Oral-nasal patient interface
By designing a decoupled structure for the nasal and oral air chambers, combined with a top plate and a front panel, the sealing is optimized and the skin contact area is reduced, solving the comfort and sealing problems of existing patient interface devices, and improving treatment compliance and user experience.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- RESMED PTY LTD
- Filing Date
- 2014-05-14
- Publication Date
- 2026-06-19
AI Technical Summary
Existing patient interface devices have problems such as poor comfort, unsightly appearance, difficulty in use, poor sealing, and high noise when treating respiratory disorders, which affect the user experience, especially when worn for a long time.
A patient interface system was designed, comprising a nasal inflation chamber and an oral inflation chamber connected by a decoupled structure. The system utilizes a combination of a top plate and a front panel to provide a releasable positioning and stabilizing structure. The design employs a gradient of flexibility and hardness to reduce skin contact area and increase comfort. Furthermore, the system adapts to different face shapes through optimized sealing and noise reduction design.
It improves patient comfort and treatment compliance, reduces seal leakage and noise, enhances the user experience, is highly adaptable, easy to install and adjust, and suitable for a wide range of people.
Smart Images

Figure CN122230176A_ABST
Abstract
Description
[0001] This application is a divisional application of application No. 202210058541.4, filed on May 14, 2014, entitled "Oral-Nose Patient Interface". Application No. 202210058541.4 is a divisional application of application No. 201810310617.1, filed on May 14, 2014, entitled "Oral-Nose Patient Interface". Application No. 201810310617.1 is a divisional application of application No. 201480028435.5 (international application No. PCT / AU2014 / 050036), filed on May 14, 2014, entitled "Oral-Nose Patient Interface". Technical Field
[0002] This technology relates to the diagnosis, treatment, and improvement of one or more respiratory disorders, and to procedures for the prevention of respiratory disorders. Specifically, this technology relates to medical devices and their use for the treatment and prevention of respiratory disorders. Background Technology
[0003] The human respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.
[0004] The respiratory tract consists of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide into terminal bronchioles. The bronchi form the conduction airway and do not participate in gas exchange. Further branching of the respiratory tract forms the respiratory bronchioles, which eventually lead to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. Please refer to the English version of John B. See *Essentials of Respiratory Physiology*.
[0005] Multiple respiratory disorders Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by upper airway obstruction during sleep. This occurs during sleep due to a combination of abnormal small upper airways and loss of normal muscle tone in the tongue region, soft palate, and posterior pharyngeal wall. This symptom typically causes affected patients to stop breathing for 30 to 120 seconds each night, sometimes 200 to 300 seconds. This often causes excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Complications include general disturbances, particularly in middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).
[0006] Cheyne-Stokes respiration (CSR) is a disorder of the respiratory system's regulatory system, characterized by rhythmic alternations of peak and trough ventilation, resulting in repeated hypoxia and reoxygenation of arterial blood. Cheyne-Stokes respiration is potentially harmful due to the repetitive oxygen deprivation. In some patients, CSR is associated with recurrent awakenings from sleep, which can cause severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).
[0007] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known factors contributing to hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.
[0008] Chronic obstructive pulmonary disease (COPD) encompasses any of several lower respiratory tract diseases that share common specific characteristics. These include increased resistance to airflow, prolonged expiratory phase, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: exertional dyspnea, chronic cough, and sputum production.
[0009] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some neuromuscular diseases are characterized by progressive muscle damage leading to reduced mobility (requiring a wheelchair), dysphagia, respiratory muscle failure, and ultimately, respiratory failure resulting in death. Neuromuscular diseases can be classified as rapidly progressive or chronically progressive: (i) rapidly progressive disorders: characterized by worsening muscle damage over several months and causing death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive disorders: characterized by worsening muscle damage over several years and only slightly reducing the likelihood of life expectancy (e.g., limb-girdle type, face-shoulder-arm type, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.
[0010] Thoracic defects are chest impairments that cause inefficient coupling between the respiratory muscles and the thoracic cavity. These defects are typically characterized by localized deficits and carry the potential for chronic hypercapnia-related respiratory failure. Scoliosis and / or posterior scoliosis can contribute to severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and decreased appetite.
[0011] In other respects, healthy individuals can use systems and devices to avoid respiratory distress.
[0012] system One known product for treating SDB is the ResMed S9 Sleep Therapy System.
[0013] treat Nasal continuous positive airway pressure (CPAP) therapy has been used to treat sleep apnea (OSA). It is assumed that CPAP acts like an air splint and prevents upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior pharyngeal wall.
[0014] Non-invasive ventilation (NIV) has been used to treat OHS, COPD, MD, and chest wall disorders.
[0015] Patient Interface Applying positive pressure air to the patient's airway inlet can be achieved using a patient interface (such as a nasal mask, full nasal mask, or nasal pillow). Various patient interface devices are known, but some suffer from one or more issues such as being unsightly, aesthetically unappealing, difficult to install, unusable, or uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Nasal masks designed for pilots as part of their personal protective equipment or for administering anesthetics allow for their original use, but prolonged wear can still be uncomfortable, for example, while sleeping.
[0016] Traditional nasal masks include full nasal masks or ResMed LIBERTY full nasal masks. Due to their size and bulk, these masks can be uncomfortable and more interfering than other masks, potentially causing discomfort for physiological reasons, including claustrophobia. Nasal masks are typically large and bulky, and can affect patient comfort and interfere with eyeglasses wear.
[0017] Sealing Formation Patient interfaces typically include a sealing formation.
[0018] One type of sealing structure extends near the periphery of the patient interface and, when force is applied to the patient interface of the sealing structure connected to the user's face, seals against the user's face. The sealing element may consist of a cushion filled with air or liquid, or a molded or formed surface of an elastic sealing component made of an elastomer, such as rubber. With this type of sealing element, if not properly applied, gaps may exist between the sealing structure and the face, requiring external force to bring the patient interface towards the face to achieve a seal.
[0019] Another type of seal-forming structure incorporates a flap seal made of thin material, positioned near the periphery of the nasal mask to provide a self-sealing effect against the user's face when positive pressure is applied inside the nasal mask. Similar to previous designs of the seal-forming part, if the fit between the face and the nasal mask is poor, external force may be required to achieve a seal, or the nasal mask may leak. Furthermore, if the shape of the seal-forming part does not conform to the patient's shape, creases or deformation may occur during use, leading to leaks.
[0020] Another form of sealant can be created using an adhesive. Some patients may find it inconvenient to frequently apply and remove facial adhesive.
[0021] A series of patient interface sealing structure technologies are disclosed in the following patent applications, which have been assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.
[0022] Positioning and stability The sealing structure of patient interfaces used in positive air pressure therapy is affected by the corresponding force of air pressure, thus influencing the seal. Various techniques have been used to position the seal formation and maintain a tight seal with appropriate areas of the face.
[0023] One technique involves using a bonding agent. See, for example, US patent application US 2010 / 0000534.
[0024] Another technique involves using one or more webbing straps with a stabilizing shoulder strap. Many of these shoulder straps suffer from one or more issues such as improper handling, discomfort, and clumsy use.
[0025] Ventilation port technology Some forms of patient interface systems may include ventilation ports that allow the expulsion of carbon dioxide from exhaled gases. Many of these ventilation ports are noisy. Others may be unusable and do not provide sufficient expulsion capacity. Some ventilation ports, for example, may disrupt the sleep of the patient's bed partner due to noise or concentrated airflow.
[0026] ResMed Limited has developed numerous improved nasal mask ventilation technologies. See WO 1998 / 034,665; WO 2000 / 078,381; US 6,581,594; US Patent Application; US 2009 / 0050156; US Patent Application 2009 / 0044808.
[0027] The previous nasal mask noise meter (ISO 17510-2:2007, 10cm H2O pressure at 1m)
[0028] (*Only one sample was measured in 10 cmH2O using CPAP mode and the test method specified in ISO 3744.) The sound pressure levels of various objects are shown below:
[0029] Nasal pillow technology One type of nasal pillow can be referenced to the AdamCircuit manufactured by Puritan Bennett. Another nasal pillow, or nasal spray, is the subject of U.S. Patent 4,782,832 (Trimble et al.), which has been assigned to Puritan Bennett.
[0030] ResMed Limited manufactures the following products incorporating nasal pillows: the SWIFT nasal pillow cover, the SWIFT LT nasal pillow cover, the SWIFT FX nasal pillow cover, and the LIBERTY full nasal pillow cover. The following patent applications (assigned to ResMed Limited) describe nasal pillow covers: International Patent Application WO 2004 / 073,778 (describes, among other things, the ResMed SWIFT nasal pillow); U.S. Patent Application 2009 / 0044808 (describes, among other things, the ResMed SWIFT LT nasal pillow); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describe the ResMed LIBERTY full nasal pillow cover and others); and International Patent Application WO 2009 / 052,560 (describes, among other things, the ResMed SWIFT FX nasal pillow cover and others). Summary of the Invention
[0031] This technology is aimed at providing medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more advantages in terms of improved comfort, cost, efficiency, ease of use and manufacturability.
[0032] This technology relates to a patient interface for providing breathable gas to a patient. The patient interface may include: an inflation chamber assembly comprising: a nasal inflation chamber at least partially defining a first air chamber surrounding the patient's nose, the nasal inflation chamber forming contact with the area below the nasal columella and the lower periphery of the nose; an oral inflation chamber at least partially defining a second air chamber surrounding the patient's mouth; and a decoupling structure at least partially connecting the nasal inflation chamber and the oral inflation chamber, and at least partially defining flow paths between the nasal inflation chamber and the oral inflation chamber, the decoupling structure decoupling relative movement between the nasal inflation chamber and the oral inflation chamber; a top plate operatively connected to the inflation chamber assembly in the nasal inflation chamber, including at least one connecting member forming a first portion of a releasably retainable positioning and stabilizing structure; and a front panel operatively connected to the inflation chamber assembly in the oral inflation chamber, forming a second portion of a releasably retainable positioning and stabilizing structure, wherein the top plate and the front panel are rigider than the inflation chamber assembly.
[0033] In the example, (a) the flow path may pneumatically connect the first air chamber and the second air chamber; (b) the top plate and the adjacent front panel are releasably connected to the inflation chamber assembly; (c) the positioning and stabilizing structure may include a retaining arm assembly having a pair of retaining arms that can be connected to the top plate; (d) each of the pair of retaining arms is allowed to bend in a plane parallel to the patient's transverse plane, and each of the pair of retaining arms may be configured to prevent bending, twisting, and / or stretching in a plane perpendicular to the patient's transverse plane; (e) each of the retaining arms may have an elliptical profile to conform to the curvature of the patient's cheek; (f) the nasal inflation chamber may include a nasal flange that defines a nasal opening and may be configured to form a seal at least on the patient's nose. (g) The nasal flange may include a recess for receiving the tip of the patient's nose; (h) The oral inflation chamber may include an oral flange defining an orifice and configured to form a seal at least on the patient's mouth; (i) The oral flange may form around the entire periphery of the oral inflation chamber, or around two opposite sides of the periphery of the oral inflation chamber, or around a large portion of the periphery of the oral inflation chamber; (j) The oral inflation chamber may include a pair of suboral pads, each disposed on a corresponding side of the oral inflation chamber to support the oral flange; (k) The oral inflation chamber may include suboral pads disposed near the oral inflation chamber and extending radially from each end of the decoupling structure to support the oral flange; (j) The decoupling structure may connect the nasal flange and the oral flange; (k) The decoupling structure may include a top surface, a bottom surface, and a connecting surface, the connecting surface having a harderness than the top surface and the bottom surface; (l) The portion of the decoupling structure relative to the patient's face may be harder than the portion adjacent to the patient's face; (m) The hardness of the decoupling structure increases radially from the portion adjacent to the patient's face to the portion relative to the patient's face; (n) The nasal contact portion of the nasal flange may be harder in the portion not in contact with the patient's nose than the portion of the nasal flange not in contact with the patient's nose; (o) The nasal flange may increase in hardness outward from the nasal opening; (p) The nasal flange has different hardness around the nasal opening at a predetermined position; (q) The lower portion of the nasal flange near the decoupling structure may be concave to seal against the patient's upper lip; (r) The nasal flange The nasal inflator may include a pair of protruding ends extending symmetrically near the nasal opening, each protruding end forming a corresponding nasal ala sealed in the patient's nose; (s) the nasal inflator may include a pair of subnasal pads, each of the pair of subnasal pads supporting one of the pair of protruding ends; (t) each of the subnasal pads may be disposed on the upper part of the oral inflator; (u) the patient interface may include a headband for releasably securing the patient interface to the patient, the headband including: a pair of top straps forming a connection to the nasal inflator; and a pair of lower straps forming a connection to the oral inflator; (v) the top plate may be permanently connected to the nasal inflator; (w) the top plate may be detachably connected to a soft connection area of the nasal inflator; (x) the top plate may be detachably attached to a hard connection area of the nasal inflator.And / or (y) the top plate and the retaining arm may be integral, and for the top plate, the retaining arm is flexible in a plane parallel to the patient's transverse plane.
[0034] Another aspect of this technology relates to a patient interface for providing breathable gas to a patient. The patient interface may include: a nasal pad for at least partially defining a nasal air chamber; a mouth pad for at least partially defining an oral air chamber, distinct from the nasal air chamber; a decoupling structure disposed between the nasal pad and the mouth pad; a top plate fixed to the nasal pad; and a pair of upper attachment members forming a pair of upper straps releasably attached to the positioning and stabilizing structure to the top plate; a front panel fixed to the mouth pad; and a pair of lower attachment members forming a pair of lower straps releasably attached to the positioning and stabilizing structure.
[0035] In the example, (a) the decoupling structure is adapted to form a pneumatic connection between the nasal air chamber and the oral air chamber; (b) the decoupling structure may include a top surface, a bottom surface, and a connecting surface, the connecting surface being more rigid than the top surface and the bottom surface; (c) the rigidity of the decoupling structure is radially varied in its periphery, such that the portion distal to the patient's face is harder than the portion proximal to the patient's face, and the nasal pad can be configured to move independently of the oral pad; (d) the nasal contact portion of the nasal pad may not be harder than the portion of the nasal pad that does not contact the patient's nose; (e) the decoupling structure may be configured to support the nasal pad on the patient's nose; (f) the portion of the nasal pad that does not contact the patient's nose may be harder than the portion that contacts the patient's nose; (g) the nasal pad may include a recess to seal the patient's upper lip; (h) (i) The nose pad may include a pair of protruding ends, each of which forms a seal between a corresponding nasal ala and a nasolabial groove on the patient's face; (i) The nose pad may include a pair of subnasal pad portions, each disposed below each corresponding protruding end to support each corresponding protruding end on the patient's face; (j) The nose pad may include wings on each side of the nose pad to seal each nasal ala of the patient's nose; (k) The mouth pad may include suboral pad portions extending radially from either end of the decoupling structure near the mouth pad to support the mouth pad on the patient's face; (l) The mouth pad may include a pair of suboral pad portions, each disposed on a corresponding side of the mouth pad to support the mouth pad on the patient's face; (m) The nose pad may be shaped to include a recess that forms a reception of the patient's nasal tip; (n) The nose pad may include a pair of suboral pad portions, each of which forms a seal between a corresponding nasal ala and a nasolabial groove on the patient's face; The pad may form the lower periphery of the patient's nose below the nasal columella; (o) the nasal pad, the mouth pad, and the decoupling structure may be integral; (p) the top plate may be permanently connected to the nasal inflator chamber; (q) the top plate is detachably attached to a soft connection area of the nasal inflator chamber; (r) the top plate is detachably attached to a hard connection area of the nasal inflator chamber; (s) the top plate and the retaining arm assembly may be integral, and a pair of retaining arms of the retaining arm assembly are bendable in a plane parallel to the patient's transverse plane relative to the top plate; (t) the positioning and stabilizing structure may include a retaining arm assembly releasably attached to the top plate on the upper attachment member; (u) the patient interface may include a frame portion detachably attached to the front panel, and the lower attachment member may be disposed on the frame portion; (v) (w) Each of the lower attachment components may include a mating portion having a mating magnet for releasably engaging a corresponding clamp of the positioning and stabilizing structure, and each of the corresponding clamps may include an oriented clamp magnet such that the mating portion engages the corresponding clamp when each clamp magnet magnetically attracts each mating magnet; (w) the patient interface may include: a top plate buffer for shock absorption at the connection between the top plate and the retaining arm assembly; and a front panel buffer for shock absorption at the connection between the front panel and the frame portion; and / or (x) the frame portion may be shaped to engage around the periphery of the front panel, the frame portion may include a latch, and the front panel includes a notch, and engagement between the latch and the notch engages the frame portion on the front panel.
[0036] Another aspect of this technology relates to a patient interface for providing breathable gas to a patient. The patient interface may include: an inflation chamber assembly comprising: a nasal inflation chamber at least partially defining a first air chamber adapted to be sealed below the nasal columella and around the lower periphery of the patient's nose; and an oral inflation chamber at least partially defining a second air chamber operatively connected to the nasal inflation chamber; and a single plate member having: an upper portion releasably attached to the nasal inflation chamber; and a lower portion detachably attached to the oral inflation chamber; wherein the upper portion of the plate member includes at least one connecting member constituting a first portion releasably retaining a positioning and stabilizing structure having a pair of retaining arms, and the lower portion of the plate member constituting a second portion releasably retaining the positioning and stabilizing structure.
[0037] In the example, (a) the inflatable chamber assembly may include a decoupling structure that at least partially connects the nasal inflatable chamber and the oral inflatable chamber, the decoupling structure at least partially defining a flow path between the nasal inflatable chamber and the oral inflatable chamber; (b) each of the pair of retaining arms is allowed to bend in a plane parallel to the patient's transverse plane, and each of the pair of retaining arms may be configured to prevent bending, twisting, and / or stretching in a plane perpendicular to the patient's transverse plane; (c) each of the at least one connecting member may include a hinge to allow a corresponding one of the pair of retaining arms to rotate relative to the upper part of the rigid plate of the unit plate member in a plane parallel to the patient's transverse plane; (d) positioning and The first portion of the stabilizing structure may include hooks for pivotally connecting the upper connecting member of the unit plate member; (e) the nasal inflator may include a nasal flange defining a nasal opening and configured to form a seal at least on the patient's nose; (e) the nasal flange may include a recess for receiving the tip of the patient's nose; (f) the oral inflator may include an oral flange defining an oral opening and configured to form a seal at least on the patient's mouth; (g) the oral flange may be formed around the entire periphery of the oral inflator, on two opposite sides of the periphery of the oral inflator, or on a large portion of the periphery of the oral inflator; (h) the oral inflator may include a pair of under-mouth pads. Each of the following components is disposed on a corresponding side of the oral inflation chamber to support the oral flange; (i) the oral inflation chamber may include a suboral pad disposed around the oral inflation chamber and extending radially from each end of the decoupling structure to support the oral flange; (j) the decoupling structure may connect the nasal flange and the oral flange; (k) the portion of the decoupling structure relative to the patient's face may be harder than the portion adjacent to the patient's face; (l) the hardness of the decoupling structure increases radially from the portion adjacent to the patient's face to the portion relative to the patient's face; (m) the nasal contact portion of the nasal flange may be harder in the portion not in contact with the patient's nose than in the portion of the nasal flange not in contact with the patient's nose; (n) (o) The nasal flange may increase in rigidity outward from the nasal opening; (p) The nasal flange has different rigidity around the nasal opening at a predetermined location; (q) The lower portion of the nasal flange near the decoupling structure may be concave to seal the patient's upper lip; (r) The nasal flange may include a pair of protruding ends that extend symmetrically near the nasal opening, each protruding end forming a corresponding nasal ala that seals the patient's nose; (s) The nasal inflation chamber may include a pair of nasal pads, each corresponding to each protruding end to support each protruding end; (t) Each of the nasal pads may be disposed on the upper part of the nasal inflation chamber; and / or (t) Each of the pair of retaining arms may have an elliptical concave surface between a first end and a second end.
[0038] Another aspect of this technology relates to a pad assembly for a patient interface used to treat sleep apnea, comprising: a nose pad engaging a nasal air chamber, the nose pad forming a seal around the lower periphery of the patient's nose; a mouth pad engaging an oral air chamber, the mouth pad forming a seal around the patient's mouth; a decoupling structure connecting the nose pad and the nasal air chamber to the mouth pad and the oral air chamber, the decoupling structure allowing the nose pad and the nasal air chamber to move relative to the mouth pad and the oral air chamber; and a pair of side supports, each of the side supports located on opposite sides of the nose pad and engaging the nose pad. A corresponding side portion to the mouth pad; a pair of lower pad support walls that provide support for the protruding end of the nose pad; and a pair of recesses, each of the recesses located on an opposite side of the nose pad, each of the recesses including a top surface defined by the nose pad and the nasal inflation chamber, each of the recesses including a bottom surface defined by the mouth pad and the oral inflation chamber, and each of the recesses including a side surface defined by the decoupling structure and corresponding portions of the opposite side support, wherein, when the patient wears the patient interface, the opening of each of the recesses is located relative to the patient's face.
[0039] In the example, (a) each of the opposing supports may include a notch to provide a pivot point for relative movement between the nose pad and the mouth pad; (b) the notch of each of the opposing supports may be open in a direction relative to the patient's face when the patient wears the patient interface; (c) the nose pad may include a pair of hardened segments, each of the pair of hardened segments may be located on opposite sides of the nasal cavity, and the hardened segments may be harder than the rest of the nose pad; (d) the pair of hardened segments may include a thickness greater than the rest of the nose pad; (e) the (f) The hardened segment may extend inward relative to the nasal pad and the nasal inflation chamber, such that the outer surface of the nasal pad does not protrude; (g) The nasal pad may include a nasal suspensory band formed coplanar with the nasal pad and constituting contact with the patient's columella; (h) The nasal pad and the nasal suspensory band may define a pair of nasal ports, each of the pair of nasal ports constituting a corresponding one of the patient's nostrils in pneumatic communication; and / or (h) The nasal suspensory band may prevent the tip of the patient's nose from extending into the nasal inflation chamber, which is at least partially defined by the nasal pad and the nasal inflation chamber.
