KR102284537B1 - Patient interface and method for making same - Google Patents

Abstract

A patient interface for delivery of a supply of pressurized air or respirable gas to an inlet of a patient's airway comprises: a cushion member comprising a retention structure and a seal forming structure permanently connected to the retention structure; a frame member attachable to the holding structure; and a mounting and positioning and stabilizing structure to the frame member.

Description

PATIENT INTERFACE AND METHOD FOR MAKING SAME

This application is a U.S. Provisional Application, filed July 27, 2012, 61/676,456, April 30, 2013, 61/817,674, filed May 14, 2013, 61/823,192, 2013 Claims the interests of Nos. 61/837,521, filed on June 20, and 61/839,916, filed on June 27, 2013. This application is an Australian Provisional Application, filed on 15 August 2012 in 2012903504, on 8 October 2012 in 2012904378, on 16 January 2013 in 2013900132 on 16 January 2013. Claims the interests of No. 2013900133, filed on June 24, 2013, No. 2013902305, filed on June 24, 2013, and No. 2013900168, filed on January 18, 2013. This application claims the benefit of 605907, filed on January 16, 2013, 610823, filed on May 21, 2013, and 605908, filed on January 16, 2013 as New Zealand applications. Each application referenced above is hereby incorporated by reference in its entirety.

3.1 Technical field

The present invention relates to one or more diagnosis, treatment, amelioration of respiratory disorders and surgery to prevent respiratory disorders. In particular, the present invention relates to medical devices and the use of said devices for treating and preventing respiratory diseases.

3.2 Description of the relevant technology

The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

The airways are narrow and short to penetrate deep into the lungs and contain many series of organs. The main function of the lungs is gas exchange, which allows oxygen to move from the atmosphere into the venous blood and carbon dioxide to escape. The trachea is divided into left and right main bronchi, which are eventually further divided into terminal bronchioles. The bronchi constitute the guided airways and do not participate in gas exchange. Another division of the airways leads to the respiratory bronchioles and eventually to the alveoli.

The alveolated region of the lung is referred to as the breathing region where gas exchange takes place.

A range of respiratory diseases exists.

Obstructive sleep apnea (OSA) A form of sleep-disordered breathing (SDB) is characterized by blockage of the upper air passages during sleep. It is caused by a combination of an abnormally small upper airway and a general loss of muscle tension in the areas of the tongue, soft palate and posterior pharyngeal wall during sleep. This condition causes the affected patient to occasionally stop breathing, usually 30-120 seconds, sometimes 200-300 breaths per night. It often causes excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. Although the affected person may not have consciousness problems, this syndrome is a common disorder, especially among middle-aged and overweight men. See US Pat. No. 4,944,310 to Sullivan.

Chain-Stokes respiration (CSR) is an impairment of respiratory control in patients with periods of alternating waxing and terminal ventilation rhythms that result in repetitive deoxidation and re-oxygenation of arterial blood.

CSR can be detrimental due to recurrent hypoxia. In some patients, CSR is accompanied by repeated awakenings during sleep, leading to severe sleep disturbances, increased sympathetic activity and increased afterload. See US Pat. No. 6532959 (Burton-Jones).

Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and arousal chronic hypercapnia in the absence of other known causes for ventilation. Symptoms include shortness of breath, morning headaches, and excessive daytime sleepiness.

Chronic obstructive pulmonary disease (COPD) comprises one of a group of low respiratory diseases that have certain characteristics in common. These include increased resistance to movement of air, prolonged exhalation phase of respiration and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is due to chronic smoking (a major risk factor), occupational exposure, air pollution, or genetic factors. Symptoms include: difficulty breathing with exercise, chronic cough and sputum production.

Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that impair the function of muscles either directly through specific muscle pathologies or indirectly through neuropathology. Some patients with NMD are characterized by progressive muscle damage that leads to death from gait loss, wheelchair use, dysphagia, respiratory muscle weakness, and eventually respiratory failure.

Neuromuscular diseases can be divided into acute and chronic progression.

(i) Rapidly progressive disease is characterized by: muscle disorders that worsen over months and die within years (eg, teenage amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)).

(ii) a variable or chronic progressive disease is characterized by:

Muscular disturbances that worsen over many years and moderately reduce life expectancy (eg, extremities, scapular brachialis, and myotonic muscular dystrophy).

Symptoms of respiratory failure in NMD include: generalized weakness on exercise, dysphagia, increased dyspnea, fatigue at rest, drowsiness, morning headaches, and difficulty concentrating and mood swings.

Chest wall disorders are a group of thoracic malformations caused by inefficient coupling between the respiratory muscles and the rib cage. The disorder is usually characterized by limited defects and shares a high long-term potential for carbon dioxide respiratory failure. Spinal and/or scoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exercise, peripheral edema, sitting breathing, repeated chest infections, morning headache, fatigue, poor sleep quality and loss of appetite. On the other hand, a healthy individual may use the system or device to prevent respiratory disease.

3.2.1 System

One known product used to treat SDB is the S9 Sleep Therapy System from ResMed.

3.2.2 Therapy

Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The hypothesis is that continuous positive airway pressure can act as an air splint and prevent upper airway obstruction by pressing the soft palate and tongue anteriorly away from the posterior oropharyngeal wall. Non-invasive ventilation (NIV) has been used to treat OHS, COPD, MD and chest wall disorders.

3.2.3 Patient Interface

Providing a positive pressure supply of air to the entrance of the patient's airways is facilitated by the use of a patient interface such as a nose mask, face mask or nose pillow. A face mask includes a mask having one or more seal forming portions covering at least the nostrils and the mouth, respectively, and one or more seal forming portions respectively covering at least the nostrils and the mouth.

However, while a range of patient interface devices are known, many of them suffer from one or more impairments, unsatisfactory aesthetics, insufficient wear, difficulty in use, and discomfort, particularly when worn for extended periods of time or when the patient is unfamiliar with the system. .

Masks designed for aviators, as part of personal protective equipment or for the administration of anesthetics, are useful for their intended purpose but are inconvenient to wear for long periods of time, for example while sleeping.

3.2.3.1 Seal forming structure

The patient interface generally includes a seal forming structure.

One type of seal forming structure extends around the patient interface and aims to seal a user's face when a force is applied to the patient interface having a seal forming structure facing the user's face. The seal forming structure may include a molded or formed surface of an air or fluid filled cushion or an elastic seal member made of an elastomer such as rubber. A gap may exist between the seal forming structure and the face when wearing is not appropriate, requiring additional force to force the patient interface against the face to achieve the seal.

Another type of seal forming structure incorporates a flap seal of thin material that is positioned around the perimeter of the mask to provide a self-sealing action to the user's face when positive pressure is applied to the mask. If there is a mismatch between the face and the mask, such as in conventional style seal formation structures, additional force may be required to seal or the mask may leak. In addition, if the shape of the seal forming structure does not match the shape of the patient, it is folded or distorted during use and leaked.

Other types of seal forming structures may use an adhesive to form the seal. Some patients may find it uncomfortable to always apply and remove the adhesive from the face. The scope of the patient interface seal forming structure technology is disclosed in the following patent applications granted to ResMed Limited: WO 1998/004310; WO 2006/074513; WO 2010/135785.

3.2.3.2 Positioning and stabilization

The seal forming structure of the patient interface used for positive pressure therapy is subjected to a force corresponding to air pressure to break the seal. Accordingly, various techniques have been used to place the seal forming structure and maintain a seal relationship with the appropriate portion of the face.

One technique is the use of adhesives. See, eg, US patent application US2010/0000534.

Another technique is the use of one or more straps and a stabilization harness. Many of these devices have one or more misuse - bulky, uncomfortable and difficult to use.

Rigid elements, also known as "rigidezers", have been conventionally used in flexible headgear. One known problem relates to the fact that rigidity that is permanently attached (eg laminated or stitched) to large areas of stretchable material limits the stretchable length of the material and affects the elastic properties of the overall headgear. Another problem relates to cleaning headgear, which requires both rigid and flexible materials to be permanently engaged with each other.

3.2.3.3 Vent technology

Some types of patient interface systems may include vents that allow the exhaled carbon dioxide to be washed out. Many of these vents are noisy. Others may block in use and provide insufficient wash out. Some vents can disrupt the patient's bed partner's sleep, for example through noise or concentrated air. Since some vents cannot be properly cleaned, they must be blocked and discarded. In order to encourage more frequent vent replacement as some vents are designed to be used for short periods of time, i.e. less than three months, they are made of fragile materials that prevent cleaning or frequent cleaning.

ResMed Limited has developed a number of improved mask venting technologies. WO 1998/034665; WO 2000/078381; US 6581594; US Patent Application US2009/0050156. See US Patent Application 2009/0044808.

Noise table of conventional masks (ISO 17510-2:2007, 10 cm H ₂ O pressure 1 m)

The various sound pressure values of the object are as follows.

3.2.3.4 Nose pillow technique

One type of nasal pillow is found in the Adam Circuit of Puritan Bennett. Another nasal pillow or nose puff is the subject of US Patent 4782832 (Trimble et al.) assigned to Puritan-Bennett.

ResMed Limited manufactures the following products incorporated into nasal pillows: SWIFT™ Nasal Pillow Mask, SWIFT II™ Nose Pillow Mask, SWIFT LT™ Nose Pillow Mask, SWIFT FX™ Nose Pillow Mask and LIBERTY Face Mask. The following patent applications assigned to ResMed Limited describe nasal pillow masks: International patent application WO/2004/073778 (describing, among other things, the features of LesMed's SWIFT ™ nasal pillow); US Patent Application 2009/0044808 (describing, among other things, the features of the SWIFT LT nose pillow from ResMede); International patent applications WO2004/063328 and WO2006/130903, describing, among other things, the features of the LIBERTY™ face mask from ResMed; International patent applications WO 2009/052560, describing, among other things, the features of the SWIFT FX™ nasal pillow from LesMed ).

3.2.4 PAP device

Positive pressure air is typically supplied to the patient's airways by a PAP device such as an electric blower. As above, the outlet of the blower is connected to the patient interface via a flexible delivery conduit.

3.2.5 Mandibular Reposition

Mandibular Repositioning Device (MRD) is one of the treatment options for sleep apnea. This is a dental-provided, custom adjustable oral appliance that holds the lower jaw in an anterior position during sleep. These mechanical projections expand the space behind the tongue and reduce the vibration of the palate by tensioning the pharyngeal wall to reduce airway collapse.

(D) Overview of the technology

It is an object of the present invention to provide a medical device for use in the diagnosis, alleviation, treatment or prevention of respiratory diseases having one or more improved comfort, cost, efficiency, usability, and ease of manufacture.

One aspect of the present invention relates to a device for use in the diagnosis, amelioration, treatment or prevention of respiratory diseases.

Another aspect of the invention relates to a method for use in the diagnosis, amelioration, treatment or prevention of respiratory diseases.

One aspect of one form of the invention is a patient interface having a seal forming structure that is removable for cleaning. This is a requirement of the present invention to provide a patient interface that is lighter, less intrusive and quieter in use compared to prior art patient interfaces. In addition, it is desirable to provide a patient interface that is intuitive for the patient when connecting the mask components prior to initiation of treatment, and is also easy to adjust and wear for treatment.

One aspect of one form of the present invention is a patient interface having a seal forming structure that is appropriately positionable to the patient interface via a hard to hard connection. Another aspect of one form of the invention is a seal forming structure of a patient interface that is removable for cleaning without requiring cutting of the headgear portion of the patient interface.

One aspect of one aspect of the present invention is a seal forming structure including a seal forming structure, a plenum chamber and a connection portion. The seal forming structure and the plenum chamber are formed of a relatively soft material, and the connecting portion is formed of a relatively hard material. In one form, the connection is removably connectable to the frame of the patient interface via, for example, a snap action, toggle, or bistable mechanism. In one form, the connection is insert molded into the plenum chamber.

One aspect of one form of the invention is a patient interface that avoids or reduces contact with the patient's septum and/or upper lip.

Another aspect of one form of the present invention is a patient interface constructed or shaped into a perimeter shape that is specifically shaped to conform to the intended wearer.

One aspect of the invention is a method of manufacturing a patient interface described herein. It is a requirement of the present invention to provide a manufacturing method that is less complex than prior art methods of manufacturing patient interfaces to increase production efficiency, uses less raw material, and requires less assembly time for the operator.

Another aspect of the invention is a patient interface for the supply of pressurized air or respirable gas to the airway inlet of a patient. The patient interface may include: a cushion member comprising a retention structure and a seal forming structure permanently connected to the retention structure; and a frame member, the holding structure and the frame member being repeatedly detachable from each other; A gas chamber is formed at least in part by the connection of the cushion member and the frame member. An increase in the pressure of the cushion member increases the sealing force between the seal forming structure and the frame member.

E.g,

(a) the seal forming structure can be co-molded with the retaining structure;

(b) the cushioning member is repeatedly detachable from the frame member by fitting at two opposing positions of the member proximate the retaining structure;

(c) the seal forming structure may include a sealing lip that seals against the frame member when the retaining structure and the frame member are attached to each other, wherein the sealing lip is configured to increase the sealing force when the air pressure in the cushion member increases. is biased towards the frame member,

(d) the seal lip may be a continuous inner peripheral edge integral with the seal forming structure;

(e) the retaining structure and the frame member may be stiffer than the sealing forming structure;

(f) the retention structure may include a pair of barbs,

(g) the frame member may include a channel configured to receive a respective bonding characteristic of the cushion member;

(h) the cushioning member may include a channel configured to receive a respective bonding characteristic of the frame member.

(i) the seal-forming structure may include a sealing flange extending around the seal-forming structure to form a seal at an airway entrance of a patient;

(j) the frame member may include a tongue portion arranged and configured to seal with the sealing flange.

(k) the cushioning member may include a plenum chamber having a rear wall disposed and configured to be positioned adjacent an upper lip of a patient in use, the plenum chamber being positioned between the retaining structure and the seal forming structure;

(l) the patient interface may include a positioning and stabilizing structure or a connector for a positioning and stabilizing structure;

(m) the patient interface may be directly connected to the gas delivery tube by a connection port;

(n) the connection port may be integrally formed with the frame of the patient interface;

(o) the connection port may be formed at an angle to the frame;

(p) the plenum chamber may comprise a recessed saddle-shaped region spanning the plenum chamber between the nasal pillows;

(q) The saddle-shaped region may span from a front wall of the plenum chamber to a rear wall of the plenum chamber.

Another aspect of the invention relates to a patient interface for providing a patient with a respirable gas. The patient interface may include: a plenum chamber having a plenum containment area; a seal forming structure disposed in the plenum chamber; a frame comprising a frame connection area and a headgear connection area; and a gas delivery tube, the gas delivery tube being insert molded into the frame.

Another aspect of the invention relates to a patient interface for providing a patient with a respirable gas. The patient interface may include: a plenum chamber having a plenum containment area; a seal forming structure disposed in the plenum chamber; a frame comprising a frame connection area and a headgear connection area; and a connection port for receiving the gas delivery tube, the connection port being connected to the frame at a limited portion or portion around the connection port.

Another aspect of the invention relates to a patient interface for providing a patient with a respirable gas.

The patient interface may include: a plenum chamber having a plenum containment area; a seal forming structure disposed in the plenum chamber; a frame comprising a frame connection area and a headgear connection area; The frame connection region is configured to attach to the plenum chamber at the plenum connection region, and the sealing lip is configured to form an air seal between the plenum connection region and the frame connection region.

E.g,

(a) The seal forming structure may include a pair of nasal pillows constructed and arranged to provide a substantially sealed pathway for respirable gases to the nostrils and to form at least partially a seal in the axial region of the patient's nose.

(b) each of the pair of nasal pillows may include an incision-conical portion pneumatically connected to the plenum chamber by a stem.

(c) the incision cone portion may include a sealing flange and a support flange, wherein the sealing flange and the support flange may be connected to the stem by the flexible region.

(d) the support flange may be configured to press the sealing flange against a region surrounding the patient's nostril.

(e) the plenum chamber may include a sealing lip, wherein the sealing lip is located at the plenum connection region.

(f) the sealing lip may be disposed annularly relative to the plenum chamber in the plenum connection region.

(g) The sealing lip may be disposed around the interior of the plenum chamber.

(h) The sealing lip may be disposed around the exterior of the plenum chamber.

(i) the seal lip may rest from the plenum chamber in opposite directions and angles of the seal forming structure.

(j) the seal lip may be configured and disposed to be deformable in a direction toward the seal forming structure such that an air seal is formed between the plenum chamber and the frame when the frame is attached to the plenum chamber through the plenum connection region.

(k) The sealing lip may be disposed around the entire interior of the plenum chamber.

(1) The sealing lip may be disposed around the entire exterior of the plenum chamber.

(m) The sealing lip and the plenum chamber may comprise one piece.

(n) The plenum connection region and the plenum chamber may be fixedly attached by simultaneous molding or injection molding.

(o) The plenum connection region and the plenum chamber may contain different materials.

(p) The plenum chamber may contain a material that is softer than the plenum connection region.

(q) the plenum chamber may comprise an elastomeric material, and the plenum connection region may comprise a polycarbonate, a high hardness silicone or a thermoplastic elastomer.

(r) The material comprising the plenum connection area and the material comprising the frame may be the same.

(s) the plenum connection area may include at least one retaining feature to facilitate connection with the frame, and the frame may include at least one complementary frame connection area to accommodate the corresponding retaining feature. there is

(t) each of the at least one retaining feature may comprise a barb, wherein the barb comprises a leading surface and a trailing surface and each at least one frame connection area comprises a lead-in surface and a retaining surface. can

(u) the complete connection of the at least one frame connection region and the at least one retention characteristic may produce a click sound when the plenum connection region is attached to the frame and the lidding surface passes through the lead-in surface;

(v) the barb is suspended from the at least one retaining feature opposite an additional surface of the at least one retaining feature.

(w) the leading surface and the trailing surface of the barb may be angled towards each other relative to and spaced apart from the additional surface.

(x) The leading surface of the barb may be angled to the additional surface by about 60 degrees.

(y) the trailing surface of the barb may be at an angle of about 75 degrees to the additional surface.

(z) the trailing surface may be angled closer to perpendicular to a surface additional than the leading surface such that the force required to attach the plenum connection area to the frame is greater than the force required to disengage the trailing from the frame. there is.

(aa) the lead-in surface of the at least one frame connection region may be coplanar with the lead-in surface of the at least one retaining characteristic during attachment.

(bb) the retaining surface of the at least one frame connecting region may be flush with the trailing surface of the at least one retaining feature when the at least one frame connecting region and the at least one retaining feature are fully connected.

(cc) the at least one retention characteristic may include a first retention characteristic and a second retention characteristic, and the at least one frame connection region may include a first frame region and a second frame connection region.

(dd) the first retention feature may be sized complementary to the first frame connection area such that the second retention characteristic cannot be coupled to the first frame connection area.

(ee) The frame may include a port connected to a conduit supplying auxiliary oxygen or configured to specify a pressure within the plenum chamber.

(ff) The port may be substantially cylindrical.

(gg) The port and the frame may include an integral body.

(hh) the port may extend from the frame in a direction substantially opposite the plenum chamber.

(ii) the port may extend low from the frame.

(jj) The frame may include at least one vent.

(kk) At least one vent may comprise a mesh.

(ll) the at least one vent may include a pair of vents each disposed on the rear surface of the frame on opposite sides.

(mm) The seal forming structure may be provided in both nostrils of a patient with a single orifice.

(nn) The patient interface may be directly connected to the gas delivery tube by a connection port.

(oo) The connection port may be integrally formed with the frame of the patient interface.

(pp) the connection port may form an angle with respect to the frame.

(qq) the plenum chamber may comprise a recessed saddle-shaped region spanning the plenum chamber between the nasal pillows;

(rr) The saddle-shaped region may span from a front wall of the plenum chamber to a rear wall of the plenum chamber.

Another aspect of one form of the invention is a patient interface constructed or shaped to have a well defined peripheral shape for engagement with an intended wearer.

One aspect of the present invention relates to a positioning and stabilizing structure of a patient interface device. The positioning and stabilizing structure may include:

at least one strap; and at least one rigid-dissipator arm, the positioning and stabilizing structure being arranged such that the at least one rigid-dissipating arm positions the at least one strap and the at least one rigid-dissipator arm relative to each other, such that the at least one strap The reinforced portion allows the at least one strap to have the desired shape, and the reinforced portion of the at least one strap to move relative to the at least one rigidizer arm.

In an embodiment,

(a) the at least one rigidizer arm may be mounted to the at least one strap within a defined area of the at least one strap.

(b) The restricted area may be adjacent to the pocket or sleeve opening.

(c) The positioning and stabilizing structure may include headgear for a patient interface device for dispensing a supply of pressurized air or respirable gas to the patient's airway inlet.

(d) at least one ridgedezer arm may be crescent-shaped.

(e) the at least one strap may be made of an elastic textile material, and the positioning and stabilizing structure is such that the at least one strap aligns with the longitudinal axis of the at least one strap and/or the rigidizer arm relative to the at least one rigid arm. It can be freely arranged to move by elastically expanding and/or contracting accordingly.

(f) the elastic length of the at least one strap may remain substantially unchanged relative to the at least one strap without the at least one rigidizer arm.

(g) The elastic fiber material may be one of the group consisting of: elastane, TPE, nylon and silicone.

(h) The positioning and stabilizing structure may be stretched along its substantially full length.

(i) the at least one strap may be elastic and may be in the form of a sleeve disposed to slip over the at least one ridgedezer arm, the at least one strap maintaining its substantially entire telescoping length and the at least one ridge arranged to be substantially freely stretchable over the dessert arm.

(j) the at least one strap may include a hollow sleeve for receiving the at least one rigid arm and at least one opening for receiving the at least one rigid arm within the sleeve.

(k) the sleeve and the at least one rigid arm may be arranged such that the at least one rigid arm moves in an axial direction within the sleeve.

(j) An end portion of the at least one rigidizer arm may be installed on the at least one strap.

(k) the at least one rigidizer arm may be installed to the at least one strap by barring, welding, gluing, heat staking, clamping, butting, snapping, and/or snapping the cover across the ends and/or snapping the cover to the outer portion. there is.

(j) the snapping on the outer portion aligns the at least one strap with the at least one rigidiser arm when the at least one rigidiser arm is mounted to the at least one strap by stepping on the outer portion, and at least one of the inside of the sleeve. This can be accomplished by pressing down on the ridgedezer arm of the and securing both the sleeve and the ridgedizer arm to the outer part.

(k) the outer portion may be an outer clip that secures both the sleeve and each end of the at least one rigidiser arm, the clip may be configured to attach an end of the positioning and stabilizing structure to each end of the mask frame and the clip may be part of the mask frame itself.

(l) The intended shape imparted is capable of applying the pressure of the positioning and stabilizing structures to any part of the wearer's face.

(m) A plurality of attachment points for attachment may be provided such that at least one anchoring position is selected and altered to allow adjustment of the elastic length of the at least one strap.

(n) the at least one rigidiser arm may be non-stretchable and may be relatively stiffer than the at least one strap.

(o) the at least one strap may include an elastic wall, wherein the elastic wall may be any one of the group consisting of woven, knitted, braided, formed, extruded.

(p) The positioning and stabilizing structure may include two or more rigidiser arms disposed symmetrically on opposite sides of the patient's face.

(q) the at least one rigidiser arm may be completely removable from the at least one strap.

(r) The positioning and stabilizing structure is capable of maintaining its entire working length and is freely elongated along the at least one ridgedizer arm.

(s) the at least one strap may include two side strap portions disposed to extend from the patient interface along a side of the patient's head and two rear strap portions disposed to extend along the back of the patient's head.

(t) The two rear strap portions cannot be adjusted other than to increase the tightness of the rear strap portion through the elasticity of the rear strap portion and by equally reducing the overall length of the positioning and stabilizing structure.

(u) The positioning and stabilizing structure may include three, four or more separate straps connected by two or more joints.

(v) the at least one strap may include two pockets each receiving the rigid-dissipator arm to releasably secure the at least one strap to the rigid-dissipator arm.

(w) The positioning and stabilizing structure may include at least one retaining means which may include loops, sleeves and/or pockets to receive and properly secure the at least one rigidity arm.

(x) the at least one retaining means may be formed on or within the at least one strap.

(y) the at least one ridgedizer arm may be installed on a guide element provided on the at least one strap.

(z) the at least one rigidizer arm may be installed on the at least one strap only at a localized point or area.

(aa) The guiding element may be a loop or sheath-shaped portion or passageway or pocket from which at least one rigidizer arm extends.

(bb) the guiding element is capable of longitudinally expanding or retracting the at least one strap relative to the at least one rigidity arm and/or allowing substantially free movement or floating of the at least one rigidity arm relative to the at least one strap can do.

(cc) the at least one strap may include a rear portion that is divided into at least two rear straps.

(dd) the at least two posterior straps may include a first posterior strap configured to engage the patient proximate the crown of the head and a second posterior strap configured to engage the patient proximate the posterior portion of the head.

(ee) each of the at least two posterior straps may be configured to retain the patient interface against the patient's nose with substantially equal tension.

(ff) each of the at least two posterior straps may be subjected to substantially the same tension when performed by the patient.

(gg) each of the at least two rear straps may be symmetrically and non-independently adjustable such that the at least two rear straps are centered on each side of the crown of the head.

(hh) a separated region may be formed between at least two rear straps and the separated region is about 200 mm long. and/or

(ii) for the patient's face the patient interface system may include: a positioning and stabilizing structure according to any one of the above embodiments; and a patient interface comprising a group consisting of: a nasal cannula, a nose prong, and a breathing mask covering the nose and/or mouth of the wearer.

Another aspect of the present invention relates to a patient interface system for providing a patient with a respirable gas. The patient interface system may include: a patient interface including a seal forming structure to provide an air connection to the patient's airway; and a positioning and stabilizing structure configured to releasably retain the patient interface to the patient, the positioning and stabilizing structure comprising at least one rigidiser arm and at least one strap. The shaped portion of the at least one strap is configured to have the shape of the at least one rigidizer arm. The shaped portion is arranged to move along a longitudinal axis of the at least one rigidizer arm.

In embodiments, (a) the at least one rigid-dissipator arm is capable of mounting to the at least one strap within a defined area of the at least one strap.

(b) The restricted area may be adjacent to the pocket or sleeve opening.

(c) The positioning and stabilizing structure may include headgear.

(d) at least one ridgedezer arm may be crescent-shaped.

(e) the at least one strap may be made of an elastic textile material and the positioning and stabilizing structure is such that the at least one strap is positioned relative to the at least one rigidity arm and along a longitudinal axis of the at least one strap and/or rigidity arm. It may be arranged to move freely by elastically expanding and/or contracting.

(f) the elastic length of the at least one strap may remain unchanged for the at least one strap without the at least one rigidizer arm.

(g) the elastic textile material may be one of the group consisting of: elastane, TPE, nylon and silicone

(h) the positioning and stabilizing structure may extend along substantially its entire length.

(i) the at least one strap may be telescoping and may be in the form of a sleeve disposed to slip over the at least one ridged arm so that the at least one strap retains its entire telescoping length and the at least one rigidizer arm arranged to be freely stretchable over the arm.

(j) the at least one strap may include a hollow sleeve for receiving the at least one rigid arm and at least one opening for receiving the at least one rigid arm into the sleeve.

(k) the sleeve and the at least one rigid arm may be arranged such that the at least one rigid arm moves substantially axially within the sleeve.

(l) An end of the at least one rigidizer arm may be installed on the at least one strap.

(m) the end of the at least one rigidiser arm is installed to the at least one strap by barging, welding, gluing, heat staking, clamping, butting, snapping, and/or stepping the cover across the end to an outer part; can be

(n) the snapping on the outer portion aligns the at least one strap with the at least one rigidiser arm when the at least one rigidiser arm is installed to the at least one strap by snapping on the outer portion, and This can be accomplished by pressing on one ridgedizer arm and securing both the sleeve and rigidizer arm to the outer part.

(o) the outer portion may be an outer clip securing both the sleeve and each end of the at least one rigidiser arm, the clip being configured to attach an end of the positioning and stabilizing structure to each end of the mask frame and the clip may be part of the mask frame itself.

(p) The shaped portion may apply the pressure of the positioning and stabilizing structure to any portion of the wearer's face.

(q) A plurality of attachment points for attachment may be provided such that at least one anchoring position is selected and altered to allow adjustment of the elastic length of the at least one strap.

(r) the at least one rigidiser arm may be non-stretchable and may be relatively stiffer than the at least one strap.

(s) the at least one strap may include an elastic wall, wherein the elastic wall may be any one of the group consisting of woven, knitted, braided, formed, extruded.

(t) The patient interface system may include two or more rigidiser arms disposed symmetrically on opposite sides of the patient's face.

(u) the at least one rigidizer arm may be completely removable from the at least one strap.

(v) the positioning and stabilizing structure is capable of maintaining its entire working length and freely extending along the at least one ridgedizer arm;

(w) the at least one strap may include two side strap portions disposed to extend from the patient interface along a side of the patient's head and two rear strap portions disposed to extend along the back of the patient's head.

(x) The two rear strap portions cannot be adjusted other than to increase the tightness of the rear strap portion through the elasticity of the rear strap portion and by equally reducing the overall length of the positioning and stabilizing structure.

(y) The patient interface system may include three, four or more separate straps connected by two or more joints.

(z) the at least one strap may include two pockets each receiving a rigid arm for releasably securing the at least one strap to the rigid arm.

(aa) The positioning and stabilizing structure may include at least one retaining means that may include loops, sleeves and/or pockets to receive and properly secure the at least one rigidity arm.

(bb) the at least one retaining means may be formed on or within the at least one strap.

(cc) the at least one ridgedizer arm may be installed on a guide element provided on the at least one strap.

(dd) the at least one rigidizer arm may be installed on the at least one strap only at a localized point or area.

(ee) The guide element may be a loop or sheath shaped portion or passageway or pocket from which at least one rigidity arm extends.

(ff) the guide element is capable of longitudinally expanding or retracting the at least one strap relative to the at least one rigidity arm and/or allowing substantially free movement or floating of the at least one rigidity arm relative to the at least one strap can do.

(gg) the at least one strap may include a rear portion that is divided into at least two rear straps.

(hh) the at least two posterior straps may include a first posterior strap configured to couple the patient proximate the crown of the head and a second posterior strap configured to couple the patient proximate the back of the head.

(ii) each of the at least two posterior straps may be configured to retain the patient interface against the patient's nose with substantially equal tension.

(jj) Each of the at least two posterior straps may be subjected to substantially the same tension when performed by the patient.

(kk) Each of the at least two rear straps may be symmetrically and non-independently adjustable such that the at least two rear straps are centered on each side of the crown of the head.

(ll) The patient interface system may include a separate region, the separated region may be formed between at least two posterior straps, wherein the separated region is about 200 mm long. and/or the patient interface system may include, for the patient's face, one of the following groups: a nasal cannula, a nose prong, and a breathing mask that covers the nose and/or mouth of the wearer.

Another aspect of the present invention relates to a positioning and stabilizing structure comprising: at least one strap; and at least one rigid Desser arm. The positioning and stabilizing structure is arranged to position the at least one rigidizer arm and the at least one strap with each other, such that the at least one rigidizer arm imparts a desired shape to the at least one strap in the stiffened portion, the at least one ridge The dessert arm is configured to be connected to the patient interface by a flexible joint such that the patient interface is displaced to connect to the patient's nose.

In embodiments, (a) the at least one rigid-dissipator arm is capable of mounting to the at least one strap within a defined area of the at least one strap.

(b) The restricted area may be adjacent to the pocket or sleeve opening.

(c) The positioning and stabilizing structure may include headgear for a patient interface device that supplies pressurized air or respirable gas to the patient's airway inlet.

(d) at least one ridgedezer arm may be crescent-shaped.

(e) the at least one strap may be made of an elastic textile material and the positioning and stabilizing structure is such that the at least one strap is positioned relative to the at least one rigidity arm and along a longitudinal axis of the at least one strap and/or rigidity arm. It may be arranged to move freely by elastically expanding and/or contracting.

(f) the elastic length of the at least one strap may remain unchanged for the at least one strap without the at least one rigidizer arm.

(g) The elastic textile material may be one of the group consisting of: elastane, TPE, nylon and silicone.

(h) the positioning and stabilizing structure may extend along substantially its entire length.

(i) the at least one strap may be telescoping and may be in the form of a sleeve disposed to slip over the at least one ridged arm so that the at least one strap retains its entire telescoping length and the at least one rigidizer arm arranged to be freely stretchable over the arm.

(j) the at least one strap may include a hollow sleeve for receiving the at least one rigid arm and at least one opening for receiving the at least one rigid arm into the sleeve.

(k) the sleeve and the at least one rigid arm may be arranged such that the at least one rigid arm moves substantially axially within the sleeve.

(l) An end of the at least one rigidizer arm may be installed on the at least one strap.

(m) the end of the at least one rigidiser arm is installed to the at least one strap by barging, welding, gluing, heat staking, clamping, butting, snapping, and/or stepping the cover across the end to an outer part; can be

(n) the snapping on the outer portion aligns the at least one strap with the at least one rigidiser arm when the at least one rigidiser arm is installed to the at least one strap by snapping on the outer portion, and This can be accomplished by pressing on one ridgedizer arm and securing both the sleeve and rigidizer arm to the outer part.

(o) the outer portion may be an outer clip securing both the sleeve and each end of the at least one rigidiser arm, the clip being configured to attach an end of the positioning and stabilizing structure to each end of the mask frame and the clip may be part of the mask frame itself.

(p) The intended shape imparted is capable of applying the pressure of the positioning and stabilizing structure to any part of the wearer's face.

(q) A plurality of attachment points for attachment may be provided such that at least one anchoring position is selected and altered to allow adjustment of the elastic length of the at least one strap.

(r) the at least one rigidiser arm may be non-stretchable and may be relatively stiffer than the at least one strap.

(s) the at least one strap may include an elastic wall, wherein the elastic wall may be any one of the group consisting of woven, knitted, braided, formed, extruded.

(t) The positioning and stabilizing structure may include two or more rigidiser arms disposed symmetrically on opposite sides of the patient's face.

(u) the at least one rigidizer arm may be completely removable from the at least one strap.

(v) the positioning and stabilizing structure is capable of maintaining its entire working length and freely extending along the at least one ridgedizer arm;

(w) the at least one strap may include two side strap portions disposed to extend from the patient interface along a side of the patient's head and two rear strap portions disposed to extend along the back of the patient's head.

(x) The two rear strap portions cannot be adjusted other than to increase the tightness of the rear strap portion through the elasticity of the rear strap portion and by equally reducing the overall length of the positioning and stabilizing structure.

(y) The positioning and stabilizing structure may include three, four or more separate straps connected by two or more joints.

(z) the at least one strap may include two pockets each receiving a rigid arm for releasably securing the at least one strap to the rigid arm.

(aa) The positioning and stabilizing structure may include at least one retaining means that may include loops, sleeves and/or pockets to receive and properly secure the at least one rigidity arm.

(bb) the at least one retaining means may be formed on or within the at least one strap.

(cc) the at least one ridgedizer arm may be installed on a guide element provided on the at least one strap.

(dd) the at least one rigidizer arm may be installed on the at least one strap only at a localized point or area.

(ee) The guide element may be a loop or sheath shaped portion or passageway or pocket from which at least one rigidity arm extends.

(ff) the guide element is capable of longitudinally expanding or retracting the at least one strap relative to the at least one rigidity arm and/or allowing substantially free movement or floating of the at least one rigidity arm relative to the at least one strap can do.

(gg) the at least one strap may include a rear portion that is divided into at least two rear straps.

(hh) the at least two posterior straps may include a first posterior strap configured to couple the patient proximate the crown of the head and a second posterior strap configured to couple the patient proximate the back of the head.

(ii) each of the at least two posterior straps may be configured to retain the patient interface against the patient's nose with substantially equal tension.

(jj) Each of the at least two posterior straps may be subjected to substantially the same tension when performed by the patient.

(kk) Each of the at least two rear straps may be symmetrically and non-independently adjustable such that the at least two rear straps are centered on each side of the crown of the head.

(ll) A separate region may be formed between at least two rear straps, the separated region being about 200 mm long. and/or the patient interface system may include, for the patient's face, one of the following groups: a nasal cannula, a nose prong, and a breathing mask that covers the nose and/or mouth of the wearer.

Another aspect of the invention relates to a positioning and stabilizing structure. The positioning and stabilizing structure may comprise at least one strap comprising at least two posterior straps, each of which is symmetrical such that at least two posterior straps are centered on each side of the patient's head crown; Independently adjustable.

In an embodiment,

(a) The positioning and stabilizing structure may include at least one rigid-dissipator arm.

(b) the at least one rigid dissipator arm is capable of mounting to the at least one strap within a defined area of the at least one strap.

(c) The restricted area may be adjacent to the pocket or sleeve opening.

(d) The positioning and stabilizing structure may include headgear for a patient interface device that supplies pressurized air or respirable gas to the patient's airway inlet.

(e) at least one ridgedezer arm may be crescent-shaped.

(f) the at least one strap may be made of an elastic textile material and the positioning and stabilizing structure is such that the at least one strap is positioned relative to and along a longitudinal axis of the at least one strap and/or rigidiser arm. It may be arranged to move freely by elastically expanding and/or contracting.

(g) the stretchable length of the at least one strap may remain unchanged for the at least one strap without the at least one rigidizer arm.

(h) The elastic textile material may be one of the group consisting of: elastane, TPE, nylon and silicone. The positioning and stabilizing structure may extend along substantially its entire length.

(i) the at least one strap may be telescoping and may be in the form of a sleeve disposed to slip over the at least one ridged arm so that the at least one strap retains its entire telescoping length and the at least one rigidizer arm arranged to be freely stretchable over the arm.

(j) the at least one strap may include a hollow sleeve for receiving the at least one rigid arm and at least one opening for receiving the at least one rigid arm into the sleeve.

(k) the sleeve and the at least one rigid arm may be arranged such that the at least one rigid arm moves substantially axially within the sleeve.

(l) An end of the at least one rigidizer arm may be installed on the at least one strap.

(m) the end of the at least one rigidiser arm is installed to the at least one strap by barging, welding, gluing, heat staking, clamping, butting, snapping, and/or stepping the cover across the end to an outer part; can be

(n) the snapping on the outer portion aligns the at least one strap with the at least one rigidiser arm when the at least one rigidiser arm is installed to the at least one strap by snapping on the outer portion, and This can be accomplished by pressing on one ridgedizer arm and securing both the sleeve and rigidizer arm to the outer part.

(o) the outer portion may be an outer clip securing both the sleeve and each end of the at least one rigidiser arm, the clip being configured to attach an end of the positioning and stabilizing structure to each end of the mask frame and the clip may be part of the mask frame itself.

(p) A plurality of attachment points for attachment may be provided such that the at least one anchoring position is selected and varied to allow adjustment of the elastic length of the at least one strap.

(q) the at least one rigidiser arm may be non-stretchable and may be relatively stiffer than the at least one strap.

(r) the at least one strap may include an elastic wall, the elastic wall including two or more rigidiser arms symmetrically disposed on opposite sides of the patient's face, and wherein the elastic wall is woven, knitted, braided, molded, extruded; It may be any one of the constituting crowds.

(s) the at least one rigidizer arm may be completely removable from the at least one strap.

(t) The positioning and stabilizing structure is capable of maintaining its entire working length and is freely elongated along the at least one ridgedizer arm.

(u) the at least one strap may include two side strap portions disposed to extend from the patient interface along a side of the patient's head and two rear strap portions disposed to extend along the back of the patient's head.

(v) The two rear strap portions cannot be adjusted other than to increase the tightness of the rear strap portion through the elasticity of the rear strap portion and by equally reducing the overall length of the positioning and stabilizing structure.

(w) The patient interface system may include three, four or more separate straps connected by two or more joints.

(x) the at least one strap may include two pockets each receiving a rigid discreet arm to releasably secure the at least one strap to the rigid disc member arm.

(y) The positioning and stabilizing structure may include at least one retaining means that may include loops, sleeves and/or pockets to receive and properly secure the at least one rigidity arm.

(z) the at least one retaining means may be formed on or within the at least one strap.

(aa) The at least one ridgedizer arm may be installed on a guide element provided on the at least one strap.

(bb) the at least one rigidizer arm may be mounted on the at least one strap only at a localized point or area.

(cc) The guiding element may be a loop or sheath shaped portion or passageway or pocket from which at least one rigidity arm extends.

(dd) the guiding element is capable of longitudinally expanding or retracting the at least one strap relative to the at least one rigidity arm and/or allowing substantially free movement or floating of the at least one rigidity arm relative to the at least one strap can do.

(ee) the at least two posterior straps may include a first posterior strap configured to engage the patient proximate the crown of the head and a second posterior strap configured to couple the patient proximate the posterior portion of the head.

(ff) each of the at least two posterior straps may be configured to retain the patient interface against the patient's nose with substantially equal tension.

(gg) When performed by a patient, each of the at least two posterior straps may be subjected to substantially the same tension.

(hh) a separated region may be formed between at least two rear straps and the separated region is about 200 mm long. and/or

(ii) the patient interface system may include a positioning and stabilization structure according to one of the above embodiments, and the patient interface system may include, for the patient's face, a group consisting of: a nose cannula, a nose prong and a breathing mask that covers the nose and/or mouth of the wearer.

Another aspect of the invention relates to positioning and stabilizing structures. The positioning and stabilizing structure may include a pair of side straps and a pair of rear straps positioned between the respective pair of side straps. The side strap pair and the rear strap pair are integral.

In an embodiment,

(a) The positioning and stabilizing structure may include a separate area formed between the pair of rear straps.

(b) The separated region begins at the distal end of each pair of rear straps.

(c) each distal end may include a reinforcement portion adjacent the isolated region.

(d) the at least one strap may be stretchable along a longitudinal side rather than a lateral axis thereof.

(e) the at least one strap may include a hole in the proximal end of each pair of side straps, the hole being sized and shaped to receive the insertion of a rigid deesser arm.

(f) at least one strap may comprise a warp-woven or knitted material. and/or

(g) at least one strap may be tubular.

Another aspect of the invention relates to a method performed by a patient, wherein the patient interface includes a positioning and stabilizing structure. The method may include: placing a seal forming structure of the patient interface relative to the airway of the patient; releasing the tensioning portion of the positioning and stabilizing structure by positioning the posterior portion of the positioning and stabilizing structure relative to the posterior portion of the patient's head; and

adjusting the tension of the positioning and stabilizing structure by depressing the spaced back strap of the rear portion of the positioning and stabilizing structure.

Another aspect of the invention relates to a patient interface system. The patient interface system may include: at least one strap comprising at least two rear straps having a separated area therebetween; A patient interface connectable to at least one strap and comprising a seal forming structure.

The at least two posterior straps may be adjustable separately so that the seal formation is positioned relative to the patient's airway and the resulting tension seal force against the patient interface is greatest when the angle between the at least two posterior straps is zero. do.

In an embodiment,

(a) Tension sealing force decreases as the angle between at least two rear straps increases.

(b) the starting angle between the at least two posterior straps may be zero such that the patient adjusts the tension sealing force by increasing the angle between the at least two posterior straps.

(c) The angle between at least two rear straps is less than or equal to 180 degrees. and/or

(d) the tension seal force when the angle between the at least two rear straps is about 180 degrees is about 40% of the tension seal force when the angle between the at least two rear straps is about zero.

Another aspect of the present invention relates to a method for iteratively coupling a positioning and stabilizing structure to a patient interface device. The method may include:

inserting the extendable rigidiser arm through the opening of the hollow telescoping fabric strap as part of the strap; and

releasably securing an end portion of the strap to the rigid deezer arm;

The positioning and stabilizing structures position the strip and rigid arm relative to each other so that the rigid portion of the strap gives the strap its intended shape in the hardened portion while allowing the rigid portion of the strap to move freely relative to the rigid portion of the strap. are placed

In an embodiment,

(a) the rigidizer arm is permanently capable of connecting to the mask frame of the patient interface device;

(b) the end of the strap may be a pocket end secured to each catch member, and/or

(c) The pocket end is wound around each catch member of the rigid deezer arm.

In another embodiment, a method of manufacturing a patient interface for the treatment of a respiratory disease is provided. The method includes cutting a vent portion in a textile formed by entangling fibers.

The method includes securing a vented portion to a mold.

The method includes permanently connecting a fixed vent portion to a mask frame made of plastic material to form a vent at the patient interface to flush exhaled air (including exhaled carbon dioxide).

Optionally, the method comprises overmolding the fixed vent portion to the mask frame having a mechanical interlock between the vent portion and the mask frame to form a vent at the patient interface to flush exhaled air (including exhaled carbon dioxide) do. The mechanical interlock provides a permanent connection between the vent portion and the mask frame such that the vent cannot be removed from the mast frame. A possible mechanical interlock is provided by one or more mushroom-shaped mechanical connecting elements. Pre-treatment can be applied to the intended bonding surface of the mast frame and the vented portion with micro-roughness to improve the bonding stiffness.

The method may also include permanently connecting a first vent portion having a first airflow rate to the mask frame. The method may also include permanently connecting a second vent portion having a second air flow rate different than the first air flow rate to the mask frame. If the average combined first and second airflow rates are within a predetermined range, the first and second vent portions are selected.

Interlacing fibers are made of a thermoplastic polymer. The thermoplastic polymer may be one of the following groups: polypropylene, polycarbonate, nylon and polyethylene. The thermoplastic polymer may be a SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material.

