Patient interface
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-12064561-B2
Publication Date
2024-08-20
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
A patient interface is provided for delivering pressurized gas to a patient at a therapeutic pressure between 4 cmH2O and 30 cmH2O while leaving the patient's mouth uncovered. The interface comprises a frame with a connection port and a pressurisable plenum chamber removably connected to the frame, and a seal-forming structure that seals against the patient's face around the patient's nares and maintains the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
The seal-forming structure includes a pair of naris ports and a nasal sling positioned between the naris ports. Each naris port corresponds to one of the patient's nares to provide pressurized gas to the corresponding naris, and the nasal sling is positioned adjacent to the patient's columella to prevent the patient's nose from extending through the naris ports. A vent structure formed on the frame allows a continuous flow of gases exhaled by the patient to pass from within the plenum chamber to ambient.
The patient interface further includes a positioning and stabilising structure with rigidiser arms connected to the frame and a strap removably connected to the rigidiser arms. The strap is length-extensible and overlies a lateral region of the patient's head superior to an otobasion superior in use. The plenum chamber comprises a retaining structure integrally moulded to removably connect the plenum chamber to the frame, and a sealing lip configured to engage the frame so that increasing air pressure within the plenum chamber increases a sealing force between the sealing lip and the frame.
The seal-forming structure and the plenum chamber are moulded from a first silicone material, while the retaining structure is moulded from a second silicone material with a higher durometer such that the retaining structure is more rigid than the seal-forming structure and the plenum chamber.
Claims Coverage
Two independent claims are reflected across the inputs. The claims cover a mouth-uncovered nasal patient interface with a pressurisable plenum chamber, paired naris ports and a nasal sling, venting of exhaled gases to ambient, a rigidiser arm and length-extensible strap positioning system, a pressure-responsive sealing lip, and differing silicone durometer materials.
Pressurized gas delivery with mouth uncovered configuration
A patient interface delivering pressurized gas at a therapeutic pressure between 4 cmH2O and 30 cmH2O, configured to leave the patient's mouth uncovered and to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use.
Removable frame-to-plenum pressurisable chamber arrangement
A frame with a connection port and a plenum chamber pressurisable to the therapeutic pressure and removably connected to the frame.
Seal geometry with paired naris ports and nasal sling adjacent columella
A seal-forming structure sealing against the patient's face around the patient's nares, with a pair of naris ports and a nasal sling positioned between the naris ports, each naris port corresponding to one of the patient's nares and the nasal sling positioned adjacent to the patient's columella to prevent the patient's nose from extending through the naris ports.
Exhaled gas venting to ambient via frame vent structure
A vent structure formed on the frame configured to allow a continuous flow of gases exhaled by the patient to pass from within the plenum chamber to ambient.
Positioning and stabilising structure with rigidiser arms and length-extensible strap
A positioning and stabilising structure configured to hold the seal-forming structure in a therapeutically effective position on the patient's face, including a pair of rigidiser arms connected to the frame and a strap removably connected to the rigidiser arms, the strap being length-extensible and overlying a lateral region of the patient's head superior to an otobasion superior in use.
Integrally moulded plenum retaining structure for removable connection
A retaining structure integrally moulded to the plenum chamber and configured to removably connect the plenum chamber to the frame.
Differing silicone durometer for rigid retaining structure versus softer seal and plenum
The seal-forming structure and the plenum chamber are moulded from a first silicone material, and the retaining structure is moulded from a second silicone material with a higher durometer such that the retaining structure is more rigid than the seal-forming structure and the plenum chamber.
Pressure-responsive sealing lip increasing sealing force with plenum pressure
A sealing lip configured to engage the frame such that an increase in air pressure within the plenum chamber causes a sealing force between the sealing lip and the frame to increase.
The claims are directed to a facial nasal patient interface that combines a pressurizable plenum and frame connection, a seal-forming structure with paired naris ports and a columella-adjacent nasal sling, venting of exhaled gases to ambient, and a headgear positioning arrangement with rigidiser arms and a length-extensible strap. Construction refinements specify differing silicone durometer for rigidity control and a pressure-responsive sealing lip that increases sealing force as plenum pressure rises.
Stated Advantages
Maintains therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle.
Allows continuous flow of gases exhaled by the patient from within the plenum chamber to ambient.
Provides increased sealing force between the sealing lip and the frame as air pressure within the plenum chamber increases.
Leaves the patient's mouth uncovered.
Helps maintain a seal against the patient's face around the patient's nares throughout the patient's respiratory cycle in use.
Provides improved rigidity by making the retaining structure more rigid than the seal-forming structure and the plenum chamber using higher durometer silicone.
Improved flexibility.
Reduced need for swivel elbows/part count and weight reduction.
Better comfort.
Reduced seal disruption.
Silent operation.
Documented Applications
Non-invasive nasal patient interface for delivering pressurized gas at therapeutic pressure between 4 cmH2O and 30 cmH2O with the mouth uncovered.
Delivering air to the patient's nares while leaving the mouth uncovered.
Integration with a PAP device system for therapy compliance, including a qualitative statement of performance and usage compliance.
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