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EP-4470588-B1 - TEXTILE PATIENT INTERFACE

EP4470588B1EP 4470588 B1EP4470588 B1EP 4470588B1EP-4470588-B1

Inventors

  • BAIGENT, Hollie Elizabeth
  • SCHEINER, RUPERT CHRISTIAN
  • TIWARI, Sandeep Kumar
  • VON MOGER, Lochlan Marcus Charles
  • WHITE, HADLEY
  • YU, Tzu-chin
  • DUNN, Jessica Lea
  • FORMICA, JUSTIN JOHN
  • GIBSON, JOEL EDWARD
  • HASKARD, KIRRILY MICHELE
  • HERMAN, Rachel
  • KOOIJ, MICHIEL
  • ROMAGNOLI, JOSE IGNACIO
  • RUMMERY, GERARD MICHAEL

Dates

Publication Date
20260513
Application Date
20151126

Claims (15)

  1. A patient interface (3000) for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to the patient's airways including at least a patient's nares, wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure in use, throughout the patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing, the patient interface comprising: a plenum chamber (3200) configured to be pressurised at a pressure above ambient pressure by the flow of air, the plenum chamber (3200) having a connection port (3600) configured to be connected to an air delivery tube to receive the flow of air; a seal-forming structure (3100) comprising: a membrane (3109) constructed from a first textile material that is air-impermeable and configured to contact the patient's face and seal around the entrance to the patient's airways including at least the patient's nares, the seal-forming structure (3100) having an opening (3101) configured to direct the flow of air to the entrance to the patient's airways including at least the patient's nares; and a mesh structure (3102) integrated with the seal-forming structure (3100) at the opening (3101); a vent (3400) comprising a plurality of vent holes configured to wash out exhaled gas from the patient during use; and a positioning and stabilising structure (3300) configured to maintain the seal-forming structure (3100) in sealing contact with the patient's face, the positioning and stabilising structure (3300) comprising at least one strap (3301, 3304, 3305, 3307) constructed from a second textile material, wherein the seal-forming structure (3100) is configured to inflate under internal pressure when the membrane (3109) is sealed against the patient's face, and wherein the membrane (3109) is flexible.
  2. The patient interface of claim 1, wherein the mesh structure (3102) comprises a filtering material configured to filter undesirable particulate matter from the flow of air before reaching the patient's airways.
  3. The patient interface of claim 1, wherein the mesh structure (3102) comprises a heat and moisture exchanging (HME) material configured to absorb heat and moisture from gas exhaled by the patient and release heat and moisture into the flow of air as it travels to the patient's airways during inhalation.
  4. The patient interface of claim 1, wherein the mesh structure (3102) comprises foam.
  5. The patient interface of any one of claims 1 to 4, wherein the first textile material is laminated with an air-impermeable material on a side that does not contact the patient.
  6. The patient interface of any one of claims 1 to 5, wherein the second textile material is air-permeable.
  7. The patient interface of any one of claims 1 to 6, wherein the positioning and stabilising structure (3300) further comprises a pair of side straps (3301), each of the side straps (3301) configured to pass along a corresponding side of the patient's face.
  8. The patient interface of claim 7, wherein the positioning and stabilising structure (3300) further comprises a pair of rigidiser arms (3303) configured to pass along a corresponding side of the patient's face, each of the rigidiser arms (3303) being connected to the plenum chamber by a rigidiser arm connector (3302), and each of the rigidiser arms (3303) being concealed by a corresponding one of the side straps (3301).
  9. The patient interface of claim 8, wherein each of the side straps (3301) is configured to cushion the patient's face against a corresponding one of the rigidiser arms (3303).
  10. The patient interface of claim 7, wherein the positioning and stabilising structure (3300) further comprises a crown strap (3307) configured to pass over the top of the patient's head and a rear strap (3305) configured to pass behind the patient's head.
  11. The patient interface of claim 10, wherein the crown strap (3307) and the rear strap (3305) are connected to each of the side straps (3301).
  12. The patient interface of any one of claims 1 to 11, wherein the vent is positioned on the plenum chamber (3200).
  13. The patient interface of any one of claims 1 to 12, wherein the seal-forming structure (3100) is a nasal cradle configured to seal around an inferior periphery of the patient's nose and at or near the tip of the patient's nose.
  14. The patient interface of any one of claims 1 to 13, wherein the seal-forming structure (3100) is configured to leave the patient's mouth uncovered.
  15. The patient interface of any one of claims 1 to 14, wherein the seal-forming structure (3100) is configured not to contact the bridge of the patient's nose.

Description

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. The present technology also relates to medical devices or apparatus, and their use. US 2014/158136 A1 discloses a mask system for providing pressurized breathable gas including at least one panel and a seal member, wherein the panel comprises a textile. The panel defines a cavity adapted to receive a patient's nose. The seal member is adapted to sealingly engage with the patient's face. The panel and seal member may be integrally formed in one piece. 2.2 DESCRIPTION OF THE RELATED ART 2.2.1 Human Respiratory System and its Disorders The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient. The airways include 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. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas. Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by events including occlusion or obstruction 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 in 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 US Patent No. 4,944,310 (Sullivan). Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by 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 US Patent No. 6,532,959 (Berthon-Jones). Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders. A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise. 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: dyspnea on exertion, chronic cough and sputum production. Neuromuscular Disease (NMD) is a broad term that encompasses 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 impairm