Permanent connections can be achieved by molecular bonding using one of the following groups: overmold copper, co-injection moulding, and two-shot (2K) injection moulding.

The patient interface may be a crowd consisting of: a nose mask, a face mask, and a nose pillow. Preferably, the patient interface is a nasal pillow or a nasal cradle.

Cutting can be one of the following groups: laser cutting, ultrasonic cutting and mechanical cutting.

The vent may be substantially semi-circular or D-shaped.

The bent portion of the textile can be provided in roll or ribbon form prior to cutting.

The vent has a maximum width of about 16 mm-about 21 mm, preferably about 18.2 mm-18.6 mm, a maximum height of about 19 mm-24 mm, preferably 21.6 mm-22 mm, about 0.36 mm- about 0.495 mm, preferably 0.40-0.45 mm. may have a thickness of

The mask frame may have two vents. The first vent is disposed on the left side of the mask frame. The second vent is located on the right side of the mask frame. The first and second vents are separated by an aperture to receive the air delivery tube.

The method may also include selectively reducing the amount of pores in the vent portion when the air flow rate through the vent portion exceeds a predetermined range.

The predetermined range may be from about 42-59 liters per minute at _{20 cm H 2} O pressure, preferably from about 47 to about 53 liters _{per minute at 20 cm H 2 O pressure.}

The air flow rate through the SEFAR material Tetex Mono 05-1010-K 080 woven polypropylene material is about 37-64 liters per minute at _{20 cm H 2} O pressure, preferably about 42 to about 58 liters _{per minute at 20 cm H 2 O pressure.} can

The porosity of the vent section can be reduced by one of the following groups: compression applying sealants and thin films, heat staking by ultrasonic welding, and plastic deformation.

The porosity of the vent portion may be reduced by partially or completely occupying the hole in the vent portion.

The porosity of the continuous peripheral edge region may be reduced.

In a second aspect, a method is provided for making a vent for flushing exhaled air (including exhaled carbon dioxide) from a patient interface.

The method includes cutting the vent portion in a semipermeable material having a predetermined amount of porosity that diffuses airflow.

The method also includes permanently connecting the vent portion to the mask frame of the patient interface to form the vent.

The predetermined amount of porosity is

At the patient interface, _{an air flow rate of approximately 42-59 liters per minute is obtained at 20 cm H 2} O pressure of the breathing gas, with an A-weighted acoustic power level of less than 25 dbA with an uncertain 3 dbA and a distance of 1 m above 17 dbA with an uncertain 3 dbA. A-weighted acoustic pressure is generated at Preferably the A-weighted acoustic power level is about 22 dbA and the A-weighted acoustic pressure is about 13 dbA.

The air flow rate can be 47-53 liters per minute at 20 cm of breathing gas, H _{2 0 pressure.}

In another aspect, a patient interface for treatment of a respiratory disease is provided. The patient interface includes a vent to flush exhaled air (including exhaled carbon dioxide). The vent is connected to a vent cap made of plastic material. The vent cap may be detachably connected to the mask frame at a vent orifice formed in the mask frame. Vents are made of textiles formed by entangled fibers. The textile has a certain amount of porosity.

The vent may have a portion closed by heat staking to achieve a desired amount of porosity.

The vent may have a surface area of about 201.6 mm ² - about 278.6 mm ^{2 .}

The surface area of the vent may have a total open area of about 1%-10%.

Another aspect of the present invention relates to a gas supply tube for supplying respirable gas in a breathing apparatus. the gas supply tube is a helical coil consisting of a plurality of adjacent coils, each coil having an outer surface separated by a width and defining a coil diameter, and coaxial with the helical coil attached to the helical coil between the plurality of adjacent coils; and a web of material having at least one fold extending radially outwardly between a plurality of adjacent coils. The at least one fold is defined by a predetermined fold line, the apex of the at least one fold defines a fold diameter, and the coil diameter is substantially equal to the fold diameter when the gas supply tube is in a neutral state.

In an embodiment,

(a) The web of material may include at least one fold extending radially outwardly along at least one length portion of the gas supply tube portion.

(b) the angle of inclination of the web of material may increase from the helical coil to the apex of the at least one fold when the gas supply tube is in a neutral state.

(c) The web of material may have an asymmetric cross-sectional shape with respect to a given fold line.

(d) A predetermined fold line may be uniformly spaced between a plurality of adjacent coils.

(e) the width separating the plurality of adjacent coils may be equal to the width of the helical coil when the gas supply tube is in a neutral state.

(f) the helical coil may comprise a greater proportion of the surface area area of the gas supply tube than at least one fold of the web of material.

(g) The outer portion of the helical coil may have a round shape.

(h) The outer surface of the helical coil may have a radius of curvature of 44 mm in its own weight when spanned over a cylinder having a diameter of 13 mm.

(i) The outer portion of the helical coil may have an elliptical shape.

(j) The helical coil may have a greater thickness than the web of material.

(k) The web of material may have a substantially uniform thickness.

(l) The helical coil may comprise a thermoplastic elastomer.

(m) the web of material may comprise a thermoplastic elastomer.

(n) The web of material and the spiral coil may be bonded to form a uniform and continuous inner surface of the gas supply tube.

(o) at least one fold may extend radially outwardly between alternating one of the plurality of adjacent coils.

(p) The helical coil may have a pitch of about 3.2 mm - about 4.7 mm.

(q) The helical coil may have a pitch of about 4.5 mm - about 4.7 mm.

(r) The helical coil may have a spring stiffness of about 0.03 N.

(s) The inner diameter of the tube may be about 18 mm in the neutral state. and/or

(t) The gas supply tube may be in one of three different states:

A neutral state in which the gas supply tube has a neutral length, an extended state in which the gas supply tube extends an extended length greater than the neutral length, and a compressed state in which the gas supply tube is compressed to a compressed length less than the neutral length.

Another aspect of the invention relates to a respiratory therapy system for supplying a patient with a respirable gas.

A respiratory therapy system may include: a breathing mask assembly worn by a user during treatment; A gas supply tube according to at least one of the embodiments described in the previous paragraph, wherein the gas supply tube has a rotatable adapter fixedly attached at a first end and fixedly attached at a second end to a breathing mask assembly; an additional gas supply tube different from the gas supply tube and rotatably attached at a third end to the gas supply tube by a rotatable adapter; and/or a breathing apparatus for generating a flow of respirable gas connected to said additional gas supply tube at a fourth end.

Another aspect of the present invention relates to a gas supply tube for supplying respirable gas in a breathing apparatus. The gas supply tube may include a helical coil comprising a plurality of adjacent coils, each coil separated by a width; A web of material coaxial with the helical coil is attached to the helical coil between a plurality of adjacent coils. The width separating the plurality of adjacent coils is substantially equal to the width of the helical coil when the gas supply tube is in a neutral state.

In an embodiment,

(a) The web of material may include at least one fold extending radially outwardly between a plurality of adjacent coils, the fold being formed by a predetermined line of folds and having an apex.

(b) the web of material may include at least one fold extending radially outwardly along at least one length portion of the gas supply tube.

(c) the at least one fold may be equally spaced between the plurality of adjacent coils.

(d) the at least one fold may comprise a greater proportion of the surface area area of the gas supply tube than the at least one fold of the web of material.

(e) an outer portion of the helical coil may define a coil diameter, and the apex of the at least one fold may define a fold diameter, the coil diameter being substantially equal to the fold diameter when the gas supply tube is in a neutral state. can

(f) the angle of inclination of the web of material may increase from the helical coil to the apex of the at least one fold when the gas supply tube is in a neutral state.

(g) the web of material may have an asymmetric cross-sectional profile for a given fold line.

(h) The outer portion of the helical coil may have a round shape.

(i) The outer surface of the helical coil may have a radius of curvature of 44 mm in its own weight when spanned over a cylinder having a diameter of 13 mm.

(j) The outer portion of the helical coil may have an elliptical shape.

(k) The helical coil may have a greater thickness than the web of material.

(l) The web of material may have a substantially uniform thickness.

(m) The helical coil may comprise a thermoplastic elastomer.

(n) the web of material may comprise a thermoplastic elastomer.

(o) The web of material and the helical coil may be bonded to form a uniform and continuous inner surface of the gas supply tube.

(p) the web of material may include at least one fold extending radially outwardly between alternating ones of the plurality of adjacent coils.

(q) The helical coil may have a pitch of about 3.2 mm - about 4.7 mm.

(r) The helical coil may have a pitch of about 4.5 mm - about 4.7 mm.

(s) The helical coil may have a spring stiffness of about 0.03 N.

(t) The inner diameter of the tube may be about 18 mm in the neutral state. and/or

(u) The gas supply tube may be in one of three different states:

A neutral state in which the gas supply tube has a neutral length, an extended state in which the gas supply tube extends an extended length greater than the neutral length, and a compressed state in which the gas supply tube is compressed to a compressed length less than the neutral length.

Another aspect of the invention relates to a respiratory therapy system for supplying a patient with a respirable gas.

A respiratory therapy system may include: a breathing mask assembly worn by a user during treatment; A gas supply tube according to at least one of the embodiments described in the previous paragraph, wherein the gas supply tube has a rotatable adapter fixedly attached at a first end and fixedly attached at a second end to a breathing mask assembly; an additional gas supply tube different from the gas supply tube and rotatably attached at a third end to the gas supply tube by a rotatable adapter; and/or a breathing apparatus for generating a flow of respirable gas connected to said additional gas supply tube at a fourth end.

Another aspect of the present invention relates to a gas supply tube for supplying respirable gas in a breathing apparatus. The gas supply tube includes a helical coil comprising a plurality of adjacent coils, and a web of material coaxial with the helical coil. Each coil is separated by a width and a web of material coaxial with the helical coil is attached to the helical coil between the plurality of adjacent coils and includes at least one at least one fold extending radially outwardly between the plurality of adjacent coils. have The apex of the at least one fold forms the fold diameter and the angle of inclination of the web of material increases from the helical coil to the apex of the at least one fold when the gas supply tube is in neutral.

In an embodiment,

(a) the at least one fold may extend radially outwardly along at least one longitudinal portion of the gas supply tube.

(b) the at least one fold may be equally spaced between the plurality of adjacent coils.

(c) an outer surface of the helical coil may define a coil diameter, and the apex of said at least one fold may define a fold diameter, wherein when the gas supply tube is in a neutral state, the coil diameter may be substantially equal. can

(d) the helical coil may include a greater proportion of the outer surface area of the gas supply tube than the apex of the at least one fold.

(e) The outer portion of the helical coil may have a round shape.

(f) The outer surface of the helical coil may have a radius of curvature of 44 mm in its own weight when spanned over a cylinder having a diameter of 13 mm.

(g) The outer portion of the helical coil may have an elliptical shape.

(h) The helical coil may have a greater thickness than the web of material.

(i) the web of material may have a substantially uniform thickness;

(j) The helical coil may comprise a thermoplastic elastomer.

(k) the web of material may comprise a thermoplastic elastomer.

(l) The web of material and the spiral coil may be bonded to form a uniform and continuous inner surface of the gas supply tube.

(m) the web of material may include at least one fold extending radially outwardly between alternating ones of the plurality of adjacent coils.

(n) The helical coil may have a pitch of about 3.2 mm - about 4.7 mm.

(o) The helical coil may have a pitch of about 4.5 mm - about 4.7 mm.

(p) The helical coil may have a spring stiffness of about 0.03 N.

(q) The inner diameter of the tube may be about 18 mm in the neutral state. and/or

(r) The gas supply tube may be in one of three different states:

A neutral state in which the gas supply tube has a neutral length, an extended state in which the gas supply tube extends an extended length greater than the neutral length, and a compressed state in which the gas supply tube is compressed to a compressed length less than the neutral length.

Another aspect of the present invention relates to a gas supply tube for supplying respirable gas in a breathing apparatus. The gas supply tube may include: a plurality of adjacent coils each separated by a width; and a web of material coaxial with the coil attached to the coil between the plurality of coils and having at least one fold extending radially outwardly between the plurality of adjacent coils. The at least one coil is formed by a peak, and the web of material includes a protruding portion adjacent a first side of the coil and a sloping portion adjacent a second side of the coil. The second side faces the first side. The inclination of the web of material is steeper from the adjacent inclined portion to the adjacent peak than the inclination of the web of material from the protrusion to the adjacent peak when the gas supply tube is in the neutral state.

In an embodiment,

(a) the at least one fold may extend radially outwardly along at least one longitudinal portion of the gas supply tube.

(b) the at least one fold may be equally spaced between the plurality of adjacent coils.

(c) an outer surface of the coil may define a coil diameter, and the peak of the at least one fold may define a fold diameter, wherein when the gas supply tube is in a neutral state, the coil diameter may be substantially the same. there is

(d) the coil may comprise a greater proportion of the outer surface area of the gas supply tube than the peak of the at least one fold.

(e) The outer portion of the coil may have a round shape.

(f) The outer surface of the coil may have a radius of curvature of 44 mm in its own weight when spanned over a cylinder having a diameter of 13 mm.

(g) The outer portion of the coil may have an elliptical shape.

(h) The coil may have a greater thickness than the web of material.

(i) the web of material may have a substantially uniform thickness;

(j) The coil may comprise a thermoplastic elastomer.

(k) the web of material may comprise a thermoplastic elastomer.

(l) The web and coil of material may be bonded to form a uniform and continuous inner surface of the gas supply tube.

(m) the web of material may include at least one fold extending radially outwardly between alternating ones of the plurality of adjacent coils.

(n) The coil may have a pitch of about 3.2 mm - about 4.7 mm.

(o) The coil may have a pitch of about 4.5 mm - about 4.7 mm.

(p) The coil may have a spring stiffness of about 0.03 N.

(q) The inner diameter of the tube may be about 18 mm in the neutral state. and/or

(r) The gas supply tube may be in one of three different states:

A neutral state in which the gas supply tube has a neutral length, an extended state in which the gas supply tube extends an extended length greater than the neutral length, and a compressed state in which the gas supply tube is compressed to a compressed length less than the neutral length.

Another aspect of the invention relates to a respiratory therapy system for supplying a patient with a respirable gas.

A respiratory therapy system may include: a breathing mask assembly worn by a user during treatment; A gas supply tube according to at least one of the embodiments described in the previous paragraph, wherein the gas supply tube has a rotatable adapter fixedly attached at a first end and fixedly attached at a second end to a breathing mask assembly; an additional gas supply tube different from the gas supply tube and rotatably attached at a third end to the gas supply tube by a rotatable adapter; and/or a breathing apparatus for generating a flow of respirable gas connected to said additional gas supply tube at a fourth end.

According to another aspect of the present invention, a patient interface for treatment of a respiratory disease is provided. The patient interface may include a rigidiser arm made of the first material. The patient interface may also include a flexible joint permanently connected to the rigidizer arm. The flexible joint is made of a second material that cannot be integrally bonded with the first material. The patient interface may also include a mask frame permanently connected to the flexible joint. The mask frame is made of a third material that is integrally bonded with the second material. Rigidizer arms and flexible joints can be permanently connected via mechanical interlocks. The first material, the second material and the third material may be different materials.

Monolithic bonding may be covalent bonding or hydrogen bonding.

The first material may be a thermoplastic polyester elastomer. The thermoplastic polyester elastomer may be Hytrel® 5556 manufactured by DuPont®.

The second material may be a thermoplastic elastomer (TPE). The TPE can be a DYNAFLEX™ TPE compound or Medalist®MD-115.

The third material may be a thermoplastic polymer. The thermoplastic polymer may be polypropylene (PP).

The flexible joint may be over molded into the mask frame.

The mechanical interlock may include protrusions extending from the rigidizer arm that is overmolded with the material of the flexible joint. The protrusion may be T-shaped with a void in the central region of the protrusion extending through the upper surface to the lower side of the protrusion of the flexible joint material passing therethrough.

The mechanical interlock may include two protrusions extending horizontally from the distal end of the rigid distal arm.

Each protrusion may have a cavity and extend through the rigidiser arm for flexible joint material passing therethrough. The patient interface may be a nasal pillow or a nasal cradle.

According to another aspect of the present invention, a patient interface for treatment of a respiratory disease is provided. The patient interface may include a rigidiser arm made of the first material. The patient interface has a mask frame permanently connected to the rigidizer arm. The mask frame may be made of a second material that cannot be integrally coupled with the first material. The first material is relatively more elastic and flexible than the second material. Rigidizer arm and mask frame are permanently connected via a mechanical interlock.

The mask frame is over-molded to the rigid-dissipator arm.

The mechanical interlock may include a sealable portion extending from a rigidizer arm that is overmolded with the material of the mask frame.

The sealable portion may have a bend and a hook portion.

According to another aspect of the present invention, a patient interface for treatment of a respiratory disease is provided. The patient interface may include a rigidiser arm made of the first material. The patient interface may also include a mask frame made of a second material and may be integrally adhered to the rigidizer arm. The first material is relatively more elastic and flexible than the second material. The first material may be a fiber reinforced composite polypropylene material, and the second material is polypropylene.

The fiber reinforced composite polypropylene material may be Curv®.

According to another aspect of the present invention, a patient interface for treatment of a respiratory disease is provided. The patient interface may include a rigidiser arm. The patient interface also has a mask frame releasably engaged with the rigidizer arm. Rigidizer may have more elasticity and flexibility than the mask frame. The rigidizer arm may include a projecting end configured to retain the pocket end of the strap in a positioning and stabilizing configuration. The protruding end may proximate the mask frame.

The patient interface may include an interlocking flexible joint releasably connectable with the rigidiser arm. The flexible joint may releasably connect with the mask frame. The flexible joint may have relatively more elasticity and flexibility than the rigid deesser arm.

The releasable connection between the rigidizer arm and the mask frame may be provided by a mechanical clip assembly.

The releasable connection between the flexible joint and the rigidizer arm and between the flexible joint and the mask frame is provided by a mechanical clip assembly.

Another aspect of the invention relates to a patient interface for the treatment of respiratory diseases. The patient interface may include a rigidiser arm that may be made of a first material that may not be stretchable; The mask frame may be made of a second material that may not be integrally bonded with the first material; The first material is relatively more elastic and flexible than the second material, and the rigidiser arm and the mask frame may be permanently connected by a mechanical interlock, the rigidiser arm may be made of the first material and may be permanently connected to the mask frame. can, such that when the patient interface is performed by the patient, the Rigidizer arm has flexibility only in a plane substantially parallel to the Frankfort horizontal plane of the patient.

In an embodiment, (a) the mask frame may be over-molded to the rigid dissipator arm.

(b) The mechanical interlock may include a sealable portion extending from the rigidizer arm that is overmolded by the material of the mask frame. and/or

(c) The sealable portion may have a bend and a hook portion.

Another aspect of the present invention relates to a rigid dissipator arm for operatively connecting a positioning and stabilizing elastic fabric strap to a mask frame. The Rigidizer arm may include a body that may have a curvature that substantially conforms to the shape of the patient's cheeks; The protruding end is configured to retain the end of the strap pocket, the protruding end may be located at the distal end of the rigidizer arm; The connector may be configured to connect to a flexible joint or mask frame, and the connector may be disposed at a distal end of the rigidizer arm.

In an embodiment,

(a) The connection portion may include at least one protrusion and at least one void configured to be overmolded for connection to a flexible joint or mask frame.

(b) The rigidizer arm may comprise a thermoplastic polyester elastomer.

(c) Rigidizer arms may include materials in which the rigiddiser arms are in only one plane. and/or

(d) Rigidizer arms may include materials that do not stretch.

Another aspect of the present invention relates to a patient interface for the supply of pressurized air or respirable gas to an airway inlet of a patient. The patient interface may include: a pair of nasal pillows permanently connected to the connection to the plenum chamber by a retaining structure and a talc permanently connected to the retaining structure; and a frame member, wherein the retaining structure and the frame member are repeatedly connectable to each other and releasable from each other; and

The opposing side of each stalk has a different material stiffness to provide increased resistance to deformation of the stalk in a direction opposite to the desired direction.

Another aspect of the present invention relates to a patient interface for the supply of pressurized air or respirable gas to an airway inlet of a patient. The patient interface may include: a cushioning member comprising a retention structure and a seal forming structure permanently connected to the retention structure; and a frame member, the retaining structure and the frame member being repeatedly connectable and releasable with each other; The seal forming structure has a greater length than the retaining structure in a direction parallel to the connection and release direction between the retaining structure and the frame member; and the cushion member has a first thickness adjacent the retaining structure and a second thickness smaller than the first thickness adjacent the seal forming structure, and the thickness of the cushion member gradually decreases from the first thickness to the second thickness.

Another aspect of the present invention relates to a patient interface system for providing a patient with a respirable gas. The patient interface may include: a patient interface including a seal forming structure to provide an air connection to the patient's airway; and a positioning and stabilizing structure comprising at least one strap and at least one rigidity arm, the positioning and stabilization structure configured to releasably retain a patient interface of a patient, wherein the at least one rigidizer arm is in a first plane substantially parallel to the sagittal plane. and a bend redirecting the longitudinal axis of the at least one rigidiser arm to a second plane substantially parallel to the coronal plane.

Another aspect of the invention relates to a patient interface for the treatment of respiratory diseases. The patient interface may include: a washable and reusable vent for flushing exhaled air having ^{a thickness of 0.45 mm or less and a weight of 234 g per m 2 or less;} The vent has a porous region defining a serpentine air flow passageway for exhaled air, wherein the porous region substantially has a level of stiffness to substantially retain its shape during the patient's breathing cycle.

Another aspect of the present invention relates to a cushion for a patient interface for supplying pressurized air or respirable gas to an airway inlet of a patient. The cushion may include: a retaining structure that can be repeatedly engaged and disengaged from the frame member; and a seal forming structure permanently connected to the retaining structure. the seal forming structure is made of a first material and the retaining structure is made of a second material having a mechanical property different from that of the first material, the second material being more rigid than the first material; The increase in air pressure in the cushion member causes the sealing force between the seal forming structure and the frame member to increase.

Another aspect of the present invention relates to a gas supply tube for supply of pressurized air or respirable gas to an airway inlet of a patient through a patient interface. The gas supply tube may include: a helical coil consisting of a plurality of adjacent coils, each coil separated by a width; A web of material coaxial with the helical coil attached to the helical coil between a plurality of adjacent coils and having at least one fold extending radially outwardly between the plurality of adjacent coils, the at least one fold being a predetermined fold line is formed by; a first end cuff for permanently and non-permanently connecting the tube to the frame of the patient interface; a second end cuff releasably and rotatably connected to the tube adapter; A gas supply tube may be in one of three different states:

a neutral state in which the gas supply tube has a neutral length, an extended state in which the gas supply tube extends along its longitudinal axis extending an extended length greater than the neutral length, and a compressed length of the gas supply tube along its longitudinal axis that is shorter than the neutral length. The compressed state that is compressed along

Another aspect of the present invention relates to a cushioning member for a patient interface for supplying pressurized air or respirable gas to an airway inlet of a patient. The cushioning member may include: a retaining structure that is repeatedly engageable and disengaged from the frame member; and a seal forming structure permanently connected to the retaining structure. the seal forming structure is made of a first material and the retaining structure is made of a second material having mechanical properties different from those of the first material and being more rigid than the first material; and the first material causes the seal forming structure to immediately conform to the finger pressure and the second material prevents the retaining structure from immediately conforming to the finger pressure.

Another aspect of the present invention relates to a cushioning member for a patient interface for supply of pressurized air or respirable gas to an airway inlet of a patient. The cushion may include: a retaining structure for repeatably engaging and disengaging from the frame member; A seal forming structure connected to the retaining structure, the seal forming structure is made of a first material and the retaining structure is made of a second material which is different from the first material and which is more rigid than the first material. and, the retaining structure has a continuous peripheral edge of the front side contacting the frame member.

Another aspect of the present invention relates to a rigid deesser arm connecting a strap of a positioning and stabilizing structure to a mask frame. The rigidizer arm may include: a body having curvature in one or more axes substantially according to the shape of the cheek of the patient; The rigidizer arm extends from the mask frame to a position adjacent to the patient's cheekbone.

Another aspect of the present invention relates to a patient interface for the supply of pressurized air or respirable gas to an airway inlet of a patient. The patient interface may include: a mask frame having a vent orifice formed within the mask frame; a vent cap made of plastic material detachably connectable to the mask frame at the vent orifice; and a vent permanently connected to the vent cap and having a porous area for cleaning exhaled air; The vent is made of a textile formed by entangling plastic fibers and a tortuous passage for exhaled air is formed by the spaces between the entangled plastic fibers; and the textile is configured such that the shape, shape, and profile of the vent does not change substantially during the patient's breathing cycle and the porous region maintains a substantially constant rate of cleaning exhaled air.

Another aspect of the invention relates to a vent cap for a patient interface for supplying pressurized air or respirable gas to an airway inlet of a patient. The vent cap may include: a vent frame for removably connecting with a vent orifice of the mask frame of the patient interface; a vent having a porous area for cleaning exhaled air; The vent is made of a textile formed by entangling plastic fibers and a tortuous passage for exhaled air is formed by the spaces between the entangled plastic fibers; and the textile is configured such that the shape, shape, and profile of the vent does not change substantially during the patient's breathing cycle and the porous region maintains a substantially constant rate of cleaning exhaled air.

Another aspect of the present invention relates to a vent for a patient interface for supplying pressurized air or respirable gas to an airway inlet of a patient. Vents may include: an entangled structure of fibers with tortuous air passages for exhaled air formed by the spaces between the entangled fibers; The entangled structure of the fibers is configured to substantially retain shape, shape and profile during the respiratory cycle of the patient. The space is configured to maintain a substantially constant rate of flushing the exhaled air.

Another aspect of the present invention relates to a patient interface for providing respirable gas to a patient. Patient interfaces include: connection ports; at least two vents; a first of the at least two vents on a first side of the connection port; and a second of the at least two vents on the second side of the connecting port, the vent being a multi-hole vent or bridging structure.

Another aspect of the present invention relates to a cushioning member for a patient interface for supplying pressurized air or respirable gas to an airway inlet of a patient. The patient interface includes a frame connectable to a cushion member. The cushion member may include a visual indicator to prevent misalignment of the cushion member when the cushion member is connected to the frame.

Another aspect of the present invention relates to a gas supply tube for supplying pressurization of respirable gas in a respirator. The gas supply tube may include: a helical coil having an outer surface defining an incoil diameter and delimited by a width and comprising a plurality of adjacent coils; A web of material coaxial with a helical coil attached to the helical coil between the plurality of coils having at least one fold extending radially outwardly between the plurality of adjacent coils, the at least one fold being formed by a predetermined fold line. . The at least one apex defines a fold diameter. When the gas supply tube is in neutral, the coil diameter is substantially equal to the fold diameter and adjacent coils are separated from each other in the neutral state; and the spiral coil and web of material are made of a thermoplastic material; The helical coil and web of material are configured such that the gas supply tube is unobstructed while being supplied with a pressurized flow of respirable gas from the breathing apparatus. The gas supply tube has a bending rigidity such that torsional tube drag does not occur at the proximal end when the distal end of the gas supply tube extends by 30 mm in a direction perpendicular to the direction of the proximal end of the gas supply tube.

Another aspect of the present invention relates to a cushioning member for a nasal pillow mask for supplying pressurized air or respirable gas to a patient's airway entrance. The cushion member may include:

a retaining structure for repeatedly connecting and disengaging the frame member; a seal forming structure for permanent connection to the retaining structure; The increase in air pressure in the cushion member causes the sealing force between the thread forming structure and the frame member to increase, and the holding force between the retaining structure and the frame member is greater than the releasing force for releasing the retaining structure from the frame member.

Another aspect of the invention relates to a patient interface for supplying pressurized air or respirable gas to an airway inlet of a patient. The patient interface includes: a cushion member including a retention structure and a seal forming structure permanently connected to the retention structure; and a frame member, wherein the retaining structure and the frame member are repeatedly connectable and disengageable from each other; and the retaining structure has a major axis having a length of about 50-60 mm and a minor axis having a length of about 25 mm - about 35 mm.

Another aspect of one form of the present invention is a patient interface molded or configured with a peripheral shape that conforms to that of the intended wearer (ie the patient) and is explicitly shaped to conform intimately with the intended wearer.

One aspect of one form of the invention is a method of manufacturing a patient interface.

Of course, some of these aspects may form sub-forms of the present invention. In addition, ancillary aspects and aspects may be combined in various ways and constitute a new form or sub-form of the present invention.

Other features of the invention will become apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.

(E) BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is shown by way of example and not limitation. In the drawings, like reference numbers indicate like elements.
5.1 Processing system
1 shows a system according to the present technology. The patient 1000 wearing the patient interface 3000 receives the air supply of the medicament from the PAP device 4000 . Air from the PAP device 4000 is humidified in the humidifier 5000 and goes to the patient 1000 along the air circuit 4170 .
FIG. 1B shows a PAP device 4000 in use on a patient 1000 wearing a nose mask.
1C shows the PAP device 4000 in use on a patient 1000 wearing a face mask.
5.2 Treatment
5.2.1 Respiratory system
2A is a schematic diagram of the human respiratory system including the nose and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveoli, heart and diaphragm.
Figure 2b shows the nasal cavity, nasal bone, transverse nasal cartilage, larger nasal wing cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, larynx, vocal cords, esophagus and trachea. Schematic diagram of the human airway, including.
5.2.2 Facial Anatomy
2C is a front view of the face with some features of the surface anatomy including upper lip, upper vermilion, lower vermillion, lower lip, mouth width, endocanthion, nasolabial region, nasolabial groove and lip tip.
Figure 2d is a surface anatomy comprising glabellar, nose root, nasal tip, under nose, upper lip, lower lip, supramenton, nasal ridge, upper otobasion, lower otobasion; A side view of the head with some features of Also the directions top, bottom and front back are indicated.
2E is another side view of the head; The approximate position of the Frankfurt horizontal plane and the nasolabial angle is indicated.
Fig. 2f is a basic view of the nose.
2G is a profile of the surface properties of the nose.
2H is a subcutaneous structure of the nose including transverse cartilage, setum cartilage, great nasal wing cartilage, lesser nasal wing cartilage and fibrous adipose tissue.
FIG. 2I is an internal cut-away view of the order of several mm from the sagittal plane between others showing the crus of the cartilage of the setum and the cartilage of the great nasal wing;
Fig. 2J is a front view of the skull bones in front and side, including the nose and zygomatic bones. The turbinate is shown and the maxilla, mandible, and bifurcation are shown.
2K is a side view of two skulls with an outline of the surface of the head with some muscles.
The following bones are shown: frontal, butterfly bones, nose, cheekbones, upper jaw, lower jaw, parietal, temporal, and occipital. Lee Yong-gi. The following muscles are shown: the biceps, masseter, sternocleidomastoid, supraspinatus and trapezius.
21 shows the anterior and lateral aspect of the nose.
5.3 PAP devices and humidifiers
3A is an exploded view of a PAP device according to an embodiment of the present invention;
3B is a perspective view of a humidifier according to an embodiment of the present invention;
3C is a schematic diagram of a pneumatic circuit of a PAP device according to an aspect of the present invention; Upstream and downstream directions are indicated.
5.4 Patient Interface
4 is a front view of a plenum chamber according to an embodiment of the present invention;
5 is a cross-sectional view taken along line 5-5 of FIG. 4;
Fig. 6 is an enlarged detail view of Fig. 1;
Fig. 7 is a top perspective view of the plenum chamber shown in Fig. 6;
Fig. 8 is a cross-sectional view taken along line 8-8 of Fig. 7;
Fig. 9 is an enlarged detail view of Fig. 8;
10 is a perspective view from the front of the plenum chamber according to an embodiment of the present invention.
Fig. 11 shows the plenum chamber shown in Fig. 10;
Fig. 12 is a cross-sectional view taken along line 12-12 of Fig. 11;
Fig. 13 is an enlarged detail view of Fig. 12;
14 is an enlarged cross-sectional view of the plenum connection area;
Fig. 15 is a side view of the patient interface of Fig. 14;
Fig. 16 is a cross-sectional view taken along line 16-16 of Fig. 15;
Fig. 17 is an enlarged detail view of Fig. 16;
18 is a side view of the patient interface in the head position of a model patient without the positioning and stabilizing structures shown.
19 is a partial bottom view of a patient interface along a model patient's head position in accordance with an aspect of the present invention. Note that only a portion of the positioning and stabilization structures connected to the frame are shown for clarity.
20 is a side view of a plenum chamber plenum connection area in accordance with one embodiment of the present invention;
Fig. 21 is a top view thereof;
22 is a front view thereof.
23 is a bottom view thereof.
Fig. 24 is a perspective view thereof;
Fig. 25 is a cross-sectional view of a connection portion where the plenum chamber and the frame are not connected and a frame connection area;
Fig. 26 is a cross-sectional view of the frame connection area and the connection portion where the plenum chamber and the frame are in contact but not fully connected;
Fig. 27 is a cross-sectional view of the frame connection area and the connection where the plenum chamber and the frame are almost completely connected to each other such that the retention characteristics are biased;
Fig. 28 is a cross-sectional view of the connection area and the frame connection area where the plenum chamber and the frame are connected but separated so that the retention characteristics are biased;
Fig. 29 is a cross-sectional view of the plenum chamber frame fully connected connection portion and frame connection area;
30 is a rear perspective view of a patient interface in accordance with an embodiment of the present invention with the plenum chamber and seal forming structure removed;
31 is a front perspective view of a patient interface in accordance with an embodiment of the present invention having a plenum chamber and a seal forming structure;
32 is a rear view of a patient interface in accordance with an embodiment of the present invention having a plenum chamber and seal forming structure;
33 is a side view of a patient interface in accordance with an embodiment of the present invention having a plenum chamber and seal forming structure;
34 is a perspective view of a patient interface in accordance with another embodiment of the present invention showing attachment of an exemplary seal forming structure and a plenum chamber to a frame of the patient interface;
35 is a cross-sectional view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention.
36 is a perspective view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention;
37 is an exploded view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention;
38 is a detailed view of an end portion of a rigid deezer arm according to an embodiment of the present invention;
39 is a perspective view of a patient interface including a mask frame, a flexible joint and a rigidizer arm in accordance with an embodiment of the present invention;
40 is a cross-sectional view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention.
41 is a perspective view of a rigid deezer arm according to an embodiment of the present invention;
42 is a cross-sectional view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention.
43 is a perspective view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention;
44 is an exploded view of a patient interface including a mask frame, a flexible joint, and a rigidizer arm in accordance with an embodiment of the present invention;
45 is a detailed view of an end of a rigid deezer arm according to an embodiment of the present invention;
46 is a detailed view of an end of a rigid deezer arm and a flexible fitting according to an embodiment of the present invention;
47 is a cross-sectional view of a rigid disser and a mask frame according to an embodiment of the present invention;
48 is a detailed cross-sectional view of a rigid digitalizer arm and a mask frame according to an embodiment of the present invention.
49 is a cross-sectional view of a rigid deesser arm and a mask frame according to an embodiment of the present invention.
50 is a perspective view of a rigid deezer arm and a mask frame according to an embodiment of the present invention;
51 is a perspective view illustrating a connection between a rigid digitalizer and a mask frame according to an embodiment of the present invention.
52 is a top plan view of the rigid-dezer arm and the mask frame according to an embodiment of the present invention, and a dotted line indicates the curvature of the rigid-dezer arm in the lateral outward direction of the coronal plane.
53 is a detailed plan view of a connection between a rigid disser and a mask frame according to an embodiment of the present invention;
54 is a cross-sectional perspective view of a rigid deezer arm mask frame according to an embodiment of the present invention;
FIG. 55 is a side view of the Rigidizer and the mask frame according to an embodiment of the present invention, and the dotted line indicates the curvature of the Rigidizer arm in the vertical downward direction of the sagittal plane.
56 is a front view of the rigid deezer and the mask frame according to the embodiment of the present invention.
57 is a perspective view of a rigid deesser arm, and shows a mask frame according to an example of the present invention.
58 is a partially exploded perspective view of a rigid deezer arm and a mask frame according to an example of the present invention.
59 is a detailed and partially exploded perspective view of a rigid deezer and a mask frame according to an embodiment of the present invention;
60 is a perspective view of a ridge deezer according to an embodiment of the present invention.
Figure 61 is a view of a rigidiser arm according to an embodiment of the present invention plotted on a grid in the XY plane;
62 is a diagram of a rigid deger arm according to an embodiment of the present invention plotted on a grid in the XZ plane;
63 is a diagram of a rigid deger arm according to an embodiment of the present invention plotted on a grid in the YZ plane.
64 is a three-dimensionally plotted view of a rigid deesser arm according to an embodiment of the present invention;
65 is a perspective view schematically illustrating a position and a stabilization structure according to an embodiment of the present invention;
66 is a cross-sectional view of a positioning and stabilizing structure along line 66-66;
67 is a schematic side view of an exemplary rigidiser arm for a positioning and stabilizing structure in accordance with the present invention;
68 is a schematic perspective view of an exemplary positioning and stabilizing structure including a rigid deesser arm in accordance with the present invention in a first state;
69 is a schematic perspective view of an exemplary positioning and stabilizing structure including a rigid deesser arm in accordance with the present invention, in a second state;
70 is a schematic perspective view of an exemplary positioning and stabilizing structure including a rigid deesser arm in accordance with the present invention in a third state;
71 is a perspective view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient;
72 is a front view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient;
73 is a side view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient;
74 is a perspective view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient;
75 is a front view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient.
76 is a side view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient;
77 is a bottom perspective view of an exemplary positioning and stabilizing structure in accordance with the present invention worn by a patient;
78 is a graph of the extension (in mm) of a strap of an exemplary positioning and stabilizing structure in accordance with the present invention over a load range (Newtons).
79 is a plan view of a strap in a positioning and stabilizing configuration according to an embodiment of the present invention during an intermediate stage of manufacture;
80 is a cross-sectional view taken along line 80-80 in FIG. 79 of a strap of a positioning and stabilizing configuration according to an embodiment of the present invention during an intermediate stage of manufacture;
81 is a plan view of a strap in a positioning and stabilizing configuration in accordance with an embodiment of the present invention;
82 is a top detail view of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention.
83 is a cross-sectional view through line 83-83 of FIG. 81 of a strap in a positioning and stabilizing configuration in accordance with an embodiment of the present invention;
84-88 are sequences of perspective views of a patient wearing a positioning and stabilizing structure in accordance with an embodiment of the present invention.
89-93 are sequences of side views of a patient wearing a positioning and stabilizing structure in accordance with an embodiment of the present invention.
94-98 are a sequence of front views of a patient wearing a positioning and stabilizing structure in accordance with an embodiment of the present invention.
99-104 are sequences of side views of a patient wearing a positioning and stabilizing structure in accordance with an embodiment of the present invention.
108-112 are a sequence of rear views of a patient wearing a positioning and stabilizing structure in accordance with an embodiment of the present invention.
113 is a detailed view of the connection between the strap and the rigid deezer arm of the positioning and stabilizing structure according to the embodiment of the present invention;
114 is another connection detail view between a strap and a rigid deezer arm in a positioning and stabilizing structure according to an embodiment of the present invention;
115 is another connection detail view between a strap and a rigid deesser arm in a positioning and stabilizing structure according to an embodiment of the present invention;
116 is another connection detail view between a strap and a rigid deesser arm in a positioning and stabilizing structure according to an embodiment of the present invention;
117 is another connection detail view between a strap and a rigid deezer arm in a positioning and stabilizing structure according to an embodiment of the present invention;
118 is another connection detail view between a strap and a rigid deesser arm in a positioning and stabilizing structure in accordance with an embodiment of the present invention;
119 is a detailed view of the connection between the strap and the rigid deezer arm of the positioning and stabilizing structure according to an embodiment of the present invention;
FIG. 120 is another connection detail view between a strap and a rigid deesser arm of a positioning and stabilizing structure according to an embodiment of the present invention; FIG.
121 is another connection detail view between a strap and a rigid deesser arm of a positioning and stabilizing structure according to an embodiment of the present invention;
122 is another connection detail view between a strap and a rigid deezer arm in a positioning and stabilizing structure according to an embodiment of the present invention;
123 is a detailed view of an isolated region of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
124 is another detailed view of an isolated area of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
125 is another detailed view of an isolated area of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
126 is a detailed view of a branching of a strap in a positioning and stabilizing structure in accordance with an embodiment of the present invention;
127 is another detailed view of a branching of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
128 is another detailed view of a branching of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
129 is another detailed view of a branching of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
130 is another detailed view of a branching of a strap in a positioning and stabilizing structure in accordance with an embodiment of the present invention;
131 is another detailed view of a branching of a strap of a positioning and stabilizing structure in accordance with an embodiment of the present invention;
132 is a perspective view of a positioning and stabilizing structure manufactured in accordance with an embodiment of the present invention;
133 is a process diagram of forming a positioning and stabilizing structure in a continuous roll in accordance with an embodiment of the present invention.
134 is a conventional embodiment illustrating a knitting process according to an embodiment of the present invention.
135 is a conventional embodiment illustrating a knitting process according to an embodiment of the present invention.
136 is a diagram of a basic warp knitted fabric in accordance with an embodiment of the present invention.
137 is a schematic view of the basic warp knitted fabric of FIG. 1;
138 is an illustration of a basic warp knitted fabric in accordance with an embodiment of the present invention.
139 is a view of a basic weft knitted fabric in accordance with an embodiment of the present invention.
140 is a side view of a positioning and stabilizing structure disposed on a patient's head in accordance with an embodiment of the present invention;
FIG. 141 is a view showing the direction of change of course or grain of the positioning and stabilizing structure of FIG. 140 in accordance with an embodiment of the present invention; FIG.
142 illustrates increased stretch in the direction of course of a knitted positioning and stabilizing structure in accordance with an embodiment of the present invention.
143 is a 3D printed link used to form a positioning and stabilizing structure in accordance with an embodiment of the present invention.
144 shows a 3D printed 3D printed position used to form a positioning and stabilizing structure in accordance with an embodiment of the present invention and a portion of a stabilizing structure comprising a rigidiser according to an embodiment of the present invention.
145 shows the 3D printed position and the stabilizing structural strap and clip according to an embodiment of the present invention.
146 is a rear perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
147 is a front perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
148 is a rear perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
149 is a side perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
150 is a side perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
151 is a side perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
152 is a top perspective view of a vent for a patient interface in accordance with an aspect of the present invention.
153 is a process flow diagram illustrating a method of manufacturing a patient interface for treatment of a respiratory disease in accordance with an embodiment of the present invention.
154 is a schematic diagram generally showing an apparatus used to practice the method of FIG. 153;
155 is a top view of a fabric depicting a vent portion after heat staking in accordance with an embodiment of the present invention.
156 is an enlarged plan view of a peripheral edge of a vent portion prior to heat staking in accordance with an embodiment of the present invention;
157 is an enlarged plan view of a peripheral edge of a vent portion after heat staking, in accordance with an embodiment of the present invention;
158 is an enlarged side cross-sectional view of a peripheral edge of a vent portion prior to heat staking, in accordance with an embodiment of the present invention;
159 is an enlarged side cross-sectional view of a peripheral edge of a vent portion after heat staking, in accordance with an embodiment of the present invention.
160 is a view of a short tube in a neutral state according to an embodiment of the present invention.
161 is a side view of a short tube in a compressed state according to an embodiment of the present invention;
162 is a side view of a short tube in an extended state according to an embodiment of the present invention;
163 is a side view of a short tube in a curved state according to an embodiment of the present invention;
164 is a cross-sectional view of a short tube along line 163-163 of FIG. 163 in accordance with an embodiment of the present invention;
165 is a perspective view of a short tube in a curved extended state in accordance with an embodiment of the present invention.
166 is a perspective view of a patient interface system in accordance with an embodiment of the present invention in use by a patient;
167 is a chart showing the air velocity (m/s) in the vertical plane along the x and z axes in the vent of the SWIFT FX ™ nasal pillow mask by ResMed Limited.
168 is a chart showing the air velocity (m/s) in the horizontal plane along the x and z axes in the vent of the SWIFT FX ™ nasal pillow mask by ResMed Ltd.
169 is a chart showing the vertical plane signals along the x and z axes in the vent of the SWIFT FX ™ nasal pillow mask by ResMed Ltd.
170 is a chart showing the horizontal plane signal along the x and z axes in the vent of the SWIFT FX ™ nasal pillow mask by ResMed Ltd.
171 is a chart illustrating air velocity (m/s) in vertical planes along the x and z axes in a vent of a patient interface system in accordance with one aspect of the present invention.
172 is a chart illustrating air velocity (m/s) in a horizontal plane along the x and z axes in a vent of a patient interface system in accordance with one aspect of the present invention.
173 is a chart illustrating vertical plane signals along the x and y axes in a vent of a patient interface system according to an aspect of the present invention.
174 is a chart illustrating horizontal plane signals along the x and y axes at a vent in a patient interface system in accordance with one aspect of the present invention.
175 is a chart comparing the velocity (m/s) along the vent axis as a function of distance (mm) in the vent of the SWIFT FX ™ nasal pillow mask by ResMed Limited and the vent of the patient interface system in accordance with one aspect of the present invention.
176 is a bottom perspective view of a reinforcing portion folded over an end of a strap of a positioning and stabilizing configuration in accordance with an aspect of the present invention;
177 is a top plan view of a reinforcing portion folded over an end of a strap of a positioning and stabilizing configuration in accordance with an aspect of the present invention;
178 is a side perspective view of a reinforcing portion folded over an end of a strap of a positioning and stabilizing configuration in accordance with an aspect of the present invention;
179 is a side plan view of a reinforcing portion folded over an end of a strap of a positioning and stabilizing configuration in accordance with an aspect of the present invention;
180 is an enlarged view of FIG. 179;
181 is an enlarged view of FIG. 177;
Figures 182-184 are a series of steps for removing a strap from a rigid deesser arm in a positioning and stabilizing configuration in accordance with an aspect of the present invention.
185 and 186 are a series of steps of attaching a strap to a rigid deezer arm having a positioning and stabilizing structure in 182-184 according to an aspect of the present invention.
FIG. 187 is a side plan view of a ridgedizer arm in a positioning and stabilizing structure in accordance with one embodiment of the present invention showing a visual indicator; FIG.
FIG. 188 is a side plan view of a ridgedezer arm in a positioning and stabilizing structure in accordance with one embodiment of the present invention showing a visual indicator.
189 is a front plan view of a frame and rigid digital arm according to an embodiment of the present invention showing visual and tactile indicators;
190 is a top plan view of a seal forming structure in accordance with one embodiment of the present invention showing a visual indicator;
191 is a rear plan view of a seal forming structure in accordance with one embodiment of the present invention showing a visual indicator;
192 is a top perspective view of a seal forming structure in accordance with one embodiment of the present invention showing a visual indicator;
193 is a cross-sectional view taken along line 193-193 of FIG. 192;
194 is a cross-sectional view taken along line 194-194 of FIG. 192;
195 is a rear plan view of a frame in accordance with one aspect of the present invention;
196 is a top plan view of a frame in accordance with one aspect of the present invention;
197 is a rear perspective view of a frame according to an aspect of the present invention;
198 is a side plan view of a frame according to one aspect of the present invention;
199 is a rear plan view of a retaining structure of a plenum connection area in accordance with one aspect of the present invention;
200 is a bottom plan view of a retaining structure of a plenum connection area in accordance with an embodiment of the present invention;
201 is a rear perspective view of a retention structure of a plenum connection area in accordance with an aspect of the present invention.
202 is a side plan view of a retaining structure of a plenum connection area in accordance with one aspect of the present invention;
203-207 show ResMed™ extending for distances of 30 mm, 60 mm, 90 mm, 120 mm with the lower end of the tube fixed in a fixed position with the longitudinal axis at the lower end perpendicular to the direction of extension before extension is initiated; Swift FX™ Nose Pillow Mask Tube.
208-212 show ResMed™ extending for distances of 30 mm, 60 mm, 90 mm, 120 mm with the lower end of the tube fixed in a fixed position with the longitudinal axis at the lower end perpendicular to the direction of extension before extension is initiated; Swift FX™ Nose Pillow Mask Tube.
213-217 show Philips ™ extensions for distances of 30 mm, 60 mm, 90 mm, 120 mm with the lower end of the tube fixed in a fixed position with the longitudinal axis at the lower end perpendicular to the direction of extension before extension is initiated; Respironics™ GoLife™ Nasal Pillow Mask Tube.
218-222 show the Philips ™ extending for distances of 30 mm, 60 mm, 90 mm, 120 mm with the lower end of the tube fixed in a fixed position with the longitudinal axis at the lower end perpendicular to the direction of extension before extension is initiated; Respironics™ Wisp™ Nasal Pillow Mask Tube.

