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Publication Number
US-11980753-B2
Publication Date
2024-05-14
Expiration Date
Abstract
The present invention provides a catheter for assisting recovery from dysphagia.
Core Innovation
The invention relates to a dysphagia-assisting intraluminal electrical pharyngeal stimulation catheter including a feeding tube and a sleeve for receiving the feeding tube. The sleeve is movable longitudinally relative to the feeding tube and is fixed in position relative to the feeding tube by a retaining formation having a first part and a second part connected by a living hinge. In the closed position, the feeding tube is clamped between the first part and the second part so that the sleeve is positionally fixed relative to the feeding tube.
The catheter includes a storage container having one or more formations for receiving at least part of the catheter. The catheter is inserted into the storage container such that at least part of the catheter is received and deformed by the one or more formations of the storage container. The storage container is exposed to pre-determined conditions of one or more of temperature, humidity, pressure, vacuum, gas or radiation for a pre-determined time to both sterilise and shape set the catheter.
After completion of the application of those conditions, the at least part of the catheter maintains its deformed shape when removed from the storage container. The storage container and sterilisation provide conditions to configure the deformed shape of the catheter, and the storage container used to confer the shape to the catheter is a final packaging for the catheter. The catheter further includes insulation concepts with layered insulation for high dielectric strength and electrode placement concepts.
Claims Coverage
The independent claim is clm-00001. It provides a manufacturing method that combines a pre-formed final packaging storage container that deforms a catheter with exposure to predetermined conditions that both sterilise and shape-set the catheter, while the catheter includes a longitudinally movable sleeve clamped by a retaining formation with a living hinge. Dependent claims further refine what is deformed and the deformation mechanism, and narrow when the predetermined conditions are applied and specify the terminal sterilisation modality.
Final packaging storage container deforms the catheter
Providing a pre-formed storage container having one or more formations for receiving at least part of a catheter, and inserting the catheter into the storage container so that at least part of the catheter is received and deformed by the one or more formations of the storage container, wherein the storage container used to confer the shape to the catheter is a final packaging for the catheter.
Sterilising and shape-setting by predetermined conditions in the container
Exposing the storage container to pre-determined conditions of one or more of temperature, humidity, pressure, vacuum, gas or radiation for a pre-determined time to both sterilise and shape set the catheter, whereby upon completion the at least part of the catheter maintains its deformed shape when removed from the storage container, and the storage container and sterilisation provide conditions to configure the deformed shape of the catheter.
Movable sleeve clamped by a living hinge retaining formation
Providing a catheter comprising a feeding tube, a sleeve for receiving the feeding tube and being movable longitudinally relative to the feeding tube and a retaining formation having a first part and a second part connected by a living hinge, attached to the sleeve for fixing the position of the sleeve relative to the feeding tube; and moving the second part relative to the first part between an open position and a closed position whereby the feeding tube is clamped between the first part and the second part to positionally fix the sleeve relative to the feeding tube.
Across the independent claim and its dependents, the main claim coverage centers on (i) using a pre-formed final packaging storage container to deform a catheter part, (ii) exposing the container to predetermined conditions to both sterilise and shape set the catheter so the deformed shape is maintained after removal, and (iii) a catheter construction in which a longitudinally movable sleeve is fixed relative to the feeding tube by a living-hinge retaining formation that clamps the feeding tube in the closed position.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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