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US 2026/0273215 A1Published application
Patient Interface Assembly with Thermoformable Seal
AssigneeMedlands Consulting Limited
InventorAlastair Edwin MCAULEY
Life of this patent
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Abstract
A face shield, patient interface and methods of use thereof are described for improved respiratory therapy of patients. In particular, a face shield is disclosed that acts as a seal when used with a patient interface. The face shield may be manufactured from a low melt temperature hard thermoplastic material. The face shield may be formed initially formed to match the general contours of the face, but not customised to a specific user's face. The face shield may be crosslinked to provide shape memory to the seal and to improve its handling properties and is configured to be thermoformed to a user's face. The face shield may be customised to the patient's facial features to a second customised shape.
Claims20
A patient interface comprising:
- a rigid frame defining a breathing chamber configured to receive pressurized respiratory gas;
- and
- a thermoformable seal coupled to the frame and configured to form a sealing interface with a user during use;
- wherein the thermoformable seal comprises cross-linked polycaprolactone, the cross-linked polycaprolactone being directly connected to the rigid frame and initially provided in a non-customized shape;
- wherein a substantial portion of the facial-contacting portion of the thermoformable seal is positioned beyond the outer perimeter of the portion of the rigid frame forming the breathing chamber, in a cheek region or a nasal bridge region, as measured in the coronal plane;
- wherein the thermoformable seal softens when heated to a temperature of about 50-70° C.;
- wherein the cross-linked polycaprolactone is configured to retain at least part of the non-customized shape of the thermoformable seal when heated above the softening temperature;
- wherein the cross-linked polycaprolactone is configured for direct contact with the patient's face during molding;
- wherein the thermoformable seal is configured to be moldable against the patient's face while softened to conform to the patient's facial contours;
- wherein the thermoformable seal retains at least part of a molded customized shape after cooling below the temperature range;
- wherein the thermoformable seal is substantially rigid at temperatures below the softening temperature range;
- and wherein the rigid frame remains substantially rigid at temperatures below 100° C.
9 more elements
A patient interface comprising:
- a rigid frame defining a breathing chamber configured to receive pressurized respiratory gas;
- and
- a thermoformable seal coupled to the frame;
- wherein the thermoformable seal comprises cross-linked polycaprolactone directly connected to the rigid frame and initially provided in a non-customized shape;
- wherein the thermoformable seal softens when heated to a temperature of about 50-70° C.;
- wherein the cross-linked polycaprolactone is configured to retain at least part of the non-customized shape of the thermoformable seal when heated above the softening temperature;
- wherein the cross-linked polycaprolactone is configured for direct contact with the patient's face during molding;
- wherein the thermoformable seal is configured to be moldable against the patient's face while softened to conform to the patient's facial contours;
- wherein the thermoformable seal retains at least part of a molded customized shape after cooling below the temperature range;
- wherein the thermoformable seal is substantially rigid at temperatures below the softening temperature range;
- wherein the rigid frame includes a stabilizing mechanism positioned relative to the thermoformable seal to substantially constrain deformation of the thermoformable seal during molding in cheek regions or upper lip regions;
- wherein the stabilizing mechanism is configured to provide a positive reference point for location of the mask assembly relative to the patient's cheek or upper lip to stabilize the mask assembly in a correct posterior and anterior location;
- wherein adjacent portions of the thermoformable seal are permitted to deform more than the constrained regions during molding;
- and wherein the rigid frame remains substantially rigid at temperatures below 100° C.
11 more elements
A patient interface comprising:
- a rigid frame defining a breathing chamber configured to receive pressurized respiratory gas;
- and
- a thermoformable seal coupled to the frame and configured to form a sealing interface with a user during use;
- wherein the thermoformable seal comprises cross-linked polycaprolactone, the cross-linked polycaprolactone being connected to the rigid frame and initially provided in a non-customized shape;
- wherein a substantial portion of the facial-contacting portion of the thermoformable seal is positioned beyond the outer perimeter of the portion of the rigid frame forming the breathing chamber, in a cheek region or a nasal bridge region, as measured in the coronal plane;
- wherein the thermoformable seal softens when heated to a temperature of about 50-70° C.;
- wherein the thermoformable seal is configured to be moldable against the patient's face while softened to conform to the patient's facial contours;
- wherein the thermoformable seal retains at least part of a molded customized shape after cooling below the temperature range;
- wherein the thermoformable seal is substantially rigid at temperatures below the softening temperature range;
- wherein an outer perimeter of the thermoformable seal where the thermoformable seal contacts the patient's face forms a projected seal area calculated in the coronal plane, and an outer perimeter of the rigid frame where the rigid frame forms the breathing chamber forms a projected frame area calculated in the coronal plane, the projected seal area being at least 1.5 times greater than the projected frame area;
- and wherein the rigid frame remains substantially rigid at temperatures below 100° C.
8 more elements
Dependencies are inferred from the claim text.