EXAMPLES OF THE DETAILED DESCRIPTION OF THE INVENTION

Before the present invention is described in more detail, it is to be understood that the invention may vary widely and is not limited to the specific examples set forth herein. It should also be understood that the terminology used in the present invention is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

6.1 Processing system

In one form, the present invention includes a device for treating a respiratory disease. The equipment 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 in FIG. 1 .

6.2 Treatment

In one form, the present invention includes a method for treating a respiratory disease comprising applying positive pressure to an entrance to an airway of a patient 1000 .

6.2.1 Nasal CPAP for OSA

In one form, the present invention includes a method of treating obstructive sleep apnea in a patient by applying continuous positive nasal airway pressure to the patient.

6.3 Patient Interface (3000)

166 , a non-invasive patient interface 3000 according to one aspect of the present invention includes the following functional aspects: a seal forming structure 3100 (see, eg, FIG. 4 ), a plenum Connection port 3600 for connection to short tube 4180 of chamber 3200 , positioning and stabilization structure 3300 and air circuit 4170 . In some aspects, a functional aspect may be provided by one or more physical components. In some aspects, a single physical component may provide one or more functional aspects. In use, the seal forming structure 3100 is arranged to surround the airway entrance of the patient 1000 so that air is readily supplied to the airway at positive pressure.

6.3.1 Seal Forming Structure 3100

In one aspect of the present invention, the seal forming structure 3100 provides a seal forming surface and may additionally provide a cushioning function.

The seal forming structure 3100 according to the present invention is made of a soft flexible elastic material such as silicone. Seal forming structure 3100 may form part of a sealed passageway for air in a PAP device delivered to a patient's nostrils.

Referring to FIG. 9 , in one form of the present invention, a seal forming structure 3100 may include a seal flange 3110 and a support flange 3120 . The sealing flange 3110 may include a relatively thin member having a thickness of about 1 mm or less, for example, about 0.25 mm to about 0.45 mm. The support flange 3120 may be relatively thicker than the sealing flange 3110 . The support flange 3120 is spring-shaped or includes a spring-shaped element and functions to support the sealing flange 3110 from buckling in use. In use, the sealing flange 3110 may be responsive to system pressure of the plenum chamber 3200 acting underneath to promote a tight sealing connection with the face, eg, the patient's nostrils. The plenum chamber 3200 is made of a flexible material such as silicon.

6.3.1.1 Nose Pillow

In one form of the invention, the seal forming structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows 3130, each nasal puff or nasal pillow having an area around the patient's nostrils. constructed and arranged to form a seal with each nostril of the patient's nose by forming a seal against the

A nasal pillow 3130 (FIG. 9) according to features of the present invention includes:

incision-cone 3140, at least one portion forming a seal on the lower portion of the patient's nose, eg, the incision-cone portion; Connect the incision-cone to the stalk 3150 , the upper flexible region 3142 at the bottom of the incision-cone 3140 , and the stalk 3150 . also,

The structure to which the nasal pillow 3130 of the present invention is connected includes a lower flexible region 3152 adjacent to the stalk 3150 . The upper flexible region 3142 and the lower flexible region 3152 are designed to facilitate a universal joint structure to which the relative motion (both displacement and angle) of the incision-cone 3140 (both displacement and angle) is applied and the structure to which the nasal pillow 3130 is connected. can work cooperatively.

In one embodiment, the incision-cone 3140 may be coaxial with the talc 3150 to which it is connected. In another embodiment, the incision-cone 3140 and the talc 3150 may not be coaxial. (Example offset for example). The nose pillow 3130 may be sized and shaped to extend laterally beyond the wall of the plenum chamber 3200 described below.

In one form of the present invention, each stalk 3150 may include variable stiffness to prevent the nose pillow 3130 from swaying forward in use due to compression and/or bending of the stalk 3150 . For example, in use, the side of the talc 3150 that is distal from the patient's face is stiffer than the area of the talc 3150 that is proximal to the patient's face. That is, when the compression or bending of the talc 3150 is not in a predetermined direction, the stiffness of other materials on the opposite side of the talc 3150 is more resistant. This prevents the pillow 3130 from swinging forward, thereby allowing the pillow 3130 to be compressed into the nostrils. This configuration can help resist buckling that causes the nasal pillow 3130 to swing forward. Variable stiffness may also be used to provide a point of weakness that facilitates swaying allowing the stalk 3150 to buckle in the intended direction. That is, compression of the nasal pillow 3130 can be achieved. This arrangement also allows the sealing force to be localized to the top of the nasal pillow 3130 . In addition, the configuration can also be made so that the deflection of the nose pillow 3130 is made in the center. The nasal pillow 3130 may be formed to be pressed against the plenum chamber 3200 when it comes into contact with the patient's face, and since the nasal pillow 3130 may be transversely wider than the plenum chamber, any plenum chamber 3200 ) does not extend over the pillow 3130 either. In other embodiments, when compressed, the nose pillow 3130 may be sized and shaped such that its perimeter is generally flush with the perimeter of the plenum chamber 3200 . In another embodiment of the invention, the stalk 3150 may be thin at the base of the incision-cone 3140 .

In one embodiment, to connect the pillow 3130 with the patient's airway entrance, the pillow 3130 has its entrance located in the nostrils. As the positioning and stabilizing structures are adjusted, the tension begins to pull the pillow 3130 into the nostrils. Continuous insertion of the pillow 3130 into the nostril causes the stalk 3150 to collapse through the trampoline 3131 moving the base of the pillow 3130 towards the upper surface of the plenum chamber 3200 . The stalk 3150 of the nasal pillow 3130 may be connected to the plenum chamber 3200 and may include a thin, reduced thickness portion. The thin portion may cause the pillow 3130 to bounce or vibrate easily and thus the patient 1000 ) can be adjusted more easily to match the wing angle.

The trampoline 3131 may be spaced apart from the lower part of the pillow 3130 or the septum and/or the upper lip of the patient 1000 to form an angle. This improves the comfort and stability of the patient interface device 3000 .

It is also expected that various sizes of the nasal pillow 3130 may be used as a plenum chamber having a connection area and a plenum connection area of a common size. This has the advantage that the plenum chamber 3200 and the pillow 3130 can be worn in a size that fits the patient's particular anatomy, eg size and nostril orientation.

In one aspect of the present invention, the seal forming structure 3100 forms a seal in at least a portion of the patient's nasal column axis region.

6.3.1.2 Nose cushion

Although a small portion of nasal pillow 3130 may enter the nose in use, the alternative form of seal forming structure 3100 is substantially external to the nose in use. 34, the seal forming structure 3100 of the non-invasive patient interface 3000 is configured to form a seal against the patient's airway surrounding both nostrils without being partially located within the nose. are placed Seal forming structure 3100 provides a single orifice for both nostrils, such as a nasal cushion or nose cradle. The seal forming structure 3100 according to the example shown in FIG. 34 includes a nose flange 3101 disposed therearound. This also represents attaching the plenum chamber 3200 and the seal forming structure 3100 to the frame 3310 .

6.3.2 Plenum Chamber (3200)

The plenum chamber 3200 according to one aspect of the present invention functions to allow air flow between the two nostrils and the supply of air from the PAP device 4000 through the short tube 4180 . The short tube 4180 is part of an air circuit 4170 that is connected to the frame 3310 through a connection port 3600 and a long tube (additional gas supply tube) 4178 that are generally connected to the PAP device 4000 . In this method, the plenum chamber 3200 selectively functions as an inlet manifold during breathing of the breathing cycle and/or as an exhaust manifold during the exhalation portion of the breathing cycle.

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

A plenum chamber 3200 according to another aspect of one form of the present invention provides a cushioning function between the seal forming structure 3100 and the positioning and stabilizing structure 3300 .

In one form of plenum chamber 3200, the inlet/outlet manifold and cushion functions are performed by the same physical components, in an alternative form of the present invention, which are formed of two or more components.

Seal forming structure 3100 and plenum chamber 3200 are formed of, for example, single and unique components.

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

The rear wall 3220 includes a rear surface 3222 (see FIG. 8 ). In one form of the present invention, seal forming structure 3100 is configured to posterior wall 3220 such that, in use, posterior surface 3222 is spaced from the patient's setum and/or upper lip as shown in FIGS. 18 and 19 . and placed. In one form, for example, where seal-forming structure 3100 includes nasal pillow 3130 , this means that posterior surface 3222 is posterior surface 3222 , as shown in FIG. 8 by nasal pillow 3130 . This is accomplished by placing the rear wall 3220 ahead of the rearmost portion 3130.1 of The placement may also concentrate the sealing force on the patient 1000 nostril as the setum and/or upper lip are released from contact with the patient interface 3000 .

The plenum chamber 3200 also includes a bent region 3230 ( FIG. 9 ) that forms a connection with the seal forming structure 3100 . The curved region 3230 may be a region divided by the front wall 3210 and/or the rear wall 3220 . Optionally, some or all of the entire respective anterior wall 3210 and posterior wall 3220 may form part of the flexion region 3230. In one aspect of the present invention that includes, there is a corresponding left flexion region 3232 and a right flexion region 3234 (FIG. 4), respectively. Flexion regions 3230 , 3232 and 3234 may respond to a force upon use of the patient interface 3000 , such as a tube dragging force, or movement of the patient's head, such as pressing the patient interface 3000 against a bed pillow. Constructed and arranged in bends and/or bends. Bend region 3230, left flex region 3232, and/or right flex region 3234 may be constructed from silicone rubber having a Type A indentation hardness in the range of about 35-about 45. However, walls 3210, 3220 A wider range is possible if the thickness of ) is adjusted to achieve the same level of force.

In another aspect of the invention shown in FIGS. 4, 7, 8, 10 and 11 , the plenum chamber 3200 has a saddle or decoupling region 3236 . As shown in FIG. 4 , bend region 3230 may include a decoupling region 3236 that may be positioned between left bend region 3232 and right bend region 3234 . The decoupling region 3236 may be concave and may extend from the anterior region 3210 to the posterior region 3220 . By forming the plenum chamber 3200 with the decoupling region 3236 as described, the right flexion region 3234 to the left flexure region 3232 is such that movement of one of the flexure regions does not substantially affect the other flexure region. can be separated.

That is, deformation and/or buckling of the left flexion region 3232 does not cause deformation in the right flexion region 3234 and vice versa. Advantageously, this allows the nasal pillow 3130 associated with the unobstructed flexion region to remain in position in the patient's corresponding nostril despite obstructions to other flexion regions.

Decoupling region 3236 may avoid contacting the septum by entering recessed between scallops 3150. Again, decoupling region 3236 may be provided with plenum chamber 3200 to allow for the desired amount of flexibility of the region. ) may be the thinnest region of Optionally, the decoupling region 3236 may be the thinnest region of the plenum chamber 3200 . Saddle area 3236 with deep curvature, septum and/or upper lip contact is minimized or avoided to improve patient comfort. The saddle region 3236 may be U- or V-shaped and may have a peak nose lip angle of between about 70° and about 120°. The saddle region 3236 may have a depth of about 0.5 mm to about 2.5 mm for the patient's periseptal gap.

The posterior wall 3220 may be disposed adjacent the upper lip in use of the patient interface 3000 as in FIGS. 18 and 19 .

In one form, the plenum chamber 3200 may also include a sealing lip 3250 ( FIG. 6 ). Sealing lip 3250 may be constructed of a flexible elastic material, such as silicone rubber having a Type A hardness in the range of about 30-50 forming a relatively soft component.

The sealing lip 3250 may be positioned or formed as part of an area around the interior surface or interior of the plenum chamber 3200 or the entire interior circumference of the plenum chamber 3200, as shown in FIGS. 5, 6 and 8 . . However, it is contemplated that the sealing lip 3250 may also be disposed around the exterior surface or exterior perimeter of the plenum chamber 3200, or around the entire exterior perimeter area of the plenum chamber 3200. Seal lip 3250 may form a pneumatic seal between plenum chamber 3200 and frame 3310 as described in more detail below. The sealing lip 3250 and the plenum chamber 3200 may be integrally formed. Other patient interface devices connect the plenum chamber and the frame to the frame and at the same time use a pneumatic seal between the frame and the plenum chamber to compress the plenum chamber made from an elastically deformable material such as silicone to form a pneumatic seal. form a seal. In contrast, one example of the present invention forms a pneumatic seal by interference at seal lip 3250 that deflects relative to frame 3310 when plenum chamber 3200 is secured to frame 3100 . When the pressure in the plenum chamber 3200 increases above atmospheric pressure to treat respiratory disorders, the pneumatic seal becomes stronger and the sealing force increases as the seal lip 3250 applies a greater force against the frame 3310. do. Air pressure in the cushion/plenum chambers of other patient interface devices does not affect the sealing force between the cushion and the frame. In addition, these other patient interface devices have cushions with sidewalls that connect with a frame and flexible sealing lips, which are not rigid and can be stretched or elastically flexed with little effort because they readily adapt to finger pressure. In particular, due to the relatively large size and characteristic ratio of the nose cushion, this causes the cushion to loosen. The sidewalls for the frame connection are very flexible so that the opposite sides of the cushions can be clamped together and brought into contact with each other with very little finger force. This easy deformation of the sidewall relative to the frame connection can be a major cause for a patient with arthritis in the hand to find it difficult to quickly attach the cushion to the frame of the other patient interfaces.

It should be understood that the seal made by the seal forming structure may improve stability by forming the plenum chamber 3200 features with sufficient stiffness. It is also possible to change the thickness of the plenum chamber 3200 to be thinner from the plenum region region 3240 to the seal forming structure 3100 . In one embodiment of the present invention, about 2-3 mm thick at or near the plenum chamber 3200, 1 mm thick at the point between the plenum connection area 3240 and the seal forming structure 3100, and the seal forming structure ( 3100) or 0.75 mm thick in the basal body. Forming the plenum chamber 3200 having the above characteristics may be accomplished with injection molding manufacturing. Such a step reduction in the thickness of the plenum chamber 3200 allows greater deformation of the silicon material closer to the stalc 3150 ldTrp, making the patient's nose more comfortable and reducing the likelihood of seal deformation.

Some nasal pillow patient interfaces are assembled in the following order: (i) plenum chamber, (ii) headgear connection, and (iii) seal forming structure.

In contrast, one example of a patient interface 3000 of the present invention has an assembly sequence of (i) a head gear connection (ii) a plenum chamber and (iii) a seal forming structure. This difference in placement means that the headgear tension does not cause deformation of the plenum chamber 3200 and the seal forming structure 3100 which results in a collapse of the sealing force.

6.3.3 Frames (3310)

4 , 10 , 75 , 76 and 166 , the frame 3310 is a short tube 4180 , a plenum chamber 3200 , and a positioning and stabilizing structure 3300 in a removable form or in a more permanent form. It functions as a central hub that connects to one of the forms.

31-33 are various views of a frame 3310 connected to a positioning and stabilizing structure 3300 having a strap 3301 via a flexible joint 3305 . The figure shows a frame 3310 without a plenum chamber 3200 and a seal forming structure 3100 . A connection port 3600 and a vent 3400 described in more detail below are disposed in the frame 3310 .

In one embodiment of the present invention, frame 3310 is formed of polypropylene.

In other embodiments of the present invention, the frame 3310 may be made of one size, but the plenum chamber 3200 and the seal forming structure 3100 are a single frame through the general sized connection characteristics described herein. It can be made in several sizes that can be mounted on

In one embodiment of the present invention, the frame 3310 may be molded without undercuts so that it can be removed from the mold without bending after molding.

6.3.4 Connection between plenum chamber and frame

In one form of the present invention, the plenum chamber 3200 may be detachably attached to the frame 3310 to facilitate the fine axis or change the seal forming structure 3100 of a different size. This allows the plenum chamber 3200 to be cleaned more frequently than the frame 3310 and short tube 4180 . In addition, the plenum chamber 3200 is removed from the strap 3301 to be cleaned. In an alternative form, the plenum chamber 3200 is not easily removable from the frame 3310 .

The plenum chamber 3200 may include a plenum connection region 3240 ( FIG. 6 ). The retaining structure 3242 of the plenum connection region 3240 has a shape and/or configuration that is complementary to that of the corresponding frame connection region 3312 ( FIG. 10 ). The retaining structure 3242 of the plenum chamber 3200 is more rigid than the other parts of the plenum chamber 3200 and is made of the same material as the frame 3310, such as polypropylene such as Rilsan® or polyamide, for example. . In another embodiment, the plenum connection area 3240 may be made of nylon, and the frame 3310 may be made of polypropylene, nylon, or polyamide, which is not a flexible material and readily conforms to finger pressure. I never do that. Thus, when they are connected to each other, there is a clicking sound and a hard click and hard to hard connection. The shape of the retaining structure 3242 is shown in Figures 20-24 in a form similar to an ark pole or hyperbolic cylinder. Retention structure 3242 is not stretchable and not extensible to retain its general shape when connected and disconnected from frame 3310 . The shape of the retaining structure 3242 is slightly flexible, but it is not within the range where opposite sides of the retaining structure 3242 can touch each other when tightened together with finger pressure. That is, both sides of the retention structure 3242 can only contact each other with a significant tightening intended by the patient 1000 that would not normally occur in a normal treatment environment. In the illustrated embodiment, the upper and lower edges of the retaining structure 3242 may be tightened closer together/easier to each other than the side edges of the retaining structure 3242 using the same amount of tightening force. 18, the curvature of the frame 3310 and retention structure 3242 is intended to follow the natural curve of the patient's upper lip and allows the patient to spread contact pressure from headgear tension evenly over the patient's upper lip. It is possible to avoid concentrating the contact pressure on a specific point of the upper lip.

This can eliminate or minimize skin damage due to long concentrated contact pressure. Another advantage to curvature is that less material is required for the flat plenum chamber 3200 compared to the frame. The flat frame requires more material for the plenum chamber 3200 at the side edges to allow the plenum chamber 3200 to conform to the patient's upper lip. Less material reduces the overall weight of the patient interface 3000 . The curvature also minimizes the projection of the patient interface 3000 anteriorly from the patient's face to improve the non-obstructiveness of the patient interface 3000 . In addition, the retaining structure 3242 may be adhered (using an adhesive) to the plenum chamber 3200 according to an embodiment of the present invention after molding. In other embodiments, an integral chemical bond (molecular adhesion) may be used between the retention structure 3242 and the plenum chamber 3200 .

In an embodiment of the present invention, retaining structure 3242 may be molded without undercuts so that it can be removed from the mold without bending after molding. Retention structure 3242 has a continuous peripheral edge on its front side that contacts frame 3310 .

The continuous peripheral edge is exposed to contact the frame 3310 for hard to hard connection. This is in contrast to the majority of soft to hard connections of some conventional masks where there is a front lip portion of the seal forming structure that covers and overlaps most of the detachable rigid retention structure. The anterior lip section is made from the LSR and is enclosed over a retaining structure that holds them together. However, such conventional masks are difficult and cumbersome to wrap the front lip portion over the detachable clip, resulting in the clip being misplaced, and possibly connecting the seal forming structure to the frame.

One purpose of retaining structure 3242 is to align plenum chamber 3200 when coupled with frame 3310 . This is because the shape of the retaining structure 3242 of the plenum chamber 3200 is retained in the space formed between the frame connection area 3312 and the obstructive portion 3314 of the frame 3310 .

Another purpose of retaining structure 3242 is to retain plenum chamber 3200 in frame 3310 by preventing relative horizontal and vertical relative movement between these two parts. The plenum connection region 3240 may include at least one retention feature 3244 , and at least one complementary frame connection region 3312 may be present. The plenum connection region 3240 may include one or more retention features 3244 (FIG. 10). In addition to preventing relative horizontal and vertical movement between the plenum chamber 3200 and the frame 3310, another purpose of the retention feature 3244 is to prevent relative longitudinal movement between these two parts. The remainder of the plenum chamber 3200 may include more flexible material than the retention structure 3242 and the plenum connection region 3240 .

In one form, plenum connection region 3240 is constructed of a rigid or semi-rigid material, such as high durometer silicone or TPE plastic, nylon, heat resistant material, polypropylene and/or polycarbonate. The plenum connection region 3240 may be constructed from different materials to different portions of the plenum chamber 3200 . For example, the plenum connection region 3240 may be a separate component that is permanently connected, in integral contact, or mechanically interlocked with the connecting portion 3202 ( FIG. 10 ) of the plenum chamber 3200 . 6 , the connecting portion 3202 of the plenum chamber 3200 may have substantially the same thickness as the retaining structure 3242 of the plenum connecting region 3240 . The plenum connection region 3240 may include a tongue portion 3211 configured and arranged to be received in engagement by a channel portion 3211.1 , eg, a channel portion of the frame 3310 . In this way, the channel portion 3211.1 may form a bonding property for the tongue portion 3211 and vice versa.

Also, the tongue portion 3211 and the channel portion 3211.1 may be sized to minimize the sealing surface of the region.

6.3.4.1.1 Attaching and removing the plenum chamber from the frame

The plenum chamber 3200 may be attached to the fixed frame 3310 , but may also be removably installed in the frame 3310 . 12 shows the plenum chamber 3200 in a connected position relative to the frame 3310 . The plenum connection area 3240 in this embodiment includes only two retaining features 3244 located on opposite sides of the connection area 3240 , for example on the rear and front sides. 12 and 13 show a section through two barbs 3246, while FIG. 17 shows another section in which barbs 3246 are not present, for example forming a channel or groove 3211.1. Resilient barbs 3246 are in the form of snap-in compression fittings to provide high retention (to prevent accidental release) and also allow relatively easy intentional removal. In FIG. 17 , the plenum connection area 3240 and frame 3310 easily fit together in the same manner as a tongue and groove. Frame 3310 and retaining structure 3242 may be formed such that tongue portion 3211 and channel portion 3211.1 are connected before retaining feature 3244 is connected to the frame.

Each retention feature 3244 may take the form of a barb 3246 ( FIGS. 6 and 13 ) having a leading surface 3246.1 and a trailing surface 3246.2 . The leading surface 3246.1 is configured to connect with the lead-in surface 3312.1 of the frame connection area 3312 of the frame 3310 as the plenum chamber 3200 and the frame 3310 move in connection with each other. As the retention feature 3244 is pressed into a deformed position, the upper and lower regions of the frame connection region 3312 and the interfering portion 3314 of the frame 3310 may also deform slightly. Also, retaining structure 3242 is slightly deformed, particularly near retaining feature 3244 (see, eg, dashed lines in FIGS. 27 and 28). 195 to 198 , the deformation of the frame connecting area 3312 and the interfering portion 3314 of the frame is controlled according to the area over which the deformation occurs through the use of the ribs 3294 and the amount of deformation allowed. In one embodiment of the present invention there are six ribs 3294 spaced about and about the interfering portion 3314 . The spacing and location of the ribs 3294 limits the deformation region of the interfering portion 3314 only to the region proximate to the retention feature 3244 . Rib 3294 is a plenum connection region to provide a tighter connection between plenum connection region 3240 and frame connection region 3312 at the point of contact when plenum chamber 3200 is connected to frame 3310 . It can be deformed adjacent to the inner surface of 3240 .

199 to 202 , the plenum connection region 3240 of the plenum chamber 3200 has ribs 3294 and corresponding notches 3295 . The notches 3295 are chamfers to minimize friction of the plenum connection area 3240 against the rib 3294 during assembly of the frame 3310 and the plenum chamber 3200 . Once the barbs 3246 are depressed by a sufficient amount, the barbs 3246 snap-fit radially outwardly such that they are in the retention position shown in FIG. 13 . The snapping action becomes an audible sound to the user, such as a confirmation click to provide feedback to the user or the patient, when an appropriate connection has been made.

In the retaining position, the trailing surface 3246.2 of the barbs 3246 engages the retaining surface 3312.2 of the frame connection area 3312, as shown in FIG. 13 . The confirmation click forms a plenum connection area 3240 of sufficient stiffness to be maximally strong in the vicinity of the plenum connection area 3240, in one embodiment of the present invention. Said stiffness can be achieved by overmolding manufacturing.

As shown in FIG. 13 , the surfaces of barbs 3246 and frame connection area 3312 are angled in a specific way to facilitate a sliding connection between plenum chamber 3200 and frame 3310 . For example, as described above, the leading surface 3246.1 and the lead-in surface 3312.1 can be formed at an angle corresponding to each other so that they can be slidably connected to each other relatively easily with respect to the surface.

Likewise, trailing surface 3246.2 and retaining surface 3312.2 may be angled relative to each other to help maintain frame 3310 and plenum chamber 3200 once connected. The angle between the trailing surface 3246.2 and the retaining surface 3312.2 is such that, for example, a pulling force applied generally along the axis of the nasal pillow 3130 releases the plenum chamber 3200 from the frame 3310. 3246 is selected to be sufficient to bend inward.

The pulling force is not required to first bias the patient 1000 radially inward by squeezing the plenum chamber 3200 in an anterior-posterior direction. Otherwise, the deflection of the radial rays of the barbs 3246 with respect to the angle concerned is simply the result of the applied axial tension force. In one embodiment of the present invention, the plenum connection area 3240 is biased, and disassembling the plenum chamber 3200 from the frame 3310 is spaced apart from the frame 3310 to tighten the plenum chamber 3200 and This is done by pulling the overflow chamber 3200.

As shown in FIG. 13 , plenum chamber 3200 is attached to frame 3310 via plenum connection area 3240 and retaining features 3244 are attached to frame connection area 3312 through barbs 3246 . Connected. As shown in the figure, the retaining surface 3312.2 of the frame connection area 3312 and the trailing surface 3246.2 of the barbs 3246 are interconnected and coplanar. For the patient to disengage the plenum chamber 3200 from the frame 3310, the patient must 3200) should be pulled.

In one embodiment of the present invention, tightening the plenum chamber 3200 reduces the axial pulling force required to remove the plenum chamber 3200 from the frame 3310 . This resistance can be "tuned" or selectively adjusted to a desired level by changing the angle at which the surfaces 3312.2, 3246.2 are connected to each other. The closer perpendicular to the surfaces 3312.2, 3246.2 with respect to the direction of the force applied by the patient 1000 to remove the plenum chamber 3200 from the frame 3310, the force required for removal. gets bigger

This angle is shown in FIG. 14 as β, where the trailing surface 3246.2 is relative to the nominal vertical axis 3246.4 (corresponding to the axial pull direction in the direction of the plenum chamber 3200 relative to the frame 3310). make an angle As β increases, the force required to remove the plenum chamber 3200 from the frame 3310 increases. Also, as β increases, dismounting may be more difficult for the patient 1000 . In one embodiment, it has been found that an angle β of about 75° can give the patient a comfortable feeling for dismounting. In other embodiments, β may vary by 30-110° or 40°-90° or 65°-85° to create an ideal level of resistance to stripping. This is chosen to minimize the possibility of accidental removal and to allow only intentional removal by the patient 1000 .

As the angle α increases, the force required to connect the retention feature 3244 and the frame connection area 3312 increases and the patient's attachment feeling to connect the components 3244 and 3312 becomes more uncomfortable. That is, as the leading surface 3246.1 of the retention characteristic 3244 slides along the lead-in surface 3312.1 of the frame connection area 3312, the user can feel the softness as the angle α decreases. In one embodiment, it has been found that an angle α of about 30° produces a comfortable release feel for the patient 1000 . In other embodiments, angle α may vary by 50-70° or 15°-60° to create an ideal level of resistance to adhesion.

Also, since the feel and force for connection and disconnection of the plenum chamber 3200 and the frame connection region 3312 can be selectively adjusted independently of each other, the angles α and β are different from the level of resistance of the removal. The level of resistance to resistance may be chosen to be felt by the patient. In one embodiment of the present invention, the angles α and β can be selected such that the angle β is greater than the angle α, where the patient has more resistance to attachment of the plenum chamber 3200 and frame 3310 than resistance to removal. The patient may be chosen to feel less. That is, the patient may find it more difficult to release the plenum chamber 3200 from the frame 3310 than to connect them.

As shown in Figure 4, one embodiment of the present invention includes a pair of retention features 3244 and 3245. As shown in the figure, exemplary retention features 3244 and 3245 differ in size. In particular, the figure shows that the retention feature 3245 disposed in the front portion of the plenum connection area 3240 is narrower than the retention feature 3244 disposed in the rear portion of the plenum connection area 3240 . By varying the size of the retention feature 3244 , the patient 1000 can attach the plenum chamber 3240 to the frame 3310 in only one direction. The arrangement is shown in FIG. 10 . This avoids failure of attachment of the patient, minimizes adverse effects on the patient interface 3000 that may result from improper attachment, provides an adequate seal to the patient's airway and reduces contact with the septum and/or upper lip of the patient 1000 . Ensure that they are properly oriented to provide comfort by allowing or avoiding them.

In FIG. 10 , it is shown that the two frame connection regions 3312 and 3313 are connected to the corresponding retaining characteristics 3244 and 3245 . The embodiment shown here shows that the narrower front retention feature 3245 is sized to correspond to the narrower front frame connection area 3313 . Also, a wider rear retention feature 3312 is associated with a rear frame connection area 3244 of that size. The above arrangement has the advantage of allowing the patient to attach the plenum chamber 3240 to the frame 3310 in only one direction, and to be formed in a unique size in a frame connection area of a unique size corresponding to one retention characteristic.

By limiting the orientation of attachment, the patient 1000 prevents the patient interface 3000 from being improperly assembled and from receiving suboptimal treatment due to the improperly assembled patient interface 3000 . The arrangement described above for this particular embodiment of the present invention is such that the patient 1000 can only fully assemble the patient interface 3000 if the components are properly aligned, so that the patient interface ( It is preferred for patients 1000 who are likely to assemble 3000) or patients 1000 who may have difficulty properly connecting the components due to visual problems.

As noted above, the angle of the leading surface 3246.1 and trailing surface 3246.2 with respect to the barbs 3246 is important to provide an optimal amount of resistance to assembly and disassembly of the patient interface 3000 . The emphasis on sizing each retention feature 3244 , 3245 and frame connection area 3312 , 3313 to ensure proper orientation of the components in assembly has been described above. Properly sized retention features 3244 , 3245 and frame connection areas 3312 , 3313 assist in securing the plenum chamber 3200 to the frame 3313 . That is, the frame connection regions 3312 and 3313 and the retention characteristics 3244 and 3245 have the frame connection regions 3312 and 3313 around the retention characteristics 3244 and 3245 and the frame connection regions 3312 and 3313 as the retention characteristics. (3244, 3245) may be sized to conform closely to each other to aid in orientation and alignment. This may be desirable for patients with limited limb function due to disease (arthritis), or patients assembling patient interface 3000 in a dark bedroom prior to sleep or where visibility is reduced due to limited vision.

In addition, the retention characteristics 3244 and 3245 and the frame connection regions 3312 and 3313 are sized to have a close conformability to each other, so that the sealing between the plenum chamber 3200 and the frame 3310 is easy between the two components. Contributes to ensuring a safe connection is maintained. In addition, the close conformability of the retention characteristics 3244 and 3245 and the frame connection regions 3312 and 3313 to each other contributes to easy uniform alignment of the plenum chamber 3200 to the frame 3310 .

In one embodiment of the present invention, a difference of 0.3 mm-2 mm is incorporated between retention characteristics 3244 and 3245 and frame connection areas 3312 and 3313.

It should be understood that the above-described connection between the frame 3310 and the plenum chamber 3200 may be used for other types of masks. These features are equally applicable to nose or face masks. Sealing under the nose bridge, such as a compact nose mask or compact face mask, may incorporate the connectivity features described herein.

In addition, a mask lacking frontal support means may include such a connection function. Also, it is assumed that examples of the present invention include a mask, such as having a nasal pillow 3130 or a nose cradle/nose flange 3101, where the seal under the tip of the nose may use this connection feature.

6.3.4.1.2 Plenum chamber and frame removal sequence

25-29 show a sequence of cross-sectional views of the connection portion 3202 of the plenum chamber 3200 and the frame connection area 3312 of the frame 3310 . The flowchart shows the process of attaching the plenum chamber 3200 to the frame 3310 . Although the figure shows only one retaining feature 3244 attached to one frame connection region, it is contemplated that there may be more than one retaining feature 3244 and more than one frame connecting region 3312 as shown in FIG. 10 and described above. should understand that Thus, during the mounting sequence of the plenum chamber 3200 and the frame, there may be more examples of the attachment sequence shown above to achieve complete attachment of the plenum chamber 3200 and frame 3312 .

25 is a cross-sectional view of a connection portion 3202 of the plenum chamber 3200 and a frame connection region 3312 of the frame 3310 where the connection portion 3202 and the frame connection region 3312 are near but not in contact with each other. am. The arrow indicates that the connecting portion 3202 and the frame connecting region 3312 are configured together. It should be understood that the plenum chamber 3200 and frame 3310 additional parts are not included for the sake of simplification in the drawings. Therefore, it should also be understood that the frame connection region 3312 and the interfering portion 3314 of the frame connection region 3312 are two parts of the frame 3310 as shown in FIG. 13 , for example. It should also be understood that the frame connection portion 3312 and the interfering portion 3314 of the frame connection portion 3312 move relative to each other through the attachment sequence. Referring to FIG. 25 , the figure shows that the sealing lip 3250 is not deformed and the retention characteristics 3244 are not deformed as none of the components 3250 , 3244 will be in contact with the frame 3310 .

26 shows the barbs 3246 of the retaining feature 3244 beginning to contact the frame connection area 3312 of the frame 3310 . In particular, the figure shows the leading surface 3246.1 of the barbs 3246 in contact with the lead-in surface 3312.1 of the frame connection area 3312 . In this figure, the retaining feature 3244 and the frame connection region 3312 are shown in contact with each other so that the retaining feature 3244 is not deflected. Further, the sealing lip 3250 is not deflected because it is not yet in contact with the interfering portion 3314 of the frame connection area 3312 . As described above, the angle α of the leading surface 3246.1 starts to affect the resistance, and the user starts connecting the leading surface 3246.1 with the lead-in surface 3312.1, so the plenum chamber 3200 and the frame connection area (3312) feel the connection.

FIG. 27 shows the plenum chamber 3200 and frame 3310 according to an attachment sequence such that the retention feature 3244 is deflected by contacting the frame connection area 3312 . As shown in the figure, the frame connection region 3312 and the interfering portion 3314 of the frame connection region 3312 are closer to the connection portion 3202 . Also shown in the figure, the leading surface 3246.1 of the barbs 3246 contacts a portion of the lead-in surface 3312.1 that is closer to the retaining surface 3312.2. That is, it can be seen that the barb 3246 moves closer for attachment with the frame connection area 3312 and moves relative to the position shown in FIG. 26 . As noted above, the connection portion 3202 and the plenum connection region 3240 of the plenum chamber 3200 may also be deflected depending on the patient tightening force. 27 shows that the retaining feature 3244 is deflected by contact with the frame connection region 3312 and the dotted line outlines the retaining feature 3244 in its undeformed state. 27 also shows that the sealing lip 3250 has not yet contacted the interfering portion 3314 of the frame connection region 3312 and thus the sealing lip 3250 has not yet been deformed. Although not shown in the figure, it should be understood that the frame connection area 3312 may be biased away from the retention feature 3244 due to the force of the portions 3312 , 3244 being forced together.

In FIG. 28 , plenum chamber 3200 and frame 3310 are nearly attached, and retention feature 3244 is almost completely connected with frame connection region 3312 . In this figure, the retention feature 3244 is still deformed, but the barbs 3246 are in contact with other portions of the frame connection area 3312 . In particular, the trailing surface 3246.2 of the barb 3246 now contacts the retaining surface 3312.2 of the frame connection area 3312 . Also, due to the angle at which the trailing surface 3246.2 and the retaining surface 3312.2 contact each other, the retaining feature 3244 and the frame connection area 3312 become non-deformable, pulling the parts together after a certain insertion distance is reached. It is tightened to connect by the intrinsic nature of the retention feature 3244 which is biased to return to its original state. 28 also shows the retention characteristics 3244 in the unstrained state with dashed lines. Also in this figure, the sealing lip 3250 is shown in contact with the interfering portion 3314 of the frame connection area 3312 . At this point in the attachment sequence, the seal may begin to form by contact of the sealing lip 3250 with the interfering portion 3314 of the frame connection area 3312 . The sealing lip 3250 may also be deflected slightly by contacting against the interfering portion 3314 of the frame connection area 3312 .

29 shows the plenum chamber 3200 and frame 3310 fully attached by the connection of the barb 3246 and frame connection area 3312 of the retaining feature 3244 . In this figure, retaining surface 3312.2 is relatively coplanar with respect to trailing surface 3246.2. Retention characteristics 3244 are also no longer biased by contacting frame connection area 3312 . Retention characteristics 3244 return to an undeformed state from a deflected or deformed state as shown in FIG. 28, and barbs 3246 and retention characteristics 3244 from the position shown in FIG. 28 to the position shown in FIG. 29. This movement can generate an audible click.

The audible click for confirmation may be desirable by providing feedback to the patient 1000 that the plenum chamber 3200 and frame 3310 are fully connected. By providing feedback to the patient 1000 about the connection completion, the patient 1000 ensures that the plenum chamber 3200 and the frame 3310 are securely attached and not separated while the patient 1000 is asleep and during treatment. You can use the patient interface 3000 with confidence.

In addition, when the plenum chamber 3200 and the frame 3310 are attached as shown in FIG. 29 , an intended level of contact sealing can be achieved. The sealing lip 3250 is shown biased relative to the interfering portion 3314 of the frame connection area 3312 . As it deflects as shown, the sealing lip 3250 engages the frame connection area 3312 with sufficient force due to the tendency of the sealing lip 3250 to return to a deformed state to produce the intended seal between the components. It may self-tighten against the interference portion 3314 .

Also, as the air pressure in the plenum chamber increases when treatment is applied, the seal lip 3250 is forced to deflect against the portion 3314 of the frame connection region 3312, thereby increasing the sealing force of that region. . When the plenum chamber 3200 is connected to the frame 3310, although a compression seal is formed between the retaining structure 3242 and the frame connection area 3312, the pressure-actuated seal also increases the air pressure therein. It is formed between a portion of the frame connection area 3312 and the sealing lip 3250 in a connection state that is strengthened accordingly.

Also, if a very large amount of component compression is required to form a compression seal, this may require more than one hand or significant effort to perform the operation, making it easy to attach and detach the plenum chamber 3200 to the frame 3310. may hinder you from doing Accordingly, in one embodiment of the present invention, the compression seal functions primarily for the purpose of creating and maintaining an air tight seal. It should be understood that this sealing effect may occur around the junction between the plenum chamber 3200 and the frame 3310 . For example, FIG. 17 shows the sealing lip 3250 in a biased state with respect to the frame connection region 3312 in the region separated from the retention feature 3244 .

Also, as shown in FIG. 5 , for example, a seal lip 3250 extends around the plenum chamber 3200 . By extending the sealing lip 3250 inwardly around the junction between the plenum chamber 3200 and the frame 3310, an intended level of sealing can be achieved through the area and preventing unintentional leakage of pressurized gas. prevent.

It should also be understood that the sealing lip 3250 may press against the interfering portion 3314 of the frame connection 3312 with a force that tightens the portions for separation. However, the frictional force due to the structural connection of the trailing surface 3246.2 of the barbs 3246 with the retaining surface 3312.2 of the frame connection area 3312 returns to an undeformed state and the plenum chamber 3200 in the frame 3310 ) is sufficient to resist the force of the sealing lip 3250 which tends to separate.

With respect to the removal of the plenum chamber 3200 and frame 3310, it should be understood that the process is substantially the reverse of the process described above. That is, the user may separate the plenum chamber 3200 from the frame 3310 by pulling these components in the opposite direction. 29 may be the start of the separation process. 25 may show that the plenum chamber 3200 and the frame 3310 are completely separated.

Tightening the plenum chamber 3200 proximate to the plenum connection area 3240 or tightening the plenum connection area 3240 and pulling it away from the frame 3310 may facilitate removal of the plenum chamber 3200 from the frame 3310. can help The patient 1000 can tighten the plenum chamber 3200 for the purpose of holding it in any position, for example, the nose pillow 3130 or the stalk 3150, and can be easily pulled apart from the frame. The twisting action may help disassemble the plenum chamber 3200 from the frame 3310 during pulling.

6.3.4.1.3 Solid hard connection

The plenum connection area 3240 and frame 3310 may be assembled and attached, as shown in FIGS. 25-29 . As noted above, the plenum connection region 3240 and/or the retaining structure 3242 may be made of a semi-rigid material, such as high durometer silicon (higher durometer than plenum chamber 3200)/TPE, plastic, nylon. , polypropylene, polyamide and/or polycarbonate.

The plenum connection region 3240 may be configured as a continuous ring or ellipse, two C-clips, one C-clip or a single continuous piece, as well as enclosing only a portion of the plenum chamber 3200 . The clip functions as a spring clip and may be in the form of a C-section or double C-section. The spring force of the spring clip may be provided by the elasticity of the plenum connection region 3240 extending against the frame connection regions 3312 , 3313 or the interfering portion 3314 of the frame 3310 . In other embodiments, the clip configuration may not be necessary if only the retaining features 3242 and 3244 retain the retaining structure 3242 and the plenum connecting region 3240 for engaging the connecting regions 3312 and 3313. and is permanently connected directly to the plenum chamber 3200. One embodiment of the present invention may include a frame 3310 comprising the same or similar semi-rigid material as the plenum connection region 3240 .

By fabricating the frame 3310 and the plenum connection region 3240 of semi-rigid material, a “hard to hard” connection or adhesive interface is formed. The "hard to hard" connection is related to the structural characteristics of the plenum connection area 3240 and the frame connection area 3312 so that the connection between the plenum chamber 3200 and the frame 3310 when the patient interface 3000 is assembled. provide the patient 1000 with a certain feeling (eg, by providing an audible snap fit or confirmation click). A design that gives the patient confidence that a secure fit has been achieved because the connection secure coupling between the plenum chamber 3200 and the frame 3310 helps in the assurance that the patient 1000 is receiving proper treatment via the patient interface 3000 . is preferably The described hard-to-hard connection may also be desirable to add stability to the seal made by the seal forming structure 3100 , which means that one or both of the plenum chamber and the frame can be used with an impaired hand, especially in a dark room. In contrast to hard-to-hard or soft-to-soft connections, which are made of flexible materials that make it difficult to properly and easily connect the frame to the frame.

