Packaged precision-lubricated ready-to-use intermittent urinary catheter
Inventors
Assignees
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Publication Number
US-10589061-B2
Publication Date
2020-03-17
Expiration Date
Abstract
A method of packaging a ready to use intermittent urinary catheter by (i) placing lubricant within a pocket formed in a base film proximate a first end of the pocket, (ii) placing a catheter within the pocket with the insertion end of the catheter proximate the first end of the pocket, (iii) partially sealing the catheter within the pocket between the base film and a cover film, (iv) pulling a vacuum within the pocket to effect controlled circumferential flow of lubricant around the insertion end portion of the catheter, and then (v) fully sealing the pocket.
Core Innovation
The invention provides a method of hermetically packaging an intermittent urinary catheter with an insertion end and a fixture end. A base film having a pocket retains the catheter with the insertion end proximate a first end of the pocket and the fixture end proximate a second end of the pocket. A limited amount of lubricant is injected into the pocket proximate the first end to form a lubricant containing pocket, and the catheter is placed so that the insertion end is positioned for lubricant interaction while the fixture end is positioned away from lubricant contact.
A cover film is sealed to the base film with an unsealed opening proximate the second end of the pocket to form an enclosed catheter containing retention chamber accessible through the opening. A vacuum is drawn on the enclosed retention chamber through the opening sufficient to compress the retention chamber and cause lubricant to circumferentially flow around and coat a portion of the exterior surface area of the insertion end length within the retention chamber. The vacuum-driven coating is controlled so that lubricant does not reach and coat the fixture end length within the retention chamber.
Thereafter, the opening is sealed so as to form a hermetically packaged intermittent urinary catheter having a circumferentially lubricated insertion end length and a lubricant-free fixture end length. The disclosure additionally describes preferred geometries for the retention chamber, including an optional enlarged lubricant compartment with a metering neck area for lubricant retention, and states that sealing is preferably heat sealing to form the hermetic package.
Claims Coverage
The independent claim set contains one independent claim covering the overall hermetic packaging method. The dependent claims add lubricant properties, coating coverage, and sealing and film structure refinements.
Hermetic packaging with lubricant pocket and vacuum-compressed retention chamber
Obtaining a base film having a pocket configured to retain an intermittent urinary catheter with the insertion end proximate the first end and the fixture end proximate the second end; injecting a limited amount of lubricant into the pocket proximate the first end; placing the catheter into the lubricant containing pocket with the insertion end proximate the first end and the fixture end proximate the second end; sealing a cover film to the base film with an unsealed opening proximate the second end of the pocket to form an enclosed catheter containing retention chamber accessible through the opening; drawing a vacuum on the enclosed retention chamber through the opening sufficient to compress the retention chamber and cause lubricant to circumferentially flow around and coat a portion of the exterior surface area of the insertion end length within the retention chamber without reaching and coating the fixture end length; and thereafter sealing the opening to form a hermetically packaged intermittent urinary catheter having a circumferentially lubricated insertion end length and a lubricant-free fixture end length.
Lubricant viscosity range at 72°F for the method
The method includes using a lubricant whose viscosity at 72°F is between 100,000 and 400,000 centipoise.
Defined alpha length circumferential coating coverage
The method places an alpha length of an intermittent urinary catheter into fluid contact with lubricant in a pocket and applies a vacuum to drive circumferential lubricant flow that coats at least 70% of the external surface area of the alpha length of the catheter.
Alpha length percentage of insertion end length
The alpha length is between 50% and 80% of the catheter’s insertion end length.
Heat sealing cover film to base film
The method further includes heat-sealing the cover film to the base film.
Planar sheet cover film
The cover film is a planar sheet.
Overall, the claim coverage centers on hermetically packaging an intermittent urinary catheter in a base/cover film pocket system, injecting a limited lubricant near the insertion end, sealing to create a retention chamber, and using vacuum to compress the chamber so lubricant circumferentially coats a defined portion of the insertion end while avoiding coating of the fixture end. Dependent claims further constrain lubricant viscosity at 72°F, define an alpha portion of the insertion end for coating, require a minimum coating coverage percentage on that alpha portion, and specify heat sealing and planar-sheet cover film structure.
Stated Advantages
Provides a hermetically packaged intermittent urinary catheter having a circumferentially lubricated insertion end length and a lubricant-free fixture end length.
Documented Applications
Packaging of an intermittent urinary catheter into a hermetically packaged, precision-lubricated ready-to-use intermittent urinary catheter.
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