of the patient are integrally formed, and the plenum chamber includes a plenum connection region and a seal-forming structure. The frame connection area may include a seal forming structure configured to seal the body below the bridge of the nose over the lower perimeter of the patient's nose and a frame with a frame connection area and a headgear connection area. , The plenum connection area is configured to attach to the plenum chamber, and the seal lip forms a pneumatic seal between the plenum connection area and the frame connection area.

In an embodiment, (a) the frame connection area may include at least one holding function unit to facilitate connection with the plenum connection area, and the plenum connection area may include at least one holding function unit corresponding thereto. It may be provided with at least one complementary connecting region for receiving, and (b) at least one holding function portion may be a hook-shaped portion, and the hook-shaped portion has a front surface and a rear surface. Of the case, at least one complementary connecting region may include a pull-in surface and a holding surface, and (c) the seal forming structure may include a recess for receiving the top of the patient's nose. (D) The adaptation region may be located above the recess, the adaptation region is thinner and more flexible than the rest of the seal forming structure, and (e) the seal forming structure. May comprise foam, gel, and / or low durometer silicone, (f) the seal forming structure may vary in thickness at a predetermined position around the nasal opening. g) The seal forming structure comprises a pair of projecting ends that extend symmetrically around the nasal opening, each projecting end sealing against a patient's facial area where the nasal wings connect to the patient's face. (H) The seal forming structure may include a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end. Often, the pair of protruding end support portions may extend at least in part into the gas chamber defined by the seal forming structure, and (i) the lower portion of the seal forming structure is the patient's upper lip. And / or (j) the seal-forming structure of the patient so that the seal-forming structure forms a pneumatic seal. Double wall cushions may be provided to prevent collapse of the seal forming structure when engaged with the nose.

Another aspect of the technique is intended for a cushioning member for a nasal cradle mask for delivering a predetermined amount of pressurized air or respiratory gas to the entrance of a patient's airway. The cushion member is an integral part of a holding structure for repetitive engagement with and disengagement from the frame member, and a nasal opening and plenum chamber for supplying pressurized gas to both nasal passages of the patient. A sealed seal-forming structure formed such that the seal-forming structure seals below the nasal bridge over the lower perimeter of the patient's nose, and the seal-forming structure and plenum chamber are removed from the holding structure. An impossibly connected seal forming structure may be provided, the increase in air pressure in the cushion member increasing the sealing force between the seal forming structure and the frame member, and the holding structure and the frame member. The holding force between them is higher than the pulling force for separating the holding structure from the frame member.

In an embodiment, (a) the seal-forming structure may include a recess for receiving the top of the patient's nose, and (b) the adaptation region may be located above the recess, said adaptation. The region is thinner and more flexible than the rest of the seal forming structure, and (c) the seal forming structure may comprise foam, gel, and / or low durometer silicone. (D) The seal-forming structure may vary in thickness at a predetermined position around the nasal opening, and (e) the seal-forming structure extends symmetrically around the nasal opening. A pair of protruding ends may be provided, and each protruding end may be configured to seal the patient's facial region where the nasal wings connect to the patient's face, (f) said seal forming structure. , A pair of protruding end support portions that correspond to each protruding end portion and are structured to support each protruding end portion may be provided, and at least a part of the pair of protruding end supporting portions is sealed. It may extend into the gas chamber defined by the forming structure, and (g) the lower portion of the seal forming structure is concave in a relaxed state to seal against the patient's upper lip and to follow the curvature of the patient's upper lip. (H) The seal forming structure may be doubled to prevent collapse of the seal forming structure when the seal forming structure is engaged with the patient's nose to form a pneumatic seal. A wall cushion may be provided and / or (i) continuously deliver positive respiratory gas flow to atmospheric pressure to the patient's airway entrance, including at least the patient's nasal entrance, in a sealed state. _{In the patient interface for, the patient interface is approximately 4 cmH 2} O to approximately 30 cmH ₂ above atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep-respiratory disorders. Configured to maintain therapeutic pressure within the range above O, said patient interface cushions while maintaining therapeutic pressure with any of the cushioning members of the previous example and at least at the entrance to the patient's nasal airway. A positioning stabilization structure to keep the member in seal contact with at least the area surrounding the entrance to the patient's nasal airway, a plenum chamber pressurized above atmospheric pressure during use, and exhaled by the patient. in order to suppress the rebreathing of CO ₂ to be minimized, and a gas outlet vent configured to allow flow to the outside of the patient interface of CO ₂ patient exhales, the patient interface.

Another aspect of the technique is intended for a cushioning member for a patient interface for delivering a predetermined amount of pressurized air or respiratory gas to the entrance of a patient's airway. The cushion member is an integral part of a holding structure for repetitive engagement with and disengagement from the frame member, and a nasal opening and plenum chamber for supplying pressurized gas to both nostrils of the patient. A sealed seal-forming structure formed such that the seal-forming structure seals below the nasal bridge over the lower perimeter of the patient's nose, and the seal-forming structure and plenum chamber are non-removable to the holding structure. The seal forming structure may include a recess for receiving the top of the nose of the patient, the seal forming structure being symmetrical around the nostril opening. It comprises a pair of projecting ends extending in a symmetric manner, and each protruding end is configured to seal against the patient's facial area where the nostrils connect to the patient's face.

In an embodiment, (a) the seal forming structure is a double wall cushion to prevent collapse of the seal forming structure when the seal forming structure is engaged with the patient's nose to form a pneumatic seal. The adaptation region may be located above the recess, and the adaptation region is thinner and more flexible than the rest of the seal-forming structure, (c). The seal-forming structure may comprise foam, gel, and / or low durometer silicone, (d) the seal-forming structure may vary in thickness at a predetermined location around the nasal opening. The seal-forming structure may include an overhang in the nose opening of the seal-forming structure, the overhang may be located in the vicinity of the recess, and (d) the seal-forming structure may include. A pair of projecting end support portions corresponding to each projecting end and structured to support each projecting end may be provided, and at least a part of the pair of projecting end support portions is formed with a seal. It may extend into the gas chamber defined by the structure, and (e) the lower portion of the seal forming structure is concave in a relaxed state to seal against the patient's upper lip and to follow the curvature of the patient's upper lip. There may be (f) the lower portion having a reduced material thickness with respect to the rest of the seal forming structure and / or (g) persistent with respect to atmospheric pressure. In the patient interface for delivering positive pressure respiratory gas flow in a sealed state to the entrance to the patient's airway, including at least the entrance to the patient's nasal passage, the patient interface is used by the patient to ameliorate sleep-breathing disorders. During sleep, the patient interface is configured to maintain therapeutic pressure within a range of _{approximately 4 cmH 2} O to approximately 30 cmH ₂ O above atmospheric pressure during use throughout the patient's respiratory cycle. To maintain therapeutic pressure with any of the cushioning members in the example and at least at the entrance to the patient's nasal airway, while maintaining the cushioning member in seal contact with at least the area surrounding the entrance to the patient's nasal airway. the patient positioning stabilizing structure, a plenum chamber which is pressurized at a pressure above atmospheric pressure during use, to minimize the rebreathing of CO ₂ exhaled by the patient, the CO ₂ that patient exhales A patient interface, which may include a gas outflow vent configured to allow flow out of the interface.

Another aspect of the technique is intended for a patient interface system for delivering respiratory gas to a patient. The patient interface includes a patient interface that includes a seal forming structure for making a pneumatic connection to the patient's airway, and includes at least one strap and at least one rigidizer arm and is configured to hold the patient interface openly to the patient. The positioning stabilization structure may be provided and at least one strap may be non-removably attached to at least one rigidizer arm at the attachment point.

In an embodiment, (a) the attachment point may be provided with ultrasonic welding, (b) the attachment point may be provided with heat caulking, (c) the attachment point may be provided with seams, and (d) attachment. The points may be provided with a hinged mechanism and / or (e) the rigidizer arm with at least one attachment point may be provided with a hook.

Another aspect of the technique is intended for a patient interface system for delivering respiratory gas to a patient. The patient interface includes a patient interface that includes a seal forming structure for making a pneumatic connection to the patient's airway, and includes at least one strap and at least one rigidizer arm and is configured to hold the patient interface openly to the patient. It may be provided with a positioning stabilization structure to be provided, and at least one strap may be releasably attached to at least one rigidizer arm.

In an embodiment, (a) at least one strap may be provided with an elastic tube, at least one rigidizer arm may be provided with a raised stopper, and (b) at least one rigidizer arm may be provided with a hook loop connection. It may be provided with tabs for releasably attaching at least one strap, (c) at least one strap may be provided with at least one lock, and at least one rigidizer arm corresponds to said at least one lock. It may be provided with at least one notch and / or (d) at least one strap by looping the at least one strap through the first and second slots of the at least one rigidizer arm. An end having a hook material may be provided to form a hook loop connection with the loop material on at least one strap.

Another aspect of the technique is intended for a patient interface system for delivering respiratory gas to a patient. The patient interface includes a patient interface that includes a seal forming structure for making a pneumatic connection to the patient's airway, and includes at least one strap and at least one rigidizer arm and is configured to hold the patient interface openly to the patient. The positioning stabilization structure may be provided, and at least one rigidizer arm may be releasably attached to the frame of the patient interface, the frame providing a seal forming structure to the patient's face. To support.

In embodiments, (a) at least one rigidizer arm can be releasably attached to the corresponding extension of the frame with a rotation lock structure, and (b) the patient interface attaches at least one rigidizer arm to the extension of the frame. A pin and a corresponding socket may be further provided for releasable attachment to the existing portion. (C) At least one rigidizer may have at least one rigidizer arm at the shaft receiving portion and the arm receiving portion as an extension of the frame. An arm and a protrusion supported on the shaft may be further provided for releasable attachment to (d) at least one rigidizer arm for releasable attachment to the frame receiving portion by snap fitting. An extension may be provided, (e) at least one rigidizer arm may be provided to be releasably attached to a receiving portion of the frame by press fitting, and (f) at least one rigidizer arm may be snapped. An extension may be provided with a strut for releasable attachment to the receiving portion of the frame by mating, or the extension may further be provided with an end to prevent rotation of the strut around the longitudinal axis. Often, the (g) frame may have at least one slot, the corresponding at least one rigidizer arm may be threaded through the slot for releasable mounting, and at least one rigidizer arm may have a locking end. Alternatively, (h) at least one rigidizer arm may be provided with an extension having a pin for releasable attachment to the socket of the frame by snap fitting, and (i) at least one rigidizer arm may be released to the frame. To allow attachment, at least one rigging arm may include a first magnet, the frame may include a second magnet, and (j) at least one rigging arm has a first having at least one post. The frame may include a second L-shaped portion having at least one hole, and at least one rigidizer arm may be provided between at least one post and at least one hole. It may be releasably attached to the frame by engagement, (k) the frame may be provided with a boss, and at least one rigidizer arm may be provided with a cavity for releasably attaching to the boss, and / Or (l) at least one rigidizer arm and flare At least one rigidizer arm may be provided with protrusions and holes for releasable attachment to and from the frame, and the extension of the frame is a slot corresponding to the protrusion and a post corresponding to the hole. And may be provided.

Another aspect of the technique is intended for a patient interface system for delivering respiratory gas to a patient. The patient interface includes a patient interface that includes a seal forming structure for making a pneumatic connection to the patient's airway, and includes at least one strap and at least one rigidizer arm and is configured to hold the patient interface openly to the patient. A positioning stabilization structure may be provided, wherein the extension connects at least one rigidizer arm to the frame of the patient interface, the frame supporting the seal forming structure against the patient's face.

In an embodiment, (a) at least one rigidizer arm may be provided with ribs at the bend to resist deformation at the bend, and (b) the extension may resist deformation at the bend. The bend may be provided with ribs and / or (c) the extension may be provided with longitudinal ribs along the straight and bends of the extension to resist deformation. ..

Another aspect of the technique is intended for a patient interface for delivering a continuous positive pressure respiratory gas stream relative to atmospheric pressure to at least the entrance to the patient's airway, including the entrance to the patient's nose. _{And the patient interface is about 4 cmH 2} O to about 30 cmH above atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep to improve sleep-breathing disorders, such as sleep aspiration. than _{2 O,} for example, generally from about 10 cm H 2 _O is configured to maintain therapeutic pressure in the range above, the patient interface includes at least the sealing structure for forming a seal with the nasal airway of the patient body, at least the patient nasal Positioning stabilization structure to maintain seal contact with at least the area surrounding the patient's nasal airway entrance while maintaining therapeutic pressure at the entrance to the airway, and atmospheric pressure during use. A plenum chamber that is pressurized to a higher pressure and a gas that is configured to allow the patient's _{exhaled CO 2} to flow out of the patient interface to minimize rebreathing of the _{CO 2 exhaled by the patient.} It may be provided with an outflow vent.

Of course, some of the embodiments may form subordinate aspects of the present technology. In addition, various examples of the sub-mode examples and / or the mode examples may be combined in various ways, and may constitute a further mode or a sub-mode of the present technology.

Other features of the art will become apparent by considering the following detailed description, abstracts, drawings, and information contained within the claims.

5 (E) Brief Description of Some Diagrams of the Drawings This technology is shown as an example in the drawings of the accompanying drawings below and is not shown in a limited way. In the figure, similar reference numbers indicate similar elements.

5.1 Treatment system
The system related to this technology is shown. The patient 1000 wearing the patient interface 3000 receives a positive pressure air supply from the PAP device 4000. The air from the PAP device 4000 is humidified by the humidifier 5000 and passes along the air circuit 4170 toward the patient 1000. The PAP device 4000 used for the patient 1000 with a nasal mask is shown. The PAP device 4000 used for the patient 1000 with a full face mask is shown. 5.2 Treatment 5.2.1 Respiratory system Shows an overview of a person's respiratory system, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sac, heart, and diaphragm. Shows a diagram of the upper respiratory tract of a person including the nasal cavity, nasal bone, lateral nasal cartilage, nasal ala cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, mesopharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. .. 5.2.2 Facial biological structure Front view of the face with some features of the surface biostructure identified, including the upper lip, upper lip red, lower lip red, lower lip, mouth width, inner corner of the eye, ala of nose, nasolabial fold, and corner points of the mouth. .. The side of the head with some features of the surface biostructure identified, including the glabellar, nose root, nose tip, nasal spine, upper lip, lower lip, upper jaw, nasal ridge, upper ear base, and lower ear base. It is a figure. Also shown are up and down, as well as front and back directions. It is a further side view of the head. Approximate positions of Frankfort horizontal plane and nasolabial fold are shown. The bottom view of the nose is shown. A side view of the surface features of the nose is shown. Shows the subcutaneous structure of the nose, including lateral cartilage, septal cartilage, alar cartilage, alar cartilage, and fibrous adipose tissue. It shows medial detachment of the nose about 7 mm from the sagittal plane, showing the medial legs of the septal cartilage and nasal ala cartilage in particular. The frontal view of the bones of the skull including the frontal bone, the temporal bone, the nasal bone, and the cheekbone is shown. The turbinates are shown, as are the maxilla, mandible, and chin ridges. The contour of the surface of the head and the side view of the skull with some muscles are shown. The following bones are shown: the frontal bone, the butterfly bone, the nose bone, the cheekbone, the maxilla, the mandible, the parietal bone, the temporal bone, and the occipital bone. A chin uplift is shown. The following muscles are shown: the digastric muscle, the masseter muscle, the sternocleidomastoid muscle, and the trapezius muscle. The anterior side view of the nose is shown. 5.3 PAP device and humidifier The exploded view of the PAP apparatus which concerns on an example of this technique is shown. The perspective view of the humidifier which concerns on one form of this technique is shown. A schematic diagram of a pneumatic circuit of a PAP device according to one embodiment of the present technology is shown. Upstream and downstream directions are shown. 5.4 Patient interface It is a front view of the plenum chamber which concerns on one form of this technique. It is a cross section along the line 5-5 of FIG. It is an enlarged detailed view drawn from FIG. It is a perspective view seen from the top of the plenum chamber shown in FIG. It is a cross section along the line 8-8 of FIG. It is an enlarged detailed view drawn from FIG. It is a perspective view seen from the front of the plenum chamber which concerns on one example of this technique. It is a figure of the plenum chamber shown in FIG. It is a cross section along the line 12-12 of FIG. It is an enlarged detailed view drawn from FIG. It is an enlarged sectional view of the plenum connection area. It is a side view of the patient interface shown in FIG. It is a cross section along the line 16-16 of FIG. It is an enlarged detailed view drawn from FIG. It is a side view of a patient interface in place on the head of a model patient in which no positioning stabilization structure is shown. It is a partial bottom view of a part of the patient interface according to one embodiment of the present technology in place on the head of a model patient. For clarity, only a portion of the positioning stabilization structure connected to the frame is shown. It is a side view of the plenum connection area of the plenum chamber which concerns on one form of this technique. It is the upper view of the plenum connection area of the plenum chamber. It is a front view of the plenum connection area of the plenum chamber. It is a bottom view of the plenum connection area of the plenum chamber. It is a perspective view of the plenum connection area of the plenum chamber. FIG. 5 is a cross-sectional view of a connection and a frame connection region where the plenum chamber and the frame are not engaged. FIG. 3 is a cross-sectional view of a connection and frame connection region where the plenum chamber and frame are in contact but not fully engaged. FIG. 5 is a cross-sectional view of a connecting portion and a frame connecting region in which the plenum chamber and the frame are almost completely engaged with each other so that the holding function portion is flexed. FIG. 5 is a cross-sectional view of a connecting portion and a frame connecting region in which the plenum chamber and the frame are engaged but separated so that the holding function portion is flexed. FIG. 5 is a cross-sectional view of a connection and a frame connection region in which the plenum chamber and frame are fully engaged. FIG. 3 is a rear perspective view of a patient interface according to an example of the present technology in which the plenum chamber and the seal forming structure have been removed. FIG. 5 is a front perspective view of a patient interface according to an example of the present technology in which the plenum chamber and seal forming structure have been removed. FIG. 3 is a rear view of a patient interface according to an example of the present technology in which the plenum chamber and seal forming structure have been removed. FIG. 5 is a side view of a patient interface according to an example of the present technology in which the plenum chamber and seal forming structure have been removed. FIG. 3 shows a perspective view of the patient interface according to another example of the art showing the attachment of a typical seal forming structure and plenum chamber to the frame of the patient interface. A cross-sectional view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. A perspective view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. An exploded view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. A detailed view of the end of the rigidizer arm according to an example of the present technology is shown. A perspective view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. A cross-sectional view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. The perspective view of the rigidizer arm which concerns on an example of this technique is shown. A cross-sectional view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. A perspective view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. An exploded view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm according to an example of the present technology is shown. A detailed view of the end of the rigidizer arm according to an example of the present technology is shown. A detailed view of an end portion of a flexible joint and a rigidizer arm according to an example of the present technology is shown. A cross-sectional view of a rigidizer and a mask frame according to an example of the present technology is shown. A detailed cross-sectional view of a rigidizer arm and a mask frame according to an example of the present technology is shown. A cross-sectional view of a rigidizer arm and a mask frame according to an example of the present technology is shown. The perspective view of the rigidizer arm and the mask frame which concerns on an example of this technique is shown. A detailed perspective view of the connection between the rigidizer and the mask frame according to an example of the present technology is shown. A plan view of the rigidizer arm and the mask frame according to an example of the present technology is shown, and the bending of the rigidizer arm in the lateral lateral direction in the coronal plane is shown by a broken line. A detailed plan view of the connection between the rigidizer and the mask frame according to an example of the present technology is shown. The cross-sectional perspective view of the rigidizer arm and the mask frame which concerns on an example of this technique is shown. A side view of the rigidizer and the mask frame according to an example of the present technology is shown, and the bending of the rigidizer arm in the vertical downward direction in the sagittal plane is shown by a broken line. A front view of a rigidizer and a mask frame according to an example of the present technology is shown. The perspective view of the rigidizer arm and the mask frame which concerns on an example of this technique is shown. A partially decomposed perspective view of the rigidizer arm and the mask frame according to an example of the present technology is shown. A detailed partial decomposition perspective view of a rigidizer and a mask frame according to an example of the present technology is shown. A perspective view of a rigidizer according to an example of the present technology is shown. The figure of the rigidizer arm which concerns on an example of this technique plotted on the grid in the XY plane is shown. The figure of the rigidizer arm which concerns on an example of this technique plotted on the square in the XZ plane is shown. The figure of the rigidizer arm which concerns on an example of this technique plotted on the square in the YZ plane is shown. A figure of a rigidizer arm according to an example of the present technology plotted in three dimensions is shown. The schematic perspective view of the positioning stabilization structure which concerns on an example of this technique is shown. The cross-sectional view of the positioning stabilization structure along the line 66-66 in FIG. 65 is shown. A schematic side view of a typical rigidizer arm for a positioning stabilization structure according to the present technology is shown. The schematic perspective view of the typical positioning stabilization structure including the rigidizer arm which concerns on this technique in the 1st state is shown. The schematic perspective view of the typical positioning stabilization structure including the rigidizer arm which concerns on this technique in the 2nd state is shown. The schematic perspective view of the typical positioning stabilization structure including the rigidizer arm which concerns on this technique in the 3rd state is shown. A perspective view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A front view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A side view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A perspective view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A front view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A side view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A downward perspective view of a typical positioning stabilization structure according to the present technology worn by a patient is shown. A graph showing the extension (unit: mm) of the strap of the positioning stabilization structure according to an example of the present technology exposed to a series of loads (unit: Newton) is shown. The plan view of the strap of the positioning stabilization structure which concerns on an example of this technique in the intermediate manufacturing stage is shown. FIG. 5 shows a cross-sectional view taken through line 80-80 of FIG. 79 of a strap of a positioning stabilization structure according to an example of the present technology during the intermediate manufacturing stage. The plan view of the strap of the positioning stabilization structure which concerns on an example of this technique is shown. A detailed plan view of the strap of the positioning stabilization structure according to an example of the present technology is shown. FIG. 5 shows a cross-sectional view taken through lines 83-83 of FIG. 81 of a strap of a positioning stabilization structure according to an example of the present technology. A series of perspective views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of perspective views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of perspective views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of perspective views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of perspective views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of front views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of front views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of front views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of front views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of front views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of side views of a patient wearing a positioning stabilization structure according to an example of the present technology are shown. A series of perspective views of a patient adjusting the patient interface according to an example of the present technology are shown. A series of perspective views of a patient adjusting the patient interface according to an example of the present technology are shown. A series of perspective views of a patient adjusting the patient interface according to an example of the present technology are shown. A series of rear views of a patient adjusting a positioning stabilization structure according to an example of the present technology are shown. A series of rear views of a patient adjusting a positioning stabilization structure according to an example of the present technology are shown. A series of rear views of a patient adjusting a positioning stabilization structure according to an example of the present technology are shown. A series of rear views of a patient adjusting a positioning stabilization structure according to an example of the present technology are shown. A series of rear views of a patient adjusting a positioning stabilization structure according to an example of the present technology are shown. A detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. A detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. Another detailed view of the connection between the strap of the positioning stabilization structure and the rigidizer arm according to an example of the present technology is shown. A detailed view of the divided region of the strap of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the strap division region of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the strap division region of the positioning stabilization structure according to an example of the present technology is shown. A detailed view of the branch portion of the strap of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the branch portion of the strap of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the branch portion of the strap of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the branch portion of the strap of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the branch portion of the strap of the positioning stabilization structure according to an example of the present technology is shown. Another detailed view of the branch portion of the strap of the positioning stabilization structure according to an example of the present technology is shown. A perspective view of a positioning stabilization structure manufactured according to an example of the present technology is shown. The process of forming a positioning stabilization structure strap from a continuous roll according to an example of the present technology is shown. A conventional example of drawing a knitting process according to an example of this technique is shown. A conventional example of drawing a knitting process according to an example of this technique is shown. A basic warp knitted fabric according to an example of this technique is shown. It is a schematic representation of the basic warp knitted fabric of FIG. 136. A basic warp knitted fabric according to an example of this technique is shown. A basic warp knitted fabric according to an example of this technique is shown. It is a side view of the positioning stabilization structure located on the head of a patient which concerns on an example of this technique. The course or grain changing direction of the positioning stabilization structure of FIG. 140 according to an example of the present technology is shown. It shows an increasing elongation in the course direction of the woven positioning stabilization structure according to an example of the present technology. A 3D printed link used to form a positioning stabilization structure according to an example of the present technology is shown. A 3D printed positioning stabilization structure fragment containing a rigidizer according to an example of the present technology is shown. A 3D printed positioning stabilization structure strap and clip according to an example of the present technology are shown. A rear perspective view of a vent for a patient interface according to one embodiment of the present art is shown. A front perspective view of a vent for a patient interface according to one embodiment of the present art is shown. A rear perspective view of a vent for a patient interface according to one embodiment of the present art is shown. A side perspective view of a vent for a patient interface according to one embodiment of the present art is shown. A side perspective view of a vent for a patient interface according to one embodiment of the present art is shown. A side perspective view of a vent for a patient interface according to one embodiment of the present art is shown. A plan perspective view of a vent for a patient interface according to one embodiment of the present art is shown. It is a process flow diagram which draws the method for manufacturing the patient interface for the treatment of the respiratory disease which concerns on an example of this technique. FIG. 5 is a system diagram that roughly depicts the equipment used to perform the method of FIG. 153. It is a top view of the cloth which draws the vent part after heat caulking which concerns on an example of this technique. It is an enlarged plan view of the peripheral edge of the vent part before heat caulking which concerns on an example of this technique. It is an enlarged plan view of the peripheral edge of the vent part after heat caulking which concerns on an example of this technique. It is an enlarged cut-off side view of the peripheral edge of the vent part before heat caulking which concerns on an example of this technique. It is an enlarged cut-out side view of the peripheral edge of the vent part after heat caulking which concerns on an example of this technique. A neutral short tube according to an example of the present technology is shown. A side view of a compressed short tube according to an example of the present technology is shown. A side view of a short tube in an extended state according to an example of the present technology is shown. A side view of a short tube in a curved state according to an example of the present technology is shown. A cross-sectional view of a short tube along line 163-163 shown in FIG. 163 according to an example of the present technology is shown. A perspective view of a short tube in a curved and extended state according to an example of the present technology is shown. It is a perspective view which shows the patient interface system which concerns on one form of this technology which a patient wears and uses. It is a chart which draws the vertical plane airflow velocity (m / s) along the x-axis and z-axis from the vent of the SWIFT FX ™ nose pillow mask by Resmed Limited. It is a chart which draws the horizontal plane airflow velocity (m / s) along the x-axis and y-axis from the vent of the SWIFT FX ™ nose pillow mask by Resmed Limited. It is a chart which draws the vertical plane signal along the x-axis and y-axis from the vent of the SWIFT FX ™ nasal pillow mask by Resmed Limited. It is a chart which draws the horizontal plane signal along the x-axis and y-axis from the vent of the SWIFT FX ™ nasal pillow mask by Resmed Limited. It is a chart which draws the vertical plane airflow velocity (m / s) along the x-axis and z-axis from the vent of the patient interface system which concerns on one form of this technique. It is a chart which draws the horizontal plane airflow velocity (m / s) along the x-axis and y-axis from the vent of the patient interface system which concerns on one form of this technique. It is a chart which draws the vertical plane signal along the x-axis and y-axis from the vent of the patient interface system which concerns on one form of this technique. It is a chart which draws the horizontal plane signal along the x-axis and y-axis from the vent of the patient interface system which concerns on one form of this technique. Chart comparing the distance (m / s) from the vent of the SWIFT FX ™ nasal pillow mask by venting of the patient interface system and Resmed Limited according to one embodiment of the present technology (velocity (m / s) along the vent axis according to mm). Is. It is a bottom perspective view of the reinforcing part which is folded over the end part of the strap of the positioning stabilization structure which concerns on one form of this technique. It is a top view of the reinforcing part which is folded over the end part of the strap of the positioning stabilization structure which concerns on one form of this technique. It is a side perspective view of the reinforcing part which is folded over the end part of the strap of the positioning stabilization structure which concerns on one form of this technique. It is a flat side view of the reinforcing part which is folded over the end part of the strap of the positioning stabilization structure which concerns on one form of this technique. It is an enlarged view of FIG. 179. It is an enlarged view of FIG. 177. A series of steps for removing the strap from the rigidizer arm of the positioning stabilization structure according to one embodiment of the present technology is shown. A series of steps for removing the strap from the rigidizer arm of the positioning stabilization structure according to one embodiment of the present technology is shown. A series of steps for removing the strap from the rigidizer arm of the positioning stabilization structure according to one embodiment of the present technology is shown. A series of steps for attaching a strap to the rigidizer arm of the positioning stabilization structure according to one embodiment of the present technology is shown. A series of steps for attaching a strap to the rigidizer arm of the positioning stabilization structure according to one embodiment of the present technology is shown. It is a plan side view of the rigidizer arm of the positioning stabilization structure which concerns on one form of this technique which shows a visual index. It is a plan side view of the rigidizer arm of the positioning stabilization structure which concerns on one form of this technique which shows a visual index. It is a plan front view of the frame and the rigidizer arm which concerns on one form of this technique which shows a visual index and a tactile index. It is a top view of the seal forming structure which concerns on one form of this technique which shows a visual index. It is a rear view of the seal forming structure which concerns on one form of this technique which shows a visual index. It is a top perspective view of the seal forming structure which concerns on one form of this technique which shows a visual index. It is sectional drawing taken through the line 193-193 of FIG. It is sectional drawing taken through line 194-194 of FIG. It is a rear view of the frame which concerns on one form of this technique. It is a top view of the frame which concerns on one form of this technique. It is a rear perspective view of the frame which concerns on one form of this technique. It is a flat side view of the frame which concerns on one form of this technique. It is a rear view of the holding structure of the plenum connection area which concerns on one form of this technique. It is a bottom view of the holding structure of the plenum connection area which concerns on one form of this technique. It is a rear perspective view of the holding structure of the plenum connection region which concerns on one form of this technique. It is a plan side view of the holding structure of the plenum connection area which concerns on one form of this technique. A tube according to one embodiment of the present technology is shown in which the lower end of the tube is held in a predetermined position in a state where the longitudinal axis of the tube at the lower end of the tube is perpendicular to the extension direction before the start of extension. One form of the present technology that is extended by a length of 30 mm in which the lower end of the tube is held in place in a state where the longitudinal axis of the tube at the lower end of the tube is perpendicular to the extension direction before the start of extension. The relevant tube is shown. One form of the present technology that is extended by a length of 60 mm in which the lower end of the tube is held in place in a state where the longitudinal axis of the tube at the lower end of the tube is perpendicular to the extension direction before the start of extension. The relevant tube is shown. One form of the present technology that is stretched by a length of 90 mm, in which the lower end of the tube is held in place in a state where the longitudinal axis of the tube at the lower end of the tube is perpendicular to the stretching direction before the start of stretching. The relevant tube is shown. One form of the present technology that is extended by a length of 120 mm in which the lower end of the tube is held in place in a state where the longitudinal axis of the tube at the lower end of the tube is perpendicular to the extension direction before the start of extension. The relevant tube is shown. ResMed ™ SWIFT FX ™ nasal pillow mask tube in which the lower end of the tube is held in place with the longitudinal axis of the tube at the lower end of the tube perpendicular to the direction of extension before extension begins. .. ResMed ™ SWIFT FX, which is stretched by a length of 30 mm, holds the bottom edge of the tube in place with the longitudinal axis of the tube at the bottom edge of the tube perpendicular to the stretch direction before the stretch begins. Trademark) Nose pillow mask tube. ResMed ™ SWIFT FX, which is stretched by a length of 60 mm, holds the bottom edge of the tube in place with the longitudinal axis of the tube at the bottom edge of the tube perpendicular to the stretch direction before the stretch begins. Trademark) Nose pillow mask tube. ResMed ™ SWIFT FX, which is stretched by a length of 90 mm, holds the bottom edge of the tube in place with the longitudinal axis of the tube at the bottom edge of the tube perpendicular to the stretch direction before the stretch begins. Trademark) Nose pillow mask tube. ResMed ™ SWIFT FX, which is stretched by a length of 120 mm, holds the bottom edge of the tube in place with the longitudinal axis of the tube at the bottom edge of the tube perpendicular to the stretch direction before the stretch begins. Trademark) Nose pillow mask tube. Philips Respironics GoLife nasal pillow mask holds the bottom of the tube in place with the longitudinal axis of the tube at the bottom of the tube perpendicular to the direction of extension before extension begins. Shows the tube. Philips Respironics ™ stretched by a length of 30 mm, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) GoLife ™ Nose Pillow Mask Tube. Philips Respironics ™ stretched by a length of 60 mm, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) GoLife ™ Nose Pillow Mask Tube. Philips Respironics ™ stretched 90 mm long, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) GoLife ™ Nose Pillow Mask Tube. Philips Respironics ™ stretched 120 mm long, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) GoLife ™ Nose Pillow Mask Tube. Philips Respironics Wisp nasal pillow mask holds the bottom of the tube in place with the longitudinal axis of the tube at the bottom of the tube perpendicular to the direction of extension before extension begins. Shows the tube. Philips Respironics ™ stretched by a length of 30 mm, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) Wisp ™ Nose Pillow Mask Tube. Philips Respironics ™ stretched by a length of 60 mm, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) Wisp ™ Nose Pillow Mask Tube. Philips Respironics ™ stretched 90 mm long, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) Wisp ™ Nose Pillow Mask Tube. Philips Respironics ™ stretched 120 mm long, with the bottom edge of the tube held in place with the longitudinal axis of the tube perpendicular to the stretch direction at the bottom edge of the tube before stretching begins. ) Wisp ™ Nose Pillow Mask Tube. The front view of the patient interface system which concerns on an example of this technique is shown. The plan view of the patient interface system which concerns on an example of this technique is shown. The left side view of the patient interface system which concerns on an example of this technique is shown. The right side view of the patient interface system which concerns on an example of this technique is shown. Another left side view of the patient interface system according to an example of the present technology is shown. Another plan view of the patient interface system according to an example of the present technology is shown. Another plan view of the patient interface system according to an example of the present technology is shown. The rear view of the patient interface system which concerns on an example of this technique is shown. Another rear view of the patient interface system according to an example of the present technology is shown. The rear perspective view of the patient interface system which concerns on an example of this technique is shown. A front view of a patient interface system according to an example of the present technology worn by a patient is shown. A plan view of a patient interface system according to an example of the present technology worn by a patient is shown. A left side view of a patient interface system according to an example of the present technology worn by a patient is shown. A front perspective view of a patient interface system according to an example of the present technology worn by a patient is shown. A right side perspective view of a patient interface system according to an example of the present technology worn by a patient is shown. A detailed right side perspective view of a patient interface system according to an example of the present technology worn by a patient is shown. Another right side perspective view of a patient interface system according to an example of the present technology worn by a patient is shown. A plan view of a patient interface system according to an example of the present technology worn by a patient is shown. The plan view of the nasal cradle cushion of the patient interface which concerns on an example of this technique is shown. FIG. 6 shows a bottom cross-sectional view taken through line 234c-234c of FIG. 234a of a patient interface nasal cradle cushion according to an example of the present technology. A side sectional view taken through line 234c-234c of FIG. 234a of a nasal cradle cushion of a patient interface according to an example of the present technique is shown. The patient's nose is indicated by a dashed line. FIG. 3 shows a plan view of another nasal cradle cushion of the patient interface according to another example of the present technology. FIG. 6 shows a bottom cross-sectional view taken through line 235c-235c of FIG. 235a of another nasal cradle cushion of a patient interface according to another example of the present art. A side sectional view taken through line 235c-235c of FIG. 235a of another nasal cradle cushion of the patient interface according to an example of the present technique is shown. The patient's nose is indicated by a dashed line. FIG. 3 shows a plan view of another nasal cradle cushion of the patient interface according to another example of the present technology. FIG. 6 shows a bottom cross-sectional view taken through line 236c-236c of FIG. 236a of another nasal cradle cushion of the patient interface according to another example of the technique. FIG. 6 shows a side sectional view taken through line 236c-236c of FIG. 236a of another nasal cradle cushion of the patient interface according to another example of the technique. The patient's nose is indicated by a dashed line. The plan view of the nasal cradle cushion of the patient interface which concerns on an example of this technique is shown. The plan view of the nasal cradle cushion of the patient interface which concerns on another example of this technique is shown. The plan view of the nasal cradle cushion of the patient interface which concerns on another example of this technique is shown. A plan view of the nasal cradle cushion of the patient interface according to another example of the present technology is shown. A cross-sectional view of a nasal cushion taken through line 238a-238a of FIG. 234a according to an example of the present technology is shown. A cross-sectional view of a nasal cushion taken through lines 238b, 238c-238b, and 238c of FIG. 239 according to an example of the present technology is shown. A cross-sectional view of a nasal cushion taken through lines 238b, 238c-238b, and 238c of FIG. 239 according to an example of the present technology is shown. The plan view of the nasal cradle cushion of the patient interface which concerns on an example of this technique is shown. A plan view of a patient interface system according to an example of the present technology worn by a patient is shown. A side view of a patient interface system according to an example of the present technology worn by a patient is shown. An enlarged perspective view of a patient interface system according to an example of the present technology worn by a patient is shown. An enlarged side view of a patient interface system according to an example of the present technology worn by a patient is shown. An enlarged front view of a patient interface system according to an example of the present technology worn by a patient is shown. A front perspective view of a seal forming structure, a plenum chamber, and a holding structure according to an example of the present technology is shown. The plan view of the seal forming structure, the plenum chamber, and the holding structure which concerns on an example of this technique is shown. The bottom view of the seal forming structure, the plenum chamber, and the holding structure which concerns on an example of this technique is shown. A side view of a seal forming structure, a plenum chamber, and a holding structure according to an example of the present technology is shown. The rear view of the seal forming structure, the plenum chamber, and the holding structure which concerns on an example of this technique is shown. The front view of the seal forming structure, the plenum chamber, and the holding structure which concerns on an example of this technique is shown. A cross-sectional view of a seal forming structure, a plenum chamber, and a holding structure taken through a line 245g-245g of FIG. 245f according to an example of the present technology is shown. Other front perspective views of the seal forming structure, the plenum chamber, and the holding structure according to an example of the present technology are shown. A cross-sectional view of a seal forming structure, a plenum chamber, and a holding structure taken through line 245i-245i of FIG. 245b according to an example of the present technology is shown. A cross-sectional view of a seal forming structure, a plenum chamber, and a holding structure taken through line 245j-245j of FIG. 245f according to an example of the present technology is shown. A cross-sectional view of a seal forming structure, a plenum chamber, and a holding structure taken through a line 245k-245k of FIG. 245c according to an example of the present technology is shown. The front perspective view of the patient interface system which concerns on an example of this technique is shown. The figure of the patient interface system which concerns on an example of this technology seen from the rear diagonally lower side is shown. The figure of the patient interface system which concerns on an example of this technology seen from the front diagonally above is shown. The figure of the patient interface system which concerns on an example of this technology seen from the front diagonally lower side is shown. A side view of the patient interface system according to an example of the present technology is shown. The bottom perspective view of the patient interface system which concerns on an example of this technique is shown. Another bottom perspective view of the patient interface system according to an example of the present technology is shown. The plan view of the patient interface system which concerns on an example of this technique is shown. A side view of the patient interface system according to an example of the present technology is shown. The plan view of the patient interface system which concerns on an example of this technique is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A rear perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. FIG. 252B shows a cross-sectional view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology taken through line 252C-252C in FIG. 252B. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. FIG. 253B shows a cross-sectional view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology taken through line 253C-253C in FIG. 253B. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A detailed plan view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a removable rigidizer arm attached to a frame for a patient interface according to an example of the present technology is shown. A detailed rear perspective view of a frame for a patient interface and a removable rigidizer arm according to an example of the present technology is shown. A perspective view of a frame and a rigidizer arm for a patient interface according to an example of the present technology is shown. A perspective view of a frame and a rigidizer arm for a patient interface according to an example of the present technology is shown. A perspective view of a frame and a rigidizer arm for a patient interface according to an example of the present technology is shown. A perspective view of a frame and a rigidizer arm for a patient interface according to an example of the present technology is shown. A perspective view of a strap and a rigidizer arm for a positioning stabilization structure for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. The perspective view of the rigidizer arm for the patient interface system which concerns on an example of this technique is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown. A perspective view of a strap for a positioning stabilization structure attached to a rigidizer arm for a patient interface system according to an example of the present technology is shown.

6 (F) Detailed Description of Examples of the Techniques Before describing the techniques in more detail, it is understood that the techniques are not limited to the various specific examples described herein. It should be. It should also be understood that the terms used in this disclosure are for the purpose of explaining the particular embodiments discussed herein and are not intended to be limiting.

6.1 Treatment system In one form, the technique comprises equipment for treating respiratory illness. The device may include a flow generator or blower for supplying pressurized breathing gas, such as air, to the patient 1000 via an air circuit 4170 leading to the patient interface 3000, as shown in FIG. 1a.

6.2 Treatment In one form, the technique comprises a method for treating a respiratory disease comprising the step of applying positive pressure to the entrance of the airway of patient 1000.

6.2.1 Nasal CPAP for OSA
In one embodiment, the technique comprises a method of treating an obstructive sleep apnea in a patient by applying continuous nasal positive airway pressure to the patient.

6.3 Patient Interface 3000
With reference to FIG. 166, the non-invasive patient interface 3000 according to one aspect of the present technology has the following functional aspects: seal forming structure 3100 (see, eg, FIG. 4), plenum chamber 3200, positioning stabilization. It includes a structure 3300 and a connection port 3600 for connecting the air circuit 4170 to the short tube 4180. In some forms, functional aspects may be conferred by one or more physical components. In some forms, one physical component may provide one or more functional aspects. During use, the seal forming structure 3100 is arranged so as to surround the entrance of the patient 1000 to the airways to facilitate the supply of positive pressure air into the airways.

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

The seal forming structure 3100 according to the present technology may be made of a flexible, flexible, elastic material such as silicone. The seal forming structure 3100 may form part of a seal path for delivering air from the PAP device to the patient's nostrils.

Referring to FIG. 9, in one embodiment of the present technology, the seal forming structure 3100 may include a seal flange 3110 and a support flange 3120. The seal flange 3110 may include a relatively thin member having a thickness of less than about 1 mm, for example about 0.25 mm to about 0.45 mm. The support flange 3120 may be relatively thicker than the seal flange 3110. The support flange 3120 is a spring-like element or includes a spring-like element and functions to support the seal flange 3110 so as not to buckle during use. In use, the seal flange 3110 readily responds to system pressure in the plenum chamber 3200 acting on the underside of the seal flange to urge the seal flange into a tight seal engagement with the face, eg, the patient's nose. Can be done. The plenum chamber 3200 is formed from a soft material such as silicone.

6.3.1.1 Nostril Pillow In one embodiment of the technique, the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs or a pair of nasal pillows 3130, each nasal puff or The nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose, for example by abutting against the outer peripheral region of the patient's nostril to form a seal.

The nose pillow 3130 (FIG. 9) according to one aspect of the present technology includes a truncated cone 3140, a truncated cone 3150, and a truncated cone 3140 in which at least a part thereof forms a seal on the lower surface of the patient's nose, for example, a truncated cone portion. Includes an upper flexible region 3142 that is on the lower surface of the surface and connects the truncated cone to the handle 3150. Also, the structure to which the nasal pillow 3130 of the present technology is connected includes a lower flexible region 3152 adjacent to the base of the handle 3150. The upper flexible region 3142 and the lower flexible region 3152 facilitate a universal joint structure that adapts to the relative movement of the truncated cone 3140 and the structure to which the nasal pillow 3130 is connected-both displacement and tilt. Can act in concert with. In one example, the truncated cone 3140 may be coaxial with the handle 3150 to which it is connected. In another example, the truncated cone 3140 and the handle 3150 do not have to be coaxial (eg, offset). The nasal pillows 3130 may be sized and / or formed so that they extend laterally beyond the walls of the plenum chamber 3200, as described below.

In one embodiment of the present technology, each stalk 3150 may be provided with variable stiffness so that the nasal pillow 3130 does not sway forward due to compression and / or bending of the stalk 3150 during use. For example, the side of the stalk 3150 away from the patient's face during use may be harder than the region of the stalk 3150 close to the patient's face. In other words, the different material stiffness on either side of the handle 3150 provides greater resistance unless the handle 3150 is compressed or bent in a predetermined direction. This even allows the pillow 3130 to be pressed against the nostrils by preventing the pillow 3130 from swinging forward. Such a configuration may help resist buckling of the stalk 3150, which results in anterior swing of the nasal pillow 3130. The variable stiffness may also be used to provide a fragility point around which the stalk 3150 buckles in a desired direction and is promoted to swing. In other words, compression of the nasal pillow 3130 can even be achieved. This configuration may allow the sealing force to be localized at the upper end of the nasal pillow 3130. In addition, this configuration may allow any bending of the nasal pillow 3130 to be moderated. The nasal pillow 3130 may be formed to compress against the plenum chamber 3200 when pressed against the patient's face, because the nasal pillow 3130 can be laterally wider than the plenum chamber. , Part of the plenum chamber 3200 does not extend beyond the pillow 3130. In another example, the nasal pillows 3130 may be formed and / or dimensioned so that their perimeters are substantially flush with the perimeter of the plenum chamber 3200 when compressed. In a further example of the technique, the handle 3150 may be the thinnest at the base of the truncated cone 3140.

In one example, the pillow 3130 is placed at the entrance to the nostrils to engage the pillow 3130 with the entrance to the patient's airways. As the positioning stabilization structure 3300 is adjusted, tension begins to pull the pillow 3130 into the nostrils. Due to the continuous insertion of the pillow 3130 into the nostrils, the handle 3150 is crushed by the trampoline 3131 which moves the base of the pillow 3130 to the upper surface of the plenum chamber 3200. The handle 3150 of the nasal pillow 3130 may be connected to the plenum chamber 3200 and may also include a thin or reduced thickness portion. The thin portion allows the pillow 3130 to easily bounce or trampoline, thus allowing the pillow 3130 to more easily adapt to the nasal wing angle of the patient 1000. The trampoline 3131 may be tilted away from the bottom of the pillow 3130 or the nasal septum and / or upper lip of the patient 1000. This improves the comfort and stability of the patient interface device 3000.

It is also envisioned that nasal pillows 3130 of various sizes may be used with plenum chambers having a commonly sized connection area and plenum connection area. This has the advantage of allowing the patient to be adapted to the patient's particular biological structure, eg, the plenum chamber 3200 and pillow 3130, which are sized to best fit the size and orientation of the nostrils.

In one embodiment of the technique, the seal forming structure 3100 forms a seal at least partially in the nasal column region of the patient's nose.

6.3.2 A small portion of the nasal pillow 3130 may enter the patient's nostrils when using the nasal cradle, but another form of seal-forming structure 3100 is substantially outside the nose when used. In one embodiment of the technique shown in FIG. 34, the seal forming structure 3100 of the patient interface 3000 is configured to form a seal surrounding both nostrils against the patient's airways without entering the nostrils. Be placed. The seal forming structure 3100 may handle both nostrils using a single orifice, eg, a nasal cradle. In FIG. 34, the seal forming structure 3100 according to the illustrated example includes a nose flange 3101 arranged over its outer periphery. This figure also shows the attachment of the plenum chamber 3200 and seal forming structure 3100 to the frame 3310.

6.3.2.1 Nose Cushion for Nose Cushion FIGS. 223-232 show some figures of a typical patient interface system 3000 with a seal forming structure 3100 in the form of a nasal cradle cushion. FIGS. 233a-233h show some diagrams of a typical patient interface system 3000 with a seal forming structure 3100 in the form of a nasal cradle cushion worn on patient 1000. The seal forming structure 3100 may seal around the lower part of the patient's nose, especially around the ala of nose and the crown of the nose. The seal forming structure 3100 may define the gas chamber 3104, which is discussed in more detail below, at least in part. During treatment, respiratory gas may be delivered to the patient from the patient interface 3000 through the gas chamber 3104 towards the nose. When the patient interface 3000 is worn by the patient, the seal forming structure 3100 may at least partially define the gas chamber 3104 with the patient's face, through which the breathing gas is positively applied to the patient. It should be understood that it may be done. For example, the seal-forming structure 3100 in the form of a nasal cradle may be sealed below the bridge of the nose (eg, the transition area between the bone and cartilage of the nose), or the crown of the patient, the nose. It may be sealed on the sides and / or on the upper lip or on the underside of these. According to another example of the present technology, the seal forming structure 3100 in the form of a nasal cradle cushion may be structured to seal around the area under the nose. In other words, the seal may be formed with the underside of the patient's nose. It should also be understood that the nasal cradle cushion is different from the nasal pillow. This is because the nasal cradle cushion can be constructed so that it can handle both nostrils with a single orifice and does not enter the patient's nostrils. The seal forming structure 3100 may be a single wall cushion, or the seal forming structure 3100 may be a double wall cushion, for example, the seal forming structure may include an undercushion. Alternatively, undercushions may be omitted and roll edges may be used around the openings of the seal forming structure 3100 to form a secure pneumatic seal around the patient's nose.

Protruding ends 3114 can be seen on both sides of the seal forming structure 3100. Each protruding end 3114 may be formed to extend from the patient interface 3000 to seal within the gap between each patient's ala of nose and nasolabial fold when worn by the patient 1000. FIG. 2c, which depicts the surface morphology of the face, shows the positions of the ala of nose and the nasolabial fold. The protruding end 3114 may partially bulge and / or deform to seal in this area. According to an example of the present technology, the concave lower portion 3212 of the seal forming structure 3100 below the opening to the gas chamber 3104 may seal against the upper lip. The concave lower portion 3212 may be curved to approximately fit a portion of the patient's upper lip to form a seal in that area. The shape of the concave lower portion 3212 can be seen, for example, in FIG. 245c, where the seal forming structure 3100 curves inward from the protruding end 3114. Since the upper lip of most patients is convex, the concave lower portion 3212 can easily fit this part of the patient's face to form an effective seal. The rear of the seal forming structure 3100, which can seal against the patient's upper lip below the opening to the gas chamber 3104, is intended to ensure a continuous path for the influx of pressurized gas into the patient's airways. It may be formed and dimensioned so as not to cover the patient's nostrils during use. According to another example of the technique, the seal forming structure 3100 may be softened in the posterior inferior region of the seal forming structure that seals against the patient's upper lip, eg, by reducing the thickness of the material.