Although retention characteristics 3242 and 3244 are described as provided for plenum chamber 3200 and connection regions 3312 and 3313 are provided on frame 3310, the location is relative to the frame and connection regions on the plenum chamber. properties and may be substituted. It is also possible to combine the retention characteristics of one part corresponding to the connection area and the domain area and retention characteristics of the connection area and the other part.

6.3.5 How to Build a Plenum Chamber

The process of manufacturing the plenum chamber 3200 involves forming a plenum connection region 3240 in a first tool, removing the molded plenum connection region 3240 from the first tool, and connecting the plenum into a second tool. inserting the region 3240 and molding the portion of the plenum chamber 3200 including the connecting portion 3202 in the second tool. The plenum connection region 3240 may be chemically bonded and/or mechanically interlocked to the connection portion 3202 .

In one form, the sealing lip 3250 is constructed and arranged to interfere with the interfering portion 3312 ( FIG. 13 ) of the frame connection area 3312 when the plenum chamber 3200 and the frame 3310 are assembled together. do.

In use, the sealing lip 3250, when assembled with the interfering portion 3314 of the frame connection area 3213, is spaced apart from the rest of the position (FIG. 6) to elastically flex and at least partially due to the elastic material, the sealing lip 3250 Press against the interfering portion 3314 (FIG. 12) to prevent air leakage between the interfering portion 3314 and the interfering portion 3314. Although it has been described that the sealing lip 3250 is provided with the plenum chamber 3200 , two or more sealing lips may be provided with at least one plenum chamber 3200 and at least one frame 3310 .

6.3.6 Positioning and Stabilization Structures (3300)

In one aspect of the present invention, a number of structural features form part of a positioning and stabilizing structure, for example a head gear assembly (sometimes referred to simply as a head gear). In an alternative form of the present invention, one or more of the above features are disposed in frame 3310 . For example, flex joint 3305 is located in whole or in part on headgear or frame 3310 . In addition, the extension 3350 may perform the same function as the flexural joint 3305 except that it is integrally formed with the rigid deesser arm 3302 .

The seal forming structure 3100 of the patient interface 3000 of the present invention may be secured in the sealed position in use by the positioning and stabilizing structure 3300 ( FIGS. 75 , 76 and 166 ). In one form, positioning and stabilizing structure 3300 includes headgear. It should be understood that the positioning and stabilizing structure 3300 is referred to as a headgear in one form of the present invention.

The headgear may be removably coupled to a portion of the patient interface, such as positioning and stabilizing structure 3300 via a headgear connector.

6.3.6.1 Strap

The positioning and stabilizing structure 3300 may include one or more straps 3301 (see, eg, FIG. 65), and one or more rigid dissipator arms (eg, see FIG. 67). The strap 3301 may be made of an elastic material and may have elastic properties. That is, the strap 3301 can be elastically stretched by the stretching force applied by the patient, and when the stretching force is released, it returns or contracts to its original length in a neutral state. Strap 3301 may be made of or include any elastomeric material, such as elastane, TPE, silicone, or the like. The material of the strap 3301 may be a combination of that material and another material. The strap 3301 may be a single-layer or multi-layer strap. The strap 3301 , particularly the side strap portions 3315 , 3316 that contact the patient 1000 during use, may be woven, knitted, twisted, molded or extruded or otherwise formed. Strap 3301 may be made of a textile material, such as a woven material. The material may, on the one hand, include artificial or natural fibers that provide intended and 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 that provides the desired elastic properties. The entire strap 3301 including the side strap portions 3315 , 3316 and the back strap portion 3317 may both be stretchable. This allows the entire length of the strap 3301 to be stretched to have a comfortable force displacement profile. To allow the strap 3301 to elongate in use, the length of the strap 3301 may be less than the circumference of an average small head patient. For example, the length of the strap 3301 may be 590 mm or less in one example, and 500 mm or less in another example. However, other lengths of strap 3301 may be provided to the patient depending on the head circumference of a particular gender.

For example, a small size strap may be 490 mm in length, and a large strap may be 540 mm long. In some situations, this means that the length of the strap 3301 has an unnecessarily high headgear tension for the patient, and a longer distance with less smooth force displacement as the smaller size strap 3301 is stretched to a longer length. This means that it doesn't have to be stretched (e.g. a small size strap around a large head).

Strap 3301 may be reinforced in frame 3301 in certain sections to a position proximate to the patient's cheekbones, for example, by an inserted rigidiser arm 3302 . Strap 3301 may take the form of a hollow ribbon. Strap 3301 can be thought of as being secured to one end of rigid-dezer arm 3302 adjacent frame 3301 and fitted over rigid-dezer arm 3302 when slid onto rigid-dezer arm 3302 .

For example, the strap 3301, including side strap portions 3315, 3316 and the rear strap portion 3317, is made by knitted warp yarn. Strap 3301 is a 3D knitted knitted fabric by computer control as a single integral part.

Changes in threads and stitches may occur at various locations depending on the strap 3301 to adjust the elasticity, stiffness, and durability of the strap 3301 at a specific location. For example, at the location of the opening, insertion point or bifurcation 3324 for buttonholes 3303, 3304 and back strap portions 3317a, 3317b, additional threads may be used for repeated and extended use of strap 3301. It may be knitted to provide reinforcement of the strap 3301 to prevent failure/breakage of the strap 3301 in such locations that are subjected to high stress when stretched while being stretched. Both the knitting method (ie warp knitting) and the elastic textile material (eg, elastane) of the strap 3301 contribute to the elastic recovery of the strap 3301 after water or dry washing of the strap 3301 . That is, the elasticity of the strap 3301 can be maintained after long-term use by regularly washing the strap 3301, and thus its lifespan is extended.

65-73 , strap 3301 is shown as a single continuous strap with two pocket ends 3311 , 3313 for attachment to frame 3310 directly or through flexible joint 3305 . However, strap 3301 may include several individual straps that may be directly connected to each other, eg, stitched, or ultrasonically welded. In FIG. 65 , strap 3301 and positioning and stabilizing structure 3300 are shown without adjusting or changing means.

However, this adjustment may be provided by changing the attachment of strap 3301 to another connection element that is more rigid than strap 3301 , such as patient interface 3000 or flexible joint 3305 . Referring to FIG. 72 , additionally or alternatively, adjustment may be performed by a mechanism such as sliding over ladder locking clips 3305.1 to rear 3317 or side strap portions 3315, 3316 (such as those shown in FIGS. 71-73). may be allowed by adding or otherwise adjusting the elastic length of strap 3301 and positioning and stabilizing structure 3300, respectively. In the embodiment of FIG. 65, strap 3301 is circular or, similar to the cross-sectional view according to FIG. 66, with dashed lines representing an inner wall (not shown) facing away from the viewer and solid lines representing an outer surface facing towards the viewer (shown). It has an elliptical oval or circular or tube-shaped configuration that may be taken from the respective schematic views of FIGS. 68-70 showing respective marks 3321a-d, 3323a-e. However, it will be understood that the positioning and stabilizing structure 3300 may take other forms, such as a flat sheet-like shape, a single multi-layered or laminated structure, and the like. The strap 3301 may have a longitudinal axis which can be understood to be an axis parallel to the plane of the paper over which the strap 3301 extends (see dashed line in FIG. 65 ).

Strap 3301 may be stitched to enhance durability and to minimize and prevent points of failure. For example, at buttonholes 3303 and 3304 and at bifurcation 3324 the region of strap 3301 is subjected to high stress when stretched at a location where it diverges into two rear strap portions 3317a, 3317b. The propensity of the material is divided into separate regions 3326 and thus reinforcing stitches in those regions is one way to solve this. For example, a central seam runs along the central longitudinal axis of strap 3301 and performs a reinforcing stitching function. The distal end of the strap 3301 and the opening of the button holes 3303 and 3304 are also ultrasonically welded to fuse the stray fibers to reinforce the strap 3301 in that area. Desirably, this also prevents the fibers of the strap 3301 from unraveling after prolonged use and repeated laundering. Other techniques are shown for reinforcing and reinforcing pocket end 3311 , distal edge and button-hole 3303 , which may include additional material such as tape. The tape may also include brand and logo information.

123-125 are detailed views of the area 3326 divided between the upper rear strap portion 3317a and the lower rear strap portion 3317b. It should be understood that the ends of the upper back strap portion 3317a and the lower strap portion 3317b are not completely smooth as a result of the stitching process, and that the figure shows edges with multiple misalignments so that imperfections can be seen. should understand that The undulations of the edges of the upper posterior strap portion 3317a and the lower posterior strap portion 3317b are not readily visible to the naked eye, and the patient 1000 is not generally discernible by touch. Also, the stippling will show the texture of the rear strap portions 3317a, 3317b while the separated areas 3326 are visible due to the absence of material.

126-131 are various details of bifurcation 3324 with upper rear strap portion 3317a and lower rear strap portion 3317b separated from side strap portion 3315. Also visible in the figure is a reinforcing portion 3325 that may include additional stitching or welding proximate to or at the junction 3324 . The reinforcement portion 3325 prevents the side strap portions 3315, 3316 from cracking and/or breaking due to stress from repeated separation of the upper rear strap portion 3317a and the lower rear strap portion 3317b. can help you do That is, the reinforcing portion 3325 may provide additional stiffness at the stress concentration location near the junction 3324 . Also shown are upper rear strap portion 3317a and lower rear strap portion 3317b at various separation angles θ. It will be understood from the figure that the reinforcement portion 3325 provides additional stiffness at the bifurcation point 3324 when the upper rear strap portion 3317a and the lower rear strap portion 3317b are unfolded from each other at a large angle θ.

176-181 , in one embodiment of the present invention, the end of the strap 3301 has a reinforcing portion 3327 with material that folds over the end of the strap 3301 . This provides additional reinforcement to the area in addition to the welded ends 3311.1, 3313.3. The material of the reinforcing portion 3327 may be different from that of the strap 3301 . The reinforcing portion 3327 may avoid or mitigate the possibility that the patient 1000 will break or strip the strap 3301 starting in the region and along the longitudinal axis. Reinforcement portion 3327 may assist in identifying the location of buttonholes 3303, 3304, thereby assisting in providing the patient with a visible or tactile indication to slip or remove strap 3301 from rigid-disser arm 3302. gives

Corner 3328 of stiffening portion 3327 is truncated and rounded so that corner 3328 is rounded at distal free end 3302.1 (see FIGS. 50 , 52 , 55 , 57 , 58 , 60 ). to almost fit This provides an aesthetically pleasing snug fit of the rigid deezer arm 3302.1. Rounded corners 3328 instead provide smooth edges to avoid scratching the surface that would otherwise occur with sharp corners.

6.3.6.2 Rigidizer arm

67 shows an example of a rigid deesser arm 3302 . As shown, the ridgedizer arm 3302 may take the shape of a crescent or semicircle. Rigidizer arm 3302 may have a generally rectangular planar shape. In other words, the rigid dissipator arm 3302 is much longer and wider than the thickness (bottom direction). Rigidizer arm 3302 has a three-dimensional shape with curvature in three axes (X, Y, and Z). The thickness of the rigid deesser arm 3302 may be substantially uniform, but its height varies throughout its length. The purpose of the shape and size of the rigidizer arm 3302 is to conform closely to the patient's cheeks so as not to interfere with the patient's face and cheeks. The ends 3319A, 3319b of the rigid arm 3302 may be rounded and/or slightly angled to the remainder of the rigid arm 3302 . Rigidizer arm 3302 in the in-plane direction of FIG. 67 to improve alignment with the shape of the patient's face, such as the shape of the patient's cheek or head lateral region (see FIGS. 71 and 72), as shown in the paper of FIG. 67. It will be appreciated that it may have an intended spatial configuration. Rigidizer arm may have a longitudinal axis, understood as an axis substantially parallel to the ground, from which rigiddiser arm 3302 extends (see dashed line in FIG. 67 ). Rigidizer arm 3302 is particularly more caustic than strap 3301 and less rigid than mask frame 3310 . In particular, the rigid arm 3302 and/or strap 3301 are coupled such that the rigid arm 3302 is shaped and provides increased stiffness in at least one direction about or in one or more axes relative to the strap 3301 . Rigidizer arm 3302 also guides or forms a direction or passageway of elongation for strap 3301 . That is, the patient stretches the strap 3301 in a direction parallel to the longitudinal axis of the rigid deesser arm 3302 . Extending the strap 3301 in the other direction results in undesirable rotation of the rigidizer arm 3302 relative to the mask frame 3310 . The stiffness of the rigid arm 3302 biases the rigid arm 3302 toward a natural, non-rotating, non-twisting, and non-deforming state.

This may, to some extent, allow the positioning and stabilizing structure 3300 to self-adjust the headgear. The self-adjusting function avoids manually shortening or lengthening the length of the headgear strap material manually, and can remember the adjusted length. This was usually a cumbersome process, as the headgear straps on either side of the face were shortened or stretched one time at a time. Such high levels of headgear tension can eliminate the patient's ability to tighten the headgear when not required to maintain good sealing force. In the illustrated embodiment, strap 3301 has a tube- or sleeve-shaped configuration. That is, the strap 3301 is hollow to accommodate the insertion of a supporter arm 3302 that is slid into the strap 3301 through the button hole 3303 .

In another example, the rigid deger arm 3302 is

It may be permanently connected in at least one location, eg, overmolded or otherwise bonded, to form an integrally chemical bond (molecular bond) between the rigidity arm 3302 and the strap 3301 .

Strap 3301 includes side strap portions 3315 , 3316 and a back strap portion 3317 positioned between the side strap portions. The side strap portions 3315, 3316 are configured to extend along the side of the patient's head when worn while the rear strap portion 3317 is extended to form along the back of the patient's back as shown in FIGS. 4-8 .

The rear strap portion 3317 may include two, three or more straps arranged in parallel, particularly to provide stability. The smaller rear strap portions 3317a and 3317b are shown equal in length, but one rear strap portion is longer than the other rear strap portion. The more smaller the rear strap portions 3317a, 3317b are provided relative to the rear strap portion 3317, the greater the spring effect is provided. That is, when the strap 3301 is manufactured, the smaller strap portions 3317a, 3317b of the same size increase, the more tension the side strap portions are pulled closer together by the rear strap portions 3317a, 3317b. (3315, 3316).

In the illustrated embodiment, the side strap portions 3315, 3316 of the strap 3301 diverge the two rear strap portions 3317a, 3317b. In one example, each back strap portion 3317a , 3317b has half the amount of elastin material compared to each side strap portion 3315 , 3316 of the strap 3301 . In one embodiment, the positioning and stabilizing structure 3300 is connected to the mask frame 3310 by a removable connection between the strap 3301 and the rigid deesser arm 3302 through button holes 3303 and 3304; Rigidizer arm 3302 is permanently connected to mask frame 3310 via a mechanical interlock. In another embodiment, a flexible joint 3305 made of TPE may be permanently connected to the rigidizer arm 3302 and the mask frame 3310 . The flexible joint 3305 is overmolded with the mask frame 3310 for a permanent connection and is permanently connected to the rigidizer arm 3302 via a mechanical interlock. In another embodiment, the flexible joint 3305 can be made of the same material as the rigid arm 3302, for example Hytrel®, and is integral with the rigid arm 3302 and the flexible joint 3305 is a mechanical interlock. may be permanently connected to the mask frame 3310 through Strap 3301 is removably connected to rigidizer arm 3302 via button holes 3303 and 3304 .

The coupling of the strap 3301 to the rigid deesser arm 3302 may occur at a location proximate to the mask frame. This type of connection allows for maximum range of motion, i.e., stretching of the strap 3301. This connection is removable so that the strap 3301 can be completely removed from the rigidizer arm 3302 and in turn the mask frame 3310 facilitates cleaning of the strap 3301 . This connection serves as an anchor point for the strap 3301 so that when the strap 3301 is stretched, the stretching force is directed away from the anchor point and spaced outward. 48-60 , the end of the strap 3301 at the anchor point is held by at least the distal end of the rigid distal arm 3302 and/or the protruding end 3306 extending from the rigid distal arm 3302 .

Those of skill in the art will appreciate that the rigid arm 3302 referenced herein is more rigid than the strap 3301 and allows the rigid arm 3302 to impart a shape to the strap 3301 . Rigidizer arm 3302 may be more rigid in or around at least one axis and is non-stretchable in contrast to strap 3301 , which may be stretched along at least one axis. In yet another embodiment, the rigid deesser arm 3302 is stretchable/extensible in a direction substantially parallel to the longitudinal axis.

Elastomers are generally stretchable, but some thermoplastic polyester elastomers, such as Hyytrel® 5556 DuPont manufactured by DuPont, are not stretchable but flexible. For example, the rigid arm 3302 may have a scissor linkage structure or a telescopic structure that allows the rigid arm 3302 to move between a fully extended position and a compressed position. The extendable rigid arm 3302 can provide a better fit for the patient 1000 with a longer face so that the length of the rigid arm 3302 can be adjusted appropriately. Optionally, the rigidizer arm 3302 is also referred to as a yoke and/or stiffener. The yoke may be understood as a rigid element configured to support the strap 3301 of the positioning and stabilizing structure 3300 . Rigidizer arm 3302 may be understood as a rigid element that, when worn on the face, forms strap 3302 of positioning and stabilizing structure 3300 .

6.3.6.3 Attachment of Strap and Rigidizer Arm

The side strap portions 3315 and 3316 of the strap 3301 shown in FIG. 65 include two button holes 3303 and 3304, respectively. The buttonholes 3303 and 3304 may be located on the outer surface of the strap 3301, that is, the surface facing away from the patient 1000 when worn, and inserted into the strap 3301 in the form of a tube or sleeve ( It is configured to receive a rigid deesser arm 3302 for inserting or removing 3302 therefrom. Optionally, buttonholes 3303 and 3304 may be located on the inner surface of strap 3301 . Buttonholes 3303 and 3304 are provided for assembling positioning and stabilizing structures 3300 while preventing accidental removal or separation of rigid arm 3302 from strap 3301 during use. , 3304 is oriented and/or shaped such that the rigid dissipator arm 3302 can be inserted and/or removed. As shown in Fig. 65, this is achieved by providing the strap 3301 with a slit-shaped structure that can be oriented horizontally side by side, for example, a button hole 3303 having a structure similar to a button hole. Optionally, button hole 3303 may be directed across strap 3301 if desired. That is, the long elongation of the button hole 3303 may extend substantially coaxially with the longitudinal axis of the strap 3302 and the rigid digital arm. This, in particular due to the elasticity of the strap 3301 , prevents accidental removal, while also allowing the rigid deesser arm 3302 to be easily inserted into a tube or sleeve shaped strap or part of the strap 3301 . The end portion of the strap 3301 between the distal tip of the strap 3301 and the buttonhole 3303 is wrapped around the edge of the rigid deezer arm 3302 and functions as an anchor point. The edge or anchor point of the ridge deger arm 3302 may be a catching member. The end portion of strap 3301 may also be referred to as pocket end 3311 . This may prevent the strap 3301 from slipping away from the inserted rigidizer arm 3302 as the strap 3301 is stretched and adjusted during wearing or doping of the patient interface 3000 .

185 and 186 , the rigid digitalizer arm 3302 may be inserted into the first button hole 3303 of the strap 3301 . In this alternative method, the strap 3301 can be slid over the rigid deesser arm 3302 through the button hole 3303 . The distal free end 3302.1 of the rigid distal arm 3302 may first be inserted into the strap 3301 through the button hole 3303 . Rigidizer arm 3302 is inserted into strap 3301 so that the end portion of strap 3301 is fixed to and caught on rigiddisser arm 3302 until most or all of rigiddisser arm 3302 is inserted into strap. more pressed Some material of the strap 3301 near the button hole 3303 is adapted to sit under the outer side 3319 of the protrusion 3309 (see FIG. 38). Once inserted into the strap 3301 , the rigid dissipator arm 3302 may generally remain unconstrained and floating within the strap 3301 , as shown in FIGS. 6-8 . Most importantly, the end portion of the strap 3301 secures the strap 3301 to the rigid arm 3302 and against the protruding end 3306 of the rigid arm 3302 when the strap 3301 is elongated. Because of the pull, the button hole 3303 can be an attachment point. In general, the location of the attachment point between the rigid dissipator arm 3302 and the strap 3301 is more important than the attachment type using, for example, the button holes 3303 and 3304 of the strap 3301 .

182-184, the type of attachment between the rigid deesser arm 3302 and the strap 3301 is that the strap 3301 can be easily removed from the rigid deesser arm 3302 to enable separate cleaning of the strap 3301. can do. That is, the cleaning and cleaning regimes for the strap 3301 may be different times in the mask frame 3310 . Patient 1000 stretches strap 3301 around button hole 3303 to disengage strap 3301 from rigidizer arm 3302 . After the distal end of the strap 3301 is released, the strap 3301 can be fully pulled out of the rigid distal arm 3302 through the button hole 3303 . Additionally or alternatively, a rigid deesser arm 3302 is attached to a strap 3301 . Attachment may be made by attaching and securing the second end of the rigidizer arm 3302 to the positioning and stabilizing structure 3300 near the button hole 3303 after insertion.

The fixation may be localized as described at the beginning of the specification. Here, the connection between the rigid dissipator arm 3302 and the strap 3301 is not distributed along the length of the strap, but is localized in an area adjacent to the button hole 3303 . Optionally, such a connection connection may be established in an area adjacent to the button hole 3304 . The attachment presses the rigid arm 3302 inside the strap 3301 and attaches both the strap and the rigid arm 3302 to an external element, such as an external clip where the rigid arm 3302 secures both the strap and each end. By fixing, this can be achieved by rod, welding, gluing, heat stacking, clamping, butting, snapping the cover over the end or snapping to the outer part. Strap 3301 may optionally be chemically coupled to rigidizer arm 3302 . Clips may be used to attach the end of the end strap 3301 to the end of each mask frame 3310 . As such, the clip may be part of the mask frame 3310 itself.

In accordance with the present invention, strap 3301 is arranged to assume the shape of rigid deesser arm 3302, but may be stretched substantially along its entire length. While the resilient positioning and stabilizing structure 3300 maintains its full working length and is freely extensible over the rigid dissipator arm 3302, the rigid positioning and stabilizing structure 3302 provides a positioning and stabilizing structure to the required portion of the face. 3300) may be given the necessary shape to face the pressure. Also, the rigidizer arm 3302 is capable of separating the tube torque in the coronal plane. Also, in particular, the sharp bend 3307 of the rigidizer arm 3302 can function as a handle and serve to isolate the tube torque in the sagittal plane. At the same time, the strap 3301 of the positioning and stabilizing structure 3300 can cover the rigid deesser arm 3302 and provide a soft feel and comfort.

The sharp bend 3307 provides stability to the patient interface 3000 . When the patient 1000 sleeps next to him, the rigid arm 3302 is pressed inward against the side of the face on the bed. A sharp bend 3307 isolates the motion at the coronal surface to prevent obstruction of the sealing force. The sharp bend 3307 tends to tighten more on the upper surface (away from the patient's face) than on the lower surface (facing the patient's face).

The lower surface of the sharp bend 3307 provides facial markings on the patient 1000 because the contact pressure is less concentrated when there is contact with the patient's septum and/or upper lip (because the nose is stretched by tube weight or tube torque). It has a larger diameter (washed) than the upper surface of the sharp bend that is avoided or minimized and softens the part. The distance between the two sharp bends 3307 is about 50 mm.

Although shown and described for the particular embodiment shown in Figures 65-70, it should be understood that strap 3301 or each strap side strap portion 3315, 3316 is provided with only one buttonhole 3303, 3304. . However, two or more buttonholes may be provided. Optionally or additionally, the strap 3301 may not be in the form of a tube or sleeve, and may have a flat single or laminated layer structure. wherein the rigidiser arm 3302 may be disposed on the strap 3301 by providing a retaining means comprising one or more loops, sleeve-shaped portions, or pockets formed on an outer surface (eg, a side facing away from the patient in use). .

Additionally or alternatively, combinations of other linking mechanisms described herein may be provided. As noted above, for example, the rigid arm 3302 may be secured to a single point or localized area, for example, as described above adjacent the pocket ends 3311, 3313 of the strap 3301, while the strap It is secured next to the strap 3301 by providing a lube or sleeve-shaped element provided on the outer surface of 3301, eg in the area of marks 3321b, 3323b. That is, the rigid deesser arm 3302 can be connected to the strap 3301 by fixing only to a localized point or region, while functioning as an additional guide element for the strap 3301 . This guiding function may be provided by a loop or sheath-shaped portion or a passageway or pocket in the strap 3301 from which the rigid dissipator arm 3302 extends based on the shape of the strap 3301 shown in FIG. 66 . Strap 3301 may be tubular, but need not be cylindrical. This allows to have the longest stretch path possible for the strap 3301 . Optionally, one or more pockets (e.g., a single open-ended pocket of an applicable length sheath for supporting the rigid arm at a midpoint or a pair of pockets each supporting each end of the rigid arm) pocket) or unattached into a plurality of loops distributed along the length of the strap 3301 . The function of the guide element is to allow the rigid arm 3302 to move or float substantially relative to the strap 3301 depending on whether it is attached to one end or not. This configuration allows the same advantages and effects as the above-described configuration. In addition, according to the embodiment of the present invention, the rigid deezer arm 3302 does not expand or contract in the same direction as the strap 3301 or bend. Rather, the rigid arm 3302 may be stretched or flexed in a plane perpendicular to the longitudinal axis.

In the illustrated and described embodiment, the rigidizer arm 3302 does not extend beyond the end of the strap 3301 . However, according to an optional aspect, the rigidity arm 3302 may attach to the strap 3301 at a point or region adjacent the ends 3311 , 3313 adjacent each pocket while extending beyond the strap 3301 , for example. can be fixed. In this configuration, the rigidiser arm 3302 can impart shape, shape, and/or stiffness to the strap 3301 , while at the same time providing a structural means, such as a flexible joint 3305 for connection with the patient interface 3000 . do. This is similar to the connector where the rigidity arm 3302 connects the strap 3301 and the positioning and stabilizing structure 3300 to the frame 3100, the plenum chamber 3200, or the seal forming structure 3100, respectively. (3302) to function.

113-122 are detailed views of the connection between the pocket ends 3311 and 3313 and the rigid dissipator arm 3302. 113 and 114 show pocket ends 3311 , 3313 around each protruding end 3306 of the rigidizer arm 3302 . The protruding end 3306 is not shown in the figure because it is covered by the pocket ends 3311 and 3313. A straight section 3351 of the extension (discussed further below) of the rigidity arm 3302 is indicated by a mark 3358 on the outer surface 3355 of the extension 3350 . The indicia 3358 may be a printed pad, raised surface, or embossed to help the patient 1000 orient the device 3000 during use when in a dark environment. A straight section of the extension 3350 is shown extending outwardly from the button hole 3303 of each pocket end 3311 , 3313 . 47-60 , the straight section 3351 is part of a rigid deesser arm 3302 . Rigidizer arm 3302 facilitates connection between strap 3301 and mask frame 3310 . 114 is a view similar to FIG. 113 , but the outer surface 3355 of the straight section 3351 is unmarked. It should be understood that, while FIG. 113 shows the connection between one rigid-dezer arm and each pocket end 3311, FIG. 114 shows the connection between another rigid-dezer arm and each other pocket end 3311. By placing the markers 3355 , 3358 on only one outer surface, the patient 1000 can use the sense of touch to orient the device 3000 to assist in fitting in a dark environment. 114 shows the flange 3359 visible through the button hole 3303 .

FIG. 115 is a more detailed view showing features similar to FIG. 114 but showing the relationship between flange 3359 and pocket end 3313 . FIG. 116 shows features similar to FIG. 113 , but with more detail of the button hole 3303 and the label 3358 of the pocket end 3313 . 117 is a more detailed view of FIG. 114 and better shows the button hole 3303 in the pocket end 3313 . 118 is a more detailed view of FIG. 113 , better showing the button hole 3303 in the pocket end 3313 . 119-122 show features similar to those shown in FIGS. 113-118, but with flange 3359 pulled out of button hole 3303 to show a better design. 119 and 122 show a rigidizer arm 3302 that includes an indicia 3358 on an outer surface 3355 extending from a button hole 3303 of the pocket end 3311 . FIG. 122 should be understood to represent a more detailed view of FIG. 119 . 120 and 121 show another rigidizer arm 3302 that may not include an indicia. FIG. 121 should be understood to represent a more detailed view of FIG. 120 .

6.3.6.4 Elongation of the Strap on the Rigidizer Arm

As can be seen in the embodiment shown in FIG. 68, the two ridgedezer arms 3302 are inserted into the side strap portions 3315, 3316 of the strap 3301 of the positioning and stabilizing structure 3300, While the deezer arm 3302 is properly secured by wrapping the strap 3301 at the same time, the sleeve-shaped configuration of the strap 3301 allows at least a portion of the strap 3301 to be stretchable or movable relative to the rigid deezer arm 3302 . do. Preferably, the stretchable portion is a substantial portion because there is a strap wrap 3301 fixed to the rigid deezer arm 3302 only at the anchor point. In some embodiments, one of the ends 3319a, 3319b of the rigid arm 3302 is generally rigid as shown in FIG. 69 and krx moves toward and abuts against each pocket end 3311 of the strap 3301 . Restrictions on movement of arm 3302 are imposed. For example, when the positioning and stabilizing structure 3300 is not on the patient's head and the strap 3301 is loose, when the inserted rigidizer arm 3302 moves too far towards the rear strap portions 3317a, 3317b. , its end 3319b may enter the open end of one of the rear strap portions 3317a, 3317b. The width of the rear strap portions 3317a and 3317b is less than the width of the support arm 3302 . An end 3319b of the rigid dissipator arm 3302 abuts each rear strap portion 3317a, 3317b that limits further movement in that direction.

Attaching the strap 3301 to the rigid deesser arm 3302 described above may also affect the size of the head that the positioning and stabilizing structure 3300 can accommodate. That is, by providing a longer strap 3301 along the rigid deesser arm 3302 , a full stretch of the positioning and stabilizing structure 3300 can be applied so that a longer perimeter of the head can be applied without the need to increase the elasticity of the strap 3301 . The possible length can be increased. In addition, the strap 3301 can be changed along the length of the rigid digitalizer arm 3302 to which it is connected. This allows for a greater range of head sizes and girths to be accommodated without the need to change the elasticity of the strap 3301 .

The length of the strap 3301 is about 400 mm-700 mm. The length of the strap 3301 may be about 490 mm. Strap 3301 can provide a comfortable level of headgear tension for most head sizes. Straps can be provided in two lengths or sizes for specific genders, with men's longer than women's. Preferably there may be two sizes/lengths for each gender. A comfortable level of headgear tension is about 2-5 Newtons. A comfortable level of headgear tension is about 2.2 newtons - about 4.7 newtons. When the strap 3301 is stretched 490mm-526mm for the small head circumference of the patient 1000, the tension of the headgear measured using the Instron tester is 2 Newtons. When the strap 3301 is stretched 490 mm-662 mm for the small head circumference of the patient 1000, the tension of the headgear measured using the Instron tester is 4.4 Newtons. For measurement, button holes 3303 and 3304 of strap 3301 are attached to a clamping fixture. A tensile tester with a load cell of 100 Newtons is used. The strap 3301 is extended and held at predetermined extension points (eg, 90.5 mm, 73 mm and 108 mm) for 1 minute and a force value (in Newtons) is recorded for each extension point. The measurements do not take into account the friction of the strap 3301 material against the patient's face or hair.

The length of the divided region 3326 formed between the two rear strap portions 3317a and 3317b is about 180mm-220mm. The length of the divided region 3326 may be 200 mm. If the length of the divided region 3326 is insufficient, since the two rear strap portions 3317a and 3317b cannot maintain their positions during treatment, they cannot wrap the patient's occipital region, and the headgear tension is set according to the patient's preference. can't keep If the length of the segmented area 3326 is too long, the two rear strap portions 3317a, 3317b will separate in front of the user's ears and pass through the top of the ear rather than over/around them, which is inconvenient and makes the two rear strap portions 3317a and 3317b uncomfortable against each other. 3317a, 3317b) decrease the maximum angle.

In the neutral and unstretched state of the strap 3301, the two rear strap portions 3317a, 3317b have an angle θ of about 0° to about 10° with each other. After wearing the patient interface 3000 , the two back strap portions 3317a , 3317b may separate from each other such that the angle θ is up to about 180°. This allows for a maximum angular range of 180° away from the two rear strap portions 3317a, 3317b, which in turn provides a great range for the reduction of headgear tension through incremental diffusion. The angle range can be limited from a basic angle of 10° to a maximum angle of 120°. The patient may use one or both hands to move the two posterior strap portions 3317a, 3317b separately or together when the occipital region is tensioned. By moving the two rear strap portions 3317a, 3317b further apart from each other, the divided area 3326 is enlarged, and the tension of the headgear is lowered to an undivided range of 2.5-5 Newtons. The tension of the headgear as measured by the load cell may be reduced from about 30% to about 50% in one embodiment or reduced to 40% or according to another embodiment. That is, for a small head circumference of the patient, the tension of the headgear can be reduced from 2 Newtons to 1.2 Newtons by increasing the distance between the two rear strap portions 3317a, 3317b. For a large head circumference of the patient, the headgear tension can be reduced from 4.4 Newtons to 2.64 Newtons by increasing the distance between the two rear strap portions 3317a and 3317b Rigidizer arm 3302 is mounted on the strap 3301 as such to extend the length of the strap 3301. In general, it can move indefinitely, and can be adjacent to one of its ends.

As shown in FIG. 70, the configuration described above allows the strap 3301 and thus the positioning and stabilizing structure to be stretched and extended in length. This extension is not limited to those portions of the strap 3301 that are not in contact or parallel with the rigid arm 3302 , as well as extension, particularly elastic extension of the strap, is achieved in the region of the rigid arm 3302 . This is along with the marks 321a-d, 3323a-e showing the length of the strap 3301 relative to the length of the ridgedezer arm 3302, along with the ridges of FIGS. It can be easily derived by comparing the length of the dessert arm 3302 . A comparison of FIGS. 68 and 70 in which the rigid deesser arm 3302 extends along marks 3321a-3321c and 3323a-3323d, respectively, in FIG. 68 in an unstretched state is readily induced. Conversely, in the stretched state according to FIG. 70 , the rigid deger arm 3302 extends only along the marks 3321a-3321b and 3323a-3323c. From there, it becomes apparent that the strap 3301 extends in and along the area in which the rigid arm 3302 is included in the strap 3301 . Rigidizer arm 3302 however remains unstretched while stretching strap 3301 .

As will be appreciated, the positioning and stabilizing structure 3300 may include one or more rigidity arms 3302 . While the foregoing description has focused on the relationship between strap 3301 and ridgedezer arm 3302, the embodiment shown in FIGS. 68-70 shows two ridges provided on each side strap portion 3315, 3316 of strap 3301. It should be noted that it includes a dessert arm 3302 . Although reference is made to one ridgedizer arm 3302, the same applies to two or more ridgedizer arms 3302 connected to the mask frame 3310.

As described above, one possible advantageous feature that allows the strap 3301 to elongate relative to the rigid arm 3302 is that the patient interface 3000 needs to separate the strap or other connection feature along the positioning and stabilizing structure 3300 . It can be worn and removed from the patient 1000 without the need.

This can be helpful for a patient using the device 3000 in a dark bedroom before or after falling asleep, without the patient needing to check for connection and removal of various components to detach the patient interface 3000 . Rather, the patient 1000 only needs to easily pull on the patient interface 3000 and the positioning and stabilizing structure 3300 and needing to position the seal forming structure when worn. However, this can be achieved by feeling all unnecessary. However, the advantage of separating the plenum chamber 3200 or the seal forming structure 3100 from the positioning and stabilizing structure 3300 may be maintained. For example, to clean the plenum chamber 3200 or seal forming structure 3100, it may be desirable to clean while the positioning and stabilizing structure 3300 is not wet. This can be facilitated by isolating the component for this purpose.

6.3.6.5 Rigidizer arm and mask frame

47-60 show a rigid-disserter arm 3302 and a mask frame 3310 according to another embodiment of the present invention.

47-49 and 54 are cross-sectional views of the rigid deesser arm 3302 and the mask frame 3310 and the connections therebetween according to an embodiment of the present invention. The extension 3350 near the sharp bend 3307 of the rigidizer arm 3302 is connected by a joint 3356 . Also near the sharp bend 3307 is the protruding end 3306 of the rigidizer arm 3302 that can hold the pocket end of the side strap portion 3316 of the positioning and stabilizing structure 3300 . In this figure, a mask frame 3310 is shown formed around a hook 3353 and an encapsulable section 3354 of the extension 3350 . An opening 3335 may be formed in the adjacent mask frame 3310 , with the mask frame 3310 surrounding the encapsulable section 3354 . The opening 3335 may be formed as a result of a molding process in which the mask frame 3310 is formed and secured around the encapsulable section of the rigid deesser arm 3302 . The rigid disser arm 3302 according to the present embodiment may be formed of Hytrel®, and the mask frame 3310 may be formed of polypropylene (PP). Hytrel® is preferred for forming rigid dissipation arms because the material resists creep. Since the materials cannot be integrally joined, the mask frame 3310 can be overmolded to the rigidizer arm 3302 in this embodiment to form a secure connection. In addition, it should be noted that in the above embodiment, the extension part 3350 and the rigid deesser arm 3302 may be integrally formed. The mask frame 3310 may be connected to a rigid distal arm 3302 at each extension 3350 located opposite the distal free end 3302.1. The extension 3350 can include a straight section 3351 connected to a bend 3352 connected to a hook 3353 . A portion of the hook 3353 and bend 3352 may form a sealable section 3354 .

It should be understood that the joint 3356 connecting the extension 3350 to the rigid dissipator arm 3302 may provide flexibility of the target point and the joint may be shaped and shaped to allow for a desired direction and degree of flexion. . Thus, once the patient interface 3000 is put on, the Rigidizer arm 3302 is stressed by tension in the strap of the positioning and stabilizing structure 3300 and the Rigidizer arm 3302 is masked at the desired location on the patient's face. It can be flexed at joint 3356 to maintain the face framing shape while helping to hold frame 3310 .

50 and 51 are perspective and detailed perspective views of a rigid deesser arm 3302 connected to a mask frame 3310 according to an embodiment of the present invention. FIG. 51 shows the encapsulable section 3354 overmolded by the mask frame 3310 and dashed line to secure the mask frame to the end of the rigidizer arm 3302 . The opening completely forms a passage through the mask frame 3310 and the hook 3353 of the rigid disser arm 3302 as shown in FIGS. 47-49.

52 and 53 are plan views and detailed plan views, respectively, of a mask frame 3310 connected to a rigid deesser arm 3302 in accordance with an embodiment of the present invention. In Fig. 52, size L represents the length of the rigid arm 3302 in the direction shown. Preferably, the nominal length L of the rigid deesser arm 3302 is 114 mm. The figure shows the joint 3356 connecting the extension to the rigid deesser arm 3302 between the protruding end 3306 and the sharp bend 3307.

55-57 are side, front, and perspective views, respectively, of the rigid digitalizer arm 3302 and the mask frame 3310 according to an embodiment of the present invention. In FIG. 55, the size H indicates the height of the rigid deesser arm 3302 in the illustrated direction. Preferably, the nominal height H of the rigid deesser arm 3302 is 33 mm. Rigidizer arm 3302 and extension 3350 are integrally formed and mask frame 3310 by overmolding mask frame 3310 to encapsulable section 3354 of extension 3350 of rigiddiser arm 3302 ) can be connected to The extension 3350 allows the nose droop by bending in a pivotal manner or perpendicularly rotating with respect to the rigid deesser arm 3302 . Because the extension 3350 has a small height, it has less material than the rest of the rigidity arm 3302 and is separated from the rest of the rigidity arm 3302 by a sharp bend 3307, so that the extension The bending of 3350 occurs localized before the rest of the rigidizer arm 3302 begins to bend. This can reduce the possibility of interruption of the sealing force.

58 and 59 show a partial exploded view and a detailed partial exploded view, respectively, of the rigid deesser arm 3302 and the mask frame 3310 in accordance with an embodiment of the present invention. Hook 3353 and sealable section 3354 of extension 3350 are shown separated from mask frame 3310 . The shape of the hook 3353 and the encapsulable section 3354 is shown in the figure above, and it should be understood that these portions are formed to ensure a stronger mechanical interlock with the mask frame 3310 when the mask frame 3310 is overmolded. do. In particular, the figure shows that the encapsulable section 3354 can be formed with a flared end at the hook 3353 to provide a retaining surface for the mask frame 3310 . In another embodiment of the present invention, the encapsulable section 3354 may include an opening for holding the rigidizer arm 3302 within the mold tool during overmolding of the mask frame 3310 . A mold tool can be inserted through the opening to stabilize the rigid arm 3302 as the mask frame is overmolded around the rigid arm 3310 . This may be desirable as the pressure of the overmolding will cause the rigidizer arm 3302 to move during the molding process and thus form a less ideal mechanical interlock with the mask 3310 .

60 is a perspective view of a rigid dissipator arm 3302 in accordance with an embodiment of the present invention and shows the rigid dissipator arm 3302 before permanent connection with the mask frame 3310. As shown in FIG. As noted above, the rigidizer arm 3302 may include a hook 3353 and a retractable section 3354 to allow connection of the mask frame 3310 via a mechanical interlock. Having the rigidity arm 3302 and frame 3310 permanently connected to each other means there are fewer removable parts and less chance of reading out parts during assembly/disassembly of the patient interface 3000 during cleaning do.

6.3.6.6 Positioning and stabilization structures for the patient

71-73 show an example of the present invention. Here, the positioning and stabilizing structure 3300 is a strap having a posterior strap portion 3317 comprising two posterior strap portions 3317a, 3317b running parallel along the patient's occipital region and a lateral strap portion 3315, 3316. (3301). The positioning and stabilizing structure 3300 includes two rigidizer arms (not shown) that are each included in each side strap portion 3315 , 3316 of the sleeve or tubular strap 3301 . Rigidizer arm 3302 imparts to strap 3301 and thus positioning and stabilizing structure 3300 a desired or intended shape and/or stiffness. For example, the side strap portions 3315 and 3316 of the strap 3301 may each have a specific curvature (Figs. 52, 54, 58 and 60 in Figs. Reference number 3323 has a curvature). In the illustrated embodiment, the positioning and stabilizing structure 3300 is a frame 3310, plenum chamber 3200, or seal forming structure to provide a respirable gas, such as air, to the airway of a patient, eventually pressurized breathable gas. (3100) is connected. In the illustrated embodiment, the respirable gas gas is provided through a hose or tube 4180 connected to the patient interface 3000 . The tube 4180 may be connected at the other end (not shown) to a source of respirable gas, such as a blower or ventilator, that provides pressurized respirable gas. The patient interface 3000 may include a frame portion or frame 3310 for coupling to the positioning and stabilizing structure 3300 or imparting structural integrity to the patient interface 3000 . The positioning and stabilizing structure 3300 may be connected to the frame 3310, the plenum chamber 3200 or the seal forming structure ( 3100) can be connected.

74-77 show features similar to those shown in FIGS. 71-73 , but the embodiment shown in FIGS. shows At each end of the side strap portion 3315 there is a pocket end 3311 , 3313 as shown in FIGS. 65 and 81 .

The pocket ends 3311 and 3313 are held to the rigidizer arms 3302 by, for example, the protruding ends 3306 of the respective rigidizer arms shown in FIGS. 47-60 (these are side strap portions 3315). , 3316) not shown in the figure).

Although not shown in FIGS. 74-77, in this embodiment, because the end welds 3311.1, 3313 shown in FIG. 81 are proximate to the pocket ends 3311, 3313, they will be retained relative to the protruding end 3306. can The rigid arm 3302 is then permanently and mechanically fixed to the mask frame 3310 by overmolding, as shown in FIGS. 47-60 .

6.3.6.7 Segmented rear straps with positioning and stabilization structures

A structure and positioning and stabilization structure 3300 of the strap 3301 according to one characteristic is preferred. In particular, the installation of the two elastic straps or rear strap portions 3317a, 3317b at the rear allows the head to be cup-shaped, and the tension vector adjusts them to unfold and properly position. Providing the two rear strap portions 3317a, 3317b allows for improved support and stability as well as increased flexibility to avoid particularly sensitive areas of the occipital region. The posterior strap portions 3317a, 3317b cup the head at the scapula to maintain position and connection. For example, depending on the patient's specific head shape and the segmented amount of posterior strap portions 3317a, 3317b, the upper posterior strap portion 3317a may be positioned adjacent the parietal bone and the lower posterior strap portion 3317b may be located on the occipital cranium or It is located adjacent to the upper fibers of the trapezius muscle (ie, near the neck or nape of the neck). Lower posterior strap portion 3317b is configured to connect to the patient's head at or below the external occipital ridge position. The tension provided by the positioning and stabilizing structure 3300 opens the relative angle between the two rear strap portions 3317a, 3317b, in contrast to the headgear of a conventional mask, which requires material length adjustment (shortening or lengthening). Or it can be easily adjusted by closing. To reduce headgear tension, when the patient interface 3000 is worn, the two rear strap portions 3317a, 3317b come close together. The adjustment method comprises a notched strap allowing only increased adjustment of a given headgear tension, requiring some attempts to tighten and release until the desired headgear tension is achieved, or the act of pulling the strap through a buckle for tightening. This is preferred due to Velcro™ (non-breaking loop fabric), which loosens the strap through the buckle, which increases the headgear tension more easily than reduces it.