[0040] Another aspect of this technology relates to a patient interface system for providing breathable gas to a patient. The patient interface may include: a pad assembly that may include: a nasal pad for at least partially defining a nasal air chamber; a mouth pad for at least partially defining an oral air chamber, distinct from the nasal air chamber; and a decoupling structure disposed between the nasal pad and the mouth pad; a positioning and stabilizing structure having a pair of underside bands; and a pair of lower attachment members configured to releasably attach a respective one of the pair of underside bands of the positioning and stabilizing structure to the pad assembly, wherein each of the pair of lower attachment members includes a thermoplastic elastomer, and each of the pair of lower attachment members has a first magnet embedded therein.
[0041] In an example, (a) the patient interface system may include: a front panel fixed to the mouthpiece; and a frame releasably attached to the front panel, wherein the pair of underattachment members are fixed to the frame; (b) the frame may include a material harder than a thermoplastic elastomer; (c) the pair of underattachment members may be molded into the frame; (d) the positioning and stabilizing structure may include a pair of clamps for attaching a corresponding one of the underattachment straps to a corresponding one of the underattachment members; (e) each of the clamps may include a second magnet for attaching... (f) Each of the pair of clamps may include a notch, and each of the pair of lower attachments may include a protrusion, and the protrusion may engage the notch when each of the pair of clamps engages the corresponding one of the pair of lower attachments; (g) Each of the pair of lower attachments may include a bend point, and each of the pair of lower attachments is configured to bend at the bend point; and / or (h) Each of the pair of lower attachments may include a region where the thickness is reduced at the bend point.
[0042] Another aspect of this technology relates to a patient interface for providing breathable gas to a patient. The patient interface may include: a nose pad for at least partially defining a nasal air chamber; a mouth pad for at least partially defining an oral air chamber, distinct from the nasal air chamber; a decoupling structure disposed between the nose pad and the mouth pad; a top plate fixed to the nose pad; and a retaining arm assembly releasably attached to the top plate, wherein the retaining arm assembly engages with the top plate at at least three contact points.
[0043] In the example, (a) the top plate may include a pair of upper attachment members, and the retaining arm assembly may include a pair of connecting members, each of the connecting members constituting an engagement of a corresponding one of the upper attachment members; (b) the retaining arm assembly may include a protrusion that engages the top plate when the retaining arm assembly engages the top plate; (c) the patient interface may include a top plate buffer to dampen the engagement between the retaining arm assembly and the top plate, the top plate buffer being located on the front side of the top plate to contact the rear side of the retaining arm assembly; (d) the top plate buffer and the nose pad may be integral, the top plate buffer extending from the nose pad across the top plate; (e) the retaining arm assembly may include a pair of retaining arms, each of the retaining arms constituting an upper band for receiving positioning and stabilizing structures; and / or (f) each of the retaining arms may include a pad to cushion the pair of retaining arms against the patient's face.
[0044] Another aspect of this technology relates to a patient interface for providing breathable gas to a patient. The patient interface may include: a nasal pad for at least partially defining a nasal air chamber; a mouth pad for at least partially defining an oral air chamber, distinct from the nasal air chamber; and a decoupling structure disposed between the nasal pad and the mouth pad, wherein the decoupling structure includes: a top surface engaging the decoupling structure to the nasal pad; a bottom surface engaging the decoupling structure to the mouth pad; and a connecting surface engaging the top surface and the bottom surface, wherein the top surface and the bottom surface are of substantially the same thickness, and wherein the connecting surface is thicker than the top surface and the bottom surface.
[0045] In the example, (a) the connecting surface may be approximately twice the thickness of the top and bottom surfaces; (b) the decoupling structure may be flexible such that the top and bottom surfaces can be positioned relative to each other at up to 50°; and / or (c) the top and bottom surfaces may be approximately 0.5 mm thick, and the connecting surface may be approximately 1.2 mm thick.
[0046] In another form of this technology, the patient interface is molded or formed with a clearly defined peripheral shape to conform to the peripheral shape of the intended wearer. This patient interface system may have a reduced number of parts compared to currently available patient interface systems. If the front panel is translucent or transparent, the patient interface system provides a visible mouth area for the patient. This patient interface system is an oronasal mask, meaning it covers both the nasal airway and the mouth. It does not obstruct the patient's vision, is considered physiologically non-threatening, and increases patient system choice and treatment compliance. The patient interface system can be flexible to accommodate jaw movement and head position throughout the night. The patient interface system provides a pressurized air or breathable gas supply to the patient's nasal passage and prevents or reduces mouth leakage by providing an effective seal between the patient's mouth and nasal passage.
[0047] Compared to the most well-known full-face mask, another form of this technology features a reduced skin contact area and fewer points of contact across the face at the patient interface. This allows for significantly reduced headband tension, resulting in a marked improvement in patient comfort. Patient comfort can be further enhanced because patients are less likely to experience claustrophobia, especially with the removal of any major areas near the eyes.
[0048] Another form of this technology is the patient interface, which can be quickly and easily adapted to all customer groups, including patients, home medical device dealers, and clinicians. For clinicians and dealers, it simplifies nasal mask selection due to its superior ease of use (fit, seal, size selection, sometimes at a distance) and intuitive assembly, allowing for self-installation even in uninstructed, unhelpful environments. The patient interface can have one primary size suitable for most general adult patient populations, and no more than two additional sizes. These three patient interface sizes will fit at least 90% of the general adult population.
[0049] Of course, portions of the aforementioned state pattern can form sub-state patterns of this technology. In addition, sub-state patterns and / or different states can be combined in various ways and also constitute additional states or sub-state patterns of this technology.
[0050] Other features of this technology will become clearer from the following embodiments, the invention abstract, the brief illustrations, and the content covered in the claims. Attached Figure Description
[0051] This technology is illustrated by way of example (and not limitation) in the accompanying drawings, wherein like reference numerals denote similar components, including: Treatment System Figure 1a The system according to this technology is displayed. Patient 1000 wears patient interface 3000 and receives a positive pressure gas supply from PAP device 4000. The air from PAP device 4000 is humidified in humidifier 5000 and delivered to patient 1000 along air duct 4170. Bed companion 1100 is also displayed simultaneously.
[0052] Figure 1b The PAP device is shown to be used in patients wearing nasal masks.
[0053] Figure 1c The PAP device is shown to be used in patients wearing full nasal masks.
[0054] treat Respiratory system Figure 2a This provides an overview of the human respiratory system, including the nasal cavity, oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and transverse nasal septum.
[0055] Figure 2b A diagram showing the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alaural cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.
[0056] Facial Anatomy Figure 2c A frontal view of a face with some surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth.
[0057] Figure 2d This is a side view of the head with some surface anatomical features, including the saddle, bridge of the nose, tip of the nose, subnasal point, upper lip, lower lip, supramenton, nasal tip, upper auricular point, and lower auricular point. The directions of up, down, front, and back are also indicated.
[0058] Figure 2e A further side view of the head indicates the approximate position of the eye-ear horizontal plane relative to the angle between the nose and lips.
[0059] Figure 2f Showing the subnasal dot diagram.
[0060] Figure 2g A side view showing the surface features of the nose.
[0061] Figure 2h This shows the subcutaneous structures of the nose, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, and fibroadipose tissue.
[0062] Figure 2i This shows the medial anatomy of the nose, approximately a few millimeters from the sagittal plane, within which the medial crura of the septal cartilage and the greater wing cartilage are displayed.
[0063] Figure 2j Shows a frontal view of the skull, including the jawbone, temporal bone, nasal bone, and zygomatic bone. Also indicated are the nasal turbinate bones, such as the maxilla, mandible, and mental protuberance.
[0064] Figure 2k This view shows a side view of the skull, including the surface outline and some muscles. The following bones are shown: jawbone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, skull, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masticatory muscle, sternocleidomastoid muscle, and trapezius muscle.
[0065] Figure 2l Anterior view showing the skull and its tissue structures.
[0066] Patient Interface Figure 3a A perspective view showing the patient interface according to one of the embodiments of this technology.
[0067] Figure 3b Displays a front view of the patient interface according to one of the embodiments of this technology.
[0068] Figure 3c A rear view of the patient interface according to one of the embodiments of this technology is displayed.
[0069] Figure 3d A top view of the patient interface according to one of the embodiments of this technology is shown.
[0070] Figure 3e A bottom view showing the patient interface according to one example of this technology.
[0071] Figure 3f A side view of the patient interface according to one of the embodiments of this technology is shown.
[0072] Figure 3gA perspective view showing a patient interface with air tubing according to one example of this technology.
[0073] Figure 3h Showing a rear view of a patient interface with air tubing according to one example of this technology.
[0074] Figure 3i Showing a front view of a patient interface containing air tubing according to one example of this technology.
[0075] Figure 3j Showing a top view of a patient interface with air tubing according to one example of this technology.
[0076] Figure 3k Showing a bottom view of a patient interface containing air tubing according to one example of this technology.
[0077] Figure 3l Showing a side view of a patient interface containing air tubing according to one example of this technology.
[0078] Figure 3m A perspective view showing a patient interface containing an air tubing worn by the patient, according to one example of this technology.
[0079] Figure 3n Showing a front view of a patient interface containing an air tube worn by an empty patient, according to one example of this technology.
[0080] Figure 3o Showing a side view of a patient interface containing an air tubing worn by the patient, according to one example of this technology.
[0081] Figure 3p Showing a top view of a patient interface containing an air tubing worn by the patient, according to one example of this technology.
[0082] Figure 3q This diagram shows a patient interface according to the technology of the present invention, with the patient interface located at a side cross-section near the patient's face. It provides a cross-sectional view of the patient's airway.
[0083] Figure 3r This is a detailed front perspective view of a portion of the patient interface according to one example of the present technology. The patient interface is shown with dashed lines, and the patient's nose, mouth, and chin are shown with solid lines.
[0084] Figure 3s Displays an exploded perspective view of the patient interface according to one of the embodiments of this technology.
[0085] Figure 3t Displays a disassembled front view of the patient interface according to one of the embodiments of this technology.
[0086] Figure 3uDisplays an exploded rear view of the patient interface according to one of the embodiments of this technology; Figure 4a A top view of a nasal bridge pad representing a patient interface according to one example of this technology is shown.
[0087] Figure 4b The nose bridge pad uses a patient interface according to one example of this technology. Figure 4a The bottom cross section diagram of line segment 4c-4c.
[0088] Figure 4c The nose bridge pad, which employs a patient interface according to one of the embodiments of this technology, is shown. Figure 4a The lateral section of line segment 4c-4c. The patient's nose is shown as a dashed line.
[0089] Figure 5a A top view showing another nose pad for a patient interface according to another example of this technology.
[0090] Figure 5b This shows another nose pad using a patient interface according to another example of this technology. Figure 5a The bottom cross section diagram of line segment 5c-5c.
[0091] Figure 5c Another nose bridge pad using a patient interface according to one of the embodiments of this technology is shown. Figure 5a The lateral section of line segment 5c-5c. The patient's nose is shown as a dashed line.
[0092] Figure 6a A top view of another nose pad showing a patient interface according to another example of this technology.
[0093] Figure 6b This shows another nose pad using a patient interface according to another example of this technology. Figure 6a The bottom cross section diagram of line segment 6c-6c.
[0094] Figure 6c This shows another nose pad using a patient interface according to another example of this technology. Figure 6a The lateral section of line segment 6c-6c. The patient's nose is shown as a dashed line.
[0095] Figure 7a A rear perspective view of the air chamber assembly of the patient interface according to one example of this technology is shown.
[0096] Figure 7b A side perspective view of the air chamber assembly of the patient interface according to one example of this technology is shown.
[0097] Figure 7c A front perspective view of the air chamber assembly of the patient interface according to one example of this technology is shown.
[0098] Figure 7d Showing a rear view of the air chamber assembly of the patient interface according to one example of this technology.
[0099] Figure 7e A front view of the air chamber assembly of the patient interface according to one example of this technology is shown.
[0100] Figure 7f Showing a top view of the air chamber assembly of the patient interface according to one example of this technology.
[0101] Figure 7g A bottom view of the air chamber assembly of the patient interface according to one example of this technology is shown.
[0102] Figure 7h A side view of the air chamber assembly of the patient interface according to one example of this technology is shown.
[0103] Figure 8a Showing a top view of the air chamber assembly of the patient interface according to one example of the present technology, and containing several line segments defining different cross sections.
[0104] Figure 8b The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a Side section view of line segment 8b-8b.
[0105] Figure 8c The air chamber assembly displaying a patient interface according to one embodiment of this technology is shown. Figure 8a The side section diagram of line segment 8c-8c.
[0106] Figure 8d The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a The side section diagram of line segment 8d-8d.
[0107] Figure 8e The air chamber assembly displaying a patient interface according to one embodiment of this technology is shown. Figure 8a The side section diagram of line segment 8e-8e.
[0108] Figure 8f The air chamber assembly displaying a patient interface according to one embodiment of this technology is shown. Figure 8a The side section diagram of line segment 8f-8f.
[0109] Figure 8g The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a The front cross section diagram of line segment 8g-8g.
[0110] Figure 8hThe display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a The front cross section diagram of line segment 8h-8h.
[0111] Figure 8i The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a The front cross section of line segment 8i-8i.
[0112] Figure 8j The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a The front perspective view of line segment 8j-8j.
[0113] Figure 8k The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a Side section diagram of line segment 8k-8k.
[0114] Figure 8l The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 8a The side section diagram of line segment 8l-8l.
[0115] Figure 9a Showing a front view of the air chamber assembly of the patient interface according to one example of the present technology, and containing several line segments defining different cross sections.
[0116] Figure 9b The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9b-9b.
[0117] Figure 9c The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9c-9c.
[0118] Figure 9d The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9d-9d.
[0119] Figure 9e The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9e-9e.
[0120] Figure 9f The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9f-9f.
[0121] Figure 9gThe display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9g-9g.
[0122] Figure 9h The display shows an air chamber assembly employing a patient interface according to one example of this technology. Figure 9a The side section diagram of line segment 9h-9h.
[0123] Figure 9i The air chamber assembly shown employs a patient interface in one form according to this technology. Figure 9a Side section view of line segment 9i-9i.
[0124] Figure 10a Showing a top view of the nasal pad of the patient interface according to one example of this technology.
[0125] Figure 10b A top view of a nasal pad for a patient interface according to another example of this technology.
[0126] Figure 10c A top view of a nasal pad for a patient interface according to another example of this technology.
[0127] Figure 10d A top view of a nasal pad for a patient interface according to another example of this technology.
[0128] Figure 11a The display adopts one of the examples according to this technology. Figure 4a The cross section of the nose pad of line segment 11a-11a.
[0129] Figure 11b The display adopts one of the examples according to this technology. Figure 13 The cross-sections of the nose pads of line segments 11b and 11c.
[0130] Figure 11c The display adopts one of the examples according to this technology. Figure 13 The cross-sections of the nose pads of line segments 11b and 11c.
[0131] Figure 12a Showing a rear view of a lower pad with an exemplary sealing structure for a mouth pad according to the present technology.
[0132] Figure 12b The rear view shows a lower pad with another exemplary sealing structure for the mouth pad according to the present technology.
[0133] Figure 12c The rear view shows a lower pad with another exemplary sealing structure for the mouth pad according to the present technology.
[0134] Figure 12dThe rear view shows a lower pad with another exemplary sealing structure for the mouth pad according to the present technology.
[0135] Figure 13 Showing a top view of a nasal bridge pad with a patient interface according to one example of this technology.
[0136] Figure 14 This displays an exploded side view of the patient interface according to one of the embodiments of this technology.
[0137] Figure 15a Showing a front view of the sealing structure, top plate, and retaining arm according to one example of this technology.
[0138] Figure 15b Showing a front view of the sealing formation structure, top plate, and retaining arm according to another example of this technology.
[0139] Figure 15c Showing a front view of the sealing structure, top plate, and retaining arm according to one example of this technology.
[0140] Figure 15d Showing a front view of the sealing structure, top plate, and retaining arm according to one example of this technology.
[0141] Figure 15e Showing a front view of the sealing structure, top plate, and retaining arm according to one example of this technology.
[0142] Figure 16a The diagram shows a top perspective view of a sealing structure and an inflation chamber according to one example of the present technology.
[0143] Figure 16b This shows a bottom perspective view of the sealing structure and the inflation chamber according to one example of the present technology.
[0144] Figure 16c Another top perspective view showing a sealing formation structure and an inflation chamber according to one example of this technology.
[0145] Figure 16d Showing a front view of the sealing structure and the inflation chamber according to one example of this technology.
[0146] Figure 16e Showing a rear view of the sealing structure and the inflation chamber according to one example of this technology.
[0147] Figure 16f Showing a top view of a sealing structure and an inflation chamber according to one example of this technology.
[0148] Figure 16g Showing a bottom view of the sealing structure and the inflation chamber according to one example of this technology.
[0149] Figure 16h Showing a side view of the sealing structure and the inflation chamber according to one example of this technology.
[0150] Figure 16i This demonstrates the adoption of one of the embodiments of this technology. Figure 16d The sealing structure of line segment 16i-16i and the cross-sectional view of the inflation chamber.
[0151] Figure 16j This demonstrates the adoption of one of the embodiments of this technology. Figure 16f The sealing structure of line segment 16j-16j and the cross-sectional view of the inflation chamber.
[0152] Figure 16k This demonstrates the adoption of one of the embodiments of this technology. Figure 16h The sealing structure of line segment 16k-16k and the cross-sectional view of the inflation chamber.
[0153] Figure 16 This demonstrates the adoption of one of the embodiments of this technology. Figure 16d The sealing structure of line segment 16l-16l and the cross-sectional view of the inflation chamber.
[0154] Figure 16m This demonstrates the adoption of one of the embodiments of this technology. Figure 16g The 16m-16m line segment is a sealed structure forming a cross-sectional view of the air chamber.
[0155] Figure 16n This shows a detailed front perspective view of the sealing structure and the inflation chamber according to one example of this technology.
[0156] Figure 16o This demonstrates an example of the adoption of one of the techniques. Figure 16d The sealing structure of line segment 16°-16° and the cross-sectional view of the inflation chamber.
[0157] Figure 17a A perspective view showing the patient interface according to one of the embodiments of this technology.
[0158] Figure 17b Displays a front view of the patient interface according to one of the embodiments of this technology.
[0159] Figure 17c A rear view of the patient interface according to one of the embodiments of this technology is displayed.
[0160] Figure 17d A top view of the patient interface according to one of the embodiments of this technology is shown.
[0161] Figure 17e A bottom view showing the patient interface according to one example of this technology.
[0162] Figure 17fA side view of the patient interface according to one of the embodiments of this technology is shown.
[0163] Figure 18a The diagram shows a perspective view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0164] Figure 18b The image shows a front view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0165] Figure 18c The diagram shows a side view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0166] Figure 18d The diagram shows a top view of a sealing structure according to one example of this technology, having a top plate and a front panel.
[0167] Figure 18e The diagram shows a rear perspective view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0168] Figure 18f The illustration shows a sealed structure with a top panel and a front panel, according to one example of this technology. Figure 18d The cross-sectional view of line segment 18f-18f.
[0169] Figure 19a A perspective view of a retaining arm assembly according to one example of this technology is shown.
[0170] Figure 19b Showing a front view of a retaining arm assembly according to one example of this technology.
[0171] Figure 19c Showing a side view of a retaining arm assembly according to one example of this technology.
[0172] Figure 19d Showing a top view of a retaining arm assembly according to one example of this technology.
[0173] Figure 19e Showing a rear view of a retaining arm assembly according to one example of this technology.
[0174] Figure 19f Showing a top view of a retaining arm assembly according to one example of this technology.
[0175] Figure 19g Another top view of the retaining arm assembly according to one example of this technology is shown.
[0176] Figure 19h Showing a rear view of a retaining arm assembly according to one example of this technology.
[0177] Figure 20aThis shows a perspective view of the front panel frame, lower attachment parts, and fixture according to one example of the present technology.
[0178] Figure 20b Showing a front view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0179] Figure 20c Showing a rear view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0180] Figure 20d Showing a side view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0181] Figure 20e Showing a top view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0182] Figure 20f Showing a partially exploded perspective view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0183] Figure 20g Showing an exploded perspective view of the front panel frame, lower attachment parts, and another part of the fixture according to one example of this technology.
[0184] Figure 20h Showing an exploded perspective view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0185] Figure 20i Displays a perspective view of the front panel frame according to one of the embodiments of this technology.
[0186] Figure 20j Displays a front view of the front panel frame according to one of the embodiments of this technology.
[0187] Figure 20k Displays a rear view of the front panel frame according to one of the embodiments of this technology.
[0188] Figure 20l Shows a side view of the front panel frame according to one of the embodiments of this technology.
[0189] Figure 20m Displays a top view of the front panel frame according to one of the embodiments of this technology.
[0190] Figure 20n Displays a rear view of the front panel frame according to one of the embodiments of this technology.
[0191] Figure 20o Showing an exploded perspective view of the front panel frame, lower attachment parts, and another part of the fixture according to one example of this technology.
[0192] Figure 20p Showing an exploded perspective view of the front panel frame, lower attachment parts, and fixture according to one example of this technology.
[0193] Figure 20q Displays a top view of the front panel frame according to one of the embodiments of this technology.
[0194] Figure 20r Displays a top view of the front panel frame according to one of the embodiments of this technology.
[0195] Figure 20s Displays a top view of the front panel frame according to one of the embodiments of this technology.
[0196] Figure 21a This shows a perspective view of the top plate according to one example of this technology.
[0197] Figure 21b Showing a front view of the top plate according to one example of this technology.
[0198] Figure 21c Showing a rear view of the top plate according to one example of this technology.
[0199] Figure 21d Showing a top view of the top plate according to one example of this technology.
[0200] Figure 21e Showing a side view of the top plate according to one example of this technology.
[0201] Figure 22a Displays a perspective view of the front panel according to one of the embodiments of this technology.
[0202] Figure 22b Displays a front view of the front panel according to one of the embodiments of this technology.
[0203] Figure 22c Displays a rear view of the front panel according to one of the embodiments of this technology.
[0204] Figure 22d Showing a side view of the front panel according to one of the embodiments of this technology.
[0205] Figure 22e Displays a top view of the front panel according to one of the embodiments of this technology.