FIGS. 233a-233h show how a typical patient interface 3000 can seal to patient 1000, especially the nose. It should be understood that the seal forming structure 3100 may be concave in shape so as to sandwich the patient's nose. The recess 3116 may receive the top of the patient's nose, and the protruding end 3114 may seal in the area of the ala of nose and the nasolabial fold. The protruding end 3114 may seal against the patient's face and nose in the area where the nasal wings connect to the patient's face near the nasolabial fold. (See FIGS. 2c, 2d, 2f) In most patients, this region is concave in shape, so that the protruding end 3114 extends into this region and seals within this region. There is. The protruding end support portion 3208 may support the nasal cushion 3112 in the region of the protruding end portion 3114 to help maintain the seal in this region and may function like an undercushion. In another example, the seal forming structure 3100 may include a roll edge around the opening to the gas chamber 3104 without including the protruding end support portion 3208. In yet another example, the seal forming structure 3100 may not be provided with a roll edge or protruding end support portion 3208.

223 to 232 also show that the recess 3116 may be included in the seal forming structure 3100. The recess 3116 may include an inwardly molded portion that extends into the nasal gas chamber 3104 to receive the top of the patient's nose when worn by the patient. The recess 3116 may enhance the seal around the apex of the patient's nose and below the apex during treatment by allowing the shape of the seal forming structure 3100 to better fit the patient's nose. The seal forming structure 3100 allows the seal forming structure to better fit the top of the patient's nose and seal around the top of the patient's nose near the recess 3116 at the opening to the seal forming structure. It may include an overhanging portion.

The seal forming structure 3100 may surround a portion of the nose of patient 1000, particularly the crown of the nose. The gas chamber 3104 may be formed by the seal forming structure 3100 and the patient's face.

The patient interface 3000 according to an example of the present technology has a surface area occupied area on the face that is significantly less noticeable than a conventional nasal face mask. For some patients, it also feels little claustrophobia. Also, specific areas with few obstacles are important. It has been found that these areas have a significant psychological impact on the bed partner, as the mask does not look very medical and "opens" the face when the bed partner looks at the mask. Because. From the patient's point of view, the typical patient interface 3000 is not in or significantly reduced from the patient's field of view. This is because the seal forming structure 3100 seals below the nasal bridge. This allows the patient to wear eyeglasses after wearing the patient interface 3000, when reading a book or watching television before falling asleep. By sealing below the bridge of the nose, inflammation can be avoided in areas where the skin is thin and sensitive to pressure and where there is a high chance of skin damage due to impaired blood flow. Another advantage is that there is no need to consider anthropometric variability between patients above the bridge of the nose, and the focus for mask coverage can be directed to anthropometric variability around the upper lip area. It may be possible. Also, unlike some other full face masks, the patient interface 3000 may not require a frontal support that may be needed to perform pressure point relief. This also avoids the problem that the frontal support is the source of pressure points and skin damage. This type of seal-forming structure 3100 may also be beneficial in that it provides an alternative for respiratory treatment patients who do not feel comfortable with the nasal pillow.

Anatomically, FIGS. 2h and 2i may be referred to for indication of the location of the transition region between the nasal bone and cartilage, which may be understood to define the nasal bridge. Thus, the typical seal-forming structure 3100 may seal over the perimeter of the patient's nose in contact with softer tissue of the nose, such as adipose tissue or cartilage. By forming a seal with the nose with these soft tissues, it is possible to avoid inflammation of the patient's skin that would otherwise occur if a harder nasal structure, i.e., a seal is formed around / over the bone. In some cases. In other words, sealing below the bridge of the nose can minimize patient discomfort. Also, by positioning the seal of the seal forming structure 3100 around this region of the nose, an effective seal can be formed. This is because the nasal tissue and the seal forming structure 3100 are compatible with each other to form the seal. The seal forming structure 3100 is mainly compatible with the nose.

The above-mentioned sealing function portion is a portion of the protruding end portion 3114 that abuts on the face of the patient 1000. Specifically, the protruding end 3114 may be an extension of the seal forming structure 3100 that seals in the region between the nasolabial fold and the ala of nose. These anatomical features can be seen in FIG. 2c. Depending on the individual facial structure of the patient, this area may correspond to a recess. Therefore, extension from the seal forming structure 3100 may be required to form a suitable seal around the patient's nose. The protruding end portion 3114 can preferably perform this function.

Another sealing function of the typical patient interface 3000 is a recess 3116 for receiving the top of the nose of the patient 1000 when the seal forming structure 3100 is worn by the patient. Specifically, as shown in FIGS. 233a to 233h, the top of the nose of the patient 1000 can be seen with a broken line in the region where the recess 3116 is located. The seal forming structure 3100 may be formed so as to seal the outer circumference of the nose on the lower surface of the nose. In other words, the seal formed by the seal forming structure 3100 for the nose may be characterized as for the lower periphery of the nose. Therefore, the seal surface of the seal forming structure 3100 may be concave to receive the nose as a whole or may form a pocket, and the seal surface of the seal forming structure may receive the top of the nose. It can be understood that the recess 3116 may be further included.

The seal forming structure 3100 may seal against the top of the nose of patient 1000. The gas chamber 3104, at least in part, with the seal forming structure 3100, the plenum chamber 3200, and the patient's nose to provide a sealed pathway for respiratory gas to enter the patient's airways through the nostrils. May be specified by.

In one example, the seal forming structure 3100 according to the present technology is composed of a flexible and flexible elastic material such as silicone. In another example of the present technology, the seal forming structure 3100, for example, the seal forming structure 3100 and its overhanging portion 3206 may be formed from foam. The seal forming structure 3100 may be formed from other materials, including foams, gels, and / or low durometer silicones, according to a further example of the art.

245a, 245d, and 245g-245k show an example of a protruding end support portion 3208. The protruding end support portion 3208 may be associated with the respective protruding end portion 3114 of the seal forming structure 3100. It may be understood that the protruding end support portion 3208 extends into the gas chamber 3104, which is at least partially defined by the seal forming structure 3100 and the plenum chamber 3200. Such a form may allow the protruding end support portion 3208 to provide sufficient support for the protruding end portion 3114 to seal against the patient's face.

The protruding end support portions 3208 can be seen on both sides of the seal forming structure 3100. The protruding end support portion 3208 may be located below the protruding end portion 3114 of the seal forming structure 3100. The protruding end support portion 3208 may be included to support the protruding end portion 3114 of the seal forming structure 3100.

As shown in FIGS. 234a to 239, the protruding end portions 3114 may be included on both sides of the seal forming structure 3100. The gas chamber 3104 and the openings to the gas chamber can also be seen. As shown in FIGS. 237a-237d, the opening to the nasal gas chamber 3104 is generally rectangular, rhombic, which may be curved at its respective short side 3104.2 and long side 3104.1, 3104.3. It may have a shape or a trapezoidal shape. The curved short side of the opening, 3104.2, may be located near each ala of nose of the nose when placed against the patient's nose. Also in this example, the distal long side 3104.1 of the opening may be on the distal end side of the patient's upper lip near the top of the nose, while the proximal long side 3104.3 is the patient. It may be proximal to the upper lip. A recess 3116 formed to receive the top of the nose is also shown.

FIGS. 234a-234c show that the seal forming structure 3100 can bend slightly upward as it approaches the distal long side 3104.1 of the opening from the recess 3116 to the gas chamber 3104. The front upper part of the seal forming structure 3100 near the recess 3116 includes a slight depression or concave region in the center so that the seal forming structure 3100 is higher on both sides than in the center. The figure also shows the outer shape of the nose with dashed lines to show how the patient's nose can be positioned with respect to the seal forming structure 3100. The top 3118 of the seal forming structure 3100 serves to seal the anterior surface of the nostrils. The apex may be located further posterior, but may gradually shift significantly to create a balloon effect to seal against the nostrils. The distal long side 3104.1 may be flipped up from the seal forming structure 3100, the seal may be elevated at the crown by contact with the nose, and the compressed pneumatic seal by pinching the nose. May bring. A recess 3116 formed to receive the top of the nose is also shown.

235a-235c also show protruding ends 3114 on either side of the seal forming structure 3100. The outer shape of the seal forming structure 3100 may incline downward as it approaches the distal side 3104.1 opening from the recess 3116 to the gas chamber 3104. This example of the seal forming structure 3100 lacks a recess in the anterior region near the recess. In other words, in this example, the seal forming structure 3100 is more circular in the region from the recess 3116 to the distal side 3104.1 of the opening to the gas chamber 3104 as compared to the example shown in FIGS. 234a-234c. / Indicates that it may be further rounded.

236a-236c show that the shape of the opening to the gas chamber 3104 may be more balloon-like and rounder than the examples shown in FIGS. 234a-234c and 235a-235c. The seal forming structure 3100 may have a linear side wall as opposed to a side wall that smoothly curves from the top surface of the seal forming structure 3100. The linear side wall may have a predetermined upper edge and may enhance the stability and strength of the seal forming structure 3100.

In another example, the seal forming structure 3100 may lack a recess in the anterior region near the recess 3116. A linear side wall of a typical nasal cushion 3112 may be included.

It should also be understood that in FIGS. 234a-234c, 235a-235c, and 236a-236c, the typical seal forming structure 3100 is shown in a substantially undeformed state. Some figures may show a small amount of deformation due to the fit with the shape of the nose shown by the dashed line. Therefore, the seal forming structure 3100 may have a concave shape as shown in the figure when it is not deformed.

It should also be understood that the seal forming structure 3100 may have a cross section of varying thickness as shown in FIGS. 238a-238c. Therefore, the region of the seal forming structure 3100 near the opening to the gas chamber 3104 may be thinner than the region where the seal forming structure 3100 attaches to the plenum chamber 3200. Preferably, this may provide the patient with greater comfort by providing a thinner, and thus more adaptable area of cushioning material at the site where a large amount of contact is made to the patient's nose.

Region 3112.1. May be near the opening to the gas chamber 3104, and region 31123 may be near the connection with the plenum chamber 3200. The region 311.2 may be the highest region near the upper outer periphery of the nasal cushion 3112.

In the seal forming structure 3100, a thickness that smoothly changes from the region 3112.1. Further, the thickness x may be thinner than the thickness z. Region 311.2 may be thicker than regions 3112.1, 311.2. Further, the thickness x may be thinner than the thickness z, and the thickness y may be thicker than x and z. Region 311.2 may be thicker than regions 3112.1, 311.2. Further, the thickness z may be thinner than the thickness x, and the thickness y may be thicker than x and z.

FIG. 239 shows another typical seal forming structure 3100 according to the present technology, the opening to the gas chamber 3104 and the protruding end 3114 being shown to allow understanding of the orientation of the seal forming structure 3100. Is done. Regions of various thicknesses are hatched differently to better indicate where the thickness of the seal forming structure 3100 can vary. Region 3113 may be the thinnest so that it can be easily fitted to the top of the nose. Region 3113 may have a thickness of about 0.35 mm, according to an example of the present technology. Region 3115 may be thicker to provide greater support to the seal forming structure 3100. Region 3115 may have a thickness of about 0.5 mm, according to an example of the present technology. Region 3117 may be thicker than the other regions to provide maximum support, resistance to deformation and to ensure an effective seal on the patient's nasal wing. Region 3117 may have a thickness of about 1 mm, according to an example of the present technology.

The lower end corner portion of the seal forming structure 3100 may have higher rigidity than other regions of the seal forming structure 3100 in order to prevent or minimize deformation at the lower end corner portion. Having a higher level of rigidity at the lower end corners of the seal forming structure 3100 reduces the possibility of interfering with the seal at these positions of the seal forming structure 3100, especially when receiving tube torque.

FIGS. 245a-245k depict further examples of the present technology. In these figures, the seal forming structure 3100, the plenum chamber 3200, and the holding structure 3242 are shown removed from the frame 3310 (not shown in these figures). These figures show a seal forming structure 3100 and a protruding end support portion 3208 extending inward from the plenum chamber 3200 to support the protruding end 3114 when engaged with the patient's nose. The protruding end support portion 3208 may be in the form of a hollow protruding portion extending into the patient interface 3000. As can be seen in FIG. 245d, the protruding end support portion 3208 may be considered as pockets formed on the sides of the seal forming structure 3100 and the plenum chamber 3200. The protruding end support portion 3208 may be formed integrally with the seal forming structure 3100 and the plenum chamber 3200. In another example, the protruding end support portion 3208 may not be hollow, but rather may be a solid extension formed integrally with the seal forming structure 3100 and the plenum chamber 3200.

It is also envisioned that the protruding end support portion 3208 may include an additional support structure made of a material that is harder than the seal forming structure 3100 and the plenum chamber 3200. According to one example of the technique, even if the side of the protruding end support portion 3208 is separated from the seal forming structure 3100 and the plenum chamber 3200 when the patient interface 3000 is not engaged with the patient's nose in a sealed state. Good things should be understood. When the patient wears the patient interface 3000, the seal forming structure 3100 and the plenum chamber 3200 may be deformed and the protruding end 3114 may be pressed against the protruding end support, thereby the protruding end. Prevents crushing and supports the protruding end to the patient. For example, the protruding end support portion 3208 supports each protruding end portion 3114 as the protruding end is deformed due to the seal engagement with the patient's face at the junction between the nasal wings and the face. You may.

Further, the protruding end supporting portion 3208 may have an outer shape such that the cross-sectional area of the protruding end supporting portion decreases as the protruding end supporting portion extends into the gas chamber 3104. The end of the protruding end support portion 3208 extending into the gas chamber 3104 as shown in FIGS. 245g and 245i-245k may be flat, or instead, the tip of the protruding end support portion. May be thinner. The wall forming the protruding end support portion 3208 may increase or decrease in thickness towards the gas chamber 3104. Further, it is assumed that the protruding end support portion 3208 may have an outer shape that is curved. For example, the protruding end support portion 3208 is curved so as to substantially follow the outer shape of each protruding end portion 3114 in a state where the seal forming structure 3100 is not in direct contact with the protruding end portion when the seal forming structure 3100 is in the relaxed state. It may have an outer shape. As can be seen in FIGS. 245g and 245i-245k, for example, the protruding end support portion 3208 has an outer shape that is substantially curved away from the respective protruding end portion 3114 and towards the holding structure 3242. May be good.

FIGS. 245f to 245h show that the seal forming structure 3100 may include a thick portion 3204. These thick portions 3204 may provide additional support to the seal forming structure 3100 when the seal forming structure is in a seal engaging state with the patient's nose and face. The thick portion 3204 may be arranged on both sides of the seal forming structure 3100 at a position such that the thick portion is near the patient's nasolabial fold when the seal forming structure engages with the patient's face. The thick portion 3204 may help seal around the ala of nose of the patient's nose by preventing the seal forming structure 3100 from collapsing due to sealing forces. The thick portion 3204 may be integrally formed with the seal forming structure 3100. The thick portion 3204 also has a seal forming structure such that the thick portion 3204 can be pressed at least partially against the respective protruding end support portion 3208 when the seal forming structure engages the patient's nose and face. It may be located on the body 3100. The thick portion 3204 may have a constant thickness over the entire thickness that is greater than the thickness of the rest of the seal forming structure 3100. Alternatively, the thick portion 3204 may have a thickness that can vary over its range.

245a, 245c-245f, 245h, 245i and 245k also show that the seal forming structure 3100 may include an overhang 3206 for sealing against the patient's nose crown. The overhang 3206 may have a reduced thickness relative to the rest of the seal forming structure 3100, and the overhang may seal around the anterior part of the patient's nose, eg, the top of the nose. May be positioned and structured to form. The overhang 3206 may extend over a considerable distance, for example, the overhang can be seen in the side view of FIG. 245d.

245a, 245b, 245d-245f, 245h, 245i and 245k show examples of a seal forming structure 3100 which may include an adaptation region 3122. The adaptable region 3122 is relatively flexible, flexible, and / or adaptable as compared to the rest of the seal forming structure 3100. The relative flexibility of the acclimatization region 3122 may be advantageous in that it can help reduce discomfort to the patient in the area of the apex of the nose and the nasal septum. The adaptation region 3122 may be relatively thin compared to the rest of the seal forming structure 3100 and thus at the top of the nose by abutting and wrapping around the top of the nose and / or by contacting the top of the nose. It may act like a mechanical spring to maintain an effective seal. For example, as can be seen in FIG. 245d, the adaptation region 3122 may be located at the seal forming structure 3100 at the apex where the seal forming structure transitions to the plenum chamber 3200. The adaptation region 3122 may be located in the seal forming structure 3100 above the recess. Further, the adaptation region 3122 may be integrated with the recess 3116. For example, as can be seen in FIG. 245e, the adaptation region 3122 may be located horizontally about approximately in the center of the seal forming structure. The seal forming structure 3100 may have a thickness of about 0.35 mm in the adaptation region 3122 according to an example of the present technology, and is one of the thinnest regions of the seal forming structure. May be good.

The figures in FIGS. 245a-245k also show a holding structure 3242 having a notch 3295 and a tongue portion 3211. Also, these figures show the seal lip 3250.

The seal forming structure 3100 may also include a visual index pad-printed on the seal forming structure to indicate to the patient the appropriate insertion depth of the nose. For example, the visual index may include the contour of the nose to indicate to the patient where the patient's nose should be aligned with respect to the seal forming structure 3100. Such a visual indicator informs the patient where the nose should be placed within the seal-forming structure 3100 so that the patient does not result in a suboptimal seal by inserting the nose too deep into the seal-forming structure. May be good.

6.3.3 Plenum Chamber 3200
A plenum chamber 3200 according to an aspect of one embodiment of the present art functions to allow air flow between the two nostrils and air supply from the PAP device 4000 via a short tube 4180. The short tube 4180 is generally part of an air circuit 4170 that connects to the frame 3310 via a long tube (further gas delivery tube) 4178 connected to the PAP device 4000 and a connection port 3600. In this way, the plenum chamber 3200 may alternately function as an intake manifold during the inspiratory portion of the respiratory cycle and / or as an exhaust manifold during the expiratory portion of the respiratory cycle.

The plenum chamber 3200 may be constructed of an elastomeric material.

The plenum chamber 3200 provides a cushioning function between the seal forming structure 3100 and the positioning stabilization structure 3300 according to another aspect of one embodiment of the present technology.

In one form of the plenum chamber 3200, the same physical components perform the inlet / exit manifold and cushioning functions, whereas in another form of the art, these functions are formed by two or more components. NS.

The seal forming structure 3100 and the plenum chamber 3200 are formed as a single integral component and may be formed, for example.

The plenum chamber 3200 comprises a front wall 3210 and a rear wall 3220.

The rear wall 3220 includes a rear surface 3222 (see FIG. 8). In one embodiment of the technique, the seal forming structure 3100 is configured with respect to the posterior wall 3220 such that the posterior surface 3222 is separated from the patient's nasal septum and / or upper lip during use, as can be seen in FIGS. 18 and 19. And placed. In one form, for example, when the seal forming structure 3100 includes a nasal pillow 3130, this is by the posterior surface 3222 as shown in FIG. 8, where the posterior surface 3222 is in front of the rearmost 3130.1 of the nasal pillow 3130. This is achieved by arranging the rear wall 3220 as such. This configuration also allows the sealing force to be concentrated in the nostrils of the patient 1000 as the septum and / or upper lip is released from contact with the patient interface 3000.

The plenum chamber 3200 also includes a bending region 3230 (FIG. 9) that forms a connection with the seal forming structure 3100. The bent region 3230 may be a region separate from the anterior wall 3210 and / or the posterior wall 3220. Alternatively, part or all of the respective anterior wall 3210 and rear wall 3220 may form part of the flexion region 3230. In one embodiment of the present technology in which the seal forming structure 3100 comprises the left and right nasal pillows 3130, there are corresponding left flexion regions 3232 and right flexion regions 3234 (FIG. 4). The flexion regions 3230, 3232, 3234 press, for example, the patient interface 3000 against the pillow of the bed according to the forces faced when using the patient interface 3000, such as tube resistance, or according to the movement of the patient's head. It is configured and arranged to bend and / or bend accordingly. The bending region 3230, the left bending region 3232, and / or the right bending region 3234 may be made of a silicone rubber having an A-type press-fitting hardness in the range of, for example, about 35 to about 45. However, a wider range is possible if the thickness of the walls 3210, 3220 is adjusted accordingly to obtain similar levels of force.

In another aspect of the art that can be seen in FIGS. 4, 7, 8, 10, and 11, the plenum chamber 3200 has a saddle region or separation region 3236. As can be seen in FIG. 4, the bending region 3230 may include a separation region 3236 that may be located between the left bending region 3232 and the right bending region 3234. The separation region 3236 may be concave in shape and may extend from the front wall 3210 to the rear wall 3220. By forming the plenum chamber 3200 having the separation region 3236 as described above, the left bending region 3232 is separated from the right bending region 3234 so that the movement in one of the bending regions does not substantially affect the other bending region. You may be able to do it. In other words, the deformation and / or buckling of the left flexion region 3232 does not interfere with the right flexion region 3234, and vice versa. Preferably, this allows the nasal pillow 3130 associated with the non-obstructive flexion region to remain in place on the patient's corresponding nostril, even though the other flexion region is impaired. The separation region 3236 can avoid contact with the nasal septum by forming a concave shape between the stalks 3150. The separation region 3236 may also be the thinnest region of the plenum chamber 3200 to allow flexibility of the desired size in this region. Alternatively, the separation region 3236 may be the thickest region of the plenum chamber 3200. By giving the saddle region 3236 a deep curvature, patient comfort can be improved by minimizing or avoiding septal and / or upper lip contact. The saddle region 3236 may be U-shaped or V-shaped and has a nasolabial fold of about 70 ° to about 120 ° at its apex. The saddle region 3236 may be about 0.5 mm to about 2.5 mm deep for clearance near the patient's nasal septum.

The posterior wall 3220 may be placed adjacent to the patient's upper lip or upper lip when using the patient interface 3000, as in the case of FIGS. 18 and 19.

In one embodiment, the plenum chamber 3200 may further include a seal lip 3250 (FIG. 6). The seal lip 3250 may be made of a flexible elastic material, such as a silicone rubber having an A-type hardness in the range of about 30 to about 50, thereby forming a relatively flexible component. As shown in FIGS. 5, 6 and 8, the seal lip 3250 may be located on or as part of the inner surface or inner circumference of the plenum chamber 3200, or may be formed as part of the inner surface or inner circumference, or the plenum chamber. It may be located over the entire inner peripheral region of the 3200. However, it is also envisioned that the seal lip 3250 may be placed over the outer surface or outer circumference of the plenum chamber 3200 or over the entire outer peripheral region of the plenum chamber 3200. The seal lip 3250 may form a pneumatic seal between the plenum chamber 3200 and the frame 3310, as described in more detail below. The seal lip 3250 and the plenum chamber 3200 may form an integral part. Other patient interface devices use a compression seal formed from an elastically deformable material to compress the plenum chamber to engage the plenum chamber with the frame and at the same time provide a pneumatic seal. A pneumatic seal is formed between the frame and the frame. On the other hand, one example of the present technology forms a pneumatic seal by interference from a seal lip 3250 that abuts and bends against the frame 3310 when the plenum chamber 3200 is first fixed to the frame 3310. When the pressure in the plenum chamber 3200 is increased above atmospheric pressure to treat respiratory distress, the seal lip 3250 is pressed against the frame 3310 by a greater force, thus strengthening the pneumatic seal and increasing the sealing force. The air pressure in the cushion / plenum chamber of these other patient interface devices does not affect the sealing force between the cushion and the frame. Also, these other patient interface devices have cushions with side walls and seal lips for engaging with the frame, which are soft and rigid because they easily adapt to acupressure. Not only that, it can be elastically stretched or bent with little effort. In particular, the relatively large size and aspect ratio of the nasal cushion contributes to the softness of the cushion. The side walls for frame engagement are so soft that both sides of the cushion can be pinched together and brought into contact with each other with very little finger force. This ease of side wall deformation for frame engagement can be a major source of difficulty in quickly connecting the cushion to the frame for patients with hand arthritis in these other patient interfaces. It should also be understood that the stability of the seal formed by the seal forming structure may be improved by forming the characteristics of the above-mentioned plenum chamber 3200 having sufficient rigidity. Further, the thickness of the plenum chamber 3200 may be changed so that the plenum chamber gradually becomes thinner from the plenum connection region 3240 toward the seal forming structure 3100. In one example of the technique, the plenum chamber 3200 may be approximately 2-3 mm thick at or near the plenum connection region 3240 and 1 mm thick at the point between the plenum connection region 3240 and the seal forming structure 3100. And may be 0.75 mm thick in or near the seal forming structure 3100. The formation of a plenum chamber 3200 with these characteristics may be achieved by injection molding. This gradual reduction in the thickness of the plenum chamber 3200 allows greater deformability of the silicone material closer to the stalk 3150 and the patient's nose, increasing comfort and reducing the likelihood of seal breakage.

Some nasal pillow patient interfaces have (i) plenum chambers, (ii) headgear connections, and (iii) seal-forming structure assembly sequences. On the other hand, one example of the patient interface 3000 of the present technology has (i) a headgear connection, (ii) a plenum chamber, and (iii) an assembly sequence of seal forming structures. This difference in placement means that headgear tension does not cause deformation of the plenum chamber 3200 and seal forming structure 3000, which can interfere with sealing forces.

6.3.4 Frame 3310
As shown in FIGS. 4, 10, 75, 76, and 166, the frame 3310 acts as a central hub, which includes a short tube 4180, a plenum chamber 3200, and a positioning stabilization structure. The body 3300 is connected in a removable manner or in a more permanent manner.

Also, FIGS. 31-33 show various views of the frame 3310 connected via the flexible joint 3305 to the positioning stabilization structure 3300 having the strap 3301. These figures show the frame 3310 without the plenum chamber 3200 and the seal forming structure 3100. Both the connection port 3600 and the vent 3400 may be arranged on the frame 3310, both of which are described in more detail below.

In one example of the technique, the frame 3310 may be made of polypropylene.

In another example of the technique, the frame 3310 may be formed in one size, but the plenum chamber 3200 and the seal forming structure 3100 are provided by the commonly dimensioned connection functions described herein. It may be formed in multiple sizes that can be attached to a single frame.

In one example of the technique, the frame 3310 may be molded without any relief grooves so that it can be removed from the mold without bending after it has been molded.

6.3.5 Connection between plenum chamber and frame In one embodiment of the technique, the plenum chamber 3200 is, for example, for ease of cleaning or for a differently dimensioned seal forming structure 3100. Can be detachably attached to the frame 3310 to replace it. This may allow the plenum chamber 3200 to be washed and washed more frequently than the frame 3310 and short tube 4180. It may also allow the plenum chamber 3200 to be washed and washed separately from the strap 3301. In another form, the plenum chamber 3200 cannot be easily removed from the frame 3310.

The plenum chamber 3200 may include a plenum contiguous zone 3240 (FIG. 6). The holding structure 3242 of the plenum connection region 3240 has a shape and / or form complementary to the shape and / or form of the corresponding frame connection area 3312 (FIG. 10). The holding structure 3242 of the plenum chamber 3200 is stiffer than the rest of the plenum chamber 3200 and may be formed from the same material as the frame 3310, such as polypropylene or polyamide such as Rilsan®. In other embodiments, the plenum contiguous zone 3240 may be made of nylon and the frame 3310 may be made of polypropylene. Nylon, polyamide, and polypropylene are not soft materials and do not easily adapt to acupressure. Thus, when the plenum connection zone and frame are engaged with each other, there is an audible click and a hard-hard connection. In FIGS. 20 to 24, the shape of the holding structure 3242 is drawn so as to resemble a parabolic column or a hyperbolic column. The holding structure 3242 is inextensible and does not expand or contract in order to maintain its general shape when it engages with the frame 3310 and when it disengages from the frame 3310. The shape of the holding structure 3242 allows a slight degree of bending, but does not allow bending to the extent that both sides of the holding structure 3242 can touch each other when pinched together by acupressure. In other words, both sides of the retention structure 3242 can only come into contact with each other with a large tightening force intended by the patient 1000, which does not occur under normal therapeutic conditions. In the illustrated example, the upper and lower edges of the holding structure 3242 can be closer to each other / easily pinched to each other than the side edges of the holding structure 3242, using the same amount of tightening force. As can be seen in FIG. 18, the curvature of the frame 3310 and the holding structure 3242 follows the natural curvature of the patient's upper lip so that the contact pressure due to headgear tension is evenly distributed over the patient's upper lip. It is possible to avoid the concentration of contact pressure at any particular point on the patient's upper lip. This can minimize or eliminate skin damage caused by long-term concentration of contact pressure. Another advantage in curvature is that less material is required for the plenum chamber 3200 compared to a flat frame. The flat frame provides more material at the lateral edges of the plenum chamber 3200 so that the plenum chamber 3200 fits the patient's upper lip. Less material results in overall weight reduction in the patient interface 3000. The curvature also minimizes any anterior protrusion of the patient interface 3000 from the patient's face, thereby improving the inconspicuousness of the patient interface 3000. Further, the holding structure 3242 may be adhered to the plenum chamber 3200 (for example, using an adhesive) after molding according to an example of the technique. In another example, an integral chemical bond (molecular attachment) between the retention structure 3242 and the plenum chamber 3200 may be utilized.

In one example of the technique, the retaining structure 3242 may be molded without any relief groove so that it can be removed from the mold without bending after it has been molded. The holding structure 3242 has a continuous outer peripheral edge on the front side in contact with the frame 3310. This continuous outer peripheral edge is exposed such that it contacts and engages with the frame 3310 in a rigid-rigid mode. This is in contrast to most soft-hard connections, where soft-hard connections cover and overlap most of the removable hard holding structure in some conventional masks. There is an anterior lip of the seal-forming structure. The anterior lip is formed from LSR and covers and wraps the holding structure so as to hold it together. However, with such conventional masks, it is difficult and cumbersome to cover the removable clip to wrap the anterior lip, and the clip can be misplaced, resulting in a seal forming structure. Cannot be connected to the frame.

One purpose of the holding structure 3242 is to align the plenum chamber 3200 when engaging with the frame 3310. This is because the shape of the holding structure 3242 of the plenum chamber 3200 is held (possibly at various depths) in the space defined between the frame connection area 3312 of the frame 3310 and the interfering unit 3314. (Fig. 29).

Another object of the holding structure 3242 is to hold the plenum chamber 3200 with respect to the frame 3310 by preventing relative lateral vertical relative movement between these two parts. The plenum contiguous zone 3240 may include at least one retaining function 3244 and may also have at least one complementary frame contiguous zone 3312. The plenum contiguous zone 3240 may include one or more holding function units 3244 (FIG. 10). In addition to preventing relative lateral vertical movement between the plenum chamber 3200 and the frame 3310, another purpose of the retaining function 3244 is to prevent relative longitudinal movement between these two parts. It is to be. The rest of the plenum chamber 3200 may be provided with a material that is more flexible than the holding structure 3242 and plenum contiguous zone 3240.

In one form, the plenum contiguous zone 3240 is composed of a hard or semi-hard material, such as high-durometer silicone or TPE, plastic, nylon, temperature resistant material, polypropylene, and / or polycarbonate. The plenum contiguous zone 3240 may be made of a different material than the rest of the plenum chamber 3200. For example, the plenum connection region 3240 may be a separate component that is irremovably connected, integrally coupled, or mechanically connected to the connection portion 3202 (FIG. 10) of the plenum chamber 3200. good. Referring to FIG. 6, the connection portion 3202 of the plenum chamber 3200 may have approximately the same thickness as the holding structure 3242 of the plenum connection region 3240. The plenum connection region 3240 may include a channel portion 3211.1. For example, a tongue portion 3211 configured and arranged to be received in a fitted state by the channel portion of the frame 3310. In this way, the channel portion 3211.1 can form a fitting functional portion for the tongue portion 3211 and vice versa. The tongue portion 3211 and the channel portion 3211.1 may also be sized to maximize the seal surface area in this region.

6.3.5.1. Installation of the plenum chamber and removal from the frame The plenum chamber 3200 may be attached and fixed to the frame 3310, or may be detachably attached to the frame 3310. FIG. 12 shows the plenum chamber 3200 at the connection position with respect to the frame 3310. The plenum connection area 3240, in this example, includes only two holding function units 3244 located on either side of the connection area 3240, eg, posterior and anterior. 12 and 13 show a cross section penetrating both hooks 3246, while FIG. 17 shows the other, where the hooks 3246 are absent, thereby forming, for example, a channel or groove 3211.1. The cross section is shown. The elastic hook-shaped portion 3246 is a kind of snap compression fitting member that provides a high holding force (to prevent accidental disengagement) and also allows relatively easy and intentional removal. In FIG. 17, the plenum contiguous zone 3240 and the frame 3310 are easily fitted together in a tongue-grooved state. The frame 3310 and the holding structure 3242 may be formed so that the tongue portion 3211 and the channel portion 3211.1. This can help align the retention function unit 3244 for connection.

Each holding function portion 3244 may form a hook-shaped portion 3246 (FIGS. 6 and 13) having a front surface 3246.1 and a rear surface 3246.2. The front surface 3246.1 is adapted to engage the pull-in surface 3312.1 of the frame connection region 3312 of the frame 3310 as the plenum chamber 3200 and the frame 3310 are moved into an engaged state with each other. When the holding function unit 3244 is pushed into a predetermined position, the holding function unit is deformed. Further, the upper region and the lower region of the frame connection region 3312 of the frame 3310 and the interference region 3314 may also be slightly deformed. Further, the holding structure 3242 may also be slightly deformed particularly in the vicinity of the holding function portion 3244 (see, for example, the broken lines in FIGS. 27 and 28). With reference to FIGS. 195-198, the deformation of the frame connection region 3312 and the interfering section 3314 of the frame 3310 is due to the use of rib 3294 with respect to the amount of deformation allowed and also with respect to the area where the deformation is to occur. Be controlled. In one example of the present technology, there are six ribs 3294 that are spaced around the interference portion 3314 and abut against the interference portion. The spacing and position of the ribs 3294 limits the area of deformation of the interfering section 3314 to only the area close to the holding function section 3244. The rib 3294 is an inner surface of the plenum connection area 3240 to provide a stronger engagement at these contact points between the plenum connection area 3240 and the frame connection area 3312 when the plenum chamber 3200 is engaged with the frame 3310. It may be deformed against the inner surface in contact with the inner surface. With reference to FIGS. 199-202, the plenum connection region 3240 of the plenum chamber 3200 has a notch 3295 to correspond to the rib 3294. The notch 3295 is a chamfer to minimize friction in the plenum connection region 3240 that abuts against the rib 3294 during assembly of the plenum chamber 3200 and frame 3310. When the hook-shaped portion 3246 is pushed in by a sufficient amount, the hook-shaped portion snap-engages outward in the radial direction so that the hook-shaped portion 3246 takes the holding position shown in FIG. The snapping action provides the user with a reassuring audible sound, such as a click, thereby giving the user or patient feedback that a proper connection has been established. At the holding position, as shown in FIG. 13, the rear surface 3246.2 of the hook-shaped portion 3246 engages with the holding surface 3312.2 of the frame connection region 3312. This reassuring click sound may be facilitated by forming a sufficiently rigid plenum connection region 3240 in one example of the technique, the rigidity of which is greatest in the vicinity of the plenum connection region 3240. This stiffness may be achieved by overmolding.

As can be seen in FIG. 13, the surfaces of the hooked portion 3246 and the frame connection region 3312 are tilted in a particular manner to facilitate a sliding connection between the plenum chamber 3200 and the frame 3310. For example, as previously mentioned, the front surface 3246.1 and the retractable surface 3312.1 may be formed with corresponding angles so that their surfaces can slide and engage with each other relatively easily. Similarly, the rear surface 3246.2 and the holding surface 3312.2 may be tilted relative to each other when connected to help hold the frame 3310 and the plenum chamber 3200. The angle between the rear surface 3246.2 and the holding surface 3312.2 is such that the tensile force applied approximately along the axis of the nasal pillow 3130 causes the hook-shaped portion 3246 to bend inward to frame the plenum chamber 3200. Selected to be sufficient to free from. This tensile force does not require the patient 1000 to flex the hook 3246 radially inward, for example by first tightening the plenum chamber 3200 in the anteroposterior direction. Rather, due to the associated angle, the radial deflection of the hooked portion 3246 occurs only as a result of the applied axial tensile force. In one example of the present technology, the plenum connection region 3240 is flexed and the disassembly of the plenum chamber 3200 from the frame 3310 is performed by pinching the plenum chamber 3200 and pulling the plenum chamber 3200 away from the frame 3310.

As can be seen in FIG. 13, the plenum chamber 3200 is attached to the frame 3310 via the plenum connection region 3240, and the holding function portion 3244 is engaged with the frame connection region 3312 by the hook-shaped portion 3246. As shown in this figure, the holding surface 3312.2 of the frame connection region 3312 and the rear surface 3246.2 of the hook-shaped portion 3246 are engaged and are in the same plane as each other. In order for the patient to remove the plenum chamber 3200 from the frame 3310, the patient pulls the plenum chamber 3200 against the frame 3310 with sufficient force to overcome the resistance of the holding surface 3312.2 against the rear surface 3246.2. Must be done. In one example of the present technology, pinching the plenum chamber 3200 reduces the axial tensile force required to remove the plenum chamber 3200 from the frame 3310. This resistance can be "tuned" to the desired level or selectively adjusted by varying the angle at which these surfaces 3312.2,3246.2 engage with each other. The closer these surfaces 3312.2,3246.2 are perpendicular to the direction of the force applied by the patient 1000 to remove the plenum chamber 3200 from the frame 3310, the more force is required to bring about the removal. growing. This angle is shown in FIG. 14 as β at which the rear surface 3246.2 is tilted with respect to the nominal vertical axis 3246.4 (corresponding to the axial tensile direction of the plenum chamber 3200 with respect to the frame 3310). As β increases, the force required to remove the plenum chamber 3200 from the frame 3310 increases. Also, as β increases, removal feels more abrupt for patient 1000. In one example, an angle β of about 75 ° has been found to produce a comfortable removal feel for the patient. In a further example, β may vary from 30 ° to 110 °, or 40 ° to 90 °, or 65 ° to 85 ° to provide an ideal resistance level to removal. .. It has been chosen to minimize the possibility of accidental detachment and to allow only intentional removal by the patient 1000.

The angle α, which is the angle between the nominal vertical axis 3246.4 and the anterior 3246.1, is similarly "aligned" such that the patient 1000 requires a certain level of force when attaching the plenum chamber 3200 to the frame 3310. Can be "acquired" or can be selectively adjusted. As the angle α increases, the force required to engage the holding function 3244 with the frame contiguous zone 3312 increases, as well as the mounting feel for the patient engaging these components 3244, 3312. It becomes more abrupt. In other words, as the front surface 3246.1 of the holding function unit 3244 slides along the pull-in surface 3312.1 of the frame connection region 3312, the user may experience a smoother engagement feel as the angle α decreases. can. In one example, an angle α of about 30 ° has been found to produce a comfortable removal feel for the patient 1000. In a further example, the angle α may vary from 50 ° to 70 ° or from 15 ° to 60 ° to provide an ideal level of resistance to removal.

Also, the angles α and β are different from the resistance level to removal because the feel and force of engagement and disengagement between the plenum chamber 3200 and the frame connection region 3312 can be adjusted independently of each other or selectively. It may be chosen to make the patient feel the level of resistance to. In one example of the technique, the angles α and β may be selected such that the angle β is greater than the angle α, whereby the patient has a mounting resistance between the plenum chamber 3200 and the frame 3310 that is less than the removal resistance. Feel. In other words, the patient may find it more difficult to remove the plenum chamber 3200 from the frame 3310 than to connect them.

As can be seen in FIG. 4, one example of the technique includes a pair of holding function units 3244, 3245. Also, as shown in this figure, typical holding function units 3244, 3245 are dimensioned differently. In particular, this figure shows that the holding function portion 3245 located at the front of the plenum connecting region 3240 is narrower than the holding function portion 3244 located at the rear of the plenum connecting region 3240. By dimensioning the retaining function 3244 differently, the patient 1000 can attach the plenum chamber 3200 to the frame 3310 in only one direction. Such a configuration is shown in FIG. This avoids patient frustration during installation, minimizes possible damage to the patient interface 3000 due to inaccurate installation, and provides a proper seal to the patient's airway. Provides comfort by reducing or avoiding contact with the nasal septum and / or upper lip of patient 1000 so that is in the correct orientation.

FIG. 10 shows the two frame connection regions 3312, 3313 engaged with the corresponding holding function units 3244, 3245. The example depicted herein shows that the narrower front holding function portion 3245 is dimensioned to correspond to the narrower front frame connection area 3313. Also, the wider rear holding function portion 3244 is engaged with the correspondingly dimensioned rear frame connection region 3312. Such a configuration, in which one retention function is uniquely dimensioned to engage the corresponding uniquely dimensioned frame connection area, allows the patient to place the plenum chamber 3200 into the frame 3310 in only one direction. It has the advantage that it can be attached. By limiting the mounting orientation, the patient 1000 is prevented from improperly assembling the patient interface 3000 and is prevented from receiving suboptimal treatment due to the improperly assembled patient interface 3000. NS. The configurations described for this particular example of the technique allow the patient 1000 to fully assemble the patient interface 3000 only if the components are properly aligned, thus causing the components to be accurate due to vision problems. It is advantageous for Patient 1000, who may have difficulty seeing how to engage with, or Patient 1000, who may be assembling Patient Interface 3000 in a dark room, such as a bedroom before bedtime.

As mentioned above, the angles of the anterior surface 3246.1 and the posterior surface 3246.2 on the hooked portion 3246 are important to provide optimal magnitude resistance to patient interface 3000 assembly and disassembly. Further, the advantage of dimensioning the holding function units 3244, 3245 and the frame connection areas 3312, 3313 correspondingly so as to ensure the proper orientation of the components at the time of assembly has also been described above. Properly dimensionalizing the holding functions 3244, 3245 and the frame contiguous zones 3312, 3313 can help guide the plenum chamber 3200 towards the frame 3310. In other words, the frame connection areas 3312, 3313 and the holding function units 3244, 3245 are aligned so that the outer circumference of the frame connection area and the outer circumference of the holding function unit 3244 orient the holding function unit 3244 toward the frame connection area 3312. They may be closely fitted and dimensioned to each other for convenience. This reduces visibility in patients with limited agility due to illness (eg, arthritis), or in a dark bedroom before bedtime or due to limited vision. It can be beneficial for patients assembling the patient interface 3000 in the state. Also, by sizing the retention functions 3244, 3245 and the frame connection areas 3312, 3313 in close contact with each other, this is because the seal between the plenum chamber 3200 and the frame 3310 is between these two components. It serves to ensure that it is maintained by facilitating strong connections. Also, a tight fit between the holding function units 3244, 3245 and the frame connection areas 3312, 3313 can help facilitate equivalent alignment of the plenum chamber 3200 with respect to the frame 3310. In one example of the present technology, a difference of 0.3 mm to 2 mm may be incorporated between the holding function portions 3244, 3245 and the frame connection areas 3312, 3313.

It should also be understood that the connection between the frame 3310 and the plenum chamber 3200 described above and below may be used with other types of masks. Such features may be applicable to nasal masks or full face masks as well. Masks that seal under the bridge of the nose, such as compact nasal masks or compact full-face masks, may incorporate the connectivity features described herein. Also, a mask lacking a frontal support may include these connecting functional parts. It is also envisioned that examples of the present technology including a mask that seals under the tip of the nose, such as a mask with a nasal pillow 3130 or a nasal cradle / nasal flange 3101, may use these connecting functional parts.

6.3.5.1.2 Plenum Chamber and Frame Installation and Removal Sequences 25-29 show a series of cross-sectional views of the connection portion 3202 of the plenum chamber 3200 and the frame connection area 3312 of the frame 3310. These sequential views show the process of mounting the plenum chamber 3200 to the frame 3310. These figures show only the attachment of one holding function unit 3244 to one frame connecting area 3312, but as can be seen in FIG. 10 and as described above, the plurality of holding function units 3244 and the plurality of frame connecting areas 3312 It should be understood that it may exist. Therefore, during the mounting sequence of the plenum chamber 3200 and the frame 3310, multiple examples of the illustrated mounting sequence may be made to achieve complete mounting of the plenum chamber 3200 and the frame 3310.

FIG. 25 shows a cross-sectional view of the connection portion 3202 of the plenum chamber 3200 and the frame connection region 3312 of the frame 3310. In this case, the connection portion 3202 and the frame connection region 3312 are located in the vicinity of each other but do not touch each other. The arrows indicate that the connection portion 3202 and the frame connection area 3312 are about to join. Needless to say, these figures do not include additional parts of the plenum chamber 3200 and frame 3310 for simplicity. Therefore, it should also be understood that, for example, as can be seen in FIG. 13, both the frame connection region 3312 and the interference portion 3314 of the frame connection region 3312 are part of the frame 3310. It should also be understood that the frame connection 3312 and the interference 3314 of the frame connection 3312 move relative to each other over the mounting sequence. Returning to FIG. 25, this figure shows that the seal lip 3250 is not deformed and the holding function portion 3244 is not deformed. This is because none of these components 3250, 3244 come into contact with the frame 3310.

FIG. 26 shows a hook-shaped portion 3246 of the holding function portion 3244 that has begun to come into contact with the frame connection region 3312 of the frame 3310. Specifically, this figure shows the front surface 3246.1 of the hook-shaped portion 3246 that comes into contact with the pull-in surface 3312.1 of the frame connection region 3312. In this figure, the holding function unit 3244 and the frame connection region 3312 are merely in contact with each other so that the holding function unit 3244 is not bent. Further, the seal lip 3250 has not been bent because it has not yet come into contact with the interference portion 3314 of the frame connection region 3312. As mentioned above, the angle α of the front 3246.1 begins to affect the resistance felt by the user to the engagement of the plenum chamber 3200 with the frame connection region 3312. This is because the front surface 3246.1 begins to engage with the pull-in surface 3312.1 in a frictional contact state.

FIG. 27 shows the plenum chamber 3200 and frame 3310 further along the mounting sequence such that the holding function portion 3244 is flexed by contact with the frame connection region 3312. As can be seen in this figure, the interference portion 3314 of the frame connection region 3312 and the frame connection region 3312 is even closer to the connection portion 3202. Further, as shown in this figure, the front surface 3246.1 of the hook-shaped portion 3246 comes into contact with a portion of the pull-in surface 3312.1 which is closer to the holding surface 3312.2. In other words, the hook-shaped portion 3246 appears to have moved closer to the attachment to the frame connection area 3312 and with respect to the position shown in FIG. As mentioned above, the connection portion 3202 and the plenum connection region 3240 of the plenum chamber 3200 may be flexed by the tightening force generated by the patient 1000. FIG. 27 also shows that the holding function unit 3244 has been bent by contact with the frame connection region 3312, and the broken line shows the outline of the holding function unit 3244 in the non-deformed state. FIG. 27 also shows that the seal lip 3250 has not yet come into contact with the interfering portion 3314 of the frame connection region 3312, and thus the seal lip 3250 has not been deformed. Although not shown in this figure, it should also be understood that the frame connection region 3312 can flex away from the holding function portion 3244 due to the forces that push these portions 3312, 3244 against each other.

In FIG. 28, the plenum chamber 3200 and the frame 3310 are substantially attached and the holding function portion 3244 is almost completely engaged with the frame connection region 3312. In this figure, the holding function portion 3244 is still deformed, but the hook-shaped portion 3246 comes into contact with different parts of the frame connection region 3312. Specifically, at this time, the rear surface 3246.2 of the hook-shaped portion 3246 comes into contact with the holding surface 3312.2 of the frame connection region 3312. Further, due to the angle at which the rear surface 3246.2 and the holding surface 3312.2 are in contact with each other, the holding function unit 3244 and the frame connection region 3312 return to the non-deformed state of the bent holding function unit 3244. The inherent tendency to try can urge them into an engaged state, which effectively pulls these parts together after reaching a certain insertion distance. Further, FIG. 28 shows the outline of the holding function unit 3244 in the non-deformed state by a broken line. It can also be seen in this figure that the seal lip 3250 is in contact with the interference portion 3314 of the frame connection region 3312. At this point in the mounting sequence, the seal may begin to form by contact between the seal lip 3250 and the interfering portion 3314 of the frame connection region 3312. The seal lip 3250 may be slightly flexed by contact with the interfering portion 3314 of the frame connection region 3312.

FIG. 29 shows the plenum chamber 3200 and frame 3310 that are fully mounted by engagement of the hooked portion 3246 of the holding function portion 3244 with the frame connection region 3312. In this figure, the holding surface 3312.2 may be relatively tightly attached to the rear surface 3246.2. Also, the holding function unit 3244 can no longer be flexed by contact with the frame connection region 3312. The return of the holding function portion 3244 from its bent or deformed state to the non-deformed state as shown in FIG. 28 is shown in FIG. 29 from the position where the hook-shaped portion 3246 and the holding function portion 3244 are shown in FIG. 28. An audible click may be generated as it moves to the indicated position. This reassuring audible click can be beneficial in that the feedback that the plenum chamber 3200 and the frame 3310 are fully engaged is given to the patient 1000. By giving this feedback to patient 1000 upon completion of engagement, patient 1000 is confident that the plenum chamber 3200 and frame 3310 will not separate while the patient 1000 is sleeping and being treated with the plenum chamber 3200 firmly attached. Patient interface 3000 may be available.

Also, the desired level of seal contact may be achieved when the plenum chamber 3200 and frame 3310 are mounted as shown in FIG. It can be seen that the seal lip 3250 is in contact with the interference portion 3314 of the frame connection region 3312 and is bent. By flexing as shown, the seal lip 3250 is itself pressed against the interfering section 3314 of the frame connection region 3312 with sufficient force due to the tendency of the seal lip 3250 to return to its non-deformed state. It may provide the desired seal between these components. Further, as the air pressure in the plenum chamber 3200 increases as the treatment is applied, the seal lip 3250 is forcibly flexed towards the interfering section 3314 of the frame connection region 3312, thereby sealing in this region. Increase force. Even if a compression seal is formed between the holding structure 3242 and the frame connection area 3312 when the plenum chamber 3200 is engaged with the frame 3310, the seal lip 3250 and the frame connection area 3312 are formed during engagement. A pressure actuating seal that becomes stronger as the internal air pressure increases is also formed between the part 3314 and the portion 3314. In certain cases, it can be assumed that the compression seal is not airtight, which results in unwanted leaks.