The length of the two smaller strap or rear strap portions 3317a, 3317b at the occipital region is the same, reducing the overall length of the side strap portions 3315, 3316 of the positioning and stabilizing structure 3300 or through the elasticity of the material. It is not adjustable except to make it tighter. For example, a sliding mechanism (not shown) may be provided to allow the straps 3301 to overlap to different degrees, thereby changing the overall length of the positioning and stabilizing structure. The non-independently adjustable strap length allows the two rear strap portions 3317a, 3317b to center themselves on the crown portion of the head. The two rear strap portions 3317a, 3317b may be symmetrical or asymmetrical. That is, the upper rear strap portion 3317a may be naturally fixed on the upper part of the head, and the lower rear strap portion 3317b may be naturally anchored on the back of the head or the lower part of the occipital lobe. This may reduce the likelihood of manually tightening one strap for another strap that has become too loose due to misfitting the positioning and stabilizing structure 3300 . This, again, not only causes discomfort but also negatively affects treatment adherence. The worsened width of the two rear strap portions 3317a , 3317b may be substantially equal to the width of the side strap portion 3315 . This is aesthetic as well as providing a visual indication for the patient to adjust the back strap portions 3317a , 3317b when wearing the patient interface 3000 . Although two rear strap portions 3317a and 3317b are described, more portions may be provided for different degrees of headgear tension adjustment.

When strap 3301 is neutral and stretched, the two rear strap portions 3317a, 3317b are interposed between them for the patient to guide or direct the rear strap portions 3317a, 3317b when the patient interface 3000 is worn. partially separated so that a gap exists. This improves the intuitiveness for adjusting headgear tension and provides a visual indication of how headgear tension is being adjusted, which is sometimes lacking in conventional masks. As described above, two or more joints may be provided to form three, four, or more positioning and stabilizing structures 3300 than a continuous piece of strap 3301 . This may complicate the assembly, but may simplify the manufacturing process. The joint may be located at the bifurcation 3324 between the side strap portions 3315, 3316 and the two rear strap portions 3317a, 3317b or may be centrally located behind it. The porcelain joint may be bared, welded, glued or overmolded, and may contain a high friction material to reduce head movement. A high friction material may be added to the interior surfaces of the rear and side strap portions 3315, 3316, 3317a, 3317b to prevent the strap from sliding against the patient's face or hair. For the arms or side strap portions 3315, 3316 this helps the positioning and stabilizing structure 3300 stay in the cheek and at the posterior strap portion 3317 the positioning and stabilizing structure 3300 slides across the occipital region. stop losing The material may be printed, cast or molded onto the surface or may be incorporated into a bonding, barging or welding process as described above. Another way to reduce the slippage of the strap is to have elastic yarns projecting from the fiber material.

As shown in FIG. 65, instead of being inserted in the button holes 3303 and 3304 located adjacent to the mask frame 3310, the rigid deesser arm 3302 is located at the bifurcation point at which the positioning and stabilizing structure 3300 branches, if necessary. 3324 may be inserted from an opening 3308 located adjacent. When the rigidity arm 3302 is inserted, it can be used to mount the rigidizer arm 3302 back into the opening of one (upper or lower) of the rear strap portions 3317a and 3317b of which the elastic material is small. This prevents the rigid dissipator arm 3302 from moving, and thus ensures proper fixation. Otherwise, the button hole 3303 is permanently bared, molded, or closed to secure the rigid arm 3302 inside the strap 3301 .

The rear partition 3326 may include two, three or more straps for stability. A positioning and stabilizing structure 3300 similar to the above may be used as a face (covering nose and mouth) or nose mask.

Other prior art positioning and stabilization structures include two or more straps at the back (which may have the same width as the side straps) where the lower back strap normally connects against the patient's head at or below the external laryngeal ridge. can have

These rear straps are not stretchable or elastic but can be adjusted in length, and the rear straps can be biased to return to their basic angle to avoid wrinkling or distortion at the point of convergence with the single side straps. For example, the default angle may be 45° to disengage between two posterior straps to be fitted and connected to the patient's head and pivoting of the posterior straps relative to each other ensures that the wearing or removal of the patient interface is the patient's face. to secure the patient interface in a position that provides tension to the seal forming structure against the The two posterior straps are biased to return at an angle of 45° and thus only function as a cup over the patient's occipital region for stability of the patient interface, and cannot maintain an angle biased at an angle of 45°.

In accordance with the use of the present invention, the provision and use of the rigid deesser arm 3302 may affect the elasticity of the strap 3301 . This allows the positioning and stabilizing structure 3300 to fit a wide range of head sizes. This is a “one size fits most” positioning, meaning that the patient wears the positioning and stabilizing structure 3300 in a bag even if the patient has not previously tried or used the positioning and stabilizing structure 3300. and a stabilizing structure 3300 . The present invention may provide a positioning and stabilizing structure 3300 that facilitates putting on and taking off the patient interface 3000 . In particular, unlike some other positioning and stabilizing structures 3300 , the tension settings do not change and/or are not lost when the mask 3000 is removed. Rigidizer arm 3302 allows for the desired shape to ensure the presence of play around the eyes and ears for comfort and visibility. The textile of the strap 3301 condenses sweat by allowing the skin to breathe and sweat naturally without the silicone, foam or plastic that creates and maintains a surface.

Providing the two elastic straps 3317a, 3317b on the back of the strap 3301 allows the patient's head to cup and the distribution of applied force adjusts by unfolding them to independently change their position. The two smaller rear strap portions 3317a and 3317b at the back of the head are not equal in length and equally increase the tightness by reducing the overall length in the strap of the positioning and stabilizing structure 3300 or without through the elasticity of the material. cannot be adjusted

6.3.6.8 Flexible Joint (3305)

19 , 71 - 73 , 75 , 76 and 166 show coupling of positioning and stabilizing structure 3300 to frame 3310 relative to plenum chamber 3200 . In particular, the joint 3305 in the rigid deesser arm 3302 and the frame 3310 is flexible and/or elastically deformable. Thus, when worn by the patient 1000 , the seal forming structure 3100 may correspond to various angles (eg, as shown in FIG. 2E ).

It should be appreciated that the flexibility of the joint 3305 allows the frame 3310, plenum chamber 3200, and other related components to move about multiple axes relative to the rigidizer arm. In one form of the invention, the frame 3310 and the plenum chamber 3200 are rotatable through a flexible joint 3305 about an axis formed between the respective ends of the rigidizer arm 3302 . This arrangement allows the seal forming structure 3100 to be angled relative to the lower region of the patient's nose over a wide range of possible nasolabial fold angles.

18 , 19 , 75 , 76 and 166 , the seal forming structure 3100 is held against the airway of the patient 1000 , such as the lower part of the patient's nose, in one embodiment, the nostrils. Proper positioning of the seal forming structure 3100 is an important factor in achieving effective sealing of the incision cone 3140 against the patient's nostrils to minimize leakage of pressurized gas with minimal retention force. As the incision cone 3140 may extend axially in the talc 3150 of the seal forming structure 3100 , it is to some extent in the direction of the patient interface 3000 relative to the patient's nose to achieve an optimal seal. It is desirable to allow the flexibility of Such flexibility of the patient allows the patient to have various nose lip angles (see FIG. 2E ) that need to be applied by a common patient interface. The flexibility can be applied to the exemplary patient interface 3000 by providing a flexible joint 3305 . In one embodiment of the present invention, a flexible joint 3305 may be disposed between the frame 3310 and the rigid arm 3302 . In this exemplary arrangement, the frame 3310 may include a material that facilitates flexing in the flexible joint 3305 with the rigid arm 3302 of the positioning and stabilizing structure 3300 . In an alternative arrangement, the rigidizer arm 3302 can be flexed through the extension 3350 to allow for proper positioning of the seal forming structure 3100 relative to the lower portion of the patient's nose. In addition, it can be expected that the bending occurs partially in two parts. Among the contemplated configurations, a desired result is that the patient interface 3000 can rotate under the patient's nose to accommodate various nasal lip angles. This flexibility provided by the flexible joint 3305 allows the trampoline 3131 to be more effective by providing a comfortable force to the patient's nostrils or nose. Without the flexible joint 3305, the trampoline 3131 would engage with the talc 3150 as tension in the positioning and stabilizing structure 3300 secures the seal forming structure 3100 in the sealed position relative to the patient's airway. Because the plenum chamber 3200 may be in a partially or fully collapsed state, it may not be very effective in maintaining stability and applying various nose wing angles.

The flexible joint 3305 forms the frame 3310 and/or the rigid arm 3302 from a material having a modulus of elasticity sufficient to allow for the flexibility of the joint 3305 while maintaining sufficient stiffness to ensure effective sealing. can be provided by Additionally or alternatively, the frame 3310 and/or the rigid arm 3302 may be structurally shaped to allow for flexibility in the region. That is, the frame 3310 and/or the rigid arm 3302 may be shaped to allow for the required amount of flexibility in the area of the joint 3305 . This can be achieved by removing some of the structures so that their stiffness is reduced to allow for bending.

Another possible advantage of this aspect of the present invention may be to reduce the bending moment coupled to the rigid deesser arm 3302 and the frame 3310 . 19, 71-73, and 75, the rigid-dezer arm 3302 may be shaped to fit the contours of the patient's face. The seal-forming structure 3100 has a relatively limited amount between the seal-forming structure 3100 , the plenum chamber and the frame 3310 secured to the nose by the positioning and stabilizing structure 3300 when connected to the patient's nostrils. may cause displacement of the frame 3310 due to its flexibility.

By providing a flexible joint 3305 between the frame 3310 and the rigid arm 3302, when the patient interface 3000 is worn by a patient, the bending moment associated with the structure is such that some of the associated forces are distributed to the flexion of the joint. can be reduced because This is desirable because the patient interface 3000 is subjected to less force in use to reduce wear and tear. Also, by distributing the force to the bending of the flexible joint 3305 , the bending of the rigidizer arm 3302 and/or the frame 3310 can be reduced. This is desirable because, when the rigid deesser arms 3302 are shaped to fit the patient's face, they can reduce compliance according to the patient's discomfort level. The same can be applied to bending of frame 3310 and bending of frame 3310 to cause seal forming structure 3100 to be displaced from the patient's nose.

It should also be understood that in the arrangement described above, it is desirable to rigidly form the rigidizer arm 3302 . By forming the rigid arm 3302 from a material with sufficient rigidity and/or molding the rigid arm with sufficient rigidity such that they have sufficient rigidity, the flexible joint 3305 is such that the seal forming structure 3100 is displaced from the patient's nose. You can guarantee that it will not be allowed. That is, an appropriate fit and effective seal can be coupled to the patient's nose and of sufficient stiffness to maintain a desired degree of conformability to the patient's face while allowing sufficient displacement of the seal forming structure 3100 to provide an effective seal. This can be accomplished through the rigid deesser arm 3302 . Rigidizer arm 3302 can be formed from Hytrel® having a flexural modulus of 180 MPa at 23°C and a tensile modulus 26 of this 180 MPa. Also qin one embodiment of the present invention, the patient interface 300 is configured such that elastic deformation occurs only at the seal forming structure 3100 and the flexible joint 3305 between the frame 3310 and the rigid deesser arm 3302. It should be understood that it can be

In this embodiment of the present invention described above without the flexible joint 3305, the extension 3350 of the rigid dissipator arm 3302 performs a function similar to the flexible joint 3305 as described above.

6.3.6.9 Tension vectors of positioning and stabilizing structures

As discussed above, the positioning and stabilizing structure 3300 preferably positions the headgear tension vector relative to the patient's head such that the compression vector associated with the seal forming structure 3100 is properly aligned with the patient's 1000 nose and nostrils. can do it 72 , 73 , 75 , and 76 , vector V illustrates exemplary directions and magnitudes of the force that in use presses seal forming structure 3100 against the nose of patient 1000 . By operatively attaching the exemplary positioning and stabilizing structure 3300 to the seal forming structure 3100 , when worn by the patient 1000 , the tension of the positioning and stabilizing structure 3300 is determined by the direction and magnitude of the vector V may be sufficient to press the patient interface 3000 against the nose or nostrils of the patient 1000 together with a force with The concept of a vector can be according to the following description.

When using a nasal pillow 3130 in accordance with an embodiment of the present invention to effectively and/or properly form a seal against a patient's nostrils, the seal forming structure 3100 is substantially the seal forming structure 3100 . should be pressed against the patient's nostrils in the coaxial direction of the The magnitude of the force should be sufficient for the seal-forming structure 3100 to form a seal around the nostrils, but not so large that the relatively soft seal-forming structure 3100 is twisted or deformed. Accordingly, a force of magnitude and direction depicted by the vector V must be provided to the seal forming structure 3100 . However, it is not ideal for the strap 3301 to sag along the side of the patient's face or across the ears and eyes. This is disturbing and uncomfortable for the patient 1000 . The two-point force and vector control allows the strap 3301 to gently stabilize the mask 3000 to properly pull the nasal pillow 3130 and form a pneumatic seal with the patient's airway.

To overcome the above problem of providing a sealing force of the required orientation and size during placement of them in a specific area of the patient's face, a rigidizer arm 3302 and/or frame 3310 as described above is provided. . Rigidizer arm 3302 and frame 3310 are intermediate media for tension transferred from positioning and stabilizing structure 3300 to seal forming structure 3100 while strap 3301 is directed away from the patient's eye. can act as That is, the positioning and stabilizing structure 3300 is capable of generating a force at one end of each rigid deesser arm 3302 and/or the frame 3310 with sufficient rigidity thanks to the tension, and the sealing forming structure It transmits the force having an appropriate direction and magnitude to the opposite end where 3100 is located. Thus, the seal forming structure 3100 can be pressed against the patient's nose to form an effective seal. In this alternative method, the rigid deger arm 3302 and/or the frame 3310 structurally release the positioning and stabilizing structure from the seal forming structure 3100 while continuing to maintain the proper orientation and magnitude of the sealing force.

As noted above, the strap 3301 of the positioning and stabilizing structure 3300 may enclose the rigid deger arm 3302 in certain embodiments. To facilitate the above-described detachment force while maintaining the sheath-shaped detachment structure of the strap 3301 and the rigid dismounting arm 3302, the rigid disassembling arm 3302 may include a smooth surface along at least one portion thereof. there is. By providing a smooth surface along the rigidity arm 3302, the strap 3301 of the positioning and stabilizing structure 3300 extends and/or presses along the rigidizer arm 3302 in a relatively free and/or low friction configuration. can be That is, the strap 3301 is floated beyond the rigid de-esser arm 3302 except for the pocket end 3311 fixed to the rigid de-esser arm 3302 . It also reduces friction of the positioning and stabilizing structure 3300 along the rigid dissipator arm 3302, thereby causing loss or damage to the pneumatic seal of the seal forming structure 3100 and/or external forces or unintended wear that may cause unpleasant wear. force can be prevented.

Some positioning and stabilization structures of conventional masks having multilayer laminate straps with layers made of different materials provide different degrees of flexibility that are permanently laminated to each other.

Another positioning and stabilizing structure of conventional masks uses rods or adhesives to permanently connect the multilayer straps together. Conversely, the positioning and stabilizing structure 3300 of the present invention has a strap 3301 releasably engaged with a rigid deesser arm 3302 . This allows for separate cleaning of the strap 3301 from the rigid deesser arm 3302 and the frame 3310 .

The possible connection is the frame 3310 and the area using the pocket end 3311 of the strap 3301 that allows for substantial extension of the entire length of the strap 3301 from the point of connection (rigidizer arm adjacent the frame 3310). A small area localized to the edge of 3302) is provided. Other positioning and stabilization structures of conventional masks are

To adjust the length of one or more headgear straps (usually by shortening the length) to adjust the headgear tension of the Chinese interface 3000 on the patient's face, an attachment buckle or Velcro™ is used. In contrast, the positioning and stabilizing structure 3300 of the present invention does not require length adjustment to adjust headgear tension, and in particular, a microscopic Motor skills are particularly useful in dark rooms, especially for patients with hand-impaired attachments.

6.3.6.10 Strap Manufacture

The positioning and stabilizing structure 3300 is fabricated from a shape with little or no material wasted during manufacturing (which is integrally formed into a known shape as a complete form without the need to cut a substantial amount of material). Optionally, positioning and stabilizing structures 3300 can each be divided into segments that are formed separately (eg, knitted) and then attached to each other. 132 depicts a single unitary seamless structure having at least two regions (eg, crown portion or back portion 210 and strap 220 ). At least two regions extend from the connection (which is the connection between the strap 220 and the rear portion 210 ), where the strap 220 extends at a different angle than the rear portion 210 . The back portion 210 and the strap 220 are formed in a continuous process (ie, the material of which the component is made and the shape of the component are formed in a single step) - this is where the sheet of material is made and the shape is cut. It is different from the process (which is not considered a single step). 132 shows the strap 220 extending in a direction or other angle relative to the back portion 210 without bifurcated or requiring shims or additional forming steps. A knitted component, such as positioning and stabilizing structure 3300, is defined to be formed into a unitary knit structure when constructed as a unitary knit element without an additional stitching or gluing process.

133, it can be formed into a continuous piece (eg, by warp knitting, circular knitting or 3D twisting) with subsequent cuts as the procedure can further increase manufacturing efficiency.

Knitting the various positioning and stabilizing structures in a continuous manner is desirable because there are very few or no steps requiring rods, fusing, gluing, or other attachments to connect the sections. As a result, manufacturing processes can be reduced, reducing the amount of material waste and substantially seamless positioning and stabilizing structure 3300 between adjacent sections, positioning and positioning and stabilizing structures 3300 made of separate joints or seamless fabrics. The stabilizing structure may be more comfortable for the patient.

6.3.6.10.1 Technology

A number of techniques can be used in accordance with the present invention to provide positioning and stabilization structures with little or no waste. The technique can create positioning and stabilization of single, integral, seamless structures. Techniques capable of creating single, integral, seamless structures include mechanical working of yarns, including interlooping (such as knitting), weaving, and/or intertwining (including braiding, notching and crocheting). . Alternative technologies for 3D printing can create positioning and stabilizing structures with single, seamless structures.

A manufacturing technique according to the present invention may have one or more of the following characteristics: (1) produces little or no waste; (2) creates a comfortable positioning and stabilization structure for the patient; (3) comfortable (4) Create a positioning and stabilizing structure that is breathable. (5) Create a positioning and stabilizing structure that minimizes facial marking. and/or 6) create a lightweight positioning and stabilizing structure.

6.3.6.10.1.1 Interlooping - knitting

In accordance with embodiments of the present invention, positioning and stabilizing structure 3300 may be formed from a knitted fabric (eg, threading a yarn or thread to form a knitted fabric). Positioning and stabilizing structure 3300 may be formed by flat knitting or circular knitting, but other knitting forms are possible. Flat or circular knits are preferred as they can create positioning and stabilizing structures 3300 having a single, seamless structure. Flat or circular knitting machines can be used to make weft knits or warp knits. A variety of knitting processes, including circular knitting and warp or weft flat knitting, may be used to make the positioning and stabilizing structural element or elements. Flat knitting may have several advantages, including but not limited to: (1) the ability to position the floating yarn within, for example, positioning and stabilizing structures to provide extra cushioning or bulk, and/or (2) positioning the ability to include loops of extra yarn on one of the upper or lower surfaces of the establishing and stabilizing structural straps, creating a soft towel material effect or forming a non-breaking loop fabric for connection with, for example, hook tape fasteners, and and/or (3) the ability to construct a 3D stereoscopic spacer fabric structure adjacent to the double-sided knit structure within the construction of a single integrated positioning and stabilizing structure.

The positioning and stabilizing structure 3300 is formed primarily from multiple yarns that are mechanically manipulated by an interlooping process to create a single unitary structure having various sections with different physical properties.

134 shows the direction in which wales or loops of one thread of weft knit fabric 64 are connected to loops of another thread. The orientation of the course 85 or loop in a single thread is shown in FIG. 135 . 136 and 137 show a basic closed loop warp knit 90 . 138 is an embodiment of a warp knit tricot jersey fabric construction in which yarns are knitted in a vertical direction by capturing another warp yarn in a zigzag manner with a wale running somewhat parallel to the course.

136-139, warp knits 90 and 90-1 include wales and forks running parallel to each other, while in the weft knit 100, the wales run perpendicular to the course. The positioning and stabilizing structure 3300 of the present invention may be formed from either a warp knit or a weft knit. Warp knits such as tricot, Raschel or locknit are usually more resistant to processing to be easily machined and may use multiple yarns (allowing the use of multiple colors or yarn types). Weft knit 100 is a single yarn However, the use of multiple yarns is also possible. The positioning and stabilizing structure 3300 of the present invention may be comprised of warp knits or weft knits.

Knitted fabrics may have different stretch properties compared to woven fabrics. Knitted fabrics are more flexible than woven fabrics that can be stretched in one direction (depending on the yarns from which they are made), thus providing a more comfortable fit for the patient. The knit fabric may be constructed in such a way that it has fabric bi-directional stretch, wherein the first yarn oriented in the first direction has less flexibility than the yarn oriented in the second direction. The arrangement may be arranged along the straps in a positioning and stabilizing structure such that the straps extend along their way but not across their width, or vice versa.

Optionally, the knit fabric may have four directions, ie, both flexible to stretch in first and second directions and in both longitudinal and transverse directions when applied to the strap.

FIG. 142 shows a strap 1200 with eye grain or course 1250 and shows how the orientation of the grain or course affects elongation. Knitted fabrics tend to stretch more easily in the course direction. Thus, positioning and stabilizing structure 3300 may be designed to stretch in one direction and resist stretching in another direction. For example, the strap 1200 tends to stretch in the width direction A (from the patient's face to the back of the head) and the stretch may be limited along the length of the strap. The configuration increases the stability of the positioning and stabilizing structure 3300 in the longitudinal direction, thereby increasing the wearing range. The strap 1200 is configured to stretch in a particular direction and resist stretching in the other direction in order for the strap 1200 to fully secure the mask assembly to the patient's face in a manner that enhances the seal with the patient's face.

140 and 141 , knitted strap 1105 includes an upper portion 1102 , a back portion 1104 , and a lower portion 1106 . The lower portion 1106 may be bifurcated or divided at the junction forming the upper portion 1102 and the rear portion 1104 . The angular direction of the upper portion 1102 is different from that of the rear portion 1104 . For example, the upper portion 1102 may extend about 30-110 degrees, about 90 degrees, or it may extend perpendicular to the rear portion 1104 . The direction of the knit or the crane or course 1150 of the knit may be changed to adjust the shape or elongation of the fabric in a particular area. For example, grain or course 1150 may be configured to curve the strap in the cheek region so as not to obstruct the patient's eyes. Also, as shown in FIG. 141 , the grain or course 1150 may be curved as indicated by arrow B to separate and form the upper portion 1102 and the rear portion 1104 . The configuration of the upper portion 1102 and the posterior portion 1104 stabilizes the strap at the position of the patient's head, thereby reinforcing the seal with the patient's face so that the knitted strap 1105 is placed over the patient's face. Allows for better fastening of the assembly.

Knitted strap 1105 may support patient interface 3000 (eg, a nose mask) to a patient's face. Connector 1120 may be used to attach strap 1105 to patient interface 3000 , and air circuit 4170 may supply breathing gas to the patient's airway through patient interface 3000 . In the illustrated embodiment, the patient interface 3000 is disposed under the patient's nose to seal the exterior surface of the patient's nose.

The positioning and stabilizing structure 3300 of the present invention may also include pockets, tunnels, layers and/or ribs. This positioning and stabilizing structure 3300 may be integrally formed by circular or flat knitting. The pocket or tunnel may be reinforced with a material that has a greater stiffness than the rigid or knitted textile and thus reinforces the positioning and stabilizing structure 3300 . Reinforcement of the positioning and stabilization structure 3300 stabilizes the mask on the user's face position well. Materials for reinforcing positioning and stabilizing structure 3300 may include plastics such as nylon, polypropylene, polycarbonate, or high-strength textiles such as braided ropes. Reinforcement of positioning and stabilizing structure 3300 may be placed in a skeletal region of the patient's head, such as the cheek, occipital or crown. Reinforcing structures can be inserted during the knitting process. For example, a harder or flatter yarn or stronger polymer element may be inserted into the knit structure during or after the knitting process. Strands or rigid elements serve to withstand tensions and stresses due to, for example, tightening positioning and purifying structural straps for treatment, further stabilizing the mask or connecting positioning and stabilizing structural pieces to attach to the mask interface Or it can help to act as a fixation medium. Optionally, the pockets or tunnels may have cushioning for added comfort. For example, a pocket or tunnel may be filled with foam, gel, floating yarn, loop yarn or other cushioning material.

Positioning and stabilizing structure 3300 may be formed from a flat knit or circular knit, and positioning and stabilizing structure 3300 has selvedges. That is, it has a finished configuration such that the ends of the yarns used to construct the positioning and stabilizing structure 3300 are not substantially present at the edges of the positioning and stabilizing structural elements.

The advantage of constructing the positioning and stabilizing structural elements in a finished form is that the yarn is not cut and therefore less likely to become entangled and may require less finishing operations. By forming the finished edge, the integrity of the positioning and stabilizing structure 3300 is maintained and equally strengthened, and with less or no post-processing, one of the following is maintained.

(1) preventing entanglement of positioning and stabilizing structures, and/or (2) forming separate soft edges (such as ultrasonically cutting and sealing soft edges to fabric-foam-fabric layer materials) and/or (3) positioning Improved aesthetics and durability properties of the setup and stabilization structure 3300.

The positioning and stabilizing structure 3300 of the present invention may be formed by regular or irregular pique knits. The pique knit directs the first yarn to the right side (the patient non-contact side that is not visible once the positioning and stabilizing structure 3300 is worn), and the second yarn to the inverted side (once the positioning and stabilizing structure 3300). 3300) invisible patient contact side) when worn. That is, the yarn exposed on the right side may be different from the yarn exposed on the upside down side. For example, the yarn on the right side may have a desirable appearance, and the yarn on the inverted side may have a good hand feel in contact with the skin on the patient. Optionally, or additionally, the right side yarn can have a first moisture wicking property and the flipped side can have a second moisture wicking property. For example, the yarn on the right may be a high proportion of ultrafine fibers having a first moisture wicking property, and the opposite side may be a high proportion of non-ultrafine fibers having a second moisture wicking characteristic.

Positioning and stabilizing structure 3300 may also, for simplicity, be formed into a single knit structure that may have uniformity and properties of material, and may be formed into a single unit comprising various sections having different physical properties joined in a seamless manner. structure can be formed. The various sections may include, but are not limited to, different degrees of stiffness, abrasion resistance, flexibility, enhanced durability, high or low hygroscopicity (hygroscopicity), hydrophilicity, respirable or air permeability, liquid permeability, stretch or stretch resistance, compressibility, It may have gusheability, supportability, rigidity, recovery, fit or formability. The various sections can be configured with different properties, such as directional stretch, such as tetragonal stretch or bi-directional stretch, stretch resistance or non-stretch with cut-through. This can be achieved by selecting, but not limited to, a particular yarn or knit structure type.

As a unified seamless structure, positioning and stabilizing structure 3300 may be formed of one piece with uniform properties or two or more sections with various properties. The two or more positioning and stabilizing structure sections may be different by using two or more different yarns of different twist, denier, fiber composition, etc. and thus imparting different physical properties to the positioning and stabilizing structure 3300 . Two or more positioning and stabilizing structural sections can be different by using two or more different knit stretch shapes in the two sections and thus imparting different physical properties to the two sections.

One area may incorporate elastane or PBT (polybutylene terephthalate polyester), for example, to enhance stretch, while another area may incorporate nylon or polyester, for example, to improve durability. can be integrated Similarly, one location area of positioning and stabilizing structure 3300 may incorporate yarn with 1 denier, while another area may incorporate yarn with greater or reduced denier, crimp or texture to form a cushion thickness or volume. may include

Two or more sections in the construction of the positioning and stabilizing structure may be joined, for example, by using tuck stitches or other knit stitches that connect the first section to the second section in a seamless manner. This is accomplished by knitting the first section, then knitting a tuck stitch between the first knitted section and the second knitted section, and then knitting the second section. The tuck stitch is used to seamlessly connect the sections between the wales, especially when using a narrow tube circular knitting machine.

Positioning and stabilizing structural pieces can be finished without seams. If it is made of undyed yarn, this can be achieved by finishing the knitting process with a yarn comprising water-soluble fibers. Soluble fibers eliminate the need to create additional seams at the edges and allow the fibers to shrink during the dyeing process and provide a properly finished edge.

To improve manufacturing efficiency, knitting machines may also be used to form a series of combined positioning and stabilizing structures, such as straps or crown components. That is, the knitting machine may form a single component comprising a plurality of positioning and stabilizing structures. Each segment of the positioning and stabilizing structure may have substantially the same shape and size. Optionally, the positioning and stabilizing structural pieces can each have a different shape and size that can be programmed in an order. Also, which may consist of (but not limited to, non-dissolving yarns, loosely knitted yarns, fine denier yarns, or easily breakable placeholder yarns), the knit release area can be, for example, a strap that separates without the need for a cutting operation. It can be knitted into a series of positioning and stabilizing structures to allow for a variety of positioning and stabilizing structures, such as

6.3.6.10.1.1.1 Variable Thread Count

In other embodiments, the thread count may be varied for the fiber to improve comfort, fit and/or performance. For example, the thread count may be higher in regions that require greater stiffness (eg, cheek region, occipital region). However, in areas where lower stiffness is required (eg, depending on the strap), the thread count is smaller, thus allowing for easier bending.

The thread count, and thus stiffness, may depend on the type of yarn, the type of stitch (eg, a criss-cross stitch may be rough) and the distance between the stitches.

6.3.6.10.1.1.2 Yarn

Yarn may be used to create the positioning and stabilizing structure 3300 of the present invention. Yarns can be synthetic, twisted or textured, and can be made from, but not limited to, nylon, polyester, acrylic, rayon or polypropylene.

The yarns may all be conventional staple yarns, microfiber yarns, or combinations thereof. Yarns may incorporate elastane fibers or filaments to provide the same stretch and recovery properties as DuPont's LYCRA-branded fibers. Yarns may be made of synthetic materials, or natural fibers such as cotton, wool or bamboo, or natural filaments such as silk.

The yarns used to construct the components of the positioning and stabilizing structures may be formed of monofilaments, or a plurality of single filaments, ie, multifilament yarns. The yarns may be separate filaments each composed of a different material. Yarns may also include filaments each formed from two or more different components, such as a dual-element yarn with filaments having different materials formed in two halves or a sheath-core configuration formed from different materials. Different degrees of twisting or crimping may affect the positioning and properties of the stabilizing structure 3300, as do other deniers.

The materials used to construct the positioning and stabilizing structure 2900 may be made of recycled or biodegradable materials and, for example, the yarn may include recycled or biodegradable fibers or filaments.

Areas of positioning and stabilizing structures 3300 (eg, but not limited to, areas in contact with the patient's pillow) for greater action, such as areas of positioning and stabilizing structures 3300 located in the occipital or nape of the neck, are more It can be woven densely and thus can be heavier and less elongated. Conversely, the area needs to be made of a thin but strong net-like construction with a patterned hole so that more moisture will accumulate through sweat. In this case, the abrasion resistance needs to be inherent in the yarn properties.

6.3.6.10.1.23D Printing

In another embodiment, the positioning and stabilizing structure 3300 may be molded using a 3D printer. As shown in FIG. 143 , it can be used to print a plurality of connected links 2802 , thereby forming a flexible 3D printed textile 2804 . Referring to FIG. 144 , the positioning and stabilizing structural piece 2900 may be formed to include a rigid deesser arm 3302 . Rigidizer arm 3302 includes holes 2922 through the links of textile 2804 as textile 2804 is printed to incorporate textile 2804 and rigidity arm 3302 . Rigidizer arm 3302 may be made of any suitable material (eg, a polymer such as nylon 12 or sintered from a metal powder or other material that may be used in an additional manufacturing process). As additive manufacturing (“3D printing” process) technology improves, it is expected that the choice of material will become broader for the purpose of 3D printed textiles, optionally including rigid elements, such as rigidity arm 3302 . Structure can be inherent in a material by virtue of its shape, composition, or structure.

Also shown in FIG. 145 , 3D printed strap 2924 may be integrated into male holes 2912 ( 1 ) and 2914 ( 1 ) and female clips 2912 , 2914 .

63.6.10.2 Formation and finishing of straps

79 and 80 show the strap 3301 in an intermediate stage of manufacture. The exemplary strap 3301 shown is the original length of the strap, not cut to length, in a knitted fabric made through the exemplary methods and processes described above. For example, a pair of buttonholes 3303 has the strap shown at the leftmost end but the finished hole is shown at the end because the one strap is cut between the holes to make the strap shown in FIG. 81 . . Also, the knitting process to form the strap 3301 circle shown in FIG. 79 forms multiple divided regions 3326 along the length of the strap. However, the finished strap 3301 shown in FIG. 81 includes only one segmented region 3326 . Also, this is because during finishing the strap 3301 is cut between the rightmost buttonhole 3303 shown in FIG. 79 to divide the circular length of the strap 3301 shown here into multiple straps.

In accordance with one embodiment of the present invention, strap 3301 may be formed using a warp labeling machine having multiple bars forming a chain of fabric. According to another example, strap 3301 may be formed on a Comez machine having six bars that engage two side strap portions 3315, 3316 and two rear strap portions 3317a, 3317b in the center. . By adding more bars to the Comez machine, you can counter the direction of knitting. The knitting process may also include forming a strap 3301 having a different weave at the bifurcation 3324 . The material of the strap 3301 may include 1740 counts. The order of the pattern shape of the strap 3301 follows: normal, then buttonhole, then normal, then separate, then normal, then buttonhole and then normal. Subsequent straps 3301 are then knitted in the same order running back towards each strap 3301 being made. In one embodiment of the present invention, the thread used to knit the strap 3301 may be wound in a double helix.

To add length at potential failure points, strap 3301 may be formed with extra stitching at those points. Potential points of failure may include buttholes 3303 and 3304 and branch points 3324 . Additional threads may also be knitted along the middle of strap 3301 for additional reinforcement.

80 is a cross-sectional view of the side strap portion 3316 of FIG. 79 along line 80-80. Bifurcation 3324 represents a division 3326 of the side strap portion 3316 and a division between the upper back strap portion 3317a and the lower rear strap portion 3317b.

_{79 shows sizes L 1} -L ₆ according to various features of strap 3301 . L ₁ represents the distance between the button hole 3303 of one strap 3301 and the button hole 3303 of an adjacent strap. In one embodiment of the present invention, L ₁ may be about 515 mm. L ₂ represents the distance between buttonholes 3303 of the same strap, and in one embodiment of the present invention, the value may be about 500 mm. L ₃ represents the length of segmented region 3326, which may be about 200 mm in one embodiment of the present invention. L ₄ represents the distance between adjacent buttonholes 3303 of adjacent straps 3301 and may be about 15 mm in one embodiment. L ₅ represents the width of the button hole 3303, which may be about 5 mm in one embodiment. L ₆ represents the width of the strap 3301, which in one embodiment may be 15 mm.

81-83 show a strap 3301 finished in accordance with an embodiment of the present invention. As shown in FIG. 81 , there is only one divided area 3326 and only one button hole 3303 at the end of each strap 3301 . Accordingly, it should be understood that the strap 3300 shown in FIG. 79 is cut and closed in accordance with one embodiment of the present invention. In addition, as shown in FIG. 81 , a strap logo 3357 formed on the strap 3301 in the form of a company logo or other artwork is shown, for example. The strap logo 3357 may be formed by pad printing or ultrasonic welding. When the strap logo 3357 is formed by ultrasonic welding, it is the rear strap portion at bifurcation 3324 that allows the patient 1000 to unfold the rear strap portions 3317a, 3317b to ensure ideal fit and strap tension. (3317a, 3317b) may help widen.

81 shows end welds 3313.1 and 3311.1. As noted above, the side strap portion 3316 may be knitted into a hollow or tubular shape. Thus, the end is open if not closed, for example by welding to prevent breakage along the open end. The end welds 3311.1 and 3313.1 may be formed by ultrasonic welding to seal loose fibers 3301 of the strap. Although ultrasonic welding may degrade the stretchability of the fabric comprising the strap 3301, it may serve to reduce fraying at the ends and add stiffness at high load points. As end welds 3311.1 and 3313.1 proximate each pocket end 3311, 3313, the end welds provide rigidity to the strap 3301 holding the rigid arm 3302 at each protruding end 3306. It should be understood that the pocket ends 3311 and 3313 and the corresponding end welds 3311.1 and 3313.1 according to an embodiment of the present invention are for holding and/or fixing the main part of the strap 3301 to the rigidizer arm 3302. do. Although the strap 3301 may lose elasticity after prolonged use, it should be understood that at least some or all of the elasticity may be restored as the strap 3301 is washed and dried.

The Stretch Wise™ headgear from Fisher & Paykel™ for the Pilairo™ mask has a rigid, detachable swivel connection between the rigid plastic headgear hook end of the strap and a rigid plastic vertical bar located on the mask frame. In contrast, strap 3301 according to one embodiment of the present invention provides rigidity between strap 3301 and mask frame 3310 that prevents problems such as wrinkling and breakage of the hook end after repeated connection and disengagement of the rigid element. It does not have a detachable connection. In order to actually engage and disengage from the rigid bar, the rigid hook end of the StretchWise™ headgear has to actually deform with a significant amount of force.

Another drawback of StretchWise™ headgear is that the elastic headgear strap does not regain its original level after washing the headgear strap. That said, the headgear StretchWise™ loosens over time. 82, similar to FIG. 80, is a cross-sectional view of strap 3301 along line 83-83. A junction 3324 indicates the beginning of a partitioned region 3326 . Also, the strap logo 3357 is shown elevated from the side strap portion 3316 in this figure.

83 is a detailed view of strap 3301 and specifically shows strap logo 3357. Also, a branch point 3324 is shown at the beginning of the divided area 3326 .

81 is also shown at an additional scale illustrating features of an exemplary strap 3301 . L ₇ represents the distance between the end of the finished strap 3301 and the end welds 3311.1, 3313.1, which in one embodiment may be about 5 mm. L ₈ represents the width of the end welds 3311.1 and 3313.1 and in one embodiment may be about 1 mm.

6.3.6.11 Patient interface and positioning and wearing of stabilization structures

The exemplary patient interface 3000 and positioning and stabilizing structure 3300 may be worn in a simple and adjustable manner in accordance with various embodiments of the present invention.

As explained in more detail below. 84-112 illustrate various sequences of a wearer (eg, a patient) wearing and adjusting the patient interface 3000 and positioning and stabilizing structure 3300 as described in greater detail below.

84-88 are a series of perspective views of patient 1000 wearing patient interface 3000 and positioning and stabilizing structure 3300 . 84 , patient 1000 begins wearing patient interface 3000 and positioning and stabilizing structure 3300 by holding patient interface 3000 and placing seal forming structure 100 on the nose. 85 shows the patient 1000 after which the patient begins to wear the positioning and stabilizing structure 3300 . Patient 1000 holds patient interface 3000 with one hand and with the other hand stretches strap 3301 over the head to pull strap 3301 near segmentation area 3326 .

86 illustrates pulling the strap 3301 towards the occipital region while holding the segmented region 3326 with one hand and the patient interface with the other hand. Upon completion of this step, a strap 3301 is placed near the crown and over the occipital lobe such that an appropriate tension sealing force is placed on the positioning and stabilizing structure 3300 to secure the patient interface 3000 against the nose of the patient 1000 . It should be located near or above the occipital region.

87 shows a positioning and stabilizing structure such that the patient 1000 then positions the rigidiser arm (not shown in the figure) below the cheekbones and adjusts the fit of the seal-forming structure 3100 to the nose to ensure a complete seal. Adjusting 3300 is shown.

Positioning the rigidity arm 3302 below the cheekbones may prevent the positioning and stabilization structure 3300 from climbing on the patient's 1000's face and laying down the patient's field of view. 88 illustrates patient 1000 with patient interface 3000 and positioning and stabilizing structures 3300 worn and ready for treatment.

89-93 are a series of side views of a patient wearing the patient interface 3000 and positioning and stabilizing structure 3300 fmf. 89 shows the patient 1000 holding the patient interface 3000 and lifting it towards the nose while holding the strap 3301 of the positioning and stabilizing structure 3300 with the other hand. At this point, the strap 3301 may not be stretched significantly. FIG. 90 shows a patient 1000 positioning the interface 3000 with one hand, relative to the nose, particularly the seal forming structure 3100 , and holding the strap 3301 of the positioning and stabilizing structure 3300 with the other hand. It shows pulling and extending over the head. Separation in segmented area 3326 can be seen by pulling on strap 3301 . FIG. 91 shows the fixation of the seal forming structure 3100 and the patient interface 3000 against the nostril while pulling the strap 3301 of the positioning and stabilizing structure 3300 towards the occipital region. At this point, the initial steps of wearing the patient interface 3000 and positioning and stabilizing structure 3300 are nearly complete so that the strap 3301 is positioned against the back of the patient 1000 . 92 shows the patient 1000 adjusting the seal forming structure 3100 and the patient interface 3000 relative to the nose to confirm proper sealing and proper positioning of the rigidiser arm 3302 relative to the cheekbones. 93 shows the patient then wearing and preparing the patient interface 3000 and positioning and stabilizing structure 3300 for treatment.

94-98 are a series of front views of patient 1000 wearing patient interface 3000 and positioning and stabilizing structure 3300 . 94 shows patient 1000 beginning to wear patient interface 3000 and positioning and stabilizing structure 3300 . Holding the patient interface 3000 with one hand and the strap 3301 of the positioning and stabilizing structure 3300 with the other hand, the patient 1000 raises the patient interface and the positioning and stabilizing structure toward the face. FIG. 95 shows patient 1000 slightly stretching positioning and stabilizing structure 3300 and strap 3301 with one hand. FIG. 95 also shows holding the patient interface 3000 with the other hand and positioning the thread forming structure 3100 relative to the nose at the base of the nose. 96 shows the strap against the occipital region while the patient 1000 stretches and pulls the strap 3301 of the positioning and stabilizing structure 3300 over the head and secures the seal forming structure 3100 and the patient interface 3000 against the nose. Positioning 3301 is shown. 97 shows a comfortable position in which the patient 1000 rests under the cheekbones such that the positioning and stabilizing structure 3300 does not rise above the patient's line of sight and the seal can be maintained against the nostril with the seal forming structure 3100. Adjusting the positioning and stabilizing structure 3300 and patient interface 3000 by positioning the rigidizer arm 3302 is shown. 98 shows the patient then wearing and preparing the patient interface 3000 and positioning and stabilizing structure 3300 for treatment.

99-104 are a series of perspective views of patient 1000 wearing patient interface 3000 and positioning and stabilizing structure 3300 . 99 shows the patient interface 3000 and positioning and stabilizing structure 3300 by stretching the strap 3301 while the patient 1000 holds the strap 3301 with one hand and the patient interface 3000 with the other hand. Shows starting to wear. FIG. 100 shows patient 1000 positioning patient interface and positioning and stabilizing structure 3300 on the head by cutting patient interface 3000 toward the face and pulling strap 3301 over the back of the head. FIG. 101 illustrates positioning the seal seal forming structure 3100 against the nostril with one hand while securing the strap 3301 in an elongated state near the occipital region. In FIG. 102 , the patient 1000 is still holding the patient interface 3000 against the nose to ensure that a proper seal is maintained as the tension sealing force is released from the strap 3301 . 103 shows the patient 1000 adjusting the patient interface 3000 relative to the nostril to ensure proper tilting and sealing as well as positioning the rigidiser arm below the cheekbones. 104 shows the patient then wearing and preparing the patient interface 3000 and positioning and stabilizing structure 3300 for treatment.

105-107 are perspective views illustrating the patient 1000 adjusting the patient interface 3000 relative to the nostril to ensure proper sealing by the seal forming structure 3100 . 105-107 , patient 1000 is shown tilting patient interface 3000 progressively downward relative to the nose to complete sealing to the nose with seal forming structure 3100 . Although the figure shows the patient adjusting the patient interface 3000 with one hand, it should be understood that the patient interface 3000 can be positioned and adjusted with two hands.

108-112 are a series of rear views of patient 1000 adjusting positioning and stabilizing structure 3300 relative to the occipital region. 108 shows a positioning and stabilizing structure 3300 placed in the occipital region. Strap 3301 is subjected to the greatest tension sealing force in this position. 109 shows the patient 1000 holding the upper posterior strap portion 3317a with one hand and the lower posterior strap portion 3317b with the other hand to separate the posterior strap portions 3317a, 3317b from the divided area 3326. pull

As the posterior strap portions 3317a, 3317b are closer to the patient interface 3000 which is positioned relative to the nostril, the tension sealing force of the positioning and stabilizing structure 3300 is reduced from the position shown in FIG. 108 . It should be understood that pulling the rear strap portions 3317a, 3317b apart from being By moving the rear strap portions 3317a , 3317b closer to the patient interface 3000 , the stretched length of the strap 3301 is reduced and the tension sealing force is reduced. FIG. 110 is similar to FIG. 109 , but in this view the patient 1000 pulls the upper posterior strap portion 3317a to further space the lower posterior strap portion 3317b.