[0206] Figure 23a Showing a front perspective view of the lower attachment component support according to one example of this technology.
[0207] Figure 23b Another front perspective view showing the lower attachment component support according to one example of this technology.
[0208] Figure 23cShowing a rear view of the lower attachment component support according to one example of this technology.
[0209] Figure 23d Showing a top perspective view of the lower attachment component support according to one example of this technology.
[0210] Figure 23e Showing a side perspective view of the lower attachment component support according to one example of this technology.
[0211] Figure 23f Showing a perspective view of the other side of the lower attachment component support according to one example of this technology.
[0212] Figure 23g Showing a front view of the lower attachment component according to one example of this technology.
[0213] Figure 23h Showing another front view of the lower attachment component according to one example of this technology.
[0214] Figure 23i Showing a rear view of the lower attachment component according to one example of this technology.
[0215] Figure 23j Showing a top view of the lower attachment component according to one example of this technology.
[0216] Figure 23k Showing a bottom view of the lower attachment component according to one example of this technology.
[0217] Figure 23 Showing a front perspective view of the lower attachment component according to one example of this technology.
[0218] Figure 23m Showing a rear perspective view of the lower attachment component according to one example of this technology.
[0219] Figure 24a A front perspective view showing the connector of the lower attachment component according to one example of this technology.
[0220] Figure 24b Another front perspective view of the connector of the lower attachment component according to one example of this technology.
[0221] Figure 24c Showing a rear view of the connector of the lower attachment component according to one example of this technology.
[0222] Figure 24d This shows a perspective view above the connector of the lower attachment component according to one example of the present technology.
[0223] Figure 24e Showing a side perspective view of the connector of the lower attachment component according to one example of this technology.
[0224] Figure 24f Another rear perspective view of the connector of the lower attachment component according to one embodiment of the present technology; Figure 25a Showing a front perspective view of a fixture according to one of the embodiments of this technology.
[0225] Figure 25b Showing another front perspective view of a fixture according to one of the embodiments of this technology.
[0226] Figure 25c Showing a rear perspective view of a fixture according to one of the embodiments of this technology.
[0227] Figure 25d Showing a top perspective view of a fixture according to one of the embodiments of this technology.
[0228] Figure 25e Showing a side perspective view of a fixture according to one of the embodiments of this technology.
[0229] Figure 25f Showing another rear perspective view of the fixture according to one example of this technology; Figure 25g Showing a front perspective view of a fixture according to one of the embodiments of this technology.
[0230] Figure 25h Showing another front perspective view of a fixture according to one of the embodiments of this technology.
[0231] Figure 25i Showing a rear perspective view of a fixture according to one of the embodiments of this technology.
[0232] Figure 25j Showing a top perspective view of a fixture according to one of the embodiments of this technology.
[0233] Figure 25k Showing a side perspective view of a fixture according to one of the embodiments of this technology.
[0234] Figure 25 Showing another rear perspective view of a fixture according to an example of this technology; Figure 26a A perspective view showing a pipe decoupling structure according to one of the embodiments of this technology.
[0235] Figure 26b Showing a front view of a pipe decoupling structure according to one of the embodiments of this technology.
[0236] Figure 26c Showing a rear view of a pipe decoupling structure according to one of the embodiments of this technology.
[0237] Figure 26d This demonstrates an example of the adoption of one of the techniques. Figure 26c A cross-sectional view of the pipe decoupling structure of line segment 26d-26d.
[0238] Figure 27a The diagram shows a perspective view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0239] Figure 27b The image shows a front view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0240] Figure 27c The diagram shows a side view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0241] Figure 27d The diagram shows a top view of a sealing structure according to one example of this technology, having a top plate and a front panel.
[0242] Figure 27e The diagram shows a rear perspective view of a sealing structure having a top plate and a front panel, according to one example of this technology.
[0243] Figure 27f The illustration shows a sealed structure with a top panel and a front panel, according to one example of this technology. Figure 27d The cross-sectional view of line segment 27f-27f.
[0244] Figure 28a This shows a perspective view of the top plate according to one example of this technology.
[0245] Figure 28b Showing a front view of the top plate according to one example of this technology.
[0246] Figure 28c Showing a rear view of the top plate according to one example of this technology.
[0247] Figure 28d Showing a top view of the top plate according to one example of this technology.
[0248] Figure 28e Showing a side view of the top plate according to one example of this technology.
[0249] Figure 29a A perspective view showing the patient interface according to one of the embodiments of this technology.
[0250] Figure 29b Displays a front view of the patient interface according to one of the embodiments of this technology.
[0251] Figure 29c A rear view of the patient interface according to one of the embodiments of this technology is displayed.
[0252] Figure 29d A top view of the patient interface according to one of the embodiments of this technology is shown.
[0253] Figure 29e A bottom view showing the patient interface according to one example of this technology.
[0254] Figure 29f A side view of the patient interface according to one of the embodiments of this technology is shown. Detailed Implementation
[0255] Before describing this technology in more detail, it should be understood that this technology is not limited to the specific examples described in this specification, which are subject to change. It should also be understood that the terminology used in this specification describes only the specific examples discussed herein and is not a limitation.
[0256] The following describes various examples relating to the sharing of one or more common components and / or parts. It should be understood that one or more parts of any example may be combined with one or more parts of another example or other examples. Furthermore, any single part or combination of parts in any example may constitute a further example.
[0257] Treatment System In one form, the technology includes a device for treating respiratory disorders. In an example, the device includes an airflow generator or booster for supplying pressurized breathing gas (such as air) to a patient 1000 via a tubing directed to a patient interface 3000.
[0258] treat In one form, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the airway inlet of the patient.
[0259] Continuous positive nasal pressure (CPAP) is relevant to symptoms of obstructive sleep apnea (OSA). In one form, the technology includes a method for treating a patient with obstructive sleep apnea by applying continuous positive pressure to the nasal cavity.
[0260] Patient Interface One embodiment of the non-invasive patient interface according to this technology includes the following functional components: a sealing structure, an inflation chamber, a positioning and stabilizing structure; and a connection port for connecting an air circuit. In some embodiments, the functional components may be provided by one or more physical components. In some embodiments, the physical components may provide one or more functional components. In use, the sealing structure is disposed around the patient's airway inlet to facilitate the supply of positive air pressure to the airway.
[0261] Figure 3a Showing a front perspective view of a patient interface 3000 according to one example of the present technology. The patient interface 3000 may include a sealing forming structure 3100, an oral inflation chamber 3200, a nasal inflation chamber 3202, and components with a positioning and stabilizing structure 3300.
[0262] The inflation chamber and the sealing structure Figure 3a It is also shown that the upper part of the sealing structure 3100 may include a nasal pad 3112 or flange to seal around the lower part of the patient's nose, particularly around the alar and tip of the nose. This nasal pad 3112 may at least partially define the upper air chamber, which will be discussed in more detail below.
[0263] Figure 3a It is also shown that the sealing structure 3100 may include a mouth pad 3110 or a flange to seal around the patient's mouth. The mouth pad 3110 may be attached to the mouth inflation chamber 3200 around the periphery 3210 of the mouth inflation chamber 3200.
[0264] Figure 3c The rear view shows several portions of the sealing structure 3100 that come into contact with the patient's face during use. The nose pad 3112 is shown connected to the upper portion of the mouth pad 3110 via a decoupling structure 3106. It should be understood that the decoupling structure 3106 may be an intermediate structure engaging the nose pad 3112 and the mouth pad 3110. The decoupling structure 3106 allows the nose pad 3112 and the mouth pad 3110 to move relative to each other while maintaining an airflow path therebetween. The nose pad 3112 may define a nasal air chamber 3104, and in use, the nasal air chamber opening 3103 of the nose pad 3112 may receive a portion of the patient's nose. During treatment, breathable gas may be provided to the patient's nose from the patient interface 3000 through the nasal air chamber 3104. The mouth pad 3110 may also include an oral air chamber 3102 and an oral air chamber opening 3101 to provide breathable gas to the patient's mouth during treatment. The front panel 3204 and the connection port 3600 are visible through the oral air chamber 3102 of the mouth pad 3110. It should be understood that when a patient wears the patient interface 3000, the front panel 3204, the inflation chamber 3200, the mouth pad 3110, the nose pad 3112, and the decoupling structure 3106 can (together with the patient's face) at least partially define the nasal air chamber 3104 and the oral air chamber 3102, through which breathable positive pressure gas can be provided to the patient.
[0265] exist Figure 3d In the nose pad 3112, a protruding end 3114 can be seen on either side. When worn by a patient, each protruding end 3114 can be shaped to extend from the patient interface 3000 to seal within the gap between the patient's nasal alae and nasolabial folds. Figure 2c (Showing the surface components of the face) Indicates the location of the nostrils and nasolabial folds. The sealing details provided by the protrusion 3114 will be described in more detail below. The protrusion 3114 may be partially spherical and / or deformed to seal this area.
[0266] Figure 3rThis illustrates how the exemplary patient interface 3000 seals the patient, particularly the nose. In this detailed front perspective view, the patient's nose, mouth, and chin are shown in solid lines, while the nose pad 3112 against the nose is shown in dashed lines. It should be understood that the nose pad 3112 may be concave to support the patient's nose. The recess 3116 shows reception of the nasal tip, and the protruding end 3114 shows a seal in the area of the nasal ala and nasolabial fold. The nasal pad support wall 3208 supports the nose pad 3112 in the area of the protruding end 3114, helping to maintain a seal in this area, and functions similarly to the nasal pad. The nasal inflation chamber 3202 is also shown. For clarity, the mouth assembly of the patient interface 3000 is not shown in this figure.
[0267] Figure 3d A recess 3116 is also shown, which may also be included on the nose pad 3112. This recess 3116 may include an inwardly shaped portion extending into the nasal air chamber 3104 to receive the tip of the patient's nose when worn. The recess 3116 provides a reinforced seal around and below the tip of the patient's nose during treatment by making the shape of the nose pad 3112 more conform to the patient's nose. The recess 3116 will be described in more detail below.
[0268] exist Figure 3m and 3n The mouth pad 3110 surrounds the mouth of the patient 1000. The oral air chamber 3102 is formed by the mouth pad 3110 surrounding the mouth of the patient 1000, the oral air chamber 3200, and the front panel 3204. In use, the air conduit 4170 can be connected to the PAP device (4000) (not shown in this figure) to provide breathable air to the patient 1000 through the mouth and the oral air chamber 3102 of the patient interface 3000.
[0269] This figure also shows the portion of the nasal pad 3112 surrounding the patient's nose, particularly the tip of the nose. The nasal air chamber 3104 is thus formed by the nasal pad 3112 and the patient's face. In this example, breathable gas from the air conduit 4170 can pass through the oral air chamber 3102, then through an opening defined by the decoupling structure 3106, and enter the nasal air chamber 3104. Figure 3m The line segment BB shown is intended to indicate the change between the nasal bone and the nasal cartilage extending from the nasal bone structure of the patient 1000. The nasal pad 3112 shown in this exemplary patient interface 3000 is designed to seal the area around the patient's nose and below the line segment BB shown in relation to the nose. In other words, the nasal pad 3112 seals the area below the columella.
[0270] According to an example of this technology, the patient interface 3000 has a 4896 mm diameter on the face. 2 Its surface area occupies less space than conventional full-face masks (e.g., the ResMed Quattro FX full-face mask, which has a face area of 7007.89 mm). 2With a surface area occupying approximately 30% less space, the mask is less conspicuous. For some patients, this may also reduce claustrophobia. Furthermore, it is important to reduce particularly conspicuous areas, as these areas have a significantly beneficial psychological effect on bed partners when looking at the mask, as they appear less medical and expose a large portion of the face. From the patient's perspective, the exemplary patient interface 3000 is not in or significantly reduced in their field of vision because the nose pad 3112 is sealed below the nasal columella. This allows patients to wear the patient interface 3000 while reading or watching television before bed. By sealing below the nasal columella, areas of thin skin are protected from pressure sensitivity and / or the high probability of skin breakage and pain due to blood flow constriction. Another advantage is that there is no need to consider changes in patient position above the nasal columella, and the appropriate focus of the mask can be directed towards changes in position around the upper lip area. Furthermore, unlike some other full-face masks, the patient interface 3000 does not require forehead support for pressure point release. This also avoids the problem of forehead support that could cause pressure point sources and / or skin breakage.
[0271] For anatomical structure, please refer to Figure 2h and 2i The location of the transition area between the nasal bone and cartilage is indicated. Therefore, the exemplary nasal pad 3112 is intended to seal against the softer tissues of the nose, such as fatty tissue and cartilage, around the patient's nose. By forming a nasal seal in these softer tissues, patient skin pain is avoided when forming a seal around / on the harder nasal structures (i.e., the bony part). In other words, patient discomfort is reduced by sealing below the columella. Simultaneously, positioning the seal of the nasal pad 3112 around this nasal area provides a better seal, as the nasal tissue and the nasal pad 3112 conform to each other to form a seal. The nasal pad 3112 should primarily conform to the nose.
[0272] Figure 3m The sealing component shown is located at the protruding end 3114 on the face of patient 1000. Specifically, the protruding end 3114 may be an extension of the nasal pad 3112, which seals the area between the nasolabial fold and the alar. These anatomical components are shown Figure 2c Depending on the individual facial structure of the patient, this area can represent the concave portion 3116, ensuring that the extension from the nasal pad 3112 necessarily forms a proper seal near the patient's nose. For example... Figure 3m As shown, the protruding end 3114 can advantageously provide this function.
[0273] Another sealing component of the exemplary patient interface 3000 is shown in Figure 3pThe nose pad 3112 includes (as described above) a recess 3116 for receiving the tip of the nose of the patient 1000 when worn by the patient. Specifically, the tip of the nose of the patient 1000 is shown as a dashed line in the area where the recess 3116 is located. This figure also shows how the nose pad 3112 is shaped to seal the periphery of the nose with its underside. In other words, the seal formed by the nose pad 3112 on the nose is characterized by its adherence to the lower and peripheral parts of the nose. Thus, in summary, it should be understood from this figure that the sealing surface of the nose pad 3112 may be concave or form a notch to receive the nose, and it may also include the recess 3116 to receive the tip of the nose.
[0274] Figure 3q The patient interface 3000 is shown as constituting different contact points that seal the patient's face. The patient interface 3000 is shown in a side sectional view. Specifically, the nose pad 3112, nasal inflation chamber 3202, mouth pad 3110, and mouth inflation chamber 3200 are shown in cross-section. See also [reference needed]. Figure 2b -f describes the relevant anatomical components. The nasal pad 3112 is shown sealing the tip of the patient's nose. The connecting region 3106.2 between the mouth pad 3110 and the nasal pad 3112 is shown sealing the patient's upper lip. It should be noted that the connecting region 3106.2 can be configured in the area below the nostrils and above the mouth, sealing the patient's upper lip without obstructing airflow into the airway. The connecting region 3106.2 can connect the rear portions of the mouth pad 3110 and the nasal pad 3112. The connecting region 3106.2 can be configured and positioned to maintain a seal below the patient's upper lip and nostrils, while allowing relative movement between the structures of the oral air chamber 3102 and the nasal air chamber 3104 (e.g., the mouth pad 3110 and the nasal pad 3112, respectively). The connecting region 3106.2 can cooperate with the decoupling structure 3106 to facilitate this relative movement.
[0275] The nasal air chamber 3104 is shown to be at least partially defined by the nasal pad 3112, the nasal inflation chamber 3202, and the patient's nose, providing a sealed path for breathable gas entering the patient's airway through the nostrils. A gap 3106.1 is also shown between the oral inflation chamber 3200 and the nasal inflation chamber 3202. Gap 3106.1 will be discussed in more detail below; however, it should be understood that despite the independent movement of the nasal pad 3112 and the oral pad 3110, gap 3106.1 contributes to maintaining a seal between the nose and mouth. This advantageously maintains a seal between the nasal pad 3112 and the nose, the connecting area 3106.2 and the upper lip, and the oral pad 3110 around the mouth, while allowing these components to move independently of each other and adapting to individual differences and patients.
[0276] like Figure 3qAs shown, the oral air chamber 3102 is at least partially defined by the mouth pad 3110, the oral air chamber 3200, and the patient's mouth to provide a sealed path for breathable gas entering the patient's airway via the mouth. A seal and / or contact with the patient's lower lip can be achieved by the mouth pad 3110. Although not shown in this figure, it should be understood that when the positioning and stabilizing structure 3300 positions the patient interface 3000 against the patient's face, the suboral pad 3120 can support the thinner mouth pad 3110 against the lower lip. In this case, the suboral pad 3120 will contact the corresponding portion of the mouth pad 3110.
[0277] In this technology, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a padding function.
[0278] In one example, the sealing structure 3100 according to the present technology is made of a soft, flexible, and elastic material, such as silicone. In another example of the present technology, the sealing structure 3100, for example, mouth pad 3110, nose pad 3112 and / or their respective underpads, may be made of a foam.
[0279] In this embodiment, the inflation chamber 3200 has a shaped periphery 3210 that, in use, complements the general facial surface contours that form the sealing area. In use, the edges of the inflation chamber 3200 are located on the adjacent surface close to the face. Actual contact with the face is provided by the sealing formation structure 3100. The sealing formation structure 3100 extends approximately around the entire periphery 3210 of the inflation chamber 3200 during use.
[0280] Figure 7a -h displays several diagrams of the sealing structure 3100 and the air chamber 3200. These diagrams show the sealing structure 3100 and the air chamber 3200 without the top plate 3206 and the front panel 3204, and without any of the associated positioning and stabilizing structures 3300.
[0281] Figure 7a Showing a rear perspective view of the sealing formation 3100 and the inflation chamber 3200. The exemplary sealing formation 3100 shown in this figure includes a mouth pad 3110 and a nose pad 3112. A connection region 3106.2 shown in this figure connects the mouth pad 3110 and the nose pad 3112. Furthermore, the decoupling structure 3106 is shown positioned between the mouth pad 3110 and the nose pad 3112.
[0282] The mouth pad 3110 and mouth inflation chamber 3200 show a portion of the mouth air chamber 3102. The opening 3101 of the mouth air chamber 3102 defined by the mouth pad 3110 is also shown.
[0283] In addition, Figure 7aThe figure shows a nasal air chamber 3202, which partially defines a nasal air chamber 3104 together with a nasal pad 3112. This exemplary nasal pad 3112 also shows a protruding end 3114 on either side. A recess 3116 for receiving the tip of the nose is also shown. The figure also shows a subnasal pad support wall 3208. The subnasal pad support wall 3208 engages with the corresponding protruding end 3114 and provides support for the protruding end 3114 when sealing the patient's nasal alae and nasolabial folds.
[0284] Figure 7b Showing a side perspective view of an exemplary sealing structure 3100 and an inflation chamber 3200. Figure 7b Display similar Figure 7a The components are shown. However, this figure also shows that the connecting region 3106.2 can be concave. In other examples, the connecting region 3106.2 can be non-concave. By forming a concave connecting region 3106.2, the mouth pad 3110 can better seal the area around the patient's mouth, and the nose pad can better seal the area around and under the patient's nose. Alternatively, a fully convex pad can also have a similar function. In this figure, a portion of the periphery 3210 of the oral inflation chamber 3200 is also shown. Furthermore, the location of the decoupling structure 3106 is indicated.
[0285] Figure 7b The subnasal pad support wall 3208 is shown in conjunction with the protruding ends 3114 of the nasal pad 3112. The subnasal pad support wall 3208 extends outward beyond the periphery of the nasal inflation chamber 3202. This structure allows the subnasal pad support wall 3208 to provide sufficient support for the protruding ends 3114 to seal the patient's face. The lower half of the subnasal pad support wall 3208 can serve as a hinge or pivot point for the decoupling structure 3106. The upper half of the subnasal pad support wall 3208 helps to position the top plate 3206.
[0286] Figure 7c This figure shows a front perspective view of an exemplary sealing structure 3100 and an inflation chamber 3200. The front portion of the nasal inflation chamber 3202 is particularly clearly shown; and the nasal pad support wall 3208, which supports the protruding end 3114 of the nasal pad 3112.
[0287] Figure 7d This figure shows a rear view of an exemplary sealing structure 3100 and an inflation chamber 3200. This figure shows a similar... Figure 7a The components are shown. On either side of the nose pad 3112, a portion of each subnasal pad support wall 3208 is shown. Furthermore, this figure shows how the connection region 3106.2 can connect the mouth pad 3110 to the nose pad 3112. Additionally, the location of the decoupling structure 3106 is indicated.
[0288] Figure 7eThis figure shows a front view of an exemplary sealing structure 3100 and an inflation chamber 3200. The mouth pad 3110 is particularly clearly shown positioned near the periphery 3210 of the oral inflation chamber 3200. Additionally, the oral chamber 3102 is shown to be defined by the mouth pad 3110 and the oral inflation chamber 3200. Furthermore, this figure shows the front portion of a decoupling structure 3106 connecting the nose pad 3112 to the mouth pad 3110. A subnasal pad support wall 3208 can be seen on either side of the nose pad 3112. The figure also shows a suboral pad 3120. This figure also shows that the suboral pad 3120 may terminate in a tapered region 3122 near either side of the nose pad 3112. Therefore, the connection region 3106.2 (not shown in this figure) between the mouth pad 3110 and the nose pad 3112 may be without a suboral pad. The advantage is that, despite the movement of the mouth pad 3110 and nose pad 3112, this allows for greater flexibility in the connecting area 3106.2, making it easy to maintain a seal on the upper lip, such as... Figure 3q As shown.
[0289] Figure 12a -d shows another exemplary configuration of the suboral pad 3120 according to the present technology. These figures show various configurations of the suboral pad 3120 with the opening 3101 of the oral cavity 3102 and the point of use. For simplicity, other components relating to the sealing forming structure 3100 have been omitted from these figures.
[0290] Figure 12a An example of mouth pad 3110 is shown, wherein a lower mouth pad 3120 surrounds the entire periphery of mouth pad 3110. Figure 12b An example of mouth pad 3110 is shown, which has two parts, a mouth pad 3120, one on each side of the mouth pad. Figure 12c The example shown shows that, except for a portion of the upper region near the mouth pad 3110, the lower mouth pad 3120 surrounds the entire periphery of the mouth pad 3110. Figure 12d Display similar Figure 12c An example, however, the portion of the mouth pad 3110 without the mouth pad 3120 is in the lower region of the mouth pad 3110.
[0291] Figure 7f This figure shows a top view of an exemplary sealing structure 3100 and an inflation chamber 3200. The figure shows a nose pad 3112 with its protruding end 3114 and recess 3116, and a nasal air chamber 3104 partially defined by the nose pad 3112. The figure also partially shows the pneumatic connection between the oral air chamber 3102 and the nasal air chamber 3104 defined by the decoupling structure 3106.
[0292] Figure 7g This figure shows a bottom view of an exemplary sealing structure 3100 and an inflation chamber 3200. The mouth pad 3110 connects to the inflation chamber 3200. Additionally, the protruding end 3114 of the nose pad 3112 is shown.
[0293] Figure 8a Another top view of the exemplary sealing structure 3100 and the inflation chamber 3200 is shown. This figure also shows some section lines to indicate subsequent diagrams. Figure 8b-8l The cross-section shown is similar to the one depicted. Figure 7f This leads to the display of similar components. However, to avoid confusion, reference numbers and guide lines have been omitted.
[0294] Figure 8b -d shows a cross-sectional view of the exemplary sealing structure 3100 and the inflation chamber 3200 along line segments 8b, 8c, 8d-8b, 8c, 8d. The nose pad 3112 is shown connected to the mouth pad 3110 via a connection region 3106.2. The oral air chamber 3102 is shown partially defined by the oral inflation chamber 3200 and the mouth pad 3110. The nasal air chamber 3104 is shown partially defined by the nasal inflation chamber 3202 and the nose pad 3112. The protruding end 3114 and the recess 3116 of the nose pad 3112 are also shown. This figure also shows how the connection region 3106.2 in this example of the art may not include a lower pad, while the mouth pad 3110 may include an oral lower pad 3120 and a nasal lower pad support wall 3208 (not shown in these figures) to support the protruding end 3114. The oral inflation chamber 3200, the nasal inflation chamber 3202, and the gap 3106.1 formed by a similar hinge-like configuration with the decoupling structure 3106 are also shown. In another example of the art, the suboral pad 3120 may include two discontinuous sides disposed on either side of the oral pad 3110, but without a suboral pad portion in the connecting region 3106.2 or in the lower central portion of the oral pad 3110. Alternatively, as Figure 7e As shown, the suboral pad 3120 can terminate near the nasal pad 3112 at the conical region 3122 on either side of it.
[0295] Figure 8b and 8c The angles α and β of the expansion of the connecting region 3106.2 are also shown respectively. Figure 8b α shows the angle from the lower part of the nose pad 3112 to the mouth pad 3110. Angle α can be approximately 80 degrees. o Approximately 180 o The range, and in an example of this technique, α can be approximately 142°. Figure 8c The angle β is the angle from the upper part of the nose pad 3112 to the mouth pad 3110. Angle β can be approximately 80 degrees. o Approximately 170 o The range, and in an example of this technology, β can be about 120°. Mouth pad 3110, nose pad 3112, mouth inflation chamber 3200, and nose inflation chamber 3202 can be integrated into one piece.
[0296] Figure 8eAnother cross-sectional view is shown, illustrating an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8e-8e. Furthermore, in this figure, the mouth pad 3110 is shown to include a lower mouth pad 3120. The connection region 3106.2 shows a lower pad without an embodiment according to this art. A gap 3106.1 formed through the mouth inflation chamber 3200, the nose inflation chamber 3202, and a similar hinged configuration with the decoupling structure 3106 is also shown. Additionally, the side portion 3106.3 of the decoupling structure 3106 is shown.
[0297] Figure 8f Another cross-sectional view is shown, employing an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8f-8f. This figure shows a similar... Figure 8e The components are shown in the example. However, this figure also shows a portion of the nasal pad support wall 3208, which is positioned to support the protruding end 3114 of the nasal pad 3112. Here, the side portion 3106.3 of the decoupling structure 3106 is shown close to the nasal pad support wall 3208.
[0298] Figure 8g Another cross-sectional view shows an exemplary sealing structure 3100 and an inflation chamber 3200 with an 8g-8g line segment. Figure 8g Showing similar again Figure 8e and 8f The components. However, this figure also shows more clearly that the nasal pad support wall 3208 is positioned below the protruding end 3114 of the nasal pad 3112.
[0299] Figure 8h Another cross-sectional view is shown, employing an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8h-8h. This figure also shows a similar... Figure 8g The components are shown. In this figure, each protruding end 3114 is shown to have a corresponding subnasal pad support wall 3208 located below it.
[0300] Figure 8i Another cross-sectional view is shown, employing an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8i-8i. This figure also shows a similar... Figure 8h The components shown.
[0301] Figure 8j Another cross-sectional view is shown, illustrating an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8j-8j. This figure also shows a similar... Figure 8f The components shown.
[0302] Figure 8k Another cross-sectional view is shown, illustrating an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8k-8k. This figure also shows a similar... Figure 8d The components shown. Figure 8k It is also particularly evident that, in the exemplary embodiment of this technology, the connecting region 3106.2 may have a concave shape to accommodate the patient's upper lip.
[0303] Figure 8l Another cross-sectional view is shown, employing an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 8l-8l. This figure also shows a similar... Figure 8d The components shown.
[0304] Figure 9a Another front view of the exemplary sealing structure 3100 and the inflation chamber 3200 is shown. This figure also shows numerous sections indicating what will appear in subsequent figures. Figure 9b-9i The cross-section shown is similar to the one depicted. Figure 7e And thus, similar components are described. However, to avoid confusion, reference numbers and guides have been omitted.
[0305] Figure 9b The diagram shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 9b-9b. Figure 9b It also shows a similar Figure 8b The component shown in -d.
[0306] Figure 9c The figure shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 9c-9c. This figure particularly shows the cross-section of the subnasal pad support wall 3208, which may include a protruding end 3114 to support the nasal pad 3112.
[0307] Figure 9d This diagram shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 formed along line segment 9d-9d. The cross-sectional view shown in this specification is taken at an angle so that the portion of the nose pad 3112 is not shown. This diagram also shows the suboral pad 3120 of the mouth pad 3110 in a particularly clear manner. In the example shown in this diagram, the tapered region 3122 of the suboral pad 3120 is also shown.
[0308] Figure 9e The diagram shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 9e-9e. Figure 9e To adopt a similar approach along Figure 9d The cross-section shows similar components.
[0309] Figure 9f This figure shows a cross-sectional view of an exemplary sealing structure 3100 and an inflatable chamber 3200 along line segment 9f-9f. This figure particularly perfectly illustrates the mouth pad 3110 and the suboral pad 3120, and how the mouth pad 3110 and the suboral pad 3120 can share a similar contour to seal the patient's face.
[0310] Figure 9g The diagram shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 9g-9g. Figure 9g For along Figure 9f A similar cross section is used, and therefore similar components are shown.
[0311] Figure 9h The diagram shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 9h-9h. Figure 9h Display similar Figure 9c The component shown includes a cross-section of the undernasal pad support wall 3208.
[0312] Figure 9i The diagram shows a cross-sectional view of an exemplary sealing structure 3100 and an inflation chamber 3200 along line segment 9i-9i. Figure 9i Display similar Figure 9b The components shown.
[0313] Figures 16a to 16o Several diagrams show another sealing structure 3100 and an inflation chamber 3200 according to an example of this technology.
[0314] According to this example, the sealing structure 3100 and the inflation chamber 3200 include a recess 3208.1 on either side of the nose pad 3112 near the side portion 3106.3 and the protruding end 3114. Figure 16a , 16d Embodiments of the notch 3208.1 are described in references 16i, 16k, and 16m-o. The notch 3208.1 may be at least partially defined by the decoupling structure 3106, the nasal pad support wall 3208, the side portion 3106.3, the nasal inflation chamber 3202, and the side support 3207. The notch 3208.1 is open in the forward direction of the sealing forming structure 3100 and the inflation chamber 3200. The notch 3208.1 also provides protection against deformation of the nasal pad 3112 in each direction. The notch 3208.1 provides compression resistance to the nasal pad 3112. This compression resistance helps reduce leakage at the corners of the nasal area, wherein the notch 3208.1 supports the nasal pad 3112 and / or the protruding end 3114 when the nasal pad 3112 contacts the patient's nose. According to an example of this technology, it is advantageous to deform the nose pad 3112 in areas other than the protruding end 3114 supported by the notch 3208.1. The notch 3208.1 and the decoupling structure 3106 may help prevent deformation of the nose pad 3112, or may help to cause deformation to occur in the target area.
[0315] Figures 16a to 16oThe side support 3207 shown in the example can be integrally formed with the sealing structure 3100 and the air chamber 3200. Therefore, in the example where the sealing structure 3100 and the air chamber 3200 are formed using silicone, the side support 3207 will also be formed using silicone. The side support 3207 can serve a hardening purpose to improve the seal between the sealing structure and the patient's face. For example, the side support 3207 can help support the nasal pad 3112 by resting against the patient's nasal ala on its side, and / or the side support can help support the protruding end 3114 by resting against the patient's facial area, where the nasal ala engagement is close to the nasolabial fold. The side support 3207 can also control the deformation of the nasal pad 3112, causing certain areas of the nasal pad to deform before others. The side support 3207 can also control the degree of deformation of specific areas of the nasal pad 3112. The side support 3207 facilitates controlled deformation of the nose pad 3112 because it allows bending under compression due to contact with the patient's face. The side support 3207 also reinforces the sides of the nose pad 3112 to decouple the compressive forces on the face and prevent the nose pad 3112 from sinking into the decoupling structure 3106.
[0316] Each of the side supports 3207 may include a notch 3209. The notch 3209 of the side support 3207 may provide a pivot point between the nose pad 3112 and the mouth pad 3110. The notch 3208.1 may also be used to control the position of the pivot point.
[0317] Side support 3207 may also provide attachment points for top plate 3206. Top plate 3206 may integrate and / or chemically bond seal-forming structure 3100 and inflation chamber 3200. In an example, silicone of seal-forming structure 3100 and inflation chamber 3200 may be formed and / or molded around top plate 3206. According to an example of the present technology, mechanical interlocking may not be required between top plate 3206 and seal-forming structure 3100 and inflation chamber 3200. Alternatively, chemical and / or integrated bonding may be absent, making mechanical interlocking required between top plate 3206 and seal-forming structure 3100 and inflation chamber 3200. Top plate 3206 may also be at least partially defined at a pivot point between nose pad 3112 and mouth pad 3110.
[0318] It is also desirable to strengthen or harden the nose pad 3112 to provide localized support in order to reduce or control deformation of a specific area of the nose pad relative to other areas. Examples of hardening may include increasing the relative thickness of the nose pad 3112 to which reinforcement is desired. Alternatively, reinforcing protrusions or other reinforcing structures may be formed on the nose pad 3112 to provide localized support to the desired degree and location.
[0319] Figure 16i , 16k-m and 16o show that the nasal pad 3112 may also include a thickened nasal pad segment 3124 on the side. The thickened nasal pad segment 3124 may be a thickened portion of the nasal pad 3112, extending inwards and generally extending into the nasal air chamber 3104. These thickened nasal pad segments 3124 can provide additional support to the nasal pad 3112 in its sealing engagement with the patient's nose and face. The thickened nasal pad segment 3124 may be located on the opposite side of the nasal pad 3112 such that when the sealing structure engages with the patient's face, it is close to the patient's nasolabial fold. The thickened nasal pad segment 3124 may also help to seal around the patient's nose and alar by preventing the nasal pad 3112 from collapsing under sealing forces. The thickened nasal pad segment 3124 may be integrally formed with the nasal pad 3112. Furthermore, the thickened nasal pad segment 3124 may be located on the nasal pad 3112, such that when the sealing structure is joined to the patient's nose and face, the thickened nasal pad segment 3124 can be at least partially pressed against the corresponding subnasal pad support wall 3208. The thickened nasal pad segment 3124 may have a constant thickness greater than the thickness of the rest of the nasal pad 3112. Alternatively, the thickness of the thickened nasal pad segment 3124 may be variable in its region.
[0320] In alternative embodiments of this technology, the thickened nose pad segment 3124, which is not provided, and other structures may be provided to increase the rigidity of these areas. For example, protrusions or other reinforcing structures may be provided for certain areas of the nose pad 3112, wherein the thickened nose pad segment 3124 demonstrates the function of hardening the nose pad 3112 in these areas.
[0321] Figure 16k This also illustrates an example of the technology, wherein the oral inflation chamber 3200 includes thickened oral inflation chamber sections 3212. These thickened oral inflation chamber sections 3212 provide additional support to the oral inflation chamber 3200 to help prevent collapse of the oral inflation chamber.
[0322] and, Figure 16j and 16k Showing a cross-sectional view of the sealing structure 3100 and the inflation chamber 3200. Relative to... Figures 8a to 8l The connection regions shown in figures 9a to 9i, these figures show that connection region 3106.2 can be relatively thick in the examples shown in these figures. Figure 16j and 16k The thickness of the connection area 3106.2 shown can also be kept consistent along its width and height. Tube torque from the air line 4170 may cause the mouth pad 3110 to be pulled on the nose pad 3112 via the decoupling structure 3106, and to expand the connection area 3106.2 in a generally vertical direction. The expansion of the connection area 3106.2 may compromise the seal of the nose pad 3112. By thickening the connection area 3106.2 and making the overall thickness consistent, this expansion of the connection area 3106.2 can be prevented, and compromise of the seal of the nose pad 3112 can be prevented and / or reduced.
[0323] Figure 16b , 16c Figures 16e, 16f, 16j, and 16o show a diagram of a nasal pad 3112, which includes a nasal suspension band 3119 that divides the opening 3103 of the nasal air chamber 3104 into nostril ports 3105. The nasal suspension band 3119 can seal along the patient's columella (see Figure 2F), allowing each nostril to be sealed individually. Alternatively, the nasal suspension band 3119 can provide columellar decompression by contacting the patient's columella without forming a seal. Furthermore, the nasal suspension band 3119 prevents the patient's nasal tip from extending beyond the nasal pad 3112 and into the nasal air chamber 3104. The nasal suspension band 3119 can also provide support for the nasal pad 3112 to prevent deformation of the nasal pad 3112 along its longitudinal axis.
[0324] The sealing structure 3100 may include a compliant region. These examples do not show the compliant region. Further examples of the compliant region are described in PCT patent application PCT / AU2014 / 000026. The compliant region may be relatively soft, elastic, and / or compliant compared to other portions of the sealing structure 3100. The relative flexibility of the compliant region is advantageous because it helps alleviate discomfort in the nasal tip and nasal septum area. The compliant region may be relatively thin compared to other portions of the sealing structure 3100, and therefore may function similarly to a mechanical spring to maintain an effective seal at the nasal tip by wrapping against and / or contacting it. The compliant region may be located on the upper apex of the sealing structure 3100, where the sealing structure 3100 transitions into the oral inflation chamber 3200 and the nasal inflation chamber 3202. The compliant region may be located on the sealing structure 3100 above the recess 3116. The compliant region may also be fused into the recess 3116. The compliant region can also be roughly centered on the sealing structure 3100 in the horizontal direction. According to an example of this technology, the sealing structure 3100 may have a thickness of about 0.35 mm in the compliant region, and may be one of the thinnest areas of the sealing structure 3100.
[0325] Exemplary nose pad like Figures 4a-4c Examples of nose pads 3112 according to this technology are shown in 5a-c and 6a-c.
[0326] Figure 4aA top view of an exemplary nose pad 3112 is shown. A protruding end 3114 is shown on either side of the nose pad 3112. A nasal air chamber 3104 and its opening 3103 are also shown. The opening 3103 of the nasal air chamber 3104 typically has a flexible rectangular, rhomboid, or trapezoidal shape on its respective smaller side 3104.2 and larger side. When placed against a patient's nose, the smaller, curved side 3104.2 of the nasal air chamber opening 3103 will be close to the corresponding ala of the nose. In this example, one of the pair of larger sides (specifically, the distal side 3104.1 of the nasal air chamber opening 3103) will be distal to the patient's upper lip and close to the tip of the nose; while the other of the pair of larger sides (a proximal side 3104.3) will be close to the patient's upper lip. A recess 3116 shaped to receive the tip of the nose is also shown.
[0327] Figure 4b Show along Figure 4a The figure shows a bottom view of an exemplary nose pad 3112, with a cross-section formed by line segment 4c-4c. This figure also shows the nasal air chamber 3104 and its opening 3103.
[0328] Figure 4c Show along Figure 4a A side perspective view of an exemplary nose pad 3112, with a cross-section formed by line segment 4c-4c. This figure again shows the nasal air chamber 3104 and its nasal air chamber opening 3103, and also indicates the recess 3116. Particularly noteworthy in this figure is the outline of the nose pad 3112 along line segment 4c-4c. As the nose pad 3112 approaches the distal side 3104.1 of the nasal air chamber opening 3103 of the nasal air chamber 3104 from the recess 3116, it appears to curve slightly upward. In this figure and... Figure 4b The upper anterior portion of the nasal pad 3112, near the recess 3116, includes a slight depression or concave area at its center through which segment 4c-4c passes, such that the nasal pad 3112 is higher on its sides than in the middle. The figure also uses dashed lines to show the outline of the nose to indicate how the patient's nose is positioned relative to the nasal pad 3112. The peak 3118 of the nasal pad 3112 seals the anterior portion of the nostril. The peak 3118 is further positioned posteriorly but transitions more gradually to create a spherical effect. The distal end 3104.1 can slide upwards from the nasal pad 3112 and improves the seal of the nasal tip because it contacts the nose earlier and causes compression and pneumatic sealing by supporting the nose with a frame. The recess 3116, shaped to receive the nasal tip, is also shown.
[0329] Figure 5a A top view of an exemplary nose pad 3112 is shown. A protruding end 3114 is shown on either side of the nose pad 3112. A nasal air chamber 3104 and its opening 3103 are also shown. The shape of the opening 3103 of the nasal air chamber 3104 is similar. Figure 4a The shape shown. The recess 3116 is also shown, shaped to receive the tip of the nose.
[0330] Figure 5b Show along Figure 5a The figure shows a bottom view of an exemplary nose pad 3112, with a cross-section formed by line segments 5c-5c. This figure also shows the nasal air chamber 3104 and its associated nasal air chamber opening 3103.
[0331] Figure 5c Show along Figure 5a A side perspective view of an exemplary nose pad 3112, with a cross-section formed by line segment 5c-5c. This figure again shows the nasal air chamber 3104 and its opening 3103, and also indicates the recess 3116. Particularly noteworthy in this figure is the outline of the nose pad 3112 along line segment 5c-5c. When compared with… Figure 4c The outline of the nose pad 3112 shown in this figure is such that it slopes downwards because the nose pad approaches the distal side 3104.1 of the opening 3103 of the nasal air chamber 3104 from the recess 3116. It also shows that this example of the nose pad 3112 has no recess in the anterior region near the recess 3116, which is shown in... Figure 4b and 4c The example shown. In other words, relative to... Figure 4c The example shown illustrates that, in the region from the recess 3116 to the distal 3104.1 of the nasal air chamber 3104 opening 3103, the nasal pad 3112 can be more annular / circular. The figure also uses dashed lines to show the outline of the nose, indicating how the patient's nose is positioned relative to the nasal pad 3112.
[0332] Figure 6a A top view of an exemplary nose pad 3112 is shown. A protruding end 3114 is shown on either side of the nose pad 3112. A nasal air chamber 3104 and its opening 3103 are also shown. The shape of the opening 3103 of the nasal air chamber 3104 is similar. Figure 4a The shape shown. In Figures 4a to 4c In the middle, the shape is larger than Figures 6a to 6c The examples shown are more similar to spheres and circles.
[0333] Figure 6b Show along Figure 6a A bottom view of an exemplary nose pad 3112, with a cross-section formed by line segments 6c-6c. This figure also shows the nasal air chamber 3104 and its opening 3103. Furthermore, compared to... Figure 4a The nose pad 3112 shown in Figures -c and 5a-5c has a smooth, curved sidewall on the top surface. This figure shows that the nose pad 3112 has a straight sidewall 3121. The straight sidewall 3121 may have a defined top edge, and is assumed to increase the stability and strength of the nose pad 3112.
[0334] Figure 6c Show along Figure 6aA side perspective view of an exemplary nose pad 3112, with a cross-section formed by line segment 6c-6c. This figure again shows the nasal air chamber 3104 and its opening 3103, and also indicates the recess 3116. Of particular note in this figure is the outline of the nose pad 3112 along line segment 6c-6c. Figure 5c As shown, this example of nose pad 3112 has no depression in the anterior region near the recess, which is evident in... Figure 4b and 4c The example shown is illustrated in this figure. This figure also shows the straight sidewall 3121 of this exemplary nose pad 3112. The figure also uses dashed lines to show the outline of the nose, indicating how the patient's nose is positioned relative to the nose pad 3112.
[0335] Furthermore, it should be understood that Figures 4a-4c 5a-5c and Figures 6a-6c The exemplary nose pad 3112 shown is displayed in a largely undeformed state. Figure 4c , 5c 6c also points out a small amount of deformation, since the construction conforms to the nose shape shown by the dotted lines. Therefore, when the nose pad 3112 is not deformed, it can have the concave shape shown in the figure.
[0336] It should also be understood that the nasal pad 3112 can have a cross-section with variable thickness. Therefore, the area of the nasal pad 3112 near the opening 3103 of the nasal air chamber 3104 can be thinner than the area where the nasal pad 3112 is attached to the nasal air chamber 3202. Advantageously, by providing a thinner and thus more flexible area of pad material at the large contact area of the patient's nose, greater comfort is provided to the patient.
[0337] Figure 10a -d indicates a further additional nasal pad 3112 according to a further example of this technology. These figures show variations in the possible shapes of the nasal air chamber 3104 opening 3103.
[0338] Figure 11a -c displays various cross-sectional profiles of the nose pad 3112 according to an example of this technology. Region 3112.1 may be adjacent to the opening 3103 of the nasal air chamber 3104, and region 3112.3 may be adjacent to the connection of the nasal inflation chamber 3202. Region 3112.2 may be the highest region around the upper periphery of the nose pad 3112.