Also, if a very large amount of compression of the components is required to form the compression seal, this may prevent the easy attachment and detachment of the plenum chamber 3200 to the frame 3310, resulting in In some cases, one hand is not enough to perform the operation, or a considerable amount of labor is required. Thus, in one example of the art, the compression seal functions primarily for the purpose of holding rather than the seal, and the pressure actuated seal primarily for the purpose of forming and maintaining an airtight seal. Works for It should be understood that such a sealing action may occur around the junction between the plenum chamber 3200 and the frame 3310. For example, FIG. 17 shows a similarly flexed seal lip 3250 that abuts against the frame connection region 3312 in a region separate from the holding function portion 3244. Further, in FIG. 5, it can be seen that, for example, the seal lip 3250 extends over the outer circumference of the plenum chamber 3200. By extending the seal lip 3250 inwardly around the junction between the plenum chamber 3200 and the frame 3310, the desired level of seal can be obtained throughout this region, thereby of the pressurized gas. Unwanted leaks are prevented.

Needless to say, the seal lip 3250 may be pressed against the interference portion 3314 of the frame connection portion 3312 with an urging force to separate these portions. However, the frictional force due to the structural engagement between the rear surface 3246.2 of the hook-shaped portion 3246 and the holding surface 3312.2 of the frame connection region 3312 causes the seal lip 3250 to return to the non-deformed state and the plenum chamber 3200. It must be sufficient to resist the force of the tendency to separate from the frame 3310.

With respect to the removal of the plenum chamber 3200 and the frame 3310, it must be understood that this process is in substantially the reverse order of the process described above. In other words, the user may separate the plenum chamber 3200 from the frame 3310 by pulling these components in opposite directions, and the figure in FIG. 29 may be the beginning of the separation process. Reference numeral 25 may represent a diagram in which the plenum chamber 3200 and the frame 3310 are completely separated. Tightening the plenum chamber 3200 near the plenum connection area 3240 or tightening the plenum connection area 3240 and pulling it away from the frame 3310 can help remove the plenum chamber 3200 from the frame 3310. It is also envisioned that the patient 1000 may tighten the plenum chamber 3200 at any location, eg, with a nasal pillow 3130 or stalk 3150, for the purpose of grasping it and simply pull it away from the frame 3310. A pulling and twisting motion can also help disengage the plenum chamber 3200 from the frame 3310.

6.3.5.1.3 Hard-to-hard connection The plenum connection area 3240 and frame 3310 may be assembled and mounted as shown in FIGS. 25-29. As mentioned above, the plenum contiguous zone 3240 and / or the retaining structure 3242 is a semi-rigid material such as high durometer silicone (durometer higher than the plenum chamber 3200) / TPE, plastic, nylon, polypropylene, polyamide, and / or. It may be composed of polycarbonate. The plenum connection region 3240 is configured to form a continuous ring or two oval C-shaped clips, one C-shaped clip, or a single continuous fragment, but surround only a portion of the plenum chamber 3200. obtain. The clip may function as a spring clip or may be in the form of a C-section or a double C-section. The spring force of the spring clip may be provided by the elasticity of the plenum connection area 3240 to extend against the frame connection areas 3312, 3313 or interference 3314 of the frame 3310. In another example, the clip form may not be required, and only the holding function portions 3242, 3244 are accompanied by the plenum connection area 3240 and / or the holding structure 3242 to engage the connection areas 3312, 3313. Instead, it is directly connected to the plenum chamber 3200 in a non-removable manner. It is also envisioned that one example of the present technology may include that the frame 3310 is made of the same or similar semi-rigid material as the plenum contiguous zone 3240. A "hard-hard" connection or coupling interface may be formed by manufacturing a frame 3310 and plenum connection region 3240 of semi-hard material. This "hard-to-hard" connection, along with the structural features of the plenum connection area 3240 and the frame connection area 3312, provides a confident feel of the connection between the plenum chamber 3200 and the frame 3310 when assembling the patient interface 3000. It may be given to patient 1000 (eg, by giving an audible snap fit or a reassuring click sound). Patients are confident that a secure fit has been achieved because the secure fit between the plenum chamber 3200 and the frame 3310 helps to ensure that the patient 1000 receives optimal treatment via the patient interface 3000. The structure given to 1000 is beneficial. The hard-to-hard connection described herein can also be beneficial in that it can add stability to the seal formed by the seal forming structure 3100. This is rigid, which makes it difficult for arthritic hands to easily and properly engage the plenum chamber and frame, especially in dark rooms, where either or both of the plenum chamber and frame are formed from soft material. This is in contrast to the soft-soft connection or the soft-soft connection.

The holding function units 3242 and 3244 are described as being provided in the plenum chamber 3200, and the connection areas 3312 and 3313 are provided in the frame 3310, which are located in the holding function unit on the frame and the connection area on the plenum chamber. It can be assumed that it will be replaced. Further, one portion may have a combination of a connection area and a holding function unit in the other portion and a corresponding holding function unit and a connection area.

6.3.6 Method of Forming a Plenum Chamber The process for manufacturing a plenum chamber 3200 is to mold the plenum connection area 3240 in a first mold and then use the formed plenum connection area 3240 as the first mold. Along with removing from the mold, the plenum connection region 3240 may be inserted into the second mold to form a portion of the plenum chamber 3200 with the connection portion 3202 in the second mold. The plenum connection region 3240 may be chemically bonded and / or mechanically connected to the connection portion 3202.

In one embodiment, the seal lip 3250 is configured and arranged to interfere with the interfering section 3314 of the frame connection region 3312 when the plenum chamber 3200 and the frame 3310 are assembled together (FIG. 13). In use, the seal lip 3250 is elastically bent away from the stationary position (FIG. 6) when assembled with the interfering section 3314 of the frame connection region 3212, and as a result of being at least partially an elastic material. It presses against the interfering section 3314 (FIG. 12) to resist or prevent air leaks between the seal lip 3250 and the interfering section 3314. Although it has been described that the seal lip 3250 is provided in the plenum chamber 3200, the seal lip may be provided in the frame 3310. Although one seal lip has been described, it can be assumed that two or more seal lips may be provided. In that case, at least one seal lip is provided in the plenum chamber 3200 and at least one seal lip is provided in the frame 3310.

6.3.7 Positioning stabilization structure 3300
It should be noted that in one embodiment of the technique, many structural features form part of the positioning stabilization structure 3300, such as a headgear assembly (sometimes referred to simply as headgear). In another embodiment of the technique, one or more of these features is located on the frame 3310. For example, all or part of the flex joint 3305 may be located in headgear or frame 3310. Further, the extending portion 3350 may perform the same function as the bending joint 3305 except that it is integrally formed with the rigidizer arm 3302.

The seal forming structure 3100 of the patient interface 3000 of the present technology may be held in the seal position by the positioning stabilization structure 3300 during use (FIGS. 75, 76, and 166). In one embodiment, the positioning stabilization structure 3300 comprises a headgear. Needless to say, the positioning stabilization structure 3300 may be referred to as headgear in one form of technology.

The headgear may be detachably connected to a portion of the patient interface, such as the positioning stabilization structure 3300, via the headgear connector.

The 6.3.7.1 strap positioning stabilization structure 3300 may include at least one strap 3301 (see, eg, FIG. 65) and at least one rigidizer arm 3302 (see, eg, FIG. 67). The strap 3301 may be made of an elastic material or may have elastic properties. In other words, the strap 3301 may be elastically stretched, for example by the stretching force applied by the patient, and will return to or contract to its original length in the neutral state upon release of the stretching force. The strap 3301 may be formed from any elastomeric material such as elastane, TPE, silicone or may be provided with any elastomeric material. The material of the strap 3301 may correspond to a combination of any of the materials described above with the other material. The strap 3301 may be a single-layer or multi-layer strap. The strap 3301, especially the side strap portions 3315, 3316 that come into contact with the patient 1000 during use, may be woven, knitted, braided, molded, extruded or otherwise formed. The strap 3301 may include or may be made of a fabric material such as a woven material. Such materials, on the one hand, may include synthetic or natural fibers, thereby providing desirable beneficial surface properties such as tactile properties and skin comfort. On the other hand, the material of the strap 3301 may include an elastomeric material to provide the desired elastomeric properties. The entire strap 3301 including the side strap portions 3315, 3316 and the back strap portion 3317 may all be extendable. This allows the overall length of the strap 3301 to be extended, thereby providing a comfortable force transfer profile. The length of the strap 3301 may be less than the patient's average head circumference in order to extend the strap 3301 during use. For example, the length of the strap 3301 may be less than 590 mm in one example and less than 500 mm in the other. However, different lengths of straps 3301 may be given to the patient, depending on the patient's head circumference, which may be gender specific. For example, the small size strap may be 490 mm in length and the large size strap may be 540 mm in length. In some situations, this means that the length of the strap 3301 does not need to be extended over large distances (ie, small size straps for large head circumferences). Stretching over large distances results in unnecessarily high headgear tension for such patients, as well as less smooth force transfer profiles as the small size strap 3301 is stretched to longer lengths.

According to another example of the present technology, the strap 3301 may not be elastic or may not be sufficiently stretchable. The rigidizer arm 3302 may or may not be included. According to these other examples, the length of the strap 3301 of the positioning stabilization structure 3300 may be adjustable using a ladder lock clip, buckle, or hook loop material. The strap 3301 may be made of a material that is substantially inelastic, such as plastic or cloth. The use of the inelastic strap 3301 may be beneficial in that the seal forming structure 3100 is a nasal cradle cushion and the seal stability can be more easily maintained when tube torque is received by the patient interface 3000. ..

The strap 3301 is stiffened in a particular area by an inserted rigidizer arm 3302, for example from the frame 3310 to a position close to the patient's cheekbones. The strap 3301 may be in the form of a hollow ribbon. The strap 3301 may be considered to be passed over the rigidizer arm 3302 as it is slid onto the rigidizer arm 3302 and secured at one end of the rigidizer arm 3302 close to the frame 3310.

In one example, the strap 3301 including the side strap portions 3315, 3316 and the back strap portion 3317 is formed by warp knitting the fabric material. Strap 3301 is a 3D knitted fabric that is computer controlled as a single piece. Changes in threads and seams may occur at various positions along the strap 3301 in order to adjust the elasticity and strength as well as the durability of the strap 3301 in a particular location. For example, openings, insertion points or buttonholes 3303, 3304, and branch points 3324 for back strap portions 3317a, 3317b are subject to high stress when the strap 3301 is extended during repeated long-term use. Further threads may be knitted to reinforce the strap 3301 at these locations to prevent defects / breakage of the strap 3301. Both the braiding method of the strap 3301 (ie, warp knitting) and the elastic fabric material (eg, elastane) contribute to the elastic recovery of the strap 3301 after washing and drying the strap 3301 in water. In other words, regular cleaning of the strap 3301 can maintain the elasticity of the strap 3301 after prolonged use, thus extending the useful life of the strap.

In FIGS. 65-73, the strap 3301 appears to be a single continuous strap with two pocket-like ends 3311, 3313 for attachment to the frame 3310 directly or via the flexible joint 3305. Shown in. However, it can be seen that the straps 3301 may include a plurality of individual straps that may be directly connected or connected to each other, for example by stitching or ultrasonic welding. In FIG. 65, the strap 3301 and the positioning stabilization structure 3300 are shown without any adjusting or changing means. However, such adjustments may be made by changing where the strap 3301 is secured to the patient interface 3000 or other connecting elements that are stiffer than the strap 3301, such as the flexible joint 3305. With reference to FIG. 72, in addition to or in lieu of this, the adjustment provides a mechanism such as a slide over the ladder lock clip 3305.1 (eg, as shown in FIGS. 71-73) to the back strap portion 3317 or side strap. It can be made possible by adding to the portions 3315, 3316, or by adjusting the stretch lengths of the strap 3301 and the positioning stabilization structure 3300, respectively. In the example shown in FIG. 65, the strap 3301 shows a schematic view of each of FIGS. 68 to 70 showing an elliptical shape or a circular shape, or an outer surface facing (visible) toward the observer as a solid line. As can be interpreted from the respective circular or elliptical marks 3321a-3321d, 3323a-3323e showing the (invisible) inner wall facing away from the observer with a dashed line, and by the cross-sectional view according to FIG. 66. It has a tubular form that can be interpreted. However, it can be seen that the positioning stabilization structure 3300 may take any other shape, such as a flat or sheet-like shape, a single layer, a multilayer or a laminated structure. The strap 3301 may have a longitudinal axis that may be understood to be substantially parallel to the paper surface, and the strap 3301 extends along this longitudinal axis (see, for example, the dashed line in FIG. 65).

Strap 3301 may have reinforced stitches to improve durability and minimize or prevent fracture points. For example, the region of the strap 3301 in the buttonholes 3303 and 3304 and the region of the strap 3301 at the position where the strap branches to the two back strap portions 3317a and 3317b at the branch point 3324 are also exposed to high stress during extension. The material tendency is to separate apart from each other at the split regions 3326, so reinforcement stitching in these regions is one way of dealing with this concern. In one example, the central seam extends along the central longitudinal axis of the strap 3301 and functions as a reinforcing seam. Also, the distal edge of the strap 3301 and the openings of the buttonholes 3303, 3304 may be ultrasonically welded to fuse any free fibers in these areas to reinforce the strap 3301. Preferably, it also prevents the fibers of the strap 3301 from fraying after long-term use and repeated washing. Other techniques for reinforcing and strengthening the pocket-shaped end 3311, the distal edge, and the buttonhole 3303 are envisioned, and the technique may include additional material such as tape. The tape may include brand information and logo information.

123-125 show a more detailed view of the split region 3326 between the upper backstrap portion 3317a and the lower backstrap portion 3317b. It should be understood that the edges of the upper backstrap portion 3317a and the lower backstrap portion 3317b are not completely smooth as a result of the knitting process, and also at a large magnification so that these figures can see defects. It should be further understood to indicate the edge with. With the naked eye, the irregularities on the edges of the upper backstrap portion 3317a and the lower backstrap portion 3317b cannot be so easily seen, and generally cannot be perceived by the patient 1000 by contact. Further, in these figures, stippling is used to show the properties of the back strap portions 3317a, 3317b, while the split region 3326 is shown blank because there is no material in the split region 3326.

126 to 131 show various detailed views of the branch point 3324 located at a location where the upper back strap portion 3317a and the lower back strap portion 3317b are separated from the side strap portions 3315 and 3316. Also visible in these figures is a stiffener 3325 that may include additional stitching or welding at or near the bifurcation point 3324. The reinforcing portion 3325 can help prevent the side strap portions 3315, 3316 from cracking and / or tearing due to stress due to repeated separation of the upper back strap portion 3317a and the lower back strap portion 3317b. In other words, the reinforcing portion 3325 can provide additional strength at the stress concentration location near the bifurcation point 3324. Further, in these figures, the upper back strap portion 3317a and the lower back strap portion 3317b are shown at various separation angles θ. It can be seen from these figures that the reinforcing portion 3325 imparts additional strength at the bifurcation point 3324 when the upper back strap portion 3317a and the lower back strap portion 3317b are extended from each other at a large angle θ.

Referring to FIGS. 176-181, in one example of the present technology, the end of the strap 3301 has a reinforcing portion 3327 in which the material is folded at the end of the strap 3301. This provides additional reinforcement in this region, in addition to the welded ends 3311.1,3313.1 (see FIG. 81). The material of the reinforcing portion 3327 may be a material different from that of the strap 3301. The stiffener 3327 can avoid or reduce the possibility that the patient 1000 will tear or tear the strap 3301 from this region along its longitudinal axis. Reinforcement 3327 serves to provide patient 1000 with visual and tactile indications as to how the strap 3301 should be slid onto the rigidizer arm 3302 or the strap 3301 should be removed from the rigidizer arm 3302. This is because the reinforcement can help locate the buttonholes 3303, 3304. The corner portion 3328 of the reinforcing portion 3327 is a rounded corner portion (FIG. 50, FIG. 52, FIG. 55, FIG. 57, FIG. 58, where the corner portion 3328 is a free end portion 3302.1 at the distal end of the rigidizer arm 3302. It has been cut and rounded so as to almost conform to (see FIG. 60). This provides an aesthetically pleasing fit with the rigidizer arm 3302. The rounded corners 3328 provide flexible edges to avoid facial scratches that could occur if they were instead sharp corners.

6.3.7.2 Rigidizer Arm FIG. 67 shows an example of the Rigidizer Arm 3302. As shown, the rigidizer arm 3302 may be crescent-shaped or semi-circular. The rigidizer arm 3302 may have a substantially elongated flat shape. In other words, the rigidizer arm 3302 is considerably larger in length and width (up and down in the paper) than in thickness (direction towards the paper). The rigidizer arm 3302 has a three-dimensional shape with curvature on all three axes (X, Y, and Z). The thickness of the register arm 3302 may be substantially uniform, but its height varies over its entire length. The purpose of the shape and dimensions of the rigidizer arm 3302 is to fit tightly to the patient's cheeks so that they remain unobtrusive and blend into the patient's face and cheeks. The ends 3319a, 3319b of the rigidizer arm 3302 may be rounded and / or slightly tilted with respect to the rest of the rigidizer arm 3302. The Rigidizer Arm 3302 may be flat as shown by the paper in FIG. 67, but the Rigidizer Arm 3302 can improve alignment with the shape of the patient's face, especially the shape of the patient's cheek or head region. It can be seen that the desired spatial morphology may be obtained in the direction toward the paper surface of FIG. 67 (see, for example, FIGS. 71 and 72). The rigidizer arm 3302 may have a longitudinal axis that may be understood to be substantially parallel to the paper surface, and the rigidizer arm 3302 extends along this longitudinal axis (see dashed line in FIG. 67).

The rigidizer arm 3302 is stiffer than the strap 3301 and not as stiff as the mask frame 3310. In particular, the rigidizer arm 3302 and / or the strap 3301 in combination, the rigidizer arm 3302 gives shape to the strap 3301 and is rigid in at least one direction or in at least one axis or around at least one axis. It is designed to give improvement. The rigidizer arm 3302 also guides or defines an extension direction or extension path for the strap 3301. In other words, the patient extends the strap 3301 in a direction substantially parallel to the longitudinal axis of the rigidizer arm 3302. Extension of the strap 3301 in the other direction results in rotation of the rigidizer arm 3302 with respect to the mask frame 3310, which is not desirable. The stiffness of the rigidizer arm 3302 urges the rigidizer arm 3302 to its natural, non-rotating, untwisted, non-deformable state. To some extent, this allows the positioning stabilization structure 3300 to be an auto-adjusting headgear. The auto-adjustment feature avoids remembering the adjusted length after manually shortening or lengthening the material length of the headgear strap. This was a cumbersome process, as headgear straps on both sides of the face generally had to be shortened or lengthened one by one. The auto-adjustment feature can eliminate the patient's ability to overtighten the headgear when such high levels of headgear tension are not required to maintain good sealing force. In the illustrated example, the strap 3301 has a tubular or sleeve-like shape. In other words, the strap 3301 is hollow to receive the insertion of the rigidizer arm 3302 which is slid into the strap 3301 through the buttonhole 3303. In another example, the rigidizer arm 3302 is an anchor in which the rigidizer arm is overmolded or adhered in at least one position, eg, to form an integral chemical bond (molecular attachment) between the rigidizer arm 3302 and the strap 3301. At the point, it may be non-removably connected to the strap 3301.

The strap 3301 includes side strap portions 3315 and 3316 and a back strap portion 3317 located between the side strap portions 3315 and 3316. As shown in FIGS. 4-8 and 166, the side strap portions 3315, 3316 extend along both sides of the patient's head when worn, while the back. The strap portion 3317 extends along the back of the patient's head. The back strap portion 3317 may be composed of two, three or more straps arranged in parallel to provide particular stability. The smaller backstrap portions 3317a, 3317b have been shown to be of equal length, but it is assumed that one backstrap portion is longer than the other backstrap portion. The larger the number of small back strap portions 3317a and 3317b in the back strap portion 3317, the greater the spring effect given. In other words, as the number of smaller backstraps 3317a, 3317b of the same size increases as the strap 3301 is manufactured, the greater tension with respect to the side straps 3315, 3316 that should be attracted to each other by the backstraps 3317a, 3317b. Is reached. In the illustrated example, the side strap portions 3315 and 3316 of the strap 3301 branch into two back strap portions 3317a and 3317b. In one example, the back strap portions 3317a, 3317b have half the amount of elastane material as compared to the side strap portions 3315, 3316 of the strap 3301. In one example, the positioning stabilization structure 3300 is connected to the mask frame 3310 by a removable connection between the strap 3301 and the rigidizer arm 3302 via buttonholes 3303, 3304, and the rigidizer arm 3302 is mechanically coupled. It is non-removably connected to the mask frame 3310. In another example, the flexible joint 3305 formed from TPE may be non-removably connected to the rigidizer arm 3302 and the mask frame 3310. The flexible joint 3305 is overmolded with the mask frame 3310 for a non-removable connection, and the flexible joint 3305 is non-removably connected to the rigidizer arm 3302 by mechanical connection. In another example, the flexible joint 3305 may be made of the same material as the rigidizer arm 3302, eg Hytrel®, and is integral with the rigidizer arm 3302, and the flexible joint 3305 is mechanical. By connecting, it is non-removably connected to the mask frame 3310. The strap 3301 is detachably connected to the rigidizer arm 3302 via the buttonholes 3303 and 3304.

The engagement of the strap 3301 with the rigidizer arm 3302 may be performed at one position near the mask frame 3310. This type of engagement allows the strap 3301 to move in the maximum range, i.e., extend. This engagement can be disengaged so that the strap 3301 can be completely removed from the rigidizer arm 3302 and thus from the mask frame 3310 to facilitate cleaning of the strap 3301. This engagement acts as an anchor point for the strap 3301 so that when the strap 3301 is extended, the extension force is directed outward away from the anchor point. Referring to FIGS. 48-60, the end of the strap 3301 located at the anchor point is held by at least the distal edge of the rigidizer arm 3302 and / or the protruding end 3306 extending from the rigidizer arm 3302.

As will be appreciated by those skilled in the art, the rigidizer arm 3302 referred to herein may be stiffer than the strap 3301 and also allows the rigidizer arm to give shape to the strap 3301. .. The rigidizer arm 3302 may be stiffer on or around at least one axis and cannot be extended in contrast to strap 3301, which can be extended along at least one axis. In another example, the rigidizer arm 3302 can be extended / extended in a direction substantially parallel to its longitudinal axis. Elastomers are generally stretchable, but some thermoplastic polyester elastomers, such as Hytrel® 5556 manufactured by DuPont®, are non-stretchable but flexible. For example, the rigidizer arm 3302 may have a scissors link structure or a telescopic structure that allows the rigidizer arm 3302 to move between a compressed position and a fully extended position. The expandable Rigidizer Arm 3302 may better fit in Patient 1000 with a long face so that the length of the Rigidizer Arm 3302 can be adjusted appropriately. Alternatively, the rigidizer arm 3302 may be referred to as a yoke and / or reinforcement. The yoke may be understood to be a rigid element that is adapted to support the strap 3301 of the positioning stabilization structure 3300. The rigidizer arm 3302 may be understood to be a rigid element that gives shape to the strap 3301 of the positioning stabilization structure 3300 when worn on the face.

6.3.7.3 Another Rigidizer Arm FIGS. 223-232 show the typical patient interface system 3000 described above. 233a-233h show such a typical patient interface system 3000 worn by a patient. FIGS. 240-244 show a further view of a typical patient interface system without the strap 3301 to show the features of the rigidizer arm 3302 included with the strap. The patient interface system 3000 shown in these figures may include a rigidizer arm 3302 to ensure an effective seal to the patient's nose by the seal forming structure 3100. It should be understood that the seal forming structure 3100 described above in connection with FIGS. 223 to 239 may be included in a typical patient interface 3000 along with the rigidizer arm 3302 shown in these drawings.

The rigidizer arm 3302 may be formed to minimize twisting and may be stiffer than the rigidizer arm 3302 described elsewhere herein. The rigid rigidizer arm 3302 may be beneficial to include with the seal forming structure 3100 in the form of a nasal cradle cushion. This is because the rigid rigidizer arm can ensure an effective seal with this type of seal forming structure. In an example having a nasal pillow as the seal forming structure 3100, the nasal pillow can help position and hold the nasal pillow itself with respect to the nostrils by extending into the nostrils. In the example where the seal forming structure 3100 is a nasal cradle cushion, such a holding function may not be easily achieved. Therefore, the rigidizer arm 3302 may be provided in the patient interface system 3000 with a nasal cradle cushion as the seal forming structure 3100 so that the seal forming structure can maintain an effective seal on the patient's nose. According to an example of the present technique, the extending portions 3370, 3371 may be configured to prevent movement of the rigidizer arm 3302 in a plane parallel to the patient's sagittal plane (see FIG. 2f) and / or. The extension may be configured to allow the rigidizer arm to flex in a plane parallel to the patient's Frankfort horizontal plane (see FIG. 2e). In other words, the rigidizer arm 3302 can flex laterally and medially with respect to the patient's face as compared to translation with respect to the mask frame 3310 to accommodate different face widths. In one example, the rigidizer arm 3302 is only allowed to bend outward and inward with respect to the patient's face, especially to increase the stability of the patient interface 3000 when tube torque is received in the sagittal plane. , May not be able to move in any other direction, or may have high resistance to movement in any other direction.

According to the example shown in FIGS. 240-244, a typical rigidizer arm 3302 is a mask frame by mechanical coupling facilitated by overmolding the frame 3310 over a portion of the extension 3370, 3371. It may be connected to 3310. The rigidizer arm 3302 may include a joint 3374 to connect the rigidizer arm 3302 to the extending portions 3370, 3371. The rigidizer arm 3302 may be integrally formed of one material with the joint 3374 and the extending portions 3370, 3371. The materials selected for these examples of rigidizer arms may be similar to those used for other examples of rigidizer arms discussed elsewhere herein. Similarly, the frame 3310 may be formed from the same material used with other examples disclosed herein. As described above, in order to bond the extending portions 3370 and 3371 to the frame 3310, it may not be possible to bond the respective materials to each other, so that an overmold connection may be necessary. The respective materials of the rigidizer arm 3302 and the frame, as well as the overmolded connections, will be described in more detail below.

The extension 3370, 3371 may be wider in the vertical direction than the extension 3350 used in the example having a nasal pillow in the example where the nasal cradle cushion is used as the seal forming structure 3100. The additional volume of the larger extension 3370, 3371 can provide resistance to the twists described above, which can be beneficial when using a nasal cradle cushion. This is because the same material is used for the rigidizer arm 3302 in both examples, but more material is needed in the nasal cradle cushion example to provide the desired increase in stiffness. According to an example of the present technology, the extending portions 3370, 3371 vertically have a width approximately equal to the width of the widest body portion of the body 3333 of the rigidizer arm 3302 in order to obtain the desired rigidity and resistance to twisting. You may. According to another example of the art, the extending portions 3370, 3371 may be wider in the vertical direction than the body 3333 of the rigidizer arm 3302 in order to obtain the desired stiffness and resistance to twisting. Alternatively, reinforcing ribs may be formed in the extending portions 3370, 3371, the extending portion may be formed with a geometric shape having a higher resistance to twisting, and / or a material having higher rigidity. The rigidizer arm 3302 may be formed from the body.

Further, as shown in FIGS. 223 to 233h, the rigidizer arm 3302 of the example in which the nasal cradle cushion is used for the seal forming structure 3100 has straps 3315 and 3316 in the same manner as in the example of using the nasal pillow. It should be understood that it may be attached. This configuration will be described in more detail elsewhere herein.

The right extension 3370 shown in these drawings is from the extension to give the patient a visual and tactile reference to properly orient the patient interface 3000 when wearing the patient interface for treatment. It also includes a seal 3372 that may be raised.

FIGS. 246a-246g show some diagrams of a typical patient interface 3000. These figures show the patient interface 3000 without the strap 3301 of the positioning stabilization structure 3300 and without the short tube 4180.

246e-246g show a diagram of the patient interface 3000 in which the protruding end support portion 3208 is visible.

The rigidizer arm 3302 may be used as a visual indicator for the patient regarding the proper insertion depth of the nose into the seal forming structure 3100. For example, the length of the rigidizer arm 3302 can be an indication of the proper position of the patient interface 3000 with respect to the ear so that the seal forming structure is optimally positioned with respect to the nose to form an effective seal.

6.3.7.4 Attaching the Strap to the Rigidizer Arm The side strap portions 3315 and 3316 of the strap 3301 shown in FIG. 65 include two buttonholes 3303 and 3304, respectively. Button holes 3303, 3304 may be located on the outer surface of the strap 3301, i.e., the surface facing away from the patient 1000 when worn, and the rigidizer arm 3302 into the tubular or sleeve-shaped strap 3301. It is designed to receive the Rigidizer Arm 3302 for insertion or to remove the Rigidizer Arm from the strap. Alternatively, the buttonholes 3303 and 3304 may be located on the inner surface of the strap 3301. Button holes 3303, 3304 allow the rigidizer arm 3302 to be inserted through such buttonholes 3303 to assemble the positioning stabilization structure 3300 while still preventing accidental detachment or separation of the rigidizer arm 3302 from the strap 3301 in use. / Or may be oriented and / or formed so that it can be removed. As shown in FIG. 65, this is achieved, for example, by providing a buttonhole 3303 having a slit-like shape similar to a buttonhole that may be oriented parallel to or laterally to the strap 3301. You may. Alternatively, the buttonhole 3303 may be oriented across the strap 3301, if desired. In other words, the elongated extension of the buttonholes 3303, 3304 may extend substantially coaxially with the longitudinal axes of both the strap 3301 and the rigidizer arm 3302. This allows easy insertion of the rigidizer arm 3302 into a tubular or sleeve-shaped strap or a portion of the strap 3301, especially due to the elasticity of the strap 3301, while preventing accidental detachment of the rigidizer arm. The end of the strap 3301 between the distal end of the strap 3301 and the buttonhole 3303 covers and wraps around the edge of the rigidizer arm 3302 and acts as an anchor point. This edge or anchor point of the rigidizer arm 3302 may be a capture member. This end of the strap 3301 may be referred to as the pocket-like end 3311. This prevents the strap 3301 from slipping off the inserted rigidizer arm 3302 when the strap 3301 is extended and adjusted while the patient interface 3000 is being worn or removed.

With reference to FIGS. 185 and 186, the rigidizer arm 3302 may be inserted into the first buttonhole 3303 of the strap 3301. In other words, the strap 3301 may be slid over the rigidizer arm 3302 via the buttonhole 3303. The free end 3302.1 at the distal end of the rigidizer arm 3302 is first inserted into the strap 3301 via the buttonhole 3303. The rigidizer arm 3302 is further pushed into the strap 3301 until most or substantially the entire rigidizer arm 3302 is inserted into the strap 3301 so that the end of the strap 3301 can be securely secured to the edge of the rigidizer arm 3302. A portion of the material of the strap 3301 near the buttonhole 3303 is adjusted to be located just below the outer surface 3319 of the protrusion 3309 (see FIG. 38). As can be seen in FIGS. 6-8, the rigidizer arm 3302 may be left in an almost unregulated state of freewheeling inside the strap 3301 when inserted into the strap 3301. Most importantly, the buttonhole 3303 must be above the mounting point. This is because the end of the strap 3301 is captured by the protruding end 3306 of the rigidizer arm 3302 to secure the strap 3301 to the rigidizer arm 3302, and the end of the strap 3301 is projected when the strap 3301 is extended. This is because it pulls against the part 3306. In general, the position of the attachment point between the rigidizer arm 3302 and the strap 3301 is more important than, for example, the type of attachment using the buttonholes 3303, 3304 of the strap 3301. Referring to FIGS. 182 to 184, the type of attachment between the rigidizer arm 3302 and the strap 3301 may facilitate easy removal of the strap 3301 from the rigidizer arm 3302 to allow individual cleaning of the strap 3301. .. In other words, the cleaning cleaning measures for the strap 3301 may be at a different time than the mask frame 3310. Patient 1000 slightly extends the strap 3301 around the buttonhole 3303 to remove the strap 3301 from the rigidizer arm 3302. After the distal end of the strap 3301 is removed, the strap 3301 may be completely separated from the rigidizer arm 3302 via the buttonhole 3303.

In addition to or in place of this, the rigidizer arm 3302 is attached to the strap 3301. The attachment may be performed by attaching or attaching the second end of the rigidizer arm 3302 near the buttonhole 3303 to the strap 3301 of the positioning stabilization structure 3300 after insertion. Fixation may be local, as discussed in the preface to the body of the specification. Here, the connection between the rigidizer arm 3302 and the strap 3301 is not distributed along the length of the strap 3301 but is locally made in the region adjacent to the buttonhole 3303. Alternatively, such a connection may be made in the area adjacent to the buttonhole 3304. Mounting can be done by sewing, welding, gluing, caulking, clamping, buttoning, snapping the cover over the edges, or by pushing the Rigidizer Arm 3302 into the Strap 3301 and strapping both the Strap and Rigidizer Arm 3302. It may be done by snapping to an external component by fixing it to an external component such as an external clip that holds both ends of the. Alternatively, the strap 3301 may be chemically attached to the rigidizer 3302. Clips may also be used to attach the ends of the strap 3301 to the respective ends of the mask frame 3310. Therefore, the clip may be part of the mask frame 3310 itself.

Using this technique, it is still possible to extend the strap approximately along its overall length, with the strap 3301 arranged in the shape of the rigidizer arm 3302. Thus, the rigidizer arm 3302 provides the required shape to direct the pressure of the positioning stabilization structure 3300 towards the required portion of the face, while the elastic positioning stabilization structure 3300 maintains its overall working length. At the same time, it can be freely extended over the rigidizer arm 3302. In addition, the rigidizer arm 3302 may disconnect tube torque within the coronal plane. Further, in particular, the sharply bent portion 3307 of the rigidizer arm 3302 may be useful for handling and disconnecting any tube torque in the sagittal plane. At the same time, the strap 3301 of the positioning stabilization structure 3300 may cover the rigidizer arm 3302 and also provide a soft feel and high comfort.

The sharp bend 3307 provides stability to the patient interface 3000. When the patient 1000 is lying sideways, the rigidizer arm 3302, which is in contact with the side of the face on the bedding, is pressed inward. The sharp bend 3307 disconnects this movement within the coronal plane to prevent it from interfering with the sealing force. The sharp bend 3307 has a tighter bend on its upper surface (facing away from the patient's face) than on its lower surface (facing the patient's face). The lower surface of the sharp bend 3307 has a larger radius than the upper surface of the sharp bend 3307, thereby smoothing the lower surface and avoiding or minimizing facial markings on the patient 1000. Be done. This is because the contact pressure is hardly concentrated when there is some contact (due to tube weight or tube torque caused by nasal droop) at the patient's septum and / or upper lip. The distance between the two sharp bends 3307 is about 50 mm.

Although illustrated and discussed with respect to the particular example shown in FIGS. 65-70, each of the strap 3301 or the side strap portions 3315, 3316 of the strap is provided with only one buttonhole 3303, 3304. It turns out that it is also good. However, two or more button holes may be provided. Alternatively or additionally, the strap 3301 may not be tubular or sleeve-like and may have a flat monolayer or laminated form. Here, the rigidizer arm 3302 comprises a holding means including one or more loops, sleeve-like portions, or pockets provided on the outer surface of the strap 3301 (eg, a surface facing away from the patient during use). It may be positioned with respect to.

In addition to or in place of this, a combination of different connecting mechanisms described herein may be provided. For example, the rigidizer arm 3302 is held adjacent to the strap 3301 by providing, for example, a loop or sleeve-like element provided on the outer surface of the strap 3301 in the area of the marks 3321b, 3323b, while being held adjacent to the strap 3301, for example, as described above. It may be secured to the strap 3301 at a single point adjacent to the pocket-shaped ends 3311, 3313 of the 3301 or in a local area. In other words, the rigidizer arm 3302 may be connected to the strap 3301 by fixing it at only one local point or region, while acting as an additional guide element to the strap 3301. Such a guide element function is provided by a loop or sheathed portion or passage or pocket of the strap 3301 in which the rigidizer arm 3302 enters and extends or extends through based on the shape of the strap 3301 shown in FIG. May be done. The strap 3301 may be tubular, but not necessarily cylindrical. This allows for the longest possible extension path for strap 3301. Alternatively, the rigidizer arm 3302 may have one or more pockets distributed along the length of the strap 3301 (eg, a single pocket with an open end of a significant length sheath that supports the rigidizer arm somewhere in the center). , Or each may be placed non-mounted in a pair of pockets that support the corresponding ends of the rigidizer arm) or in multiple loops. Such a guide element function allows the rigidizer arm 3302 to move or float with respect to the strap 3301, whether or not it is attached at one end. Such a form enables the same advantages and benefits as those described above. Further, according to an example of the technique, the rigidizer arm 3302 does not extend or bend in the same direction as the strap 3301. Rather, the rigidizer arm 3302 may extend or bend in a plane substantially perpendicular to its longitudinal axis.

In the illustrated and discussed example, the rigidizer arm 3302 does not extend beyond the end of strap 3301. However, according to another aspect, the rigidizer arm 3302 may be fixed, for example, to the strap 3301 at a point or region adjacent to the respective pocket-shaped ends 3311, 3313, extending beyond the strap 3301. In such a form, the rigidizer arm 3302 may impart shape, geometry, and / or stiffness to the strap 3301, while at the same time structurally such as a flexible joint 3305 for connecting to the patient interface 3000. Means may be provided. Thereby, the rigidizer arm 3302 functions as a rigidizer arm 3302 and as a connector for connecting the strap 3301 and the positioning stabilization structure 3300 to the frame 3310, the plenum chamber 3200, or the seal forming structure 3100, respectively. You can do both.

113 to 122 show detailed views of the connection between the pocket-shaped ends 3311, 3313 and the rigidizer arm 3302. 113 and 114 show pocket-shaped ends 3311, 3313 around the respective protruding ends 3306 of the rigidizer arm 3302. In these figures, the protruding ends 3306 are invisible because they are covered by the pocket-shaped ends 3311, 3313. A straight portion 3351 of the extending portion 3350 (described further below) of the rigidizer arm 3302 is shown on the outer surface 3355 of the extending portion 3350 with a seal 3358. The seal 3358 may be a pad-printed raised surface or embossed portion to help orient the device 3000 during use when the patient 1000 is in a dark environment. The straight portion 3351 of the extending portion 3350 may be visible extending outward from the button holes 3303 of the respective pocket-shaped ends 3311 and 3313. The straight portion 3351 is a part of the rigidizer arm 3302, as shown in FIGS. 47-60, and the rigidizer arm 3302 facilitates the connection between the strap 3301 and the mask frame 3310. FIG. 114 shows a diagram similar to that of FIG. 113, but the outer surface 3355 of the straight line portion 3351 is not accompanied by a seal. FIG. 113 depicts the connection between one rigidizer arm 3302 and each pocket-shaped end 3311, while FIG. 114 depicts the connection between the other rigidizer arm 3302 and each other pocket-shaped end 3313. Should be understood. By placing the seal 3358 on only one outer surface 3355, the patient 1000 can use the tactile sensation to orient the device 3000 to aid in fitting in a dark environment. FIG. 114 also shows the flange 3359 visible through the buttonhole 3303.

FIG. 115 shows similar features to FIG. 114, but is a further detailed view to better show the relationship between the flange 3359 and the pocket-shaped end 3313. Also, FIG. 116 shows the same features as FIG. 113, but is a further detailed view to better show the seal 3358 and the buttonhole 3303 of the pocket-shaped end 3313.

FIG. 117 shows a further detailed view of FIG. 114 to better illustrate the buttonhole 3303 of the pocket-shaped end 3313. FIG. 118 shows a further detailed view of FIG. 113 to better illustrate the buttonhole 3303 of the pocket-shaped end 3313.

119-122 show features similar to those shown in 113-118, but in these figures the flange 3359 is pulled out of the buttonhole 3303 to better illustrate its morphology. 119-122 show a rigidizer arm 3302 that includes a seal 3358 on an outer surface 3355 extending from the buttonhole 3303 of the pocket-shaped end 3311. It should be understood that FIG. 122 shows a more detailed view of FIG. 119. 120 and 121 show another rigidizer arm 3302 that may not include a seal. It should be understood that FIG. 121 shows a more detailed view of FIG. 120.

262A and 262B show other examples of the art in which the strap 3301 includes an elastic tube 3301.1 for attaching the strap to the rigidizer arm 3302. According to this example, the strap 3301 may include an elastic tube 3301.1 that is secured to the end of the strap. FIG. 262A shows the strap 3301 and elastic tube 3301.1 removed from the rigidizer arm 3302, and for simplicity, a portion of the rigidizer arm is not shown. To attach the strap 3301 to the rigidizer arm 3302, the patient slides the elastic tube 3301.1 along the length of the rigidizer arm until the elastic tube reaches the ridge stopper 3302.6 on the rigidizer arm. Although not shown in FIGS. 262A and 262B, it should be understood that a predetermined length rigidizer arm 3302 is received inside the strap 3301 up to the point of the raised stopper 3302.6. The raised stopper 3302.6 prevents the patient from pushing the strap 3301 too far along the length of the rigidizer arm 3302 and attaches the strap to the rigidizer arm in the desired position to maintain the intended extendable length of the strap. You may be able to do it. The shape, size, and material of the elastic tube 3301.1 are selected so that sufficient holding force due to friction is created between the elastic tube and the rigidizer arm 3302 when the elastic tube reaches the raised stopper 3302.6. May be done. In other words, the frictional force between the elastic tube 3301.1 and the rigidizer arm 3302 is such that the tension at the strap 3301 is less than the frictional force holding the elastic tube on the rigidizer arm when the patient wears the patient interface 3000. The elastic tube must be high enough to prevent it from being pulled away from the rigidizer arm. The elastic tube 3301.1 may be made of a material that has a relatively high coefficient of static friction with the material of the rigidizer arm 3302 so that the strap 3301 is held on the rigidizer arm. Also, the material of the elastic tube 3301.1 must be stretchable so that the elastic tube can be deformed as it slides down the rigidizer arm 3302 towards the raised stopper 3302.6.

FIG. 263 shows another example of the art in which a tab 3470 may be formed on the rigidizer arm 3302 to hold the strap 3301 on the rigidizer arm using a hook loop connection. The tab 3470 may be fixed to the rigidizer arm 3302 and / or formed integrally with the rigidizer arm 3302, and the tab may include hook material 3471. Thus, at least a portion of the outer surface of the strap 3301 may be formed from loop material on at least a portion of its outer surface to engage the tab 3470 in a hook loop connection. To attach the strap 3301 to the rigidizer arm 3302, the patient slides the strap along the length of the rigidizer arm and lifts the tab 3470 to slide the strap under the tab and release the tab to loop the strap material. The portion may engage with the hook material 3471 on the strap. The size of the tab 3470 should be selected so that a sufficient area of hook material engages the strap 3301 to produce a sufficiently high holding force to resist the tension of the strap when worn by the patient. In this example, the entire strap 3301 may be manufactured to have a loop material on its outer surface in order to save the cost of manufacturing the strap. Therefore, in such an example, the loop material must be sufficiently flexible to avoid inflammation of the patient's skin. It should also be understood that the tab 3470 may include a loop material instead of the hook material, in which case the strap 3301 may have a portion of the hook material for adhering to the loop material of the tab. .. Also, the tab 3470 is formed from elastic material so that the tab can be pulled away from the rigidizer arm 3302 to attach the strap 3301 and then upon release, the tab can engage the strap with sufficient force to maintain the hook loop connection. It should be understood that it may be done.

264A and 264B show another example of the art in which the strap 3301 may include a lock 3301.2 to engage the notch 3302.2 on the rigidizer arm 3302. According to this example of the present technology, the lock 3301.2 may be located at the end of the strap 3301 and also engages the lock 3301.2 with the corresponding notch 3302.2 of the rigidizer arm 3302. To urge, the strap may contain elastic material at this end. In this example, the lock 3301.2 is held in the corresponding notch 3302.2 of the rigidizer arm 3302 with sufficient force to resist the tension of the strap when the patient interface 3000 is worn by the patient. The strap 3301 must be sufficiently elastic at its ends in order to be. 264A and 264B show the technology in which one notch 3302.2 on the upper edge of the rigidizer arm 3302 and one notch on the lower edge of the rigidizer arm work with the corresponding lock 3301.2 on the strap 3301. However, it should be understood that any number and / or corresponding corresponding locks and notches in any number and / or position may be used as long as sufficient holding power is maintained.

FIG. 265 shows an example of the present technology in which the strap 3301 comprises a predetermined length of loop material 3301.3 and a piece of hook material 3301.4 at or near the end of the strap 3301.5. The rigidizer arm 3302 according to this example of the present technology includes a first slot 3302.7 and a second slot 3302.8. To attach the strap 3301 to the rigidizer arm 3302, the strap is first threaded through the first slot 3302.7 and then looped back through the second slot 3302.8. To secure the strap 3301 to the rigidizer arm 3302, the hook material 3301.4 at the end of the strap 3301.5 is coupled with the loop material 3301.3. This example of the art may allow some adjustment of the extendable length of the strap 3301 based on where the hook material 3301.4 is attached to the loop material 3301.3. It should also be understood that the positions of hook material 3301.4 and loop material 3301.3 may be replaceable.

The examples shown in FIGS. 262A-265 include a strap 3301 that can be removed from the rigidizer arm 3302 and flipped so that both sides of the strap can be used for contact with the patient. This may be advantageous in that the strap 3301 does not have to be completely used when the surface on one side of the strap is abraded. Rather, the patient may simply invert the strap 3301 so that the useful life of the strap can be extended.

Also, in any of the aforementioned examples where the strap 3301 of the positioning stabilization structure 3300 is removable, the detachability of the strap may be beneficial to the overall life cycle of the patient interface 3000. For example, the strap 3301 may have a shorter service life than the assembly of the frame 3310 and the short tube 4180 so that the expiration of the strap does not require replacement of the entire patient interface 3000. In other words, the strap 3301 can be replaced when it expires, and a new strap can be used with the rest of the unexpired patient interface 3000.

6.3.7.4.1 Non-removable mounting alternatives Figures 266-270 allow the strap 3301 to be non-removably attached to the rigidizer arm 3302, i.e. the patient cannot remove the strap from the rigidizer. , Another example of the present technology is shown. The non-removable attachment of the strap 3301 to the rigidizer arm 3302 may be beneficial in that the patient does not have to pass the strap over the rigidizer arm and the strap is unlikely to come off the rigidizer arm.

FIG. 266 shows an example of the present technology in which the strap 3301 is irremovably secured to the rigidizer arm 3302 at attachment point 3304. According to this example, the attachment point 3304 may be formed by ultrasonic welding of the strap 3301 to the rigidizer arm 3302. Two attachment points 3304 are shown on the surface of the rigidizer arm 3302 that points away from the patient during use, but the number, size, and number of attachment points 3304, as long as the desired extendable length of the strap 3301 relative to the rigidizer arm 3302 is maintained. It should be understood that the shape and / or position may be changed.

FIG. 267 shows an example of the present technology similar to the example shown in FIG. 266. However, the example shown in FIG. 267 includes a mounting point 3304 formed by thermal caulking rather than ultrasonic welding. It should also be understood that the size, shape, number, and / or position of attachment points 3304 may be varied as long as the desired extendable length of strap 3301 relative to the rigidizer arm 3302 is maintained.

FIG. 268 shows a further example of the present technology similar to the example shown in FIG. 266. However, the example shown in FIG. 268 includes a mounting point 3304 formed by stitching. It should also be understood that the size, shape, number, and / or position of attachment points 3304 may be varied as long as the desired extendable length of strap 3301 relative to the rigidizer arm 3302 is maintained.

FIG. 269 shows another example of the present technology in which the attachment point 3304 is hinged to the rigidizer arm 3302 to irremovably secure the strap 3301 to the rigidizer arm. For example, attachment point 3304 may perforate the fabric of strap 3301 to form a non-removable attachment.

FIG. 270 shows another example of the art in which the non-removable attachment of the strap 3301 to the rigidizer arm 3302 uses a hook at attachment point 3304. The hooked portion of the attachment point 3304 may be formed integrally with the rigidizer arm 3302 and the relatively flexible fabric of the strap is gripped and removed by the hooked portion when the strap 3301 is first slid onto the rigidizer arm. It may be oriented so that it cannot be mounted. In other words, the hook of attachment point 3304 may be oriented so that when the patient interface 3000 is worn by the patient, it faces in the direction opposite to the tension of the strap 3301.

6.3.7.5 Extension of the strap with respect to the rigidizer arm As can be seen in the example shown in FIG. 68, the two rigidizer arms 3302 are inserted into the side strap portions 3315, 3316 of the strap 3301 of the positioning stabilization structure 3300, and the rigidizer arm The 3302 is held in place by the surrounding strap 3301, while the sleeve-like form of the strap 3301 allows at least a portion of the strap 3301 to extend or move with respect to the rigidizer arm 3302. Preferably, this extendable portion is a substantial portion. This is because the strap 3301 is fixed to the rigidizer arm 3302 only at the anchor point. In some examples, the limitation of movement of the rigidizer arm 3302 is generally such that one of the ends of the rigidizer arm 3302, 3319a or 3319b, moves to the respective pocket-like end 3311 of the strap 3301, as in FIG. 69. It is imposed when it comes into contact with the strap. For example, when the positioning stabilization structure 3300 is not on the patient's head and the strap 3301 is loose, when the inserted rigidizer arm 3302 moves extremely towards the back straps 3317a, 3317b, its end 3319b will move. It may enter the open end of one of these back strap portions 3317a and 3317b. Since the width of the back strap portions 3317a, 3317b is smaller than the width of the rigidizer arm 3302, the end portion 3319b of the rigidizer arm 3302 comes into contact with the respective back strap portions 3317a, 3317b, whereby further movement of the rigidizer arm in this direction is possible. Be restricted.

The attachment of the strap 3301 to the rigidizer arm 3302 described in the previous section may also affect the size of the head that the positioning stabilization structure 3300 can accept. In other words, a longer length strap 3301 may be provided along the rigidizer arm 3302 to increase the overall extendable length of the positioning stabilization structure 3300, thereby expanding and contracting the strap 3301. It may be possible to accept a head with a considerably large circumference without the need to increase sex. Further, the place where the strap 3301 is connected may be changed along the length of the rigidizer arm 3302. This allows a fairly large head size range and head circumference range to be accommodated without the need to change the elasticity of the strap 3301.

The length of the strap 3301 is about 400 mm to 700 mm. The length of the strap 3301 may be about 490 mm. Strap 3301 can provide a level of headgear tension that is comfortable for most head sizes. The straps may have two gender-specific lengths or sizes, one for the male population is longer than the female version. Preferably, there may be two sizes / lengths of strap 3301 for each gender. Comfortable levels of headgear tension range from about 2 Newtons to about 5 Newtons. Comfortable levels of headgear tension range from about 2.2 Newtons to about 4.7 Newtons. When the strap 3301 is extended from 490 mm to 526 mm for the patient 1000 with a small head circumference, the headgear tension measured using the Instron tester is 2 Newtons. When the strap 3301 is extended from 490 mm to 662 mm for a patient with a large head circumference, the headgear tension measured using the Instron tester is 4.4 Newton. Button holes 3303, 3304 on the strap 3301 are attached to the clamp fixture for measurement. A tensile tester with a 100 Newton load cell is used. The strap 3301 is stretched and held at predetermined stretch points (eg, 90.5 mm, 73 mm, and 108 mm) for 1 minute, and a force value (in Newton) is recorded for each stretch point. Such measurements do not take into account any friction of the material of the strap 3301 against the patient's face or hair.

The length of the divided region 3326 defined between the two back strap portions 3317a and 3317b is about 180 mm to about 220 mm. The length of the divided region 3326 may be 200 mm. If the length of the split region 3326 is not long enough, the two backstraps 3317a, 3317b will not be able to surround the back of the patient's head and may therefore maintain their position during treatment. No, the headgear tension remains unsuitable for the patient's taste. If the length of the divided region 3326 is too long, the two back strap portions 3317a and 3317b are separated in front of the user's ear, which is unpleasant. This is because the backstraps pass across the ears rather than above the ears / around the ears, thereby reducing the maximum angular range of the two backstraps 3317a, 3317b with respect to each other.

In the neutral, unextended state of the strap 3301, the two back strap portions 3317a, 3317b form an angle θ of about 0 ° to about 10 ° with respect to each other. After wearing the patient interface 3000, the two back strap portions 3317a, 3317b may be separated from each other so that the angle θ can be up to about 180 °. This allows a maximum angular range of 180 °, which provides a large reduction range of headgear tension by gradually widening and separating the two backstrap portions 3317a, 3317b. The angle range may be narrowed from a default angle of 10 ° to a maximum angle of 120 °. The patient may use one or both hands to move the two back straps 3317a, 3317b apart or closer together under the tension currently acting on the back of his head. By moving the two backstraps 3317a, 3317b further away from each other, the split region 3326 is widened, thereby reducing the headgear tension from the unsplit range of 2.5-5 Newtons. Headgear tension may be reduced from about 30%, as measured by the load cell, to about 50% in one example, or to about 40% in another. In other words, for patients with a small head circumference, the headgear tension may be reduced from 2 Newtons to 1.2 Newtons by increasing the distance between the two backstraps 3317a, 3317b. For patients with a large head circumference, headgear tension may be reduced from 4.4 Newtons to 2.64 Newtons by increasing the distance between the two backstraps 3317a, 3317b.

Thus, the rigidizer arm 3302 may be allowed to move almost unlimitedly along the length of the strap 3301, may be attached to the strap 3301, or may be adjacent to one of the ends of the strap. good.

The discussed form allows the strap 3301, and thus the positioning stabilization structure 3300, to extend and extend in length, as shown in FIG. Such stretch is not limited to the portion of the strap 3301 that is not in contact with or parallel to the rigidizer arm 3302, and stretch of the strap 3301, especially elastic stretch, is also achieved in the region of the rigidizer arm 3302. This is a mark 3321a to 3321d, 3323a that visualizes the length of the rigidizer arm 3302 in FIGS. 68 and 70 (the strap 3301 is extended but remains the same) and the length of the strap 3301 relative to the length of the rigidizer arm 3002. It can be easily derived from the comparison with ~ 3323e. In FIG. 68 in the non-extended state, the extension of the rigidizer arm 3302 along the marks 3321a to 3321c and 3323a to 3323d can be easily derived by comparing FIGS. 68 and 70. On the contrary, in the extended state according to FIG. 70, the rigidizer arm 3302 extends only along the marks 3321a to 3321b and 3323a to 3323c. From this, it becomes clear that the strap 3301 is extended along the region where the rigidizer arm 3302 is housed in the strap 3301. However, while the strap 3301 is being extended, the rigidizer arm 3302 remains unextended.

Needless to say, the positioning stabilization structure 3300 may include one or more rigidizer arms 3302. Although the previous discussion has focused on the relationship between the rigidizer arm 3302 and the strap 3301, the example shown in FIGS. 68-70 comprises two rigidizer arms 3302 and each side strap portion 3315, 3316 of the strap 3301. It should be noted that one rigidizer arm is provided within. Therefore, although the previous comment ultimately refers to one rigidizer arm 3302, it also applies to two or more rigidizer arms 3302 connected to the mask frame 3310.

One more advantageous attribute that allows the strap 3301 to extend relative to the rigidizer arm 3302 as described above is that the patient interface 3000 with the positioning stabilization structure 3300 does not need to remove any strap or other connection function. It may be that it may be attached and detached by the patient 1000. It uses the device 3000 in a dark bedroom before or after sleep in that the patient does not need to be able to see the connections or disconnections of the various components to attach or remove the patient interface 3000. Can be useful for 1000 patients. Rather, the patient 1000 simply wears or removes the patient interface 3000 and the positioning stabilization structure 3300, and may also need to position the seal forming structure 3100 if worn. .. However, this can all be achieved by touch and does not need to be seen.

However, it may still be advantageous to allow the removal of the plenum chamber 3200 or seal forming structure 3100 from the positioning stabilization structure 3300. For example, in order to clean the plenum chamber 3200 or the seal forming structure 3100, it may be desirable to clean the plenum chamber or the seal forming structure without wetting the positioning stabilization structure 3300. This can be facilitated by making these components removable for such purposes.

6.3.7.6 Rigidizer Arm and Mask Frame FIGS. 47-60 show the rigidizer arm 3302 and the mask frame 3310 according to a further example of the present technology.

47-49 and 54 show cross-sectional views of the rigidizer arm 3302 and mask frame 3310 according to an example of the present technology and the connections between them. In the vicinity of the sharply bent portion 3307 of the rigidizer arm 3302, the extending portion 3350 is connected by a joint 3356. Further, in the vicinity of the sharply bent portion 3307, there is also a protruding end portion 3306 of the rigidizer arm 3302 which may hold the pocket-shaped end portion of the side strap portion 3316 of the positioning stabilization structure 3300. In these figures, it can be seen that the mask frame 3310 is formed around the encapsulationable portion 3354 and the hook 3353 of the extending portion 3350. The mask frame 3310 may have an opening 3335 formed in the vicinity of a place where the mask frame 3310 surrounds the encapsulation portion 3354. The openings 3335 may be formed as a result of an overmolding process in which the mask frame 3310 is formed and secured around the encapsulation portion 3354 of the rigidizer arm 3302. The rigidizer arm 3302 according to this example may be formed of Hytrel®, or the mask frame 3310 may be formed of polypropylene (PP). Hytrel® is desirable for forming the rigidizer arm 3302. This is because this material is resistant to creep. In this example, the mask frame 3310 may be overmolded into the rigidizer arm 3302 to form a secure connection, as these materials cannot be integrally bonded. It should also be noted that in this example, the extension 3350 and the rigidizer arm 3302 may be integrally formed. The mask frame 3310 may be connected to the rigidizer arm 3302 by a respective extension 3350 located opposite the free end 3302.1 at the distal end. The extending portion 3350 may include a straight portion 3351 coupled to a bent portion 3352 coupled to the hook 3353. A part of the hook 3353 and the bent portion 3352 may form a sealable portion 3354.

A joint 3356 connecting the extension 3350 to the rigidizer arm 3302 may provide a flexible target point, and the joint may be formed to allow flexion in the desired direction and to the desired degree. It should be understood that it is also good. Thus, when the patient interface 3000 is worn and the rigidizer arm 3302 is stressed by tension from the straps of the positioning stabilization structure 3300, the rigidizer arm 3302 bends at the joint 3356, whereby the rigidizer arm is directed against the patient's face. The facial skeleton shape can be retained while helping to retain the mask frame 3310 in the desired position.

50 and 51 show a perspective view and a detailed perspective view of the rigidizer arm 3302 connected to the mask frame 3310, respectively, according to an example of the present technology. FIG. 51 further shows the encapsulationable portion 3354 overmolded by the mask frame 3310 to secure the mask frame to the end of the rigidizer arm 3302 with a dashed line. Similar to the case of FIGS. 47-49, the opening 3335 forming a passage completely penetrating the hook 3353 of the rigidizer arm 3302 and the mask frame 3310 can be seen.

52 and 53 show a plan view and a detailed plan view of the mask frame 3310 connected to the rigidizer arm 3302, respectively, according to an example of the present technology. In FIG. 52, dimension L indicates the length of the rigidizer arm 3302 in the direction shown. Preferably, the rigidizer arm 3302 has a nominal length L of 114 mm. These figures show particularly well how the joint 3356 can connect the extension 3350 to the rigidizer arm 3302 between the protruding end 3306 and the sharp bend 3307.

FIGS. 55 to 57 show a side view, a front view, and a perspective view of the rigidizer arm 3302 and the mask frame 3310 according to an example of the present technology, respectively. In FIG. 55, dimension H indicates the height of the rigidizer arm 3302 in the direction shown. Preferably, the rigidizer arm 3302 has a nominal height H of 33 mm. The rigidizer arm 3302 and the extending portion 3350 may be connected to the mask frame 3310 by overmolding the mask frame 3310 with respect to the encapsulating portion 3354 of the extending portion 3350 of the rigidizer arm 3302 after being formed as an integral product. .. The extension 3350 accepts the nasal droop by bending in a vertical or rotational mode with respect to the rigidizer arm 3302. The extension 3350 has a lower height than the rest of the rigidizer arm 3302 and has less material, and is separated from the rest of the rigidizer arm 3302 by a sharp bend 3307, so that the extension 3350 is bent. Occurs localized before the rest of the rigidizer arm 3302 begins to bend. This reduces the possibility of interfering with the sealing force.

58 and 59 show a partial decomposition diagram and a detailed partial decomposition diagram of the rigidizer 3302 and the mask frame 3310 according to an example of the present technology, respectively. It can be seen that the hook 3353 of the extending portion 3350 and the encapsulating portion 3354 are separated from the mask frame 3310. In these figures, the shapes of the hook 3353 and the encapsulation part 3354 can be seen, and also so that these parts ensure a stronger mechanical connection with the mask frame 3310 when the mask frame 3310 is overmolded. It should be understood that it is formed. Specifically, these figures show that the encapsulation portion 3354 may be formed at the hook 3353 with a flared end to provide a surface for holding against the mask frame 3310. In another example of the art, the encapsulationable portion 3354 may include an opening for holding the rigidizer arm 3302 in the mold during overmolding of the mask frame 3310. A mold may be inserted through this opening to stabilize the rigidizer arm 3302 as the mask frame 3310 is overmolded around the rigidizer. This can be beneficial as the overmolding pressure can cause the rigidizer arm 3302 to move during the molding process so that a mechanical connection that is never ideal with the mask frame 3310 is formed.

FIG. 60 shows a perspective view of the rigidizer arm 3302 according to an example of the present technology. This figure shows the rigidizer arm 3302 before the non-removable connection with the mask frame 3310. As discussed just now, the rigidizer arm 3302 may include a hook 3353 and an encapsulation part 3354 to allow connection to the mask frame 3310 by mechanical coupling. This connects the rigidizer arm 3302 to the frame 3310 in a non-removable manner. The non-removable connection of the rigidizer arm 3302 and the frame 3310 to each other means that there are few removable parts and it is unlikely that parts will be lost during assembly / disassembly of the patient interface 3000 during cleaning. do.

6.3.3.7.6.1 Improving stability between the frame and the rigidizer arm According to a specific example of the present technology, the frame 3310 and the rigidizer arm 3302 can be coupled in a manner that enhances the stability of the patient interface 3000. It may be desirable.

FIG. 260A shows an example of the present technology in which the rigidizer arm 3302 is formed on the frame 3310. The frame 3310 and the rigidizer arm 3302 may be integrally formed. This example does not include the extension 3350 provided in other examples to provide the desired magnitude of bending strength at the junction between the frame 3310 and the rigidizer arm 3302. Rather, an extension arm 3302.3 is formed to connect the rigidizer arm 3302 to the frame 3310. As part of the molding process, voids 3302.4 may be formed between the extending arms 3302.3 to remove unwanted material. It is understood that by widening and separating the upper and lower extension arms 3302.3, the moment of inertia where the extension arms connect to the frame can be increased around the axis XX shown in FIG. 260A. It should be. Equation for the moment of inertia of the joint around the X-X may be simplified to I = bh ^3/12. Therefore, the increase in h, that is, the increase in space between the upper and lower extension arms 3302.3, is the moment of inertia I around XX as compared to b, that is, the increase in the thickness of the extension arm. Brings a great increase in. Further, by optimizing the geometrical shape of the rigidizer arm, the rigidizer arm 3302 and / or the extension arm 3302.3 can be further thinned.

FIG. 260B shows another example of the art in which the rigidizer arm 3302 may be coupled to the frame 3310 by a rod 3302.5. The rod 3302.5 may be made of metal or other similar material with similar rigidity. Further, the rigidizer arm 3302 of this example may be formed of a relatively hard material such as nylon.

FIG. 261A shows another example of the art in which it may be desirable to increase the stability of the rigidizer arm 3302 and the extension 3350. A pair of rigidizer arm ribs 3460 may be provided on the sharply bent portion 3307 of the rigidizer arm 3302 in order to increase the rigidity. In order to increase the rigidity, a pair of extending portion ribs 3461 may be provided at the bending portion 3352 of the extending portion. The sharp bends 3307 and 3352 may be prone to unwanted deflection when the patient interface 3000 is worn by the patient. Therefore, these ribs can prevent excessive bending of the rigidizer arm 3302 and / or the extending portion 3350.

FIG. 261B shows another example of the art in which it may be desirable to increase the stability of the extension 3350. In this example, longitudinal ribs 3462 are provided along a portion of the extending portion 3350 in the longitudinal direction. The longitudinal rib 3462 may extend through the bend 3352 to the straight portion 3351. The longitudinal rib 3462 can increase the rigidity of the extending portion 3350 to prevent excessive bending.

6.3.7.7 Positioning stabilization structure worn by the patient FIGS. 71-73 show an example of the present technology. Here, the positioning stabilization structure 3300 includes a strap 3301 having side strap portions 3315, 3316 and a back strap portion 3317, and the back strap portion 3317 extends parallel along the back surface of the patient's head. It includes two back strap portions 3317a and 3317b. The positioning stabilization structure 3300 comprises two rigidizer arms (not shown), each housed within the respective side strap portions 3315, 3316 of the sleeve-shaped or tubular strap 3301. The rigidizer arm 3302 imparts a predetermined shape or desired shape and / or rigidity to the strap 3301 and thus to the positioning stabilization structure 3300. For example, the side strap portions 3315, 3316 of the strap 3301 have a specific curvature to follow the desired contour around the patient's face, achieved by providing the correspondingly formed rigidizer arms 3302 (FIG. 52, FIG. See the curvature of reference number 3323 in FIGS. 54, 58, and 60). In the illustrated example, the positioning stabilization structure 3300 is a frame 3310, a plenum chamber 3200, or a seal forming structure to provide a breathing gas such as air, and thus a pressurized breathing gas, to the patient's airways. Connected to 3100. In the illustrated example, such respiratory gas is provided via a hose or tube 4180 connected to the patient interface 3000. The tube 4180 may have other ends (not shown) connected to a breathing gas source such as a blower or ventilator for supplying pressurized breathing gas. The patient interface 3000 may include a frame portion or frame 3310 to provide structural integrity to the patient interface 3000 and / or to connect to the positioning stabilization structure 3300. The positioning stabilization structure 3300 may be connected to the frame 3310, the plenum chamber 3200, or the seal forming structure 3100 via a separate connector means (not shown) provided on the strap 3301 and / or the rigidizer arm 3302. ..

74-77 show similar features to those shown in FIGS. 71-73, but the examples shown in FIGS. 74-76 and 77 are of a positioning stabilization structure 3300 and a mask frame 3310. Draw different connections between. At each end of the side straps 3315, 3316, there are pocket-shaped ends 3311, 3313 as shown in FIGS. 65 and 81. These pocket-shaped ends 3311 and 3313 are visible, for example, by the protruding ends 3306 of the respective rigidizer arms shown in FIGS. 47-60 (in these figures, the rigidizer arms are within the side straps 3315, 3316). Not) held on. Although not visible in FIGS. 74-77, in this example, the welded ends 3311.1, 3313.1 depicted in FIG. 81 are pocket-shaped so that the welded ends can be held against the protruding end 3306. It should be understood that it helps to close the ends 3311, 3313. The rigidizer arm 3302 is then irremovably mechanically secured to the mask frame 3310 by overmolding, as described, for example, in connection with FIGS. 47-60.

6.3.7.7.1 Attaching the Rigidizer Arm to the Patient Interface According to a further example of the present technology, the Rigidizer Arm 3302 may be removable. By allowing the rigidizer arm to be removed from the patient interface 3000, the rigidizer arm 3302 undergoes little strain during transport and storage. When the rigidizer arm 3302 is removable, the patient interface 3000 can be packaged more compactly in a manner that appropriately supports each individual component. Further, by making the rigidizer arm 3302 separable, the rigidizer arm can be separated for cleaning. In some examples, it should be understood that the extension 3350 may be removed from the frame 3310. In another example, the rigidizer arm 3302 may be removed from the extension 3350, in which case the extension may be non-removably attached to the frame 3310. A further advantage of the removable rigidizer arm 3302 may be that the attachment mechanism can be formed to provide an audible click sound that is an indication to the patient that gives the patient the peace of mind that the components have been effectively fixed. .. Such an audible click sound may be facilitated, for example, by a hard-hard connection between the rigidizer arm 3302 and the frame 3310. Rigid-rigid connections can be beneficial for patients suffering from fine motor nerve capacity. This is because the rigid-to-rigid connection allows the patient to more easily assemble the patient interface 3000 and the patient can be confident that he or she has assembled it. Also, the removable rigidizer arm 3302 can be beneficial to the patient in that the patient can customize the patient interface 3000 due to component compatibility. For example, the patient interface 3000 may be sold with a set of many rigidizer arms 3302 with different curvature profiles, shapes, lengths, and / or stiffness, from which the patient has facial geometry and / or rigidity. You may choose the most suitable set based on your comfort. This can provide better fit and greater comfort, which can enhance patient adherence to treatment. Also, the set of rigidizer arms 3302 may be provided in different colors to give the patient a variety of aesthetic choices.

248A and 248B show an example of a rigidizer arm 3302 that is removed from the patient interface 3000 at the extension 3350 and attached to the patient interface 3000. The protruding end 3306 of the rigidizer arm 3302 may be provided with a protruding 3380 with a lock blade 3381, which may be supported by a shaft (not shown). The straight portion 3351 of the extending portion 3350 may be provided with an opening 3382 having a notch 3383. A stopper 3384 may be provided on the straight portion 3351 of the extending portion 3350. The openings 3382 and notches 3383 may be dimensioned and formed corresponding to the protrusions 3380 and the wings 3381. To assemble the rigidizer arm 3302 to the extension 3350, the protrusions 3380 and wings 3381 are extended through the corresponding openings 3382 and notches 3383 until the wings come into contact with their respective stoppers 3384. It is rotated. Therefore, the length of the shaft is dimensioned to be slightly greater than the width of the straight portion 3351 of the extension 3350 to minimize play between the rigidizer arm 3302 and the extension 3350 at the time of attachment. Should be attached. It should be understood that the rigidizer arm 3302 may be fixed by rotation in only one direction. This may be achieved, for example, by locating stoppers 3384 on each side of the opening 3382 such that the rigidizer arm 3302 is fixed by rotation in the clockwise direction, as shown in FIG. 248B. Also, to prevent assembly errors in the rigidizer arm 3302, that is, to prevent the right rigidizer arm from being attached to the left extension and vice versa, the corresponding protrusion-wing and opening. -It should be understood that the pair with the notch may be dimensioned differently. Therefore, the patient can only reliably attach the right side rigidizer arm 3302 to the right extension 3350 and the left side rigidizer arm to the left extension.

249A and 249B show other examples of the present technology in which the rigidizer arm 3302 may be removable. In this example, the extending portion 3350 may be provided with a pair of pins 3385 extending from the extending portion. Each of the pins 3385 may have a head on the shaft, and the shaft is fixed to the extending portion 3350. The head of each pin 3385 may be larger in diameter than the shaft of each pin to allow attachment to the socket 3386 formed at the protruding end 3306 of the rigidizer arm 3302. The socket 3386 may include a slit to allow the material of the protruding end 3306 to flex so that the head of the pin 3385 can pass through each socket. Therefore, the length of the shaft of the pin 3385 should be dimensioned to be slightly greater than the width of the protruding end 3306 to minimize play when the rigidizer arm 3302 is attached. Also, the pin 3385 and the corresponding socket 3386 may be separated or dimensioned differently to prevent assembly errors in the rigidizer arm 3302. For example, the spacing and / or positioning of the pin 3385 of the right side rigidizer arm 3302 and extension 3350 and the corresponding socket 3386 is such that the patient cannot attach the left side rigidizer arm to the right extension and vice versa. , May be different from the left side. In another example, the left rigidizer arm 3302 and the pin 3385 and socket 3386 of the extension 3350 have the right rigidizer arm and vice versa such that the patient cannot attach the left rigidizer arm to the right extension and vice versa. It may be dimensioned differently than the extension pins and sockets.

250A-250C show another example of the removable rigidizer arm 3302 according to the present technology. In this example, the rigidizer arm 3302 includes a protrusion 3393 having an arm 3394 to secure the rigidizer arm to the extension 3350. The arm 3394 and the protrusion 3393 may extend from the shaft 3395 on the rigidizer arm 3302, and the arm, the protrusion and the shaft may be formed integrally with the rigidizer arm 3302. Therefore, the extending portion 3350 is provided with a slot 3392, and the arm 3394 and the protruding portion 3393 are passed through the slot 3392 during mounting. Further, the extending portion 3350 is also formed with a shaft receiving portion 3390 and an arm receiving portion 3391 for receiving the shaft 3395 and the arm 3394, respectively. In order to attach the rigidizer arm 3302 to the extension 3350, the shaft 3395, the protrusion 3393, and the arm 3394 are passed through the slot 3392, and the shaft and the protrusion are engaged with the shaft receiving portion 3390 and the arm receiving portion 3391, respectively. You will be drawn into a state of doing. The arm receiving portion 3391 may be narrower than the shaft 3395 and the arm 3394 to ensure a frictional fit when the arm is engaged with the arm receiving portion. To remove the rigidizer arm 3302 from the extension 3350, the patient slides the rigidizer arm 3302 in the direction opposite to the mounting direction. It should also be understood that the diameter of the protruding portion 3393 may be larger than the diameter of the shaft receiving portion 3390 in order to prevent disassembly. To prevent assembly errors, the arm 3394 and protrusion 3393 of the right rigidizer arm 3302 are sized and / or formed to fit only into the arm receiving 3391 and shaft receiving 3390 of the right extending 3350. Also, the arm and protrusion of the left side rigidizer arm may be dimensioned and / or formed so as to fit only into the arm receiving portion and the shaft receiving portion of the left extending portion.

251A and 251B show other examples of the rigidizer arm 3302 which may be removable. According to this example, the extending portion 3350 may be formed integrally with the rigidizer arm 3302. The extending portion 3350 may include a flared end portion 3387 that attaches to a receiving portion 3388 on the frame 3310. The flared end 3387 may be slid into a slot 3389 in the receiving portion 3388 for mounting the extending portion 3350 and the rigidizer arm 3302, and its engagement may form a press fit. The receiving portion 3388 may be a component separate from the frame 3310 attached to the frame, or the receiving portion may be formed integrally with the frame. To prevent assembly errors, the flared ends 3387 and slots 3389 on the right side may be dimensioned and / or formed differently from the flared ends and slots on the left side.

252A-252C show other examples of the rigidizer arm 3302 which may be removable. According to this example, the extending portion 3350 may be formed integrally with the rigidizer arm 3302. The extending portion 3350 may be formed so as to perform a snap-type engagement with the receiving portion 3310.1. The receiving portion 3310.1 may be a component separate from the frame 3310 attached to the frame, or the receiving portion may be formed integrally with the frame. The receiving portion 3310.1 may include a pocket 3310.2 and a recess 3310.3 to receive the extending portion 3350 for mounting the rigidizer arm 3302. The extension 3350 includes a bend 3396 that facilitates snap engagement. The extending portion 3350 may be formed of an elastic material, and the extending portion may be formed by reducing the angle of the extending portion 3396 when the extending portion is arranged in the receiving portion 3310.1. It may be sized to be compressed. This compression of the extension 3350 pushes the protrusion 3397 into the recess 3310.3. When the bend 3396 is pushed into the pocket 3310.2. Tabs 3398 may be provided to facilitate detachment. The patient can release the protrusion 3397 from the recess 3310 and remove the rigidizer arm 3302 by pressing the tab 3398 to further compress the bend 3396. Further, in order to prevent assembly mistakes, the right extending portion 3350 and the corresponding receiving portion 3310.1 may be dimensioned and / or formed differently from the left extending portion and the corresponding receiving portion. good.

253A-253C show other examples of the rigidizer arm 3302 which may be removable. According to this example, the extending portion 3350 may be formed integrally with the rigidizer arm 3302. The extending portion 3350 may be formed so as to perform a snap-type engagement with the receiving portion 3310.1. In this example, the extending portion 3350 may be held by the receiving portion 3310.1. The receiving portion 3310.1 may be a component separate from the frame 3310 attached to the frame, or the receiving portion may be formed integrally with the frame. In this example, the support column 3399 may be provided near the end portion 3350.1 of the extending portion 3350. In order to attach the extending portion 3350, the strut 3399 is inserted into the pocket 3310.2 of the receiving portion 331.1. The stanchion 3399 may have a circular cross-sectional shape to engage the complementary recess 3310.4 of the pocket 3310.2. Similarly, cross-sectional shapes of non-circular columns 3399 such as squares, rectangles, triangles, and ellipses are assumed. In this example, since each of these surfaces may be curved, an end receiving portion 3310.5 may be provided in the pocket 3310.2 to receive the end portion 3350.1 of the extending portion 3350. The engagement of the end receiving portion 3310.5 with the end portion 3350.1 of the extending portion 3350 can prevent undesired rotation of the extending portion 3350 and the rigidizer arm 3302 around the longitudinal axis of the column 3399. Therefore, this is due to the movement of the rigidizer arm 3302 only due to the deflection caused by the deformability of the rigidizer arm 3302 and the extension 3350, and the play of engagement between the extension and the receiver 3310.1. You can avoid it. Therefore, in order to prevent assembly mistakes, the right extending portion 3350 and the corresponding receiving portion 3310.1 may be dimensioned and / or formed differently from the left extending portion and the receiving portion.

254A and 254B show other examples of the rigidizer arm 3302 which may be removable. This example may not include the extension 3350 formed with the rigidizer arm 3302. Rather, the rigidizer arm 3302 is formed at the ends of the first bent portion 3340, the first straight portion 3341, the second bent portion 3342, the second straight portion 3343, and the second straight portion 3343. A lock end 3344 may be formed. Slots 3345 may be provided on both sides of the frame 3310, and each rigidizer arm 3302 is passed through the slots 3345 for attachment to the frame. Each slot 3345 may be dimensioned and formed to allow the respective rigidizer arm 3302 to pass through the slot, but to prevent the rigidizer arm from being pulled out through the slot, each slot has its own locking end. It may be smaller. To prevent assembly errors, the right side rigidizer arm 3302 and the corresponding slot 3345 may be formed and / or dimensioned differently from the left side rigidizer arm and slot. Also, the portions of the rigidizer arm 3302 previously mentioned as the first straight portion 3341 and the second linear portion 3343 do not have to be straight, and these portions as needed to give the desired shape / outer shape. It should be understood that may be curved instead. Further, the rigidizer arm 3302 may have other curved portions and / or bent portions as desired as long as the rigidizer arm can be passed through the slot.

FIGS. 255A and 255B show other examples of the rigidizer arm 3302 which may be removable. According to this example, the extending portion 3350 may be formed integrally with the rigidizer arm 3302. This example includes a pin 3385 whose head is supported by a shaft on an extension 3350. The head of pin 3385 may be larger in diameter than the shaft. Sockets 3386 may be integrally formed on both sides of the frame 3310 for snap engagement with each pin 3385. To prevent assembly errors, the pin 3385 of the right rigidizer arm 3302 and the corresponding socket 3386 may be dimensioned and / or formed differently than the left pin and socket.

256A-256C show another example of the rigidizer arm 3302 which may be removable. According to this example, the extending portion 3350 may be formed integrally with the rigidizer arm 3302. The receiving portion 3410 and the first magnet 3412 may be provided on the frame 3310. A second magnet 3413 may be provided on the extension 3350 to secure the rigidizer arm 3302 to the frame 3310. Therefore, the magnetic poles of the first magnet 3412 and the second magnet 3413 may be oriented so that the first magnet and the second magnet are attracted to each other. The extending portion 3350 may be provided with a post 3411 near the second magnet 3413 in order to engage with the receiving portion 3410 so that the extending portion is properly positioned by the receiving portion. It should also be understood that the right post 3411 and receiving 3410 may be formed and / or dimensioned differently than the left post and receiving to prevent assembly errors. To prevent assembly errors, the magnetic poles of the first magnet 3412 and the second magnet 3413 on the right side may be oriented opposite to the magnetic poles of the first magnet and the second magnet on the left side, thereby. Magnet attraction occurs only when the left and right magnets are engaged, and when the patient attempts to place the left rigidizer arm 3302 within the right receiver 3410 or vice versa, the magnets Repulsion prevents engagement.

257A and 257B show other examples of the rigidizer arm 3302 which may be removable. The frame 3310 may include a first L-shaped portion 3420 on both sides, and a second L-shaped portion 3423 may be formed on each rigidizer arm 3302. By moving the L-shaped portions toward each other in opposite vertical directions in order to attach the frame 3310 to the rigidizer arm 3302, the first L-shaped portion 3420 is brought into an engaged state with the second L-shaped portion 3423. Will be done. The first L-shaped portion 3420 and the second L-shaped portion 3423 are then rotated relative to each other and fixed in place. The second overlapping portion 3424 may engage with the first recess 3421, and the first overlapping portion 3422 may engage with the second recess 3425. Pegs 3426 may be provided in the first recess 3421 and the second recess 3425. In order to fix the first L-shaped portion 3420 and the second L-shaped portion 3423, each peg 3426 engages with a hole 3427 provided in the first overlapping portion 3422 and the second overlapping portion 3424. You may. Holes 3427 in these examples are indicated by dashed lines to indicate that they do not extend completely through the first superposition 3422 and the second superposition 3424, according to another example. For example, it should be understood that the hole can be completely penetrated and extended. It should also be understood that the engagement between each peg 3426 and hole 3427 may include press-fitting or frictional fitting to ensure a secure connection. In yet another example, the pegs 3426 may have hooks at the ends of the shaft, and the corresponding holes so that the hooks of each peg lock into their respective holes when engaged. The 3427 may extend completely through the first overlapping portion 3422 and the second overlapping portion 3424. In another example, the pegs 3426 can be provided in the first overlap 3422 and the second overlap 3424, and the holes 3427 are provided in the first recess 3421 and the second recess 3425. It should be understood that it can be done.

258A and 258B show other examples of the rigidizer arm 3302 which may be removable. According to this example, the extending portion 3350 may be formed integrally with the rigidizer arm 3302. Bosses 3430 may be formed on both sides of the frame 3310, and cavities 3431 may be formed at the ends of each extension 3350 to receive the bosses. The boss 3430 and cavity 3431 may be formed and dimensioned to form a secure frictional fit. It should also be understood that in another example, the boss 3430 may be formed in the extending portion 3350 and the cavity 3431 may be provided in the frame 3310. Also, the right boss 3430 and cavity 3431 may be formed and / or dimensioned differently from the left boss and cavity to prevent assembly errors.

259A-259C show other examples of the rigidizer arm 3302 which may be removable. A post 3452 and a pair of slots 3453 may be provided in the extension 3350. The rigidizer arm 3302 may be provided with a hole 3451 to receive the post 3452, and a pair of protrusions 3450 may be provided on the rigidizer arm 3302 to engage with each slot 3453. To attach the rigidizer arm 3302 to the extension 3350, the protrusion 3450 is first passed through the corresponding slot 3453 of the extension, and then the post 3452 is holed 3451 to prevent separation of the rigidizer arm from the extension. Engage. The bent shape of the protrusion 3450 can help secure the protrusion as it is passed through the opening 3453. The post 3452 may also include a head that is expanded relative to the shaft of the post so that the post engages tightly with the hole 3451. In another example, the post 3452 and slot 3453 need not be provided in the extension 3350 as long as complementary components are positioned such that the protrusion engages the slot and the post engages the hole. It should be understood that the holes 3451 and protrusions 3450 do not need to be provided on the rigidizer arm 3302. Also, a plurality of posts 3452 and a plurality of holes 3451 may be provided as long as a complementary number is given. Also, more or less corresponding protrusions 3450 and slots 3453 may be provided, provided a complementary number is given. Further, in order to prevent an assembly error, the number of protrusions 3450 and slots 3453, and the number of posts 3452 and holes 3451 are set to the left extending portion 3350 and the rigidizer arm 3302 and the right extending portion 3350 and the rigidizer arm 3302. It should be understood that they may differ between them. Alternatively, in order to prevent assembly errors, the size and / or shape of the protrusions 3450 and slot 3453, and the size and / or shape of the posts 3452 and holes 3451 are set to the left extension 3350 and the rigidizer arm 3302 and the right extension. It may be different between the existing portion 3350 and the rigidizer arm 3302.

6.3.7.8 Divided back straps of the positioning stabilization structure According to one aspect, the structures of the strap 3301 and the positioning stabilization structure 3300 are beneficial. In particular, if two elastic straps or back strap portions 3317a and 3317b are provided on the back, the head can be surrounded and the tension vector can be adjusted by appropriately positioning these straps, for example, by unfolding the straps. In addition, the provision of the two back strap portions 3317a and 3317b provides better support and stability, and can increase flexibility while avoiding particularly sensitive areas on the back of the head. The back strap portions 3317a, 3317b are adapted to surround the head with a calvaria to maintain position and engagement. In one example, the upper backstrap portion 3317a is located near the parietal bone and the lower side, depending on the particular head shape of the patient and the size of the splits of the backstrap portions 3317a, 3317b. The back strap portion 3317b is located near the upper fibers of the occipital bone or trapezius muscle (ie, near the upper neck or dorsal neck of the neck). The lower back strap portion 3317b may be configured to engage the patient's head at or below the external occipital protuberance. Unlike conventional mask headgear, which requires material length adjustment (shortening or lengthening), the tension applied by the positioning stabilization structure 3300 opens the relative angle between the two back straps 3317a, 3317b. Or you can adjust it just by closing it. When the patient interface 3000 is worn, the two back strap portions 3317a, 3317b are further separated on the back of the head to reduce headgear tension. In order to increase the headgear tension, the two back strap portions 3317a and 3317b are brought close to each other. This mode of adjustment requires a strap with a notch that allows only a preset gradual adjustment of the headgear tension, Velcro® that requires several attempts to tighten and untighten until the desired headgear tension is obtained. ) (Continuous loop fabric) Straps, or straps through the buckle, which are easier to increase than decrease due to the action of pulling the strap through the buckle for tightening. It is more advantageous than looping. Also, the patient 1000 hesitates to make a mistake in the headgear tension or change the headgear tension.

The two smaller straps on the back of the head, i.e. the back straps 3317a, 3317b, may be of equal length and may be of equal length, except due to the elasticity of the material, or a positioning stabilization structure. It is not adjustable except by reducing the overall length of the 3300 side straps 3315, 3316 to equally increase the tightening of both back straps. For example, a slide mechanism (not shown) may be provided in which the straps 3301 are stacked to different degrees so that the overall length of the positioning stabilization structure 3300 can be changed. The independently adjustable strap length allows the two back strap portions 3317a, 3317b to necessarily center themselves on the crown. The two back strap portions 3317a and 3317b may be symmetrical or asymmetrical. In other words, the upper back strap portion 3317a may necessarily be anchored to the crown, while the lower back strap portion 3317b is necessarily anchored to the back of the head near the occipital lobe or below it. May be good. This can reduce the possibility of overtightening one strap by hand to compensate for the other strap being too loose, thereby resulting in an incorrect fit of the positioning stabilization structure 3300. .. Moreover, this can not only cause discomfort, but can also adversely affect treatment compliance. The combined width of both back strap portions 3317a and 3317b may be substantially equal to the width of the side strap portions 3315. This is aesthetically pleasing and provides the patient with a visual indicator for adjusting the back strap portions 3317a, 3317b when wearing the patient interface 3000. Although the two back strap portions 3317a and 3317b have been described, a larger number can be assumed, and according to this, different degrees of adjustment of the headgear tension can be given. When the strap 3301 is in the neutral state and is not stretched, there should be a gap between the two back straps to encourage or suggest that the patient adjust the back straps 3317a, 3317b when wearing the patient interface 3000. In addition, the two back strap portions 3317a and 3317b are partially separated from each other. This enhances intuition for adjusting headgear tension and visually suggests how headgear tension can be adjusted, but traditional masks sometimes lack this.

As described above, instead of making the strap 3301 one continuous component, two or more joints are provided to form the positioning stabilization structure 3300 from three, four, or more separate straps. Can be done. This can complicate assembly, but can simplify the manufacturing process. The joint may be arranged at the branch point 3324 between the side strap portions 3315, 3316 and the two back strap portions 3317a, 3317b, or may be concentrated on the back surface. The joints may be sewn, welded, glued or overmolded and may incorporate high friction materials to help reduce movement on the head. The high friction material pads to increase the relative surface friction between the straps 3301, 3317a, 3317b and the patient's skin or hair and maintain the position of the straps 3301, 3317a, 3317b on the patient's head. Printing, silicone printing may be included. The high friction material may be present only on the patient contact surface of the back strap portions 3317a, 3317b. This is because the rigidizer arm 3302 may perform some or most of the function of maintaining the position of the side straps 3315, 3316 with respect to the patient's face.

High friction material may be added to the inner surfaces of the back and side straps 3315, 3316, 3317a, 3317b to reduce slippage of the straps against the patient's face or hair. With respect to the arm or side strap portions 3315, 3316, this helps the positioning stabilization structure 3300 to stay on the cheeks, and at the back strap portion 3317, thereby the positioning stabilization structure 3300 is on the head. You can prevent it from sliding across the back. Such materials may be printed, poured or molded on the surface or incorporated into the process of jointing, sewing or welding as described above. Another way to reduce strap slippage is to allow the elastic yarn to protrude from the fabric material.

The rigidizer arm 3302 is optionally located near the branch point 3324 where the positioning stabilization structure 3300 branches, instead of being inserted through the buttonholes 3303 and 3304 located near the mask frame 3310 as shown in FIG. It can be inserted through the opening 3308 to be made. At the time the rigidizer arm 3302 is inserted, the elasticity of the material can be used to return and hook the rigidizer arm 3302 inside the opening of one (upper or lower) of the smaller backstraps 3317a, 3317b. This prevents the rigidizer arm 3302 from moving and thus allows the rigidizer arm to be fixed in place. Otherwise, the buttonholes 3303, 3304 can be sewn, molded, or otherwise permanently closed to trap the rigidizer arm 3302 within the strap 3301.

The split area 3326 on the back may include two, three, or more straps for stability. The positioning stabilization structure 3300 as described above may be used with a full face mask (covering the nose and mouth) or a nasal mask. Other positioning stabilization structures of conventional masks that may have two or more straps (which may be the same width as the side straps) on the back, in this case the lower back straps, are generally the external occipital prosthesis. It touches and engages with the patient's head on or below the ridge. Such back straps are non-stretchable or inelastic, but may be adjustable in length, and the back straps should avoid wrinkling or twisting at the point of convergence with a single side strap. It may be urged to return to the default angle. For example, the default angle may be 45 ° in the split between the two backstraps to surround and engage the patient's head, and the swivel of the backstraps relative to each other is the patient interface. This is to attach and detach the patient interface in order to fix the patient in a predetermined position and apply tension to the seal forming structure against the patient's face. The two back straps are urged to return to a 45 ° angle and therefore only serve to surround the back of the patient's head for stability of the patient interface, which from a 45 ° angle. Cannot maintain any angle.

By using this technique, the extendable length of the strap 3301 can be affected when the rigidizer arm 3302 is provided and used. This allows the positioning stabilization structure 3300 to fit a large range of head sizes. This can effectively be a "one size optimal fit" positioning stabilization structure 3300, even if the patient has not previously tried on or used the positioning stabilization structure 3300. , Means that the positioning stabilization structure 3300 taken out of the bag is likely to fit the patient. The present technology may provide a positioning stabilization structure 3300 that allows easy attachment and detachment of the patient interface 3000. In particular, this may mean that, unlike some other positioning stabilization structures, the tension setting does not need to change and / or the tension setting is not lost when the mask 3000 is removed. The rigidizer arm 3302 may define the desired shape so that there is clearance around the eyes and ears for comfort and visibility. The fabric of strap 3301 may also allow the skin to breathe naturally and sweat without the need for silicone, foam, or plastic to bring and retain surface heat and condensate from sweat.

When two elastic straps 3317a and 3317b are provided on the back of the strap 3301, the patient's head can be surrounded and the distribution of the applied force can be adjusted by expanding the straps and changing the positions of the straps independently. can. The two smaller back straps 3317a, 3317b on the back of the head may be of equal length and may be of equal length, except due to the elasticity of the material, or with the straps of the positioning stabilization structure 3300. It may be non-adjustable unless it is due to equal tightening of both back straps by shortening the overall length.

6.3.7.9 Flexible joint 3305
19, 71-73, 75, 76, and 166 also show the connection of the positioning stabilization structure 3300 to the frame 3310 associated with the plenum chamber 3200. In particular, the joint 3305 of the rigidizer arm 3302 and the frame 3310 may be flexible and / or elastically deformable. Therefore, the seal forming structure 3100 may be able to accept various nasolabial folds (eg, shown in FIG. 2e) when worn by patient 1000. Therefore, it should be understood that the flexibility of this joint 3305 allows the frame 3310, the plenum chamber 3200, and other related components to move around many axes relative to the rigidizer arm 3302. In one embodiment of the technique, the frame 3310 and the plenum chamber 3200 may be rotatable about one axis defined between the respective ends of the rigidizer arm 3302 via the flexible joint 3305. Such a configuration may allow the seal forming structure 3100 to be applied and angled to the subnasal region of patient 1000 over a wide range of possible possible nasolabial folds.

As can be seen in FIGS. 18, 19, 75, 76, and 166, the seal forming structure 3100 abuts on the underside of the nose of patient 1000 and, in one example, on the patient's airways such as the nostrils. Is retained. The proper position of the seal forming structure 3100 is a critical factor in obtaining an effective seal of the truncated cone 3140 to the patient's nostrils so that the leakage of pressurized gas is minimized with minimal holding force. .. Since the truncated cone 3140 can extend axially from the handle 3150 of the seal forming structure 3100, allow some degree of freedom in the direction of the patient interface 3000 with respect to the patient's nose in order to obtain the optimum seal. Can be beneficial. Such degrees of freedom can be beneficial as patients may have different nasolabial folds (see FIG. 2e) that may need to be accepted by a common patient interface. This degree of freedom may be achieved by providing a flexible joint 3305 in a typical patient interface 3000. In an example of the present technology, the flexible joint 3305 may be located between the frame 3310 and the rigidizer arm 3302. In such a typical arrangement, the frame 3310 may be constructed of a material that facilitates bending at the flexible joint 3305 by the rigidizer arm 3302 of the positioning stabilization structure 3300. In another configuration, the rigidizer arm 3302 may bend through the extension 3350 to allow proper positioning of the seal forming structure 3100 with respect to the patient's underside of the nose. It is also assumed that bending may occur partially in both parts. In any assumed configuration, the desired result is that the patient interface 3000 can rotate with respect to the patient's underside of the nose so that it can accept various nasolabial folds. This degree of freedom provided by the flexible joint 3305 allows the trampoline 3131 to be more effective in exerting a comfortable force against the patient's nostrils or nose. Without the flexible joint 3305, the trampoline 3131 would be less effective in accepting different nasal wing angles and maintaining stability. This is a condition in which the handle 3150 and the plenum chamber 3200 are already partially or completely collapsed when the tension from the positioning stabilization structure 3300 holds the seal forming structure 3100 in a seal position where it abuts against the patient's airway. Because it is in.

The flexible joint 3305 may be provided by forming the frame 3310 and / or the rigidizer arm 3302 from a material having sufficient elastic modulus to allow flexibility in the joint 3305. In addition to or in lieu of this, the frame 3310 and / or the rigidizer arm 3302 may be structurally formed to allow flexibility in this region. In other words, the frame 3310 and / or the rigidizer arm 3302 may be formed to allow the required amount of flexibility in the area of the joint 3305. This may be achieved by removing some of these structures so that the stiffness of the structures is reduced to allow flexion.

A further conceivable advantage of this aspect of the art may be that it reduces the bending moment associated with the rigidizer arm 3302 and frame 3310. As shown in FIGS. 19, 71-73, 75, the rigidizer arm 3302 may be formed to fit the contour of the patient's face. Also, a comparison between the seal forming structure 3100, the plenum chamber 3200, and the frame 3310 held against the nose by the positioning stabilization structure 3300 when the seal forming structure 3100 engages the patient's nostrils. Due to the limited size of flexibility, the nostrils may cause displacement of the frame 3310. By providing the flexible joint 3305 between the frame 3310 and the rigidizer arm 3302, some of the associated forces can be dissipated into the flexion of the joint, so that these structures when the patient interface 3000 is worn by the patient. The bending moment associated with the body can be reduced. This can be beneficial as the patient interface 3000 receives less force during use to reduce wear and tear. Further, by dissipating these forces to the bending of the flexible joint 3305, the bending of the rigidizer arm 3302 and / or the frame 3310 can be reduced. This can be beneficial as bending the rigidizer arm may reduce the fit if the rigidizer arm 3302 is formed to fit the patient's face, thereby causing discomfort to the patient. The same may apply to the bending of the frame 3310, and the bending of the frame 3310 may also move the seal forming structure 3100 from the patient's nose.

It should also be understood that in the configurations described above, it may be beneficial to reinforce the rigidizer arm 3302. By forming the rigidizer arm 3302 from a material that is sufficiently rigid and / or by shaping the rigidizer arm 3302 so that they are sufficiently rigid, the flexible joint 3305 allows the seal forming structure 3100 to be placed on the patient's nose. It can also be assumed that it cannot be moved from. In other words, proper fit and effective sealing allow sufficient movement of the seal forming structure 3100 so that the seal forming structure can engage with the patient's nose to provide an effective seal. It may be achieved by a rigidizer arm 3302 that is sufficiently rigid to maintain the desired degree of compatibility with the patient's face. The rigidizer arm 3302 may be formed from Hytrel® having a flexural modulus of 180 MPa and a tensile coefficient of 180 MPa (26) at 23 ° C. Further, in one aspect of the present technology, the patient interface 3000 may be structured such that elastic deformation occurs only in the flexible joint 3305 and the seal forming structure 3100 between the frame 3310 and the rigidizer arm 3302. Should be understood.

In the above-mentioned example of the present technology without the flexible joint 3305, the extending portion 3350 of the rigidizer arm 3302 performs the same function as the above-mentioned flexible joint 3305.

6.3.7.7.10 Tension vector of positioning stabilization structure As mentioned above, a typical positioning stabilization structure 3300 preferably has a compression vector associated with the seal forming structure 3100 on the patient's nose or The headgear tension vector may be positioned relative to the patient's head so that it is properly aligned with the nostrils. As shown in FIGS. 72, 73, 75, and 76, a vector V is drawn to indicate the typical direction and magnitude of the force that presses the seal forming structure 3100 against the nose of patient 1000 during use. .. By operably attaching the typical positioning stabilization structure 3300 to the seal forming structure 3100, the tension of the positioning stabilization structure 3300 when worn by the patient 1000 is the direction and magnitude of the vector V. It may be sufficient to press the patient interface 3000 against the nose or nostrils of the patient 1000 with a force having. The concept of vector may be explained as follows. In order to properly and / or effectively form a seal around the nostrils of patient 1000, when using the nasal pillow 3130 depicted in this example of the present invention, the length of each stalk 3150 of the seal forming structure 3100. The seal forming structure 3100 must be pressed against the patient's nostrils in a direction approximately coaxial with the directional axis. The magnitude of the force must also be sufficient to allow the seal forming structure 3100 to seal around the nostrils, but not large enough to cause discomfort or deformation of the relatively flexible seal forming structure 3100. .. Therefore, a force of magnitude and direction drawn as a vector V must be applied to the seal forming structure 3100. However, it is not ideal for the strap 3301 to be worn across the eyes or across the ears along the sides of the patient's nose. This can be unpleasant and confusing for Patient 1000. The two-point force vector control allows the strap 3301 to gradually stabilize the mask 3000 and pull the nasal pillow 3130 into place to form a pneumatic seal with the patient's airways.

The rigidizer arm 3302 and / or frame 3310 described above may be provided to overcome this problem of the need to provide the required direction and magnitude of sealing force while moving from a particular area of the patient's face. The rigidizer arm 3302 and / or frame 3310 acts as an intermediary to transfer tension from the positioning stabilization structure 3300 to the seal forming structure 3100, allowing the strap 3301 to be oriented away from the patient's eye. You may. In other words, the positioning stabilization structure 3300 can generate a force at one end of each rigidizer arm 3302 and / or frame 3310 by being in the extended state, and the rigidizer arm 3302 and / or frame 3310 is sufficient. Due to its rigidity, this force of equivalent direction and magnitude is transmitted to both ends of the seal forming structure 3100 where it is located. Therefore, the seal forming structure 3100 can be pressed against the patient's nose to form an effective seal. In other words, the rigidizer arm 3302 and / or the frame 3310 serves to structurally separate the positioning stabilization structure 3300 from the seal forming structure 3100 while maintaining a sealing force of the appropriate direction and magnitude.

As mentioned above, in certain examples, straps 3301 of the positioning stabilization structure 3300 may surround the rigidizer arm 3302. To facilitate the force separation described in the previous paragraph while maintaining this sheathed arrangement of the strap 3301 and the rigidizer arm 3302, the rigidizer arm 3302 may be provided with a smooth surface along at least a portion thereof. .. By providing a smooth surface along the rigidizer arm 3302, the strap 3301 of the positioning stabilization structure 3300 can extend and / or compress along the rigidizer arm 3302 in a relatively free and / or low friction mode. .. In other words, the strap 3301 floats over the rigidizer arm 3302, except for the pocket-shaped end 3311 to which it is secured to the rigidizer arm 3302. Also, by reducing the friction of the positioning stabilization structure 3300 along the rigidizer arm 3302, an undesired external force that may result in loss or breakage of the pneumatic seal of the seal forming structure 3100 and / or unpleasant fit. Can be avoided.

In some positioning stabilization structures of conventional masks with multi-layered laminated straps, layers made of different materials that give different degrees of flexibility are permanently superposed on each other. Other positioning stabilization structures of conventional masks use stitches or adhesives to connect the multi-layer straps to each other in a non-removable manner. On the other hand, the positioning stabilization structure 3300 of the present technology has a strap 3301 that can be releasably engaged with the rigidizer arm 3302. This allows the strap 3301 to be cleaned separately from the rigidizer arm 3302 and the frame 3310. The releasable engagement is provided in a small area local area (the edge of the rigidizer arm 3302 near the frame 3310) using the pocket-like end 3311 of the strap 3301, thereby connecting with the frame 3310. It is possible to extend the entire length of the strap 3301 from the point. Other positioning stabilization structures of conventional masks adjust the length of one or more headgear straps (usually adjusted by shortening the length) to provide headgear tension in the patient interface 3000 on the patient's face. Adjustable buckles or Velcro® may be used for adjustment. On the other hand, the positioning stabilization structure 3300 of the present technology does not require length adjustment to adjust the headgear tension and also has an adjusting buckle or Velcro® to adjust the headgear tension, especially in a dark room. ) May be particularly beneficial for patients with arthritic hands who may lack good motor skills.

6.3.7.11 Manufacture of straps The positioning stabilization structure 3300 is molded (eg, without the need to cut out any significant amount of material, or integrally formed into a shape known as "full fashioning". It is manufactured to produce little or no waste material. Alternatively, the positioning stabilization structure 3300 may be divided into a plurality of segments, each of which is manufactured to be molded separately (eg, by knitting) and then attached to each other. FIG. 132 illustrates a single, one-piece, seamless structure having at least two regions (crown or rear 210 and strap 220), where at least two regions are joints (the joints are It extends from the connection between the strap 220 and the rear 210), and the strap 220 extends to the rear 210 in different angular directions. The rear 210 and strap 220 are formed in a continuous process (ie, the material forming the component and the shape of the component are formed in a single step) -this is after the sheet of material has been formed. It is different from the process of being cut and shaped (which is not considered a single step). FIG. 132 also shows that the strap 220 branches or extends towards the rear 210 at different angles or in different directions without the need for a stitching step or a further forming step.

Knitted components, such as the Positioning Stabilization Structure 3300, are defined to be formed from an "integral knitting structure" when configured as an integral knitting element with virtually no further stitching or joining process. NS.

As shown in FIG. 133, the strap 220 may be formed as a continuous piece to be subsequently cut (eg, by warp knitting, circular knitting, or 3D braiding). This is because this procedure can further improve manufacturing efficiency.

Knitting various positioning stabilization structural parts in a continuous manner may sew, fuse, bond, or otherwise lack or few additional manufacturing steps required to attach. It can be beneficial because it does not exist. As a result, the steps in the manufacturing process can be reduced, the amount of waste material is reduced, there are almost no seams between adjacent parts of the positioning stabilization structure 3300, and there are no noticeable joints or seams. The positioning stabilization structure 3300 formed from the fabric can be more comfortable for the patient.

6.3.7.11.1 Techniques Many techniques can be used according to this technique to manufacture and mold Positioning Stabilization 3300 with little or no waste material. The technique can result in a positioning stabilization structure that is a single integral seamless structure. Techniques that can result in a single, one-piece, seamless structure include yarns including interlooping (such as knitting), confounding, and / or interwinning (including braiding, knotting, and crocheting). Mechanical operation of. Another technique for 3D printing can also form a positioning stabilization structure with an integral seamless structure.

The manufacturing technology according to this technology has the following features: (1) produces little or no waste, (2) provides a positioning stabilization structure that is comfortable for the patient, and (3) a comfortable positioning stabilization structure. Bringing the body, (4) Bringing a breathable positioning stabilization structure, (5) Bringing a positioning stabilization structure that can minimize face marking, and / or (6) Lightweight positioning stabilization It may have one or more of which result in a structure.

6.3.7.11.1.1 Interlooping-Knitting According to an example of this technique, the positioning stabilization structure 3300 has interlooping such as knitting (eg, yarn or plying to form a knitted fabric). It may be formed by weaving). The positioning stabilization structure 3300 may be formed by weft knitting or circular knitting, but other forms of knitting may also be envisioned. Weft and circular knitting can be beneficial as they can form a positioning stabilization structure 3300 with an integral seamless structure. A weft or circular knitting machine may be utilized to form a weft or warp knit. Various knitting processes may be utilized, including circular knitting and warp-or weft-weft knitting, to produce one or more positioning stabilization structure components. Weft knitting can (1) position the floating yarn within, for example, the positioning stabilization structure strap to provide additional cushioning or bulk, and / or (2) the top surface of the positioning stabilization structure strap. Or it may contain additional loops of yarn on either of the undersides, thus providing the effect of a flexible terry woven fabric material, for example, or forming a seamless loop fabric to engage with the hook tape fasteners. Able and / or (3) the ability to knit a 3D dimensional spacer woven structure adjacent to a double-sided knitted structure within a single integrated positioning stabilization structure configuration, but limited to these. It may have some advantages that it does not.

The positioning stabilization structure 3300 may be formed primarily from multiple threads that are mechanically manipulated by an interlooping process to provide a single integral structure with different parts with different physical properties. ..

FIG. 134 shows the wales of the weft woven fabric 64, that is, the direction in which the loop of one yarn intersects the loop of another yarn. Course 85, the direction of the loop from a single thread, is shown in FIG. 136 and 137 show a basic closed loop warp knit 90. FIG. 138 shows an example of a warp knit tricot jersey woven structure in which the yarn is knitted in a vertical zigzag manner to capture other warp yarns with the wales extending substantially parallel to the course.

Referring to FIGS. 136-139, the warp knits 90, 90-1 have wales and courses extending parallel to each other, while in the weft knit 100 the wales extend perpendicular to the course. The positioning stabilization structure 3300 of the present technology may be formed by either warp knitting or weft knitting. Warp knits, such as tricots, Russells, or rock knits, are generally more durable against continuous operation, easier to machine, and can use multiple yarns (multiple colors or yarns). Allows the use of types). The weft knitting 100 can be formed by using a single yarn, but the use of a plurality of yarns can also be assumed. The positioning stabilization structure 3300 of the present technology may be composed of warp knitting or weft knitting.

Knitted fabrics may have different stretch properties than woven fabrics. Knitted fabrics are generally more flexible than woven fabrics that can only stretch in one direction (depending on the threads that make up the fabric) and can therefore provide a more comfortable fit for the patient. The knitted fabric may be configured such that the fabric stretches in two directions-that is, the first yarn oriented in the first direction is lower than the second yarn oriented in the second direction. Has flexibility. This configuration may be desirable along the straps of the positioning stabilization structure 3300, in which case the straps can extend along their length but cannot extend across their width, or their The reverse is also true. Alternatively, the knitted fabric may be stretched in four directions. That is, both the first and second directional threads are flexible so that application to the strap allows stretching in both the longitudinal and lateral directions.

The example of FIG. 142 shows a strap 1200 with grain or course 1250 and also illustrates how the direction of grain or course affects elongation. Knitted fabrics tend to stretch more easily in the direction of the course. Therefore, the positioning stabilization structure 3300 can be formed so as to extend in a specific direction and to resist extension in other directions. For example, the strap 1200 tends to stretch in its width direction A (from the patient's face to the back of the head), and stretch along the length of the strap may be restricted. This form can increase the stability of the positioning stabilization structure 3300 in the length direction while increasing the fitting range. The strap 1200 stretches in a particular direction and resists stretching in the other direction so that the strap 1200 can successfully hold the mask assembly onto the patient's face in a manner that enhances the seal with the patient's face. It may be configured in.

With reference to FIGS. 140 and 141, the knitted strap 1105 includes an upper 1102, a rear 1104, and a lower 1106. The lower 1106 may branch or branch at the joint to form the upper 1102 and the rear 1104. The angular direction of the upper 1102 may be different from that of the rear 1104. For example, the upper 1102 may extend about 30-110 ° with respect to the rear 1104, or may extend about 90 ° or perpendicular to the rear 1104. The knitting direction, or the grain or course 1150 of the knitting, may be modified to adjust the shape or elongation of the fabric in a particular area. For example, the grain or course 1150 may be configured to bend the strap in the buccal area to avoid obstructing the patient's eyes. Also, as shown in FIG. 141, the grain or course 1150 may bend and split, as indicated by the arrow B, thereby forming an upper 1102 and a rear 1104. Such a form of the upper 1102 and the posterior 1104 stabilizes the strap in place on the patient's head, thus placing the mask assembly on the patient's face in such a manner that the braided strap 1105 enhances the seal with the patient's face. You may be able to hold it well.

The braided strap 1105 may support the patient interface 3000 (eg, nasal mask) on the patient's face. The connector 1120 may be used to attach the strap 1105 to the patient interface 3000, or the air circuit 4170 may deliver respiratory gas to the patient's airways via the patient interface 3000. In the illustrated example, the patient interface 3000 is located below the patient's nose and seals against the outer surface of the patient's nose.

The positioning stabilization structure 3300 of the present technology may further include pockets, tunnels, layers, and / or ribs. Such positioning stabilization structure 3300 may be integrally formed by circular knitting or weft knitting. The pocket or tunnel may be reinforced with a material that has a higher rigidity or hardness than the knitted fabric, thereby curing the positioning stabilization structure 3300. Curing of the positioning stabilization structure 3300 can better stabilize the mask in place on the user's face. Materials used to cure the positioning stabilization structure 3300 may include plastics such as nylon, polypropylene, polycarbonate, or more rigid cloths such as braided ropes. The hardened portion of the positioning stabilization structure 3300 may be located in the bone region of the patient's head, such as the cheeks, occipital region, or parietal region. Reinforcing structures may be inserted during the knitting process, for example, more rigid or flatter yarns or hard polymer elements may be inserted into the knitting structure during or after the knitting process. .. The plying or rigid components serve to withstand twisting and support the stresses resulting from, for example, tightening of the positioning stabilization structure straps for treatment, or to better stabilize the mask, or It serves as a binder or fastener for attaching the positioning stabilization structure piece to the mask interface.

Alternatively, the pocket or tunnel may be cushioned for added comfort. For example, the pocket or tunnel may be filled with foam, gel, floating yarn, looped yarn, or other cushioning material.

The positioning stabilization structure 3300 may be formed by weft knitting or circular knitting, in which case the positioning stabilization structure 3300 has a woven end. That is, the positioning stabilization structure 3300 has a finishing form such that the end portion of the thread used for forming the positioning stabilization structure 3300 does not substantially exist at the edge portion of the positioning stabilization structure component. It may be formed to have. The advantage of molding the positioning stabilization structure components into a finished shape is that the threads are not cut and are therefore less likely to unravel and may require few finishing steps. It is a point. By forming the finishing edge, the integrity of the positioning stabilization structure 3300 is maintained or further enhanced, and (1) to prevent unraveling of the positioning stabilization structure components, and / Or (2) to form a prominent but flexible edge (eg, when ultrasonically cutting and sealing a "flexible edge" into a woven-foam-woven laminate material) and / Alternatively, (3) little or no post-processing steps are required to enhance the aesthetic and durability properties of the positioning stabilization structure 3300.

The positioning stabilization structure 3300 of the present technology may be formed by regular or irregular picketite. The pickenit orients the first thread on the correct side (the side that does not come into contact with the patient when the positioning stabilization structure 3300 is worn) and the second thread on the wrong side (positioning stabilization structure 3300). Orient on the side that comes into contact with the patient, which is invisible when the thread is worn. That is, the thread exposed on the correct side may be different from the thread exposed on the incorrect side. For example, the thread on the right side may have a pleasing appearance, or the thread on the wrong side may have a good feel to contact the patient's skin. Alternatively or additionally, the thread on the correct side may have a first moisture wicking property and the wrong side may have a second moisture wicking property. For example, the thread on the correct side may have a high percentage of microfibers with a first moisture wicking property, and the wrong side may have a high percentage of non-microfibers with a second moisture wicking property. It may have a fiber.

The Positioning Stabilized Structure 3300 may be formed as an integral knitted structure, which may be of uniform material and properties, for simplicity, but has different physical properties that are joined in a seamless manner. It may be formed as an integral structure including various parts. The various parts are, for example, different degrees of strength, abrasion resistance, abrasion resistance, flexibility, high durability, higher or lower hygroscopicity (moisture absorption), moisture wicking ability, hydrophilicity, breathability. Alternatively, they may exhibit, but are not limited to, air permeable, liquid permeable, eccentric or stretch resistant, compressible, cushioning capacity, support, stiffness, recovery, fit, and shape. The various moieties may be configured to exhibit a change in directional elongation, such as quadrulateral elongation or bidirectional elongation, tailoring level elongation resistance, or non-extension. This may be achieved, for example, but not limited to, by selecting a particular thread or knitting structure type.

The positioning stabilization structure 3300 as an integral seamless structure may be integrally formed with two or more portions having uniform properties or various properties. Two or more positioning stabilization structure portions differ by using two or more different threads with different twists, denier, fiber composition, etc., and thus by imparting different physical characteristics to the positioning stabilization structure 3300. You may. The two or more positioning stabilization structure parts may differ by using two or more different knit stitch types and thus by imparting unique physical properties to the two parts.

One region may incorporate, for example, elastane or PBT (polybutylene terephthalate polyester) to increase elasticity, while the other region may incorporate, for example, nylon or polyester to increase durability. Similarly, one region of the positioning stabilization structure 3300 may incorporate 1 denier yarn, while the other region may incorporate higher or lower denier to customize cushioning, thickness, or bulk. It may contain threads that are crimped or have properties.

Two or more portions within the positioning stabilization structure configuration may be connected, for example, by using tack stitches or other knit stitches that join the first portion to the second portion in a seamless manner. .. This is achieved by knitting the first part, then knitting the tack stitch between the first knitted part and the second knitted part, and then knitting the second part. Tuck stitches are used to seamlessly connect the parts between the wales, especially when using a thin tube circular knitting machine.

The positioning stabilization structure piece may be finished without seams. If the positioning stabilization structure pieces are formed with undyed yarn, this may be achieved by finishing the knitting process with yarn containing water-soluble fibers. The water-soluble fibers allow the fabric to shrink during the dyeing process and provide a well-finished edge, thereby eliminating the need to form additional seams on the edge.

To increase manufacturing efficiency, the knitting machine may be utilized to form a series of coupled positioning stabilization structure components such as straps or crown components. That is, the knitting machine may form a single component that includes a plurality of positioning stabilization structural pieces. Each of the positioning stabilization structure segments may have approximately the same shape and size. Alternatively, each of the positioning stabilization structure pieces may further have different shapes and sizes that may be programmed sequentially. Also, in order to allow the various positioning stabilization structural parts, such as straps, to be separated without the need for cutting work, the knitting release area (eg, meltable yarn, loosely knitted yarn, finer denier yarn, or , But not limited to, may consist of easily tearing placeholder yarns) may be woven into a series of positioning stabilization structure components.

6.3.7.11.1.1.1 Variable yarn count In other examples, the yarn count may vary across the fabric to enhance comfort, fit and / or performance. For example, the thread count may be higher in areas that require greater rigidity (eg, buccal area, occipital region). However, in areas where lower stiffness is desired (eg, areas along the straps), the yarn count may be lower, which allows the material to bend more easily.

The thread count, and thus the stiffness, may be determined by the type of thread, the type of stitch (eg, cross stitches are more rigid), and the distance between the stitches.

6.3.7.11.1.1.2 The yarn may be used to form the positioning stabilization structure 3300 of the present technology. The yarn may be synthetic, twisted or textured and may be formed from, but not limited to, nylon, polyester, acrylic, rayon, or polypropylene. The yarn may be a conventional short fiber yarn, a microfiber yarn, or a combination thereof. The yarn may incorporate elastane fibers or filaments, such as LYCRA trademarked fibers provided by DuPont, to provide elongation and recovery properties. The yarn may be formed from synthetic materials or natural fibers such as cotton, wool or bamboo, or natural filaments such as silk.

The yarn used to construct any component of the positioning stabilization structure may be formed from a single fiber or a plurality of single length fibers, i.e., a multifiber yarn.

The yarn may contain separate filaments, each of which is made of a different material. The yarn may also include long fibers, each of which is formed of two or more different materials, such as a sheath-core form formed of different materials or a composite yarn with long fibers having two halves. Different degrees of twisting or crimping and different denier can affect the properties of the positioning stabilization structure 3300.

The material used to construct the Positioning Stabilization Structure Component 2900 may be reusable or biodegradable, for example the yarn may be reusable or biodegradable fibers or long fibers. It may be included.

A part of the positioning stabilization structure 3300 that is exposed to heavy wear, such as a part of the positioning stabilization structure 3300 located on the back of the head or on the neck of the head (eg, a part or area that is in contact with the patient's pillow. , But not limited to) may be formed densely in some cases, and thus may be heavier and more difficult to expand. Conversely, this site may be exposed to the maximum amount of water accumulated by sweat and therefore may need to consist of a thin but strong reticulum with a custom opening pattern. In this case, the abrasion resistance may have to be unique only to the yarn properties.

6.3.7.11.1.2 3D Printing In another example, the positioning stabilization structure 3300 may be manufactured to be shaped using a 3D printer. As shown in FIG. 143, a 3D printer may be used to print a plurality of connection links 2802, thereby forming a flexible 3D printing cloth 2804. With reference to FIG. 144, the positioning stabilization structure piece 2900 may be formed to include the rigidizer arm 3302. The rigidizer arm 3302 includes holes 2922, and the links of the fabric 2804 may pass through these holes 2922 when the fabric 2804 is printed to integrate the fabric 2804 and the rigidizer arm 3302. The rigidizer arm 3302 can be formed from any suitable material (eg, a polymer such as nylon 12, a sintered solid from a metal powder, or any other material that can be used as an additive manufacturing process). As additive manufacturing (“3D printing” process) techniques improve, it is expected that the choice of materials for 3D printing fabrics by optionally encapsulating rigid components such as the rigidizer arm 3302 will be widened. The structure can be material specific or based on shape, form, or structure.

Also, as shown in FIG. 145, the 3D printing strap 2924 may be incorporated into the holes 2912 (1), 2914 (1) of the male and female clips 2912, 2914.

6.3.7.11.2 Molding and Finishing of Straps Figures 79 and 80 show a diagram of strap 3301 in the intermediate steps of manufacturing. The typical strap 3301 shown is the raw length of the strap that, in some examples, has not been cut to a predetermined length from the knitting material produced by the methods and processes described above. For example, a pair of buttonholes 3303 can be seen at the leftmost end of the strap 3301, but at the time it is finished there is only a hole at that end. This is because the raw straps are cut between these holes in order to manufacture the straps shown in FIG. Also, the knitting process of forming the raw length strap 3301 shown in FIG. 79 forms a plurality of split regions 3326 along the length of the strap. However, the finished strap 3301 shown in FIG. 81 includes only one split region 3326. Again, as before, this means that during finishing, the strap 3301 is cut between the rightmost buttonholes 3303 shown in FIG. 79, and the raw length strap 3301 shown therein goes into multiple straps. Because it is separated from.

According to one example of the technique, the strap 3301 may be formed using a warp labeling machine with a plurality of bars to form chains on the fabric. According to another example, the strap 3301 may be formed by a Comez machine having six bars for centering the two side straps 3315, 3316 and the two back straps 3317a, 3317b. More bars may be added to the Comez machine to accommodate more knitting directions. The knitting process may also include forming straps 3301 at bifurcation points 3324 using different weaves. The material of strap 3301 may include 1740 count. The order of the pattern types for knitting the strap 3301 may be as follows. That is, usually then the buttonhole, then the normal, then the split, then the normal, then the buttonhole, and then the normal. Then, for each strap 3301 manufactured, the subsequent strap 3301 advances and is knitted again in this same order.

In one example of the present technology, the yarn used to knit the strap 3301 may be wound in a double helix.

To add additional strength to the expected fracture points, the strap 3301 may be formed with additional stitches at these points. Possible break points include buttonholes 3303, 3304 and branch point 3324. Further, additional threads may be knitted along the center of the strap 3301 for further reinforcement.

FIG. 80 shows a cross-sectional view of the side strap portion 3316 of FIG. 79 taken through line 80-80. It can be seen that the branch point 3324 indicates the division region 3326 of the side strap portion 3316 and the division between the upper back strap portion 3317a and the lower back strap portion 3317b.

FIG. 79 also shows _{dimensions L 1 to} L ₆ in various features of strap 3301. L ₁ indicates the distance between the button hole 3303 of one strap 3301 and the button hole 3303 of the adjacent strap. In one example of the technique, L ₁ may be about 515 mm. L ₂ indicates the distance between the buttonholes 3303 of the same strap 3301, which may be about 500 mm, according to one example. L ₃ indicates the length of the split region 3326, which may be about 200 mm in one example of the technique. L ₄ represents may indicate the distance between the buttonholes 3303 adjacent the adjacent strap 3301, in one example may be about 15 mm. L ₅ may indicate the width of the buttonhole 3303 and may be about 5 mm in one example. L ₆ may indicate the width of the strap 3301 and may be about 15 mm in one example.

81 to 83 show a diagram of the finished strap 3301 according to an example of the present technology. As can be seen in FIG. 81, there is only one split region 3326 and one buttonhole 3303 at each end of the strap 3301. Therefore, it should be understood that the strap 3301 has been cut and finished from the strap 3301 shown in FIG. 79 according to an example of the technique. Also shown in FIG. 81 is the strap logo 3357, which may be formed on the strap 3301 in the form of, for example, a company logo or other artwork. The strap logo 3357 may be formed by pad printing or ultrasonic welding. If the strap logo 3357 is formed by ultrasonic welding, it will encourage the patient 1000 to spread the back straps 3317a, 3317b to ensure ideal fit and strap tension. It can help spread 3317b at branch point 3324.

FIG. 81 also shows the welded ends 3311.1 and 3313.1. As described above, the side strap portion 3316 may be woven into a hollow or tubular shape. Thus, the ends are open if not closed, for example by welding to prevent tearing along the open ends. The welded ends 3311.1,3313.1 may be formed by ultrasonic welding to seal the loose fibers of the strap 3301. Ultrasonic welding may reduce the stretchability of the fabrics that make up the strap 3301, but can help reduce fraying at the ends and add strength at high stress points. Since the welded ends 3311.1 and 3313.1 are located near the respective pocket-shaped ends 3311, 3313, the welded ends are held by the straps 3301 with respect to the rigidizer arm 3302 at their respective protruding ends 3306. Gives strength for. Needless to say, the pocket-shaped ends 3311, 3313 and their respective welded ends 3311.1, 3313.1 are for holding and / or fixing to the rigidizer arm 3302, according to one example of the art. It is the main part of the strap 3301. The strap 3301 may lose its elasticity after long-term use, but it should be understood that washing and drying the strap 3301 can restore at least some or all of this elasticity. ..

StretchWise ™ headgear, provided by Fisher & Paykel ™ for Pilario ™ masks, is rigid between the hard plastic hooked end of the headgear strap and the hard plastic vertical bar located on the mask frame. Has a removable rotating connection. On the other hand, the strap 3301 of one example of the present technology does not have a rigid removable connection between the strap 3301 and the mask frame 3310, whereby the hook after repeated engagement and disengagement of the rigid components. Problems such as creep and breakage of the edge are avoided. A considerable amount of force is required to substantially deform the hard hooked end of the StretchWise ™ headgear and engage it with the hard bar. On the other hand, the rigidizer arm 3302 of the present technology is inserted into the buttonhole 3303 of the strap 3301 and held in the pocket-shaped end of the strap 3301 without such considerable force. This is because no plastic deformation of either the rigidizer arm 3302 or the strap 3301 is required to connect the strap 3301 to the mask frame 3310 or to remove the strap 3301 from the mask frame 3310. Another flaw in StretchWise ™ headgear is that after cleaning the headgear straps, the elasticity of the headgear straps does not recover to near the original level of elasticity. In other words, StretchWise ™ headgear loosens over time.

FIG. 82, similar to FIG. 80, shows a cross-sectional view of the strap 3301 taken through line 83-83 of FIG. A branch point 3324 indicating the start of the division region 3326 can be seen. Further, in this figure, it can be seen that the strap logo 3357 is raised from the side strap portion 3316.

FIG. 83 shows a detailed view of the strap 3301, with particular the strap logo 3357. Also, the branch point 3324 can be seen at the beginning of the division region 3326.

FIG. 81 also shows additional dimensions that characterize a typical strap 3301. L ₇ may indicate the distance between the finished ends of the strap 3301 at the welded ends 3311.1, 3313.1 and may be about 5 mm in one example. L ₈ may indicate the width of the welded ends 3311.1, 3313.1, and in one example, it may be about 1 mm.

6.3.7.12 Wearing Patient Interface and Positioning Stabilization Structure A typical patient interface 3000 and positioning stabilization structure 3300 are worn in a simple but adjustable manner according to various examples of the present art. May be done. As described in more detail below, FIGS. 84-112 depict various procedures for the wearer (ie patient) 1000 to wear and adjust the patient interface 3000 and the positioning stabilization structure 3300.

84-88 show a series of perspective views of the patient 1000 wearing the patient interface 3000 and the positioning stabilization structure 3300. In FIG. 84, the patient 1000 begins to wear the patient interface 3000 and the positioning stabilization structure 3300 by holding the patient interface 3000 and placing the seal forming structure 3100 against the nose. FIG. 85 then shows the patient 1000 starting to wear the positioning stabilization structure 3300. Patient 1000 holds the patient interface 3000 with one hand while pulling the strap 3301 near the split region 3326 and extends the strap 3301 over the head. FIG. 86 then shows the patient 1000 pulling the strap 3301 further towards the back of the head while still holding the split region 3326 with one hand and the patient interface 3000 with the other hand. At the completion of this step, in order to hold the patient interface 3000 against the nose of the patient 1000, the strap 3301 is near the crown and so that proper tensile sealing force is distributed to the positioning stabilization structure 3300. It must be located near the occipital lobe or above the occipital lobe and behind the head. FIG. 87 then shows a positioning stabilization structure to position the rigidizer arm (not visible in these figures) below the cheekbones and adjust the fit of the seal forming structure 3100 to the nose to ensure a complete seal. Shows 1000 patients who regulate body 3300. By locating the rigidizer arm 3302 below the cheekbones, the positioning stabilization structure 3300 can be prevented from sliding up over the face of the patient 1000 and into the patient's line of sight. Then, FIG. 88 shows a patient 1000 wearing a patient interface 3000 and a positioning stabilization structure 3300 to prepare for treatment.

89-93 show a series of side views of the patient 1000 wearing the patient interface 3000 and the positioning stabilization structure 3300. FIG. 89 shows a patient 1000 holding the patient interface 3000 with one hand and pulling it up towards the nose while holding the strap 3301 of the positioning stabilization structure 3300 with the other hand. At this point, the strap 3301 does not have to be significantly stretched. FIG. 90 shows the patient interface 3000, in particular the seal forming structure 3100, positioned against the nose with one hand and the strap 3301 of the positioning stabilization structure 3300 pulled over the head with the other hand. Shows 1000 patients to be stretched to. It can be seen that the separation at the split region 3326 works similarly due to the tension of the strap 3301. FIG. 91 shows the patient 1000 pulling the strap 3301 of the positioning stabilization structure 3300 further towards the back of the head while still holding the seal forming structure 3100 and the patient interface 3000 against the nose. At this point, the first step in wearing the patient interface 3000 and the positioning stabilization structure 3300 should be nearly complete so that the strap 3301 is positioned against the back of the patient 1000's head. FIG. 92 then shows the patient 1000 adjusting the seal forming structure 3100 and the patient interface 3000 to the nose to ensure proper sealing and proper positioning of the rigidizer arm 3302 with respect to the cheekbones. FIG. 93 then shows a patient 1000 wearing a patient interface 3000 and a positioning stabilization structure 3300 to prepare for treatment.

94-98 show a series of front views of the patient 1000 wearing the patient interface 3000 and the positioning stabilization structure 3300. FIG. 94 shows the patient 1000 starting to wear the patient interface 3000 and the positioning stabilization structure 3300. Holding the patient interface 3000 in one hand and the strap 3301 of the positioning stabilization structure 3300 in the other hand, the patient 1000 pulls the patient interface and the positioning stabilization structure toward the face. FIG. 95 shows a patient 1000 holding the positioning stabilization structure 3300 in one hand and slightly extending the strap 3301. FIG. 95 also shows a patient interface 3000 held by the other hand in the vicinity of the nose to place the seal forming structure 3100 against the nose. FIG. 96 shows the nose of the seal forming structure 3100 and the patient interface 3000 while extending the strap 3301 of the positioning stabilization structure 3300 and pulling it over the head and positioning the strap 3301 with respect to the back of the head. The patient 1000 which has been put on and held by the patient is shown. FIG. 97 then comfortably seals the rigidizer arm 3302 under the cheekbones so that the positioning stabilization structure 3300 does not slide into the patient's line of sight and the seal forming structure 3100 can maintain a seal to the nose. A patient 1000 that adjusts the positioning stabilization structure 3300 and the patient interface 3000 by positioning in a proper position is shown. Then, FIG. 98 shows a patient 1000 wearing a patient interface 3000 and a positioning stabilization structure 3300 to prepare for treatment.

99-104 show a series of perspective views of the patient 1000 wearing the patient interface 3000 and the positioning stabilization structure 3300. FIG. 99 shows a patient 1000 who begins to wear the patient interface 3000 and the positioning stabilization structure 3300 by extending the strap 3301 while holding the strap 3301 in one hand and the patient interface 3000 in the other hand. .. FIG. 100 then shows the patient 1000 placing the patient interface 3000 and the positioning stabilization structure 3300 on the head by pulling the patient interface 3000 towards the face and pulling the strap 3301 over the back of the head. FIG. 101 then shows a patient 1000 holding the strap 3301 in an extended state near the back of the head while placing the seal forming structure 3100 against the nostrils with one hand. FIG. 102 then shows the patient 1000 positioning the strap 3301 on the back of the head by beginning to release the tensile sealing force of the strap. In FIG. 102, the patient 1000 still holds the patient interface 3000 against the nose to ensure that the proper seal is held when the tensile sealing force is released from the strap 3301. FIG. 103 shows a patient 1000 who adjusts the patient interface 3000 to the nostrils to ensure proper fit and seal and to position the rigidizer arm below the cheekbones. FIG. 104 then shows a patient 1000 wearing a patient interface 3000 and a positioning stabilization structure 3300 to prepare for treatment.

FIGS. 105-5 are perspective views of the patient 1000 adjusting the patient interface 3000 with respect to the nostrils to ensure proper sealing by the seal forming structure 3100. From FIGS. 105 to 107, it can be seen that the patient 1000 gradually tilts the patient interface 3000 further downward with respect to the nose to complete the seal to the nose with the seal forming structure 3100. These figures show the patient 1000 adjusting the patient interface 3000 with one hand, but it should be understood that the patient interface 3000 can be positioned and adjusted with two hands.

FIGS. 108-112 show a series of back views of the patient 1000 adjusting the positioning stabilization structure 3300 with respect to the back of the head. FIG. 108 shows the positioning stabilization structure 3300 in contact with the back surface of the head. The strap 3301 has its maximum tensile sealing force at this position. After that, FIG. 109 shows the patient 1000 holding the upper back strap portion 3317a with one hand and the lower back strap portion 3317b with the other hand and pulling these back strap portions 3317a and 3317b apart in the divided region 3326. show. It should be understood that by pulling these back strap portions 3317a, 3317b apart, the tensile sealing force in the positioning stabilization structure 3300 is reduced from the position shown in FIG. 108. This is because the back strap portions 3317a and 3317b come closer to the patient interface 3000, which is stationary at a fixed position with respect to the nostrils. By bringing the back strap portions 3317a, 3317b closer to the patient interface 3000, the extension length of the strap 3301 is reduced, thereby reducing the tensile sealing force of the strap. FIG. 110 is similar to FIG. 109, but in this figure the patient 1000 has further pulled the upper backstrap portion 3317a and the lower backstrap portion 3317b apart. It should be understood that the tensile sealing force in the positioning stabilization structure 3300 is further reduced due to the spread of the back strap portions 3317a and 3317b. FIG. 111 shows a further view of the patient 1000 with the upper backstrap portion 3317a and the lower backstrap portion 3317b spread apart. The tensile sealing force is reduced again from the position shown in FIG. 110. Also, at this point, patient 1000 has almost completed the adjustment of the positioning stabilization structure 3300 to the desired level of tensile sealing force. The upper back strap portion 3317a may be located near the crown, and the lower back strap portion 3317b may be located near the occipital lobe or below it. FIG. 112 then shows the patient 1000 in which the positioning stabilization structure 3300 has been fully adjusted to the desired level of tensile sealing force. In this case as well, the upper back strap portion 3317a may be located near the crown, and the lower back strap portion 3317b may be located near the occipital lobe or below it. Further, it should be understood that as the upper back strap portion 3317a and the lower back strap portion 3317b are separated from each other, the tensile sealing force in the positioning stabilization structure 3300 decreases, and therefore θ increases accordingly. Although not shown in these figures, in FIG. 108, θ may be about 0 ° and θ is increased by the adjustment sequence. When θ has increased to the maximum value of about 180 ° in FIG. 112, the tensile sealing force in the positioning stabilization structure 3300 may be about 40% of the tensile sealing force in FIG. 108. In another example of the present technology, for example, when the rigidizer arm 3302 extends to the branch point 3324 and is divided into both an upper arm and a lower arm slightly extending into the back strap portions 3317a and 3317b, the upper side is used. The angle θ may be maintained at a predetermined value at the first point of branching between the back strap portion 3317a and the lower back strap portion 3317b. This can urge the patient 1000 to separate the back strap portions 3317a and 3317b to adjust the headgear tension. It also reinforces the bifurcation point 3324 at the Y-shaped portion where the side strap portions 3315, 3316 merge with the back strap portions 3317a, 3317b, for example using external seam tape or plastic clips. Such a plastic clip can provide an opportunity for branding by pad-printing brand information and logo information on the clip.

In one embodiment of the technique, the positioning stabilization structure 3300 has two connection points with the frame 3310, so there are two rigidizer arms 3302 and a single hollow strap 3301 with a split region 3326. .. One problem with this type of patient interface 3000 is that the split region 3326 slides up or down depending on which back straps 3317a, 3317b pull more. To address this issue, the split region 3326 in contact with the back of the patient's head has a uniform distribution in bidirectional (vertical) tension. Therefore, the problem of sliding up or down is alleviated.

The positioning stabilization structure 3300 may include at least one strap 3301 (see, eg, FIG. 166) and at least one rigid element or rigidizer arm 3302 (see, eg, FIG. 19). The strap may be made of an elastic material or may have elastic properties. In other words, the strap 3301 may be elastically stretched, for example, by an extension force, and upon release of the extension force, the strap 3301 returns to its original length or contracts. The strap 3301 may be formed from any elastomeric material such as elastane, TPE, silicone, or may comprise such an elastomeric material. Further, the strap material may correspond to a combination of any of the above materials with another material. The strap 3301 may be a single-layer strap or a multi-layer strap. The side of the strap 3301, especially the side that comes into contact with the patient during use, may be woven, knitted, braided, molded, extruded or shaped. This may be achieved if the strap 3301 is formed from or comprises a layer of material exhibiting its respective properties. The strap 3301 may include or is formed from a fabric material such as a woven material. Such materials, on the one hand, may include artificial or natural fibers to provide desirable and beneficial surface properties such as tactile properties. On the other hand, the strap material may include an elastomeric material to provide the desired elastomeric properties.

In FIGS. 65-145, the strap 3301 is shown as one individual strap for attachment to the seal forming structure 3100 either directly or via the frame 3310. However, it can be seen that the straps 3301 may include a plurality of individual straps that are connected or may be connected to each other. However, adjustments may be made by changing where the straps are secured to the patient interface or other rigid elements such as connectors. In addition to or in lieu of this, the adjustment is made by adding a mechanism (eg, as shown in FIGS. 75, 76, and 166) to the back strap or side strap, such as a slide over the rudder lock clip, or otherwise. If not, it can be made possible by adjusting the elastic lengths of the strap 3301 and the positioning stabilization structure 3300, respectively.

6.3.7.13 Rigidizer arm 3302
As can be seen in FIGS. 19 and 166, an example of the present technology may include reinforcing headgear to hold the patient interface 3000 against the patient 1000. As shown in the drawings depicting this example, the positioning stabilization structure 3300 may include at least one rigidizer arm 3302.

In this example of the technique, the seal forming structure 3100 of the patient interface 3000 is held in a desired position on the underside of the nose of the patient 1000 by the support of the rigidizer arm 3302. The positioning stabilization structure 3300 may position the patient interface 3000 so that the patient interface does not come into contact with the patient 1000 except for the seal forming structure 3100.

In certain prior art examples, the patient interface may be adapted to at least partially contact the patient's upper lip, thereby as described in US Pat. No. 7,900,635. The anterior surface of the patient's upper lip provides an index of support for holding the patient interface in the desired position. However, in this example, it is desirable that the patient interface 3000 does not abut on the upper lip of the patient 1000, as can be seen in FIGS. 18 and 19. In particular, FIG. 19 shows that the posterior wall 3220 of the plenum chamber 3200 is shown separated from the nasal septum and / or upper lip of patient 1000 by a gap or spacing S. This arrangement has the advantage of preventing the patient 1000's nasal septum and / or upper lip from being inflamed or damaged by contact and friction with the posterior wall 3220 of the Plenum Chamber 3200 during long-term wear. Avoiding the concentration of pressure on the nasal septum and / or specific areas of the upper lip can prevent the cause of skin damage and pain.

The placement of this particular example, in which the patient's nasal septum and / or upper lip is separated from the posterior wall 3220 of the plenum chamber 3200, is achieved by the rigidizer arm 3302, as can be seen in FIGS. 19 and 166. As shown in FIG. 19, the rigidizer arm 3302 of the positioning stabilization structure 3300 may be supported against the cheek of patient 1000 approximately above the nasolabial fold (see FIG. 2c). The rigidizer arm 3302 of the positioning stabilization structure 3300 may be formed with a predetermined curvature in the curvature profile 3323 in order to bring the patient's cheekbone closer to the curvature of the patient's corresponding cheek region. The rigidizer arm 3302 may extend across a significant portion of the buccal region from the connection with the frame 3310 to the free end 3302.1 at the distal end of the rigidizer arm 3302. The distance from the connection point with the frame 3310 to the free end 3302.1 at the distal end of the rigidizer arm 3302 is about 120 mm. The rigidizer arm 3302 may extend substantially parallel to the nasal wing so as to be away from the patient's face, at a predetermined angle, for example at a substantially right angle. In other words, the inner surface of the main portion 3333 of the rigidizer arm 3302, in particular the inner surface of the curved profile 3323, is in contact with and extends across a significant portion of the patient's buccal region. This contact provides semi-fixed positioning and locking of the patient interface 3000 to the patient's face. This contact minimizes any translation of the Rigidizer Arm 3302 with respect to the patient's face. Also, the region of the curvature profile 3323, at least near the sharp bend 3307, is designed to maintain contact with the patient's cheekbones or cheeks. When patient 1000 lies with one side of his face against the bed pillow, the force exerted on the rigidizer arm 3302 and / or part of the extension 3350 or flexible joint 3305 on the bed pillow , Minimized, or prevented from being transmitted to other rigidizer arms. This is because the sharp bends 3307 and extension 3350s of the rigidizer arm 3302 absorb most of such force before it affects the seal with the patient's airways. In other words, the region of the curvature profile 3323 is in contact with the patient's cheek and there is some absorption of this force by the extension 3350 or the flexible joint 3305, which acts laterally on the positioning stabilization structure 3300. The force is at least partially cut off.

Also, the rigidizer arm 3302 may support the separation of the patient interface 3000, thereby holding the patient interface 3000 in a position that does not cause unwanted contact of the patient interface 3000 with respect to the nasal septum and / or upper lip. The tension of the patient interface 3000 can position the patient interface 3000 in the desired position on the underside of the patient's nose. Further, the rigidizer arm 3302 may be sized so that the posterior wall 3220 is separated from the patient's nasal septum and / or upper lip by a distance S. Also, the tension of the positioning stabilization structure 3300 is transmitted primarily to the patient's cheeks throughout the width and width of the rigidizer arm 3302, without opposition inward towards the patient 1000's face to press against the nose. .. This typical arrangement is beneficial. This is compared to using the patient's nose and / or upper lip, which can be more sensitive due to its cartilage by using the cheek tissue, which is a relatively large facial area to dissipate retention. This is because it can provide greater comfort to the patient. Also, this typical arrangement allows the seal forming structure 3100 to be held on the underside of the patient's nose with sufficient force to form a seal against the patient's airways. Prevents retention from increasing to levels that cause discomfort in Patient 1000.

It may be desirable to avoid contact between the rigidizer arm 3302 and the plenum chamber 3200. Therefore, the plenum chamber 3200 may be formed wide enough to avoid contact with the rigidizer arm 3302.

6.3.7.14 Extension of the headgear strap with respect to the rigidizer arm In the example shown in FIG. 166, two rigidizer arms 3302 are inserted into the left and right side strap portions 3315 and 3316 of the strap 3301 of the positioning stabilization structure 3300, and the rigidizer arms are inserted. The sleeve-like form of the strap 3301 allows at least a portion of the strap to extend or move relative to the rigidizer, while the 3302 is held in place by the surrounding strap 3301. The rigidizer arm 3302 is not visible in this figure as it is housed within the strap 3301.

The attachment of the strap 3301 to the rigidizer arm 3302 described in the previous section may also affect the size of the head that the positioning stabilization structure 3300 can accept. In other words, by providing a larger length strap 3301 along the rigidizer arm 3302, it may be possible to increase the overall extendable length of the positioning stabilization structure 3300, whereby the stretchability of the strap. It may be possible to accept a larger head without the need to increase. Further, the location to which the strap 3301 is connected may be changed along the length of the rigidizer arm 3302. This allows an even larger range of head sizes to be accepted without it.

Therefore, the rigidizer arm 3302 may be allowed to move along the length of the sleeve with almost no limitation, may be attached to the sleeve 3301, or may be adjacent to one of the ends of the sleeve. good.

6.3.7.15 Divided back straps of the positioning stabilization structure According to one aspect, the structures of the strap 3301 and the positioning stabilization structure 3300 are beneficial. In particular, as shown in FIG. 166, when two elastic straps or strap portions 3317a, 3317b are provided on the back, the tension vector surrounds the head by appropriately positioning these straps, for example by expanding them. Can be adjusted. Also, the provision of the two back strap portions 3317a, 3317b can provide better support and stability, avoiding particularly sensitive areas on the back of the head, and increase flexibility.

The two small straps or straps 3317a, 3317b on the back of the head may be of equal length and may be of equal length, except due to the elasticity of the material or the overall length of the positioning stabilization structure at the arm. It is not adjustable except by increasing the tightening of both straps equally by shortening. For example, a slide mechanism (not shown) that allows the straps to be stacked to different degrees and thereby changes the overall length of the positioning stabilization structure 3300 may be provided.

As described above, instead of making the strap 3301 one continuous component, two or more joints are provided to form the positioning stabilization structure 3300 from three, four, or more separate straps. Can be done. This can complicate assembly, but can simplify the manufacturing process. The joint may be located at the branch or Y joint between the side straps 3315, 3316 and the two back straps 3317a, 3317b, or may be concentrated on the back. The joints may be sewn, welded, glued or overmolded and may incorporate high friction materials to help reduce movement on the head.

In one example of the technique, one or more threads of the strap 3301 may consist of an adhesive or glue. After the strap 3301 is manufactured using this thread, heat is applied to the strap 3301 to reinforce the strap 3301 in or near the area of the adhesive or glue thread, thereby causing the adhesive or glue thread to reinforce the strap 3301. Be melted.

High friction material may be added to the inner surfaces of the back straps and side straps 3315, 3316, 3317a, 3317b to reduce strap slippage. With respect to the arm or side strap portions 3315, 3316, this helps the positioning stabilization structure 3300 to stay on the cheeks, and at the back strap portion 3317, thereby the positioning stabilization structure 3300 is on the head. You can prevent it from sliding across the back. Such materials may be printed, poured or molded on the surface or incorporated into the process of jointing, sewing or welding as described above.

The split area 3326 on the back of the patient's head may include two, three, or more straps 3317a, 3317b for stability. The positioning stabilization structure 3300 as described above may be used with a full face mask (one or more seals for the nose and mouth) or a nasal mask.

It is assumed that the maximum allowable distance between the back strap portions 3317a and 3317b can be limited or restricted in order to prevent the back strap portions 3317a and 3317b from being separated completely or being separated beyond a predetermined distance. Can be. A coupling strap across the split region 3326 or a net across the split region 3326 may be connected to the back straps 3317a, 3317b to limit the ability of the back straps to split apart beyond a predetermined distance.

6.3.7.16 Connection between mask frame and rigidizer arm According to an example of the art which should be described in more detail below with reference to FIGS. 35-5, the patient interface 3000 is with the mask frame 3310. It may include a rigidizer arm 3302 and the like. As will be apparent from the following description, the rigidizer arm 3302 effectively seals the seal forming structure 3100 to the patient's airway while orienting the strap 3301 of the positioning stabilization structure 3300 away from the patient's eyes and line of sight. The tension vector produced by one or more straps 3301 of the positioning stabilization structure 3300 may function to direct in a desired direction in order to ensure that. Therefore, it should also be understood that the rigidizer arm 3302 and the mask frame 3310 must be formed and connected to facilitate the effective direction of sealing force. It may be beneficial to allow the rigidizer arm 3302 to flex with respect to the mask frame 3310 to accommodate the various shapes and sizes of the patient's face and head. The direction and degree of flexion between the rigidizer arm 3302 and the mask frame 3310 may be specifically controlled to enhance patient comfort. The flexible joint 3305 may achieve this, or the rigidizer arm 3302 may be directly connected to the mask frame 3310.

6.3.7.16.1 Flexible Joint for Connecting Rigidizer Arm and Mask Frame With reference to FIGS. 35-38, the patient interface 3000 is generally flexible with the mask frame 3310 and the rigidizer arm 3302. It is provided with a sex joint 3305. The holding structure 3242 may be detachably attached to and detached from the mask frame 3310. The holding structure 3242 may hold the seal forming structure 3100 on the mask frame 3310. The rigidizer arm 3302 may be formed from a thermosetting material or a thermoplastic material. For example, Hytrel® 5556 manufactured by DuPont ™ is a thermoplastic polymeric elastomer that has excellent creep resistance and may be used as a material for the Rigidizer Arm 3302. The rigidizer arm 3302 may be part of a positioning stabilization structure 3300 for positioning and holding the mask frame 3310 in place on the patient's face for respiratory therapy. In one example, the positioning stabilization structure 3300 has two rigidizer arms 3302 at its distal end. Each rigidizer arm 3302 may be non-removably connected to both sides of the mask frame 3310.

The elastic woven strap 3301 forms a positioning stabilization structure 3300 as disclosed in US Provisional Application No. 61 / 676,456, filed July 27, 2012, which is incorporated herein by reference in its entirety. It may be slid over each rigidizer arm 3302 to do so. The elastic woven strap 3301 may extend around the patient 1000's head or may be branched for automatic adjustment. The rigidizer arm 3302 may also include a protruding end 3306 that holds the pocket-like end of the elastic woven strap 3301. In one example, the rigidizer arm 3302 is inserted into a buttonhole near the pocket-shaped end and into a hollow elastic woven strap 3301. When the elastic woven strap 3301 is extended when the patient interface 3000 is worn, the headgear tension vector and the direction of extension of the elastic woven strap 3301 are guided by the shape and shape of the rigidizer arm 3302. The protruding end 3306 is a fixed anchor at the base of the rigidizer arm 3302 near the mask frame 3310 and provides a starting point for extension of the elastic woven strap 3301. The protruding end 3306 allows the elastic fabric strap 3301 to be connected to and detached from the rigidizer arm 3302 to facilitate cleaning of the elastic fabric strap 3301 separately from the mask frame 3310 and the rigidizer arm 3302. The rigidizer arm 3302 also surrounds the face with a frame by keeping the elastic fabric strap 3301 away from the eyes and above the ears, whereby the patient feels unobtrusive to the patient interface 3000. The rigidizer arm 3302 may generally be a flat arm of a predetermined thickness. The thickness of the rigidizer arm 3302 may vary along its length, may be approximately 1 mm at the free end 3302.1 at the distal end, and near the connection point with the flexible joint 3305. Gradually increases in thickness to 1.5 mm along the curvature profile 3323 to the distal end of the Rigidizer Arm 3302. The free end 3302.1 at the distal end has less material than the other region of the rigidizer arm 3302, so the free end 3302.1 at the distal end first before the other region of the rigidizer arm 3302 begins to bend. Or in the vicinity there is a tendency for arbitrary bending of the rigidizer arm 3302 to occur. The order of flexion is designed to enhance comfort. This is because the free end 3302.1 at the distal end can be a particularly sensitive area of the face, close to the patient's ears, cheekbones, and temples, and may require adaptation and low resistance to bending and deformation. Is. The sharp bend 3307 may be provided at the distal end of the rigidizer arm 3302 near the connection point with the flexible joint 3305. The sharp bend 3307 may have an angle of approximately 90 ° or less. Further, the sharply bent portion 3307 may bring about an increase in rigidity in order to fix the rigidizer arm 3302 in a predetermined position with respect to the mask frame 3310. The sharp bend 3307 may prevent or minimize longitudinal extension. The sharp bend 3307 may also accept compression of the rigidizer arm 3302. If a force is applied to the side surface of the rigidizer arm 3302 within the coronal plane, most of the flexion can occur at or near the sharp bend 3307.