It should be understood that the tension sealing force of positioning and stabilizing structure 3300 further decreases as rear strap portions 3317a, 3317b unfold. 111 is another view in which the patient 1000 unfolds the upper posterior strap portion 3317a to further space the lower posterior strap portion 3317b. The tension sealing force decreases again at the position shown in FIG. 110 . Also, at this point, the patient 1000 is nearly complete with positioning and adjusting the stabilizing structure 3300 to the desired level of tension sealing force. The upper posterior strap portion 3317a may be located near the top of the head and the lower posterior strap portion 3317b may be located near or below the occipital lobe. 112 shows the patient then adjusting the positioning and stabilizing structure 3300 to the desired level of tension sealing force. Again, the upper posterior strap portion 3317a may be located near the top of the head and the lower posterior strap portion 3317b may be located near or below the occipital lobe. It should also be understood that the tension sealing force of the positioning and stabilizing structure 3300 decreases as the upper rear strap portion 3317a and the lower rear strap portion 3317b are pulled apart from each other and thus the angle θ increases.

Although not shown in the figure, the angle θ may be about 0° in FIG. 108 and increases with the adjustment sequence. When the angle θ is increased to a maximum of about 180° in FIG. 112 , then the tension sealing force of positioning and stabilizing structure 3300 may be about 40% of the tension sealing force in FIG. 108 . In another embodiment of the present invention, the upper rear strap portion, when the rigid deezer arm 3302 extends to a bifurcation 3324 and is divided into upper and lower arms extending slightly into rear strap portions 3317a and 3317b. It is possible to maintain the angle θ at a predetermined value at the initial point of the bifurcation of the 3317a and the lower rear strap portion 3317b. This may allow the patient 1000 to split the rear strap portions 3317a, 3317b to adjust the headgear tension. In addition, the bifurcation 3324 is reinforced using, for example, external shim tape or plastic clips in the Y-shaped section where the side strap portions 3315, 3316 converge to the rear strap portions 3317a, 3317b. Such a plastic clip can provide a brand promotion opportunity by pad printing the brand and logo information on the top.

In one aspect of the present invention, positioning and stabilizing structure 3300 has two connection points with frame 3310 , two rigid-deezer arms 3302 and a single hollow strap 3301 have divided areas 3326 . One problem with this type of patient interface 3000 is that the segmented region 3326 may swing up and down as the back strap portions 3317a, 3317b are pulled further. For the above problem, the divided region 3326 in contact with the patient's occipital region is further pulled in the (top to bottom) direction and distributed. Therefore, the vertical fluctuation problem is alleviated. The positioning and stabilizing structure 3300 may include at least one strap 3301 (see, eg, FIG. 166) and at least one rigid element or rigid arm 3302 (see, eg, FIG. 19). can The strap may be made of an elastic material and may have elastic properties. That is, the strap 3301 may be elastically stretched by, for example, a stretching force, and return or contract to its original length when the stretching force is released. Strap 3301 may be made of or include any elastic material, such as elastane, TPE, silicone, or the like. The strap material may represent other materials and any combination of these materials. Strap 3301 may be a single-layer or multi-layer strap. The side of strap 3301, particularly the side that contacts the patient in use, may be woven, knitted, braided, molded, extruded, or otherwise formed. This may be accomplished by a strap 3301 further comprising or made of a layer of material exhibiting respective properties. Strap 3301 may be made of or include a textile material, such as a woven material. The material may, on the one hand, include artificial or natural fibers that provide the desired desired surface properties, such as tactile properties. On the other hand, the strap material may comprise an elastomeric material that provides the desired elastic properties.

65-145, strap 3301 is shown as one individual strap attached directly to seal forming structure 3100 or through frame 3310, strap 3301 may include a plurality of individual straps or , can be understood to be interconnected. However, adjustment may be provided by varying the position at which the strap is secured to a patient interface or other rigid element, such as a connector. Additionally or alternatively, adjustment may include adding a mechanism such as sliding over a ladder lock clip of a rear or side strap (eg, as shown in FIGS. 75 , 76 and 166 ) or positioning and stabilizing with strap 3301 . This may be accomplished by adjusting each stretch length of the structure 3300 .

6.3.6.12 Rigidizer Arm (3302)

19 and 166 , this embodiment of the present invention may include stiffening headgear to retain the patient's interface 3000 on the patient 1000 . As shown in the exemplary figure above, the positioning and stabilizing structure 3300 may include at least one rigid-dissipating arm 3302 . In an embodiment of the present invention, the seal forming structure 3100 of the patient interface 3000 is held in its intended position under the nose of the patient 1000 by the support of the rigidizer arm 3302 . The positioning and stabilizing structure 3300 may position the patient interface so as not to contact the patient 1000 except for the seal forming structure 3100 .

In certain prior art embodiments, measurement of a support as a patient interface that at least partially rests against the patient's upper lip so that the face of the patient's upper lip holds the patient interface in a desired position as described in US Pat. No. 7,900,635. can be designed to provide However, in this embodiment, as shown in FIGS. 18 and 19 , it is preferred that the patient's interface 3000 does not rest on the upper lip of the patient 1000 . In particular, FIG. 19 shows that the posterior wall 3220 of the plenum chamber 3200 is separated from the septum and/or upper lip of the patient 1000 by a gap or gap S. This shape has the advantage of preventing irritation or injury to the patient 1000 in the septum and/or upper lip due to contact and friction with the rear wall 3220 of the plenum chamber 3200 when worn for a long time. Avoiding pressure concentrated on specific areas of the septum and/or upper lip can prevent skin damage and inflammation formation.

19 and 166, the separation of the patient's septum and/or upper lip from the posterior wall 3220 of the plenum chamber 3200 is accomplished by a rigid dissipator arm 3302, in a particular embodiment configuration. . As shown in FIG. 19 , the rigid dissipator arm 3302 and positioning and stabilizing structure 3300 may be supported over the cheek of patient 1000 , approximately over the nasolabial fold (see FIG. 2C ).

The rigidity arm 3302 of the positioning and stabilizing structure 3300 may be formed into a predetermined curve by a curved profile 3323 that approximates the curve of the patient's corresponding cheek region up to the patient's cheekbones. Rigidizer arm 3302 may extend over a substantial portion of the cheek area from the point of connection with frame 3310 to the distal free end 3302.1 of rigiddiser arm 3302 . There is about 120 mm between the point of connection with the frame 3310 to the distal free end 3302.1 of the rigidizer arm 3301 . Rigidizer arm 3302 may extend away from the patient's face, eg, approximately at right angles, and substantially parallel to the nasal wing. That is, the inner surface of the main section 3333 of the rigidizer arm 3302, particularly the curved profile 3323, contacts and extends over a substantial portion of the patient's cheek region. The contact positions and locks the patient interface 3000 on the patient's face in a semi-fixed position. The contact minimizes vertical movement of the rigidizer arm 3302 relative to the patient's face. It is also intended that a minimal area of the curved profile 3323 adjacent the sharp bend 3307 remains in contact with the patient's cheekbones or cheeks. When the patient 1000 is lying on one side of his or her face against the bed pillow, the force applied against the flexible joint 3305 or part of the rigidity arm 3302 and/or extension 3350 of the bed pillow is applied. The force is prevented or minimized from being transmitted to the other rigid arm, because the sharp bend 3307 and the extension of the rigid arm 3302 absorb most of the force before it affects the patient's airway and seal.

That is, the lateral forces acting on the positioning and stabilizing structure 3300 are at least partially released, which means that the area of the curved profile 3323 is in contact with the patient's cheeks and is caused by the extension 3350 or flexible joint 3305 . This is because some of the force is absorbed.

Rigidizer arm 3302 may also provide supported release of patient interface 3000 such that patient interface 3000 does not cause unintentional contact of patient interface 3000 against the septum and/or upper lip. Tension of the positioning and stabilizing structure 3300 that holds the patient interface 3000 in position allows it to be positioned in the intended location under the patient's nose. Further, the rigid dissipator arm 3302 may be sized such that the rear wall 3220 is spaced from the patient's septum and/or upper lip by a gap S. Also, the tension of the positioning and stabilizing structure 3300 is transmitted primarily to the patient's cheeks through the width and width of the rigidizer arm 3302 and not inwardly towards the face of the patient 1000 relative to the nose.

This exemplary arrangement is desirable because it uses the tissue of the cheeks, a relatively large area of the face, to distribute the retention force, and allows the patient to more schist without using the patient's nose and/or upper lip, which may be more sensitive due to the nature of the cartilage. can feel the

This exemplary arrangement also does not allow the retention of the patient 1000 to be raised to a level that causes discomfort to the patient, while forming a seal with an amount of force sufficient to form a seal against the patient's airway under the patient's nose. structure 3100 is maintained.

It may be desirable to avoid contact between the rigidizer arm 3302 and the plenum chamber 3200 . Accordingly, the plenum chamber 3200 can be made wide enough to avoid contact with the rigid dissipator arm 3302 .

6.3.6.13 Elongation of the Headgear Strap on the Rigidizer Arm

In the embodiment shown in FIG. 166, the two rigid deezer arms 3302 are inserted into the left and right side strap portions 3315 and 3316 of the strap 3301 of the positioning and stabilizing structure 3300, and the rigid deezer arms 3302 By enclosing this strap 3301, it is secured, while at the same time the sleeve-shaped configuration of the strap 3301 allows at least a portion of the strap to stretch or move relative to the rigidity. The rigid dispenser arm 3302 is included in the strap 3301 and is not shown in the figure.

As described above, attaching the strap 3301 to the rigid deesser arm 3302 may affect the size of the head in which the positioning and stabilizing structure 3300 is accommodated. That is, by providing a longer strap 3301 along the rigid deesser arm 3302, the overall stretchable length of the positioning and stabilizing structure 3300 so that a larger head can be accommodated without the need to increase the stretchability of the strap. can increase In addition, the strap 3301 may be changed along the length of the rigid deezer arm 3302 to which it is connected. This allows for a larger range of head sizes.

Accordingly, the rigidity arm 3302 can move generally without restriction along the length of the sleeve attached to the sleeve 3301 and proximate one of its ends.

6.3.6.14 Segmented rear strap with positioning and stabilizing structure

In one aspect, the structure and positioning and stabilization structure 3300 of the strap 3301 is preferred. In particular, as shown in FIG. 166 , providing two elastic straps or strap portions 3317a, 3317b at the back allows the head to be accommodated, unfold and position them appropriately so that the tension vector can be adjusted. The provision of two rear strap portions 3317a, 3317b may provide better support and stability as well as increased flexibility to avoid particularly sensitive areas of the occipital region.

The two smaller straps or strap portions 3317a, 3317b in the occipital region may be of equal length, either through the elasticity of the material or through reducing the overall length in the arms of the positioning and stabilizing structure, thereby increasing the tightness equally. cannot be adjusted except for For example, a slide mechanism (not shown) may be provided to allow the straps to overlap to different extents, thus changing the overall length of the positioning and stabilizing structure 3300 .

As noted above, two or more joints may provide for forming the positioning and stabilizing structure 3300 with three, four or more separate straps rather than the strap 3301 being a continuous piece. This may complicate assembly, but may simplify the manufacturing process. The joint may be disposed at a bifurcation or Y-junction between the side strap portions 3315, 3316 and the two rear strap portions 3317a, 3317b or at the rear center. The joint may be bared, welded, glued, or overmolded and may incorporate a high friction material to reduce head movement.

In one embodiment of the present invention, one or more threads of strap 3301 may be comprised of an adhesive or adhesive. After the strap 3301 is made of the thread, heat is applied to the strap 3301 so that the adhesive or adhesive thread melts to reinforce the strap 3301 in the area adjacent to or adjacent to the adhesive or adhesive thread.

A high friction material may be added to the inner surfaces of the rear and side strap portions 3315, 3316, 3317a, 3317b to reduce strap slippage. For the arm or side strap portions 3315, 3316, this helps the positioning and stabilizing structure 3300 to rest on the cheek and back strap portion 3317, and the positioning and stabilizing structure 3300 transverses the occipital region. Prevents from getting messy. The material may be printed, cast or molded onto a printing surface or may be incorporated into a joint, bar or welding process as described above.

The segmented region 3326 of the patient's occipital region may include two, three or more straps 3317a, 3317b for stability. A positioning and stabilizing structure 3300 similar to that described above may be used with a face (one or more seals for the nose and mouth) or a nasal mask.

The maximum distance allowed between the rear strap portions 3317a, 3317b may be limited or restrained to prevent the rear strap portions 3317a, 3317b from being split more than a predetermined distance or completely separated. A connecting strap across the segmented area 3326 or netting across the segmented area 3326 may connect the rear strap portions 3317a, 3317b which limit the ability to segment apart more than a predetermined distance.

6.3.6.15 Connection between Mask Frame and Rigidizer Arm

In accordance with an embodiment of the invention described in greater detail with reference to FIGS. 35-64 , the patient interface 1000 may include a mask frame 3310 and a rigid-dissipator arm 3302 . As will become clear from the following description,

Rigidizer arm 3302 provides effective sealing of seal forming structure 3100 against the patient's airway while strap 3301 of positioning and stabilizing structure 3300 is oriented away from the patient's eyes and field of view. It may serve to direct the vector of tension generated by the strap or strap 3301 of the positioning and stabilizing structure 3300 in the direction it is intended to ensure.

Therefore, it should be understood that it must be connected to the rigid deesser arm 3302 and the mask frame 3310 to facilitate the effective direction of the sealing force. Rigidizer arm 3302 may preferably be flexed relative to mask frame 3310 to accommodate various shapes and sizes of the patient's face and head. In order to improve patient comfort, the direction and degree of curvature between the rigidizer arm 3302 and the mask frame 3310 can be specifically controlled. A flexible joint 3305 may do this or a rigidizer arm 3302 may be connected directly to the mask frame 3310 .

6.3.6.15.1 Flexible joint connecting Rigidizer arm and mask frame

35-38 , a patient interface 3000 is provided that generally includes a mask frame 3310 , a rigidizer arm 3302 , and a flexible joint 3305 . Retention structure 3242 may be removably and detachably attached to mask frame 3310 . The retaining structure 3242 may fix the sealing structure 3100 to the mask frame 3310 . Rigidizer arm 3302 may be made of a thermosetting resin or a thermoplastic resin. For example, Hytrel™ manufactured by DuPont is a thermoplastic polyester elastomer that exhibits excellent creep resistance and can be used as a material for the rigid deger arm 3302 . Rigidizer arm 3302 may be part of a positioning and stabilizing structure 3300 that positions mask frame 3310 in a patient's face position for delivery of respiratory therapy. In one embodiment, the positioning and stabilizing structure 3300 has two rigid distal arms 3302 at its distal end. Each rigidizer arm 3302 may be permanently connected to both sides of the mask frame 3310 .

The elastic fabric strap 3301 is adapted to form a positioning and stabilizing structure 3300, for example, as disclosed in US Provisional Application No. 61/676,456, filed July 27, 2012, which is incorporated herein by reference in its entirety. It can be slid over each ridgedezer arm 3302 . An elastic textile strap 3301 may extend around the head of the patient 1000 and may be bifurcated to provide self-adjustment. Rigidizer arm 3302 may include a projecting end 3306 that retains a pocket end of elastic fabric strap 3301 . In one embodiment, the rigidity arm 3302 is inserted into the hollow elastic fabric strap 3301 through a button hole adjacent the pocket end. When the elastic fabric strap 3301 is stretched as the patient interface 3000 is worn, the stretch of the elastic fabric strap 3301 and the direction of the headgear tension vector are guided by the shape and profile of the rigid arm 3302 . The protruding end 3306 is an anchor secured to the base of the rigidizer arm 3302 adjacent the mask frame 3310 and provides a starting point for stretching of the elastic fabric strap 3301 . The protruding end 3306 is detached from the mask frame 3310 and the rigid deezer arm 3302 to facilitate cleaning of the elastic woven strap 3301, an elastic woven strap 3301 is connected from the rigid dezer arm 3302. and to be released.

Rigidizer arm 3302 forms a face frame by preventing elastic fabric strap 3301 from being spaced from the eye and patient interface 3000 being perceived as unobtrusive. Rigidizer arm 3302 may generally be a flat arm of any thickness. The thickness of the rigid arm 3302 can vary along its length, and can be about 1 mm at the distal end 3302.1, when the distal portion of the rigid arm 3302 is adjacent the flexible joint 3305 and the point of connection. The thickness gradually increases to 1.5 mm along the curved profile 3323 until .

Because the distal free end 3302.1 has less material for the other regions of the rigid distal arm 3302, first at or adjacent to the distal free end 3302.1 before the other regions of the rigid distal arm 3302 begin to flex. There is a tendency for bending of the rigid deesser arm 3302 to occur. The sequence of flexion is to improve comfort as the distal free end 3302.1 is close to the patient's ears, cheekbones and temples, which may be particularly sensitive areas of the face and where conformability and less resistance to bending and deformation are required.

A sharp bend 3307 may be provided at the distal end of the rigidizer arm 3302 proximate the point of connection with the flexible joint 3305 . The sharp bend 3307 may be at an angle of approximately 90 degrees or less. The sharp bend 3307 may provide increased rigidity to secure the rigidity arm 3302 in position relative to the mask frame 3310 . The sharp bend 3307 may prevent or minimize elongation in the longitudinal direction. Also, the sharp bend 3307 can accommodate compression of the rigid deesser arm 3302 . When a force is applied to the side of the rigidizer arm 3302 in the coronal plane, most of the bending may occur adjacent or adjacent to the sharp bend 3307 .

A 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 elasticity. For example, DYNAFLEX™ TPE compound or Medalist® MD-115 can be used. The mask frame 3310 may be made of a polypropylene (PP) material. PP is a thermoplastic polymer with good fatigue resistance. An advantage of the flexible joint 3305 is that it allows the rigidizer arm 3302 and the mask frame 3310 to be permanently connected to each other. Hytrel® and PP cannot be bonded to each other by forming integral covalent or hydrogen bonds. Integral bonding includes chemical bonding that does not use an added adhesive material. In one embodiment, the rigid distal arm 3302 is provided with a protrusion 3309 extending outwardly from the distal portion of the rigid distal arm 3302 . Referring to FIG. 38 , the inner side 3318 of the protrusion 3309 is the surface of the ridgedezer arm 3302 from which the protrusion 3309 extends. The outer exposed side 3319 of the protrusion 3309 is opposite the inner side 3318 (see FIG. 38 ). The protrusion 3309 may have a void 3320 in a central region of the protrusion 3309 . The void 3320 may extend substantially vertically through the projection 3309 from the top side 3321 to the bottom side 3322 of the projection 3309, and may be surrounded around its perimeter by the projection 3309. there is. The outer side 3319 may be a planar surface that extends substantially beyond the protrusion 3309 . When viewed from above, the protrusion 3309 may have a generally T-shaped cross-section with the void 3320 visible in the central region. The protrusion 3309 may optionally or additionally serve to retain the elastic fabric strap at the protruding end 3306 .

Another advantage of the flexible joint 3305 is that it is relatively more flexible than the rigidizer arm 3302 . The flexibility may be provided by the combination of TPE materials and structural features of the flexible joint 3305 . Structurally, the flexible joint 3305 may have a predetermined thickness that can be flexed to a predetermined degree and, again, the amount of curvature of the flexible joint 3305 may be selected to contribute to the degree of bending. The flexible joint 3305 may be bent in a radial direction along a longitudinal axis with respect to the mask frame 3310 , but may be prevented from being bent in other directions. This flexibility may provide the patient interface 3000 with self-adjustment capabilities, and may compensate for deviations in facial contour, nose drop, or sleeping position. The flexion can accommodate the body range of most patients. Greater flexibility may require this position compared to the flexibility within the rigidizer arm 3302 itself. Since the bending is limited in a certain direction, the stability of the mask frame 3310 can be improved, and when the elastic fabric of the positioning and stabilizing structure 3300 requires adjustment, the position of the mask frame 3310 is substantially It can be held against the nose and mouth.

The flexible joint may be over-molded to the mask frame 3310 . PP and TPE may be integrally bonded to each other. That is, a fusion bond or a chemical bond (molecular adhesion) is possible between the flexible joint 3305 and the mask frame 3310 . This may form a permanent connection between the flexible joint 3305 and the mask frame 3310 . The flexible joint 3305 may be over-molded to the protrusion 3309 of the rigidizer arm 3302 . TPE and Hytrel® cannot be integrally bonded to each other. However, during overmolding in accordance with embodiments of the present invention, the TPE material for the flexible joint 3305 flows into and around the void 3320 of the projection 3309 . TPE material surrounds the front and rear sides and upper and lower sides 3321 , 3322 of the protrusion 3309 . Consequently, a mechanical interlock may thus be provided to form a permanent connection between the flexible joint 3305 and the rigidizer arm 3302 .

The outer side 3319 of the protrusion 3309 may be flush with the outer surface of the flexible joint 3305 . This is visually aesthetically pleasing.

42-46 , in another embodiment, there may be an extension 3350 at the distal end of the rigid distal arm 3302 . The extension 3350 may protrude from the outer surface of the rigidizer arm 3302 through the stem 3361 . The extension 3350 may be L-shaped when viewed from above. The extension 3350 may have a sharp bend 3307 of about 90 degrees that separates the first section 3363 from the second section 3364 of the extension 3350 . The first section 3363 may be oriented in a plane parallel to the outer surface of the rigidizer arm 3302 at its distal end. The end 3363A of the first section 3363 may have a curved edge. The second section 3364 may have a smaller height and thickness than the first section 3363 . The upper and lower edges of the second section 3364 may be set as the upper and lower edges of the first section 3363 . Rigidizer arm 3302 may include a protruding end 3306 that retains pocket end 3311 of elastic textile strap 3301 . The stem 3361 may optionally or additionally serve to retain the elastic textile strap 3301 to the protruding end 3306 .

The second section 3364 may have a first protrusion 3365 and a second protrusion 3366 . The protrusions 3365 and 3366 may extend laterally from the rigid dissipator arm 3302. A first slot 3367 is adjacent to the first protrusion 3365, and the second slot 3368 is It may be adjacent to the second protrusion 3366 . Slots 3367 and 3368 may each provide a void through the thickness of second section 3364 and may have approximately the same height as protrusions 3365 and 3366 .

A flexible joint 3305 made of TPE can be over-molded to the second section 3364 of the extension 3350 of the rigidizer arm 3302 . During overmolding, TPE material may flow through slots 3367 , 3368 and surround protrusions 3365 , 3366 . A majority of the second section 3364 may be surrounded by the TPE material of the flexible joint 3305 . This may provide a mechanical interlock so that the flexible joint 3305 can be permanently connected to the rigidizer arm 3302 .

Because the second section 3,364 can have a smaller height and thickness than the first section 3363 , the TPE material overmolded into the second section 3364 does not protrude excessively beyond the first section 3363 . The flexible joint 3305 may be overmolded to the mask frame 3310 connecting the rigid joint 3302 and the flexible joint 3305 to each other. Similar to the embodiments described above, a relatively greater degree of flexibility may be provided by a flexible joint 3305 relative to the rigidizer arm 3302 . The bending of the position and control of the bending direction can accommodate most of the patient's anatomical measurement range and maintain the stability of the patient interface 3000 during use.

6.3.6.15.2 Direct connection between Rigidizer arm and mask frame

39-41, in another embodiment, a flexible joint 3305 made of TPE may not be required. An extension 3350 may be used. Rigidizer arm 3302 can have a body or main section 3333 that includes a curved profile 3323 and a sharp bend 3307 . Rigidizer arm 3302 may include a projecting end 3306 that retains a pocket end of an elastic fabric strap. The curved profile 3323 along most of the longitudinal axis may be formed to correspond to an obtuse angle to closely follow the contour of the patient's face. At the distal end of the rigid distal arm 3302 , an extension 3350 may be provided behind the sharp bend 3307 . Extension 3350 may protrude outwardly from ridgedezer arm 3302 in a tubular surface. A recess 3329 (see FIGS. 40 , 50 , 57 , 58 ) may be formed in the surface of the rigid arm 3302 at the point where the extension 3350 protrudes from the rigid arm 3302 . The height of the extension 3350 may be smaller than the height of the main section 3333 of the rigid deesser arm 3302 . This allows for greater flexibility for the extension 3350 compared to the main section 3333 of the rigidizer arm 3302, due to the relative reduction in material for the extension 3350 with respect to the rigidity arm 3302. can do. The Rigidizer arm 3302 including the extension 3350 may be made of Hytrel®. Hytrel® has a Rigidizer having a flexural modulus of 180 MPa at 23°C and a tensile modulus 26 of 180 MPa at 23°C. Provide arm 3302. Encapsulable section 3354 of extension 3350 may be overmolded from the PP material of mask frame 3310 at the edge of mask frame 3310.

This is done in the mold and during overmolding, the PP material of the mask frame 3310 is applied to the inside, outside, and top of the encapsulable section 3354 to permanently connect the mask frame 3310 and the rigidizer arm 3302 via a mechanical interlock. and surrounding the lower surface. The encapsulation of the encapsulable section 3354 of the extension 3350 by the PP material of the mask frame 3310 provides mechanical retention without 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 to or near the bend 3352 . That is, the rigid disserter arm 3302 may pivot with respect to the mask frame 3310 . Position the pivot point as an anterior line as possible with the patient's 1000 nose pillow and nostrils to accommodate for changes in nasal droop and minimize induced moment arm and tube drag in the air circuit 4170. put

The bending and rotational moments of the rigidiser arm 3302 relative to the mask frame 3310 in a coronal plane are desirable without excessive required to eliminate or minimize pinching of the patient's cheek between the two rigiddiser arms 3302. It is intended to accommodate various head widths with a force of less than 1 or 2 newtons. The distance between the two bends 3352 is about 62 mm. This spacing between the two bends 3352 avoids the protruding end 306 and extension 3350 or flexible joint 3305 of the rigidizer arm 3302 touching the patient's nose adjacent to the side of the patient's nose and the tip of the nose. can This area of the patient's face may be particularly sensitive so avoiding contact with this area may improve comfort.

When the patient interface 3000 is worn, the rigidizer arm 3302 can unfold outward to accommodate various head widths. Pivot of the rigid arm 3302 relative to the mask frame 3310 may occur to flex the rigid arm 3302 along a longitudinal axis.

6.3.6.15.3 Additional Features and Embodiments of the Invention

In another embodiment, the rigid dissipator arm 3302 may be relatively elastically flexible than the mask frame 3310 . That is, the rigid deezer arm 3302 may be formed in a plane parallel to the Frankfort horizontal and transverse planes so as to be bent only in the horizontal direction. Also, the rigid disser arm 3302 may not be bent in the vertical direction, that is, in a plane perpendicular to the Frankfurt horizontal plane. That is, the Rigidizer arm 3302 may be more flexible in a plane parallel to the Frankfort vertical and transverse planes, and less flexible (preferably inflexible) than other planes. Also, the material of the rigidizer arm 3302 may not be stretchable or extensible. When the rigid arm 3302 is extended at its end, the curved profile of the rigid arm 3302 is flattened. The above features, alone or in combination with shape and size, may allow the rigidizer arm 3302 to flex and/or frame the patient's face without flexing or wobbling up or down relative to the patient's ear. In turn, this allows the elastic fabric strap 3001 to proceed over the patient's ear adjacent to the upper aspiration (obasion superior).

35-38, an indicia, such as a company logo, may be provided on the outer surface 3319 of the protrusion 3309 to conceal the mechanical interlock location. 39-41 , the indicia may be provided on the outer surface 3355 of the extension 3350 . The indicia may provide a visual aid to the patient in determining the correct orientation of the patient interface 3000 to prevent flipping when wearing the patient interface 3000 . If the indicia is a raised/embossed surface this may provide tactile feedback to the patient when wearing the patient interface 3000 in a dark environment.

In another embodiment, an adhesion promoter may be used after surface treatment to permanently connect the rigidizer arm 3302 to the mask frame 3310 or permanently connect the rigidizer arm to the flexible joint 3305, the embodiment There is no need for mechanical interlocks.

In another embodiment, the rigidizer arm 3302 is made of a material that can be integrally coupled with the mask frame 3310 made of PP material. Rigidizer arm 3302 may be made of, for example, a fiber reinforced PP composite material such as Curv® manufactured by Propex. Curv® has the same level of resilient flexibility as Hytrel. The Curv® is provided in sheet form and needs to be laser cut with the rigidizer arm 3302 to the desired shape. To achieve a desired thickness for the rigid arm 3302, compression or layering of the sheet may be performed to adjust the thickness of the rigid arm 3302 in a specific area. Since Curv® is made of the same material as the mask frame 3310, when the rigidizer arm 3302 is over-molded to the mask 3310 frame, integral coupling is possible.

Patient interface 3000 may include a nasal pillow or nose cradle as disclosed in US Provisional Application No. 61/823,192, filed May 14, 2013, the disclosure of which is incorporated herein by reference in its entirety. The nasal pillow may be releasably connected to the mask frame 3310 . After the rigidity arm 3302 is permanently connected to the mask frame 3310, the elastic fabric strap of the positioning and stabilizing structure 3300 can be slid over the rigidizer arm 3302 and secured to the rigiddisser arm 3302. can

While a T-shaped protrusion 3309 has been described, it is of another shape including a mushroom-shaped protrusion that permanently connects the rigidizer arm 3302 mechanically (through a flexible joint in one embodiment) to the permanent mask frame 3310 . and form is expected to be possible. Although a void 3320 is described, the protrusion 3309 may be void-free and may rather have a recess or slot to retain the flexible joint 3305 or mask frame 3310 to the rigidizer arm 3302 .

It is contemplated that an arrangement opposite to the above-described connection arrangement is possible and may provide a protrusion extending from the mask frame 3310 or flexible joint 3305 rather than the rigidizer arm 3302 . Rigidizer arm 3302 in this example is overmolded to flexible joint 3305 or mask frame 3310 .

It is expected that the flexible joint 3305 can be permanently connected to the mask frame 3310 without any coupling. For example, a mechanical interlock may be provided to permanently connect the flexible joint 3305 to the mask frame 3310 .

Although the rigidizer arm 3302, the flexible joint 3305, and the mask frame 3310 are described as being permanently connected to each other, some or all of them are releasable from each other, for example, using a mechanical clip (snap fit) assembly. It is expected that it can be detached.

6.3.6.16 Rigidizer arm shape

Figures 61-64 show a rigid deesser arm 3302 in accordance with an embodiment of the present invention configured in two and three dimensions.

Figures 61-63 are three two-dimensional views of a rigid de-esser arm 3302 in accordance with an embodiment of the present invention configured in a grid.

Fig. 61 shows the X-Y plane, Fig. 62 shows the X-Z plane, and Fig. 63 shows the Y-Z plane. Sources are indicated in the drawings for directions. Numbered coordinates are marked on each of these and the coordinates may define the curve of the ridgedizer arm 3302 in the plane. The following table lists the coordinates of the profile of the Rigidizer arm 3302 shown in the figure. It should be understood that each coordinate is numbered consistently through each of the four figures.

Figures 61-64 are shown, as well as the source, to assist in orientation of the rigid deesser arm 3302 in accordance with an embodiment of the present invention, configured in two and three dimensions, in the X, Y and Z axes.

The curved shape of the Rigidizer arm 3302 is intended to conform closely to the patient's cheek. The Rigidizer arm 3302 contacts the patient's cheek in use, with an elastic fabric strap 1200 covering the Rigidizer arm 3302. ) to avoid sliding on the patient's face.

For example, the rigid arm 3302 may be slightly below the patient's cheekbones to prevent the rigid arm 3302 from sliding upwards. It can also increase friction to prevent slipping between most or all of the inner surface of the rigidizer arm 3302 and the patient's face and ultimately minimize interference with the sealing force. The shape of the curved profile 3323 of the Rigidizer arm 3302 conforms to the positioning and stable structure 3300 between the eye and the ear over most of the body range. This orientation is desirable because it is aesthetically pleasing and unobtrusive from the perspective of the patient 1000 and the patient's bed partner 1100 . Viewed from above, the curved profile 3323 of the rigid arm 3302 has a greater radius than the rigid arm 3302 when viewed from the side.

6.3.6.17 Rigidizer arm flexibility

As described above and with reference to FIGS. 52 and 55 , the rigid dissipator arm 3302 is more flexible in a specific direction at a specific position along the rigid dissipator arm 3302 . The flexural stiffness of the rigid deesser arm 3302 is compared. For comparative purposes, the flexibility of the ridgedezer arm 3302 is measured for the reinforced headgear of some conventional masks by RESMED Limited in the lateral lateral direction in the coronal plane and in the lower vertical direction in the sagittal plane.

The comparison shows the difference in force (in Newtons) required to displace the upper distal end tip of the reinforced headgear element when connected to the mask frame at a distance of 5 mm. The choice of the upper distal tip of the reinforced headgear element in a measured position is because the particular type of flexibility provides a fit without compromising seal stability because the position contacts sensitive facial regions. The measurement of flexibility in the external lateral direction (outer lateral) of the coronal plane is to measure the ability of the rigidiser arm 3302 to receive a patient with a large face width as shown in FIG. 52 with a broken line. The resilient flexibility of the Rigidizer arm 3302 allows the interface 3000 to more accurately fit a wider range of face shapes. For example, the same patient interface 3000 may be used for a patient with a narrower angled face (a so-called crocodile shape), such as one with a wider flat face (a so-called panda shape).

Measuring the direction of flexibility from the sagittal surface to the inferior vertical (vertical inferior) is the rigid deesser arm 3302 that handles the tube torque exerted by the air circuit 4170 during treatment as shown in FIG. 55 with a broken line. ) to measure the ability of Both measurements are performed using an Instron machine with a 50N load cell.

To measure the vertical downward direction, each mask has headgear elements secured to a plate and seated horizontally therewith and reinforced at an angle perpendicular to the patient's face. The plate is fixed to the large round base plate used in Instron machines. A rigidised headgear element is secured to a jig to prevent twisting and slipping, the jig being manually lowered into contact with the upper distal tip of the reinforced headgear element. The Instron machine is zeroed in the height position. Next, a compression extension of 5 mm is applied at a rate of 50 mm/min, and the measurement is recorded.

To measure the lateral outward direction, spacers and 90 elbows are secured to the first plate. Each mask is secured to a second plate and rests horizontally therewith, and has a headgear element reinforced at an angle perpendicular to the patient's face. A spring clamp is used to secure the 90° elbow and the second plate to the first plate such that the first plate is held perpendicular to the second plate. A large prong is used to position the upper distal tip of the reinforced headgear element. The Instron machine is zeroed in this height position. Next, a compressive expansion of 5 mm is applied at a rate of 50 mm/min, and the measurement is recorded.

The above measurements show that the rigidity arm 3302 connected to the frame 3310 is more flexible in both directions by a significant factor. In order to accommodate a large face width, the Rigidizer arm 3302 is 1.8 times more flexible than the second maximum flexible mask in the above direction (RESMED Mirage swift LT). In order to accommodate the tube torque, the rigid arm 3302 is connected to the frame 3310, and the rigid arm 3302 is 8.39 times more flexible than the second maximum flexible mask in the above direction (RESMED Pixi). Having the rigidiser arm 3302 that is more flexible when displaced in this direction provides the patient with less sealing obstruction induced by tube torque and more comfort, thus improving patient compliance during treatment depending on frequency of use and duration of treatment. is increased

The relative flexibility of the rigid dissipator arm 3302 in the other direction is also an important consideration. If the flexibility in the vertical downward direction (ie equal to the side out direction) is too high, there may be instability in the sealing work. In one embodiment, the rigid dissipator arm 3302 is more flexible in a laterally outward direction than in a vertical downward direction. Rigidizer arm 3302 is 9-10 times more flexible in a laterally outward direction than in a vertical downward direction. Preferably, the rigid dissipator arm 3302 is about 9.23 times more flexible in the laterally outward direction than in the vertical downward direction. Tube torque may be referred to with a shorter tube 4180 (eg, lighter weight, more cohesive, more flexible) or other mask elements having the use of swivel connectors, ball and socket joints, or gussets or corrugations. However, the various face widths are mainly addressed by the flexibility of the rigid arm 3302, so the rigid arm 3302 needs to have more flexibility in the laterally outward direction compared to the vertical downward direction.

Some reinforced headgear elements of conventional masks are more rigid than component frames. Typically, these strong headgears use threaded arms and bolts to manually adjust the headgear to fit the patient's head.

Although the flexible frame improves mask comfort, provides a good seal, minimizes unintentional leaks and minimizes headgear straps from being over-tightened even with low pressure for comfort, the flexible frame is sealable and releasable. Some difficulties may arise if necessary to make it removable. The seal forming structure is elastically flexible to form a seal against the patient's airway. If both the seal forming structure and the frame have similar flexibility (ie, very flexible or floppy), the patient 1000, particularly a patient with a handicap in a dark room, will have difficulty connecting the two parts together.

Some reinforced headgear components of conventional masks are removable from the frame. Generally, this is a snap fit or clip connection method between the rigid element arm and the frame, both rigid and rigid.

This type of hard-to-hard connection between the rigidiser arm and the mask frame causes discomfort to patients with larger face widths because a pinching force is felt when the rigiddiser arm is subjected to force to flex outward. It allows for less flexion at the point of connection where more force is required to flex at the point. Some of these elements of the rigid headgear have a hard clip at the distal end of the rigidizer arm for releasably connecting with the frame. The hard clip is permanently connected to the headgear strap where the tub or other laundry items can be damaged when the headgear is washed in the washing machine. Also, some components of the reinforced headgear tend to require a patient interface with a wider frame starting from the frame position at a longer length where the headgear straps are spaced apart from each other. The wider frame may integrally form the side arms that are considered part of the frame as they are made of the same material. A wider frame may be perceived as annoying and aesthetically undesirable to patient 1000 and its bed partner because it covers a larger mark on the face. In contrast, in one embodiment of the present invention, rigid deesser arm 3302 is made of a material that is more flexible than frame 3310 , but less flexible than strap 1200 . That is, strap 1200 is the most flexible component of positioning and stabilizing structure 3300 as it is made of elastic fabric. The most flexible element of the positioning and stabilizing structure 3300 is the rigid deger arm 3302 made of, for example, Hytrel®. The most rigid and strong element is the frame 3310 that is not easily bent, stretched or bent as a whole because it is the seal forming structure 3100 that forms a seal with the airway of the patient by elastic deformation. The difference in flexibility of the individual components can control the amount of flex at a particular location, and can also determine the order in which certain components begin to flex when a specific force is applied, i.e. tube torque, or to accommodate a larger face width. there is.

Differences in the flexibility of the individual components may release forces before they begin to interfere with the sealing of the seal forming structure 3100 in a particular method or sequence. This factor is to demand comfort, stability and good sealing for the patient interface 3000 at the same time. Another advantage of the rigid arm 3302 is that the same sized rigid arm 3302 can be used with a different sized seal forming structure 3100 or a different sized headgear strap 3301 and patient interface 3000 . . When the Rigidizer arm 3302 is curved inward, it is likely to first contact the side of the patient's nose before making contact with the nasal pillow 3130 and releasing the seal. Thereafter, the internal range of movement of the rigidizer arm 3302 is limited by the patient's nose, and thus, movement in this direction thus minimizes or eliminates disruption of the sealing force.

6.3.7 Vent (3400)

In one form, interface 3000 includes a vent 3400 constructed and arranged to clean exhaled air (including exhaled carbon dioxide). One form of the vent 3400 according to the present invention includes a plurality of very small holes, that is, a multi-hole vent. Two or more multi-hole vents may be provided in the frame 3310 . These may be placed on either side of the connection port 3600 for the air circuit 4170 . The hole may be an intermediate space between the fibers of the textile material. Optionally, these holes may be micro-holes (1 micron or less) formed in a substrate of a semi-transmissive material using a laser drill operating in the ultraviolet spectral range. The laser drilled micro-holes may be straight-walled or tapered/trumpet shaped. Another way to create micro-holes is to use a chemical etchant after masking an area of the substrate. There may be about 20 - about 80 holes or about 32 - about 42 holes or about 36 - about 38 holes. In one embodiment, when the shape of the vent 3400 is insert-molded, the direction of the hole through the thickness of the vent 3400 may be deformed to be inclined rather than vertical.

This may prevent exhalation of breath (including exhaled carbon dioxide) directly into the face of bed partner 1100 when patient 1000 is facing bed partner 1100 . In one embodiment, the final number of holes may be determined by blanking the holes a few holes from the original larger number of holes. For example, you can block 2 holes from 40 holes so that the final number of holes is 38 holes. The ability to selectively block holes with respect to the amount and location of the holes being blocked provides increased control over the airflow rate and air diffusion pattern.

146-152 , the patient interface 3000 is a nasal pillow mask and preferably two vents 3400 are located in the plenum chamber 3200 of the mask frame 3310 or in particular a cushion of the mask frame 3310 . It is placed on a clip (ie pre-assembled with the cushion).

A connection port 3600 or short tube 4180 is located between the two vents 3400 . 153 and 154 , a method of manufacturing a patient interface 3000 for treatment of a respiratory disease is provided. A porous textile is received 51 for processing. The method includes cutting (57) the vent portions (72, 73) from the textile. The textile is formed by interlacing fibers to form an interlaced structure that defines a curved air passageway through which air passes. The textile has a certain amount of porosity. The vent portion is fixed (59) to the mold. The fixed vent is permanently connected 60 to the mask frame 3310 . Both the vent portion 3310 and the mask frame 3310 may be made of a plastic material. This forms a vent 3400 to clean the exhaled air (including exhaled carbon dioxide) by the patient interface 3000 .

Any type of cutting tool 67 can be, for example, a laser or mechanical cutter used to cut the bent portions 72 , 73 from textiles. More than one vent portion may be cut from the textile 65 at the same time, preferably both vent portions are cut to form two vents at the same time. When the two are cut from approximately the same area of the textile 65, the airflow rates and material properties of the two vent portions can sometimes be substantially similar. This helps to determine and place the mating material to be fed, reducing the amount of calibration for the equipment to adjust the airflow rate if necessary. In another embodiment, if heat staking is required by the staking punch 68, before heat staking, rather than cutting the bent portions 72 and 73, the vent portions 72 and 73 are made of the textile ( 65) can be cleaved. In this scenario, the first cut may be removed by the cutter 67 .

In one embodiment of the present invention, the interlaced fiber material is a thermosetting or thermoplastic resin which may include polyester, nylon, polyethylene and preferably polypropylene. In a particular embodiment, the textile 65 may be a SEFAR material Tetex Mono 05-1010-K 80 woven from a polypropylene material. Thermosetting resins may also be used. The textile is generally provided prior to the cutting process or in the form of a ribbon roll 65 . The textile 65 weave is preferably a satin weave. However, other weaves are expected to include plain weave, plain reverse dutch weave, and warp twill weave. Textile 65 may also be knitted (eg warp knit) instead of woven. The voids or holes formed in the knitting/weaving of the fibers through the textile 65 need not have a uniform size as there are slight differences between the positioning, spacing and compression of the fibers in the weave of the textile. The void preferably forms a tortuous airflow path between adjacent fibers through the thickness of the textile rather than a straight through hole. The tortuous air flow passages may have different pressure zones along the air passages (higher or lower). The serpentine airflow passageway greatly diffuses the airflow to reduce noise. If the voids are straight through-holes, the fibers of the textile 65 may be arranged in the form of a mesh grid or matrix. Preferably, the air flow exiting the vent 3400 is non-linear, avoiding lamina flow and creating a broad plume with turbulence.

Patient interface 3000 includes a nasal mask, face mask, or nasal pillow. The mask frame 3310 of the patient interface 3000 has at least one vent 3400 , preferably two vents 3400 . When there are two vents 3400 , the left vent is located on the right side of the front surface of the mask frame 3310 , and the right vent is located on the left side of the front surface of the mask frame 3310 . The left and right vents 3400 are separated by an aperture or connection port 3600 that receives a short tube operatively connected to the PAP device 4000 . Optionally, a single continuous vent 3400 located in the center of the mask frame is possible and a short tube 4180 is connected to the side of the mask frame 3310 . A single continuous vent 3400 may have a surface area surface area equal to the combined surface area surface area of the two vents 3400 .

In one embodiment, two or more vents 3400 are provided in the mask frame 3310 . The total or average airflow rate through all vents 3400 is used to obtain the desired airflow rate by selecting vent portions with different airflow rates. For example, a first vent portion with a low airflow rate may be used with a second vent portion with a high airflow rate. The two vent portions combined can then provide an average airflow rate with the desired airflow rate.

Vent portions are cut or removed from the fabric by laser cutting, ultrasonic cutting or mechanical cutting or thermal cutting (using a hot anvil). Laser, ultrasonic and thermal cutting are performed as they cut and melt the peripheral edge of the vent 3400 to remove the stray fibers having loose ends at the peripheral edge of the vent 3400 . The laser cutter 69 may be used for laser cutting. Laser, ultrasonic and thermal cutting also aid in subsequent overmolding as it flattens the perimeter edges of the vents and makes them easier to overmold compared to non-planar edges. Accordingly, the trapped air bubbles are avoided at the bonding position between the vent 3400 and the mask frame 3310 so that the integrated vent 3400 makes the mask frame 3310 visually and structurally very stable.

Permanent connection can be achieved by molecular bonding using overmolding, co-injection molding or two-shot (2K) injection molding. This creates an integral bond and is strengthened when the materials of the vent portion with the mask frame 3310 interact by forming covalent or hydrogen bonds. Some molds are reinserted to allow the previously molded part to form a new plastic layer around the first part. This is referred to as overmolding. The overmolding process involves the use of two materials to form one cohesive component. There are two types of overmolding: insert and "two-shot (2K)".

