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EP-4374899-B1 - POSITIONING AND STABILIZING STRUCTURE FOR A PATIENT INTERFACE

EP4374899B1EP 4374899 B1EP4374899 B1EP 4374899B1EP-4374899-B1

Inventors

  • LENG, WAI HOONG

Dates

Publication Date
20260513
Application Date
20200214

Claims (13)

  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 a patient's airways including at least entrance of a patient's nares, wherein the patient interface (3000) 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 a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing; said patient interface (3000) comprising: a plenum chamber (3200) at least partially forming a cavity pressurisable to a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure, said plenum chamber (3200) including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; and a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having a hole formed therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the cavity throughout the patient's respiratory cycle in use; a positioning and stabilising structure (3300) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure (3300) being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use, wherein the positioning and stabilizing structure comprises a one-piece knitted headgear strap (3301) of a single piece of material, the knitted headgear strap (3301) including: at least one first area having a first knit structure; at least one second area having a second mesh knit structure forming at least one ventilation area (3350) having increased flexibility as compared to the first area; and at least one third area having a rigidized knit structure (3345) directly adjacent the at least one ventilation area (3350), the rigidized knit structure (3345) having increased rigidity as compared to the first knit structure and the second mesh knit structure, the rigidized knit structure being a pique knit structure.
  2. The patient interface (3000) of claim 1, wherein the pique knit structure is bordering the at least one ventilation area (3350).
  3. The patient interface of any one of claims 1 to 2, wherein the pique knit structure surrounds the at least one ventilation area (3350).
  4. The patient interface (3000) of any one of claims 1 to 3, wherein the pique knit structure is a pique rib structure.
  5. The patient interface (3000) of any one of claims 1 to 4, wherein the second mesh knit structure is a pique mesh knit structure.
  6. The patient interface (3000) of any one of claims 1 to 5, wherein the ventilation areas (3350) have increased breathability as compared to the at least one first area and the at least one third area.
  7. The patient interface (3000) of any one of claims 1 to 6, wherein the knitted headgear strap (3301) comprises a ring strap portion (3340) having a superior portion configured to overlay the parietal bones of the patient's head in use and having an inferior portion configured to overlay or lie inferior to the occipital bone of the patient's head in use, the ring strap potion defining a loop.
  8. The patient interface (3000) of claim 7, wherein the ring strap portion (3340) has an inner edge (3341) and an outer edge (3342), and the pique knit structure extends along the inner edge (3341) of the ring strap portion (3340).
  9. The patient interface (3000) of any one of claims 7 and 8, wherein the pique knit structure forms a loop extending along the entire inner edge of the ring strap portion (3340).
  10. The patient interface (3000) of any one of claims 7 to 9, wherein the ring strap portion (3340) includes the at least one ventilation area (3350).
  11. The patient interface (3000) of any one of claims 1 to 10, wherein the knitted headgear strap (3301) further comprises a neck strap portion (3334) configured to overlay the occipital bone of the patient's head and/or lie against the patient's neck in use, and the neck strap portion (3334) includes the at least one ventilation area (3350).
  12. The patient interface (3000) of any one of claims 1 to 11, wherein the first knit structure is a jersey knit structure.
  13. A treatment system for treatment of sleep disordered breathing, comprising: the patient interface (3000) according to any one of claims 1 to 12; a respiratory pressure therapy (RPT) device (4000) to supply breathable gas at positive pressure; and an air delivery tube (4170) to pass the breathable gas from the RPT device (4000) to the patient interface (3000).

Description

2 BACKGROUND OF THE TECHNOLOGY 2.1 FIELD OF THE TECHNOLOGY The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use. In particular, the invention relates to a patient interface and a treatment system. 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 inhaled air into the venous blood and carbon dioxide to move in the opposite direction. 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 2012. A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas. Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders. A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings. 2.2.2 Therapy Various therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV) and Invasive ventilation (IV) have been used to treat one or more of the above respiratory disorders. Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing. 2.2.3 Treatment Systems These therapies may be provided by a treatment system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it. A treatment system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, and data management. Another form of treatment system is a mandibular repositioning device. 2.2.3.1 Patient Interface A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and/or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH2O. Certain other mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient. Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth. Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips. Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one's side in be