[0339] Figure 11a The display uses along Figure 4a The cross-section of nose pad 3112 is shown in line segment 11a-11a. This cross-section shows the smooth variation in thickness of nose pad 3112 from region 3112.1 to region 3112.3. Additionally, thickness x may be less than thickness z.
[0340] Figure 11b The display uses along Figure 13The cross-section of the nose pad 3112 is shown in line segments 11b, c-11b, c. This cross-section shows that region 3112.2 may suddenly become thicker than regions 3112.1 and 3112.3. In addition, thickness x may be less than thickness z and thickness y may be greater than x and z.
[0341] Figure 11c The display uses along Figure 13 The cross-section of the nose pad 3112 is shown in the line segments 11b, c-11b, c. Region 3112.2 can harden relative to other regions 3112.1 and 3112.3. This cross-section shows that region 3112.2 may suddenly become thicker than regions 3112.1 and 3112.3. Furthermore, thickness z can be less than thickness x and thickness y can be greater than both x and z.
[0342] Figure 13 A top view of another exemplary nasal pad 3112 according to the present technology is shown. The nasal air chamber 3104, opening 3103, and protruding end 3114 are indicated to better clarify the orientation of the nasal pad 3112. Different lines are used to indicate areas of varying thickness to better indicate where the stiffness and / or thickness of the nasal pad 3112 may vary. Area 3113 may be the thinnest to allow for adaptation to the shape of the nasal tip. Area 3113 according to one embodiment of the present technology may have a thickness of approximately 0.35 mm. Area 3115 may be thicker to provide greater support for the nasal pad 3112. Area 3115 according to one embodiment of the present technology may have a thickness of approximately 0.5 mm. Area 3117 may be thicker than other areas to provide maximum support, prevent deformation, and ensure an effective seal of the patient's nasal ala. Area 3117 according to one embodiment of the present technology may have a thickness of approximately 1 mm.
[0343] Decoupling structure Figure 3cThe decoupling structure 3106 shown provides a connection between the nose pad 3112 and the mouth pad 3110. The decoupling structure 3106 also defines a pneumatic connection between the oral air chamber 3102 and the nasal air chamber 3104. Therefore, during treatment, when the patient is provided with positive pressure breathable gas, the gas can enter the patient interface via the connection port 3600 and flow directly into the oral air chamber 3102, which is at least partially defined by the inflation chamber 3200, the front panel 3204, the mouth pad 3110, and the decoupling structure 3106. The gas can then flow to the patient's mouth. Breathable gas can also be provided to the patient's nose via the nasal air chamber opening 3103 and through the nasal air chamber 3104, which is at least partially defined by the nose pad 3112, the nasal inflation chamber 3202, and the decoupling structure 3106. To reach the nasal air chamber 3104, gas must flow from the oral air chamber 3102 through the pneumatic passage defined by the decoupling structure 3106, and then into the nasal air chamber 3104. However, it should be understood that an port may be provided at the top plate 3206 or the nasal pad 3112 to receive breathable gas. In this case, the flow pattern through the patient interface 3000 is absolutely reversible.
[0344] about Figure 3c The decoupling structure 3106 shown allows the nose pad 3112 and mouth pad 3110 to move independently of each other when worn by a patient. When the patient wears the positioning and stabilizing structure 3300 (e.g., a headband) (described in more detail below), the nose pad 3112 can press against the patient's face, especially the nose, through the force transferred from the top plate 3206 along the holding arm 3302. Additionally, the mouth pad 3110 can press against the patient's face, especially the mouth, through the force transferred from the headband 3306 to the front panel 3204. Because different sets of headbands 3306 can press against different parts of the patient's face (e.g., the nose and mouth respectively) of the patient interface 3000 (e.g., the nose pad 3112 and mouth pad 3110), the nose pad 3112 and mouth pad 3110 can advantageously move independently of each other due to the decoupling structure 3106.
[0345] The decoupling structure 3106 can be used to connect the mouth pad 3110 and the nose pad 3112 to facilitate this independent movement. Allowing independent movement of the mouth pad 3110 and the nose pad 3112 allows for a more suitable seal for different patient face shapes, and helps maintain a seal on the patient's face regardless of movement in different areas of the face, movement of the air line 4170, or external forces. Moreover, since the patient interface 3000 can seal two separate areas of the face, nose, and mouth, two corresponding openings must be provided to supply breathable gas to the patient. By allowing the sealing structures (e.g., the mouth pad 3110 and the nose pad 3112) to move independently, a seal can be maintained around the nose, independent of the seal around the mouth, to prevent unwanted leakage and, therefore, pressure loss through one or both openings.
[0346] The decoupling structure 3106 may also form portions of the walls of the oral air chamber 3200 and the nasal air chamber 3202 in the forward direction. The decoupling structure 3106 may also be elastically flexible to allow relative movement and / or length extension between the structures defining the oral air chamber 3102 and the nasal air chamber 3104. Thus, the oral air chamber 3200 and the nasal air chamber 3202 can extend away from each other or compress together, while maintaining a pneumatic connection between the oral air chamber 3102 and the nasal air chamber 3104. Furthermore, the decoupling structure 3106 also allows these structures (e.g., the oral air chamber 3200 and the nasal air chamber 3202) to tilt relative to each other, while maintaining a pneumatic connection between the oral air chamber 3102 and the nasal air chamber 3104 and maintaining a seal on the patient's face.
[0347] The decoupling structure 3106 may also include: a top surface 3106.4, a connecting surface 3106.5, and a bottom surface 3106.6. The connecting surface 3106.5 may be relatively harder than the top surface 3106.4 and the bottom surface 3106.6. It should be understood that the bottom surface 3106.6 may be a separation surface separating from the mouth pad 3110. It should be understood that the top surface 3106.4 may be a separation surface separating from the nose pad 3112. The greater hardness of the connecting surface 3106.5 may be achieved by reinforcing protrusions or other reinforcing structures or by making the connecting surface 3106.5 thicker than the top surface 3106.4 and the bottom surface 3106.6. According to an example, each of the top surface 3106.4 and the bottom surface 3106.6 may have a thickness of 0.5 mm, and the connecting surface 3106.5 may have a thickness of 1.2 mm. According to a further example of this technology, a specific value of the thickness can be varied while maintaining the same thickness ratio between the top surface 3106.4, the connecting surface 3106.5, and the bottom surface 3106.6.
[0348] In a further example of this technology, the relative thicknesses of the top surface 3106.4, the connecting surface 3106.5, and the bottom surface 3106.6 can be selected to allow for a desired degree of flexibility in the decoupling structure 3106. In this example, the decoupling structure 3106 may be able to bend, such that the top surface 3106.4 and the bottom surface 3106.6 can be positioned relative to each other at a temperature of up to about 45° to about 50°.
[0349] Furthermore, according to a further example of the present invention, the angle between the top surface 3106.4 and the connecting surface 3106.5 can be between approximately 80° and approximately 140°. According to yet another further example of the present invention, the angle between the top surface 3106.4 and the connecting surface 3106.5 can be approximately 90°. It should be understood that the angle between the top surface 3106.4 and the connecting surface 3106.5 is variable in the length of the decoupling structure 3106 due to its curved shape. If the angle between the top surface 3106.4 and the connecting surface 3106.5 is greater than 90° in a particular example, it can be more easily stretched or separated from the nose structure and the mouth structure. If the angle between the top surface 3106.4 and the connecting surface 3106.5 is less than 90° in a particular example, it can be more easily compressed towards the nose structure and the mouth structure.
[0350] According to a further example of the present invention, the angle between the bottom surface 3106.6 and the connecting surface 3106.5 may be between approximately 80° and approximately 140°. According to yet another further example of the present invention, the angle between the bottom surface 3106.6 and the connecting surface 3106.5 may be approximately 90°. If the angle between the bottom surface 3106.6 and the connecting surface 3106.5 is greater than 90° in a certain example, it can be more easily stretched or separated from the nasal and oral structures. If the angle between the bottom surface 3106.6 and the connecting surface 3106.5 is less than 90° in a certain example, it can be more easily compressed towards the nasal and oral structures.
[0351] Another advantageous feature of this exemplary patient interface 3000 is also shown in Figure 3m In this context, the nasal pad 3112 and the mouth pad 3110 are each capable of independently forming a seal around an individual anatomical part of the patient. As previously discussed, the nasal pad 3112 is intended to seal around the patient's nose, and the mouth pad 3110 is intended to seal around the patient's mouth. For example... Figure 3c The decoupling structure 3106 shown allows the nose pad 3112 and mouth pad 3110 to move independently and seal independently of each other. By attaching the top straps 3310 to the nose pad 3112 through the top plate 3206, the nose pad 3112 can be pressed against the nose of the patient 1000 when the patient interface 3000 is worn. Additionally, the lower straps 3312 can press the mouth pad 3110 around the patient's mouth via their connection to the front panel 3204.
[0352] It should be understood that each corresponding pair of straps (top strap 3310 and lower strap 3312) represents a separate vector along its guiding tension to hold the corresponding portion of the patient interface 3000 against the patient's face. In other words, the top strap 3310 is used to hold the nose pad 3112 against the nose, and the lower strap 3312 is used to hold the mouth pad 3110 against the mouth. Although these pads can move independently of each other, the decoupling structure 3106 allows for a pneumatic connection between the mouth pad 3110 and the nose pad 3112. Thus, the patient interface 3000 can be adapted to different patient head and face shapes. Furthermore, it should be understood that the ability to individually form a corresponding seal despite patient movement allows the patient interface 3000 to maintain these seals.
[0353] Figure 7h A side view of an exemplary sealing structure 3100 and an inflation chamber 3200 is shown. This figure shows a nose pad 3112 attached to the nose inflation chamber 3202 and a protruding end 3114 supported by a subnasal pad support wall 3208 near the side 3106.3 of the decoupling structure 3106. The mouth inflation chamber 3200 is shown disposed around its periphery 3210 with the mouth pad 3110. Furthermore, in this figure, the decoupling structure 3106 is shown connecting the mouth pad 3110 to the nose pad 3112. A similar hinge configuration is particularly shown in this figure. The nose inflation chamber 3202 and the nose pad 3112 can receive the mouth inflation chamber 3200 and the mouth pad 3110 via a connection via the decoupling structure 3106 and a connection area 3106.2 (not shown in this figure). It should be understood that when the entire patient interface 3000 is placed on the patient, this hinge-like configuration allows the nasal inflation chamber 3202 and the nasal pad 3112 to tilt, depending on the force applied to the patient's face. Therefore, the oral inflation chamber 3200 and the nasal inflation chamber 3202 can approach each other at a gap 3106.1.
[0354] By providing a gap 3106.1 between the front portions of the oral inflation chamber 3200 and the nasal inflation chamber 3202, as shown in the figure, it allows the components of the oral inflation chamber 3200 and the nasal inflation chamber 3202 to move independently of each other to a certain degree of freedom before they come into contact. It should also be understood that the nasal pad 3112 and the oral pad 3110 can move independently of each other, and an effective seal is further maintained by providing a decoupling structure 3106 with radially variable thickness or different hardness. Therefore, the decoupling structure 3106 can be thinnest or least hard at the point of contact with the patient's upper lip, and its thickness / hardness can increase radially towards the front portion of the decoupling structure 3106. This configuration maintains an effective seal on the upper lip while also providing sufficient support and structure for the oral pad 3110 and the nasal pad 3112. The decoupling structure 3106 can be thicker at its apex at the closed end of the gap 3106.1 compared to the open end near the gap 3106.1. This change prevents distortion and improves hinge function because the thicker portion of the decoupling structure 3106 at the closed end of the gap 3106.1 can be used as a pivot point.
[0355] Figure 14 A partially exploded side view showing another example of the present technology. This example may include a mouth pad 3110 and a nose pad 3112, a mouth inflation chamber 3200, and a nose inflation chamber 3202, which are connected by a decoupling structure 3106 in a manner similar to other examples disclosed in this specification. The upper or top plate 3206 and the lower or front panel 3204 are shown without the nose inflation chamber 3202 and the mouth inflation chamber 3200 connected, respectively. Furthermore, the upper attachment member 3252 shows a connecting member 3304 connecting the retaining arm 3302, which has been partially cut off for simplicity. This figure also shows an intermediate or connecting portion 3205, which may connect the top plate 3206 and the front panel 3204 to form a single-piece component. The connecting portion 3205 can be molded and sized to substantially conform to the shape of the decoupling structure 3106, such that when the top plate 3206, the front panel 3204, and the integral component of the connecting portion 3205 are attached to the nasal inflation chamber 3202 and the oral inflation chamber 3200, the connecting portion 3205 can be substantially flush with the decoupling structure 3106. To allow the oral inflation chamber 3200 and the nasal inflation chamber 3202 to move relative to each other as described in this specification, the connecting portion 3205 can be advantageously formed using silicone or any other suitable, soft, elastic, airtight, and biocompatible material.
[0356] In another example of this technology, a portion of the decoupling structure 3106 near the gap 3106.1 can be removed, so that only the nasal pad support wall 3208 and / or the connecting region 3106.2 connects the orifice air chamber 3200 and the nasal air chamber 3202, as well as the mouth pad 3110 and the nasal pad 3112. In this example, the connecting portion 3205 can also perform a sealing function to provide a pneumatically sealed connection between the orifice air chamber 3102 and the nasal air chamber 3104. In other words, when the top plate 3206, the connecting portion 3205, and the integral component with the front panel 3204 connect the orifice air chamber 3200 and the nasal air chamber 3202, the connecting portion 3205 can effectively replace the removed portion of the decoupling structure 3106. Furthermore, in this example, it may be desirable to use silicone or any other similar material to form the connecting portion 3205.
[0357] 5.3.3 Top and front panel connection components, retaining arms, and positioning and stabilizing structures In use, a rigid top plate 3206 can be attached to the nasal inflation chamber 3202 relative to the front of the nasal pad 3112 on the patient's face. The top plate 3206 can be made of a rigid material, such as EMS-Grivory Grilamid® TR 90. The top plate 3206 may include at least one upper attachment member 3252. In one example, a pair of upper attachment members 3252 may be configured on either side of the top plate 3206 to releasably and rotatably connect to corresponding retaining arms 3302 of the positioning and stabilizing structure 3300. UBE America Inc. utilizes DuPont.TM Ubesta® nylon and Hytrel®, made from TPE, polypropylene, and other elastic polymers and materials, are possible materials for the retainer arm 3302. While allowing the retainer arm 3302 to be flexible, other materials may also be used for the generally non-stretchable retainer arm 3302. The retainer arm 3302 may be flexible in a direction parallel to the patient's coronal plane (see [link]). Figure 2e While exhibiting no significant elasticity in other directions, the retaining arm 3302 is hinged, allowing the connecting part 3304 of the retaining arm to rotate about the attachment part 3252 on the top plate 3206. In one example of this technology, the retaining arm 3302 can rotate up to about 90° about the hinged upper attachment part 3252. In another example, the retaining arm 3302 can rotate more than 180° about the hinged upper attachment part 3252. Rotation can also be provided by ball-and-socket connections, hinges, free-direction joints; or by overlapping molding using silicone, TPE, or TPU. At each opposite end of the retaining arm 3302, there may be openings 3308 to receive corresponding headbands 3306 of the positioning and stabilizing structure 3300, which will be discussed in more detail below. Between each end of the retaining arm 3302, there may also be a bend shaped to generally conform to the curvature of the patient's face.
[0358] Figure 3s -u shows a further example of the disassembled patient interface 3000 and retaining arm 3302 to illustrate an exemplary hinge-like connection between each of the upper attachment parts 3252 and the connecting part 3304. As discussed above, it should be understood that the retaining arm 3302 is rotatable up to about 90 degrees in a plane parallel to the patient's coronal plane. o Or, in another example, it can exceed 180°.
[0359] On the opposite side of mouth pad 3110, front panel 3204 or base plate may be attached to interface inflation chamber 3200. Attached components may include a press-fit of soft material onto a hard material using overlapping molding; or a pad clamp relying on the circumferential stress of silicone. Front panel 3204 may include connection port 3600 facilitating connection of air conduit 4170 (not shown here). Furthermore, front panel 3204 may include at least one lower attachment member 3250 for attaching the headbands of positioning and stabilizing structure 3300, which will be discussed in more detail below. The lower attachment member 3250 shown in this example may be a female head clamp receiving structure to receive the male head clamp of attachment strap 3306. Alternatively, the configuration may include a male head structure to receive a female head clamp.
[0360] exist Figure 3bThe exemplary patient interface 3000 shown in the front view includes a top plate 3206 connected to a nose pad 3112 and having at least one upper attachment member 3252 on either side. A retaining arm 3302 is shown connected to the corresponding upper attachment member 3252 via a connecting member 3304. Furthermore, in this figure, the front panel 3204 shows the front side of the connection port inflation chamber 3200. The connection port 3600 shown on the front panel 3204 is circular, pneumatically connecting to an air conduit 4170 (e.g., via a tube decoupling structure 3500, discussed further below). The lower attachment member 3250 is also shown on either side of the front panel 3204. A decoupling structure 3106 is shown in this figure, and a side portion 3106.3 of the decoupling structure is also shown.
[0361] Figure 3c Showing a rear view of an exemplary patient interface 3000. In this figure, a pair of retaining arms 3302 show corresponding connecting parts 3304 extending and connecting to the respective attached parts 3252. Openings 3308 are shown at each corresponding opposite end of the retaining arms 3302 for connecting the headband 3306 of the positioning and stabilizing structure 3300. This figure indicates the location of the decoupling structure 3106, together with the connection area 3106.2 of the mouth pad 3110 and the nose pad 3112.
[0362] Figure 3d Showing a top view of a patient interface 3000 according to one embodiment of the present technology. In this top view, a portion of the nasal pad 3112 that contacts the patient's nose is shown, as well as the opening 3103 of the nasal air chamber 3104. This upper view also shows the connecting part 3304 of the retaining arm 3302, which is connected to an upper attachment part 3252 on either side of the top plate 3206, not shown in this particular figure. The oral air chamber 3200 also shows a front panel 3204 connected to the periphery 3210 of the air chamber. A lower attachment part 3250 is shown on either side of the front panel 3204. The front panel 3204 also shows a connection port 3600.
[0363] Figure 3e Showing a bottom view of an exemplary patient interface 3000 according to the present technology. This figure shows an oral inflation chamber 3200 connected to the periphery 3210 of a front panel 3204. A lower attachment member 3250 extends from the front panel 3204. A connection port 3600 on the front panel 3204 is also shown. The mouth pad 3110 and nose pad 3112, together with the protruding end 3114 of the nose pad 3112, are shown in this figure. A retaining arm 3302 is also shown, however... Figure 3e The connection between the retaining arm 3302 and the top plate 3206 is not shown.
[0364] Figure 3fA side view of an exemplary patient interface 3000 according to the present technology is shown. A retaining arm 3302 is shown extending from a connecting member 3304, the retaining arm being an upper attachment member 3252 connecting to a top plate 3206. Additionally, Figure 3f The inflatable chamber 3200 is shown connected to the front panel 3204 at its periphery 3210. On the front panel 3204, the lower attachment part 3250 and the connection port 3600 are visible. The nose pad 3112 and the mouth pad 3110 are also shown. The location of the decoupling structure 3106 and one of the side portions 3106.3 is also shown. The gap 3106.1 between the nose inflatable chamber 3202 and the mouth inflatable chamber 3200 is also shown, allowing these components to bend or move toward each other while maintaining connection. It should be understood that the gap 3106.1 can be the distance between the mouth inflatable chamber 3200 and the nose inflatable chamber 3202, and therefore, the gap 3106.1 can define the distance that allows these structures to be further toward each other. The gap 3106.1 can extend laterally between the mouth inflatable chamber 3200 and the nose inflatable chamber 3202, and the gap 3106.1 can face forward.
[0365] Figure 3m This figure shows another front perspective view of an exemplary patient interface 3000. This figure shows a similar... Figure 3g The components shown are also shown, and the patient 1000 wearing the patient interface 3000 is also shown. The headband 3306 of the positioning and stabilization structure 3300 is shown to releasably secure the patient interface 3000 to the patient 1000. The headband 3306 shows at least one top strap 3310 connected to a corresponding retaining arm 3302 in its corresponding opening 3308. In the shown example, each top strap 3310 passes through the corresponding opening 3308, which in this example is the opening of the retaining arm 3302. This example also shows at least one lower strap 3312 connected to the lower attachment member 3250 by passing through a portion of a clamp 3314, which releasably connects to the corresponding lower attachment member 3250.
[0366] Figure 3n Another front view of an exemplary patient interface 3000 maintained on patient 1000 is shown. The patient interface 3000 in this figure is shown held on patient 1000's face by a top strap 3310 and a lower strap 3312. The top strap 3310 is connected to a retaining arm 3302, and the lower strap 3312 is attached to the lower attachment member 3250 by a clamp 3314. Furthermore, in this example, a nose pad 3112 seals patient 1000's nose, and a mouth pad 3110 seals patient 1000's mouth. This figure shows a decoupling structure 3106, and also shows a side portion 3106.3 of the decoupling structure 3106.
[0367] Figure 3oShowing another side view of the patient interface 3000. In the figure, the patient interface 3000 is held in place on the face of the patient 1000 by a headband 3306. A top strap 3310 is connected to a retaining arm 3302 to press a nose pad 3112 against the nose, and a lower strap 3312 is connected to a front panel 3204 to press a mouth pad 3110 against the mouth of the patient 1000. In this figure, the lower strap 3312 extends below the patient 1000's ears, and the top strap 3310 extends above the patient's ears and below the eyes. As discussed above, the retaining arm 3302 may be made of a relatively hard material, such as nylon. Therefore, if the retaining arm 3302 rubs against and / or comes into direct contact with the patient 1000's face, it may cause facial pain. Therefore, Figure 3o The protective sleeve 3316 is also shown, which can surround the retaining arm 3302 as a cushioning pad for the retaining arm on the patient's face. The figure also shows the location of the decoupling structure 3106. The retaining arm 3302 can be integrated with or fabricated together with the face pad 3305, rather than being an additional protective sleeve.