The flexible joint 3305 may be provided between the rigidizer arm 3302 and the mask frame 3310. The flexible joint 3305 may be made of a thermoplastic elastomer (TPE) that provides high elastic properties. For example, Dynaflex® TPE compounds or Medilist® MD115 may be used. The mask frame 3310 may be made of polypropylene (PP) material. PP is a thermoplastic polymer having good fatigue resistance. The advantage of the flexible joint 3305 may be that it allows the rigidizer arm 3302 and the mask frame 3310 to be non-removably connected to each other. Hytrel® and PP cannot be integrally bonded to each other by forming covalent or hydrogen bonds. One-piece bonds include chemical bonds, but without the use of additional adhesives. In one example, the rigidizer arm 3302 is provided with a protruding portion 3309 extending outward from the distal end of the rigidizer arm 3302. Referring to FIG. 38, the inner surface 3318 of the protrusion 3309 is the surface of the rigidizer arm 3302, from which the protrusion 3309 extends. The outer exposed surface 3319 of the protrusion 3309 is opposite to the inner surface 3318 (see FIG. 38). The protrusion 3309 may have a gap 3320 in the central region of the protrusion 3309. The gap 3320 may extend substantially vertically from the upper surface 3321 through the protrusion 3309 to the lower surface 3322 of the protrusion 3309, or may be surrounded by the protrusion 3309 over its outer circumference. The outer surface 3319 may be a substantially flat surface extending beyond the protrusion 3309. When viewed from above, the protrusion 3309 may have a substantially T-shaped cross section in which the void 3320 is visible in the central region. The protrusion 3309 may serve in place of or in addition to the protrusion 3306 to hold the elastic woven strap.

Another advantage of the flexible joint 3305 may be that it is relatively more flexible than the rigidizer arm 3302. This flexibility may be imparted by a combination of TPE material and the structural features of the flexible joint 3305. Structurally, the flexible joint 3305 may have a predetermined thickness to allow a predetermined degree of flexion, and the magnitude of curvature of the flexible joint 3305 may be a degree of flexion. May be selected to contribute to. The flexible joint 3305 may be able to bend radially with respect to the mask frame 3310 about its longitudinal axis, but may be resistant to bending in other directions. This flexibility may provide the patient interface 3000 with auto-adjustment capabilities and may compensate for facial contours, nasal tilt, or deviations from sleeping postures. This flexion may accept the anthropometric range of most patients. At this position, greater flexibility may be required compared to the flexibility within the rigidizer arm 3302 itself. Further, since the bending is restricted in a specific direction, the stability of the mask frame 3310 can be improved, and the position of the mask frame 3310 can be adjusted when the elastic woven fabric of the positioning stabilization structure 3300 needs to be adjusted. Can be almost maintained against the nose and mouth.

The flexible joint 3305 may be overmolded into the mask frame 3310. PP and TPE can be integrally bonded to each other. In other words, a fusion bond or a chemical bond (molecular attachment) between the flexible joint 3305 and the mask frame 3310 can be assumed. This may form a non-removable connection between the flexible joint 3305 and the mask frame 3310. The flexible joint 3305 may be overmolded into the protrusion 3309 of the rigidizer arm 3302. TPE and Hytrel® cannot be combined integrally with each other. However, during the overmolding according to an example of the present technology, the TPE material for the flexible joint 3305 flows into the gap 3320 of the protrusion 3309 and flows around the protrusion 3309. The TPE material surrounds the front and rear surfaces and the upper and lower surfaces 3321, 3322 of the protrusion 3309. As a result, a mechanical connection can be provided to form a non-removable connection between the flexible joint 3305 and the rigidizer arm 3302. The outer surface 3319 of the protrusion 3309 may be coplanar with the outer surface of the flexible joint 3305. This is visually beautiful.

With reference to FIGS. 42-46, in another example, there may be an extension 3350 at the distal end of the rigidizer arm 3302. The extending portion 3350 may protrude from the outer surface of the rigidizer arm 3302 via the stem 3361. The extending portion 3350 may have an L shape when viewed from above. The extending portion 3350 may have a sharp bent portion 3307 of about 90 ° that separates the first portion 3363 of the extending portion 3350 from the second portion 3364. The first portion 3363 may be oriented at the distal end in a plane parallel to the outer surface of the rigidizer arm 3302. The end 3363A of the first portion 3363 may have curved corners. The second portion 3364 may have a lower height and thickness than the first portion 3363. Therefore, the upper and lower edges of the second portion 3364 may be retracted from the upper and lower edges of the first portion 3363. The rigidizer arm 3302 may also include a protruding end 3306 that holds the pocket-shaped end 3311 of the elastic woven strap 3301. The stem 3361 may serve to hold the elastic woven strap in place of or in addition to the protruding end 3306.

The second portion 3364 may have a first overhang 3365 and a second overhang 3366. The protrusions 3365 and 3366 may extend laterally from the rigidizer arm 3302 in the outward direction. There is a first slot 3637 adjacent to the first protrusion 3365 and a second slot 3368 adjacent to the second protrusion 3366. Slots 3667 and 3368 may each form a gap penetrating the thickness of the second portion 3364, and may have approximately the same height as the protrusions 3365 and 3366, respectively.

The flexible joint 3305 formed from TPE may be overmolded into a second portion 3364 of the extending portion 3350 of the rigidizer arm 3302. During overmolding, TPE material may flow through slots 3667,3368 and surround the protrusions 3365,3366. Most of the second portion 3364 may be surrounded by the TPE material of the flexible joint 3305. This may provide a mechanical connection that allows the flexible joint 3305 to be non-removably connected to the rigidizer arm 3302. Since the second portion 3364 may have a lower height and thickness than the first portion 3363, the TPE material overmolded into the second portion 3364 exceeds the first portion 3363 excessively. It does not have to protrude. Further, the flexible joint 3305 may be overmolded on the mask frame 3310 in order to connect the flexible joint 3305 and the rigidizer arm 3302 to the mask frame 3310.

Similar to the examples described above, the flexible joint 3305 may provide greater flexibility with respect to the rigidizer arm 3302. Control of flexion and flexion direction at this position can accommodate the anthropometric range of most patients and also maintains the stability of the patient interface 3000 during use.

6.3.7.16.2 Direct connection between the rigidizer arm and the mask frame With reference to FIGS. 39-41, in other examples the flexible joint 3305 formed from TPE is not required. You may. The extending portion 3350 may be used. The rigidizer arm 3302 may have a body or main portion 3333 having a curved profile 3323 and a sharp bend 3307. The rigidizer arm 3302 may include a protruding end 3306 that holds the pocket-like end of the elastic woven strap. The curvature profile 3323 may be formed along most of its longitudinal axis to correspond to an obtuse angle to closely follow the contour of the patient's face. The distal end of the rigidizer arm 3302 may be provided with an extension 3350 after the sharp bend 3307. The extending portion 3350 may project outward from the rigidizer arm 3302 in the coronal plane. A recess 3329 (see FIGS. 40, 50, 57, 58) may be formed on the surface of the rigidizer arm 3302 at a point where the extending portion 3350 protrudes from the rigidizer arm 3302. The height of the extending portion 3350 may be lower than the height of the main portion 3333 of the rigidizer arm 3302. This may allow greater flexibility in the extension 3350 compared to the main portion 3333 of the rigizer arm 3302 due to the relative reduction of material for the extension 3350 relative to the rigging arm 3302. The rigidizer arm 3302, including the extension 3350, may be formed from Hytrel®. Hytrel® provides the rigidizer arm 3302 with a flexural modulus of 180 MPa and a tensile coefficient of 180 MPa (26) at 23 ° C. The encapsulationable portion 3354 of the extending portion 3350 may be overmolded with the PP material of the mask frame 3310 at the edge of the mask frame 3310. This is done in the mold during overmolding and the PP material of the mask frame 3310 is mechanically connected to connect the rigidizer arm 3302 to the mask frame 3310 in a non-removable manner, so that the inner, outer and upper surfaces of the encapsulating portion 3354 , And the lower surface may be surrounded. Encapsulation of the encapsulationable portion 3354 of the extension 3350 with the PP material of the mask frame 3310 provides mechanical retention without the integral coupling between the rigidizer arm 3302 and the mask frame 3310.

The connection between the rigidizer arm 3302 and the mask frame 3310 is a hinge connection at or near the bend 3352. In other words, the rigidizer arm 3302 can rotate with respect to the mask frame 3310. The position of the rotation point should be aligned with the nasal pillow and the nostrils of the patient 1000 as much as possible to accommodate various nasal droops and to minimize the moment arm and tube resistance caused by the air circuit 4170. It's ahead. The flexion and rotation of the rigidizer arm 3302 relative to the mask frame 3310 in the coronal plane is preferably to minimize or eliminate tightening of the patient's cheeks between the two rigidizer arms 3302 without excessive force. This is to accept various head widths with less than one or two Newtons of force required. The distance between the two bends 3352 is about 62 mm. This spacing between the two bends 3352 prevents the protruding end 3306 and extension 3350 or flexible joint 3305 of the rigidizer arm 3302 from contacting the patient's nose near the crown and sides of the patient's nose. do. Since these areas of the patient's face are particularly sensitive, avoiding contact in these areas can improve comfort.

When the patient interface 3000 is worn, the rigidizer arm 3302 may be extended outward to accommodate various head widths. Rotation of the rigidizer arm 3302 with respect to the mask frame 3310 occurs similar to bending of the rigidizer arm 3302 along its longitudinal axis.

6.3.7.16.3 Further Features and Examples of the Technique In other examples, the rigidizer arm 3302 may be relatively more elastically flexible than the mask frame 3310. The rigidizer arm 3302 may be formed to be flexible only in the horizontal direction, i.e., in the Frankfort horizontal plane and in a plane parallel to the cross section. Also, the rigidizer arm 3302 may not be flexible in the vertical direction, i.e., in a plane perpendicular to the Frankfort horizontal plane. In other words, the rigidizer arm 3302 is more flexible in the Frankfort horizontal plane and in a plane parallel to the cross section, and has little flexibility in any other plane (preferably inflexible). Further, the material of the rigidizer arm 3302 does not have to be stretchable or expandable. When the rigidizer arm 3302 is extended at its end, the curved profile of the rigidizer arm 3302 becomes flat. These features, alone or in combination with shape and dimensions, allow the rigidizer arm 3302 to slide up or up across the patient's ear or without sliding down or down against the patient's ear. It may be possible to bend and / or surround the face of patient 1000 with a frame. This also allows the elastic woven strap 3301 to move back and forth above the patient's ear near the base of the upper ear.

In the examples shown in FIGS. 35 to 38, a seal such as a company logo may be provided on the outer surface 3319 of the protrusion 3309 to hide the position of the mechanical connection. In the example shown in FIGS. 39 to 41, the seal may be provided on the outer surface 3355 of the extending portion 3350. The seal may visually assist the patient in determining the correct orientation of the patient interface 3000 to prevent the patient interface from being worn upside down when wearing the patient interface 3000. If the seal is also a raised / embossed surface, this can provide tactile feedback to the patient 1000, especially if the patient is wearing the patient interface 3000 in a dark environment.

In a further example, an adhesion promoter is used to connect the rigidizer arm 3302 to the mask frame 3310 in a non-removable manner or to connect the rigidizer arm to the flexible joint 3305 in a non-removable manner after surface treatment. You may. In this example, no mechanical connection is required.

In another example, the rigidizer arm 3302 is made of a material that can be integrally coupled with a mask frame 3310 made of PP material. The rigidizer arm 3302 may be formed from a fiber reinforced composite PP material, for example Curv® manufactured by Propex Inc. Curv® has the same level of elastic flexibility as Hytrel®. Curv® is provided in the form of a sheet and requires laser cutting into the desired shape of the rigidizer arm 3302. In order to obtain the desired thickness for the rigidizer arm 3302, the sheet may be compressed or stratified to adjust the thickness of the rigidizer arm 3302 in a particular region. Since Curv® is formed from the same material as the mask frame 3310, it can be integrally coupled when the rigidizer arm 3302 is overmolded into the mask frame 3310.

Patient Interface 3000 may include, for example, the nasal cradle disclosed in US Provisional Application No. 61 / 823,192 filed May 14, 2013, which is incorporated herein by reference in its entirety. The nasal pillow may be releasably engaged with the mask frame 3310. After the rigidizer arm 3302 is non-removably connected to the mask frame 3310, the elastic woven strap of the positioning stabilization structure 3300 may be slid over the rigidizer arm 3302 and secured to the rigidizer arm 3302.

Although the T-shaped protrusion 3309 has been described, it includes a mushroom-shaped protrusion to mechanically and non-removably connect the rigidizer arm 3302 to the mask frame 3310 (via a flexible joint in one example). It is envisioned that other shapes and forms are possible. Although the gap 3320 has been described, the protrusion 3309 may not have a gap, but rather may have a recess or a slot, in order to hold the flexible joint 3305 or the mask frame 3310 on the rigidizer arm 3302. Is assumed.

It is assumed that the connection arrangement described can be reversed to provide a protrusion extending from the mask frame 3310 or the flexible joint 3305 instead of the rigidizer arm 3302. In such an example, the rigidizer arm 3302 is overmolded into a flexible joint 3305 or mask frame 3310.

It is envisioned that the flexible joint 3305 can be non-removably connected to the mask frame 3310 without integral coupling. For example, a mechanical connection may be provided to connect the flexible joint 3305 to the mask frame 3310 in a non-removable manner.

Although the rigidizer arm 3302, the flexible joint 3305, and the mask frame 3310 have been described as non-removably connected to each other, some or all of them may be connected using, for example, a mechanical clip (snap mating) assembly. It is assumed that they may be removable from each other.

6.3.7.77 Shape of Rigidizer Arm FIGS. 61-64 show the Rigidizer Arm 3302 according to an example of the present technology plotted in two and three dimensions. FIGS. 61 to 63 show three two-dimensional views of the rigidizer arm 3302 according to an example of the present technology plotted on the squares. FIG. 61 shows the XY plane, FIG. 62 shows the XY plane, and FIG. 63 shows the YY plane. These figures also show the origin for directional purposes. Numbered coordinates are also indicated for each of these, which may define the curvature of the rigidizer arm 3302 within these planes.

The table below lists the coordinates of the outer shape of the rigidizer arm 3302 shown in these figures. It should be understood that each coordinate is consistently numbered across each of the four figures.

FIG. 64 shows a further view of the rigidizer arm 3302 drawn in FIGS. 61-63 in three dimensions. The X, Y, Z axes are shown as well as the origin to help with the direction.

The curved shape of the rigidizer arm 3302 closely follows the patient's cheek. With the elastic fabric strap 1200 covering the rigidizer arm 3302, the relative position of the rigidizer arm 3302 in contact with the patient's cheek during use prevents the rigidizer arm from slipping over the patient's face. For example, the Rigidizer Arm 3302 may be located slightly below the patient's cheekbones, thereby preventing the Rigidizer Arm 3302 from sliding upwards. Also, contact between most or all of the inner surface of the rigidizer arm 3302 and the patient's face increases friction in order to prevent slippage and ultimately minimize disruption to the sealing force. You may let me. The shape of the curved profile 3323 of the rigidizer arm 3302 orients the positioning stabilization structure 3300 between the eyes and ears over most of the anthropometric range. This direction is beneficial in terms of the patient 1000 and the patient's bed partner 1100 because it is aesthetic and unobtrusive. When viewed from above, the curved profile 3323 of the rigidizer arm 3302 has a larger radius than the rigidizer arm 3302 when viewed from the side.

6.3.7.18 Flexibility of Rigidizer Arm As described above with reference to FIGS. 52 and 55, the Rigidizer Arm 3302 has greater flexibility in a particular direction at a particular position along the Rigidizer Arm 3302. .. The flexural rigidity of the rigidizer arm 3302 is compared. For comparative purposes, the flexibility of the rigidizer arm 3302 is measured laterally laterally within the coronal plane and vertically downwards within the sagittal plane, as opposed to the cured headgear of some conventional masks by Resmed Limited. Will be done.

This comparison shows the difference in force (Newton) required to move the upper distal end of the cured headgear component by a distance of 5 mm when connected to the mask frame. The upper distal end of the cured headgear component is selected as the measurement position because this position makes contact with the sensitive facial area, and certain types of flexibility provide comfort without compromising seal stability. Because it gives a sword. Measuring the direction of flexibility (lateral lateral) in the lateral lateral direction within the coronal plane attempts to measure the ability of the rigidizer arm 3302 to accommodate patients with large facial widths, as shown by the dashed line in FIG. There is. The elastic flexibility of the rigidizer arm 3302 allows the patient interface 3000 to better fit a wider range of facial shapes. For example, the same patient interface 3000 as a patient with a wider flat face (so-called panda shape) can be used in a patient with a thin, skinny face (so-called crocodile shape). Measuring the direction of flexibility in the sagittal plane in the vertical downward direction (vertical downward) can handle the tube torque exerted by the air circuit 4170 during treatment as shown by the dashed line in FIG. 55. I am trying to measure the capacity of 3302. Both measurements are obtained using an Instron machine with a 50N load cell.

To measure vertically downwards, each mask is secured to a plate, located flush with the plate, and has a cured headgear component, usually at an angle above the patient's face. This plate is fastened to a large circular base plate used for Instron machines. The cured headgear component is held in the jig to prevent twisting and slipping, and the jig is manually lowered so that it contacts the upper distal end of the cured headgear component. The Instron aircraft is set to zero at this height position. Next, a compression stretch of 5 mm is applied at a rate of 50 mm / min and the measurements are recorded.

A spacer and a 90 ° elbow are secured to the first plate to measure the lateral lateral direction. Each mask is secured to a second plate, located at the same height as the plate, and has a cured headgear component, usually at an angle on the patient's face. A spring clamp is used to secure the second plate to the 90 ° elbow on the first plate so that the first plate is held perpendicular to the second plate. A large protrusion is used to position it at the upper distal end of the cured headgear component. The Instron aircraft is set to zero at this height position. Next, a compression stretch of 5 mm is applied at a rate of 50 mm / min and the measurements are recorded.

Measurements indicate that the rigidizer arm 3302 connected to the frame 3310 has greater flexibility in both directions by a significant multiple. To accommodate the larger face width, the rigidizer arm 3302 has 1.8 times greater flexibility than the second most flexible mask in this direction (ResMed Mirage Swift LT). The rigidizer arm 3302, which is connected to the frame 3310 to receive tube torque, has 8.39 times more flexibility than the mask (ResMed Pixi), which is the second most flexible in this direction. By having greater flexibility, the rigidizer arm 3302 provides greater comfort to patient 1000 when moved in these directions and is therefore unlikely to have seal breakage caused by tube torque. Improve patient compliance with respect to frequency of use and duration of treatment.

The relative flexibility of the rigidizer arm 3302 in different directions is also an important consideration. If the vertical downward flexibility is very high (ie, equal to the lateral lateral direction), the seal may become unstable. In one example, the rigidizer arm 3302 is more flexible in the laterally lateral direction than in the vertical downward direction. The rigidizer arm 3302 is 9 to 10 times more flexible in the lateral lateral direction than in the vertical downward direction. Preferably, the rigidizer arm 3302 is about 9.23 times more flexible in the laterally lateral direction than in the vertical downward direction. The tube torque may also be treated in conjunction with other mask components with a short tube 4180 (eg, this will make the tube even lighter, fit more closely to the body line, or , Further increasing flexibility), or may be treated in conjunction with the use of swivel connectors, ball socket joints, or gussets, or pleated parts. However, various face widths are mainly handled by the flexibility of the Rigidizer Arm 3302, so the Rigidizer Arm 3302 needs to have greater flexibility in the lateral and lateral directions than in the vertical downward direction.

Some hardened headgear components of conventional masks are harder than the frame. Generally, these stiff headgear components use threaded arms and bolts to manually adjust the headgear and fit it onto the patient's head. The flexible frame improves the comfort of the mask, provides a good seal, minimizes accidental leaks, and minimizes the risk of headgear straps overtightening for low pressure levels for treatment, Some difficulty arises if the flexible frame needs to be releasably removable from the seal forming structure. Seal-forming structures are elastically flexible so that they form a seal against the patient's airways. If both the seal-forming structure and the frame have similar flexibility (ie, very flexible or soft), patients 1000, especially those with arthritis in the hands in a dark room, will have these. It is difficult to engage the two parts with each other.

Some hardened headgear components of conventional masks can be removed from the frame. Generally, this is done by snap fitting or clip connection between the rigidizer arm and the mask frame, which are all rigid and rigid components. This type of hard-to-hard connection between the rigidizer arm and the frame can result in low flexibility at the connection point. This means that more force is required to bend at this point, which causes discomfort in patients with wide faces. This is because the rigidizer arm may be subjected to a tightening force when it is forcibly bent outward. Some of these rigidizer headgear components have a rigid clip at the distal end of the rigidizer arm for releasable connection to the frame. The rigid clip is non-removably connected to the headgear strap, which can damage the washer tube or other laundry as the headgear is washed in the washer. Also, some of these hardened headgear components tend to require a patient interface with a wide frame, which means that the headgear straps start at a frame position that is more distant from the others. .. Wide frames may have lateral arms that are integrally formed, and these lateral arms are considered part of the frame because they are made of the same material. Wide frames may be viewed by Patient 1000 and Patient Bed Partner 1110 as more prominent and aesthetically unfavorable. This is because those wide frames occupy a larger area on the face. On the other hand, in one example of the present technology, the rigidizer arm 3302 is formed from a material that is more flexible than the frame 3310 but less flexible than the strap 1200. In other words, the strap 1200 is the most flexible component of the positioning stabilization structure 3300 because it is formed from elastic fabric. The second most flexible component of the positioning stabilization structure 3300 is, in one example, a rigidizer arm 3302 formed from Hytrel®. The hardest or most rigid component is the frame 3310, which is not easily or at all bent, stretched, or bent. This is because the seal forming structure 3100 is adapted to form a seal with the patient's airway by elastic deformation. The difference in flexibility of the individual components can be controlled at a particular location and when a particular force is applied, i.e. when tube torque is applied or when a large face width is accepted. The order in which the components of the above begin to bend can also be determined. Also, the difference in flexibility of the individual components may separate these forces before the forces can begin to interfere with the seal of the seal forming structure 3100 in a particular mode or order. These factors aim to simultaneously address the requirements for patient interface 3000: comfort, stability, and good seal formation. Another advantage of the Rigidizer Arm 3302 is that the same size Rigidizer Arm 3302 can be used for a patient interface 3000 with a different size seal forming structure 3100 or a different size headgear strap 3301. When the rigidizer arm 3302 is bent inward, the rigidizer arm may first contact the side of the patient's nose before contacting the nasal pillow 3130 and removing the seal. At this time, the medial movement range of the rigidizer arm 3302 is limited by the patient's nose, and thus the disturbance of the sealing force due to movement in such a direction is minimized or eliminated.

6.3.8 Vent 3400
In one embodiment, the patient interface 3000 may include a vent 3400 configured and arranged to allow the outflow of exhaled breath (including exhaled carbon dioxide).

One form of the vent 3400 according to the present art comprises a plurality of very small holes, i.e., a multi-hole vent. Two or more multi-hole vents may be provided on the frame 3310. These vents may be located on either side of the connection port 3600 for the air circuit 4170. These holes may be gaps between the fibers of the fabric material. Alternatively, these holes may be microholes (1 micron or less) formed on a substrate of a semipermeable material using a laser drill operating within the ultraviolet spectral range. The laser-drilled microholes may be straight wall or tapered / trumpet shaped. Another method of forming micropores is by using a chemical etchant after masking off the area of the substrate. There may be about 20 to about 80 holes, or about 32 to about 42 holes, or about 36 to about 38 holes. In one example, when this form of vent 3400 is insert molded, the direction of the holes through the thickness of the vent 3400 may be changed to be oblique rather than vertical. This avoids exhalation (including exhaled carbon dioxide) that blows directly into the face of bed partner 1100 when patient 1000 is facing bed partner 1100. In one example, the final number of holes may be determined by closing some holes from the original large number of holes. For example, there may be 40 holes, 2 holes closed (by filling), so that the final number of holes is 38. The ability to selectively close holes with respect to both the amount and location of the holes to be closed improves control of air velocity and air diffusion patterns.

With reference to FIGS. 146-152, the patient interface 3000 is a nasal pillow mask, and preferably two vents 3400 are located within the plenum chamber 3200 of the mask frame 3310, or specifically the mask. It is located on the cushion clip of the frame 3310 (which may be pre-assembled with the cushion). A connecting port 3600 or a short tube 4180 is located between the two vents 3400. With reference to FIGS. 153 and 154, a method for manufacturing a patient interface 3000 for the treatment of respiratory diseases is provided. A porous cloth is received for treatment (51). The method comprises cutting the vents 72, 73 from the cloth (57). The cloth is formed by entwining fibers to form an entangled structure that defines a winding air path for air to pass through. The cloth has a porosity of a predetermined size. The vent portion is held in the mold (59). The retained vent is non-removably connected to the mask frame 3310 (60). Both the vent portion and the mask frame 3310 may be formed of a plastic material. This forms a vent 3400 for the patient interface 3000 to drain exhaled breath (including exhaled carbon dioxide).

Any type of cutting instrument 67, such as a laser or mechanical cutter, may be used to cut the vents 72, 73 from the cloth 65. A plurality of vents can be cut from the cloth 65 at the same time, and preferably the two vents are cut to form the two vents at the same time. If two are cut from approximately the same area of cloth 65, the air velocity and material properties of the two vents may sometimes be similar. This helps determine and locate defective materials that have been supplied and reduces the amount of calibration required by the instrument to adjust the air velocity. In another example where thermal caulking with a caulking punch 68 is required, the vents 72, 73 may be cut from the cloth 65 after thermal caulking, rather than the vents 72, 73 being cut before thermal caulking. can. In such a scenario, the first cut by the cutter 67 can be eliminated.

In one example of the art, the material of the entangled fibers is a thermosetting or thermoplastic which may include polyester, nylon, polyethylene, and preferably polypropylene. In certain examples, the cloth 65 may be a SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material. Thermosetting materials may be used. The fabric is generally prepared in the form of a roll or ribbon 65 prior to the cutting step. The weave of the cloth 65 is preferably a satin weave. However, other weaves are envisioned, including plain weave, inverted plain weave, and twill weave. Further, the cloth 65 may be knitted instead of weaving (for example, warp knitting). The voids or holes formed through the fabric 65 by knitting / weaving fibers do not necessarily have uniform dimensions. This is because there are some changes in fiber positioning, spacing, and compression in the weaving of the fabric. The voids are preferably not linear through the holes, but rather define a winding air flow path between adjacent fibers over the thickness of the cloth 65. The winding air flow path may have different pressure regions (high pressure or low pressure) along the air passage. The winding air flow path diffuses the air flow considerably, thereby reducing noise. If the voids penetrate the holes and are straight, the fibers of the cloth 65 may be arranged in the form of a mesh grid or matrix. Preferably, the airflow exiting the vent 3400 is not linear, avoids laminar flow, and produces a wide columnar jet with turbulence.

The patient interface 3000 includes a nasal mask, a full face mask, or a nasal pillow. The mask frame 3310 of the patient interface 3000 has at least one vent 3400, preferably two vents 3400. When two vents 3400 are present, the left vent is located on the left side of the front surface of the mask frame 3310 and the right vent is located on the right side of the front surface of the mask frame 3310. The left and right vents 3400 are separated by an opening or connecting port 3600 for receiving a short tube 4180 operably connected to the PAP device 4000. Alternatively, a single continuous vent 3400 located in the center of the mask frame 3310 can be envisioned, with the short tube 4180 connected to the side surface of the mask frame 3310. A single contiguous vent may have a surface area equal to the combined surface area of the two vents 3400.

In one example where two or more vents 3400 are provided on the mask frame 3310, the overall or average air velocity through all vents 3400 is to obtain the desired air velocity by selecting vents with different air velocity. Used for. For example, a first vent with a low air velocity may be used with a second vent with a high air velocity. At this time, the two vent portions to be combined may give an average air flow velocity, which is a desirable air flow velocity.

The vent is cut or removed from the fabric by laser cutting, ultrasonic cutting, mechanical cutting, or thermal cutting (using high temperature anvil). Laser cutting, ultrasonic cutting, and thermal cutting are because they cut and fuse the outer edges of the vent 3400 to eliminate free fibers with frayed ends on the outer edges of the vent 3400. A laser cutter 69 can be used for laser cutting. Also, laser cutting, ultrasonic cutting, and thermal cutting are useful for subsequent overmolding. This is because the cutting flattens the outer periphery of the vent and makes it easier to overmold compared to non-uniform edges. As a result, air bubbles are avoided at the coupling position between the vent 3400 and the mask frame 3310, which makes the mask frame 3310 with the vent 3400 integrated visually very attractive and structurally reliable. It will be possible.

Non-removable connections can be obtained by molecular attachment using overmolding, two-color molding, or two-shot (2K) injection molding. This provides an integral bond and is strengthened when the material of the vent and the material of the mask frame 3310 interact by forming a covalent bond or a hydrogen bond. Some molds allow the already molded part to be reinserted so that a new layer of plastic can form around the first part. This is called overmolding. The overmolding process involves the use of two materials to form one cohesive component. There are two types of overmolding, namely insert molding and "two shot (2K)" molding.

Two-shot molding and multi-shot molding are designed to be "overmolded" within a single molding cycle and must be processed in a dedicated injection molding machine with two or more injection units. This process is actually an injection molding process that is performed twice. A high level of molecular adhesion is obtained. The method for manufacturing the patient interface 3000 described above may be performed by overmolding the vent portion of the cloth onto the mask frame 3310. The vent portion is held in the mold 70, and the molding machine 71 overmolds the vent portion to the mask frame 3310. Since the cloth 65 and the mask frame 3310 are preferably formed from the same plastic material, the overmold achieves a material fusion between the cloth vent and the mask frame 3310, which is a structurally strong and permanent bond. .. In the final assembled patient interface 3000, the vent 3400 and the mask frame 3310 are almost undetectable to the naked eye as two separate parts.

The vent 3400 has a maximum cross-sectional width of about 16 mm to about 21 mm, preferably 18.2 to 18.6 mm, a maximum cross-sectional height of about 19 mm to about 25 mm, preferably 21.6 mm to 22 mm, and a maximum cross-sectional height of about 0.36 mm to. It has a thickness of about 0.495 mm, preferably 0.40 to 0.45 mm. Therefore, the surface area of the two vents 3400 is about 800 mm ² . Surface area of the porous region of the vent 3400, about 201.6mm ² ~ about 278.6Mm ^2, preferably may be 240 mm ^2. Therefore, if the two bent 3400, surface area of the porous region is about 480 mm ² 500 mm ^2. The front surface of the mask frame 3310 has a surface area ^{of about 1800 mm 2.} The surface area of the vent 3400 occupies at least 35% of the surface area of the front surface of the mask frame 3310. Preferably, the two vents 3400 occupy 40% to 60% of the front surface of the mask frame 3310. Preferably, the two vents 3400 occupy 45% to 55% of the front surface of the mask frame 3310. More preferably, the two vents 3400 occupy about 50% of the front surface of the mask frame 3310. The entangled fibers of the vent 3400 provide a semi-rigid woven structure that is designed to form a significant area of the anterior surface of the mask frame 3310. The vent 3400 is rigid enough to support its own weight under gravity and does not fold itself in the presence of tube torque and is not soft. Some conventional masks with vents made of frayed fabrics are unable to maintain their shape, geometry, and shape during the patient's respiratory cycle (inspiration and exhalation) and are therefore treated. The vent folds in itself. When such conventional vents fold themselves, the porous area of the vents is randomly reduced by a predetermined percentage. This is because the folds may partially or completely block the vent at these folds. This results in an inadequate outflow of exhaled breath (including exhaled carbon dioxide). In contrast, the vent 3400 of the present technology does not fold itself, thus allowing the porous region of the vent 3400 to maintain a substantially constant outflow rate in exhalation during the respiratory cycle of patient 1000, thereby. Proper outflow of exhaled breath (including exhaled carbon dioxide) is provided during treatment.

In one example, the airflow velocity at the vent of the cloth 65 is first measured by the airflow meter 66 (52). A decision is made as to whether there is a difference between the measured air velocity and the desired air velocity (53). When the airflow velocity through the vent portion exceeds a predetermined range (56), the magnitude of the porosity of the vent portion is selectively reduced (54). Desired predetermined range is from about 42 to about 59 l / min at 20 cmH ₂ O pressure, preferably about 47 to about 55 l / min at 20 cmH ₂ O pressure. For example, air velocity through the SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material, from about 37 to about 64 liters of 20 cmH ₂ O pressure, even preferably about 42 to about 58 liters of 20 cmH ₂ O pressure good. The variation over the length of the cloth may be sinusoidal over the length of the cloth ribbon. Different areas of fabric when first received from the fabric manufacturer exhibit different airflow velocities due to the manufacturing process but not limited to calendering without uniform heat and force distribution. There is. After the porosity of the vent has been reduced, the air velocity is measured again to verify that it is currently within a predetermined range (55). The average diameter of the void openings is preferably less than 0.1 mm, preferably giving a total opening area (porous region) of about 1% to 10% of the surface area of the vent 3400. For example, the total opening area (porous region) may be 22 mm ^{2 when the surface area of the vent is 240 mm 2.}

If a desired airflow velocity is present in the cloth 65, the hole in the outer peripheral region of the desired vent is optionally closed (56A). The outer peripheral edge region of the vent portion is overmolded by the mask frame 3310. Since the holes existing in the outer peripheral region have been closed, the airflow velocities at the vents should not differ significantly after overmolding.

In some examples, the airflow velocity may be measured after the vent has been cut from the fabric (58), and the vent may be measured after being overmolded into the mask frame (61). This makes it possible to know the airflow velocity after a particular manufacturing step and to determine that the airflow velocity is within the desired predetermined range. As a result, it is possible to prevent waste such that the parts are discarded as soon as it is found that the parts are not within the desired predetermined range.

Porosity of the vent can be reduced by several methods including thermal caulking, plastic deformation by compression, ultrasonic welding, application of encapsulants (eg hot melt adhesives), and application of thin films. Preferably, to reduce porosity due to high accuracy, high certainty of hole closure in the fabric, manufacturing speed, good visual appeal after heat caulking, and no additional material is required. Thermal caulking with punch 68 is used. When heating a plastic material, some material shrinkage occurs as the excess material surrounds certain physical dimensions for the shape of the vent. The porosity of the vent is reduced by partially or completely closing the vent hole. The caulking punch 68 may use several heat welding heads of various sizes to perform thermal caulking. The size of the heat welding head is selected according to the airflow velocity of the vent, in which case a larger size is used if the airflow velocity is very high.

The order of the cutting step and the porosity reduction step may be replaced. In other words, the porosity reduction may be made first with respect to the cloth 65, after which the vents are cut from the cloth 65. In such a scenario, cutting by the cutter 67 can be eliminated.

Any site or region of the vent may be selected to reduce porosity. Preferably, the porosity of the substantially continuous outer peripheral region of the vent is reduced. This area provides good visual appeal as the vents are adjacent to or at the location where the mask frame is overmolded. Any visual difference between the outer marginal area of the vent and the rest of the area may not be very noticeable at this location. This is because the location may appear to be a predetermined edge of the mask frame 3310 for receiving the vent 3400. Alternatively, the site for porosity reduction may be in the form of a character / letter or logo in the central region 79 of the vent 3400 to enhance visual impact and improve brand awareness. The form may be used as a replacement index for patient 1000 to replace the vent 3400 after a particular period of use.

After reducing the porosity of the region of the vent, in order to verify that lies within the desired predetermined range of about 47 to 53 liters / min at 20 cmH 2 _O pressure airflow speed at the present time, the bent portion by the airflow meter 66 The air velocity is measured again. If the airflow velocity is not within the currently desired predetermined range, the vent may be reheated or the vent is discarded. Thus, the ability to dispose of only defective vents minimizes waste by avoiding having to dispose of mask frames with overmolded defective vents. In a further example of a nasal pillow, it avoids discarding the mask frame, which is an overmolded air delivery tube.

156 and 158 show a portion of cloth 65 before heat caulking. The frayed end 81 of the vertically oriented fibers 80 (warp) along the upper edge of the cloth 65 is visible. The opening of the void 83 is defined between the vertically oriented fibers 80 and the horizontally oriented fibers 82 (weft). Some voids 83 are considered to be more porous than others. This is because those voids have a larger opening, thus allowing more airflow through that opening, allowing increased expiratory outflow.

157 and 159 show a portion of cloth 65 after heat caulking. The voids 83 that were already present prior to caulking have been closed to reduce or prevent airflow through the voids. Although FIG. 157 is merely a schematic depiction for illustrative purposes, photomicrographs show individual fabrics after heat caulking due to heat-induced material deformation and fiber melting and compression of the heat caulking process. It is likely to reveal that the fibers cannot be detected visually. The side cross section depicted in FIG. 159 shows that the individual fibers of the cloth 65 after heat caulking cannot be visually detected due to heat-induced material deformation and melting of the fibers and compression of the heat caulking process. .. Therefore, this region of the vent portion after heat caulking becomes substantially impervious to air in order to selectively adjust the overall air velocity of the entire vent portion.

Referring to FIG. 155, a portion of cloth 65 has two vents 72, 73 that are intentionally heated to vent left and right. A conceptual left vent portion 84 is also drawn showing the contour of the vent portion before caulking. The vent portions 72 and 73 have a semicircular shape or a D shape. The vent portions 72 and 73 substantially match the shape of the vent opening of the mask frame 3310. The vents 72, 73 are initially formed slightly larger than the vent opening to help overmold and to take into account the expected plastic shrinkage due to heat caulking and heat from subsequent steps of overmolding. .. Preferably, the outer peripheral edges of the vents 72, 73 are continuously curved or arched without straight lines. The two corners 74,75 with acute angles are the distal ends of the longer side 76 of the vent. The longer side 76 has a length in the range of about 19 mm to about 24 mm, preferably 21.6 mm to 22 mm. On the opposite side of the longer side 76 is a third corner 77 of the vent with an obtuse angle. The substantially continuous outer peripheral edge region 78 of the vent portion is heated in this region to reduce the porosity of the fabric material 65. The outer peripheral region 78 may have an alignment function / pin. The width in the outer peripheral region 78 to be heated is selected based on the magnitude of the porosity to be reduced to obtain the desired air velocity throughout the vent. The central region 79, located within the outer peripheral region 78, has not been heat crimped and has the same porosity as the original cloth 65.

The sound caused by the exhalation (including exhaled carbon dioxide) passing through the vent 3400 is when the patient 1000 exhales through his nose and the exhalation (including exhaled carbon dioxide) exits through the vent 3400. Minimized due to increased air diffusion, especially as it passes through the cloth / entangled fibers in the nasal pillow. Diffusion of exhaled breath (including exhaled carbon dioxide) avoids direct or concentrated airflow to bed partner 1100 or patient 1000, depending on venting direction and sleeping position. Referring to FIGS. 167-175, in one example of the technique, the vent 3400 is significantly more diffused than the multi-hole vent of the SWIFT FX ™ nasal pillow mask by Resmed Limited. Referring to FIG. 175, the air velocity of exhaled air (including exhaled carbon dioxide) from the vent 3400 of the present technology is about 5 times lower than that of the SWIFT FX nasal pillow mask at a distance close to a vent of about 100 mm. .. In other words, the patient 1000 and the patient's bed partner 1100 are less likely to feel the exhalation (including exhaled carbon dioxide) from the vent 3400 as compared to the multi-hole vent. This enhances the comfort of the patient 1000 and the patient's bed partner 1100. Average air velocity was measured using a directional heat ray anemometer in a closed room with a non-straight curve. Air velocity is an important factor in whether a person can feel the exhaled breath (including exhaled carbon dioxide) passing through the vent 3400. Other factors that may affect what is felt by a person not measured in FIGS. 167-175 include chamber temperature, human hair follicle density, and human skin sensitivities. Further away from the vents, the air velocity of exhaled air (including exhaled carbon dioxide) from both vents approaches zero and is indistinguishable from the surrounding environmental conditions. However, the air velocity of the exhaled air (including exhaled carbon dioxide) from the vent 3400 of the present technology reaches this limit of zero at a distance closer to the vent 3400 than the multi-hole vent. The specific multi-hole vents that have been used in SWIFT FX ™ nose pillow masks have been compared, but in terms of noise level and air diffusion, the Vent 3400 of the present technology is superior to most multi-hole vents. Is assumed.

Other methods for producing vent 3400 for outflow of exhaled breath (including exhaled carbon dioxide) from patient interface 3000 are also provided. The vent portion is cut from a semipermeable material having a thickness of less than 0.45 mm and a porosity of a predetermined size for diffusing the air flow. Cutting is performed when the semipermeable material is given in the form of a large sheet, ribbon, or roll with a particularly large width. The vent portion is molecularly attached to the mask frame 3310 of the patient interface to form the vent 3400. Porosity of predetermined size is such that an airflow velocity of about 47-53 liters / minute can be obtained from the patient interface with a breathing gas of _{20 cmH2 O pressure.} Further, the porosity of a predetermined size is 25dbA or less with an uncertainty of 3dbA and the A-weighted sound power level of 17dbA or less with an uncertainty of 3dbA at a distance of 1 meter. It is supposed to be generated. Preferably, the A-bewerte sound power level dbA (uncertainty) is about 22.1 (3) dbA and the A-bewerteter sound pressure dbA (uncertainty) is about 14.1 (3) dbA. , 10 cm H ₂ O pressure at 1m, ISO 17510-2: was measured using 2007. In other words, the vent 3400 of the present technology is quieter than the multi-hole vent of a conventional mask as described in the conventional mask noise table described at the beginning of the description of the related art. Patient 1000 and patient bed partner 1100 are less likely to hear the sound caused by exhalation (including exhaled carbon dioxide) passing through vent 3400 compared to multi-hole vent. Other techniques described above for heat caulking or closing holes may be used to specifically adjust the airflow velocity at the vent as needed until the desired airflow velocity is obtained.

The vent portion 72 is held in the mold 70 so that the vent portion 72 can be overmolded in the mask frame 3310 in the molding machine 71. The semipermeable material may or may not be a cloth as long as the thickness is less than about 0.45 mm. The thin vent is one feature that makes it possible to provide a compact and unobtrusive patient interface 3000. Also, the thin vent formed on the mask frame 3310 has a visual appeal. This is because the fusion between these two parts appears to be seamless and coplanar, and the thin vents do not need to project excessively inward or outward with respect to the mask frame 3310. Also, the thin vent is lighter due to less material required, which reduces the overall weight of the patient interface 3000. For example, the fabric material 65 may weigh ^{about 200-250 grams / m 2.} The fabric material 65 may weigh from about 217 to about 234 grams / m ² . Smaller diameter fibers can result in a thinner fabric material to obtain the same airflow velocity, which also results in a lighter vent 3400.

Vent 3400 of patient interface 3000 is easy to clean and can be reused. A mild wash solution or soapy water can be used to wash the vent 3400. Hot water can also be used for cleaning and circulated to the vent 3400. The vent 3400 can be hand-washed and rinsed from the mask frame 3310 without disassembling. This is because the vent is non-removably connected to the mask frame 3310, for example overmolded. Fewer removable parts for the patient interface 3000 avoids the possibility of losing individual parts and reduces cleaning time by not having to remove and reassemble many parts from each other. When the vent 3400 is formed by entwining plastic fibers, the durability of the vent 3400 is repetitive, unlike vents formed from other less durable materials such as woven or GORE-TEX ™. It is maintained even after cleaning. Unlike the Vent 3400 of the present technology, GORE-TEX ™ is a non-woven material whose voids are very rapidly closed during use by atmospheric particulate matter trapped in the voids, thereby ultimately. Causes significant obstruction of the vent. Vent obstruction causes an improper outflow of exhaled breath (including exhaled carbon dioxide CO ₂ ) by the patient, resulting in increased levels of _{CO 2 in the blood, ultimately leading to CO 2} rebreathing. The resulting hypoxia is brought about. Also, GORE-TEX ™ voids are invisible to the naked eye, so patients cannot visually determine obstructions caused by mucous membranes, dust, debris, and dirt. Washing the GORE-TEX ™ material with water does not alleviate this problem. This is because the purpose of GORE-TEX ™ is to repel water. Unlike the Vent 3400 of the present technology, GORE-TEX ™ is a sturdy material because it resembles paper and is easily torn and easily broken when attempted to clean with a brush or finger. No. This is a further reason why GORE-TEX ™ cannot be cleaned and reused because it is irreparably damaged by the cleaning process due to its paper-like fragility. Sintered materials, such as sintered cylindrical blocks for venting, are in that the pores of the sintered material are clogged after use and cannot be properly cleaned for reuse and the visual inspection of the blockage is not visible to the naked eye. , With the same defects as GORE-TEX ™. Vents made from non-plastic materials are not as easily manufactured as the vents 3400 of the present invention. This is because those vents may require additional manufacturing steps or they cannot be detachably connected to the mask frame by integral coupling such as overmolding. Without the integral connection between the vent and the mask frame, durability and reliability may be reduced and / or the visual aesthetics may be poor.

In one example, the vent 3400 has a consistent and continuous air flow through the vent 3400 to allow proper outflow of exhaled breath (including exhaled carbon dioxide). The vent 3400 can be manufactured at high speed and is assembled at high speed, resulting in lower production costs compared to some prior art vent manufacturing methods. This is due to its relatively simple geometry, the few processing steps required for the vent 3400 to be non-removably attached to the mask frame 3310, and the equipment required when air velocity adjustment is required. This can be due to the small amount of types and processing steps. Also, if the vent 3400 is a fabric formed of entangled plastic fibers, the vent has a woven appearance, which is for the patient 1000 and the patient's bed partner 1100 as compared to a multi-hole vent or a sintered block vent. It feels aesthetically pleasing.

Another example for manufacturing the vent 3400 will be described. Plastic fibers are spun single-length fibers that are woven or knitted into confounding structures on narrow looms. The entangled structure may be in the form of a narrow ribbon rather than a roll with a large width. Alternatively, the plastic fiber may be a multi-length fiber that can provide a tighter winding than the single-length fiber and a more winding path than the single-length fiber. This allows for greater control of the permeability of the fabric 65 as thermal cutting is avoided. Another advantage is that the heat caulking step of the above example for controlling and compensating the airflow velocity can be avoided or the number of heat welding heads for the caulking punch 68 can be reduced. Therefore, the cloth 65 of the vent 3400 can be manufactured within the desired predetermined range, and only to block the outer peripheral region of the vent 3400 for the purpose of overmolding the mask frame 3310 for non-removable mounting. Hot caulking is used.

It may be possible to further limit any unintended changes in air velocity of the vent 3400 during manufacturing. In the example described above, the roll or ribbon 65 may be calendered, which is a finishing process in which the roll or ribbon 65 is passed under the rollers at high temperature and pressure to form a flat sheet. However, in another example, the roll or ribbon 65 does not have to be calendered first, but instead is first cut into narrow ribbons that are approximately as wide as the height of the vent 3400. Each of the narrow ribbons flattens these ribbons using a heating roller with contact surfaces that are approximately as wide as the width of the ribbons so that heat and pressure are evenly applied to the ribbons. It is calendered to make it. Therefore, any unintended change in air velocity of the vent 3400 caused by non-uniform calendering can be avoided.

In another example, the cloth 65 may be uniformly calendered with a given pressure and a given level of heat to obtain a desired airflow velocity within a given range. Therefore, the above-mentioned heat caulking step for adjusting the airflow velocity by closing the void may be avoided.

In another example, the cloth 65 may omit calendering and void blockage. The cloth 65 may be woven or woven into a confounding structure into a narrow ribbon or strip state. The cloth 65 is then cut into the shapes of the vents 72 and 73 using the cutting / melting technique described above. The vents 72, 73 are then non-removably connected to the frame 3310 or other component in the pneumatic path of the patient interface 3000.

Although the vent 3400 has been described as being formed from confounding plastic fibers, it is also biocompatible and to prevent changes in the shape, geometry and profile of the vent 3400 during the respiratory cycle of the patient 1000. It is envisioned that a material for fibers other than plastic, which has the flexural rigidity of, may be used. For example, thin metal wires or threads may be used. Additives are injected to reinforce the metal or thread skeleton of the vent and provide flexural rigidity to prevent the shape, geometry and profile of the vent 3400 from changing during the respiratory cycle of patient 1000. You may. Vent 3400 is described as having the form of a confounding structure containing woven or knitted fibers.

6.3.8.1 Positioning of Vent 3400 In one embodiment of the technique, the vent 3400 is located on or formed as part of frame 3310. Specifically, in the example of the present technology depicted in FIGS. 75 and 76, a pair of vents 3400 may be arranged on both sides of the front surface of the frame 3310. In one example, the anterior surface of the mask frame 3310 is curved and therefore the vent 3400 does not face in a direction perpendicular to the sagittal plane, but rather the vertical axis between the sagittal plane and the coronal plane. Facing. Positioning the vent 3400 on the mask frame 3310 in this way directs the air flow from the vent 3400 to the sides rather than the straight center, thereby allowing the patient 1000 to face the bed partner directly. The direct flow of air to the bed partner 1100 is avoided. The central anterior region of the patient interface 3000 has a lower average air velocity from the vent 3400 than the region along the vent axis, i.e., along the direction perpendicular to the superficial anterior surface of the vent 3400.

