Patient interface with seal-forming structure
Inventors
Henry, Robert Edward • Smith, Christopher James • Barbara, Anthony Paul • Barlow, Adam Francis • Edwards, Craig David • Forrester, Martin • Goldspink, Lachlan Richard • Haskard, Kirrily Michele • Hitchcock, William Laurence • Jourdan, Ralph • Lee, Murray William • May, Frederick Arlet • Rummery, Gerard Michael • Scheiner, Rupert Christian • Shanmuga Sundara, Shiva Kumar • Tan, Chia Ik • Wagner, Stewart Joseph • Wells, Alicia Kristianne • Nga, Lemmy • HO, Hason Tin-Yan • Smart, Gregory Scott
Assignees
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Publication Number
US-11179534-B2
Publication Date
2021-11-23
Expiration Date
Abstract
A patient interface for delivery of a supply of pressurised air or breathable gas to an entrance of a patient's airways comprising: a cushion member that includes a retaining structure and a seal-forming structure permanently connected to the retaining structure; a frame member attachable to the retaining structure; and a positioning and stabilising structure attachable to the frame member.
Core Innovation
The invention provides a patient interface for delivering pressurized gas to a patient to treat sleep disordered breathing. The interface comprises a seal-forming structure in the form of a nasal cradle cushion having a pair of naris ports separated by a nasal sling, with each naris port configured to provide pressurized gas to a corresponding one of the patient's nares. The seal-forming structure forms, at least in part, a gas chamber and is configured to prevent the patient's nose from entering the gas chamber while sealing against an inferior periphery of the patient's nose and at or near the patient's pronasale.
The seal-forming structure is structured not to enter the nostrils of the patient in use and includes a pair of protruding ends positioned on corresponding lateral sides. Each protruding end is configured to engage a region of the patient's face between the corresponding ala of the patient's nose and the corresponding nasolabial sulcus. The seal-forming structure further includes protruding end support sections cantilevered from an interior surface such that each support section extends into the gas chamber in a medial direction to contact and support a corresponding protruding end when deformed by contact with the patient's face.
The seal-forming structure includes a recessed portion configured to engage the tip of the patient's nose during use and a compliant region located above the recessed portion, the compliant region being thinner and more flexible than a remainder of the seal-forming structure. In addition, a plenum chamber is formed in one piece with the seal-forming structure, includes a plenum connection region, and forms, at least in part, the gas chamber, with a frame attached to the plenum chamber at the plenum connection region and having a connection port.
Claims Coverage
The combined claim coverage presents one independent claim set centered on a nasal cradle cushion seal-forming structure that forms a gas chamber and prevents nose entry, together with a one-piece plenum chamber and attached frame connection port. The inventive features also include lateral protruding ends, cantilevered interior support sections that extend into the gas chamber, and a recessed nose-tip region with a thinner compliant region above it.
Nasal cradle cushion sealing without nostril entry
A seal-forming structure in the form of a nasal cradle cushion having a pair of naris ports separated by a nasal sling, each naris port configured to provide pressurized gas to a corresponding nares, the seal-forming structure forming, at least in part, a gas chamber, and being configured to prevent the patient's nose from entering the gas chamber while sealing against an inferior periphery of the patient's nose and at or near the patient's pronasale, and structured so as not to enter the nostrils in use.
Integrated plenum chamber formed with seal-forming structure
A plenum chamber formed in one piece with the seal-forming structure, the plenum chamber including a plenum connection region and forming, at least in part, the gas chamber.
Frame with plenum attachment and connection port
A frame attached to the plenum chamber at the plenum connection region, the frame having a connection port.
Protruding ends engaging the ala-to-nasolabial sulcus region
The seal-forming structure comprises a pair of protruding ends, each positioned on a corresponding lateral side of the seal-forming structure and configured to engage a region of the patient's face between the corresponding ala of the patient's nose and the corresponding nasolabial sulcus.
Cantilevered protruding end support sections
The seal-forming structure comprises a pair of protruding end support sections cantilevered from an interior surface of the seal-forming structure such that each support section extends into the gas chamber in a medial direction to contact and support a corresponding protruding end when the corresponding protruding end is deformed by contact with the patient's face.
Recessed tip engagement and compliant region above recessed portion
The seal-forming structure includes a recessed portion configured to engage the tip of the patient's nose during use, and a compliant region located above the recessed portion, the compliant region being thinner and more flexible than a remainder of the seal-forming structure.
The claims collectively require a nasal cradle cushion that seals near the pronasale without entering the nostrils, a one-piece plenum chamber with an attached frame and connection port, and facial-region sealing via protruding ends supported by cantilevered support sections extending into the gas chamber; the claims also include a recessed nose-tip region and a thinner, more flexible compliant region above it.
Stated Advantages
Improved comfort and unobtrusiveness.
Reduced claustrophobia and bed-partner discomfort.
Improved fitting and assembly reliability for patients.
Stabilizes the seal while allowing continuous, intuitive adjustment of headgear tension.
Helps avoid entering or crossing sensitive nape regions by using tension force alignment without straps crossing sensitive regions.
Accommodates nasolabial angle variation while reducing bending moments via a flexible joint between rigidiser arms and the mask frame.
Maintains seal by aligning force direction using the “Tension Vectors” concept.
Provides sealing against an inferior periphery of the patient's nose and at or near the patient's pronasale.
Prevents the patient's nose from entering the gas chamber.
Is structured so as not to enter the nostrils of the patient in use.
Documented Applications
Treating sleep disordered breathing by delivering pressurized gas to a patient using a patient interface.
Treating sleep disordered breathing using a nasal CPAP-type patient interface delivering pressurized gas to a patient.
Treating obstructive sleep apnea (OSA).
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