Two-shot or multi-shot molds are designed to be "over molded" within a single molding cycle and must be processed on special injection molding machines with two or more injection units. The above process is actually an injection molding process performed twice. A high level of molecular adhesion is obtained. The above-described method of manufacturing the patient interface 3000 may be performed by over-molding a vent portion of the textile on the mask frame 3310 . The vent portion is fixed to the mold 70 , and the molding machine 71 over-molds the vent portion on the mask frame 3310 . Because textile 65 and mask frame 3310 are preferably made of the same plastic material, overmolding performs a fusion of material between the vented portion of the textil and mask frame 3310 that is structurally strong and permanently bonded. . In the final assembled patient interface 3000, the vent 3400 and the mask frame 3310 are two separate parts that are substantially detectable by the human eye.

The vent 3400 has a maximum cross-sectional width of about 16 mm - about 21 mm, preferably 18.2 - 18.6 mm and a maximum cross-sectional height of about 19 mm - about 25 mm, preferably 21.6 mm - 22 mm, and about 0.36 mm - about 0.495 mm, Preferably it has a thickness of 0.40 - 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 is approximately 201.6mm ² - is between about 278.6mm ^2, preferably, it may be 240mm ^2. Thus, the surface area of the porous region for both vents 3400 is about 480 mm ² - 500 mm ² . The front side of the mask frame 3310 has a surface area ^{of about 1800 mm 2 .} The surface area of the vent 3400 includes at least 35% of the surface area of the front side of the mask frame 3310 . Preferably, the two vents 3400 cover 40% - 60% of the front side of the mask frame 3310 . Preferably, both vents 3400 cover 45% - 55% of the front side of the mask frame 3310 . Both vents 3400 preferably cover about 50% of the front side of the mask frame 3310 . The interlaced fibers of the vent 3400 provide a semi-rigid woven structure that forms a significant area of the front surface of the mask frame 3310 . The vent 3400 can support its own weight of gravity when there is a torque tube, and has sufficient rigidity not to come into contact with itself, and is not a floppy. Some conventional masks with vents made of loose fabric are unable to retain their shape, shape and profile during the patient's breathing cycle (inhalation and exhalation) and thus fold on themselves during treatment. When such a conventional vent folds on itself, the porous area of the vent decreases at a rate in a random manner because the fold over the section partially or completely obstructs the vent in that part. This results in insufficient cleaning of exhaled air (including exhaled carbon dioxide). In contrast, since the vent 3400 of the present invention does not abut itself, the porous region of the vent 3400 breathes in the patient 1000 so that exhaled air (including exhaled carbon dioxide) results in adequate cleaning during treatment. It can be ensured that a substantially constant rate of washing is maintained during the cycle.

In one embodiment, the airflow rate of the vent portion of the textile 65 is first measured 52 with a second airflow meter 66 . A decision 53 is made based on whether there is a difference between the measured airflow rate and the intended airflow rate. If the air flow rate through the vent portion exceeds 56 a predetermined range, the amount of porosity in the vent portion is optionally reduced 54 . The desired predetermined range is about 42-59 liters per minute at _{20 cm H 2} 0 pressure, preferably about 47-55 liters per minute at _{20 cm H 2 0 pressure.}

For example, the airflow rate through the SEFAR material Tetex Mono 05-1010-K 80 woven from polypro material is _{about 37 - 64 liters per minute at 20 cm H 2} 0 pressure, preferably about 37 - 64 liters per minute at _{20 cm H 2 0 pressure.} It is about 42 - 58 liters. Variation over the length of the textile can form a sine wave over the length of the textile ribbon. Different areas of the textile, when first received from the textile manufacturer, may exhibit different airflow rates due to the manufacturing process, but are not limited to calendering without heat and force distribution.

After the porosity of the vent portion has been reduced, it is again measured 55 to verify that the air flow rate is now within a predetermined range. The average diameter of the openings of the voids preferably provides a total opening area (porous area) of 0.1 mm or less, preferably about 1% - 10% of the surface area of the vent 3400 . For example, the total open area (porous area) with a surface area of 240 mm ² of the vent may be ^{22 mm 2 .}

If a desired airflow rate is present in the textile 65, optionally, the hole in the peripheral region of the desired vent portion is occluded 56A. The peripheral edge region of the bent portion is overmolded to the mask frame 3310 . Since the hole existing in the peripheral edge region is closed, the air flow rate of the vent portion does not differ significantly after overmolding.

In some embodiments, after the vent portion is cut from the textile, the airflow rate may be measured 58 , and the vent may also be measured 61 after overmolding to the mask frame. It can be determined and known that the airflow rate is within a desired predetermined range after a particular manufacturing step. This can prevent wastage by allowing some to be immediately discarded as soon as it is known that they are not within the intended predetermined range.

The porosity of the vent portion can be reduced in several ways, including:

Heat stacking, plastic deformation by compression, ultrasonic welding, application of sealants (eg hot melt adhesives), and application of thin films. Preferably, heat staking with a staking punch 68 is used to reduce porosity due to increased precision after heat staking, greater certainty of occlusion of holes in the textile, speed of manufacture, and good visual appeal and no additional material is required. don't Some material shrinkage occurs when a plastic material is heated, which is believed to be having excess material surrounding certain physical dimensions for the shape of the vent.

The porosity of the vent portion is reduced either partially by occlusion or by completely occluding the hole in the vent portion. The staking punch 68 may use several thermal welding heads of various sizes to perform thermal staking. The size of the thermal welding head is chosen according to the airflow rate of the vent, where the larger size is used when the airflow rate is very high.

The order of the cleavage and porosity reduction steps can be interchanged. That is, the porosity reduction may be performed first on the textile 65 , and then the vent portion is cut from the textile 65 . In this scenario, the cut may be removed by the cutter 67 .

Any area or area of the vent portion may be selected to reduce porosity. Preferably, the porosity of the substantially continuous peripheral edge of the vent portion is reduced. This provides visual appeal as the vent portion is adjacent to where it is overmolded into the mask frame. The visible difference between the peripheral edge region and the rest of the vent portion may not be noticeable to the human eye at this location since it appears as the defined edge of the mask frame 3310 for receiving the vent 3400 . Optionally, the area of reduced porosity may be in the form of a character/character or logo in the central area 79 of the vent 3400 to enhance the visual effect and increase awareness. Also, after a certain period of use, the patient 1000 may be used as a replacement indicator to replace the vent 3400 . After reducing the porosity of the area of the vent section, the air flow rate in the vent section is measured with an air flow rate meter to confirm that the air flow rate is within the intended predetermined range of about 47-53 liters per minute at 20 _{cm H 2 20 pressure.} (66) again.

If the airflow rate is not within the desired predetermined range, the vented portion may again undergo heat staking and the vented portion is discarded. This minimizes waste by avoiding discarding the mask frame with overmolded defective vents, only when the defective vent portion is discarded. In another embodiment for a nasal pillow, also avoid discarding the mask frame with the air supply tube being overmolded.

156 and 158 show cross-sections of textile 65 prior to heat staking. The loose ends of fibers 80 (warp) oriented vertically along the upper edge of textile 65 are visible. Openings in voids 83 are formed between vertically oriented fibers 80 and horizontally oriented fibers 82 (weft yarns). Some voids 83 are considered more porous than others because they have larger openings and thus allow greater airflow through them to increase exhaled air cleaning.

157 and 159 show a cross-section of the textile 65 after heat staking. Voids 83 that were previously present prior to heat staking are closed to shrink or prevent airflow. 157 is only a graphic depiction for explanation. However, the micrograph can easily show that the separated fibers of the textile after heat staking are visually undetectable due to the material deformation of the fibers by heat and the melting and compression of the heat staking process. The side cross-sectional view shown in FIG. 159 shows that the individual fibers of the textile 65 after heat staking are visually undetectable due to the material deformation of the fibers due to heat and compression of the melting and heat staking process. Thus, after heat staking, said region of the vented portion becomes substantially air impermeable to selectively adjust the overall airflow rate of the entire vented portion.

In FIG. 155 , a section of textile 65 has two bent portions 72 , 73 heat staked left and right bent. The nominal left vent portion 84 shows the outline of the vent portion prior to heat staking. The vent portions 72 and 73 are semicircular or D-shaped. Each vent portion 72 , 73 substantially conforms to the shape of the vent hole of the mask frame 3310 . Vent portions 72, 73 are initially made slightly smaller than the vent holes to support overmolding and also to account for expected plastic shrinkage due to heat from heat staking and subsequent steps of overmolding.

Preferably, the peripheral edge of each vent portion 72 , 73 is not straight and is a continuous curve or arcuate. The two acutely angled corners 74 , 75 are the distal ends of the longer side 76 of the bent portion. The long side 76 has a length in the range of about 19 mm to about 24 mm, preferably 21.6 mm to 22 mm. The third corner 77 of the obtuse bent portion is opposite the long side 76 . The substantially continuous peripheral edge region 78 of the vent portion is heat staked to reduce the porosity of the textile material 65 in that region. The width for the perimeter region 78 to be heat staked is selected based on the amount of porosity to be reduced to achieve the desired overall heat flow rate through the vent. The central region 79 located within the peripheral edge region 78 has no heat staking applied thereto and the porosity is maintained according to the original textile 65 .

The sound evoked by the exhaled air (including exhaled carbon dioxide) passing through the vent 3400 is produced when the patient 1000 breathes through the nose and the exhaled air (including the exhaled carbon dioxide) passes through the vent 3400, This is minimized as air is more diffused as it passes through the textile/interlace fibers, especially for nose pillows. Diffusion of exhaled air (including exhaled carbon dioxide) avoids direct or concentrated airflow to patient 1000 or bed partner 1100 depending on vent orientation and lifespan location. 167 and 175, in one embodiment of the present invention, the vent 3400 spreads much more than the multi-hole vent of the ^{SWIFT FX TM nose pillow mask from RESMED Limited.} 175 , at a distance close to the vent at about 100 mm, the velocity of exhaled air (including exhaled carbon dioxide) from the vent 3400 of the present invention is about 5 times less than that of the SWIFT FX™ nasal pillow mask, i.e., the patient 1000 and its bed partner 1100 feel less exhaled air (including exhaled carbon dioxide) from the vent 3400 compared to the multi-hole vent. This improves the comfort of the patient 1000 and its bed partner 1100 . The average air velocity has a non-linear curve and was measured using a directional hot wire anemometer in an enclosed space. Air velocity 3400 is an important factor in whether exhaled air (including exhaled carbon dioxide) passing through the vent can be felt by the user. Other factors affecting what a person feels, not measured in FIGS. 167-175 include ambient room temperature, human hair density, and human skin sensitivity. At greater distances from the vents, the velocity of exhaled air (including exhaled carbon dioxide) from both vents approaches zero and is distinct from ambient environmental conditions. However, the velocity of exhaled air (including exhaled carbon dioxide) from the vent 3400 of the present technology may reach this limit of zero at a distance closer to the vent 3400 than a multi-hole vent. Although certain multi-hole vents used in the SWIFT FX™ nose pillow mask were compared, it is expected that the vent 3400 of the present invention is the best in terms of noise level and air diffusion compared to the maximum multi-hole vent.

Another method of making a vent 3400 for cleaning exhaled air (including exhaled carbon dioxide) from the patient interface 3000 is provided. The vent portion is cut from a semi-permeable material having a thickness less than 0.45 mm to diffuse the air flow and a predetermined amount of porosity for air diffusion. Cutting occurs when the semipermeable material is provided in the form of a larger sheet, ribbon or roll, particularly with a large width. The vent portion is molecularly bonded to the patient mask frame 3310 of the patient interface to form a vent 3400 . The predetermined amount of porosity results in an air flow rate of about 47-53 liters per minute at _{20 cm H 2} 0 pressure of breathing gas at the patient interface 3000 . In addition, the predetermined amount of porosity causes the A-weighted noise pressure to occur at a distance of 1 m below 25 dbA with an uncertainty of 3 dbA and below 17 dbA with an uncertainty of 3 dbA. Preferably the A-weighted acoustic power level dbA (uncertainty) is about 22.1(3) dbA and the A-weighted sound pressure dbA (uncertainty) is about 14.1, measured using ISO 17510-2:2007 with a pressure of _{10 cm H 2 O at 1 m.} (3) Make it dbA. That is, the vent 3400 of the present invention is quieter than the multi-hole vent of a conventional mask as described in the noise table of the prior art mask described earlier in the description of the related art. Patient 1000 and its bed partner 1100 rarely hear sounds caused by exhaled air (including exhaled carbon dioxide) passing through vent 3400 as compared to a multi-hole vent. Heat staking or other aforementioned techniques of hole occlusion can be used, if necessary, to adjust the airflow rate, particularly in the vent section, until the desired airflow is achieved.

The vent portion 72 is secured to the mold 70 such that the vent portion 72 is overmolded to the mask frame 3310 of the molding machine 71 . The semipermeable material may be textile or non-textile as long as the thickness is less than about 0.45 mm. The thin vent is a feature that allows a small, unobstructed patient interface 3000 to be provided. Also, a thin vent molded into the mask frame 3310 is visually appealing because the fusion between the two parts appears seamless and coplanar and the thin vent must not protrude excessively inward or outward relative to the mask frame 3310. There is this. In addition, the thin vent is lightweight to reduce the overall weight of the patient interface 3000 as less material is required. For example, the textile material 65 may weigh about 200-250 grams per ^{m 2 .} Textile material 65 may weigh about 217-234 grams per ^{m 2 .} A smaller diameter fiber can produce a thinner textile material to achieve the same airflow rate, which results in a lighter vent 3400 .

The vent 3400 of the patient interface 3000 is simple to clean and can be reused. A mild cleaning solution or soapy water can be used to clean the vent. Hot water may also be used to flow through vent 3400 for cleaning. Since the vent is, for example, overmolded and permanently connected to the mask frame 3310 , it can be hand washed and cleaned without being disassembled from the mask frame 3310 .

Less separable portions for the patient interface 3000 eliminate the need to disassemble and reattach many portions to each other, avoiding the possibility of losing individual portions and reducing cleaning time. If the vent 3400 is formed from interlaced plastic fibers, the durability of the vent 3400 is maintained after repeated washing as opposed to vents made from textile fibers or other less durable materials such as GORE-TEX™. In contrast to the vent 3400 of the present invention, GORE-TEX™ is a non-woven material and its voids clog very quickly during use from atmospheric particulate matter entrapped in the voids, eventually resulting in significant clogging of the vent. Blockage of the vent results in insufficient irrigation of the patient's exhaled air (including exhaled carbon dioxide C02), _{leading to increased blood C0 2} levels and ultimately to hypoxia by _{C0 2 rebreathing.} In addition, the voids in GORE-TEX™ are invisible to the naked eye, making it impossible for the patient to visually identify blockages by mucus, dirt, contamination and stains. Washing the GORE-TEX™ material with water does not alleviate the above problem because the purpose of GORE-TEX™ is to water repellent. In contrast to the vent 3400 of the present invention, GORE-TEX ™ is a paper-like material that is not as robust as it is easily broken and damaged when cleaning with a brush or fingers is attempted. This is why GORE-TEX ™ cannot be washed and reused as it is irreparably damaged by the cleaning process due to the fragile paper.

Sintered materials, such as sintered round blocks for venting, are similar to GORE-TEX™ as the microscopic pores of the sintered material are clogged after use and cannot be properly cleaned upon reuse and cannot be clearly visually inspected for blockage. have similar flaws. Vents made from non-plastic materials cannot be manufactured as easily as the vents 3400 of the present invention because they may require additional manufacturing steps or cannot be permanently connected to the mask frame using integral bonding such as overmolding. , there is no integral bonding between the vent and the mask frame, the durability and reliability are reduced, and the visual aesthetics is not satisfactory.

In one embodiment, the vent 3400 allows a consistent and continuous airflow through the vent 3400 to allow adequate cleaning of exhaled air (including exhaled carbon dioxide). The vent 3400 is quick to manufacture and assemble and has a low cost compared to some conventional vent manufacturing methods. This can be due to the relatively simple geometry and the small amount of processing steps permanently attached to the mask frame 3310, and also because the type of equipment and processing steps are small if adjustments to the airflow rate are required.

In addition, when the vent 3400 is a textile formed by interlaced plastic fibers, it gives aesthetic satisfaction to the patient 1000 and its bed partner 1100 compared to a multi-hole vent or a sintered block vent.

Another embodiment describes the manufacture of vent 3400 . Plastic fibers are spun monofilament and woven or knitted on a loom in an interlaced structure. The interlaced structure may be in the form of a roll having a larger width than in the form of a narrow ribbon. Optionally, the plastic fibers may be multifilaments capable of providing tighter turns and complex passages than monofilaments. This provides greater control over the investment in textile 65 as heat slitting is avoided. The thermal staking step of the above-described embodiment for controlling and correcting the air flow rate is avoided, and the number of thermal welding heads for the staking punch 68 can be reduced. Thus, the textile 65 of the vent 3400 can be fabricated within a desired predetermined range and the area around the perimeter of the vent 3400 for the purpose of heat staking overmolding to the mask frame 3310 for permanent attachment. is used only to blank off

It may be possible to limit unintended variations in the airflow rate of the vent 3400 during manufacture. In the embodiment described above, the roll 65 or ribbon 65 can be calendered in a finishing process in which the roll 65 or ribbon 65 passes under the roller at a high temperature and pressurizes to create a flat sheet. there is. However, in other embodiments, the roll 65 or ribbon may not be un-calendered, but instead is first cut into narrow ribbons having a width substantially similar to the height of the vent 3400 . Each of the narrow ribbons is calendered to flatten them using a heated roller having a contact surface having a width substantially similar to that of the ribbon to ensure that heat and pressure are applied evenly to the ribbon. Accordingly, unintentional fluctuations in the air flow rate of the vent 3400 due to non-uniform calendering can be avoided.

In other embodiments, the textile 65 may be uniformly calendered to a predetermined pressure and predetermined heat level to achieve a desired airflow rate within a predetermined range. Thus, the heat staking step described above for the purpose of controlling the airflow rate by occluding the void can be avoided.

In another embodiment, the textile 65 may omit the calendar and void occlusion. Textile 65 may be knitted or woven into an interlaced structure with narrow ribbons or strips. Textile 65 is cut using fusing/cutting techniques described above into the shape of bent portions 72 and 73 . Vent portions 72 , 73 are then permanently connected to frame 3310 or other components of the pneumatic passageway of patient interface 3000 .

Although the vent 3400 has been described as being made of interlaced plastic fibers, a biocompatible material for a fiber other than plastic is used to prevent the shape, shape, and profile of the vent 3400 from changing during the patient's 1000 breathing cycle. It is expected to have the same bending stiffness for For example, a thin metal wire or yarn may be used.

Additives may be sprayed to strengthen the metal or yarn of the vent to provide bending stiffness to prevent the shape, shape, and profile of the vent 3400 from changing during the patient 1000's breathing cycle. Vent 3400 is described as having the form of an interlace structure comprising woven and knitted fibers.

6.3.7.1 Location of the vent (3400)

In one form of the present invention, the vent 3400 is located on or formed as part of the frame 3310 . In particular, in the embodiment of the present invention shown in FIGS. 75 and 76 , a pair of vents 3400 may be disposed on either side of the front surface of the frame 3310 . In one embodiment, the anterior surface of the mask frame 3310 is curved such that the vent 3400 does not face a direction perpendicular to the sagittal surface, but rather faces a vertical axis between the sagittal and coronal surfaces. Placing the vent 3400 in this manner in the mask frame 3310 ensures that when the patient 1000 is directly facing that bed partner, the flow of air from the vent 3400 will be directed to the bed partner 1100 rather than to the side. ) is directed towards the center of a straight line that prevents the direct flow of air towards it. The region in front of the center of the patient interface 3000 has a lower average air velocity from the vent 3400 compared to the region along the vent axis, ie, a region along a direction perpendicular to the anterior surface of the surface of the vent 3400 .

Although the vent 3400 has been described as being permanently connected to the frame 3310, the vent 3400 is, for example, different from the pneumatic area of the patient's interface 3000, i.e., exhaled air (exhaled air). It may be located at or adjacent to the cuff/adapter 4190 or seal forming structure 3100 to allow cleaning of (including carbon dioxide) (see FIGS. 1B and 1C ). Where the patient interface 3000 has an elbow that separates the torque tube, the vent 3400 may be permanently connected to another pneumatic element in the pneumatic region of the patient interface 3000 , for example to the elbow.

The pore size properties of the vent 3400 can be estimated using the bubble point test method described by the American Society in Standards of Testing and Materials (ASMT) Method F316. The bubble point test is a sensitive visual technique. The textile material 65 may have a bubble point pressure of about 60- about 100 psig (per square inch gauge). Preferably, the bubble point pressure of the textile material 65 has a bubble point pressure of about 80 psig.

In one embodiment of the invention, the vent 3400 may serve as a removable vent cap for the patient interface 3000 . The vent cap has a vent frame for removably connecting with the vent orifice. The vent orifice may be disposed in the mask frame, elbow or cushion member/plenum chamber 3200 . The textile material 65 of the vent 3400 is permanently connected to the vent frame. Vent 3400 has a porous area for cleaning exhaled air. Textile 65 is in the form of interlaced fibers. Complex air passages for exhaled air are formed by the spaces between the interlaced fibers. The textile is configured such that the shape, shape, and profile of the vent does not substantially change during the breathing cycle of the patient 1000 and the porous region substantially maintains a constant ratio for exhaled air.

Although vent 3400 is described as an interlaced structure, vent 3400 may have a nonwoven structure such as a fiber reinforced polymer in the form of an unsealed porous plastic. A two layer structure for vent 3400 is enabled by having a nonwoven structure as a first structure bonded to a woven structure as a second layer.

6.3.8 Connection Port (3600)

As shown in FIG. 166 , the connection port 3600 allows connection of the patient interface 3000 to the short tube 4180 of the air circuit 4170 . In one embodiment of the present invention, the short tube 4180 may be connected directly to the patient's interface 3000 by a connection port 3600 . Short tube 4180 may be connected to frame 3310 at connection port 3600 by insert molding a frame on short tube 4180 . The connection port 3600 may be located at the patient's interface 3000 , and may provide a fixed or movable connection to the gas supply tube 4180 .

The connection port 3600 may be part of the frame 3310 such that the frame is integrally molded to include the connection port. Also, the connection port 3600 may be connected to the frame 3310 at a limited portion or portions of its periphery. This opens the area between the connection port 3600 and the frame 3310, which may include the vent 3400 described above. As shown in Figures 10, 15 and 18. The connection port 3600 may be angled in the mask to form an angle with respect to the frame 3310 facing the tube. In addition, the connection port 3600 may be inclined at an angle with respect to the frame 3310 in any direction. In the illustrated embodiment, the connection port 3600 is angled downwardly relative to the frame 3310 to accommodate a majority of a patient with a generally downward facing tube 4180 during treatment. This may minimize looping of the tube 4180 and improve the sealing and stability of the patient interface 3000 during treatment. In addition, the connection port 3600 may be formed separately from the frame 3310 , and the components may be connected such that the connection port 3600 can rotate with respect to the frame 3310 using a swivel connection. In such an embodiment, it may improve the tube torque reduction of the short tube 4180 that would interfere with the sealing force, or it may improve the fit and seal when the short tube 4180 is configured in a tube-up position over the patient's head. .

18 shows a short tube 4180 that is angled downward with respect to the patient interface 3000 due to the connection of the connection port 3600 that is formed at a downward angle with respect to the frame 3310 . The arrangement may be spaced a great distance to prevent tangling to prevent looping out of the short tube 4180 from the patient.

It should also be appreciated that the flow of gas into the patient interface 3000 is more evenly distributed in embodiments of the present invention in which the air is not used to connect the flow of air to the patient interface 3000 . A sharp bend in the elbow allows a high density flowline to be placed on one side of the elbow. This can lead to jetting where the flow condenses and this can result in inadequate flow into the patient interface 3000 nasal pillow 3130 . It should also be understood that the vent 3400 described above may contribute to a reduction in jetting. While the use of an elbow in a conventional mask releases tube torque by allowing at least relative rotational motion between the air circuit 4170 and the frame 3310, one form of the present invention decouples the tube torque that a conventional elbow is responsible for. It has a particularly floppy short tube 4180 that can be used.

6.3.9 Forehead support

In one form of the invention, the patient interface 3000 does not include a forehead support means. In one form, the patient interface 3000 provides sufficient stability to open the eye and nose bones without the need for forehead support, undisturbedness.

In one alternative form, the patient interface 3000 includes a forehead support means.

6.3.10 Prevention of suffocation

In one form of the invention, the patient interface 3000 may include an anti-choking valve (AAV). In another embodiment of the present invention, when using a face mask, the AAV may include a decoupling structure 4190 (see FIG. 1B ), an air circuit 4170 (see FIGS. 1A-1C ) or a patient interface 3000 . can

6.3.11 Ports

In one form of the invention, the patient interface 3000 may include one or more supplemental oxygen ports 4185 to provide access to a volume within the plenum chamber 3200 . In one form, it can provide supplemental oxygen to the clinician. In one form, this allows a direct measurement of the gas appropriate to the plenum chamber 3200, such as pressure.

6.4 Decoupling Structure (4190)

Patient interface 3000 includes at least one decoupling structure, for example a rotatable cuff or adapter 4190 or ball and socket as shown in FIGS. 1B and 1C . 1B and 1C , the decoupling of tube drag is provided at least in part by the short tube 4180 . In this manner, the short tube 4180 functions, at least in part, as a decoupling structure 4190 .

1B and 1C , the end of the short tube 4180 is a rotatable cuff or adapter that facilitates connection to a third end of an additional gas supply tube 4178 that may differ at least on one side from the short tube. 4190). Rotatable cuff 4190 allows short tube 4180 and additional gas supply tube 4178 to rotate relative to each other at each end. Additional gas supply tube 4178 may include features similar to short tube 4180 , but may have a larger inner diameter (eg, 18 mm - 22 mm). The additional degree of freedom provided to the tube may help reduce tube drag by alleviating torsion, and thus distortion, of the air circuit 4170 . The other end of the additional gas supply tube 4178 may be connected to the PAP device 4000 .

6.4.1 Short Tube (4180)

In one form of the present invention, short tube 4180 is connected to frame 3310 at a connection port as shown in FIG. 166 and forms part of air circuit 4170 .

Short tube 4180 is a gas supply tube according to an aspect of the present invention constructed and arranged to allow the flow of air or respirable gas between PAP device 4000 and patient interface 3000 .

The gas supply tube is placed on the patient and other surfaces in use (eg, back bed, nightstand, hospital bed, table, floor) to affect tube drag, which represents the force exerted on the tube during use. Because the short tube 4180 is connected to the patient interface 3000 to provide respirable gas to the patient 1000 , the tube drag may affect the connection between the patient interface 3000 and the patient 1000 . there is. For example, tension and torsional tube drag may cause the patient interface 3000 to displace from the patient's face, causing respirable gas to leak from the patient interface 3000 . Therefore, it is desirable to reduce tube drag. This makes the short tube 4180 lighter, improves its flexibility (eg, by reducing its bend radius so that the tube 4180 can be bent more tightly), and at least on the short tube 4180 . This can be achieved by adding one degree of freedom. Also, this reduction in tube drag should be done without significantly reducing the stiffness of the tube 4180 so that it can resist occlusion forces, for example, when the patient places his or her arm on the tube or twists it into a twisted position. .

160-162 show three side views of the exemplary short tube 4180 in three different states. 160 shows the short tube 4180 in a neutral or steady state. In the neutral state, the short tube 4180 is not affected by external forces. That is, it is not stretched or compressed. The short tube 4180 may consist of a web 4172 of material spaced between adjacent coils of the helical coil 4174 . The helical coil 4174 of the short tube 4180 may have a width of WC. The web 4172 of material may span the distance between adjacent coils WF. Also, as shown in FIG. 160 , the web 4172 web of material may be folded such that the apex or peak of the fold 4182 extends radially outwardly between adjacent coils. It should be understood that due to the folding of the web 4172 of material, the width of the material comprising the web 4172 of material may be wider than the width between adjacent coils WF. Additionally, the web 4172 of material may be folded along a predetermined fold line 4186 .

Also, as shown in FIG. 160 , when the short tube 4180 is in a neutral state, the distance between adjacent coils WF may be equal to or substantially equal to the width of the spiral coil WC. In this configuration, the maximum bending radius R (shown in FIG. 163) of the tube 4180 is reduced, and the flexibility is improved. This is because a greater amount of material than prior art tubes must be used to extend the distance between adjacent coils. In one case, a distance WF equal to the width of the coil WC causes a large amount of material to extend that distance and as it folds a greater amount of material must be provided to include the web 4172 of material. This principle is explained in more detail in FIG. 163 . The folded shape is important to the overall flexibility of the tube. The more the web is folded to a larger radius, the more flexible the tube is produced. Very sharp corrugations make the tube less flexible. After multiple thermal disinfection cycles, the folds sag and the tube becomes less flexible. When the fold is relaxed, the folded diameter decreases with respect to the coil diameter, and the fold peak portion is lowered.

Also in FIG. 160 , folding web 4172 of material extends radially outward from short tube 4180 as well as folding web 4172 of material is centered between adjacent coils of helical coil 4174 . will do 160 also shows how the slope of the web 4172 of material increases from adjacent coils of the helical coil 4174 towards the apex or piece of fold 4182 . That is, the web 4172 of material is flattened further away from a given fold line 4186 and the web of material 4172 is sharply jagged at or near the peak of the fold 4182 .

It can also be seen in FIG. 160 that the outer portion or outer surface 4184 of the helical coil 4174 has a curved profile that is rounded over a wide angle, as described in more detail below. That is, the helical coil 4174 may have a profile of a portion of the perimeter of the ellipse. By providing the helical coil 4174 rounded outer surface or profile 4184 , a soft and smooth tactile feel can be provided to the patient 1000 . The rounded outer surface 4184 may also reduce the propensity of the short tube 4180 to sharpen the surface when used such as bedding, patient clothing, bedroom or hospital furniture. As shown in FIG. 160 , the coil diameter DC, which is the diameter of the plurality of helical coils measured perpendicular to the longitudinal axis of the short tube 4180 , is shown.

As shown in FIG. 160 , the short tube 4180 , in a neutral state, supplies gas such that the apex or peak of the fold 4182 is substantially flush with or flush with the outer surface 4184 of the helical coil 4174 . It has a fold of web 4172 of material that rises radially outward from the tube. The folds of the web 4172 of material also define a fold diameter DF between opposite vertices of the folds 4182 measured perpendicular to the longitudinal axis of the short tube 4180 . In another way, when the short tube 4180 is in the neutral state, the diameter of the web 4172 of the material extending transverse to the longitudinal axis of the gas supply tube is such that the diameter of the web 4172 extends each outer surface 4184 across the longitudinal axis. It may be equal to the diameter of the helical coil 4174 .

Also, one cylinder may circumscribe the apex or peak of the fold 4182 and the outer surface 4184 of the helical coil 4174 flush when the short tube 4180 is placed in a straight line in the neutral state. Also, when the short tube 4180 is in the neutral state, the fold diameter DF may be equal to, or substantially equal to, the coil diameter DC.

This configuration, with the rounded outer profile 4184 of the helical coil 4174, may provide an improved tactile sensation that feels soft and smooth to the patient. Also, the reduced sharpness properties of the short tube 4180 can be enhanced by having a peak or apex of the fold 4182 because it also does not have a single surface that protrudes sharply on the outer surface.

In another embodiment of the present invention, the web 4172 of material may be folded multiple times between adjacent coils of the helical coil 4174 . This may allow for more flexibility of the short tube 4180 with extension added due to the additional amount of material between each adjacent coil. Also, in another embodiment of the present invention, the web of material 4172 is along the length of the short tube 4180 folded between adjacent coils of the spiral coil 4174 and other areas of the gas supply tube where the web of material is not folded. It may be a specific region or part. Such an arrangement may allow for varying degrees of flexibility and extensibility along the length of the gas supply tube. For example, an increased or decreased stiffness may be provided to a portion of the short tube 4180 at a location proximate to the patient interface 3000 and the PAP device 4000 . In one embodiment, the portion of short tube 4180 near patient interface 3000 and PAP device 400 is a unit length of tube to increase the stiffness of the tube in that area to ensure that kinks are reduced in that area. It may have fewer folds per. Another reason why sections of web 4172 of material do not fold may be manufacturing reasons. For example, there is no fold of web 4172 at the distal end where overmolding of the cuff occurs. This may reduce the tendency to create a weak portion of the web 4172 that clamps the cuff into the folded web in this position that may be caught in a weak pinch.

161 is another side view of an exemplary short tube 4180 . In this figure, the short tube 4180 is in a compressed or retracted state. In the above state, when in the neutral state shown in FIG. 160 , the length of the short tube 4180 should be less than the length. For example, the short tube 4180 may be compressed to a length that is about 50% of its neutral state. When the short tube 4180 is compressed in its compression state, the web 4172 of material is compressed such that its fold becomes steeper and the distance between adjacent coils WF of the helical coil 4174 is reduced. In the compressed state, the distance WF between adjacent coils can be reduced to less than or equal to the width of the helical coil WC. Also, the apex or peak of the fold 4182 of the web 4172 of material may be brought out further such that the apex or peak rises above the outer surface 4184 of the helical coil 4174 . That is, the web 4172 of material may be larger. The effect can be controlled by the amount of material between the adjacent coils, the folding angle and the thickness TW. Moreover, it should also be understood that the width of the helical coil WC may not decrease during compression of the short tube 4180 , but may be forced together with other adjacent coil springs of the helical coil 4174 . 161 , when the short tube 4180 is in compression, the apex or angle of the peak 4182 of the fold of the web 4172 of material (ie, each portion of the web of material on either side of a given fold line) angle) decreases and again the web of material becomes larger.

162 is a further side view of the short tube 4180 when in its expanded or extended state. In this state, the short tube 4180 may have a greater length than in the neutral state shown in FIG. 160 . For example, the short tube 4180 can extend up to 200% of its length when in its neutral state. Also shown in this figure is that the distance between adjacent coils WF of the helical coil 4174 increases and the folds of the web 4172 of material flatten out. Also, the distance WF between adjacent coils may be increased to be greater than the width of the spiral coil WC. 162, the apex or peak of the fold 4182 of the web 4172 of material may be forced radially inwardly such that the apex or peak is lowered below the height of the outer surface 4184 of the helical coil 4174. there is. Again, this can be controlled by the amount of material between the adjacent coil and the fold angle. Also, it should be understood that the width of the helical coil WC may not increase while the short tube 4180 is extended, but other adjacent coils of the helical coil 4174 may be forced to be spaced in common with other springs. 162, the angle at the apex or peak of the folds of the web of material when the short tube 4180 is in the extended state (ie, the angle between each portion of the web of material on either side of a given fold line) ) is increased and again the web 4172 of material can be flattened.

163 shows an exemplary short tube 4180 curved between its ends. When curved as shown in FIG. 163 , a web 4172 of material between adjacent coils and helical coil 4174 may extend from the outer side of the curved portion 4179 and an inner portion of the bend 4176 . of material can be compressed. When curved as above, the limit of the bending radius R can be better understood. In one embodiment, when wrapped over a cylinder having a diameter of 13 mm, the tube may have a bend radius R of 44 mm under its own weight (ie no weight is added). 163 , the greater the amount of material comprising the web 4172 of material, the less bending, since the outer side of the curved portion 4179 can only extend up to the maximum possible distance of the adjacent coil WF. A radius R is possible.

At the outer portion of the bend 4179 , the short tube 4180 can only bend and extend in the outer portion 4179 up to the width of the web 4172 of material provided between adjacent coils. Thus, when more material is provided to the web 4172 of material between adjacent coils, the flexibility is reduced because the short tube 4180 is bent such that the outer portion of the bend 4179 extends further and the maximum bend radius R is reduced. is improved

It is also shown that the distance between adjacent coils WF on the inside of the curved inner portion of bend 4176 decreases to the point where adjacent coils of helical coil 4174 almost touch. Accordingly, the bend radius R is limited by the web 4172 of material at the inner portion of the bend 4176 . 164 , the web 4172 of material is compressed between adjacent coils of the helical coil 4174 at the interior of the bend 4176 . Thus, the thicker the web 4172 of material, the greater the maximum radius of bend R is obtained, the greater the amount of material between adjacent cones, the less they will approach each other in the interior of the bend 4176. because it can

Thus, in order to optimize the bend radius R of the short tube 4180, a sufficient width of the web 4172 of material must be such that the outer portion of the bend 4179 extends to meet the desired bend radius, as well as of the web of material. Sufficient thickness must be provided so that adjacent coils of helical coil 4174 are brought together at the interior of bend 4176 to achieve the desired radius of bend.

164 is a cross-sectional view of an exemplary short tube 4180 as shown in FIG. 163 . The cross-sectional view of the short tube 4180 shows the gas supply tube in a neutral state such that the distance between adjacent coils WF is equal to the width of the false helical coil WC. The short tube 4180 has an inner diameter DI of about 18 mm. The short tube 4180 may have a pitch P of between 3.2 mm-4.7 mm, preferably between 4.5 mm-4.7 mm. The figure also shows that the helical coil 4174 can have a thickness TC greater than the thickness TW of the web 4172 of the material. With the helical coil 4174 having a greater thickness than the web 4172 of the material, the helical coil can provide structural rigidity, which gives the short tube 4180 a spring effect. It can also be seen in the figure that the web 4172 of material can have a substantially uniform and/or continuous thickness.

164 also shows that at least a portion of the web 4172 of material may be asymmetric with respect to a given fold line 4186 . For example, the web 4172 of material may include a helical coil 4174 on one side of a given fold line 4186 and a protruding portion 4181 adjacent the helical coil, and the beveled portion 4183 is a helical coil. It can be included on another side adjacent to another side of it. Further, the slope of the web 4172 of the material to the apex or peak 4182 of the fold may be steeper at the side of the beveled portion 4183 than at the side of the raised portion 4181 .

Because the steepness is different, when the short tube 4180 is in the neutral state, the width WFS between the edge of the spiral coil and the predetermined fold line 4186 is on the side of the inclined portion 4183. The side of the protruding portion 4181 The width WFF between the edge of the spiral coil and a given fold line may be less than WFF. Thus, upon expansion, the web 4172 of material can be extended such that the WFS is increased than the WFF because a greater amount of material is included in the region.

That is, the short tube 4180 may extend a certain amount in a first direction (eg, from the beveled portion 4183 to the projecting portion 4181 ) and opposite to the first direction (eg, the projected portion). from 4181 to beveled portion 4183) may extend in different amounts. Because the patient 1000 can move while wearing the patient interface 3000 and thus need greater extensibility in the orientation of the patient 1000 , the patient interface 3000 attaches to the short tube 4180 at one end. The arrangement is preferred and attached to the PAP device 4000 at the other end. The asymmetric profile of tube 4180 is typically a result of how tube 4180 is made. Optionally, although described above, the web 4172 of material may have a profile that is substantially symmetrical about a predetermined fold line 4186 .

164 , the width of the protruding portion WH and the width of the inclined portion WS may be different. Accordingly, the web 4172 of material may bend over a greater extent towards the adjacent coil across the angled portion 4183 than it does across the raised portion 4181 . That is, due to the larger gap in the WS, greater flexibility (ie, smaller bend diameter) may exist in that particular region than in the WH with a smaller gap.

Also, due to the smaller gap in the WH, the portion may be compressible to a lesser extent than in the WS, since the web 4172 of material is already closer to the coil 4174 in the WH than in the WS.

Another characteristic shown in FIG. 164 is that the surface area (eg, the outermost surface area of short tube 4180 ) is generally better felt for helical coil 4174 than web 4172 in general, particularly when , if the folds of the web are very sharp, a greater proportion may be covered by the outer surface 4184 of the helical coil 4174 than the web 4172 of the material. This may provide a better tactile sensation for the patient, as shown in FIG. 164 , and the outer surface 4184 of the helical coil 4174 is round and thus softer than the apex or peak of the folds of the web 4172 of material. .

Also shown in FIG. 164 is that the web 4172 of material and the helical coil 4174 can be integrally bonded so that the inner surface of the short tube 4180 is smooth and continuous. It is understood that adjacent sides of the web 4172 of material may be joined together to form a smooth and continuous inner surface, or that the web of material 4172 may be bonded to adjacent sides of adjacent coils of the helical coil 4174 . shall. By forming the short tube 4180 in this way, a smoother flow of respirable gas can be provided through the gas supply tube so that the inner surface is smooth and continuous. Generally, the fold is formed after overmolding of the cuff at both ends of the short tube 4180 to prevent tape pinching.

It should also be understood that any suitable combination of materials may include a web 4172 and a helical coil 4174 of material. The material of each component 4172 , 4174 may be the same, or they may differ in at least one aspect. In one embodiment of the present invention, the web of material 4172 and the helical coil 4174 may be made of a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU). Both the web 4172 and the helical coil 4174 of material are of the same plastic material (or different blends of the same plastic material) desirable to provide an integral chemical bond (molecular adhesion) between the web 4172 and the coil 4174. can be prepared from. Material selection is limited by a number of factors. The mechanical properties for the web 4172 of material to allow for flexibility is a decisive factor. The ability to withstand thermal disinfection is another important factor. Sticky and unsightly are other factors. In addition, the short tube 4180 prevents occlusion and must withstand hoop stress when a force applied to the surrounding surface of the tube 4180 is applied, which may occur if a patient's limb is placed on top of the short tube 4180. . This is addressed by providing a short tube with a minimum inner diameter 4180 and specifying the helix pitch and structural stiffness of the helical coil 4174 .

The choice of material may 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 stronger the spring stiffness (K) under a constant load, the smaller the deflection. The spring rate is the amount of weight required to bias a spring (all springs) per unit of measure. For example, materials having different modulus of elasticity and different bending stiffness may be used for web 4172 and helical coil 4174 of material to form the desired spring stiffness, respectively. Likewise, the stiffness of the spring may be selected using the same material as the modulus of elasticity of both the web 4172 and the helical coil 4174 of the material. Also, as described with reference to FIG. 164 , the pitch of the helical coil 4174 may affect the spring stiffness of the gas supply tube 4180 , and the spring stiffness may be about 0.03 N/mm.

165 is another view of an exemplary short tube 4180 in a bent or bent state. In this view similar to FIG. 163 , the short tube 4180 is curved over a radius R . However, in this figure, the short tube 4180 is at one end due to gravity, and the edge of a flat, raised surface (e.g., to show how the tube 4180 can bend when under tension) For example, it is shown spanned over a table). The weight of the portion of the short tube 4180 that hangs over the corner of the table causes the tube 4180 to extend and bend in the area of the tube 4180 near the edge of the table. The figure shows bending characteristics similar to that shown in FIG. 163 . In particular, the web 4172 of material extends from the outer side of the bent region 4179 and is compressed at the inner portion of the bend 4176 such that the WF is greater on the outside than on the inside.

166 shows an example short tube 4180 attached directly to the patient interface 3000 . In a conventional mask, the gas supply tube is attached to the mask through a swivel elbow. By reorienting the gas supply tube with the swivel elbow at the junction with the patient interface, conventional assemblies seek to reduce tube drag, but including the swivel elbow in turn can mitigate the reduction in tube drag weight and components. add Thus, in accordance with the present invention, the short tube 4180 can be directly connected to the mask frame 3310 . 166 shows that a short tube 4180 can be angled downward in the connection to the mask frame 3310 which can contribute to reducing tube drag. The lower angle may be facilitated in part by the connecting port 3600 .

1B and 1C , a short tube 4180 according to the present invention is shown connecting, at its first end, a patient interface 3000 . The connection may be a fixed connection as described above with respect to FIG. 166 . In this embodiment, the cuff is overmolded to the first end of the tube 4180 which is overmolded to the corresponding connection port 3600 formed in the patient interface 3000 . In this embodiment, there is no elbow between the tube 4180 and the mask frame 3310 . In another embodiment, a swivel elbow may be positioned between the tube 4180 and the mask frame 3310 to allow the swivel elbow and tube 4180 to rotate freely relative to the mask frame 3310 .

It should be understood that the patient interface 3000 shown in the figure is shown in dashed lines to indicate that various other patient interfaces may be connected to the short tube 4180 . The second end of the short tube 4180 has a rotating cuff, swivel cuff or adapter 4190 to facilitate connection to a third end of an additional gas delivery tube that may be different from the short tube 4180 . The rotation cuff allows the short tube 4180 and the additional gas supply tube to rotate relative to each other at each end. Additional gas supply tube 4178 may include features similar to short tube 4180 , but may have a larger inner diameter (eg, 18 mm - 22 mm). The additional degrees of freedom provided to the tubes 4178 and 4180 can help reduce tube drag by alleviating the torsion, decoupling, tube drag and consequent distortion of the short tube 4180 experienced. A fourth end of the additional gas supply tube 4178 may be connected to the PAP device 4000 . The snapped two-piece swivel is molded into the cuff. Optionally, it is also possible for the swivel of one part to be snapped.

203-222, a tube 4180 of the present invention is compared to a conventional short tube having a helical coil.