Although the vent 3400 has been described as being non-removably connected to the frame 3310, the vent 3400 has been described elsewhere in the pneumatic region of the patient interface 3000, eg, near or near the seal forming structure 3100, or cuff / It is envisioned that it may be located on the adapter 4190 (see FIGS. 1b and 1c) to allow the outflow of exhaled breath (including exhaled carbon dioxide). The vent 3400 may be non-removably connected to other pneumatic components within the pneumatic region of the patient interface 3000, eg to the elbow if the patient interface 3000 has an elbow to disconnect tube torque.

The pore size characteristics of the vent 3400 may be estimated using the foaming point inspection method described in Method F316 of the American Society for Testing and Materials Standards (ASTM). The bubbling point test is a high-sensitivity visual technique. The fabric material 65 may have a bubbling point pressure of about 60 to about 100 psig (psig: per square inch gauge). Preferably, the foaming point pressure of the fabric material 65 has a foaming point pressure of about 80 psig.

In one example of the technique, the vent 3400 may be provided as a removable vent cap for the patient interface 3000. The vent cap has a vent frame for removable engagement with the vent orifice. The vent orifice may be located on the mask frame, elbow, or cushion member / plenum chamber 3200. The fabric material 65 of the vent 3400 is non-removably connected to the vent frame. Vent 3400 has a porous region for exhaled breath outflow. The cloth 65 is in the form of confounding fibers. A winding air path for exhalation is defined by the space between the confounding fibers. The cloth is structured so that the shape, geometry, and profile of the vents are substantially unchanged during the respiratory cycle of patient 1000 and the porous region maintains a nearly constant outflow rate for exhalation. NS.

Although the vent 3400 has been described as a confounding structure, the vent 3400 may have a non-woven structure such as a fiber reinforced polymer in the form of an unsealed porous plastic matrix. A two-layer structure for the vent 3400 is possible by combining the non-woven structure as the first layer with the woven structure as the second layer.

6.3.9 Connection port 3600
The connection port 3600 allows the connection of the patient interface 3000 to the short tube 4180 of the air circuit 4170, as shown in FIG. 166. In one example of the technique, the short tube 4180 may be directly connected to the patient interface 3000 by a connection port 3600. The short tube 4180 may be connected to the frame 3310 at the connection port 3600 by insert molding the frame into the short tube 4180. The connection port 3600 may be located at the patient interface 3000 and may include either a fixed connection or a movable connection to the gas delivery tube 4180.

The connection port 3600 may be part of the frame 3310 so that the frame is shaped to include the connection port integrally. Further, the connection port 3600 may be connected to the frame 3310 by a limited one or a plurality of portions on the outer circumference thereof. This may provide open areas between the connection port 3600 and the frame 3310, and these open areas may include vents 3400 as described herein. As shown in FIGS. 10, 15, and 18, the connection port 3600 may be formed at an angle to the frame 3310 to orient the tube at an angle from the mask. Further, the connection port 3600 may be tilted at an arbitrary angle and in an arbitrary direction with respect to the frame 3310. In the illustrated example, the connection port 3600 is generally tilted downward with respect to the frame 3310 to accommodate the majority of patients with the tube 4180 pointing downwards during the procedure. This can minimize looping of the tube 4180 and improve the seal and stability of the patient interface 3000 during the procedure. It may also be possible to form the connection port 3600 separately from the frame 3310 and connect these components so that the connection port 3600 can rotate with respect to the frame 3310 using a swivel connection. In such an example, the tube torque of the short tube 4180, which interferes with the sealing force, can be improved or reduced, or the short tube 4180 is set in the position where the tube is turned up toward the upper part of the patient's head. Comfort and seal can be improved if done.

FIG. 18 shows a short tube 4180 tilted downward with respect to the patient interface 3000 by the connection of the short tube to the connection port 3600 formed at a downward angle with respect to the frame 3310. This arrangement can prevent entanglement by preventing the short tube 4180 from looping outwards away from the patient at long distances.

It should also be understood that in an example of a technique in which an elbow is not used to connect the air circuit 4170 to the patient interface 3000, the inflow of gas into the patient interface 3000 can be more evenly distributed. The sharp bends in the elbow can cause dense streamlines on one side of the elbow. This may result in a jet of dense flow, which may result in a suboptimal flow to the patient interface 3000, especially the nasal pillow 3130. It should also be understood that the vent 3400 described above can contribute to the reduction of jets. Although the use of elbows in conventional masks has been to dissociate tube torque by allowing at least relative rotational movement between the air circuit 4170 and the frame 3310, one form of the art is conventional. It has a particularly soft short tube 4180 capable of decoupling the tube torque involving the elbow.

6.3.10 Frontal Support In one embodiment of the technique, Patient Interface 3000 does not include a frontal support. In one form, the patient interface 3000 provides sufficient stability that the frontal support is not needed, thereby making it less noticeable and opening the eyes and nasal bones.

In one alternative form, the patient interface 3000 comprises a frontal support.

6.3.11 Anti-suffocation In one embodiment of the technique, the patient interface 3000 may include an anti-suffocation valve (AAV). In a further example of the technique, AAV is included with the separation structure 4190 (see FIG. 1b), air circuit 4170 (see FIGS. 1a-1c), or patient interface 3000 when a full face mask is used. You may.
6.3.12 port

In one embodiment of the technique, the patient interface 3000 may include one or more oxygenation ports 4185 that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to provide supplemental oxygen. In one form, this allows direct measurement of characteristic gases in the plenum chamber 3200, such as pressure.

6.4 Separation structure 4190
In one embodiment, the patient interface 3000 comprises at least one separate structure, eg, a rotatable cuff or adapter 4190 as shown in FIGS. 1b and 1c, or a ball socket. With reference to FIGS. 1b and 1c, the separation of tube resistance is at least partially carried out by the short tube 4180. In this way, the short tube 4180 functions at least partially as a separation structure 4190.

With reference to FIGS. 1b and 1c, the end of the short tube 4180 to facilitate connection to a third end of the additional gas delivery tube 4178, which may differ from the short tube 4180 in at least one embodiment. Has a rotatable cuff or adapter 4190. The rotatable cuff 4190 allows the short tube 4180 and the additional gas delivery tube 4178 to rotate relative to each other at their respective ends. The additional gas delivery tube 4178 may incorporate features similar to the short tube 4180, but may have a larger inner diameter (eg 18 mm-22 mm). This additional degree of freedom given to the tube can help reduce the tube resistance by reducing the twist of the air circuit 4170 and thus the entanglement of the air circuit 4170. The other end of the additional gas delivery tube 4178 may be connected to the PAP device 4000.

6.4.1 Short tube 4180
In one embodiment of the technique, as shown in FIG. 166, a short tube 4180 is connected to the frame 3310 at a connecting port to form part of the air circuit 4170.

The short tube 4180 is a gas delivery tube according to an aspect of the present technology and is configured and arranged to allow air flow or respiratory gas flow between the PAP device 4000 and the patient interface 3000.

The gas delivery tube is exposed to a tube resistance force that corresponds to the force that the tube receives during use. This is because the delivery tube lies on the patient or on other surfaces (eg, beds, sleeping chamber tables, hospital beds, tables, floors, etc.) during use. Since the short tube 4180 is connected to the patient interface 3000 to supply respiratory gas to the patient 1000, these tube resistances can affect the connection between the patient interface 3000 and the patient 1000. For example, the tube resistance of tension or twist may cause the patient interface 3000 to move off the patient's face, which may cause a leak of respiratory gas from the patient interface 3000. Therefore, it is desirable to reduce the tube resistance. This reduces the weight of the short tube 4180 and improves the flexibility of the short tube (eg, by reducing the bending radius of the tube so that the tube 4180 can be bent more tightly) as well as being short. It may be achieved by adding at least one degree of freedom for tube 4180. Also, such a reduction in tube resistance is such that the tube can resist the occlusion force, for example when the patient may place his arm on the tube 4180 or when twisted to a flexed position. Must be achieved without significantly reducing the strength of.

FIGS. 160-162 show three side views of a typical short tube 4180 in three different states. FIG. 160 shows a short tube 4180 in a neutral or normal state. In the neutral state, the short tube 4180 is not exposed to any external force. That is, the short tube is not stretched or compressed. The short tube 1480 may consist of a web 4172 of material that is spaced between adjacent coils of the spiral coil 4174. The spiral coil 4174 of the short tube 4180 may have a width of WC. The web 4172 of the material may span the distance WF between adjacent coils. Further, as shown in FIG. 160, the web 4172 of the material may be bent so that the apex or peak 4182 of the bent portion extends radially outward from between the adjacent coils. It should be understood that due to the bends in the material web 4172, the width of the material constituting the material web 4172 may be wider than the width WF between adjacent coils. Further, the web 4172 of the material may be bent along a predetermined bending line 4186.

Further, as shown in FIG. 160, the distance WF between adjacent coils may be equal to or substantially equal to the width WC of the spiral coils when the short tube 4180 is in the neutral state. In such an arrangement, the maximum bend radius R of the tube 4180 (shown in FIG. 163) is reduced to improve flexibility. This is because more material must be used than in prior art tubes to span the distance between adjacent coils. As an example, if the distance WF is equal to the width WC of the coil, a larger amount of material will span that distance and the coil will be bent, so that even more material must be provided to provide the material web 4172. Must be. This principle will be described in more detail in connection with FIG. 163. The shape of the bend is important for the overall flexibility of the tube. The larger the radius of the bend in the web, the more flexible the tube will be. Very sharp creases reduce the flexibility of the tube. After multiple heat disinfection cycles, the bends begin to loosen, reducing the flexibility of the tube. It is observed that when the folds are relaxed, the fold diameter is reduced relative to the coil diameter, so that the ridges of the folds are lowered.

Further, in FIG. 160, not only the bent portion of the material web 4172 extends radially outward from the short tube 4180, but also the bent portion of the material web 4172 is located at the center between adjacent coils of the spiral coil 4174. You can see that. FIG. 160 also shows how the tilt of the web 4172 of the material can increase from adjacent coils of the spiral coil 4174 towards the apex or peak 4182 of the bend. In other words, the material web 4172 becomes flatter as it moves away from the predetermined bend line 4186, and the material web 4172 becomes steep and pointed near the apex or peak 4182 of the bend.

Further, in FIG. 160, as will be described in more detail below, it can be seen that the outer portion or the outer surface 4184 of the spiral coil 4174 has a curved shape rounded over a wide angle. In other words, the spiral coil 4174 may have the shape of a part of the outer circumference of the ellipse. By providing the spiral coil 4174 with a rounded outer surface or shape 4184, a more flexible and smoother tactile sensation may be provided to the patient 1000. The rounded outer surface 4184 can also reduce the tendency of the short tube 4180 to get caught on the surface of bedding, patient clothing, bedroom or hospital furniture, etc. during use. As can be seen in FIG. 160, one can see the coil diameter DC, which is the diameter of one of the plurality of spiral coils measured perpendicular to the longitudinal axis of the short tube 4180.

In another feature that can be seen in FIG. 160, the short tube 4180, in its neutral state, delivers gas such that the apex or peak 4182 of the bend is approximately the same height or height as the outer surface 4184 of the spiral coil 4174. It has a bend in web 4172 of material that rises radially outward from the tube. Further, the bent portion of the web 4172 of the material defines a bent portion diameter DF measured perpendicular to the longitudinal axis of the short tube 4180 between the vertices 4182 on both sides of the bent portion. In other words, when the short tube 4180 is in its neutral state, the diameter of the web 4172 of the material across the longitudinal axis of the gas delivery tube and across each apex 4182 of its bends is the diameter of each outer surface across the longitudinal axis. It may be equal to the diameter of the spiral coil 4174 straddling 4184. It can also be said that if the short tube 4180 is arranged straight in a neutral state, a single cylinder can be circumscribed in the same plane with respect to the apex or peak 4182 of the bend and the outer surface 4184 of the spiral coil 4174. can. Further, it may be said that the bent portion diameter DF is equal to or substantially equal to the coil diameter DC when the short tube 4180 is in the neutral state.

Such a configuration, in combination with the rounded outer shape 4184 of the spiral coil 4174, can provide an improvement in tactile sensation, thereby producing a smoother and more flexible feel for the patient. Further, the reduction of the scratching tendency of the short tube 4180 can be promoted by raising the apex or peak 4182 of the bent portion and the outer surface 4184 of the spiral coil 4174 to the same height. This is because there is no single surface that projects significantly so that it catches on the outer surface.

In another example of the art, the web 4172 of the material may be bent multiple times between adjacent coils of the spiral coil 4174. This allows for the additional flexibility of the short tube 4180, along with additional stretchability, due to the amount of additional material between each adjacent coil. Also, in another example of the present technology, a specific region or portion along the length of a short tube 4180 in which the material web 4172 is bent between adjacent coils of the spiral coil 4174 and a gas delivery in which the material web is not bent. There may be other regions of the tube. Such a configuration may allow the degree of flexibility and stretchability to vary along the length of the gas delivery tube. For example, a portion of the short tube 4180 with increased or decreased stiffness may be provided in the vicinity of the patient interface 3000 and the PAP device 4000. In one example, the portion of the short tube 4180 in the vicinity of the patient interface 3000 and the PAP device 4000 is a unit of tube to increase the stiffness of the tube in these areas and reduce kink in these areas. The number of bent portions per length may be small. Another reason for not bending a portion of the web 4172 of the material may be for manufacturing reasons. For example, at the distal end where the cuff is to be overmolded, the web 4172 does not have a bend. This can reduce the tendency to form fragile spots on the web 4172 where the web joins the cuff. This is because the webs bent at these positions can be trapped in a weakly tightened state.

FIG. 161 shows another side view of a typical short tube 4180. In this figure, the short tube 4180 is in a compressed or contracted state. In this state, the length of the short tube 4180 is shorter than its length when it is in the neutral state shown in FIG. 160. For example, the short tube 4180 may be compressed up to 50% shorter than in the neutral state. When the short tube 4180 is compressed to its compressed state, the web 4172 of the material is compressed so that its bends are steeper and the distance WF between adjacent coils of the spiral coil 4174 is reduced. In the compressed state, the distance WF between adjacent coils may be reduced to be smaller than the width WC of the spiral coils. Further, the apex or crest 4182 of the bent portion of the web 4172 of the material may be further pushed outward in the radial direction so that the apex or crest rises above the outer surface 4184 of the spiral coil 4174. In other words, the web 4172 of the material may be even taller. This action may be controlled by the amount of material between adjacent coils and the angle and thickness TW of the bends of the web 4172 of the material. Also, while the width WC of the spiral coil does not have to decrease during compression of the short tube 4180, adjacent coils of the spiral coil 4174 may be brought closer to each other, as is common with other springs. Should also be understood. Also, in FIG. 161 when the short tube 4180 is in a compressed state, the angle at the apex or peak 4182 of the bend of the web 4172 of the material (ie, each portion of the web of material on either side of a predetermined bend line). It can be seen that the angle between them) is reduced and the web length of the material may be further increased as before.

FIG. 162 shows a further side view of the short tube 4180 when it is in its expanded or extended state. In this state, the short tube 4180 may have a longer length than in the neutral state shown in FIG. 160. For example, the short tube 4180 may be extended up to 200% of its length when in the neutral state. Further, in this figure, it can be seen that the distance WF between adjacent coils of the spiral coil 4174 increases, and the bent portion of the web 4172 of the material becomes flatter. Further, the distance WF between adjacent coils can be increased to a width larger than the width WC of the spiral coil. Further, as can be seen in FIG. 162, the vertices or ridges 4182 of the bends of the web 4172 of the material can be pushed radially inward so that the vertices or ridges are below the height of the outer surface 4184 of the spiral coil 4174. .. Again, this may be controlled by the amount of material between adjacent coils and the angle of the bend. Also, while the width WC of the spiral coil does not have to increase during the extension of the short tube 4180, the adjacent coils of the spiral coil 4174 may be pulled apart, as is common with other springs. Should be understood. Also, in FIG. 162, when the short tube 4180 is in the stretched state, the angle at the apex or peak of the web bend of the material (ie, between each portion of the web of material on either side of a given bend line). It can be seen that the angle) may be increased and the web 4172 of the material may be further flattened as before.

FIG. 163 shows a typical short tube 4180 curved between two ends. When curved as shown in FIG. 163, the material web 4172 between adjacent coils of the spiral coil 4174 can be extended at 4179 outside the bend and the material web 4176 inside the bend can be compressed. .. When curved in this way, the limit of the bending radius R can be better understood. In one example, the tube may have a bend radius R of 44 mm under its own weight when wrapped over a cylinder having a diameter of 13 mm (ie, no additional weight is added). Status). The greater the amount of material that makes up the material web 4172, the smaller the possible bend radius R. This is because, as can be seen in FIG. 163, the outer side 4179 of the curved portion can be extended only up to the maximum possible distance WF between adjacent coils. At the outer 4179 of the bend, the short tube 4180 can only bend and extend at the outer 4179 up to the width of the web 4172 of the material provided between the adjacent coils. Therefore, if more material is provided for the web 4172 of material between adjacent coils, the short tube 4180 can be bent so that the outer 4179 of the bend is further extended, and the maximum bend radius R is reduced. Therefore, the flexibility is improved.

Further, it can be seen that the distance WF between the adjacent coils inside the curved inner 4176 of the bent portion is reduced to the point where the adjacent coils of the spiral coil 4174 are substantially in contact with each other. Therefore, the bend radius R is also limited by the web 4172 of the material located inside the bend 4176. As can be seen in FIG. 164, the web 4172 of the material is compressed between adjacent coils of the spiral coil 4174 at the interior 4176 of the bend. Therefore, the thicker the web 4172 of the material, the larger the maximum bending radius R. This is because the larger the amount of material between the adjacent coils, the more difficult it is for the coils to come close to each other at the inside 4176 of the bent portion.

Therefore, in order to optimize the bend radius R of the short tube 4180, a web 4172 made of a material wide enough to allow the outer 4179 of the bend to extend to meet the desired bend radius. Although it must be provided, a web of material of sufficient thickness must also be provided so that adjacent coils of the spiral coil 4174 can approach at the interior 4176 of the bend to achieve the desired bend radius.

FIG. 164 shows a cross-sectional view of a typical short tube 4180 taken as shown in FIG. 163. This cross section of the short tube 4180 shows the gas delivery tube in its neutral state so that the distance WF between adjacent coils is equal to the width WC of the spiral coil. Further, the short tube 4180 may have an inner diameter DI of about 18 mm. The short tube 4180 may have a pitch P of 3.2 mm to 4.7 mm, or preferably 4.5 mm to 4.7 mm. The figure also shows that the spiral coil 4174 may have a thickness TC greater than the thickness TW of the web 4172 of the material. If the spiral coil 4174 is thicker than the web 4172 of the material, the spiral coil can provide structural strength and this will spring the short tube 4180. Also in this figure, it can be seen that the web 4172 of the material may have a substantially uniform and / or continuous thickness.

FIG. 164 also shows that at least a portion of the material web 4172 may be asymmetrical around a predetermined bend line 4186. For example, the web 4172 of the material may include a hump 4181 adjacent to the spiral coil 4174 on one side of the predetermined bending line 4186 and an inclined portion 4183 adjacent to the spiral coil on the other side. May be included. Further, the inclination of the web 4172 of the material with respect to the apex or the peak 4182 of the bent portion may be steeper on the side of the inclined portion 4183 than on the side of the knob portion 4181. Due to the different steepness of the slope, when the short tube 4180 is in the neutral state, the width WFS between the edge of the spiral coil on the side of the slope 4183 and the predetermined bending line 4186 is on the side of the bump 4181. It may be smaller than the width WFF between the edge of the spiral coil and the predetermined bending line. Therefore, when stretched, the web 4172 of the material can be stretched so that the WFS is greater than the WFF. This is because a larger amount of material is contained in the area. In other words, the short tube 4180 may be stretched by a certain amount in the first direction (eg, from the slope 4183 to the bump 4181) and in the second direction opposite to the first direction. It may be stretched by different amounts (eg, from the aneurysm to the slope). Such a configuration can be beneficial if the patient interface 3000 is attached to one end of the short tube 4180 and the PAP device 4000 is attached to the other end. This is because the patient 1000 may move while wearing the patient interface 3000 and therefore may require a greater amount of elasticity in the direction of the patient 1000. The asymmetrical shape of the tube 4180 is generally the result of how the tube 4180 was formed. However, as another method, it can be assumed that the web 4172 of the material has a substantially symmetrical shape around a predetermined bend line 4186.

As can be seen in FIG. 164, the width WH of the aneurysm portion and the width WS of the inclined portion may be different. Therefore, the web 4172 of the material may be bent across the inclined portion 4183 toward the adjacent coil over a larger range than across the knob portion 4181. In other words, due to the large gaps in WS, there may be greater magnitude of flexibility (ie, smaller bend radii) in WH with smaller gaps in this particular region. Also, due to the small gaps in the WH, this portion may be compressed to a lesser degree than in the WS because the web 4172 of the material is already closer to the coil 4174 in the WH than in the WS.

Another feature shown in FIG. 164 is the outermost surface area (eg, the outermost of the short tube 4180) when the spiral coil 4174 generally feels better than the web 4172, especially if the bends in the web are very sharp. Surface area) can be occupied by the outer surface 4184 of the spiral coil 4174 in a larger proportion than the web 4172 of the material. This can give the patient a better tactile sensation. This is because, as can be seen in FIG. 164, the outer surface 4184 of the spiral coil 4174 is rounded and therefore smoother than the apex or peak 4182 of the bend of the web 4172 of the material.

Also, as can be seen in FIG. 164, the web 4172 and the spiral coil 4174 of the material may be integrally coupled so that the inner surface of the short tube 4180 is smooth and continuous. Adjacent sides of material webs 4172 may be joined to each other to form a smooth, continuous inner surface, or material webs 4172 may be joined to adjacent sides of adjacent coils of spiral coil 4174. Should be understood. By forming the short tube 4180 so that the inner surface is smooth and continuous in this way, a smoother flow of respiratory gas may be provided through the gas delivery tube. Generally, in order to prevent tape tightening, the bent portion is formed after overmolding the cuffs at both ends of the short tube 4180.

It should also be understood that any suitable combination of materials may constitute the web 4172 and spiral coil 4174 of the material. The materials of each component 4172, 4174 may be the same or may differ in at least one aspect. In one example of the art, the web 4172 and spiral coil 4174 of the material may be made of thermoplastic elastomer (TPE) or thermoplastic polyurethane (TPU). Both the web 4172 and the coil 4174 are formed from the same plastic material (or a different mixture of the same plastic material) that favors an integral chemical bond (molecular attachment) between the web 4172 and the coil 4174. May be good. Material selection is constrained by many factors. The mechanical properties of the material for the web 4172 that allow it to be flexible are a decisive factor. The ability to withstand heat disinfection is another important factor. Another factor is that it is sticky and not sticky. Also, the short tube 4180 must withstand hoop stresses to avoid blockages when applying external forces to the outer peripheral surface of the tube 4180, which can occur when the patient's limbs are located above the short tube 4180. This is addressed by giving the short tube 4180 a minimum inner diameter to determine the helical pitch and structural stiffness of the helical coil 4174.

The choice of material can also affect the spring stiffness of the short tube 4180 (P = kx, where P is the load, k is the stiffness and x is the deflection). The greater the rigidity k of the spring, the smaller the deflection under a constant load. The spring ratio is the amount of weight required to bend a spring (arbitrary spring) per measurement unit. For example, materials with different modulus of elasticity and different flexural rigidity may be used for each of the web 4172 and spiral coil 4174 of the material to provide the desired spring stiffness. Similarly, spring stiffness may be selected by using a material with the same modulus in both the web 4172 and the spiral coil 4174 of the material. The pitch of the spiral coil 4174 described in connection with FIG. 164 can also affect the spring stiffness of the gas delivery tube 4180. In one example, the spring stiffness may be about 0.03 N / mm.

FIG. 165 shows another figure of a typical short tube 4180 in a bent or curved state. In this figure as well, as in FIG. 163, the short tube 4180 is curved over a radius R. However, in this figure, to clarify how the tube 4180 can bend when tensioned at one end due to gravity, the short tube 4180 has a flat, high surface (eg, table) edge. It looks like it is hung down. The weight of the portion of the short tube 4180 that hangs over the corner of the table can cause the tube 4180 to stretch and bend in the area of the tube 4180 near the edge of the table. This figure depicts bending properties similar to those shown in FIG. 163. Specifically, the web 4172 of the material is stretched at 4179 outside the bend region and compressed at 4176 inside the bend so that the WF is larger outside than inside the bend.

FIG. 166 shows a typical short tube 4180 attached directly to the patient interface 3000. In conventional masks, the gas delivery tube is attached to the mask via a swivel elbow. The prior art assembly seeks to reduce tube resistance by redirecting the gas delivery tube with a swivel elbow at its junction with the patient interface. However, the inclusion of swivel elbows increases weight and components, which can suppress a decrease in tube resistance. Therefore, according to the present technology, the short tube 4180 may be directly connected to the mask frame 3310. FIG. 166 further shows that the short tube 4180 may be tilted downward from the connection to the mask frame 3310, which may also contribute to the reduction of tube resistance. The downward angle may be partially smoothed by the connection port 3600.

With reference to FIGS. 1b and 1c again, the short tube 4180 according to the present technology appears to have the patient interface 3000 connected to the first end. This connection may be the fixed connection described above in connection with FIG. 166. In this example, the cuff is overmolded to the first end of the tube 4180 and then the first end of the tube 4180 to the corresponding connection port 3600 formed on the patient interface 3000. This example is elbowless in the sense that there is no elbow between the tube 4180 and the mask frame 3310. In another example, the swivel elbow can be positioned between the tube 4180 and the mask frame 3310 to allow the swivel elbow and tube 4180 to rotate freely with respect to the mask frame 3310. It should be understood that the patient interface 3000 shown in these figures is indicated by a dashed line to indicate that various different patient interfaces may be connected to the short tube 4180. The second end of the short tube 4180 may be different from the short tube 4180. A rotatable cuff, swivel cuff, or adapter to facilitate connection to the third end of the additional gas delivery tube 4178. It is 4190. The rotatable cuff allows the short tube 4180 and the additional gas delivery tube 4178 to rotate relative to each other at their respective ends. The additional gas delivery tube 4178 may incorporate the same features as the short tube 4180, but may have a larger inner diameter (eg, 18 mm to 22 mm). This additional degree of freedom given to the tubes 4178,4180 reduces the twist of the short tube 4180 and cuts off any tube resistance that the short chew receives, thus increasing the tube resistance by cutting off the kink. Can help reduce. The fourth end of the additional gas delivery tube 4178 may be connected to the PAP device 4000. A two-part swivel that attaches to the snap is assembled to the cuff by in-mold molding. Alternatively, a snap-type one-part swivel can be assumed.

With reference to FIGS. 203-222, the tube 4180 of the present technology is compared to a conventional short tube having a spiral coil. The comparison shows that the tube 4180 of the present technology has excellent bending rigidity or softness. This is because the tube has a lower gram weight (gf) when the tube 4180 is stretched. The lower end of the tube is held in a fixed position so that the longitudinal axis of the tube begins at an angle perpendicular to the direction of the force applied to extend the short tube. In other words, the lower end of the short tube is held so that it initially contacts parallel to the horizontal plane (see FIGS. 203, 208, 213, 218). The upper end of the short tube is held by the Instron machine directly above the held lower end of the short tube. The Instron machine extends the short tube vertically upwards by a distance of 30 mm in a series of steps from 0 mm to 30 mm, 60 mm, 90 mm, and 120 mm. In addition, the Instron machine measures the force that may correspond to the spring rigidity of the short tube in Newton units for each distance. Torque Gauge RM No. MTSD05997 and Mecmesin Force Gauge RM No, MFGX05996 are used to measure gram weight at the fixed lower end of the short tube for each distance the short tube is extended. Will be done. Since the tubes have different weights and lengths, the Instron machine, torque gauge, and force gauge are set to zero in the initial position. By adjusting the measuring instrument to zero in this way, the measured value becomes independent of the weight and length of each tube. A 1 cm grid is also placed in the background to roughly indicate the angle of the short tube for each distance. The comparison shows:

The above comparison shows that only the short tube 4180 of the present technology begins to receive tube torque with an extension between 30 mm and 60 mm, while conventional tubes already receive tube torque with an extension of 30 mm. At all measured distances, conventional tubes have a fairly high gram weight, indicating that they are less flexible and have higher flexural rigidity compared to the tube 4180 of the present technology. Therefore, in tube 4180, there is little possibility of seal breakage as a result of tube torque as compared to conventional tubes. The softness of the tube 1480 also allows the tube to be connected directly to the frame 3310 without the need for a swivel elbow or ball socket elbow commonly used to handle tube torque. This eliminates additional components, which results in a reduction in overall weight at the patient interface 3000. Because the tube 4180 is rarely felt by the patient 1000 and the tube gives the patient 1000 greater freedom of movement before any tube resistance acts to pull the seal forming structure 3100 away from the patient's face. Comfort is improved.

As mentioned above, the short tube may provide tube resistance as the short tube 4180 is moved relative to the patient interface 3000. Tube resistance may include forces and / or moments here, but it can be understood that the term tube resistance includes forces and / or moments, unless otherwise stated.

One of the causes of such tube resistance may be the bending of the short tube 4180. For example, the bending created by the short tube 4180 as the patient 1000 distracts his body from the PAP device 4000 can provide tube resistance at the patient interface 3000, which optionally interferes with the seal. And / or cause discomfort to the patient.

To demonstrate the effect of tube resistance, a brief depiction of a system with patient interface 3000 and short tube 4180 may be considered. In this system, it may be assumed that the patient interface is located on the patient 1000 and the headgear is disconnected from the patient interface. In this case, the patient interface 3000 has to react to some tube resistance. In this case, for example, some moment may act on the patient 1000 as a couple, and / or some force may act on the patient 1000 by the same contradictory reaction forces.

The tube resistance resulting in the patient interface 3000 may be associated with the structure of the short tube 4180. More specifically, when the short tube 4180 is bent, the flexural rigidity of the short tube 4180 can affect the tube resistance provided by the patient interface 3000.

In general, when a cylindrical tubular object with a constant cross section is fixed at a fixed end and loaded at the free end (ie, cantilever), the resulting force and moment at the fixed end is d = Pl. it can be expressed as ³ / 3EI (ignoring gravity). Here, d is the deflection, P is the normal force, l is the length of the tube, E is the elastic modulus of the material, and I is the moment of inertia of area of the cross section. Here, the resulting reaction at the fixed end is the normal force of P in the opposite direction and the moment of lP.

Applying this to a system with patient interface 3000 and short tube 4180, the reaction at the proximal end is the normal force of P and the moment of lP that may form part of the tube resistance. The above equation may be rewritten to P = 3dEI / l ^3. At this time, with respect to the predetermined deflection d (that is, the deflection in the motion given by the patient 1000) and the tube length l, the tube resistance increases as the EI increases, or the tube resistance increases as the EI decreases. Will be reduced.

Respect cross section constant circular tube, I is the equation _{^{I = π (d o 4 -d}} i 4) / 64 may be calculated using. Thus, as an example, for a given inner diameter (di) of 15 mm, a reduction in outer diameter (do) from 19 mm to 18 mm reduces tube resistance by about 32%. Similarly, a reduction in the modulus of elasticity of the material used results in a reduction in tube resistance, but the relationship in this case can be linear.

Therefore, the short tube 4180 in the present art does not have to be circular in cross section, but the overall flexural rigidity of the short tube 4180 is the geometry of various parts of the short tube 4180 such as the web 4172 of the material and the spiral coil 4174. It can be the result of geometric morphology and material properties.

A decrease in the flexural rigidity of the short tube 4180 may result in a decrease in the structural integrity of the short tube 4180. That is, as an example, if the thickness of the web 4172 of the material is changed by reducing the outer diameter of the short tube 4180, the flexural rigidity, and thus the tube resistance, can be reduced, which is the short tube 4180. It may result in a more fragile structure of the short tube 4180 and may cause blockage of the short tube 4180 during normal use.

Therefore, the advantage of the present technology is the combination of the geometry and material of the short tube 4180, which acts to reduce bending stiffness while avoiding blockages and maintaining adequate strength for durability.

The tube 4180 is substantially quiet, without the annoying noise / static friction that can be caused by the axial compression and expansion of the tube 4180. One example for reducing or eliminating noise may be the addition of additives to prevent the coils of the spiral coils 4174 from sticking to each other. Traditional tubes for patient interfaces are known to suffer from this type of noise that can be offensive to the patient 1000 and the patient's bed partner 1100 because it is an intermittent noise when trying to sleep. I came. The tube 4180 is intended to be lightweight to minimize the tube resistance caused by the weight of the tube 4180 under gravity. In one example of the present technology, in the neutral state, the tube 4180 may have a length of about 285 mm to 305 mm including the end cuff and a weight of about 18.7 g to 19.1 g. You may. Therefore, the weight of the tube 4180 with the end cuff may be from about 62.6 g / m to 65.6 g / m. There is no air leakage between the tube 4180 and the end cuff that is overmolded at the end of the tube 4180. One of the end cuffs may be a swivel cuff 4190 to allow 360 ° relative rotation between the short tube 4180 and the long tube 4178, while the other end cuff does not swivel. It is a frame cuff. The swivel cuff 4190 may have a ridge that provides a tactile outer rim that allows the tube 4180 to be detached from the tube adapter 4190 connected to the long tube 4178 by the index finger of the patient 1000. The ridge can withstand greater forces to increase the durability of the swivel end cuff 4190 and short tube 4180 after repeated engagement and disengagement with respect to the long tube 4178.

Although a single spiral coil 4174 has been described, it is envisioned that more spiral coils may be provided in the tube 4180. If a plurality of spiral coils are provided in the tube 4180, multi-start (double start, triple start, etc.), in other words, multi-row is possible. This increases the softness of the tube 4180 and reduces the tube resistance, but by having a strong structure, each spiral coil can be formed from a different material or each spiral to prevent or resist kink and blockage. It may allow the coils to have different dimensions.

6.4.1.1.1 Mask System One or more of the mask components may be configured and arranged together to dissociate the tube torque to minimize the possibility of seal breakage. The short tube 4180 is capable of decoupling tube torque due to its high softness and ability to stretch. If the tube torque is larger than the short tube 4180 can be separated, the positioning stabilization structure 3300 also separates the tube torque. The rigidizer arm 3302 bends in the sagittal plane to disconnect the tube torque. Also, the cushioning function of the plenum chamber 3200 and / or the seal forming structure 3100 disconnects tube torque of some magnitude. Any combination of two or more of these features enhances the ability to dissociate tube torque. All combinations of these features further enhance the ability to disconnect larger tube torques.

One or more of the mask components may be configured and placed together to enhance comfort for the patient 1000. The short tube 4180 is lightweight, and the plenum chamber 3200 and seal forming structure 3100 are also lightweight, so the headgear tension provided by the positioning stabilization structure 3300 does not become unpleasantly high to provide a good seal. It's enough. Reducing the need for the elbow to connect the short tube 4180 to the frame 3310 also reduces the overall weight of the patient interface 3000, which reduces the level of headgear tension required by the positioning stabilization structure 3300. Also, the perception by the patient 1000 when the patient interface 3000 is lightweight is that it is "almost not there", which makes it not feel like wearing the patient interface 3000 and causes claustrophobia. It causes almost no claustrophobia. The shape and flexibility of the rigidizer arm 3302 provides comfort to the patient 1000. This is because the rigidizer arm is located below the cheekbones and the rigidizer arm orients the headgear strap 3301 around the patient's ears, which can be a sensitive facial area for some patients 1000. The strap 3301 is made of woven fabric and feels good on the patient's skin. This is because the strap 3301 does not retain surface heat and condensates from sweat as compared to plastic headgear straps. Also, the strap 3301 formed from the woven fabric has a lower density than the plastic material, which leads to a reduction in weight and bulk. The split area 3326 of the strap 3301 allows the headgear tension to be adjusted to a level that the patient 1000 feels comfortable with. Any combination of two or more of these features enhances comfort for Patient 1000. All combinations of these features greatly enhance comfort for the patient 1000.

One or more of the mask components may be configured and arranged together to increase the chance of optimal sealing with the patient 1000. This provides better therapeutic compliance and increases average daily use by an additional 36 minutes. Optimal sealing can be obtained by combining the improved tube torque decoupling as described above with the high comfort for the patient 1000.

One or more of the mask components may be configured and arranged together to enhance the visual appeal of the patient interface 3000, which results in better therapeutic compliance, especially in the first patient 1000. The patient interface 3000 has a low profile and a small occupied area on the patient's face. This is because the frame 3310 is not very wide and is curved to correspond to the geometry of the face. Also, the integrated strap 3301 with the split area 3326 and the smooth continuous surface of the curved profile of the rigidizer arm 3323 is not obtrusive, does not look bulky or complex, and covers a large surface area of the patient's face. No. Any combination of any two or more of these features enhances the visual appeal of the patient interface 3000. All combinations of these features greatly enhance the visual appeal of the patient interface 3000.

One or more of the mask components may be configured and arranged together to improve the assembly and disassembly of the patient interface 3000. The patient interface 3000 provides simplicity for the patient 1000 due to the presence of two components, the seal forming structure 3100 and the strap 3301, which are removable from the frame 3310. The low number of removable components also means that the patient interface 3000 is easy to assemble and disassemble when it needs to be cleaned. The frame 3310, the plenum chamber 3200 / seal forming structure 3100, and the strap 3301 may be individually cleaned on different schedules, for example, the plenum chamber 3200 / seal forming structure 3100 is cleaned more frequently than the strap 3301. You may. The shape and structure of the components visually and tactilely suggest to the patient 1000 how to assemble and disassemble the patient interface 3000 in an intuitive manner. For example, the fitting relationship between the plenum chamber 3200 and the frame 3310, which produces an audible click when the engagement is correct, is intuitive to patient 1000. Also, providing visual and tactile indicators on the frame 3310, the plenum chamber 3200, and the positioning stabilization structure 3300 allows the patient 1000 to misassemble / disassemble or misorient / misalign the mask components. Add additional guides to avoid. Some of these features are particularly beneficial for Patient 1000 with arthritis in the hands in a dark environment. For example, an audible click may be heard, or the feel and feel of the shape of the mask component, as well as the tactile index, are also useful in low light conditions. Also, wearing or removing the patient interface 3000 by simply extending the strap 3301 avoids complicated engagement / disengagement procedures. Any combination of two or more of these features enhances the simplification of the patient interface 3000. All combinations of these features greatly enhance the simplification of the patient interface 3000.

In one example of the art, the frame assembly includes a frame 3310, a short tube 4180, a vent 3400, and a subassembly of the rigidizer arm 3302. The subassemblies of the frame assembly are non-removably connected to each other, for example, the frame 3310 and the short tube 4180 are non-removably connected to each other, the frame 3310 and the rigidizer arm 3302 are non-removably connected to each other, and the frame 3310 and vent. The 3400 and the 3400 are non-removably connected to each other. The cushion assembly can be detachably engaged with the frame assembly. The cushion assembly includes a seal forming structure 3100, a plenum chamber 3200, a holding structure 3242, and a plenum connection area 3240. The strap 3301 can be detachably engaged with the frame assembly, in particular the rigidizer arm 3302.

Although the strap 3301 formed from the fabric has been described, it is assumed that at least the distal end of the strap may be formed from a silicone or plastic material. Silicone straps allow overmolding into the plenum chamber 3200 for non-removable connections.

6.4.1.1.2 Prevention of inaccurate assembly and disassembly of the mask system With reference to FIGS. 187-190, the patient interface 3000 has the wrong orientation when engaging with the mask components. Visual and tactile indicators are provided to prevent or minimize. These indicators also give the patient 1000 intuition as the mask components disengage from each other. In FIGS. 187 and 188, pad printing 3290 is provided on the outer surface 3355 of the extending portion 3350 of the rigidizer arm 3302. The mask name and brand logo are pad-printed to suggest to the patient 1000 the direction in which the word is directed to the upper right side. These prints provide a visual indication to the patient 1000. In FIG. 189, a raised / embossed string 3291 is present near the upper edge of the frame 3310. This string provides the patient 1000 with visual and tactile indicators of whether the frame 3310 is directed up or down, and in low light when the strap 3301 is attached to the rigidizer arm 3302. Especially useful. Further, a concave character string 3292 exists on the outer surface of the rigidizer arm 3302. This string provides the patient 1000 with a visual and tactile indicator of the orientation of the Rigidizer Arm 3302 and is useful in attaching the strap 3301 to the Rigidizer Arm 3302. Pad printing 3293 may be present on one side of the plenum chamber 3200. Pad printing 3293 may display the left pillow 3130 and the right pillow 3130 and the size (small, medium, large) of the seal forming structure 3100. For example, when the patient 1000 sees the pad print 3293 on the plenum chamber 3200, the patient notices that he is facing the top surface of the plenum chamber 3200. All these visual and tactile indicators help the patient 1000 identify the sides and surface of the patient interface 3000 to avoid misorientation and improper assembly and disassembly. This avoids accidental damage to the patient interface 3000 and also alleviates any user frustration associated with assembly and disassembly.

6.5 PAP device 4000
A PAP device 4000 according to one aspect of the present technology comprises mechanical pneumatic components 4100 and electrical components 4200 and is programmed to execute one or more algorithms 4300. The PAP device may have an outer housing 4010, which is formed in two parts, i.e., an upper 4012 of the outer housing 4010 and a lower 4014 of the outer housing 4010. .. In another embodiment, the outer housing 4010 may include one or more panels 4015. The PAP device 4000 may include a housing 4016 that supports one or more internal components of the PAP device 4000. In one form, the pneumatic block 4020 is supported by or formed as part of the housing 4016. The PAP device 4000 may include a handle 4018.

The air pressure path of the PAP device 4000 may include an inlet air filter 4112, an inlet muffler, a controllable pressure device capable of supplying positive pressure air (eg, a controllable blower 4142), and an outlet muffler. One or more pressure sensors and flow rate sensors may be included in the pneumatic path.

The pneumatic block 4020 may form part of a pneumatic path located within the outer housing 4010.

The PAP device 4000 may have a power supply 4210 and one or more input devices 4220. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In another embodiment, the PAP device 4000 may include a plurality of PCBA4202.

6.5.1 Mechanical Pneumatic Components of PAP Equipment 4100
6.5.1.1 Air filter 4110
The PAP device 4000 according to one embodiment of the present technology may include one air filter 4110 or a plurality of air filters 4110.

In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the controllable blower 4142. See FIG. 3c.

In one embodiment, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000. See FIG. 3c.

6.5.1.2 Pressure device 4140
In one embodiment of the present technology is a blower 4142 in which the pressure device for creating a positive air flow is controllable. For example, the blower 4142 may include a brushless DC motor in which one or more impellers are housed in a spiral. The blower 4142 _{can deliver a predetermined amount of air in the range of about 4 cmH 2} O to about 20 cmH ₂ O, or in other forms with _{a positive pressure of up to about 30 cmH 2} O, for example about 120 liters / minute. You may.

6.6 Humidifier 5000
6.6.1 Humidifier Overview In one embodiment of the present technology, as shown in FIG. 3b, a humidifier 5000 which may include a water reservoir and a heating plate is provided.

6.7 Glossary For the purposes of disclosure of this technology, one or more of the following definitions may apply in certain embodiments of this technology. In other embodiments of the art, different definitions may apply.

6.7.1 General Rules Air: In certain embodiments of the present technology, the air supplied to the patient may be the atmosphere, and in other embodiments of the present technology, the atmosphere may be oxygenated.

Continuous Positive Airway Pressure (CPAP): CPAP treatment applies a predetermined amount of air or respiratory gas to the airway inlet at a pressure that is persistently positive to the atmosphere and preferably at a nearly constant pressure throughout the patient's respiratory cycle. Interpreted to mean doing. In some forms, the pressure at the entrance to the airways varies by a few centimeters of water within a single respiratory cycle, for example high during inspiration and low during expiration. In some forms, the pressure at the entrance to the airways is slightly higher during exhalation and slightly lower during inspiration. In some forms, pressure varies between different respiratory cycles of the patient, eg, increases in response to detection of signs of partial upper airway obstruction, and decreases in the absence of signs of partial upper airway obstruction. NS.

6.7.2 Aspects of the PAP device Air circuit: A conduit or tube configured and arranged to deliver a predetermined amount of air or respiratory gas between the PAP device and the patient interface during use. In particular, the air circuit may be fluid connected to the outlet of the pneumatic block and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inspiration and expiration. In other cases, a single limb is used.

APAP: Automatic airway positive pressure. Positive airway pressure that can be continuously adjusted between the minimum and maximum limits depending on the presence or absence of signs of SDB events.

Blower or flow generator: A device that delivers an air stream with a pressure above the ambient pressure.

Controller: A device or part of a device that adjusts the output based on the input. For example, one form of controller has a controlled variable-a control variable-that constitutes an input to the device. The output of the device is a function of the current value of the control variable and a set point for the variable. The servo ventilator may include a controller having ventilation as an input, a target ventilation volume as a set point, and a pressure support level as an output. Other forms of input may be one or more of oxygen saturation (SaO2), carbon dioxide partial pressure (PCO2), operation, signals from plethysmographs, and peak flow rates. The setting point of the controller may be one or more of fixed, variable, or learning. For example, the set point in the ventilator may be the long-term average of the patient's measured ventilation. Other ventilators may have ventilation volume setting points that change over time. The pressure controller may be configured to control a blower or pump to deliver air at a particular pressure.

Treatment: Treatment in this context may be one or more of positive pressure therapy, oxygen therapy, carbon dioxide therapy, dead space control, and administration of the drug.

Motor: A device that converts electrical energy into the rotational movement of a member. In this context, a rotating member is an impeller that rotates in a predetermined position about a fixed axis to exert pressure on air moving along the axis of rotation.

Airway positive pressure (PAP) device: A device for supplying a predetermined amount of positive pressure air to the airways.

Transducer: A device for converting one form of energy or signal into another form of energy or signal. The transducer may be a sensor or detector for converting mechanical energy (such as motion) into an electrical signal. Examples of transducers include pressure sensors, flow rate sensors, carbon dioxide (CO ₂ ) sensors, oxygen (O ₂ ) sensors, effort sensors, motion sensors, noise sensors, plethysmographs, and cameras.

6.7.3 Aspects of the respiratory cycle Apnea: Apnea is preferably said to occur when the flow rate drops below a predetermined threshold for a predetermined duration, eg, 10 seconds. Obstructive apnea is said to occur when some obstruction of the airways does not allow air flow despite patient effort. Central apnea is said to occur when apnea is detected due to diminished or lack of respiratory effort.

Duty cycle: The ratio of inspiratory time Ti to total respiration time Ttot.

Effort (breathing): Preferably, breathing effort is said to be the work performed by a person who breathes spontaneously to try to breathe.

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

Flow Limit: Preferably, the flow limit is interpreted as the state of the patient's respiratory event in which increased effort by the patient does not cause a corresponding increase in flow. If a flow limit occurs during the inspiratory portion of the respiratory cycle, it may be described as the inspiratory flow limit. If a flow limit occurs during the expiratory portion of the respiratory cycle, it may be described as the expiratory flow limit.

Decreased breathing: Preferably, decreased breathing is interpreted as a decrease in flow rather than an interruption in flow. In one form, respiratory depression may be said to occur when there is a subthreshold decrease in flow rate over a predetermined duration. In one form in adulthood, any of the following is considered respiratory depression.

(I) 30% reduction in patients breathing for at least 10 seconds + associated 4% desaturation, or
(Ii) Decrease (but less than 50%) in patients breathing for at least 10 seconds with at least 3% associated desaturation or arousal.

Inspiratory part of the respiratory cycle: Preferably, the period from the start of the inspiratory flow to the start of the expiratory flow is interpreted as the inspiratory part of the respiratory cycle.

Openness (airway): The degree to which the airway is open, or the range in which the airway is open. The open airway is open. Airway patency may be quantified using, for example, a value of 1 that is open and a value of zero (0) that is obstructed.

Positive end-expiratory pressure (PEEP): Pressure above the atmospheric pressure in the lungs present at the end of exhalation.

Peak flow rate (Qpeak): The maximum value of the flow rate in the inspiratory part of the respiratory flow waveform.

Respiratory flow, air flow, patient air flow, respiratory air flow (Qr): These synonyms are "true respiratory flow", which is the actual respiratory flow faced by the patient, usually expressed in units of liters / minute. Alternatively, it may be understood to indicate an estimate of the respiratory airflow of the PAP device as opposed to the "true respiratory airflow".

Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort.

(Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

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

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

Typical Recent Ventilation: A value of ventilation where recent values over some given timescale tend to gather around it, that is, an indicator of the central tendency of recent values of ventilation.

Upper airway obstruction (UAO): Includes both partial and complete upper airway obstruction. This may be associated with a flow limit condition (Sterling resistance behavior) in which the level of flow may increase or decrease slightly as the pressure difference across the upper respiratory tract increases.

Ventilation (Vent): An indicator of the total amount of gas exchanged by the patient's respiratory system per unit time, including both inspiratory and expiratory flow. When expressed as the amount per minute, this amount is often referred to as "respiratory volume". Respiratory volume is sometimes given simply as a volume that is understood to be the volume per minute.

6.7.4 PAP device parameters Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate and ventilation volume have the same amount or mass per unit time, but flow rate is measured over a fairly short period of time. Flow rates may be nominally positive in the inspiratory portion of the patient's respiratory cycle and thus may be negative in the expiratory portion of the patient's respiratory cycle. In some cases, the reference to the flow rate is a scalar quantity, i.e. a quantity having only magnitude. In other cases, the reference to flow rate is a vector quantity, i.e. a quantity having both magnitude and direction. The symbol Q is given to the flow rate. The total flow rate Qt is the flow rate of air coming out of the PAP device. The vent flow rate Qv is the flow rate of air coming out of the vent to allow the exhaled gas to flow out. The leak flow rate Ql is the flow rate of an unintended leak from the patient interface system. Respiratory flow rate QR is the flow rate of air received into the patient's respiratory system.

Leakage: Preferably, the term leak is interpreted as the flow of air into the surrounding environment. The leak may be intentional, for example, to allow the outflow of _{exhaled CO 2.} The leak may not be intentional, for example as a result of an incomplete seal between the mask and the patient's face.