[0368] Figure 3p Another top view of an exemplary patient interface 3000 is shown. In this top view, the patient interface 3000 is shown held in place on the face of a patient 1000 by a headband 3306. The top strap 3310 shows a corresponding opening 3308 for connecting the retaining arm 3302, and the lower strap 3312 shows a lower attachment part (3250) connected via a clamp 3314.
[0369] In the example, when the sealing structure 3100 of the patient interface 3000 of this technology is used, it is held in a sealed position by positioning and stabilizing structure 3300.
[0370] In this technical form, the holding arm 3302 discussed above may include components similar to the positioning and stabilizing structure 3300. Alternatively, the holding arm 3302 may include components similar to the patient interface 3000.
[0371] The positioning and stabilizing structure 3300 may include a headband 3306. The headband may include at least a top strap 3310, a lower strap 3312, and a rear section. Furthermore, the headband 3306 may include a single piece made of a soft, elastic material. A layer (e.g., an outer layer) of the headband that does not contact the patient's skin during wear may have connecting tabs secured to the respective ends of the top strap 3310 and the lower strap 3312. This connection may include a hook-and-loop connection, and the outer layer may include a loop material. This connection allows the top strap 3310 and the lower strap 3312 to pass around the attachment points of the patient interface 3000 to releasably and / or adjustably retain the patient interface on the patient's head via the headband 3306. Other connections may include ladder buckles or pull tabs that are not hook-and-loop fasteners.
[0372] By including a retaining arm 3302 in the patient interface 3000 and attaching the retaining arm to the nasal inflation chamber 3202 via a top plate 3206, the top band 3310 of the positioning and stabilizing structure 3300 can be advantageously positioned. To effectively seal the patient's nose, as described above, it may be desirable to have the nasal pad 3112 pressed firmly against the underside of the nose in a generally upward direction. When these top bands 3310 are decoupled from the nasal inflation chamber 3202, the retaining arm 3302 allows for proper guidance of the tension vector generated by the top bands 3310 of the positioning and stabilizing structure 3300, preventing the top bands 3310 from passing through the patient's eyes. In other words, when the top bands 3310 are positioned away from the patient's face, a sufficiently rigid retaining arm 3302 will allow the top bands 3310 of the positioning and stabilizing structure 3300 to effectively pull the nasal pad 3112 on the patient's nose, making the patient more comfortable, able to wear glasses, and see more easily, etc.
[0373] Figure 15a -e indicates the various top plate 3206 and retaining arm 3302 connected and sealed to form structure 3100 according to the embodiments of this technology.
[0374] Figure 15a The sealing structure 3100 is shown using a dotted drawing method. The retaining arm 3302 and the top plate 3206 are integral parts according to the described example. It can be seen that the upper attachment part 3252 and the connecting part 3304 are not shown. Therefore, the connection between the top plate 3206 and the retaining arm 3302 can be elastic to allow the retaining arm 3302 to deviate due to tension from the positioning and stabilizing structure 3300. Furthermore, according to this example, the top plate 3206 is permanently connected to the sealing structure 3100.
[0375] It should be understood that, through a permanent connection, the top panel 3206 can engage the nose inflation chamber 3202, and / or the front panel 3204 can engage the mouth inflation chamber 3200. The permanent connection can be facilitated by molding to form a mechanical interlock; alternatively, the components can be joined by chemical bonding. It should be understood that a permanent connection means that the disconnection of the component connection is irreversible, preventing the component from returning to its connected state. Disconnection of this permanent connection may, for example, require tearing, damaging, or destroying one or more of the components, making operative reconnection impossible.
[0376] Alternatively, via a non-permanent connection, the top plate 3206 may engage the nose inflation chamber 3202, and / or the front panel 3204 may engage the mouth inflation chamber 3200. A non-permanent connection may include a connection where components can be detached from each other and reattached via a reversible connection. In other words, detachment of components does not require, for example, tearing, damaging, or destroying one or more of the components to prevent them from being operatively reattached. In a non-permanent connection, when the detached components are reattached, the device returns to an operative state.
[0377] Figure 15bshow Figure 15a A similar example. In this example, the top plate 3206 can be connected and sealed to form structure 3100 via a hard-to-soft connection in the flexible connection area 3130. In other words, the top plate 3206 and the retaining arm 3302 are detachable.
[0378] Figure 15c show Figure 15a Another variation of the example shown. Figure 15c In this example, the top plate 3206 includes an attachment member 3252 on the top plate 3206 and a connection member 3304 on the retaining arm 3302. Thus, the top plate 3206 is permanently fixed to the sealing structure 3100, but the retaining arm 3302 is rotatable and removable from the top plate 3206.
[0379] Figure 15d show Figure 15b A similar example exists. In this example, there is a hard-to-hard connection between the top plate 3206 and the hard-connected region 3132.
[0380] Figure 15e This illustrates an example of a hard-to-hard connection including a top plate 3206 and a hard-connection region 3132. This example also includes an attachment member 3252 on the top plate 3206 and a connection member 3304 on the retaining arm 3302. Therefore, the top plate 3206 can be removed from the sealing structure 3100, but the retaining arm 3302 is rotatable and can be removed or disconnected from the top plate 3206.
[0381] Another example of this technology may include a lower attachment member 3250, which is magnetic and provided with a hinge, such as the example described in PCT patent application No. PCT / AU2014 / 000021. This hinge allows the lower attachment member 3250 to move in a plane (e.g., a plane parallel to the patient's transverse plane) in a direction about an axis. This configuration provides greater control over the positioning and stabilization of the structure 3300 attaching the lower attachment member 3250, and provides greater stability of the sealing pad 3110 on the patient's face.
[0382] Figures 17a to 17f and Figures 19a to 19h This illustrates an assembly of a retaining arm assembly 3301 according to another example of the present technology. This retaining arm assembly 3301 is detachable from the top plate 3206. The connecting part 3304 of these examples of the retaining arm assembly 3301 may include an aperture shaped to conform to a corresponding upper attachment part 3252.
[0383] The retaining arm assembly 3301 may include two components. The retaining arm 3302 and the top cover 3303 may be integrally formed with the connecting member 3304 and the opening 3308 also molded thereon. Nylon or Hytrel® may be used to form the retaining arm 3302 and the top cover 3303. A pad 3305 may also be overmolded onto each retaining arm 3302. The pad 3305 may be formed using a thermoplastic elastomer. The pad 3305 may serve as a cushioning pad for the retaining arm 3302 on the patient's face (e.g., cheek) and prevent wrinkles from forming on the patient's skin after wearing the patient interface for several hours (e.g., a treatment session).
[0384] The retaining arm 3302 can also be formed by elliptical bending, (for example) such as Figure 19d As shown. Furthermore, the retaining arm 3302 can be elastic only in the direction parallel to the patient's coronal plane (see...). Figure 2e For example, the retaining arm 3302 can be positioned inwards and outwards relative to the patient's face. In other words, the retaining arm 3302 can be substantially elastic in a single plane parallel to the patient's transverse plane. This allows the retaining arm 3302 to adapt to different patient face widths. Furthermore, it prevents the retaining arm 3302 from extending along its respective longitudinal axis. It also prevents the retaining arm 3302 from twisting along its respective longitudinal axis. Additionally, it prevents the retaining arm 3302 from bending upwards or downwards relative to the patient's face, for example, in the upward or downward direction. Preventing deformation of the retaining arm 3302 in these directions is beneficial for the stability of the patient wearing the patient interface 3000.
[0385] According to an example of this technology, ensuring that the retaining arm assembly 3301 is secured to the top plate 3206 for engagement with each other helps to reduce relative movement between the top plate 3206 and the retaining arm assembly 3301. To ensure that relative movement between the top plate 3206 and the retaining arm assembly 3301 is properly controlled, these components may be configured to engage with each other at at least three points. Connecting members 3304 may provide two of these contact points, while another structure of the retaining arm assembly 3301 located between connecting members 3304 may provide a third contact point.
[0386] Figure 19d and 19e It is also shown that the retaining arm assembly 3301 may include a protrusion 3307. When the retaining arm assembly 3301 is attached to the top plate 3206, the protrusion 3307 can help reduce relative movement between the nose pad 3112 and the top plate 3206 during engagement of the retaining arm assembly 3301. The protrusion 3307 may have a triangular cross-sectional profile to guide the retaining arm assembly 3301 into engagement with the top plate 3206. The protrusion 3307 also helps reduce bending and / or twisting during engagement of the retaining arm assembly 3301 and the top plate 3206. Therefore, the protrusion 3307 and the connecting member 3304 can provide three contact points on the retaining arm assembly engaging the top plate 3206.
[0387] According to a further example of this technology, in addition to the connecting component, the structure other than the protrusion 3307 can be provided for a third contact point. For example, the top plate 3206 and the retaining arm assembly 3301 can engage with the rod of the insertion orifice at the third contact point.
[0388] Figures 19f to 19h This illustrates another example of the retaining arm assembly 3301. According to this example, a claw 3309 may be positioned on the rear side of the retaining arm assembly 3301, adjacent to each of the retaining arms 3302, near the top cover 3303. The claw 3309 may engage the corresponding side support of the side support 3207 to secure the retaining arm assembly 3301 to the nose pad 3112.
[0389] Figures 29a to 29f This illustrates another example of the technology. These diagrams show components similar to... Figures 17a to 17f The components shown. However, the pipe decoupling structure 3500 is not shown. Figures 29a to 29f It should be understood that the tube decoupling structure 3500, as described anywhere in this specification, can be attached to the connection port 3600.
[0390] Top panel and front panel Regarding the front panel 3204 and top panel 3206 as described above, it is advantageous to choose a material that is relatively harder than, for example, a nose pad 3112 made of an elastic material (such as silicone). Choosing a relatively hard material provides an effective positioning point for the positioning and stabilizing structure 3300 (e.g., the retaining arm 3302), allowing the positioning and stabilizing structure 3300 to attach the sealing forming structure 3100 in a fixed position. When the positioning and stabilizing structure 3300 is directly connected to the sealing forming structure 3100 made of a relatively elastic material (such as silicone), this configuration may cause undesirable deformation of the mouth pad 3110 and nose pad 3112 when the patient wears the device and tension is applied to the positioning and stabilizing structure 3300. Tension may be particularly applied in the anterior / posterior direction. Examples of the positioning and stabilizing structure 3300 may be made using Breathe-O-Prene™, Soft Edge™, and / or stretchable fabrics.
[0391] Furthermore, by utilizing relatively rigid materials to form the front panel 3204 and top panel 3206, these components can be shaped to have a curvature roughly the same as that of the patient's face, thus ensuring a better seal through proper support and sealing of the forming structure 3100. When the positioning and stabilizing structure 3300 generates a tension vector V that is approximately parallel to the eye-ear plane, such as Figure 3o As shown, this also ensures an effective seal of the patient's airway.
[0392] The use of a relatively rigid material for the front panel 3204 and top plate 3206 is also advantageous, as the relatively rigid material prevents external deformation of the seal-forming structure 3100 to the point where it overlaps inward toward the face. This configuration also helps ensure that the seal-forming structure 3100 applies even sealing pressure to the patient's face. The headband 3306 of the positioning and stabilizing structure 3300 can generate a tension vector to seal the seal-forming structure 3100 onto the patient's face; however, the front panel 3204 and top plate 3206 can help distribute these sealing forces across the mouth pad 3110 and nose pad 3112. By distributing these sealing forces over a wider area, pressure and / or deformation can be confined to specific areas of the mouth pad 3110 and nose pad 3112, such as the area near the headband 3306.
[0393] Additionally, by utilizing a relatively rigid material to form the top plate 3206, unwanted vertical bending of the retaining arm 3302 can be prevented when the patient interface 3000 is worn, while still allowing pivoting of the retaining arm 3302 in a plane parallel to the patient's coronal plane. It should be understood that a small amount of vertical deflection is permissible.
[0394] Furthermore, by using a relatively rigid material for the front panel 3204, the patient can more easily attach the lower strap 3312 of the positioning and stabilization structure 3100. This is because the lower attachment component 3250 can remain in a fairly fixed position when the patient wears the patient interface 3000.
[0395] Furthermore, if the positioning and stabilizing structure 3300 is not directly connected to the sealing structure 3100, the patient can more easily disassemble and assemble the patient interface 3000 with the positioning and stabilizing structure 3300 (e.g., for cleaning purposes).
[0396] The top strap 3310 and lower strap 3312 are respectively attached via the top plate 3206 and the front panel 3204, allowing for better control of the nose pad 3112's seal on the nose. For example, decoupling the nose pad 3112 allows the top strap 3310 to provide targeted upward pressure on the underside of the nose and / or targeted inward pressure on the face. It also allows control of the nose pad 3112's height relative to the nose and its lateral position (e.g., left and right). Furthermore, the nose pad 3112 can be controlled to rotate relative to the nose and about an axis parallel to the longitudinal axis of the top plate 3206. These components provide these advantages that might otherwise be impossible when all headbands of the positioning and stabilizing structure 3300 are connected to a common front plate. Therefore, the embodiments disclosed in this specification can provide a more effective and stable seal around the patient's nose. It should also be understood that, by utilizing the decoupling structure 3106 to connect the nasal inflation chamber 3202 to the oral inflation chamber 3200, the top band 3310 of the positioning and stabilizing structure 3300 can also control the relative height of the mouth pad 3110.
[0397] In this technical specification, various headband configurations can be used with the exemplary patient interface 3000 described herein. Examples of this technical specification may utilize headbands similar to those disclosed in U.S. Patent Application Publication No. 2012 / 0138061. Further variations may include a top band 3310, which is shorter than those disclosed in the aforementioned patent application publication due to the connection of the top band to the retaining arm 3302.
[0398] In a further example of this technology, the positioning and stabilizing structure 3300 may include components disclosed in PCT Patent Application No. PCT / AU2013 / 000830 or U.S. Patent Application Publication No. 2014 / 0026890. The positioning and stabilizing structure 3300 disclosed in the references may be used as a top strap 3310. The lower strap 3312 may be a neoprene CommonLine headband.
[0399] According to a further example of this technology, one dimension of the top plate 3206 and the front panel 3204 can be used for various dimensions of the sealing structure 3100 and the oral inflation chamber 3200. This advantageously reduces the number of parts required to manufacture the patient interface 3000 to accommodate different patient head / face sizes. Therefore, according to this example of the technology, only the sealing structure 3100 and the oral inflation chamber 3200 may need to be molded in different dimensions.
[0400] Figures 18a to 18f Examples of top panel 3206 and front panel 3204 according to further examples of the present technology are shown in 21a to 21e, 22a to 22, and 28 to 28e. Figures 18a to 18f The top panel 3206 and front panel 3204 are respectively attached to the nasal inflation chamber 3202 and the oral inflation chamber 3200. According to an example of this technology, the top panel 3206 and front panel 3204 can be formed using a relatively hard material compared to silicone. By overlapping the nasal inflation chamber 3202 and the oral inflation chamber 3200 to the top panel 3206 and front panel 3204, the top panel 3206 and front panel 3204 can respectively join the nasal inflation chamber 3202 and the oral inflation chamber 3200. The nasal inflation chamber 3202, nasal pad 3112, oral inflation chamber 3200, oral pad 3110, and decoupling structure 3106 can be molded into a single piece using silicone.
[0401] Figure 18a , 18b Figures 18c and 18f also show the top plate buffer 3214 and the front panel buffer 3215. The top plate buffer 3214 can be integrally formed with the nasal inflation chamber 3202 and can be formed using silicone. When the nasal inflation chamber 3202 is overmolded onto the top plate 3206, the silicone can enter through the orifice 3217 and through the ejector hole 3216 of the top plate 3206 to form the top plate buffer 3214, as shown. Figures 21a to 21eAs shown. The orifice 3217 and ejector orifice 3216 together provide a clear flow path for the silicone as it overlaps and is molded onto the top plate 3206. Alternatively, the ejector orifice 3216 may not be open to provide a channel for silicone flow during overlapping molding, but instead, the ejector orifice 3216 may include a notch that can be filled with silicone to form a mechanical interlock and provide cushioning. When the retaining arm assembly 3301 engages the top plate 3206, the top plate cushioning portion 3214 can press against the rear side of the top plate cover 3303. The top plate cushioning portion 3214, made of a material relatively softer than the top plate 3206 and top plate cover 3303, such as silicone, can dampen the hard-on-hard connection to reduce or eliminate wobbling of these components.
[0402] The top plate buffer portion 3214, which is integral with the nasal inflation chamber 3202 and connects to the orifice 3217 of the top plate 3206, can also provide a retaining function to keep the top plate 3206 in position within the nasal inflation chamber 3202.
[0403] The protrusion 3307 can also work in conjunction with the top plate buffer 3214 to provide damping and / or retention between the top plate 3206 and the retaining arm assembly 3301. The engagement of the protrusion 3307 with the top plate buffer 3214 and the top plate 3206 provides damping and / or retention, and the relative dimensions of these components can be selected to ensure the desired degree of damping and / or retention.
[0404] The front panel cushioning portion 3215 may extend forward from the periphery of the inlet air chamber 3200. The front panel cushioning portion 3215 may be integrally formed with the inlet air chamber 3200. The front panel cushioning portion 3215 may be made of silicone. The front panel cushioning portion 3215 may also dampen the rigid-on-rigid connection between the front panel 3204 and the frame portion 3251 to reduce or eliminate loosening caused by the connection.
[0405] Figures 21a to 21e The top plate 3206 is shown as separate, and Figures 22a to 22e Displays the separate front panel 3204.
[0406] The upper attachment part 3252 of the top plate 3206 can be connected to the retaining arm assembly 3301 in the connecting part 3304, such as Figures 17a to 17f As shown. The upper attachment member 3252 of these examples may include a hard notch and / or undercut, which engages the corresponding connection member 3304 to attach the retaining arm assembly 3301.
[0407] The front panel 3204 may also include cut-off portions 3213 on each side to connect the frame portion 3251 to the front panel. Each cut-off portion 3213 may extend laterally from the front panel 3204. The cut-off portions 3213 may facilitate a hard-to-hard connection (e.g., between two relatively rigid components) between the front panel 3204 and the frame portion 3251. The hard-to-hard connection may be in the form of a snap-fit and may produce an audible click when the frame portion 3251 is attached to the front panel 3204. Additionally, a connection port 3600 is shown formed on the front panel 3204. Figures 17a to 17f The frame 3251 is shown attached around the front panel 3204.
[0408] Figures 28a to 28e Display similar to Figures 21a to 21e Another example of the top plate 3206 shown. However, Figures 28a to 28e The example shown illustrates that recesses 3219 are provided on each ejector hole 3216 on its rear side. Recesses 3219 can provide deeper silicone flow during the molding process of the sealing formation structure 3100 and the inlet inflation chamber 3200 onto the top plate 3206. Recesses 3219 can be hemispherical, and therefore can also provide a larger surface area for attaching silicone to the top plate 3206, which, according to an example of the present technology, can be self-adhesive liquid silicone rubber (LSR).
[0409] Figures 27a to 27f This illustrates another example of the technology. These figures show the sealing structure 3100, and the front panel 3204 and top panel 3206. These figures show similar examples. Figures 18a to 18f The example shown is that the sealing structure 3100 can be formed using silicone and can be overmolded onto the top panel 3206 and the front panel 3204 to join these components. Figures 27a to 27f Another example is shown where the top plate 3206 can be almost completely embedded in the sealing structure 3100. In other words, when the sealing structure 3100 is overmolded onto the top plate 3206, the sealing structure can completely surround the top plate 3206, minimizing the exposure of the top plate 3206. Furthermore, the protrusion 3218 can be formed extending from the top plate 3206 and can be integrally formed with the sealing structure 3100. When the retaining arm assembly 3301 engages the top plate 3206, the protrusion 3218 functions similarly to the cushioning and / or shock absorption function of the top plate buffer 3214. Additionally, the protrusion 3218 can be formed in a barbed shape, thus serving a retaining function.
[0410] In a further alternative embodiment, the protrusion 3218 may be integrally formed with the top plate 3206. In this example, the barb shape of the protrusion 3218 can serve a retaining function, but since it is made of the same fairly rigid material as the top plate 3206, it may not be able to serve as a cushioning and / or damping function. Therefore, the overlapping molded silicone (generally surrounding the top plate 3206) of the sealing forming structure 3100 can serve as a cushioning and / or damping function.
[0411] Figures 20a to 20a Images 23a to 23f, 24a to 24f, and 25a to 25f show the frame portion 3251 with clamp 3314, the lower attachment part 3250, and their respective sub-assemblies.
[0412] The frame portion 3251 may also include latches 3253 on each side for engaging individual notches in the cut-off portion 3213 to facilitate attachment of the front panel 3204. The latches 3253 attaching to the cut-off portion 3213 can generate circumferential stress in the frame portion 3251, holding the frame portion in place of the front panel 3204. A lower attachment member 3250 may also be formed on the frame portion 3251. Figure 20f As shown, for example, each of the lower attachment members 3250 may include a mating surface 3254 that engages each of the clamps 3314. Figure 20g Each mating surface 3254 may be located on the mating portion 3255 of the lower attachment member 3250. Each lower attachment member 3250 may include a wing 3257 to engage each of the frame portion 3251 to the mating portion 3255.
[0413] The wing 3257 can be joined to the frame 3251 by overlapping molding the wing 3257 with the frame extension 3259 of the frame portion, thereby forming a mechanical interlock. The frame extension 3259 then extends to the corresponding recess 3258 of the wing 3257. The mating portion 3255 can also be joined to the wing 3257 by simultaneously overlapping molding, thereby forming a mechanical interlock between the wing 3257 and the mating portion 3255. Therefore, the mating extension 3256 can also extend to the recess 3258 of the wing 3257.
[0414] The wing 3257 can be formed using a thermoplastic elastomer. The wing 3257 can also be elastic, allowing the lower attachment member 3250 to function like a hinge. In other words, due to the flexibility of the lower attachment member 3250, it can move forward / backward, allowing the tension of the headband 3306 to bend and hold the patient interface 3000 in place when the patient wears it. The mating part 3255 can also be formed using a thermoplastic elastomer.
[0415] The clamp 3314 may include a rod 3315, and a lower strap 3312 may be wrapped around the rod to attach the clamp 3314 to the lower strap 3312.