The comparison shows that the tube 4180 of the present invention has better bending stiffness or relaxation as it has a lower gram-force (GF) when the tube 4180 is stretched. The lower end of the tube is held in a fixed position such that the longitudinal axis of the tube begins at an angle perpendicular to the direction of the force applied to elongate the short tube. That is, the lower end of the short tube is initially held parallel and tangent to the horizontal plane (see Figs. 203, 208, 213, 218). The upper end of the short tube is held by the Instron machine directly over the lower end of the fixed short tube. The Instron machine draws a short tube with a distance of 30 mm in a series of steps from 0-30 mm, -60 mm, -90 mm and -120 mm in a vertical upward direction. The Instron machine also measures the Newtonian force at each distance, which can counteract the spring stiffness of the short tube. Torque gauges and force gauges (torque gauge RM No.MTSD05997 and Mecmesin force gauge RMNo.MFGX05996) are used to measure the gram-force of the fixed lower end of a short tube at each distance it extends. Because the tubes have different weights and lengths in their initial position, the Instron machine, torque gauge and force gauge are zeroed. By zeroing the measuring equipment in this way, the measurement is independent of the weight and measurement of each tube. A 1 cm grid is usually placed in the background to indicate the angle of the short tube at each distance. The comparison is as follows:

The comparison shows that the short tube 4,180 of the present invention only begins to experience tube torque between 30 mm and 60 mm elongation, whereas the conventional tube already experiences tube torque with 30 mm elongation. For every measured distance, the conventional tube has significantly higher gram-forces with less floppy and has a higher bending stiffness compared to the tube 4180 of the present invention. Thus, sealing disruptions, such as a result of torque tube, are less likely to occur in tube 4180 than conventional tubes. Also, the relaxation of tube 4180 allows direct connection to frame 3310 without the need for swivel elbows or ball and socket elbows commonly used to address tube torque.

This eliminates the additional portion that leads to an overall weight reduction for the patient interface 3000 . Improved comfort because the tube 4180 is barely felt by the patient 1000 and provides a greater degree of freedom of movement to the patient 1000 before tube drag occurs such that the seal forming structure 3100 pulls the patient's face. do.

As discussed above, the short tube 4180 can be moved relative to the patient interface 3000, creating tube drag. Wherein tube drag includes forces and/or moments, it will be understood that the term tube drag includes forces and/or moments unless otherwise specified.

One cause of this tube drag is that the short tube 4180 can bend. For example, bending created in short tube 4180 by patient 1000 turning the body away from PAP device 4000 causes tube drag on patient interface 3000 to cause discomfort to the patient and potentially disrupt sealing. can cause

To demonstrate the effect of tube drag, a simplified representation of a system comprising a patient interface 3000 and a short tube 4180 can be considered. In the system, it can be assumed that the patient interface is disposed on the patient 1000 and the head gear is decoupled from the patient interface. In this case, any tube drag must be reacted by the patient interface 3000 . All of the moments illustrated may be reacted with a force coupling on the patient 1000 , and/or all of the forces may be reacted with a reaction force that is equal and opposite in direction to the patient 1000 . The resulting tube drag at the patient interface 3000 may be related to the structure of the short tube 4180 . In particular, as the short tube 4180 bends, the bending stiffness of the short tube 4180 can affect the tube drag force formed at the patient interface 3000 .

When a cylindrical tubular object of usually constant cross-section is fixed to a fixed end and loaded onto a free end (ie, a cantilever), the resulting force and moment at the fixed end are

d= Pl ³ /3EI (ignoring gravity)

where 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 second moment of the cross-sectional area.

Here, the binding reaction at the fixed end is the normal force of P and the moment of IP in the opposite direction.

Applying this to a system comprising a patient interface 3000 and a short tube 4180, the response of the proximal end is the normal force of P and the moment of IP which may form part of the tube drag force. The above formula is as follows.

The above equation can be rearranged as

P= 3dEI/l ³

Given a deflection d (for a given movement by the patient 1000), and a tube length l, the tube drag increases as EI increases, and the tube drag decreases.

For a circular tube of constant cross-section, I can be calculated using the equation

I=π(d ⁴ ₀ - d ⁴ _i )/64. Thus, for example, for an inner diameter (d _{i ) given as 15 mm, a reduction of the outer diameter (d 0} ) by 19 mm-18 mm reduces the tube drag by about 32%. Likewise, while the above relationship may be linear in this case, a reduction in the elastic modulus of the material used will achieve a reduction in tube drag.

Thus, while the short tube 4180 of the present invention may not be a circular tube of constant cross-section, the overall bending stiffness of the short tube 4180 is similar to that of the web 4172 and helical coil 4174 of the short tube 4180 . It can be a result of the shape and material properties of the various parts of

Reducing the bending stiffness of the short tube 4180 may cause weakening of the structural integrity of the short tube 4180 . That is, for example, if the thickness of the web 4172 of material is changed by reducing the outer diameter of the short tube 4180, the bending stiffness and thus the tube drag may be reduced, but this will make the short tube 4180 more brittle. This allows for easy construction and, during normal use, may result in occlusion of the short tube 4180. Thus, an advantage of the present invention is the combination of material and shape of the short tube 4180 that works to reduce bending stiffness while maintaining adequate stiffness to prevent clogging and to be durable.

Tube 4180 is substantially quiet with no sticky noise/stiction that can occur in axial compression and extension of tube 4180 . One embodiment that reduces or eliminates noise may apply an additive to prevent the coils of the helical coil 4174 from sticking together. Conventional tubing for patient interfaces is known to produce intermittent noise when attempting to sleep and suffer from a type of noise that annoys patient 1000 and its bed partner 1100 . The tube 4180 is designed to be lightweight in order to minimize tube drag caused by the weight of the tube 4180 under gravity. In one embodiment of the present invention, in the neutral state, the length 4180 of the tube may be about 285 mm - 305 mm including the end cuff, and may be about 18.7 g - 19.1 g. Thus, the weight of the tube 4180 with the end cuff may be 62.6 g/m - 65.6 g/m. There is no air leakage between tube 4180 and the end cuff overmolded at the end of tube 4180 . One of the cuff ends may allow a swivel cuff 4190 to rotate 360° relative between the short tube 4180 and the long tube 4178, while the other end cuff is a non-swivel frame cuff. The swivel cuff 4190 can have a bump off that provides an external tactile edge for the index finger of the patient 1000 that can release the tube 4180 from the tube adapter 4190 connected to the elongate tube 4178 . The bump off can withstand higher forces to improve the durability of the swivel end cuff 4190 and the short tube 4180 after repeated engagement and disengagement from the long tube 4178 .

Although a single helical coil 4174 has been described, it is contemplated that more helical coils 4180 may be provided for the tube. The number of helical coils for tube 4180 may be multi-start (double start, triple start, etc.), i.e., more than one thread. This allows each helical coil to be made of a different material or have a different size to enhance the relaxation of the tube 4180 to reduce tube drag, as well as have a strong construction, thereby preventing or resisting kinking and blockage. there is.

6.4.1.1.1 Mask system

One or more mask elements may be constructed and arranged to separate the torque tube to minimize the possibility of sealing disruption. Short tube 4180 can isolate tube torque due to its enhanced relaxation and elongation capabilities. If the torque tube is greater than the decoupling of the short tube 4180 , the positioning and stabilizing structure 3300 also decouples the tube torque. Rigidizer arm 3302 flexed in the sagittal plane separates the tube torque. In addition, the cushioning function of the plenum chamber 3200 and/or the sealing molded structure 3100 separates the torque tube to some extent. Any combination of two or more of these features improves the ability to separate the torque tube. Any combination of the above features enhances the ability to separate larger amounts of torque tube.

One or more mask elements may be constructed and placed together to improve patient 1000 comfort. The short tube 4180 is light, the plenum chamber 3200 and the seal forming structure 3100 are also light, so the headgear tension provided by the positioning and stabilizing structure 3300 is inconveniently to provide a satisfactory seal. You may not need a high one. Reducing the need for an elbow connecting the short tube 4180 to the frame 3310 also lowers the tension level of the headgear required for the positioning and stabilizing structure 3300, thereby reducing the overall weight of the patient interface 3000. . Also, when the patient interface 3000 is lightweight to such a degree that it is "almost not there" so that wearing the patient interface 3000 is not felt by the patient 1000, the feeling of the patient 1000 causes less anxiety and fear. . The shape and flexibility of the rigidizer arms 3302 makes them comfortable for the patient 1000 as they are placed under the cheekbones and facing the headgear strap 3301 around the patient's ears, which may be a sensitive facial area for some patients 1000 . to provide.

The strap 3301 is made of woven textile, so it does not retain surface heat and does not condense sweat compared to a plastic headgear strap, so it feels good on the patient's skin. In addition, the strap 3301 made of woven textile is less dense than the plastic material which results in weight and volume reduction. The segmented area 3326 of the strap 3301 allows the patient 1000 to adjust the headgear tension to a comfortable feel level for them. Combinations of two or more of these functions enhance the comfort of the patient 1000 . The combination of all these features greatly improves the comfort of the patient 1000 .

One or more mask elements may be constructed and placed together to improve an optimal sealing opportunity with the patient 1000 . This may lead to better adherence to treatment and an additional increase in average daily usage of 36 minutes. As discussed above, optimal sealing can be achieved through a combination of improved comfort and improved decoupling of the torque tube for the patient 1000 .

One or more mask elements may be constructed and placed together to enhance the visual appeal of the patient interface 3000 , particularly resulting in better treatment compliance for the first time patient 1000 . Because the frame 3310 is not very wide and is curved to match the shape of the face, the patient interface 3000 has a low profile and small footprint on the patient's face. In addition, a single strap 3301 with a smooth continuous surface of the curved profile of the segmented area 3326 and the rigidizer arm 3323 is not obstructed, bulky or complex, and covers a large surface of the patient's face. I never do that. Any combination of two or more of the above features enhances the visual appeal of the patient interface 3000 . The combination of all these features greatly enhances the visual appeal of the patient interface 3000 .

One or more mask elements may be constructed and placed together to enhance assembly and disassembly of the patient interface 3000 . Patient interface 3000 provides simplicity to patient 1000 as there are two separable components in frame 3310 that is seal forming structure 3100 and strap 3301 . Fewer removable elements means that the patient interface 3000 is easy to assemble and is easy to assemble and disassemble when the patient interface 3000 needs to be cleaned. Frame 3310, plenum chamber 3200/seal forming structure 3100, and strap 3301 may be cleaned individually and according to other schedules, for example, plenum chamber 3200/seal forming structure 3100. Structure 3100 may be cleaned more frequently than strap 3301 .

The shape and structure of the components suggest to the patient 1000 a method of assembling and disassembling the patient interface 3000 in a way that is visually and tactilely intuitive to the patient. For example, the coupling relationship between the frame 3310 and the plenum chamber 3200 that produces an audible click when the connection is appropriate is intuitive to the patient 1000 . In addition, providing visual and tactile markings to the frame 3310, plenum chamber 3200, and positioning and stabilizing structure 3300 can be used to avoid misalignment/disassembly or disorientation/misalignment of the mask elements to patient 1000. add more guides. Some of these features are particularly advantageous for the patient 1000 with arthritis in the hand in a dark environment.

For example, clicks may be audible or the tactile and feel and tactile markings of the components of the mask are useful in low light conditions. Also, by simply stretching the strap 3301 to detach the patient interface 3000 from the patient's face, complicated engagement/disengagement procedures are avoided. Any combination of two or more of these functions enhances the simplicity of the patient's interface 3000 . The combination of all these features greatly improves the simplicity of the patient interface 3000 .

In one embodiment of the invention, the frame assembly includes a frame 3400 , a short tube 4180 , a vent 3400 , and a subassembly of a rigid arm 3302 . The sub-assemblies of the frame assembly are permanently connected to each other. For example, frame 3310 and short tube 4180 are permanently connected to each other, frame 3310 and rigid arm 3302 are permanently connected to each other, and frame 3310 and vent 3400 are permanently connected to each other. Connected. The cushion assembly may be removably connected to the frame assembly. The cushion assembly includes a seal forming structure 3100 , a plenum chamber 3200 , a retention structure 3242 , and a plenum connection region 3240 . The strap 3301 may be removably connected to the frame assembly and in particular to the rigid deesser arm 3302 .

Although a woven strap 3301 is described, it is contemplated that the strap may be made of a silicone or plastic material, at least at the distal end. A silicone strap may be overmolded to the plenum chamber 3200 for a permanent connection.

6.4.1.1.2 To avoid incorrect assembly and disassembly of the mask system

187-190, the patient interface 3000 is provided with visual and tactile markings to prevent or minimize erroneous detachment when connecting mask elements together. They also provide the patient 1000 with intuition when releasing mask elements from each other. 187 and 188 , a pad print 3355 is provided on the outer surface of the extension 3350 of the rigid deesser arm 3302 . The mask name and brand logo are pad printed to indicate to the patient 1000 the direction in which the words are placed in the right direction. This provides a visual indication to the patient 1000 . In FIG. 189 , there is raised/embossed text 3291 near the top edge of frame 3310 . This provides the patient 1000 with a visual and tactile indication of whether the frame 3310 is tilted up or down and is useful when the strap 3301 is attached to the rigid arm 3302 in low light conditions. There is also an engraved text 3292 on the outer surface of the ridgedezer arm 3302. This provides the patient with a visual and tactile indication of the orientation of the rigidizer arm 3302 and assists in attaching the strap 3301 to the rigidizer arm 3302 . There may be pad prints 3293 on one side of the plenum chamber 3200 . The pad print 3293 may indicate the left pillow 3130 and the right pillow 3130 , and may also indicate the size (small, medium, large) of the seal forming structure 3100 . For example, when the patient 1000 looks at the padprint 3293 on the plenum chamber 3200, it will be recognized that it is facing the upper surface of the plenum chamber 3200. All of these visual and tactile markers help the patient 1000 to identify the sides and surfaces of the patient interface 3000 to prevent disorientation and improper assembly and disassembly. This can prevent accidental damage to the patient interface 3000 and also alleviate user complaints related to assembly and disassembly.

6.5 PAP Devices (4000)

A PAP device 4000 according to an aspect of the present invention includes a mechanical and pneumatic component 4100 , an electrical component 4200 , and is programmed to execute one or more algorithms 4300 . The PAP device may have an outer housing 4010 formed in two parts, an upper portion 4012 of the outer housing 4010 , and a lower portion 4014 of the outer housing 4010 . In an alternative form, the outer housing 4010 may include one or more panels 4015 . The PAP device 4000 may include a chassis 4016 that supports one or more internal elements of the PAP device 4000 . In one form, the pneumatic block 4020 is supported by the chassis or is formed as part of the chassis 4016 . The PAP device 4000 may include a handle 4018 .

The pneumatic passageway of the PAP device 4000 may include an intake air filter 4112, an intake muffler, a controllable pressure device capable of supplying air at positive pressure (eg, a controllable blower 4142), and an outlet muffler. One or more pressure sensors and flow sensors may be included in the pneumatic passageway. The pneumatic block 4020 may include a portion of the pneumatic passageway located within the outer housing 4010 . The PAP device 4000 may have a power supply 4210 and one or more input devices 4220 . The electronic component 4200 may be mounted to one printed circuit board assembly (PCBA) 4202 , and in an alternative form, the PAP device 4000 may include one or more PCBAs 4202 .

6.5.1 PAP Unit Mechanical and Pneumatic Components (4100)

6.5.1.1 Air Filter (4110)

The PAP device 4000 according to an embodiment of the present invention may include one air filter 4110 or a plurality of air filters 4110 .

In one form, intake air filter 4112 is located at the beginning of the pneumatic passage upstream of the controllable blower. See Figure 3c.

In one form, an exhaust air filter 4114 , eg, an antibacterial filter, is positioned between the pneumatic block 4020 and the patient interface 3000 . See Figure 3c.

6.5.1.2 Pressure Device (4140)

In one form of the invention, the pressure control device for creating a flow of air at positive pressure is a blower 4142 . For example, blower 4142 may include one or more impellers housed in a volute and a brushless DC motor. The blower 4142 is

For example, in the range of about 4 cm H ₂ O - about 20 cm H ₂ O, or in other forms up to about 30 cm H ₂ O, it is possible to deliver about 120 liters/min of supply air.

6.6 Humidifier 5000

6.6.1 Humidifier Overview

In one aspect of the present invention as shown in FIG. 3B , a humidifier 5000 that may include a water container and a heating plate is provided.

6.7 Glossary

For the purpose of disclosure of the present invention, one or more of the following definitions may apply in certain aspects of the present invention. Alternative definitions may apply in other aspects of the invention.

6.7.1 General

Air: In certain forms of the present invention, the air supplied to the patient may be the atmosphere, and in other forms of the present invention the atmosphere may be supplemented with oxygen.

Continuous Positive Airway Pressure (CPAP): CPAP treatment refers to the application of supplying air or respirable gas to the inlet of the airway at a continuous positive pressure relative to the atmosphere, preferably constant throughout the patient's respiratory cycle. In some forms, the airway inlet pressure can vary, for example, by up to several cm of water in a single cycle, higher during inhalation and lower during exhalation. In some forms, the pressure at the entrance to the airway is slightly higher on inhalation and slightly lower on exhalation. In some forms, for example, the pressure may vary between different respiratory cycles of the patient, increasing in response to detection of an indication of partial upper airway obstruction and decreasing in the absence of indication of partial upper airway obstruction.

6.7.2 Characteristics of the PAP device

Air Circuit: A conduit or tube of air or respirable gas between the PAP device and the patient interface. In particular, the idle circuit may be in fluid communication with the pneumatic block and the outlet of the patient interface. The air circuit may be referred to as an air supply tube. In some cases there may be separate delays in the circuit for inhalation and exhalation. In other cases, a single lag is used.

APAP: Automatic positive airway pressure. Continuously adjustable positive airway pressure between maximum and minimum limits, with or without markers of SDB events.

Blower or flow generator: A device that delivers a flow of air at a pressure greater than or equal to ambient pressure.

Controller: A device or part of a device that regulates its output according to its inputs. For example, one type of controller has 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 the set point for that variable. The servo ventilator may include a controller having a level of ventilation as an input, a target ventilation as a set point, and a level of pressure support as an output. Other types of inputs may be one or more of oxygen saturation (SA02), partial pressure of carbon dioxide (PC02), transport, signal from a photoplethysmogram, and peak flow. The set point of the controller can be one fixed variable or a learned variable. For example, the setpoint of the ventilator may be a long-term average of the measured patient ventilators. Another ventilator may have a ventilator set point over time. The pressure controller may be configured to control the blower or to pump to provide air at a specific pressure.

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

Motor: A device that converts electrical energy into rotational motion of a member. In the context of the present invention, the rotating member is an impeller which rotates in place relative to a fixed axis to impart increasing pressure to the air moving along the rotating axis.

Positive Airway Pressure (PAP) Device: A device for providing a supply of air to the airways at positive pressure.

Transducer: A device that converts one form of energy or signal into another. A transducer may be a sensor or detector that converts mechanical energy (eg, movement) into an electrical signal. Examples of transducers include pressure sensors, flow sensors, carbon dioxide (C02) sensors, oxygen (0 ₂ ) sensors, force sensors, motion sensors, noise sensors, plethysmographs and cameras.

6.7.3 Characteristics of the respiratory cycle

Apnea: Preferably, apnea is said to occur when flow falls below a predetermined threshold for a period of time, eg, 10 seconds. Obstructive apnea occurs when, despite the patient's efforts, some airway obstructions do not allow airflow. Central apnea occurs when apnea is detected as a decrease in breathing effort, or lack of breathing effort.

Duty cycle: ratio of inhalation time, Ti, Ttot to total breathing time.

Effort (breath): Desirable Breath effort is a task performed by a person breathing voluntarily to try to breathe.

The expiratory portion of the respiratory cycle: the period from the beginning of the expiratory flow to the beginning of the inspiratory flow.

Flow Restriction: Preferably, flow restriction is accepted as a state of the patient's respiratory event if an increase in patient effort does not result in a corresponding increase in flow. Flow restriction can be described as a restriction of inhalation flow that occurs during the inspiratory portion of the respiratory cycle. Flow restriction occurs during some exhalation cycle and can be described as expiratory flow restriction.

Hypnea: Preferably, hypoventilation is not a decrease in flow or cessation of flow. In one form, hypoventilation can be said to occur when there is a subthreshold decrease in flow over a period of time. In one form of adulthood, one of the following may be considered hypoventilation.

(i) a 30% reduction in patients breathing for at least 10 seconds plus associated 4% unsaturated respiration; or

(ii) Patients breathing for at least 10 seconds with an associated duration or arousal of at least 3%.

Inspiratory part of respiratory cycle: Preferably the period from the beginning of the inhalation flow to the beginning of the exhalation flow is considered the inhalation part of the respiratory cycle.

Openness (airway): Degree or extent to which the airway is open An open airway is an open airway, and airway patency is quantified, for example, as open with a value of 1 and closed with a value of 0.

End-tidal-positive pressure (PEEP): The atmospheric pressure in the lungs present at the end of the expiration.

Peak flow (Qpeak): The maximum value of flow in the inhalation portion of the respiratory flow waveform.

Respiratory Flow, Airflow, Patient Airflow, Respiratory Airflow (QR): These synonyms are used in contrast to “true breathing flow” or “true breathing airflow,” which is the actual breathing flow experienced by a patient, usually expressed in liters per minute, It may be understood to refer to an estimate of the inhalation airflow of the PAP device.

Respiratory volume (VT): The volume of exhaled air during normal breathing without inhalation of air or additional effort applied.

(inhalation) time (Ti): the duration of the inhalation portion of the respiratory flow waveform.

(expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

(Total) Time (Ttot): The total length between the beginning of the inspiratory portion of one respiratory flow waveform and the beginning of the inspiratory portion of the next respiratory flow waveform.

Typical Recent Ventilation: A measure of the ventilation value for which the most recent value for some given timescale tends to be in a cluster, ie the central tendency of the recent values of the ventilation.

Upper Airway Obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a condition of flow restriction where the flow level may slightly increase or even decrease with a pressure differential across the upper airway (Starling resistor behavior).

Ventilation (ventilation): A measure of the total amount of gas exchanged by the patient's respiratory system, including both inspiratory and expiratory flows per unit time. Expressed in volume per minute, this amount is often referred to as "min ventilation". Minute ventilation is sometimes given simply as a volume, which is understood as a volume per minute.

6.7.4 PAP device parameters

Flow rate: The instantaneous volume (or mass) of air transferred per unit time. Although the flow rate and the ventilation have the same volume or mass per unit time of the same size, the flow rate is measured for a very short time. Flow may be a nominally positive value for the inhalation portion of the patient's respiratory cycle, and a negative value for the expiratory portion of the patient's respiratory cycle. In some cases, a reference to a flow rate may be a reference to a scalar quantity, ie, a quantity having only magnitude. In other cases, the reference to the flow rate may be a vector quantity, a quantity having both magnitude and direction. The flow is given by the symbol Q. Total flow Qt is the flow of air leaving the PAP unit. The vent flow QV is the flow of air leaving the vent to allow the purging of exhaled gases. Leak flow QL is the unintended leak flow rate in the patient interface system. Respiratory flow, QR, is the flow of air received by the patient's respiratory system.

Leak: Preferably, the word leak is described as a flow of air around it. A leak may be, for example, an intentional leak that allows cleaning of _{exhaled C0 2 .} The leak may 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 can be measured in a range of units including cm H ₂ O, gf/cm ^{2 , and hectopascals.} 1 cm H ₂ O is equal to 1 g-f/cm ² , which is about 0.98 hectopascals. In this specification, unless otherwise stated, pressures are given _{in cm H 2 O.} For nasal CPAP treatment of OSA, reference to treatment pressure is reference to pressure in the range of _{about 4-20 cm H 2} O or about 4-30 cm H _{2 O.} The pressure at the patient interface is given by the symbol Pm.

Acoustic Power: The energy per unit time delivered by sound waves. Sound power is proportional to the square of the sound pressure multiplied by the area of the wavefront. The sound output is usually given in decibels SWL, ie decibels for the relevant power, 10 ^-12 watts.

Sound Pressure: A local deviation in ambient pressure at a given time instant as a result of a sound wave propagating through a medium. Acoustic power is usually decibels for a reference power given in ^{SPL, ie generally 20*10 -6} Pascals (PA), taking into account the threshold of human hearing.

6.7.5 Anatomy of the face

Ala: outer outer wall or "wing" of each nostril (plural: alar)

Alare: The most lateral point of the nose wing.

Point of wing curvature (or wing crest): Found at the most posterior point of the curved baseline of each wing, in the crease formed by the union of the cheek and wing.

Auricular or Pina: The visible part of the entire outer ear.

(Nose)bone framework: The bone structure of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

(nose)cartilaginous framework: The cartilage framework of the nose includes the septum, lateral large and small cartilages.

Nasal column: A strip of skin that separates the nostrils and runs from the pronasale to the upper lip.

Nasal column angle: The angle between the horizontal plane and the vertical line drawn during the intersection of the nostrils and the nasolabial points.

Frankfurt horizontal plane: a line extending from the lowest point of the orbital margin to the left ear bead. The auricle point is the deepest point in the upper notch of the auricle of the pinna.

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

Lateral non-cartilaginous: usually triangular plate of cartilage. Its upper margin is connected to the nasal bone and frontal process of the maxilla, and its lower edge is connected to the cartilage of the large wing.

Large wing cartilage: The cartilaginous plate below the lateral nasal cartilage. It is a curve around the anterior portion of the nostril. Its posterior end is connected to the frontal process of the maxilla by a coarse fibrous membrane containing three or four small cartilages of the wing.

Nostrils (nostrils): Oval openings that form the entrance to the nasal passages. The singular form of nostrils is nostrils. The nostrils are separated by the nasal septum.

Nassau-lip sulcus or Nassau-lip fold: A skin fold or groove running on each side of the nose at the corner of the mouth, separating the cheeks from the upper lip.

Nassau-Lip Angle: The angle between the nasal column and the upper lip while intersecting with the nasolabial point.

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

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

Pronasale: The most protruding point or tip of the nose, identifiable in a side view of the rest of the head.

pharynx: a middle groove running from the lower border of the septum to the top of the lip in the upper lip region.

Mandibular Point: Anteriormost point of the jaw, located in the soft tissue.

Ridge (nose): The nasal ridge extends from the apex to the apex, the mid-projection of the nose.

Sagittal surface: a vertical plane passing from anterior (anterior) to posterior (posterior) dividing the body into right and left halves.

Sellion: The most concave point covering the anterior suture area of the nose located in the soft tissue.

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

Subbalare: The point in the lower margin of the base of the wing where the base of the wing connects with the skin of the upper lip.

Infranasal point: The point where the mid-sagittal plane, located in the soft tissue, meets the upper lip and the nasal column.

Supramentale: The greatest concave point on the midline of the lower lip between the labrale inferius and the soft tissue pogonion.

6.7.6 Anatomy of the skull

Frontal Bone: The frontal bone contains a large vertical section, the squama frontalis, corresponding to the area known as the forehead.

Mandible: The mandible forms the lower jaw. Mental projections are the jaw bone projections that form the jaw.

Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla protrudes upwardly by the side of the nose and forms part of the lateral border.

Nasal Bones: The nasal bones are two small rectangular bones that vary in size and individual shape; They are positioned side by side in the middle and upper parts of the face and form their junction, namely the "bridge" of the nose of the nose.

Nasion: The junction of the frontal bone and the two nasal bones, the region directly depressed between the eye and the upper part of the nose bridge.

Occipital Bones: The occipital bones are located on the back and bottom of the skull. The cranial cavity contains an elliptical foramen that communicates with the spinal canal, the foramen magnum. The curved plate behind the large foramen is the squama occipitalis.

Orbit: The bony cavity of the skull contains the eyeball.

Parietal Bone: The parietal bone, when joined together, is the bone that forms the roof and sides of the two skulls.

Temporary Bones: Temporary bones support the parts of the face known as temples located at the base and sides of the skull.

Cheekbone Bone: The face is located in the upper and lateral parts of the face and contains two cheekbones that form the cheekbones.

6.7.7 Anatomy of the respiratory system

Diaphragm: A sheet of muscle that extends across the floor of the rib cage. The diaphragm separates the chest cavity containing the heart, lungs and ribs from the abdominal cavity. As the diaphragm contracts, the volume of the chest cavity increases, and air is drawn into the lungs.

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

Lungs: Human respiratory system. The conducting region of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. Respiratory zones include respiratory bronchioles, alveolar ducts, and alveoli.

nasal cavity: nasal cavity (nasal or nasal fossa) A large air-filled space in the middle of the face, in the upper and lower parts of the nose. The nasal cavity is divided in two by a vertical pin called the septum. On the sides of the nasal cavity there are three horizontal projections called the nasal conchae (singular "concha") or turbinate. At the front of the nasal cavity, there is a nose that rejoins the pharynx through the nasopharyngeal foramen.

pharynx: the part of the throat located directly behind the esophagus and posterior part of the nasal cavity

The pharynx is usually divided into three parts: the epipharynx (the nasal part of the pharynx), the mesopharynx (the mouth part of the pharynx), and the laryngopharynx.

6.7.8 Materials

Silicone or silicone elastomer: synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC manufactured by Dow Corning Corporation (included within the scope of products marketed under this trademark). Another manufacturer of LSR is Wacker. Unless otherwise specified, the preferred form of LSR has an indentation hardness of Shore A (or Type A) in the range of about 35- about 45 as measured using ASTM D2240.

Polycarbonate: Bisphenol-A carbonate A typical transparent thermoplastic polymer.

6.7.9 Characteristics of the patient interface

Asphyxiation Valve (AAV): A component or subassembly of a mask system that reduces the risk of _{excessive C0 2} when rebreathing of a patient by opening to atmosphere in a failsafe manner.

Elbow: Conduit facing the axis of airflow that changes direction at an angle. In one form, the angle may be about 90°. In another aspect, the angle may be less than or equal to 90°. The conduit may have an approximately circular cross-section. In other forms, the conduit may have an elliptical or rectangular cross-section.

Frame: Frame means a mask jaw that supports a tension load between two or more points connected to a positioning and stabilizing structure. The mask frame may be a non-sealing load-bearing structure of the mask. However, some forms of the mask frame may be sealed.

Positioning and Stabilizing Structure: Positioning and stabilizing structure refers to a form of positioning and stabilizing structure designed for use on the head. Preferably, the positioning and stabilizing structure comprises a collection of one or more struts, ties, and stiffeners configured to maintain a patient interface positioned on the patient's face for delivery of respiratory therapy. Some ties are formed from soft and flexible elastic materials such as laminated composites of foam and fabric.

Membrane: The membrane is preferably a generally thin element that is not particularly resistant to bending but resists stretching.

Plenum Chamber: A mask plenum chamber means the average portion of the patient's interface with walls enclosing a volume of space, said volume having air pressurized above atmospheric pressure in use. The shell may form part of a wall of the mask plenum chamber. In one form, the patient's facial region forms one of the walls of the plenum chamber.

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

Shell: A shell preferably means a curved structure with bending, tensile and compressive stiffness. For example, it is the portion of the mask that forms the curved structural wall of the mask. Preferably, it is relatively thin compared to its overall size. In some forms, the shell may be faceted. Preferably in some versions the wall may not be sealed, but the wall may be sealed.

Reinforcement: Reinforcement means a structural component intended to increase the flexibility of another component in at least one direction.

Strut: A strut is a component for increasing the compressibility of at least one component in another direction.

Swivel: (Noun) A subassembly of components configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, the swivel may be configured to rotate at an angle of at least 360°. In yet another form, the swivel may be configured to rotate through an angle of less than 360°. When used in the context of an air supply conduit, the subassembly of the component preferably comprises a cylindrical conduit coupled pair. Preferably, little or no airflow leaks from the swivel in use.

Ties: Ties are structural components designed to resist tension.

Vent: (Noun) Allows leakage of a controlled proportion of air from the conduit to the interior or ambient air of the mask, allowing the _{purging of exhaled carbon dioxide (C0 2} ) and supply of oxygen (0 _{2 ).}

6.7.10 Terminology used in relation to the patient interface

Curvature (of the surface): A region of a surface that has a saddle shape that curves upward in one direction and downward in the other direction is said to have negative curvature. A region of a surface with a dome that bends in the same direction in both principal directions can be said to have a positive curvature. A flat surface is one with zero curvature.

Floppy: The property of a material, structure or composite having a combination of the following characteristics: - Immediate adaptation to finger pressure.

- Unable to maintain its shape when supporting its own weight.

- non-stiffness

- Can be stretchable or elastically bent with little effort.

A floppy property may have an associated orientation. Here, a particular material, structure or composite may have floppy properties in a first direction, but may for example be rigid or rigid in a second direction orthogonal to the first direction.

Elastic: able to deform substantially elastically and release substantially all of its energy upon unloading in a relatively short time, such as 1 second.

Rigidity: Not easily deformed by finger pressure, and/or tension or load normally encountered when establishing and maintaining a patient interface that is in sealing relationship with the patient's airway entrance.

Semi-rigid: means sufficiently rigid without being substantially distorted by the effects of mechanical forces normally applied in positive pressure airway therapy.

6.8 Other remarks

The published portions of this patent document contain copyrighted material. The copyright owner has no problem facsimile reproduction by anyone of the patent document or patent specification as it appears in the Patent Office patent files or records, but otherwise reserves all copyrights. Unless the context dictates otherwise, where a range of values is provided, to the tenth of the unit of the lower limit between the upper and lower limits of that range, and any other specified or intervening value, the stated range is within the present invention. It should be understood that this includes The upper and lower limits of these intervening ranges, which may independently be included in an intervening range, are also included within the invention, subject to the limits specifically excluded within the given range.

A stated range including one or both of the above limitations is also intended to exclude either or both of the above included limitations included in the invention. Also, where the foregoing values or values are recited herein as being embodied as part of the present invention, such values may be inferred unless otherwise stated, and such values are in fact to be employed in any suitable manner to that extent. It is understood that the technology may allow or require implementation of the technology. It should also be understood that in the values recited above, any and all recitations may vary by as much as 10 to 20% by way of maximum value.

Unless defined otherwise, 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 technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the description is limited to exemplary methods and materials.

When it is recognized that a particular material is desirably used to construct a component, obvious alternative materials having similar properties may be substituted. Also, unless otherwise indicated, it is understood that any and all components described herein may be manufactured together or separately.

It is to be noted that the singular forms include plural equivalents thereof, unless the context used in the specification and claims clearly dictates otherwise.

All publications mentioned herein are incorporated by reference to describe the methods and/or materials covered by these publications. The publications described herein are provided solely for their invention prior to the filing date of this application. Nothing in this specification is to be construed as an admission that the present invention is not entitled to presuppose such disclosure by virtue of prior art. In addition, the publication date provided may differ from the actual publication date, which may require independent confirmation.

Also, in interpreting the invention, all terms are to be interpreted broadly in a reasonable manner consistent with the context. In particular, the terms "comprising", "comprising" are to be construed as indicating elements, parts or steps in a non-exclusive manner, wherein the reinforced element, component or step is not expressly recited by any other element, component or step. With the step a bond is present or used.

The subject matter used in the detailed description is included for the convenience of the reader's reference and should not be used to limit the subject matter found throughout the specification or claims. The above subject matter cannot be used to limit the interpretation of the claims or the scope of the claims.

Although the present invention has been described with reference to specific embodiments, it should be understood that the embodiments are illustrative of the application of principles and techniques. In some embodiments, descriptions of terms and symbols may refer to specific details that are not necessary for practice. For example, the terms "first" and "second" may be used and may be used to distinguish distinct elements, and are not intended solely to indicate an order, unless otherwise specified. Also, although the process steps of a methodology may be described or shown in order, such order is not required. Those skilled in the art will recognize that this order may be varied and/or features thereof may be performed simultaneously or synchronously.

Accordingly, it should be understood that numerous modifications may be made in accordance with the exemplary embodiments and other arrangements may be made without departing from the spirit and scope of the present invention.

7.1 Patent Literature

US Patent 7,743,767; US Pat. No. 7,318,437; US Patent Publication 2009/0044808; WO Publication 2000/069521; US Pat. No. 5,724,965; US Patent 6,119,694. US Patent 6,823,869; US Patent Publication 2009/0044808; WO Publication 2009/052560; WO Publication 2005/010608; US Patent 4,782,832; WO Publication 2002/11804; US Pat. No. 6,854,465; US Publication 2010/0000543; US Publication 2009/0107508; WO Publication 2011/121466; US Patent 7,562,658; EP Patent Patent Patent EP 1356841; US Publication 2012/0318270; US 8439038; US 2009/0078259; US Publication 2009/0277525; US Publication 2010/0224276; US 6,581,594; US Publication 2009/0050156; US2010/0319700; US Publication 2009/0044810.

64: weft knitted fabric 65: fiber 66: air flow meter
67: cutting tool 68: staking punch 69: laser cutter
70: mold 71: molding machine 72: vent part
73: bent portion 74: acute angle corner of bent portion 75: acute angle corner of bent portion
76: long side of the bent portion 77: obtuse corner of the bent portion
78: peripheral edge of bent portion 79: central region of bent portion
80: vertically oriented fibers 81: loose ends 82: horizontally oriented fibers
83: void 84: nominal left vent part 85: course
90: basic closed loop warp knit 100: weft knit
210: posterior part 220: strap 1000: patient
1100: bed partner 1102: knitted strap upper part
1104: a rear portion of the knitted strap 1105: a knitted strap
1106: lower part of the knitted strap 1120: connector
1150: course 1200: strap 1250: course
*2802: Linked Links 2804: Flexible 3D Printed Textiles
2900: positioning and stabilizing structural piece 2904: textile
2912(1): hole 2912: female clip 2914: female clip
*2914(1): Hole 2922: Rigidezer Arm's Hole
2924: 3D printed strap 3000: patient interface
3100: seal forming structure 3101: nose flange
3110: sealing flange 3120: supporting flange 3130: nasal pillow
3130.1 posterior segment 3140: incision cone
3142: upper flexible area 3150: stalk
3152: flexible area 3200: plenum chamber
3202: connection part 3210: front wall 3211: tongue part
3211.1: channel portion 3220: rear wall 3222: rear surface
3230: flexion region 3232: left flexion region 3234: right flexion region
3236: decoupling area 3240: plenum connection area
3242: retention structure 3244: wide retention characteristic 3245: narrow retention characteristic
3246: barbs 3246.1: leading surface 3246.2: trailing surface
3246.3: additional surface 3246.4: nominal vertical axis
3250: sealing lip 3290: pad printing
3291: embossed text 3292: concave text
*3293: pad print 3294: rib 3295: notch
3300: positioning and stabilization structure 3301: strap
3302: Rigidizer arm 3302.1: Distal free end
3303: buttonhole 3305: flexible joint
3306: protruding end 3307: shop vent
3308: opening 3309: protrusion 3310: frame
3311: pocket end 3311.1: weld end
3312: large frame connection area 3312.1: lead-in surface
3312.2: retaining surface 3313: narrow frame connection area
3313.1: weld end 3314: interference part
3315: right side strap portion 3316: left side strap portion
3317: rear strap 3317a: rear strap portion
3317b: rear strap portion 3318: inner side of the protrusion
3319: the outer side of the protrusion 3319a: the end of the rigid deezer arm
3319b: the end of the rigid deezer arm 3320: the void of the protrusion
3321: upper side of the protrusion 3321a-3321d: mark
3322: lower surface of the protrusion 3323: curved profile of the rigid deezer arm
3323a-3323e: Mark 3324: Junction
3325: reinforcement part 3326: partition area
3327: reinforcement portion 3328: rounded corners
3329: Rigidezer arm recess 3333: Rigidezer arm main section
3335: opening of frame 3350: extension
3351: straight section of extension 3352: bend of extension
3353: hook of the extension 3354: encapsulating section of the extension
3355: outer surface of the extension 3356: joint
3357; Strap Logo 3358: Cover
3359: flange 3361: stem
3363: first section of extension 3364: second section of extension
3365: first projection of second section 3366: second projection of second section
3367: first slot in second section 3368: second slot in second section
3400: vent 3600: connection port
4000: PAP device 4100: outer housing
4012: upper portion of the outer housing 4014: lower portion of the outer housing
4015: panel 4016: chassis
4018: handle 4020: pneumatic block
4100: pneumatic element 4112: intake air filter
4142: control blower 4170: air circuit
4172: web of material 4174: spiral coil
4176: inner part of the bend 4178: long tube
4179: outer part of the bend 4180: short tube
4181: indented portion 4182: peak of fold
4183: inclined portion 4184: outer surface of the spiral coil
4185: make-up oxygen port 4186: fold line
4190: rotation adapter 4200: electrical element
4202: printed circuit assembly (PCBA) 4210: electrical power supply
4220: input device 5000: humidifier

Claims (20)

A patient interface comprising:
a frame comprising a connection port sized and configured to receive a flow of air at a therapeutic pressure of _{at least 4 cm H 2} O above atmospheric pressure for respiration by a patient;
a plenum chamber pressurizable to said treatment pressure and removably connected to a frame;
constructed and arranged to seal against a patient's face around the patient's nostrils such that a stream of air at said therapeutic pressure is delivered to the patient's nostrils, and in use to maintain therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; the seal forming structure constructed and arranged, the seal forming structure and the plenum chamber are molded into a single unique component;
a vent structure formed on the frame and configured to pass a continuous flow of gas exhaled by the patient to the periphery within the plenum chamber and sized and shaped to maintain a treatment pressure in the plenum chamber in use;
A positioning and stabilizing structure configured to maintain the seal forming structure in a therapeutically effective position on a patient's face, the positioning and stabilizing structure having a pair of rigidiser arms connected to a frame and a strap removably connected to the pair of rigiddiser arms, the positioning and stabilizing structure comprising: the strap may extend in length and is constructed and arranged such that at least a portion overlies a corresponding lateral region of the patient's upper head relative to the patient's upper autobasis in use;
a retaining structure integrally molded to the plenum chamber and configured to removably connect the plenum chamber to a frame; and
a gas delivery tube connected to the frame at the connection port and configured to direct a flow of air at a treatment pressure to the plenum chamber;
the patient interface is configured to leave the patient's mouth uncovered;
the seal forming structure and the plenum chamber are formed of a first silicone material, and the retaining structure is formed of a second silicon material having a hardness higher than that of the first material, so that the retaining structure is more rigid than the seal forming structure and the plenum chamber; and
wherein the plenum chamber further comprises a sealing lip configured to engage the frame such that an increase in air pressure in the plenum chamber increases a sealing force between the sealing lip and the frame. The patient interface of claim 1 , wherein the patient interface does not include a forehead support. The patient interface of claim 1 , wherein the frame is constructed of a plastic material. 4. The patient interface of claim 3, wherein the plastic material is polypropylene. 4. The patient interface of claim 3, wherein the rigidizer arm is constructed of a flexible material that cannot be integrally coupled to the plastic material of the frame. 6. The patient interface of claim 5, wherein the plastic material of the frame is overmolded to the flexible material of the rigid arm to permanently connect the frame and the rigid arm with a mechanical interlock. 6. The patient interface of claim 5, wherein the flexible material is a thermoplastic elastomer. The patient interface of claim 1 , wherein the frame is overmolded to the rigid arm and permanently connects the frame and the rigid arm with a mechanical interlock. The patient interface of claim 1 , wherein the seal forming structure is configured to not enter the patient's nostrils during use. 2. The method of claim 1, wherein the frame further comprises a channel portion and the retaining structure further comprises a tongue portion, the tongue portion configured to releasably engage the channel portion in a tongue and groove arrangement. with the patient interface. The patient interface of claim 1, wherein the vent structure further comprises two groups of vent holes, each group of vent holes located on a corresponding side of the connection port. The patient interface of claim 1 , wherein the frame is molded into the gas delivery tube to permanently connect the frame and the gas delivery tube. The patient interface of claim 1 , wherein the strap is comprised of a textile material. 14. The patient interface of claim 13, wherein the textile material further comprises an elastic material such that the strap is elastically stretchable. 14. The patient interface of claim 13, wherein the textile material is warp knit such that the strap is elastically stretchable. 14. The patient interface of claim 13, wherein the strap further comprises a pair of side strap portions, each side strap portion configured to be positioned along a corresponding side of the patient's head in use. 17. The method of claim 16, wherein each side strap portion has a tubular structure and a hole in its corresponding free end, and
and each rigidizer arm is inserted into a corresponding side strap portion. 18. The rigidizer arm of claim 17, wherein the free end of each side strap portion connects each side strap portion to a corresponding rigidizer arm such that each rigidizer arm imparts its curvature to the corresponding side strap portion. engaging a corresponding one, wherein each side strap portion is elastic relative to a corresponding rigidiser arm. 18. The patient interface of claim 17, wherein the free end of each side strap portion surrounds and abuts a portion of the corresponding rigidizer arm to limit movement of the strap relative to the corresponding rigidizer arm. The method of claim 1,
the patient interface does not include a forehead support;
The frame is made of plastic material and the frame is overmolded on the rigidizer arm to permanently connect the frame and the rigidizer arm with a mechanical interlock.
The seal-forming structure is configured not to enter the patient's nostrils during use,
the frame further includes a channel portion and the retaining structure further includes a tongue portion, the tongue portion configured to releasably engage the channel portion in a tongue and groove arrangement;
The vent structure further includes two groups of vent holes, each group of vent holes located on a corresponding side of the connecting port,
The frame is molded into the gas delivery tube to permanently connect the frame and the gas delivery tube,
The strap is made of textile material,
the strap further comprises a pair of side strap portions, each side strap portion configured to be positioned along a corresponding side of the patient's head in use;
each side strap portion has a tubular structure and a hole in its corresponding free end;
Each Rigidizer arm is inserted into the corresponding side strap,
the free end of each side strap portion engages a corresponding one of the rigidiser arms to connect each of the side strap portions to a corresponding rigidiser arm such that each rigidizer arm imparts its curvature to the corresponding side strap portion;
Each side strap section is stretchable against the corresponding Rigidizer arm,
and the free end of each side strap portion surrounds and abuts a portion of the corresponding rigidizer arm to limit movement of the strap relative to the corresponding rigidizer arm.

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