Pressure: Force per unit area. Pressure may be measured in a series of units including _{cmH 2} O, gf / cm ^{2, hectopascals.} 1 cmH ₂ O is equal to 1 g-f / cm ² and is about 0.98 hectopascals. In this specification, unless stated otherwise, the pressure given in units of cm H 2 _O. For nasal CPAP treatment of OSA, the reference to the treatment pressure is a pressure in the range of _{about 4-20 cmH 2} O, or a reference to _{about 4-30 cmH 2 O.} The pressure in the patient interface is given the symbol Pm.

Sound power: Energy per unit time transmitted by sound waves. Sound power is proportional to the product of the square of sound pressure and the area of the wave surface. Sound power is usually given in units of decibel SWL, i.e. in decibels relative to reference power ^{, usually interpreted as 10-12 watts.}

Sound pressure: Local deviation from ambient pressure at a given time as a result of sound waves traveling through the medium. Sound pressure is usually given in units of decibels SPL, i.e., units of decibels relative to reference power ^{, usually interpreted as 20 × 10-6 pascals (Pa), which is considered the threshold for human hearing.}

6.7.5 Facial biostructure Ala: The outer wall or "wing" of each nostril (plural: alar).

Outermost point of the nasal wing (alare): The outermost point of the nasal wing.

Nasal wing curvature (or nasal wing apex) point: The posterior point in the curvature baseline of each nasal wing found at the crease formed by the connection of the nasal wing with the cheek.

Auricle (auricula) or pinna: The visible outer part of the ear.

(Nose) Skeleton: The nasal skeleton comprises the nasal bone, the frontal process of maxilla, and the nose of the frontal bone.

(Nose) cartilage skeleton: The nasal cartilage skeleton includes the nasal septum, lateral cartilage, alar cartilage, and alar cartilage.

Nostril: A piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

Nostril angle: The angle between the line drawn through the midpoint of the nostril opening and the line drawn perpendicular to the Frank Fort horizontal plane across the nasal spine.

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

Glabellar: The highest point in the median sagittal plane of the forehead, located on the soft tissue.

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

Large nasal wing cartilage: A plate of cartilage located below the lateral nasal cartilage. The alar cartilage is curved around the anterior part of the nostril. The posterior end is connected to the frontal process of maxilla by a tough fibrous membrane containing three or four small cartilage of the nasal wing.

Nostrils (nostrils): Approximately oval openings that form the entrance to the nasal passages. The singular form of the nostrils (nares) is the nostrils (naris (nostril)). The nostrils are separated by the nasal septum.

Nasolabial fold or Naso-labial fold: A fold or groove in the skin that separates the cheeks from the upper lip and extends from both sides of the nose to the corners of the mouth.

Nasolabial fold: The angle between the nasal column and the upper lip across the nasal spine.

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

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

Nose tip: The most prominent point or apex of the nose that can be identified in the remaining side view of part of the head.

Philtrum: A midline groove extending from the lower edge of the nasal septum to the upper edge of the lip in the upper lip area.

Pogonion: The front midpoint of the jaw, located on the soft tissue.

Ridge (nasal ridge): The ridge of the nose is the midline process of the nose that extends from the base of the nose to the tip of the nose.

Sagittal plane: A vertical plane that passes from the front (front) to the back (back) of the body divided into right and left halves.

Nasal root: The most concave point lying on the area of the frontal nasal suture, located on the soft tissue.

Septal cartilage (nasal septal cartilage): The nasal septal cartilage forms part of the septum and divides the anterior part of the nasal cavity.

Bottom point of the nasal wing: The lower edge of the nasal wing base where the base of the nasal wing joins the skin of the upper (upper) lip.

Nasal spine: The point on the soft tissue where the nasal column meets the upper lip in the median sagittal plane.

Splatoon: The lowest point in the midpoint of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

6.7.6 Skull structure Frontal bone: The frontal bone contains a large vertical portion, i.e., the squamous part of the frontal, which corresponds to the area known as the forehead.

Mandible: The mandible forms the lower jaw. A chin ridge is a chin bone ridge that forms a chin.

Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of maxilla protrudes upward by the lateral surface of the nose and forms part of the lateral boundary of the nose.

Nasal bone: The nasal bone is two small oval bones of different individuals that differ in size and shape. The nasal bones are placed side by side in the middle and top of the face, and their joints form the "beams" of the nose.

Nasion: The intersection of the frontal bone and the two nasal bones, a recessed area just between the eye and the upper part of the nasal bridge.

Occipital bone: The occipital bone is located in the lower posterior part of the skull. The occipital bone contains an elliptical opening, the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital scale.

Orbit: The cavity of the skull that houses the eyeball.

Top of the skull: The top of the skull is the bone that forms the top and sides of the skull when joined together.

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

Cheekbones: The face contains two cheekbones that are located on the top and sides of the face and form cheek ridges.

6.7.7 Respiratory system structure Diaphragm: A muscular layer that extends across the bottom of the thorax. The diaphragm separates the thoracic cavity, which houses the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

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

Lungs: Human respiratory organs. The conduction area of the lung includes the trachea, bronchioles, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space behind the nose in the center of the face. The nasal cavity is divided into two by vertical fins called the nasal septum. On both sides of the nasal cavity are three horizontal extensions called the turbinate (conchae) (singular "concha") or turbinate. In front of the nasal cavity is the nose, whose back integrates into the nasopharynx through the choana.

Pharynx: A part of the throat located just below (below) the nasal cavity and above the esophagus and larynx. The throat usually has three parts: the nasopharynx (nasopharynx) (the nose of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the pharynx (the hypopharynx). ) And.

6.7.8 Material Silicone or Silicone Elastomer: Synthetic rubber. In this specification, the reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercial LSR is SILASTIC manufactured by Dow Corning (included in a series of products sold under this trademark). Another manufacturer of LSR is Wacker. Unless the exact opposite is explicitly stated, the preferred form of LSR has a Shore A (or Type A) press-fit hardness in the range of about 35 to about 45 as measured using ASTM D2240.

Polycarbonate: A generally transparent thermoplastic polymer of bisphenol A carbonate.

6.7.9 Patient Interface Aspect Anti-suffocation Valve (AAV): A component or subassembly of a mask system that reduces the risk _{of excessive CO 2} rebreathing by a patient by opening to the atmosphere in a fail-safe manner.

Elbow: A conduit that directs the axis of an air flow to change direction over a given angle. In one form, the angle may be about 90 °. In other forms, the angle may be less than 90 °. The conduit may have a substantially circular cross section. In other forms, the conduit may have an elliptical or rectangular cross section.

Frame: Frame is interpreted to mean a mask structure that supports a tension load between two or more connection points with a positioning stabilization structure. The mask frame may be a load-supporting structure that is not airtight in the mask. However, some forms of the mask frame may be airtight.

Positioning Stabilization Structure: Positioning stabilization structure is interpreted to mean a form of positioning stabilization structure that has come to be used on the head. Preferably, the positioning stabilization structure is an assembly of one or more struts, cords, reinforcements configured to position and hold the patient interface in place on the patient's face to provide respiratory therapy. To be equipped with. Some laces are formed from a flexible, flexible elastic material such as a laminated composite of foam and woven fabric.

Membrane: Membrane is interpreted to mean a generally thin element that has substantially no bending resistance but has elongation resistance, preferably in the context of, for example, a sealing portion and / or a facial contact portion.

Plenum Chamber: A mask Plenum chamber is interpreted to mean a portion of a patient interface that has a wall that encloses a predetermined volume of space, said volume having air internally that is pressurized above atmospheric pressure during use. .. The outer shell may form part of the wall of the mask plenum chamber. In one form, the area of the patient's face forms one of the walls of the plenum chamber.

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

Outer shell: Preferably, the outer shell is interpreted to mean a curved structure having flexural rigidity, tensile rigidity, and compressive rigidity, for example, a part of a mask forming a curved structure wall of the mask. Preferably, the outer shell is relatively thin relative to its overall dimensions. In some forms, the outer shell may be chamfered. Preferably, such walls are airtight, but in some forms they do not have to be airtight.

Reinforcement: Reinforcement is interpreted to mean a structural component that is designed to increase the bending resistance of other components in at least one direction.

Struts: Struts are interpreted as structural components that are designed to increase the compression resistance of other components in at least one direction.

Swivel: (noun) A subassembly of components that are configured to rotate around a common axis, preferably under low torque, preferably independently. In one form, the swivel may be configured to rotate over an angle of at least 360 °. In other embodiments, the swivel may be configured to rotate over an angle of less than 360 °. The component subassembly, when used in the context of an air delivery conduit, preferably comprises a adapted pair of cylindrical conduits. Preferably, there is little or no airflow leakage from the swivel during use.

String: A string is interpreted as a structural component that is designed to resist tension.

Vent: (noun) Allows a deliberately controlled rate of leakage of air from inside the mask to allow the outflow of _{exhaled carbon dioxide (CO 2 ) and the supply of oxygen (O 2).} A structure or a conduit to the outside air.

6.7.10 Terminology used for patient interfaces (surface) Curvature: A region of the surface with a saddle shape that bends upwards in one direction and downwards in different directions is said to have a negative curvature. Areas of the surface that have a dome shape that bends similarly in the two main directions are said to have a positive curvature. A flat surface is interpreted to have zero curvature.

Soft: The quality of a material, structure, or complex that is a combination of the following characteristics:
・ Easy to adapt to acupressure.
-It cannot maintain its shape when it can support its own weight.
・ It is not hard.
-Can be elastically stretched or bent with little effort.

The quality of being soft may have a relevant orientation, and thus a particular material, structure, or complex may be soft in the first direction, but in the second direction. For example, it may be highly rigid or rigid in a second direction perpendicular to the first direction.

Elasticity: Within a relatively short time such as 1 second, it can be deformed almost elastically and almost all of the energy can be released when the load is removed.

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

Semi-rigid: Means that it is sufficiently rigid so that it is not substantially distorted under the action of mechanical forces commonly applied during positive airway pressure treatment.

6.8 Other Findings Some of the disclosures in this patent document include subject matter subject to copyright protection. The copyright owner has no objection to reproduction by either the patent document or the patent disclosure. This is because the reproduction appears in the patent file or record of the Patent and Trademark Office, but otherwise reserves all copyrights.

Unless the context explicitly states, if a range of values is given, each value up to 1/10 of the unit of the lower bound between the upper and lower bounds of the range, and any other. It is understood that the stated values or values within the stated range are included within the present technology. Upper and lower limits that may be independently included within the intervening range of these intervening ranges are also included within the art under the constraints of any particularly excluded limits within the stated range. If the stated range includes one or both of its limits, then a range that excludes one or both of those included limits is also included within the art. It is also understood that where one or more values are stated herein to be implemented as part of the art, such values may be approximated unless otherwise stated. And such values may be utilized up to any suitable significant figure. However, only if practical technical implementation allows or requires it. It should also be understood that any all stated values may be variable by 10-20% from the stated values.

Unless otherwise specified, 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 and material similar to or equivalent to the methods and materials described herein may be used in the practice or testing of the present technology, but a limited number of typical methods and materials are used herein. Methods and materials are described.

If it is deemed preferable that a particular material be used to make up one component, another trivial material with similar properties may be used as an alternative. It is also understood that all components described herein can be manufactured together or individually, and thus may be manufactured, unless the opposite is explicitly stated.

The singular forms "one (a)", "one (an)", and "the" used herein and in the appended claims have a particularly clear context. It should be noted that if not indicated, it will include multiple equivalents of them.

All publications referred to herein are incorporated herein by reference to disclose and explain the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. None of this specification should be construed as a confession that the art has no right to precede such publications based on prior invention. Also, the dates of publications given may differ from the actual publication dates, and the publication dates may need to be confirmed independently.

Also, in interpreting the disclosure, all terms should be interpreted in the broadest and reasonable manner consistent with the context. In particular, the terms "provide" and "provide" should be construed as referring to an element, component, or step in a non-exclusive manner, and the mentioned element, component, or , Suggests that the step may exist, be utilized, or be combined with other elements, components, or steps that are not explicitly mentioned.

Subject titles used in the detailed description are included solely for ease of reference by the reader and should not be used to limit the subject matter found throughout the scope of the disclosure or claims. Subject titles should not be used with a limited interpretation of the scope of one or more claims.

Although the techniques herein have been described in the context of specific embodiments, it goes without saying that these examples are merely illustrations of the principles and applications of the techniques. In some cases, terminology and symbols may suggest specific details that are not needed to implement the technique. For example, the terms "first" and "second" may be used, but unless otherwise stated, they are not intended to indicate any order and are between separate elements. May be used to distinguish. Also, process steps in a methodology may be described or illustrated in a predetermined order, but such ordering is not required. As will be appreciated by those skilled in the art, such ordering may be modified and / or the embodiments may be performed simultaneously or even synchronously.

Therefore, it should be understood that numerous changes may be made to the illustrated embodiments and other configurations may be devised without departing from the ideas and scope of the present invention. Is.

51 Receive the cloth 52 Measure the airflow velocity 53 Determine the difference 54 Selectively reduce the pore ratio 55 Measure the airflow velocity 56 The airflow velocity exceeds the range 56A Block the vent part 57 Cut 58 Measure the airflow velocity 59 Hold the vent in the mold 60 Vent is connected 61 Measure the airflow velocity of the vent 64 Weft knitted fabric 65 Cloth 66 Airflow meter 67 Cutting instrument 68 Caulking punch 69 Laser cutter 70 Mold 71 Molding machine 72 Vent part 73 Vent part 74 Acute angle part of the vent part 75 Acute angle part of the vent part 76 Long side of the vent part 77 Dull angle part of the vent part 78 Outer peripheral area of the vent part 79 Central area of the vent part 80 Vertically oriented Fiber 81 Frayed ends 82 Horizontally oriented fibers 83 Voids 84 Conceptual left vent 85 Course 90 Basic closed loop warp 90-1 Warp 100 Weft knit 210 Rear 220 strap 1000 Patient 1100 Bed partner 1102 Knit strap Upper part 1104 Knitted strap rear part 1105 Knitted strap 1106 Knitted strap lower part 1120 Connector 1150 Course 1200 Strap 1250 Course 2802 Connected link 2804 Flexible 3D printed cloth 2900 Positioning stabilization structure part 2912 (1) Hole 2912 Male clip 2914 Female Clip 2914 (1) Hole 2922 Rigidizer Arm Hole 2924 3D Printing Strap 3000 Patient Interface 3100 Seal Forming Structure 3104 Gas Chamber 3104.1 Distal Long Side 3104.2 Short Side 3104.3 Proximal Long Side 3101 Nose Flange 3110 Seal Flanges 3112 Nose Cushion 3112.1. Area 311.22 Area 31123 Area 3113 Area 3114 Protruding End 3115 Area 3116 Recess 3117 Area 3118 Top 3120 Support Flange 3122 Adaptation Area 3130 Nose Pillow 3130.1. Base 3142 Upper flexible area 3150 Handle part 3152 Lower flexible area 3200 Plenum chamber 3202 Connection part 3204 Thick part 3206 Overhang part 3 208 Protruding end support 3210 Front wall 3211 Tongue 3211.1 Channel 3212 Concave lower part 3220 Rear wall 3222 Rear 3230 Bending area 3232 Left bending area 3234 Right bending area 3236 Separation area 3240 Plenum connection area 3242 Holding structure 3244 Wide holding Functional part 3245 Narrow holding functional part 3246 Hook-shaped part 3246.1 Front 3246.2 Rear 3246.4 Nominal vertical axis 3250 Seal lip 3290 Pad printing 3291 Embossed character string 3292 Concave character string 3293 Pad printing 3294 Rib 3295 Notch 3300 Positioning stabilization structure 3301 Strap 3301.1 Elastic tube 3301.2 Lock 3301.3 Loop part 3301.4 Hook part 3301.5 End 3302 Rigidizer arm 3302.1 Free end at distal end 3302.2 Cut Notch 3302.3 Extended Arm 3302.4 Void 3302.5 Rod 3302.6 Raised Stopper 3302.7 First Slot 3302.8 Second Slot 3303 Button Hole 3304 Mounting Point 3305 Flexible Joint 3305.1 Ladder Lock Clip 3306 Protruding end 3307 Sharp bend 3308 Opening 3309 Protruding 3310 Frame 3310. Receiving part 3310.2 Pocket 3310.3 Recessed 3310.4 Recess 3310.5 End receiving part 3311 Pocket-shaped end 3311.1 Welded end 3312 Wide frame connection area 3312.1 Pull-in surface 3312.2 Holding surface 3313 Narrow frame connection area 3313.1 Welding end 3314 Interference part 3315 Right side strap part 3316 Left side strap part 3317 Back strap part 3317a Upper back strap part 3317b Lower back strap part 3318 Inner surface of the protruding part 3319 Outer surface of the protruding part 3319a End of the rigidizer arm 3319b End of the rigidizer arm 3320 Space of the protruding part 3321 Upper surface of the protruding part 3321a to 3321d Mark 3322 Lower surface of the protruding part 3323 ~ 3323e mark 3324 branch point 3325 Reinforcement 3326 Division 3327 Reinforcement 3328 Rounded corners 3329 Rigidizer arm recess 3333 Rigidizer arm main part 3335 Frame opening 3340 First bend 3341 First straight part 3342 Second bend 3343 Second Straight part 3344 Lock end 3345 Slot 3350 Extended part 3350.1 End 3351 Straight part of extended part 3352 Bent part of extended part 3353 Hook of extended part 3354 Encapsulated part of extended part 3355 Outer surface 3356 Joint 3357 Strap logo 3358 Certificate 3359 Flange 3361 Stem 3363 Extension first part 3363A End 3364 Extension second part 3365 Second part first protrusion 3366 Second part 2nd protrusion 3637 1st slot of 2nd part 3368 2nd slot of 2nd part 3370 Extension 3371 Extension 3372 Certificate 3374 Joint 3380 Projection 3381 Wing 3382 Opening 3383 Notch 3384 Stopper 3385 Pin 3386 Socket 3387 Flare End 3388 Receiving 3389 Slot 3390 Shaft Receiving 3391 Arm Receiving 3392 Slot 3393 Protruding 3394 Arm 3395 Shaft 3396 Bending 3397 Protruding 3398 Tab 3399 Strut 3400 Vent 3400 Magnet 3411 Post 3413 Second magnet 3420 First L-shaped part 3421 First recess 3422 First overlapping part 3423 Second L-shaped part 3424 Second overlapping part 3425 Second recess 3426 Peg 3427 Hole 3430 Boss 3431 Cavity 3450 Protrusion 3451 Hole 3452 Post 3453 Slot 3460 Rigidizer Arm Rib 3461 Extension Rib 3462 Longitudinal Rib 3470 Tab 3471 Hook Material 3600 Connection Port 4000 PAP Device 4010 Outer Housing 4012 Outer Housing 4012 Bottom of 4015 Panel 4016 Housing 4018 Handle 4020 Pneumatic Block 4100 Pneumatic components 4110 Pneumatic components 4112 Intake air filter 4114 Outlet air filter 4140 Pressure device 4142 Blower 4142 Controllable blower 4170 Pneumatic circuit 4172 Material web 4174 Spiral coil 4176 Bend inside 4178 Long tube 4179 Bend outside 4180 Short tube 4181 Nodule 4182 Folded mountain 4183 Inclined 4184 Spiral coil outer surface 4185 Oxygen supply port 4186 Folded wire 4190 Rotable adapter 4200 Electrical components 4202 Printed circuit assembly (PCBA)
4210 Power supply 4220 Input device 4300 Algorithm 5000 Humidifier DC Coil diameter DF Bending part diameter TC Spiral coil thickness TW Material web thickness WC Spiral coil width WF Spiral coil width WF Width between adjacent coils WFF Spiral coil on the side of the hump Width between the edge of the WFS inclined part and the edge of the spiral coil on the side of the WFS inclined part Width between the edge of the spiral coil and the predetermined bending line WH The width of the bump part WS The width of the inclined part

7.1 Patent Documents US Patent No. 7,734,767; US Patent Nos. 7,318,437; US Patent Application Publication No. 2009/0044808; International Publication No. 2000/069521; US Patent No. 5,724 965; US Patent No. 6,119,694; US Patent No. 6,823,869; US Patent Application Publication No. 2009/0044808; International Publication No. 2009/052560; International Publication No. 2005/010608; United States Patent No. 4,782,832; International Publication No. 2002/11804; US Patent No. 6,854,465, US Patent Application Publication No. 2001/0000543; US Patent Application Publication No. 2009/0100508; International Publication No. 2011/121466; US Patent No. 7,562,658; European Patent No. 2,022,528; European Patent No. 1356841; US Patent Application Publication No. 2012/0318270; US Patent No. 8439038; US Patent Application Publication No. 2009/0078259; US Patent Application Publication No. 2009/0277525; US Patent Application Publication No. 2010/02224276; US Patent No. 6,581,594; US Patent Application Publication No. 2009/0050156; US Patent Application Publication No. 2010/0319700; US Patent Application Publication No. 2009/0044810

Further aspects of the invention are provided by the subject matter of the following sections.
[Item 1]
In the patient interface for delivering pressurized gas to the patient to treat sleep apnea
A seal-forming structure in which a nasal opening for supplying pressurized gas to both nostrils of a patient and a plenum chamber are integrally formed, wherein the plenum chamber includes a plenum connection region, and the seal-forming structure is formed. A seal-forming structure configured to seal below the bridge of the nose over the lower perimeter of the patient's nose.
A frame that can be releasably attached to the plenum connection zone,
A connection port formed integrally with the frame and
A gas delivery tube that is non-removably coupled to the frame at the connection port,
The gas delivery tube
A spiral coil composed of a plurality of adjacent coils, each of which is separated by a width and has an outer surface that defines a coil diameter.
It is coaxial with the spiral coil and is attached to the spiral coil between adjacent coils of the plurality of adjacent coils, and extends radially outward between adjacent coils of the plurality of adjacent coils. A web of material having at least one bend that is present, said at least one bend being defined by a predetermined bend line.
Patient interface with.
[Item 2]
The apex of the at least one bend defines the diameter of the bend.
When the gas delivery tube is in the neutral state, the coil diameter is substantially equal to the bent portion diameter, and in the neutral state, adjacent coils are separated from each other.
The gas delivery tube has three different states, namely, a neutral state in which the gas delivery tube has a neutral length, and an extension in which the gas delivery tube is extended along its longitudinal axis to an extension length longer than the neutral length. The patient interface according to any of the preceding paragraphs, wherein the gas delivery tube forms one of a compressed state in which the gas delivery tube is compressed along its longitudinal axis to a compression length shorter than the neutral length.
[Item 3]
The patient interface of any of the preceding sections, wherein the web of material comprises at least one bend extending radially outward along at least one longitudinal portion of the gas delivery tube.
[Item 4]
The patient interface of any of the preceding paragraphs, wherein the web of material has an angle of inclination that increases from the spiral coil to the apex of the at least one bend when the gas delivery tube is in the neutral state.
[Item 5]
The patient interface according to any previous section, wherein the web of the material has an asymmetric cross-sectional shape near a predetermined bend line.
[Item 6]
The patient interface according to any of the preceding paragraph, wherein the predetermined bending line is evenly spaced between adjacent coils of the plurality of adjacent coils.
[Item 7]
The patient interface according to any previous section, wherein the width of separating the adjacent coils among the plurality of adjacent coils is substantially equal to the width of the spiral coil when the gas delivery tube is in the neutral state.
[Item 8]
The patient interface according to any of the preceding paragraph, wherein the spiral coil occupies a surface area ratio of the gas delivery tube that is larger than the at least one bend in the web of the material.
[Item 9]
The patient interface according to any previous section, wherein the outer portion of the spiral coil has a rounded outer shape.
[Item 10]
The patient interface according to any of the preceding paragraphs, wherein the spiral coil has a thickness greater than the web of the material.
[Item 11]
The patient interface according to any previous section, wherein the web of the material has a substantially uniform thickness.
[Item 12]
The spiral coil comprises a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU) and / or
The patient interface of any of the preceding sections, wherein the web of material comprises a thermoplastic elastomer (TPE) or thermoplastic polyurethane (TPU).
[Item 13]
The patient interface according to any of the preceding paragraph, wherein the gas delivery tube is irremovably coupled to the frame at the connection port by insert molding the frame into the gas delivery tube.
[Item 14]
The patient interface of any of the preceding sections, wherein the web of material and the spiral coil are coupled to form a uniform, continuous inner surface of the gas delivery tube.
[Item 15]
The patient interface according to any of the preceding paragraph, wherein at least one bend extends radially outwardly between every other coil of the plurality of adjacent coils.
[Item 16]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure comprises a recess for receiving the top of the patient's nose.
[Item 17]
As described in any of the preceding paragraphs, wherein the seal forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal forming structure. Patient interface.
[Item 18]
The patient interface according to any of the preceding paragraph, wherein the seal forming structure comprises a foam, a gel, and / or a low durometer silicone.
[Item 19]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure varies in thickness at a predetermined position around the nasal opening.
[Item 20]
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. The patient interface described in any of the preceding sections configured in.
[Item 21]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The patient interface of any of the preceding paragraphs, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 22]
The patient interface according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state to follow the curvature of the patient's upper lip.
[Item 23]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. The patient interface described in.
[Item 24]
In the patient interface for delivering pressurized gas to the patient to treat sleep apnea
A seal-forming structure in which a nasal opening for supplying pressurized gas to both nostrils of a patient and a plenum chamber are integrally formed, wherein the plenum chamber includes a plenum connection region and the seal-forming structure is formed. With a seal-forming structure, which is configured to seal below the bridge of the nose over the lower perimeter of the patient's nose.
A frame that can be releasably attached to the plenum connection zone, wherein the frame comprises a first material.
A pair of rigidizer arms containing a second material, wherein the second material is different from the first material.
With
A patient interface in which the frame and the pair of rigidizers are non-removably connected.
[Item 25]
The patient interface according to any of the preceding paragraphs, wherein the first material is relatively elastically flexible than the second material.
[Item 26]
The patient interface according to any of the preceding paragraphs, wherein the frame is overmolded into the pair of rigidizer arms to form a mechanical connection.
[Item 27]
The patient interface according to any preceding section, wherein the mechanical connection comprises an encapsulation portion extending from each of the pair of rigidizer arms overmolded by the material of the frame.
[Item 28]
The patient interface of any of the preceding sections, wherein the encapsulation portion has a hook and a portion of the bend.
[Item 29]
The patient interface according to any of the preceding paragraphs, wherein the first material can be used to be integrally coupled with the second material.
[Item 30]
The patient interface according to any of the preceding paragraph, wherein the first material is a thermoplastic polyester elastomer and the second material is a thermoplastic polymer.
[Item 31]
The patient interface according to any of the preceding paragraphs, wherein the thermoplastic polymer is polypropylene (PP).
[Item 32]
The patient interface according to any of the preceding paragraph, wherein the first material is a fiber reinforced composite polypropylene material and the second material is polypropylene.
[Item 33]
Each of the pair of rigidizer arms includes a protruding end configured to hold a pocket-like end of the strap of the positioning stabilization structure, and the protruding end is in the vicinity of the frame as described in any of the preceding paragraphs. Patient interface.
[Item 34]
The first material is non-expandable and each of the pair of rigidizer arms is structured so that it is more flexible in a plane substantially parallel to the patient's Frankfort horizontal plane compared to the other planes. Any patient interface described in the previous section.
[Item 35]
Each of the rigidizer arms
With a body that has a curvature that closely follows the patient's cheek shape,
A connection that is configured to connect to the frame, wherein the connection is located at the distal end of the rigidizer arm.
The patient interface described in any of the preceding sections comprising.
[Item 36]
The patient interface of any of the preceding sections, wherein the connection comprises at least one protrusion and at least one void configured to be overmolded to connect to the frame.
[Item 37]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure comprises a recess for receiving the top of the patient's nose.
[Item 38]
As described in any of the preceding paragraphs, wherein the seal forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal forming structure. Patient interface.
[Item 39]
The patient interface according to any of the preceding paragraph, wherein the seal forming structure comprises a foam, a gel, and / or a low durometer silicone.
[Item 40]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure varies in thickness at a predetermined position around the nasal opening.
[Item 41]
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. The patient interface described in any of the preceding sections configured in.
[Item 42]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The patient interface of any of the preceding paragraphs, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 43]
The patient interface according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state to follow the curvature of the patient's upper lip.
[Item 44]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. The patient interface described in.
[Item 45]
In the patient interface for delivering pressurized gas to the patient to treat sleep apnea
A seal-forming structure in which a nasal opening for supplying pressurized gas to both nostrils of a patient and a plenum chamber are integrally formed, wherein the plenum chamber includes a plenum connection region, and the seal-forming structure is formed. A seal-forming structure configured to seal below the bridge of the nose over the lower perimeter of the patient's nose.
A frame that can be releasably attached to the plenum connection zone,
A connection port formed integrally with the frame and
With at least one vent for draining exhaled breath, the vent being irremovably connected to the frame.
With
The at least one vent is made of a cloth formed by entwining plastic fibers, the cloth having a porosity of a predetermined size, a patient interface.
[Item 46]
The patient interface of any of the preceding sections, wherein the at least one vent comprises two vents that are irremovably connected to the frame on either side of the connection port.
[Item 47]
The patient according to any of the preceding paragraphs, wherein the two vents include a first vent having a first airflow velocity and a second vent having a second airflow velocity different from the first airflow velocity. interface.
[Item 48]
The first airflow velocity and the second airflow velocity are described in any preceding paragraph in which the average airflow velocity of the first airflow velocity and the second airflow velocity is selected so as to be within a predetermined range. Patient interface.
[Item 49]
The first airflow velocity and / or the second airflow velocity is obtained by heating a part of the first vent and / or a part of the second vent to a porosity of a predetermined size. Any patient interface described in the previous section.
[Item 50]
The patient interface according to any of the preceding paragraph, wherein the plastic fiber is formed of a thermoplastic polymer from any one of the group consisting of polypropylene, woven polypropylene material, polycarbonate, nylon, and polyethylene.
[Item 51]
The at least one vent is irremovably connected to the frame by molecular attachment using any one from the group consisting of overmolding, co-injection molding, and two-shot (2K) injection molding. The patient interface described in.
[Item 52]
The patient interface according to any of the preceding paragraphs, wherein the at least one vent has a semicircular or D-shape.
[Item 53]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure comprises a recess for receiving the top of the patient's nose.
[Item 54]
As described in any of the preceding paragraphs, wherein the seal forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal forming structure. Patient interface.
[Item 55]
The patient interface according to any of the preceding paragraph, wherein the seal forming structure comprises foam, gel, and / or low durometer silicone.
[Item 56]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure varies in thickness at a predetermined position around the nasal opening.
[Item 57]
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. The patient interface described in any of the preceding sections configured in.
[Item 58]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The patient interface of any of the preceding paragraphs, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 59]
The patient interface according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state to follow the curvature of the patient's upper lip.
[Item 60]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. The patient interface described in.
[Item 61]
In the positioning stabilization structure for the patient interface device,
With at least one strap
At least one rigidizer arm, wherein the at least one rigidizer arm includes a main body and an extension for connecting the main body to a mask frame.
With
The positioning stabilization structure has a predetermined shape that allows at least a cured portion of the at least one strap to move relative to the at least one rigidizer arm so that the at least one rigidizer arm cures the at least one strap. The at least one strap and the at least one rigidizer arm are arranged so as to be positioned relative to each other so that the at least one strap is provided at the portion to be provided.
The extending portion is a positioning stabilizing structure configured to prevent the movement of the at least one rigidizer arm with respect to the mask frame in a plane parallel to the sagittal plane of the patient.
[Item 62]
The positioning stabilization structure according to any of the preceding paragraph, wherein the extension is configured to allow flexion of the at least one rigidizer arm in a plane parallel to the Frankfort horizontal plane of the patient.
[Item 63]
The positioning stabilizing structure according to any previous section, wherein the at least one rigidizer arm is attached to the at least one strap in a limited area of the at least one strap.
[Item 64]
The positioning stabilization structure according to any previous section, wherein the limited area is adjacent to the pocket or sleeve opening of the at least one strap.
[Item 65]
The positioning stabilizing structure according to any previous section, wherein the extending portion has a width substantially equal to the widest portion of the main body.
[Item 66]
The positioning stabilizing structure according to any previous section, wherein the at least one rigidizer arm is formed so as to extend from the mask frame to a position close to the patient's cheekbone or a position below the cheekbone.
[Item 67]
The positioning stabilization structure according to any one of the preceding paragraphs, wherein the at least one rigidizer arm has a crescent-shaped side surface outer shape.
[Item 68]
The end of the at least one rigidizer arm is attached to the at least one strap.
The at least one rigidizer arm is attached to at least one strap by sewing, welding, gluing, caulking, clamping, buttoning, snapping the cover over the edges and / or snapping to an external component. Any of the positioning stabilization structures described in the preceding section that are attached.
[Item 69]
The at least one strap allows the length of the positioning stabilization structure to be adjusted by at least one of the bending of the at least one rigidizer arm, the rudder lock clip, the buckle connection, and the hook and loop connection. Any of the positioning stabilization structures described in the preceding section that are substantially inelastic.
[Item 70]
The predetermined shape given is any of the positioning stabilization structures according to the preceding paragraph that directs the pressure of the positioning stabilization structure to a predetermined portion of the wearer's face.
[Item 71]
The positioning stabilization structure according to any previous section, wherein the at least one rigidizer arm cannot be extended and has a rigidity relatively higher than that of the at least one strap.
[Item 72]
The positioning stabilization structure according to any previous section further comprising two or more rigidizer arms symmetrically arranged on both sides of the patient's face.
[Item 73]
The positioning stabilization structure according to any previous section, wherein the at least one rigidizer arm is completely removable from the at least one strap.
[Item 74]
The positioning stabilization structure according to any of the preceding paragraph, wherein the at least one strap comprises two pockets, each of which receives one rigidizer arm to releasably secure the at least one strap to the rigidizer arm.
[Item 75]
The at least one strap comprises at least one holding means, which holds a loop, sleeve, and / or pocket for receiving the at least one rigidizer arm and holding the at least one rigidizer arm in place. Any of the positioning stabilization structures according to the preceding section.
[Item 76]
The at least one rigidizer arm comprises at least one holding means, which holds a loop, sleeve, and / or pocket for receiving the at least one strap and holding the at least one strap in place. Any of the positioning stabilization structures according to the preceding section.
[Item 77]
The positioning stabilization structure according to any previous section, wherein the at least one rigidizer arm is attached to a guide element provided on the at least one strap.
[Item 78]
The positioning stabilization structure according to any of the preceding paragraph, wherein the guide element is a loop or sheath or passage or pocket into which the at least one rigidizer arm extends or extends through.
[Item 79]
The guide element allows longitudinal expansion or contraction of the at least one strap with respect to the at least one rigidizer arm and / or allows almost free movement or free movement of the at least one rigidizer arm with respect to the at least one strap. Any positioning stabilization structure described in the previous section that allows.
[Item 80]
The positioning stabilizing structure according to any preceding item, wherein the extending portion is irremovably fixed to the mask frame and the main body is removable from the extending portion.
[Item 81]
The positioning stabilizing structure according to any preceding item, wherein the extending portion and the main body are integrated, and the extending portion is removable from the mask frame.
[Item 82]
In a patient interface system for delivering a continuous positive respiratory gas flow to atmospheric pressure to at least the entrance to the patient's airway, including the entrance to the patient's nose, the patient interface is a sleep-breathing disorder. It is configured to maintain therapeutic pressure within a range of _{approximately 4 cmH 2} O to approximately 30 cmH ₂ O above the atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep. , The patient interface system
With any of the positioning stabilization structures described in the previous section,
Patient interface and
With
The patient interface
A seal-forming structure for supplying a pressurized gas to at least both nasal passages of a patient and a plenum chamber pressurized at a pressure higher than atmospheric pressure during use, wherein the seal-forming structure and the plenum chamber are used. And the seal forming structure, wherein the plenum chamber includes a plenum connecting area and the seal forming structure is configured to seal below the nasal bridge over the lower outer periphery of the patient's nose.
To minimize the rebreathing of CO ₂ exhaled by the patient, a gas outlet vent configured to allow flow to the outside of the patient interface of CO ₂ patient exhales,
A frame that can be releasably attached to the plenum connection zone,
Patient interface system with.
[Item 83]
In the cushioning member for the patient interface to deliver a predetermined amount of pressurized air or respiratory gas to the entrance of the patient's airway.
Retaining structures for repeatable engagement with and disengagement from the frame member,
A seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nose holes of the patient are integrally formed, and the seal-forming structure extends over the lower outer periphery of the patient's nose and is more than a nasal bridge. With a seal forming structure configured to seal on the underside and the seal forming structure and the plenum chamber being irremovably connected to the holding structure.
With
The seal forming structure is formed from a first material, and the holding structure is formed from a second material having different mechanical properties from the first material, and the second material is the first material. Harder than the material of
A cushion member in which an increase in air pressure in the cushion member enhances a sealing force between the seal forming structure and the frame member.
[Item 84]
The cushion member according to any one of the preceding paragraphs, wherein the first material is silicone, and the second material is silicone having a higher durometer than the first material.
[Item 85]
The cushion member according to any preceding item, further comprising a plenum chamber located between the holding structure and the seal forming structure.
[Item 86]
The cushion member according to any one of the preceding paragraphs, further comprising a frame member formed from the second material.
[Item 87]
The first material allows the seal forming structure to easily adapt to acupressure, and the second material allows the holding structure to not easily adapt to acupressure as described in any of the preceding paragraphs. Cushion member.
[Item 88]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure includes a recess for receiving the top of the patient's nose.
[Item 89]
As described in any of the preceding paragraphs, wherein the seal-forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal-forming structure. Cushion member.
[Item 90]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure contains a foam, a gel, and / or a low durometer silicone.
[Item 91]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure changes in thickness at a predetermined position around the nasal opening.
[Item 92]
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. The cushion member according to any of the preceding paragraphs.
[Item 93]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The cushion member according to any preceding paragraph, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 94]
The cushion member according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state so as to follow the curvature of the patient's upper lip.
[Item 95]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. Cushion member described in.
[Item 96]
In a patient interface for delivering a continuous positive respiratory gas flow to atmospheric pressure to at least the entrance to the patient's airway, including the entrance to the patient's nasal passage, the patient interface is a sleep-breathing disorder. It is configured to maintain therapeutic pressure within the range of _{about 4 cmH 2} O to about 30 cmH ₂ O above atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep. The patient interface
With any cushion member described in the previous section,
A positioning stabilization structure for maintaining therapeutic pressure at least at the entrance to the patient's nasal airway while maintaining seal contact with the cushion member at least in contact with the area surrounding the entrance to the patient's nasal airway.
A plenum chamber that is pressurized at a pressure above atmospheric pressure during use,
To minimize the rebreathing of CO ₂ exhaled by the patient, a gas outlet vent configured to allow flow to the outside of the patient interface of CO ₂ patient exhales,
A patient interface.
[Item 97]
In the patient interface for giving respiratory gas to the patient
A seal-forming structure in which a nasal opening for supplying pressurized gas to both nostrils of a patient and a plenum chamber are integrally formed, wherein the plenum chamber includes a plenum connection region, and the seal-forming structure is formed. A seal-forming structure configured to seal below the bridge of the nose over the lower perimeter of the patient's nose.
A frame with a frame connection area and a headgear connection area,
Prepare
The frame connection area is configured to attach to the plenum chamber at the plenum connection area.
A patient interface in which the seal lip forms a pneumatic seal between the plenum connection area and the frame connection area.
[Item 98]
The frame connection area comprises at least one holding function for facilitating connection with the plenum connection area.
The patient interface of any of the preceding paragraphs, wherein the plenum connection zone comprises at least one complementary connection zone to receive at least one retaining functional portion corresponding thereto.
[Item 99]
5. Patient interface.
[Item 100]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure comprises a recess for receiving the top of the patient's nose.
[Item 101]
As described in any of the preceding paragraphs, wherein the seal forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal forming structure. Patient interface.
[Item 102]
The patient interface according to any of the preceding paragraph, wherein the seal forming structure comprises foam, gel, and / or low durometer silicone.
[Item 103]
The patient interface according to any of the preceding paragraphs, wherein the seal forming structure varies in thickness at a predetermined position around the nasal opening.
[Item 104]
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. The patient interface described in any of the preceding sections configured in.
[Item 105]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The patient interface of any of the preceding paragraphs, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 106]
The patient interface according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state to follow the curvature of the patient's upper lip.
[Item 107]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. The patient interface described in.
[Item 108]
In a cushioning member for a nasal cradle mask to deliver a predetermined amount of pressurized air or respiratory gas to the entrance of the patient's airway.
Retaining structures for repeatable engagement with and disengagement from the frame member,
A seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nose holes of the patient are integrally formed, and the seal-forming structure extends over the lower outer periphery of the patient's nose and is more than a nasal bridge. With a seal forming structure configured to seal on the underside, the seal forming structure and the plenum chamber are irremovably connected to the holding structure.
With
The increase in air pressure in the cushion member increases the sealing force between the seal forming structure and the frame member.
A cushion member in which the holding force between the holding structure and the frame member is higher than the separating force for separating the holding structure from the frame member.
[Item 109]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure includes a recess for receiving the top of the patient's nose.
[Item 110]
The optional previous section, wherein the seal forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal forming structure. Cushion member.
[Item 111]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure contains a foam, a gel, and / or a low durometer silicone.
[Item 112]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure changes in thickness at a predetermined position around the nasal opening.
[Item 113]
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. The cushion member according to any of the preceding paragraphs.
[Item 114]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The cushion member according to any preceding paragraph, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 115]
The cushion member according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state so as to follow the curvature of the patient's upper lip.
[Item 116]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. Cushion member described in.
[Item 117]
In a patient interface for delivering a continuous positive respiratory gas flow to atmospheric pressure to at least the entrance to the patient's airway, including the entrance to the patient's nasal passage, the patient interface is a sleep-breathing disorder. It is configured to maintain therapeutic pressure within the range of _{about 4 cmH 2} O to about 30 cmH ₂ O above atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep. The patient interface
With any cushion member described in the previous section,
A positioning stabilization structure for maintaining therapeutic pressure at least at the entrance to the patient's nasal airway while maintaining seal contact with the cushion member at least in contact with the area surrounding the entrance to the patient's nasal airway.
A plenum chamber that is pressurized at a pressure above atmospheric pressure during use,
To minimize the rebreathing of CO ₂ exhaled by the patient, a gas outlet vent configured to allow flow to the outside of the patient interface of CO ₂ patient exhales,
A patient interface.
[Item 118]
In the cushioning member for the patient interface to deliver a predetermined amount of pressurized air or respiratory gas to the entrance of the patient's airway.
Retaining structures for repeatable engagement with and disengagement from the frame member,
A seal-forming structure in which a nasal opening and a plenum chamber for supplying pressurized gas to both nose holes of the patient are integrally formed, and the seal-forming structure extends over the lower outer periphery of the patient's nose and is more than a nasal bridge. With a seal forming structure configured to seal on the underside, the seal forming structure and the plenum chamber are irremovably connected to the holding structure.
With
The seal forming structure includes a recess for receiving the top of the patient's nose.
The seal forming structure comprises a pair of protruding ends that extend symmetrically around the nasal opening so that each protruding end seals against the patient's facial area where the nasal wings connect to the patient's face. Cushion member composed of.
[Item 119]
The seal-forming structure of any of the preceding paragraphs comprises a double wall cushion to prevent the seal-forming structure from collapsing when the seal-forming structure is engaged with the patient's nose to form a pneumatic seal. Cushion member described in.
[Item 120]
As described in any of the preceding paragraphs, wherein the seal-forming structure comprises an acclimatization region located above the recess, the acclimatization region being thinner and more flexible than the rest of the seal-forming structure. Cushion member.
[Item 121]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure contains a foam, a gel, and / or a low durometer silicone.
[Item 122]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure changes in thickness at a predetermined position around the nasal opening.
[Item 123]
The cushion member according to any one of the preceding paragraphs, wherein the seal forming structure includes an overhanging portion in the nose opening of the seal forming structure, and the overhanging portion is located in the vicinity of the recess.
[Item 124]
The seal forming structure comprises a pair of protruding end support portions that correspond to each protruding end and are structured to support each protruding end.
The cushion member according to any preceding paragraph, wherein the pair of protruding end support portions extend at least in part into a gas chamber defined by the seal forming structure.
[Item 125]
The cushion member according to any of the preceding paragraph, wherein the lower portion of the seal forming structure seals against the patient's upper lip and is concave in a relaxed state so as to follow the curvature of the patient's upper lip.
[Item 126]
The lower portion is any cushioning member according to the preceding paragraph that has a reduced material thickness with respect to the rest of the seal forming structure.
[Item 127]
In a patient interface for delivering a continuous positive respiratory gas flow to atmospheric pressure, at least to the entrance to the patient's airway, including the entrance to the patient's nostrils, in a sealed state.
The patient interface provides therapeutic pressure within a range of _{approximately 4 cmH 2} O to approximately 30 cmH ₂ O above atmospheric pressure during use throughout the patient's respiratory cycle while the patient is asleep to ameliorate sleep apnea. The patient interface is configured to maintain
With any cushion member described in the previous section,
A positioning stabilization structure for maintaining therapeutic pressure at least at the entrance to the patient's nasal airway while maintaining seal contact with the cushion member at least in contact with the area surrounding the entrance to the patient's nasal airway.
A plenum chamber that is pressurized at a pressure above atmospheric pressure during use,
To minimize the rebreathing of CO ₂ exhaled by the patient, a gas outlet vent configured to allow flow to the outside of the patient interface of CO ₂ patient exhales,
Patient interface with.

Claims (18)

A patient interface configured to deliver, in a sealed state, a supply of breathable gas that is continuously positively pressurized to the ambient air pressure to the patient's nose, said patient interface is sleep. To ameliorate respiratory distress, maintain therapeutic pressure in the range of _{approximately 4 cmH 2} O to approximately 30 cmH ₂ O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep. Is composed of
The patient interface
To allow flow to the outside of the patient interface of CO ₂ patients vomited includes configurations gas outlet vent to minimize rebreathing of CO ₂ the patient vomited a frame member,
A cushioning member configured to deliver a pressurized breathable gas supply to the patient's nostrils,
The cushion member is provided with
A seal-forming structure that is configured to seal the patient's face around both nasal passages around the lower part of the patient's nose, resulting in the seal-forming structure. The seal forming structure is configured to prevent entry into the patient's nose during use, under the bridge of the nose, on the lateral side of the patient's nose and on the patient's upper lip, said seal forming. The structure does not have an undercushion, the seal forming structure and
A plenum chamber, which is connected to the seal forming structure and at least partially forms a gas chamber,
A holding structure configured to be releasably engaged with the frame member to releasably secure the seal forming structure and the plenum chamber to the frame member.
Including
The patient interface
Said seal forming structure, a constructed positioned stabilizing structure so as to maintain in contact the patient's face and seal while maintaining the therapeutic pressure in the patient's nares, said positioning stabilizing structure Includes a pair of rigidizer arms, each of which is coupled to the corresponding side surface of the frame member, the positioning stabilization structure includes a strap having two ends, each end corresponding to the rigidizer arm. With a positioning stabilization structure, detachably connected to one,
The seal forming structure and the plenum chamber are made of a first material of one piece, the holding structure is made of a second material, the first material is silicone, and the first material. the second material is a silicone having a higher durometer than the first material, as a result, the retaining structure, said rigid than the seal forming structure and the plenum chamber is rather high,
The plenum chamber further includes a seal lip configured to contact the frame member, which increases the sealing force of the seal lip on the frame member as the air pressure in the gas chamber increases. The patient interface is configured to be. The patient interface according to claim 1, wherein the plenum chamber is disposed between the holding structure and the seal forming structure. Said frame member, said first material and said second flexible than the material is made from a low third material, the patient interface of claim 1 or 2. The patient interface according to any one of claims 1 to 3, wherein the first material is more flexible than the second material. The seal forming structure includes a recess configured to receive the tip of the patient's nose.
Any one of claims 1 to 4, wherein the recess is located in a region of the seal-forming structure that is thinner than a laterally adjacent region of the seal-forming structure configured to contact the patient's nasal wing. The patient interface described in. 5. The seal-forming structure comprises an acclimatization region disposed above the recess, which is thin and flexible with respect to the rest of the seal-forming structure, claim 5. Patient interface. The patient interface according to any one of claims 1 to 6, wherein the seal forming structure has various thicknesses adjacent to the nasal opening at a predetermined position around the nasal opening. The seal forming structure includes a pair of protruding ends that extend symmetrically with respect to the nasal opening, and each protruding end is configured to seal the area of the patient's face where the nasal wings join the patient's face. The patient interface according to any one of claims 1 to 7. The patient interface according to any one of claims 1 to 8, wherein the lower portion of the seal forming structure is concave in a relaxed state so as to seal the patient's upper lip and follow the curvature of the patient's upper lip. The patient interface according to any one of claims 1 to 9, wherein the frame member further comprises a rib, and the plenum chamber further comprises a notch corresponding to the rib. The patient according to any one of claims 1 to 10, wherein the holding structure is permanently bonded to the plenum chamber by a chemical bond between the first material and the second material. interface. The patient interface according to any one of claims 1 to 11, wherein the pair of rigidizer arms are made of a material different from the material of the frame member. The patient interface according to any one of claims 1 to 12 , wherein the pair of rigidizer arms are permanently coupled to the frame member by mechanical coupling. The patient interface according to any one of claims 1 to 13 , wherein the gas outflow vent further comprises two groups of vent holes, each of which is located on the corresponding side surface of the frame member. The frame member further comprises a port and a tube connected to the frame member at the port so that the tube directs a pressurized breathable gas supply through the port to the gas chamber. The patient interface according to any one of claims 1 to 14 , which is configured. The seal-forming structure further comprises a pair of thick portions, each of which contacts the patient's face at or proximal to the patient's corresponding nasolabial fold during use. The patient interface according to any one of claims 1 to 15 , which is located on the corresponding side surface of the seal forming structure. The patient interface according to claim 16 , wherein the thick portion is thicker than an adjacent portion of the seal forming structure. Said seal forming structure consists of a single nasal opening configured to provide a supply of breathable gas under pressure to both the patient's nares in use, any one of the claims 1 to 17 The patient interface described in paragraph 1.

Images