[0416] For engaging the clamp 3314 to the lower attachment member 3250, a magnetic connection may be provided. A clamp magnet 3260 may be provided for each of the clamps 3314 in a clamp recess 3317, and a mating magnet 3261 may be provided for each of the mating portions 3255 of the lower attachment member 3250 within a mating recess 3262. The ends of each clamp magnet 3260 and each mating magnet 3261 may be arranged such that a magnetic attraction is generated between these magnets to tighten and retain the clamp 3314 to the lower attachment member 3250. Furthermore, a further example of these attachment configurations is disclosed in PCT Patent Application No. PCT / AU2014 / 000021, the entire contents of which are incorporated herein by reference.
[0417] These examples of mating portions 3255 may also include guide surfaces 3263 and protrusions 3264 to position the clamp 3314 during attachment. Furthermore, each of the clamps 3314 may include a receiving surface 3319 to engage the corresponding guide surface 3263; and a notch 3318 to engage the corresponding protrusion 3264. When the clamp 3314 is attached to the corresponding mating portion 3255 of the lower attachment member 3250, the engagement of the notch 3318 and the protrusion 3264 prevents rotation of the clamp 3314 relative to the mating portion 3255 of the lower attachment member 3250. When the patient wears the patient interface 3000, this helps ensure that the tension vector direction of the lower tether 3312 is correctly aligned.
[0418] The guide surface 3263 may have a curved profile. The guide surface 3263 may also be shaped to form a protruding end. The receiving surface 3319 may be shaped to conform to the shape of the guide surface 3263. The shape of the guide surface 3263 may also have guiding and / or retaining functions. The curved profile and slope of the guide surface 3263 allow the receiving surface 3319 to slide and slide into position along the guide surface 3263, such that the protrusion 3264 engages the notch 3318. This is advantageous because when a patient wears the patient interface 3000, it is not easy for the patient to align the clamp 3314 with the lower attachment part 3250. Furthermore, the patient may be in a dark environment, have limited tactile ability, and / or limited vision, making it difficult to align the clamp 3314 with the lower attachment part 3250. Therefore, structuring the guide surface 3263 to guide the receiving surface 3319, thus positioning the clamp 3314, helps ensure the correct and secure mating of the patient interface 3000.
[0419] Figure 20n The diagram shows a rear view of the frame portion 3251 and the lower attachment member 3250. According to this example, each of the lower attachment members 3250 may include a bending point, shown in this figure as a thickness-reducing segment 3266. When subjected to tension from the lower strap 3312 of the positioning and stabilizing structure 3300, the lower attachment member 3250 may deform and bend in the rear direction of the bending point. The lower attachment member may include a thermoplastic elastomer.
[0420] Figure 20q to 20s A top view showing the frame portion 3251 and the lower attachment member 3250, which are further examples of this technology. Figure 20q Notch 3265 is shown at the bend point on the front side of each of the lower attachment parts 3250. Figure 20q The notch 3265 shown allows the lower attachment part 3250 to bend in the forward direction through the notch 3265. Figure 20r Notch 3265 is shown at the bend point on the rear side of each of the lower attachment parts 3250. Figure 20r The notch 3265 shown allows the lower attachment member 3250 to bend rearward through the notch 3265. It should be understood that, according to a further example of the present technology, the notch 3265 may be provided on both the rear and front sides of each lower attachment member 3250.
[0421] Figure 20s Another top view showing the frame portion 3251 and the lower attachment member 3250 according to an example of the present technology. According to this example, the bending point may include a thickness reduction section 3266 that reduces the thickness of the lower attachment member 3250 from the rear and front sides to allow the lower attachment member to bend in both directions.
[0422] Figure 20o and 20p Display similar to Figure 20g and 20h An exploded view of the component. However, Figure 20o and 20p Also shown is the mating part magnet receiving unit 3267. Each of the mating part magnet receiving units 3267 can be configured to receive the corresponding mating part magnet 3261. Figure 23g to 23m Also shown is the magnet receiving unit 3267 of the mating part.
[0423] Figure 20p and 25g Version 25l also shows that the clamp 3314 may include a clamp magnet receiving unit 3321 and a clamp magnet cover 3320 to fix the clamp magnet 3260 inside the clamp 3314. The clamp magnet cover 3320 may use a snap fastener to fix the clamp magnet 3260 to the clamp magnet receiving unit 3321.
[0424] 5.3.4 Ventilation port, pipe decoupling structure, connection port, and anti-suffocation valve In one embodiment, the patient interface 3000 includes a ventilation port 3400 configured to allow the expulsion of exhaled carbon dioxide.
[0425] The ventilation port 3400 according to this technology includes a plurality of holes, for example, about 20 to about 80 holes; or about 40 to about 60 holes; or about 45 to about 55 holes. It is also conceivable to have more than 80 holes.
[0426] In this example, the vent 3400 is located in the inlet chamber 3200. Alternatively, the vent 3400 is located in the tube decoupling structure 3500, for example, the rotary bearing 3510.
[0427] In another embodiment of this technology, the vent 3400 may be located on the top panel 3206 and / or the front panel 3204. In this embodiment, the pipe decoupling structure 3500 may not include the vent.
[0428] The vent 3400 can be made using a mesh material or a linear array laser-cut or fabricated. The vent 3400 can also be made using a material or fabric interwoven with plastic fibers. The interwoven plastic fiber material is a thermoplastic polymer, including polycarbonate, nylon, polyethylene, and preferably polypropylene. Specifically, the fabric can be a woven polypropylene material such as SEFAR material TETEX Mono 05-1010-K 080. The fabric is typically supplied in the form of rollers or ribbons. The weave of the fabric is preferably satin. However, other weaves are possible, including plain weave, plain reverse Dutch weave, and twill weave. The gaps or holes defined by the weave of the fibers through the fabric do not necessarily need to have uniform dimensions, due to some variation in the positioning, spacing, and compression of the fibers in the fabric weave. The gaps are preferably not straight through holes, but rather defined as curved airflow paths between adjacent fibers through the fabric thickness. Curved airflow paths significantly diffuse airflow, thereby reducing noise. If the gaps are straight through holes, the fibers of the fabric can be arranged in a mesh pattern.
[0429] In one example, the airflow at the ventilation openings of the fabric is first measured using an air flow meter. A difference between the measured airflow rate and the desired airflow rate is determined. If the airflow rate through the ventilation openings exceeds the predetermined range, the number of pores in the ventilation openings is reduced. The desired predetermined range is approximately 42 to 59 liters per minute at 20 cm H2O pressure; preferably, it is approximately 47 to 53 liters per minute at 20 cm H2O pressure. For example, the airflow rate of SEFAR material TETEX Mono 05-1010-K080 woven polypropylene material can be approximately 37 to 64 liters per minute at 20 cm H2O pressure; preferably, it is approximately 42 to 58 liters per minute at 20 cm H2O pressure. The variation in airflow rate over the webbing length of the SEFAR fabric can follow a sinusoidal curve. When initially received from the fabric supplier, different areas of the SEFAR fabric will exhibit different airflow velocities. After reducing the pores, the airflow rate is measured again for verification to confirm that it is now within the predetermined range. The average diameter of the vent opening is preferably less than 0.1 mm, and it preferably provides approximately 1% to 10% of the total opening area of the vent surface area. For example, the total opening area could be 22 mm². 2 The surface area of the ventilation port is 240 mm. 2 .
[0430] Alternatively, if the desired airflow is achieved through fabric, the holes in the peripheral area of the vent will be blocked. The peripheral area of the vent is overlapped and molded onto the top plate 3206 and / or the front panel 3204. Since the holes in the peripheral area are blocked, the airflow rate of the vent should not differ after the overlap molding.
[0431] In some examples, the airflow rate is measured after the vent is cut from the fabric, and also after overlapping molding on the top plate 3206 and / or the front panel 3204. This allows it to be known and determined whether the airflow rate is within the desired predetermined range after each step. This prevents waste, allowing the portion to be discarded as soon as it is known to be outside the desired predetermined range.
[0432] Several methods can reduce the porosity of venting openings, including: hot-melt welding, compression molding, ultrasonic welding, application of sealants (e.g., hot-melt adhesives), and application of thin films. Hot-melt welding using a concave-convex joint is preferred for reducing porosity due to increased precision, greater fabric pore closure certainty, process speed, good visual appeal after welding, and the elimination of the need for additional material. When thermoplastic materials are heated, some material shrinkage occurs, indicating excessive material around the specific solid dimensions of the venting opening shape. Porosity at the venting opening can be reduced by partially or completely blocking the pores.
[0433] Porosity can be reduced in any area or region of the vent. Preferably, porosity is reduced in the continuous peripheral area of the vent. This provides good visual appeal because it is adjacent to or overlaps with the vent on the top plate 3206 and / or front panel 3204. Any visual difference between the continuous peripheral area and the rest of the vent will not be noticeable to the human eye in this location, as it presents the defining edge of the top plate 3206 and / or front panel 3204 for receiving the vent 3400. Alternatively, the area with reduced porosity in the central region of the vent may be in the form of characters / letters or a logo pattern to enhance visual impact and increase brand awareness.
[0434] When the patient exhales through their nose and carbon dioxide flows out through the ventilation opening, the sound caused by exhaled carbon dioxide through the opening is the lowest, at 340°, because the exhaled carbon dioxide passes through the fabric, especially the nasal pillow. The diffusion of exhaled carbon dioxide should avoid a direct or concentrated flow of air to the bed partner or the patient; this depends on the direction of the ventilation opening and the sleeping position.
[0435] The ventilation port of the patient interface is easy to clean. Mild detergent or soapy water can be used to clean the ventilation port. Hot water can also be used to rinse the ventilation port. The ventilation port can be hand-washed and cleaned without disassembling it from the top panel 3206 and / or front panel 3204, as it is permanently attached (e.g., overmolded) to the top panel 3206 and / or front panel 3204. The fewer removable parts of the patient interface reduce the possibility of losing any parts and also reduce cleaning time, as it eliminates the need to separate and reattach each component. Compared to ventilation ports made of another less durable material (e.g., fabric), the ventilation port, being formed from plastic fibers, maintains its durability even after repeated washing.
[0436] The ventilation vents are quiet. The sound energy generated by exhaled carbon dioxide is evenly distributed. Vibrations caused by exhaled carbon dioxide touching the top panel 3206 and / or the front panel 3204 may cause vibrations in the top panel 3206 and / or the front panel 3204. The ventilation vents can dampen these vibrations.
[0437] In one embodiment, the patient interface 3000 includes at least one tubing decoupling structure 3500, such as a rotary bearing or ball joint. The tubing decoupling structure 3500 may also include an elbow component. The tubing decoupling structure 3500 can be separated between the tubing and the nozzle.
[0438] Connection port 3600 allows connection of air conduit 4170. Air conduit 4170 may include a short conduit connecting to a longer conduit. Examples of the conduit may include the conduit component disclosed in PCT patent application No. PCT / AU2013 / 000830. A rotatable adapter may also be included to connect the short conduit to the long conduit.
[0439] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve 3800.
[0440] Figure 3g This figure shows another front perspective view of an exemplary patient interface 3000 according to the present technology. This view is similar to... Figure 3a The figure shows the components, but also includes components connecting the patient interface 3000 to the PAP device 4000. These additionally shown components include at least one vent 3400 radially disposed near the connection port 3600. In the illustrated example, the vent 3400 includes a plurality of vents surrounding the connection port 3600. The components of the vent 3400 will be discussed in more detail below. The figure also shows a tubing decoupling structure 3500 connecting the air conduit 4170 to the connection port 3600 on the front panel 3204 of the patient interface 3000. The tubing decoupling structure 3500 may be an elbow and may include a swivel bearing 3510 to allow the tubing decoupling structure 3500 and the air conduit 4170 to rotate relative to the patient interface 3000 near the connection port 3600. The tubing decoupling structure 3500 in this figure also includes an anti-asphyxiation valve 3800, which will be described in more detail below. Additionally, Figure 3g The air line 4170 may include a sleeve 4172 for attaching the air line to the pipe decoupling structure 3500.
[0441] Figure 3h Display similar to Figure 3c A rear view of the components of an exemplary patient interface 3000. However, Figure 3h The patient interface 3000 is also shown to include an air vent 3400, which is in the form of a plurality of air vents radially arranged near the connection port 3600. The cap 4172 and air conduit 4170 are also shown. The location of the decoupling structure 3106 and the connection area 3106.2 together with the mouth pad 3110 and the nose pad 3112 are indicated in the figure.
[0442] Figure 3i Display similar to Figure 3b A front view of an exemplary patient interface 3000. Figure 3i The figure also shows the connection port 3600 of the tube decoupling structure 3500 attached to the front panel 3204 of the patient interface 3000. This figure also shows the ventilation port 3400, which is in the form of a plurality of ventilation ports radially arranged near the connection port 3600. The anti-asphyxiation valve 3800 is also shown on the tube decoupling structure 3500. The sleeve 4172 and the air line 4170 are also shown connected to the tube decoupling structure 3500. This figure shows the decoupling structure 3106, and also shows the side portion 3106.3 of the decoupling structure 3106.
[0443] Figure 3j Display similar to Figure 3dTop view of an exemplary patient interface 3000 of the component shown. Figure 3d Also shown is a ventilation port 3400, which is in the form of a plurality of ventilation ports arranged around the connection port 3600. Extending from the connection port 3600 are a pipe decoupling structure 3500 and an anti-suffocation valve 3800 disposed thereon.
[0444] Figure 3k Showing a bottom view of an exemplary patient interface 3000. This figure is similar to... Figure 3e Similar components are shown. Furthermore, this figure shows that the vent 3400 includes a plurality of vents radially arranged near the connection port 3600. The pipe decoupling structure 3500 is shown extending from the connection port 3600. The sleeve 4172 and air conduit 4170 are also shown.
[0445] Figure 3l Display similar Figure 3f The example patient interface 3000 is shown as a side view. Therefore, Figure 3l Display similar Figure 3f The components shown. However, Figure 3l The diagram also shows that the ventilation port 3400 includes a plurality of ventilation ports radially arranged near the connection port 3600. A pipe decoupling structure 3500 is shown at one end connected to the connection port 3600, and at the other end connected to the air conduit 4170 via a sleeve 4172. The location of the decoupling structure 3106 and one of its sides 3106.3 are also shown. A gap 3106.1 between the nasal inflation chamber 3202 and the oral inflation chamber 3200 is also shown, allowing these components to bend or move toward each other.
[0446] according to Figures 17a to 17f and Figures 26a to 26dIn the illustrated examples, the tube decoupling structure 3500 may engage the front panel 3204 with the connection port 3600. In these examples, an air vent 3400 may be formed on the tube decoupling structure 3500. In these examples, the tube decoupling structure 3500 may include an elbow that rotates at the connection port 3600. The tube decoupling structure 3500 may also include a swivel bearing 3510 for connecting the air duct 4170. The tube decoupling structure 3500 may include a baffle 3520 for separating the pressurized gas flow path from the PAP device 4000 from the flow path of the patient's exhaled gas (e.g., CO2) (which exits through the air vent 3400). By separating these flow paths, the baffle 3520 may improve the evacuation of exhaled gas (e.g., CO2). The tube decoupling structure 3500 may also include a quick-release mechanism 3530, which allows the patient to easily attach and disconnect the tube decoupling structure 3500 from the connection port 3600 on the front panel 3204. The quick-release mechanism 3530 may also be configured to provide a latching engagement between the connection port 3600 and the tube decoupling structure 3500, and engagement will produce an audible click to ensure the patient has completed the connection. The tube decoupling structure 3500 may also include an anti-asphyxiation valve 3800.
[0447] Vocabulary In certain forms of this technology, for the purposes of this disclosure, one or more of the following limitations may be applied in a particular form of this technology. In other forms of this technology, other limitations may be applied.
[0448] General Rules Air: Air will include breathable gases, such as air containing supplemental oxygen.
[0449] Continuous Positive Airway Pressure (CPAP): CPAP therapy means supplying air or breathable gas to the airway inlet through the patient's respiratory cycle at a continuous, preferably constant, positive atmospheric pressure. In some forms, the airway inlet pressure varies by a few centimeters per minute during a single respiratory cycle, for example, higher during inhalation and lower during exhalation. In some forms, the airway inlet pressure is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure changes between different respiratory cycles, for example, increasing with the detection of an indication of partial upper airway obstruction and decreasing with the absence of an indication of partial upper airway obstruction.
[0450] AP device state Air Circuit: A tubing or tube is used to construct and connect the PAP device to the patient interface to deliver a supply of air or breathable gas. Specifically, an air circuit may be a fluid-connected pneumatic section to the outlet of the patient interface. Air circuits may be referred to as air conduction tubes. In some cases, there may be separate protrusions on the tubing for inhalation and exhalation. In other cases, a single protrusion may be used.
[0451] APAP (Automatic Positive Airway Pressure): Automated positive airway pressure ventilation.
[0452] Blower or flow generator: A device that transmits airflow above ambient pressure.
[0453] Controller: A device, or part of a device, used to adjust an output based on an input. For example, the controller may be variable under the control of a control variable constituting the input of the device. The output of the device is a function of the current value of the control variable and is the setpoint of the variable. A servo ventilator may include a controller having ventilation as an input, a target ventilation as a setpoint, and a pressure support level as an output. Other forms of input may be one or more of oxygen saturation (SaO2), partial pressure of carbon dioxide (PCO2), action, a signal from a photovolume description signaling instrument, and maximum flow rate. The setpoint of the controller may be one or more of a fixed value, a variable value, or a learned value. For example, the setpoint of a ventilator may be a long-term average of the patient's measured ventilation. Another ventilator may have a ventilation setpoint that varies over time. A pressure controller may constitute a control for a booster or pump to deliver air at a specific pressure.
[0454] Therapy: Therapy as described in the instructions may include positive pressure therapy, oxygen therapy, carbon dioxide therapy, dead space control, and one or more of the following: medication.
[0455] Positive Airway Pressure (PAP) Device: A device used to provide a positive pressure air supply to the respiratory tract.
[0456] Facial Anatomy Alar (or ala): The outer wall or "wing" of each nostril.
[0457] Alar angle: The angle between the nostrils when viewed from above.
[0458] Alare: The outermost point on the upper part of the nostril.
[0459] Alar point or the outermost point of the nasal ala (Alar Curvature or Alar Crest): the last point of the curved baseline of each nasal ala, formed by the crease where the nasal ala joins the cheek.
[0460] Auricle or pinna: The entire visible external part of the ear.
[0461] (Nose) Bony Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the jawbone.
[0462] (Nose) Cartilaginous Framework: The cartilaginous framework of the nose includes the nasal septum, sides, and major and minor alar cartilages.
[0463] The columella: the skin section that separates the nostrils and extends from the tip of the nose to the upper lip.
[0464] Columella Angle: The angle between the line segment that intersects the subnasal point and the line segment drawn through the midpoint of the nostril and the line segment drawn perpendicular to the horizontal plane of the eye and ear.
[0465] Frankfort Horizontal Plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch of the tragus, which is higher than the outer ear.
[0466] Glabella: The most prominent point of soft tissue located in the midsagittal plane of the forehead.
[0467] Lateral Nasal Cartilage: This is usually a small cartilage plate with its upper edge connecting the nasal bone to the frontal process of the maxilla, and its lower edge connecting to the alar cartilage.
[0468] Lower lip (lower lip inferius): The point where the vermilion border of the lower lip intersects with the midline sagittal plane.
[0469] Upper lip (upper (labrale superius)): The point on the midsagittal plane of the upper lip, located on a line that crosses the vermilion border and the skin boundary.
[0470] Major alar cartilage: A cartilaginous plate located below the lateral nasal cartilage. It curves around the anterior part of the nostrils and its posterior end is connected to the frontal process of the maxilla via a tough fibrous membrane containing three or four minor alar cartilages.
[0471] Nostrils (Naris / Nares (Nostrils)): These are small, nearly circular openings that form the entrance to the nasal cavity. The nostrils are separated by the nasal septum.
[0472] Naso-labial folds (Naso-labial Fold): Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.
[0473] Naso-labial angle: The angle between the columella and the upper lip when the subnasal point intersects.
[0474] Otobasion inferior: The lowest point connecting the auricle to the facial skin.
[0475] Otobasion superior: the highest point connecting the auricle to the facial skin.
[0476] Pronasale: The most prominent point of the nose or the tip of the nose, which can be identified from a side view of the rest of the head.
[0477] The philtrum is the nasolabial groove that runs from the lower edge of the nasal septum to the upper lip area.
[0478] Pogonion: Located in the soft tissue, at the very front midpoint of the chin.
[0479] Nasal ridge (Nasal Ridge): The nasal ridge is the midline protrusion of the nose, extending from the bridge of the nose to the tip of the nose.
[0480] Sagittal Plane: A vertical plane that divides the body into right and left halves from the front (anterior) to the back (posterior).
[0481] Sellion: Located in the soft tissue, it is the most concave point above the nasolabial fold.
[0482] Septal cartilage (Nasal): The septal cartilage forms the septum and separates the anterior part of the nasal cavity.
[0483] Subalare: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper lip.
[0484] Subnasal Point: Located in the soft tissue, it is the point where the columella meets the upper lip in the midsagittal plane.
[0485] Supramentale: The largest indentation on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue chin point.
[0486] Anatomical structure of the skull Frontal bone: The frontal bone includes the large vertical part, namely the frontal scale, which corresponds to the area called the forehead.
[0487] Mandible: The mandible forms the lower jaw. Mental protuberance is the bony protuberance that forms the chin.
[0488] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye socket. The frontal process of the maxilla extends upward along the nasal side and forms part of its transverse boundary.
[0489] Nasal bone: The nasal bone consists of two small oval bones of different sizes and formed in different individuals; they are located side by side in the middle and upper part of the face, and their junction forms the "bridge of the nose".
[0490] Nassion: The point where the frontal bone intersects with the two nasal bones, directly between the eyes and the depression above the bridge of the nose.
[0491] Occipital bone: The occipital bone is located on the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity connects to the vertebral canal. Behind the foramen magnum is the occipital squamus.
[0492] Parietal bone: The parietal bone is the bone that forms the skullcap and sides of the skull when they are joined together.
[0493] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the face, which is called the temple.
