Search

US-12623380-B2 - Foam cushion respiratory apparatus

US12623380B2US 12623380 B2US12623380 B2US 12623380B2US-12623380-B2

Abstract

A mask apparatus for a respiratory treatment can permit delivery of breathable gas to a user. In one example, the mask may employ a frame and cushion to form a seal for both mouth and nose. The frame may be adapted for coupling with a respiratory treatment apparatus so as to permit communication of a pressurized gas from the respiratory treatment apparatus. The cushion, which may be foam, and a frame component may be made in an overmoulding process that moulds the frame onto a pre-formed foam cushion. Such a moulding process may form a mechanical and/or chemical bonding of the foam and mask frame component. The mask frame component may be a shell of plenum chamber, such as for both nose and mouth. Various features of the cushion may further promote sealing and comfort for the under the nose design.

Inventors

  • Grant Moiler
  • Nigel Quarmby

Assignees

  • ResMed Pty Ltd

Dates

Publication Date
20260512
Application Date
20220720

Claims (9)

  1. 1 . An apparatus for forming a mask structure for a respiratory treatment, the apparatus comprising: a bottom mould comprising a portion configured to receive a foam cushion; an inner moulding core comprising an outer surface and an inner surface, wherein the outer surface has a convex shape corresponding to a shape of an inner surface of a mask frame component, wherein the inner moulding core has a ridge at an edge of the outer surface of the inner moulding core and the inner moulding core is configured to fasten to the bottom mould such that the ridge of the inner moulding core compresses the foam cushion; and a top mould comprising a shaped portion, wherein the shaped portion has a concave shape corresponding to a shape of an outer surface of the mask frame component, wherein the top mould has an outer clamping ridge at an edge of the shaped portion, the top mould is configured to fasten to the bottom mould such that the outer clamping ridge compresses the foam cushion, and the shaped portion of the top mould is oriented toward the outer surface of the inner moulding core, wherein material is injectable into the apparatus such that the injected material bonds to a first portion of the foam cushion, the outer surface of the inner moulding core shapes the inner surface of the mask frame component, and the shaped portion of the top mould shapes the outer surface of the mask frame component to form the mask frame component, and wherein the ridge of the inner moulding core and the outer clamping ridge of the top mould each compress the foam cushion to prevent the injected material from spreading to parts of the foam cushion other than the first portion of the foam cushion.
  2. 2 . The apparatus of claim 1 , wherein the bottom mould includes a surface and the portion of the bottom mould comprises a recess in the surface for receiving the foam cushion.
  3. 3 . The apparatus of claim 2 , wherein the recess of the bottom mould includes a center mound and the ridge of the inner moulding core compresses the foam cushion over the center mound of the bottom mould to deform the foam cushion to a contoured profile associated with a contour of a patient's face.
  4. 4 . The apparatus of claim 1 , wherein the mask frame component formed by the apparatus is a shell of a plenum chamber.
  5. 5 . The apparatus of claim 1 , wherein the inner moulding core includes a nasal region and an oral region.
  6. 6 . The apparatus of claim 1 , wherein the bottom mould includes alignment projections that extend from a surface of the bottom mould and the top mould includes alignment ports that are recessed into a surface of the top mould, wherein the alignment ports receive the alignment projections to align the bottom mould with respect to the top mould.
  7. 7 . The apparatus of claim 1 , wherein the inner moulding core directs a flow of the injected material.
  8. 8 . The apparatus of claim 1 , wherein the top mould includes an injection insert, wherein the injected material is insertable into an interior of the apparatus through the injection insert.
  9. 9 . A method for forming a mask structure for a respiratory treatment, the method using the apparatus of claim 1 and comprising: inserting the foam cushion into the bottom mould; attaching the bottom mould to the top mould; injecting the material into the apparatus, wherein the injected material bonds to the first portion of the foam cushion so as to form the mask structure; and releasing the mask structure from the apparatus.

Description

1 CROSS REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. application Ser. No. 15/509,638, filed Mar. 8, 2017, which is a national phase entry under 35 U.S.C. § 371 of International Application No. PCT/AU2015/050608 filed Oct. 7, 2015, published in English, which claims priority from U.S. Provisional Patent Application No. 62/062,444 filed Oct. 10, 2014, the disclosures of which are hereby incorporated herein by reference. 2 BACKGROUND OF THE TECHNOLOGY 2.1 Field of the Technology The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory-related disorders. In particular, the present technology relates to medical devices or apparatus, and their use. Such devices may include an interface for directing a treatment to a patient respiratory system. 2.2 Description of the Related Art The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient. The airways consist of a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the air into the venous blood and carbon dioxide to move out. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011. A range of respiratory disorders exist. Obstructive Sleep Apnoea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by occlusion of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See U.S. Pat. No. 4,944,310 (Sullivan). Cheyne-Stokes Respiration (CSR) is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation, causing repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones). Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness. Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnoea on exertion, chronic cough and sputum production. Neuromuscular Disease (NMD) may encompass many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagi