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Publication Number
US-12226587-B2
Publication Date
2025-02-18
Expiration Date
Abstract
A rigid package or container for a sterile pre-lubricated, ready to use female-length catheter with enhanced gel holders and simple constructions. A main body of the rigid container has a hollow interior which may receive a gel holder defining an inner cavity filled with a lubricating gel. The gel holder partly inserts into the main body and a tube of the catheter inserts through the gel holder into the main body with a proximal outlet projecting out of the gel holder so as to be graspable. Alternatively, the gel may be provided within the hollow interior of the main body. A rigid and closed cap seals to either the main body or the gel holder and closes the hollow interior of the main body.
Core Innovation
The invention relates to a sterile pre-lubricated female urinary catheter package that includes a urinary catheter having an elongated flexible tube with a closed distal tip and one or more flow openings in an adjacent sidewall, and a proximal outlet attached to a proximal end with a through passage in communication with a lumen. A rigid generally tubular main body having a distal closed end and a proximal open mouth defines a hollow interior, and a rigid cap is secured to the open mouth to seal the urinary catheter within the hollow interior in a sterile manner.
A lubricating gel cavity is defined within the main body by a pair of spaced apart internal barriers, including a distal barrier and a proximal barrier extending transversely across the hollow interior. Each barrier has a central throughbore or respective aperture sized to permit passage of the tube, where the aperture of the distal barrier is sized to substantially prohibit gel from passing distally past the distal barrier and is configured to conform to the tube to discourage gel from passing distally beyond the distal barrier.
When the urinary catheter is inserted through the open mouth and withdrawn from the main body, gel from the gel cavity remains on the tube, including at least a portion of the proximal outlet remaining outside the main body during insertion and withdrawal. Structural variants include forming the distal barrier as a molded feature within the main body while the proximal barrier is formed by an insert separate from the main body, as well as main body geometries such as an hourglass or a narrowed intermediate portion to cooperate with the internal barriers and gel retention.
Claims Coverage
The document provides two independent claims that cover a urinary catheter package with a rigid tubular main body sealed by a rigid cap in a sterile manner, where lubricating gel is retained on withdrawal by a gel cavity defined between two internal barriers with tube-sized throughbores/apertures (total of two independent inventive claim sets).
Gel cavity defined by spaced internal barriers with tube-sized apertures
A pair of spaced apart internal barriers including a distal barrier and a proximal barrier positioned within the main body and extending transversely across the hollow interior, each having a central throughbore sized to permit passage of the tube, wherein the throughbore of the distal barrier is sized approximately the same as the tube to substantially prohibit gel from passing distally past the distal barrier, such that the urinary catheter may be withdrawn from the main body and lubricating gel from the gel cavity remains on the tube.
Sterile sealing with rigid cap over the open mouth while proximal outlet remains outside
A rigid cap secured to the open mouth of the main body so as to seal the urinary catheter within the hollow interior in a sterile manner, wherein the tube may be inserted through the open mouth and into the hollow interior through both barriers such that at least a portion of the proximal outlet remains outside the main body.
Distal barrier formed as molded feature and proximal barrier formed by separate insert
The distal barrier is formed by a molded feature within the main body and the proximal barrier is formed by an insert separate from the main body.
Main body intermediate portion with reduced inner diameter
A rigid generally tubular main body having a proximal end portion including an open mouth, a distal end portion opposite the proximal end portion, and an intermediate portion positioned between the distal end portion and the proximal end portion, wherein an inner diameter of the intermediate portion is less than an inner diameter of the proximal end portion.
Distal aperture conforming to the tube to discourage distal gel passage
Each of the proximal barrier and the distal barrier comprises a corresponding and respective aperture sized to permit passage of the tube, wherein the aperture of the distal barrier is configured to conform to the tube to discourage gel from passing distally beyond the distal barrier.
Across the independent claims, the core claim coverage is directed to retaining lubricating gel on the catheter during withdrawal by defining a gel cavity between a proximal and distal internal barrier with tube-sized throughbores/apertures (including a distal aperture sized to substantially prohibit or configured to discourage distal gel migration), all within a sterile sealed rigid tubular main body using a rigid cap.
Stated Advantages
Lubricating gel from the gel cavity remains on the tube when the urinary catheter is withdrawn.
At least a portion of the proximal outlet remains outside the main body.
Gel migration distally past the distal barrier is substantially prohibited or discouraged by sizing and conformance of the distal barrier aperture to the tube.
Documented Applications
Not explicitly described in patent.
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