[0494] Zygomatic bone: The face includes two cheekbones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.
[0495] Respiratory system anatomy Diaphragm: A muscle that extends across the base of the thoracic cavity. The diaphragm separates the abdominal cavity from the thoracic cavity, which includes the heart, lungs, and ribs. When the diaphragm contracts, the volume of the thoracic cavity increases, allowing air to enter the lungs.
[0496] Larynx: The larynx, or the part of the throat, which houses the vocal cords and connects the lower part of the laryngopharynx (hypopharynx) to the trachea.
[0497] Lungs: The human respiratory organs. The guiding sections of the lungs include the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory organ sections include the respiratory bronchioles, pulmonary ducts, and alveoli.
[0498] Nasal Cavity: The nasal cavity (or nasal socket) is a large, air-filled space located above and behind the nose in the center of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal ectodes called nasal passages or nasal turbinates. The anterior part of the nasal cavity is the nose, while the posterior part merges into the nasopharynx through the posterior nasal aperture.
[0499] Pharynx: Located directly below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).
[0500] materials Silicone or silicone elastomer: A synthetic rubber. In this specification, the silicone referred to is a liquid silicone rubber (LSR) or a compression-molded silicone rubber (CMSR). The commercially available LSR is SILASTIC (including several products sold under this trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise stated, preferred forms of LSR have a Shore A (or Type A) indentation hardness in the range of approximately 35 to approximately 45 as measured using ASTM D2240.
[0501] Polycarbonate: A typical transparent thermoplastic polymer of bisphenol A type carbonate.
[0502] Patient interface status Anti-asphyxia valve (AAV): A component or subassembly of a nasal mask system that reduces the risk of patients breathing excessive CO2 again by allowing the system to be open to the atmosphere in a fail-safe manner.
[0503] Elbow: A conduit that guides a flow axis or air to change the direction of its flow at an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be less than 90 degrees. The conduit can have a roughly circular cross-section. In yet another form, the conduit can have an elliptical or rectangular cross-section.
[0504] Frame: The frame refers to the nasal mask structure that bears the tensile load between two or more points connecting the headband. The nasal mask frame can be a non-airtight load-bearing structure of the nasal mask. However, some nasal mask frames can also be airtight.
[0505] Functional dead space: Functional dead space refers to at least one area within the airway that collects the patient's exhaled air, preventing the normal flow of gas within the airway from effectively expelling the exhaled air from the airway.
[0506] Headgear: A headgear refers to a form of positioning and stabilizing structure designed for use over the head. Ideally, a headgear comprises one or more pillars, straps, and reinforcing components that position and maintain the patient interface on the patient's face for delivering respiratory therapy. Some straps are made of soft, flexible, and elastic materials, such as laminated composite materials of foam and fabric.
[0507] Membrane: A diaphragm is a thin component that is generally flexible but has tensile strength.
[0508] Plenum Chamber: A nasal mask inflation chamber refers to a component of the patient interface that has walls enclosing a spatial volume containing air, which is pressurized above atmospheric pressure for use. The housing may form part of the walls of the nasal mask inflation chamber. In one configuration, the area of the patient's face forms one of the walls of the inflation chamber.
[0509] Seal: A seal is a structure or barrier intended to prevent air from flowing through the interface between two surfaces; or, a seal means to prevent air from flowing.
[0510] Shell: A shell refers to a curved structure with bending, tensile, and compressive rigidity, such as the curved structural wall of a nasal mask. Ideally, it should be relatively thin relative to its overall dimensions. In some forms, the shell may have facets. Although in some forms the wall is not airtight, it is preferable that the wall is airtight.
[0511] Stiffener: A stiffener is a structural component designed to improve the bending resistance of another component in at least one direction.
[0512] Strut: A strut refers to a structural component designed to enhance the compressibility of another component in at least one direction.
[0513] Swivel: The subassemblies of the component are preferably configured to rotate independently about a common axis under low torque. In one form, the swivel bearing can be configured to rotate at least 360 degrees. In another form, the swivel bearing can be configured to rotate less than 360 degrees. When used in an air-lined environment, the subassemblies of the component preferably include mating pairs of cylindrical conduits. Ideally, minimal or no airflow should leak from the swivel bearing during use.
[0514] Tie: A tie is a structural component designed to resist tension.
[0515] Vent: Allows for planned control of the leakage rate from inside the nasal mask or cannula to ambient air, allowing the exhaled carbon dioxide (CO2) to be expelled and oxygen (O2) to be supplied.
[0516] Terminology related to patient interface Surface curvature: A surface region with a saddle shape that curves upward in one direction and downward in other directions has negative curvature; a surface region with a dome shape (curving in the same way in both principal directions) has positive curvature. A plane has zero curvature.
[0517] Flexibility (Floppy): The quality of a material, structure, or composite material that utilizes a combination of the following properties: It easily adapts to finger pressure.
[0518] When the weight supporting it is applied, it can no longer maintain its shape.
[0519] Not hard.
[0520] It can be stretched or bent elastically with a little force.
[0521] The quality of flexibility can have an associated direction. Therefore, a particular material, structure or composite material may be flexible in the first direction, but inelastic or rigid in the second direction, for example, the second direction may be perpendicular to the first direction.
[0522] Resilient: It can deform elastically and releases most of its energy when removed within a relatively short period of time, such as 1 second.
[0523] Rigid: Not easily deformed by finger pressure and / or tension or load typically encountered when establishing and maintaining a seal between the patient interface and the patient's airway inlet.
[0524] Semi-rigid: refers to a material that is sufficiently rigid not to be significantly distorted under the mechanical forces typically applied during positive airway pressure therapy.
[0525] Other supplementary notes Unless otherwise specified, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described in this specification may be used in the practice or testing of this technology, this specification describes only a limited number of exemplary methods and materials.
[0526] It must be noted that, as used in this specification and the scope of the patent application below, unless otherwise expressly specified in this specification, the singular forms “a,” “an,” and “the” include their plural equivalents.
[0527] Furthermore, in interpreting this invention, all terms should be interpreted in a broad and reasonable manner consistent with this specification. In particular, the terms "comprising" and "including" should be interpreted in a non-exclusive manner as components, elements, or steps that indicate that the referenced component, element, or step may be present or used in conjunction with other components, elements, or steps not expressly referenced.
[0528] While the techniques described in this specification have been referenced to specific examples, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some examples, terms and symbols may imply that specific details for implementing the technology are unnecessary. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different components. Furthermore, although the processing steps in the method are described or illustrated in a certain order, this order is not necessarily required. Those skilled in the art will understand that this order can be modified and / or its manner can be performed simultaneously or even concurrently.
[0529] Therefore, it should be understood that various modifications can be made to the illustrative example, and other configurations can be designed without deviating from the spirit and scope of this technology.
[0530] Symbol Explanation Patient 1000 1100 bed partners Patient Interface 3000 Sealing Formation Structure 3100 Nasal air chamber opening 3101 Breath chamber 3102 Breath chamber opening 3103 Nasal air chamber 3104 Distal side 3104.1 The smaller side is 3104.2. Proximal 3104.3 Nostril port 3105 Decoupling structure 3106 Gap 3106.1 Connecting area 3106.2 Side section 3106.3 Top surface 3106.4 Connection surface 3106.5 Bottom 3106.6 Mouth pad 3110 Nose pad 3112 Area 3112.1 Area 3112.2 Area 3112.3 Area 3113 Protruding end 3114 Area 3115 Recess 3116 Area 3117 Peak 3118 Nasal suspensory band 3119 3120 under mouth pad straight sidewall 3121 Conical region 3122 Thickened nasal pad segment 3124 Soft connection area 3130 Hard-connect area 3132 3200 air chamber Nasal inflation chamber 3202 Front panel 3204 Connector 3205 Top plate 3206 Side support component 3207 Nasal support wall 3208 Notch 3208.1 Gap 3209 3210 surrounding area Oral inflation chamber section 3212 Cut off part 3213 Top plate buffer section 3214 Front panel buffer section 3215 Recess 3216 Orifice 3217 Extender part 3218 Recess 3219 Lower attachment part 3250 Frame 3251 Upper attachment part 3252 Detent 3253 Mating surface 3254 Coordination Unit 3255 3256 protruding part of mating part Wing 3257 Recess 3258 Frame extension part 3259 Clamp magnet 3260 Magnet 3261 for mating parts Recess 3262 of mating part Guide surface 3263 Protrusion 3264 Gap 3265 Thickness reduction segment 3266 Magnet receiving unit 3267 Positioning and stabilizing structure 3300 Hold-up arm assembly 3301 Hold arm 3302 Top panel cover 3303 Connecting component 3304 Pad 3305 Headband 3306 Protrusion 3307 Opening 3308 Claw 3309 Top band 3310 Lower lace 3312 Fixture 3314 Member 3315 Protective Case 3316 Fixture notch 3317 Gap 3318 Acceptance area 3319 Fixture Magnet Cover 3320 Clamp magnet receiving unit 3321 3400 air exchange ports Decoupling tube structure 3500 3510 rotary bearing Partition 3520 Rapid release mechanism 3530 Connection port 3600 Anti-suffocation valve 3800 PAP device 4000 Air duct 4170 4172 (Touch) Humidifier 5000.
Claims
1. A patient interface for providing breathable gas to a patient, the patient interface comprising: Pad assembly, including: A nasal pad having a concave shape between a first side and a second side to receive and seal the lower periphery of the patient's nose, the nasal pad including a nasal opening configured to guide breathable gas to the patient's nostrils during use. The nasal air chamber, together with the nasal pad, forms a nasal air chamber; A mouth pad, configured to surround the patient's mouth and contact and seal the patient's face, the mouth pad including an orifice configured to direct breathable gas to the patient's mouth during use; The mouth air chamber forms an oral air chamber with the mouth pad, and the nasal air chamber and the oral air chamber are pneumatically connected within the pad assembly; Anti-suffocation valve; A positioning and stabilizing structure includes a pair of upper side straps, a pair of lower side straps, and a rear portion, wherein the pair of upper side straps and the pair of lower side straps extend from the rear portion; and A single plate member, removably connected to the pad assembly, includes a connection port configured to connect to an air supply line, the connection port being configured to receive breathable gas from the air supply line and guide breathable gas into the pad assembly so that the patient can breathe during use. The single plate member includes an upper portion and a lower portion, and the upper portion of the single plate member contacts the nasal inflation chamber to support the nasal pad against the patient's face during use.
2. The patient interface according to claim 1, wherein, The nasal pad includes a recess configured to receive the tip of the patient's nose during use. The nasal pad includes a pair of peaks, each of which is laterally positioned outside the recess and configured to extend in an anterior direction relative to the patient during use, wherein the recess is recessed below the peaks.
3. The patient interface according to claim 1, wherein, The oral inflation chamber also includes an air exchange port configured to allow the expulsion of exhaled carbon dioxide, the air exchange port having multiple orifices.
4. The patient interface according to claim 1, wherein, The nasal pad also includes a pair of protruding ends, each of which is positioned on a corresponding lateral surface of the nasal pad and configured to contact and seal the patient’s face between the corresponding nasal ala and the corresponding nasolabial groove.
5. The patient interface according to claim 1, wherein, In use, the nasal opening increases in lateral width relative to the patient from the anterior edge to the posterior edge.
6. The patient interface according to claim 1, wherein, The nose pad increases in thickness along the direction from the nasal opening outwards.
7. The patient interface according to claim 1, wherein, The lower portion of the nasal pad is concave to seal the patient's upper lip during use.
8. The patient interface according to claim 1, wherein, The positioning and stabilizing structure includes a pair of clamps, and wherein the lower portion of the single plate member includes a pair of lower attachment members, each of the lower side strips being removably connected to a corresponding clamp in the clamps, each of the lower attachment members including a clamp receiving member, and each clamp in the clamps being removably connected to a corresponding lower attachment member in the lower attachment members.
9. The patient interface according to claim 8, wherein, Each of the lower side straps includes hook material and loop material for removable connection to a corresponding clamp in the fixture.
10. The patient interface according to claim 1, wherein, The anterior side of the nasal inflation chamber includes a recessed area, and The shape and size of the upper portion of the single plate member are designed to complement the lower surface of the recessed area of the nasal inflator when the single plate member is removably connected to the pad assembly.
11. The patient interface according to claim 10, wherein, The upper portion of the single-plate member includes a pair of lateral portions that, in use, extend further in the forward direction relative to the patient than a central portion positioned between the lateral portions. The shape and size of the lateral portion and the middle portion are designed to be substantially flush with the lower surface of the recessed area when the single plate member is removably connected to the pad assembly.
12. The patient interface according to claim 1, wherein, The single plate component is made of a single piece of material, and The single-plate component is relatively harder than the nose pad and the mouth pad.
13. The patient interface according to claim 1, wherein, The nasal pad also includes a nasal suspension band that divides the nasal opening into a pair of nostril ports, each of the pair of nostril ports corresponding to each of the patient's nostrils.
14. The patient interface according to claim 1, wherein, The nasal opening is a single opening configured to guide breathable gas to the patient's two nostrils during use.
15. The patient interface according to claim 1, wherein, The nose pad includes: A first region is positioned close to the opening on each side of the opening, and the first region is configured to contact the patient's nose. A second region, adjacent to and laterally outward from the first region, is thicker than the first region; and A third region is adjacent to the second region and positioned laterally outward from the second region, the third region having a different thickness relative to the second region.
16. The patient interface according to claim 15, wherein, The nose pad has a curved shape extending from the first region, through the second region, to the third region, with the apex of the curved shape located in the second region.
17. The patient interface according to claim 16, wherein, The third region is thicker than the second region.
18. The patient interface according to claim 16, wherein, The third region is thinner than the second region and thicker than the first region.
19. The patient interface according to claim 16, wherein, The third region is thinner than the first region and the second region.
20. The patient interface of claim 1, further comprising a retaining arm assembly removably connected to the upper portion of the single plate member.
21. The patient interface according to claim 20, wherein, The retaining arm is assembled as a single piece and extends through the upper portion of the single plate member.
22. The patient interface according to claim 20, wherein, Each of the upper side bands is removably connected to the retaining arm assembly.
23. A patient interface for providing breathable gas to a patient, the patient interface comprising: Pad assembly, including: A nasal inflator includes a nasal pad having a concave shape between a first side and a second side to receive and seal the lower periphery of the patient's nose, the nasal pad including a nasal opening configured to guide breathable gas into the patient's nostrils during use. An oral inflation chamber includes a mouth pad configured to surround the patient's mouth and contact and seal the patient's face, the mouth pad including an orifice configured to guide breathable gas to the patient's mouth during use; Anti-suffocation valve; A positioning and stabilizing structure, including an upper band, a lower band, and a rear portion, wherein the upper band and the lower band extend from the rear portion; and The front panel has a connection port configured to connect to an air supply tube, the connection port being configured to receive breathable gas from the air supply tube and guide the breathable gas into the pad assembly so that the patient can breathe during use. Top plate; and A connecting portion connects the top plate and the front panel to form a single structure that can be removably connected to the pad assembly. The top plate contacts the nasal inflation chamber to support the nasal pad against the patient's face during use.
24. The patient interface according to claim 23, wherein, The nasal pad includes a recess configured to receive the tip of the patient's nose in use, wherein the nasal pad includes a pair of peaks, each of which is laterally positioned outside the recess and configured to extend in an anterior direction relative to the patient in use. The recess extends below the peak.
25. The patient interface according to claim 23, wherein, The oral inflation chamber also includes an air exchange port configured to allow the expulsion of exhaled carbon dioxide, the air exchange port having multiple orifices.
26. The patient interface according to claim 23, wherein, The nasal pad also includes a pair of protruding ends, each of which is positioned on a corresponding lateral surface of the nasal pad and configured to contact and seal the patient’s face between the corresponding nasal ala and the corresponding nasolabial groove.
27. The patient interface according to claim 23, wherein, In use, the nasal opening increases in lateral width relative to the patient from the anterior edge to the posterior edge.
28. The patient interface according to claim 23, wherein, The nose pad increases in thickness along the direction from the nasal opening outwards.
29. The patient interface according to claim 23, wherein, The lower portion of the nasal pad is concave to seal the patient's upper lip during use.
30. The patient interface according to claim 23, wherein, The positioning and stabilizing structure also includes a clamp, and The front panel has a lower attachment member, each of the lower side strips being removably connected to a corresponding clamp in the clamps, each of the lower attachment members including a clamp receiver, and each clamp in the clamps being removably connected to a corresponding lower attachment member in the lower attachment members.
31. The patient interface according to claim 30, wherein, The upper band includes hook material and ring material for removable connection to a corresponding clamp in the fixture.
32. The patient interface according to claim 23, wherein, The anterior side of the nasal inflation chamber includes a recessed area, and The top plate is shaped and sized to complement the lower surface of the recessed area of the nasal inflation chamber when the single structure is removably attached to the pad assembly.
33. The patient interface according to claim 32, wherein, The top plate includes a pair of lateral portions that, in use, extend further in the forward direction relative to the patient than a central portion positioned between the lateral portions. The shape and size of the lateral portion and the middle portion are designed to be substantially flush with the lower surface of the recessed area when the single structure is removably connected to the pad assembly.
34. The patient interface according to claim 23, wherein, The single structure is made of a single material, and The single mechanism is relatively more rigid than the nose pad and the mouth pad.
35. The patient interface according to claim 23, wherein, The nasal pad also includes a nasal suspension band that divides the nasal opening into a pair of nostril ports, each of the pair of nostril ports corresponding to each of the patient's nostrils.
36. The patient interface according to claim 23, wherein, The nasal opening is a single opening configured to guide breathable gas to the patient's two nostrils during use.
37. The patient interface according to claim 23, wherein, The nose pad includes: A first region is positioned close to the opening on each side of the opening, and the first region is configured to contact the patient's nose. A second region, adjacent to and laterally outward from the first region, is thicker than the first region; and A third region is adjacent to the second region and positioned laterally outward from the second region, the third region having a different thickness relative to the second region.
38. The patient interface according to claim 37, wherein, The nose pad has a curved shape extending from the first region, through the second region, to the third region, with the apex of the curved shape located in the second region.
39. The patient interface according to claim 38, wherein, The third region is thicker than the second region.
40. The patient interface according to claim 38, wherein, The third region is thinner than the second region and thicker than the first region.
41. The patient interface according to claim 38, wherein, The third region is thinner than the first region and the second region.
42. The patient interface of claim 23 further includes a retaining arm assembly removably connected to the top plate of the single structure.
43. The patient interface according to claim 42, wherein, The retaining arm is assembled as a single piece and extends through the top plate of the single structure.
44. The patient interface according to claim 42, wherein, Each of the upper side bands is removably connected to the retaining arm assembly.
45. A patient interface for providing breathable gas to a patient, the patient interface comprising: Nasal pad, used to at least partially define the nasal air chamber; Mouth pad, used to at least partially define an oral air chamber that is distinct from the nasal air chamber; A decoupling structure is disposed between the nose pad and the mouth pad; The top plate is fixed to the nose pad; as well as The retaining arm assembly can be releasably attached to the top plate. The retaining arm assembly and the top plate engage at at least three contact points.
46. The patient interface according to claim 45, wherein, The top plate includes a pair of upper attachment members, and the retaining arm assembly includes a pair of connecting members, each of the connecting members constituting engagement with a corresponding one of the pair of upper attachment members.
47. The patient interface according to claim 45 or 46, wherein, The retaining arm assembly includes a protrusion that engages the top plate when the retaining arm assembly engages the top plate.
48. The patient interface according to any one of claims 45-47, further comprising a top plate buffer for damping the engagement between the retaining arm assembly and the top plate, the top plate buffer being located on the front side of the top plate to contact the rear side of the retaining arm assembly.
49. The patient interface according to claim 48, wherein, The top plate buffer portion and the nose pad are integrally formed, and the top plate buffer portion extends from the nose pad through the top plate.
50. A pad assembly for a patient interface used to treat sleep apnea in a patient, the pad assembly comprising: A nasal pad is attached to a nasal inflation chamber, the nasal pad being configured to seal the lower periphery of the patient's nose. A mouth pad is attached to an oral inflation chamber, the mouth pad being configured to seal around the patient's mouth. A decoupling structure connects the nose pad and the nasal inflation chamber to the mouth pad and the oral inflation chamber, the decoupling structure being configured to allow the nose pad and the nasal inflation chamber to move relative to the mouth pad and the oral inflation chamber; A pair of side supports, each of the pair of side supports being located on the opposite side of the nose pad and engaging the respective lateral surface of the nose pad to the mouth pad; A pair of lower pad support walls are provided for supporting the protruding end that is placed rearward on the nose pad; as well as A pair of notches, each of the notches located on opposite sides of the nose pad, each of the notches including a top surface defined by the nose pad and the nasal inflation chamber, each of the notches including a bottom surface defined by the mouth pad and the mouth inflation chamber, and each of the notches including a side surface defined by the decoupling structure and a corresponding side support of the pair of side supports. When the patient interface is worn by the patient, the opening of each of the pair of notches is positioned opposite the patient's face.
51. The pad assembly according to claim 50, wherein, Each of the opposing support members includes a notch to provide a pivot point for relative movement between the nose pad and the mouth pad.
52. The pad assembly according to claim 51, wherein, When the patient wears the patient interface, each notch of the opposite support opens in the direction relative to the patient's face.
53. A patient interface for providing breathable gas to a patient, the patient interface comprising: Nasal pad, used to at least partially define the nasal air chamber; Mouth pad, used to at least partially define an oral air chamber that is distinct from the nasal air chamber; and A decoupling structure is disposed between the nose pad and the mouth pad. The decoupling structure includes: attaching the decoupling structure to the top surface of the nose pad, attaching the decoupling structure to the bottom surface of the mouth pad, and a connecting surface that connects the top surface and the bottom surface. Wherein, the top surface and the bottom surface are substantially the same thickness, and The connecting surface is thicker than the top surface and the bottom surface.
54. The patient interface according to claim 53, wherein, The thickness of the connecting surface is approximately twice that of the top surface and the bottom surface.
55. The patient interface according to claim 53 or 54, wherein, The decoupling structure is designed to be flexible, allowing the top and bottom surfaces to be positioned relative to each other at an angle of up to 50°.
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