Surgery – Means or method for facilitating removal of non therapeutic... – Urinary catheter
Reexamination Certificate
2001-07-19
2003-08-05
Reichle, Karen (Department: 3761)
Surgery
Means or method for facilitating removal of non therapeutic...
Urinary catheter
C604S172000, C604S263000, C604S265000, C604S275000, C604S327000
Reexamination Certificate
active
06602244
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
Urinary catheters for draining the bladder through the urethra are commonly packaged in sterile and pre-lubricated condition in flexible containers or pouches. In some cases, the catheters are intended to be fully removed from such containers at the time of catheterization, whereas in others the containers and catheters may remain in communication with the containers then serving as urine-collecting pouches. Reference may be had to U.S. Pat. Nos. 3,854,483 (Powers), 5,226,530 (Golden), 3,934,721 (Juster et al), 6,004,305 (Hursman et al), 5,147,341 (Starke et al) and 6,053,905 (Daignault et al) as illustrative of the art.
Catheterization commonly involves inserting the distal tip of a catheter (sometimes protected against contamination by an introducer sleeve as disclosed, for example, in U.S. Pat. No. 3,854,483 and U.S. Pat. No. 4,652,259) into the urethra and then longitudinally collapsing and extending the pouch in an accordion-like manner until the tip reaches the bladder. Such action is illustrated, for example, in U.S. Pat. No. 4,062,363 (Bonner). By gripping the remote (proximal) end of the catheter between the walls of the pouch during the pouch-collapsing phase, the catheter is advanced in a distal direction and, conversely, during the pouch-extending phase, the catheter is held against reverse sliding movement by gripping it between the pouch walls near the pouch's distal end. The operation is a two-handed one requiring considerable dexterity to insure that the catheter is advanced during the pouch-collapsing phase and not retracted during the pouch-extending phase.
Complications may arise that make such a procedure even more difficult. For example, fluid pressure may tend to expel the catheter and require the user to continue gripping the catheter between the walls of the pouch to hold it in place during voiding. Because the catheter is lubricated, immobilizing it by applying a gripping force to the walls of the pouch may require more strength and dexterity than patients can provide, thereby precluding self-catheterization.
In an effort to reduce such problems, some packages for prelubricated catheters contain gripping devices that may be squeezed to help hold a catheter against reverse sliding movement (see U.S. Pat. Nos. 6,053,905, 6,004,305 and WO 98/06642). Typically, such gripping devices are designed to engage the side surfaces of a catheter but, since those surfaces are already lubricated, slippage may still readily occur.
Lubricating and gripping systems used in current catheter packages often have other shortcomings as well. Lubricant gel may not be retained in one area of such a package but may be free to migrate into the urine-collective chamber, causing the walls of the pouch to stick together and make voiding more difficult. Squeezable gripping devices, even if properly fitted onto the tip of a catheter during production, may slip off during storage and transport, requiring a user to refit such a device prior to catheterization. Further, in some constructions, lubricant tends to be unevenly distributed over the surfaces of a catheter, causing patient discomfort and risking possible injury during catheterization.
This invention therefore concerns an improved self-lubricating catheter package that overcomes or at least greatly reduces the aforementioned defects and disadvantages of current products. More specifically, this invention involves a catheter package in which lubricant (preferably in the form of a gel) is retained in a housing located within the distal end portion of a pouch. Means are provided to insure even distribution of the lubricant over the surfaces of a catheter during a catheterization procedure. The housing includes gripping means which, in contrast to conventional devices, normally holds a catheter against sliding movement and releases that catheter for movement only when squeezing forces are applied by a user's fingers. Since the gripping means automatically restrains sliding movement of the catheter in the absence of such squeezing forces, the device holds the catheter in place during storage and transport, thereby eliminating the possibility that a user might have to reinsert the catheter into the gripping device prior to use. Further, the gripping device easily holds the catheter in place in the urethra during voiding and also eliminates or greatly reduces the possibility of reverse movement of the catheter during the pouch-collapsing and pouch-extending phases of catheterization. The catheter gripping and lubricating device is therefore believed to be considerably more effective in operation and ease of use than existing devices and, when used in combination with a flexible container or pouch, results in a catheter package that is superior to current assemblies.
Briefly, the catheter gripping and lubricating device includes a deformable and shape-recoverable housing of elastomeric material defining a lubricant chamber. At its distal end, the chamber is substantially closed by an end cap having an axial catheter-receiving passage extending therethrough. The opposite or proximal end of the chamber includes a retention wall that restrains lubricant flow in a proximal direction from the housing. The retention wall is apertured to allow sliding movement of a catheter into and through the lubricant chamber of the housing.
Catheter gripping means is located at the proximal end portion of the housing in advance of (i.e., proximal to) the apertured retention wall and lubricant chamber. The gripping means normally grips opposite side surfaces of a catheter to restrain its sliding movement but is deformable upon the application of squeezing force (by a user's fingers applied against the opposite side walls of the housing) to selectively release the catheter for sliding movement. The catheter gripping means includes a pair of deformable clamping members that normally frictionally engage opposite side surfaces of the catheter, such clamping members extending between and being connected to upper and lower walls of the housing so that squeezing forces applied to those walls will cause the clamping members to bow outwardly away from each other and release the catheter for sliding movement.
The catheter gripping and lubricating device is located within the distal end of a pouch that maintains the catheter in sterile condition prior to use and may advantageously serve as a urine collection pouch during catheterization. Ideally, side surfaces of the guide housing's end cap are heat sealed or otherwise bonded to inside surfaces of the pouch at its distal end. The end cap includes a tubular extension that projects through and beyond the pouch's distal end, and in one preferred embodiment of the invention such extension carries a soft pliant introducer sleeve designed to protect the catheter tip against contamination by non-sterile urethral surfaces immediately adjacent the urethral opening.
A lubricant, preferably in the form of a lubricant gel, is disposed in the lubricant chamber. The passage of the distal end cap, including the extension of that end cap, is of a diameter sufficiently greater than the outside diameter of the catheter to insure that a thin even coating of lubricant is applied to and remains on the catheter as it is advanced into the urethra. In that connection, it is to be noted that squeezing forces applied to the lubricant housing for purposes of releasing the gripping means also helps to insure that lubricant will be forced into contact with the external surfaces of the catheter as it advances through the lubricant chamber.
Other features, objects and advantages of the invention will become apparent from the drawings and specification.
REFERENCES:
patent: 3556294 (1971-01-01), Walck, III
patent: 3854483 (1974-12-01), Powers
patent: 3898993 (1975-08-01), Taniguchi
patent: 3934721 (1976-01-01), Juster et al.
patent: 4062363 (1977-12-01), Bonner, Jr.
patent: 4230115 (1980-10-01), Walz, Jr. et al.
patent: 4622033 (1986-11-01), Taniguchi
patent: 4652259 (1987-03-01), O
Creaven Martin P.
Kavanagh Seamus T.
Hollister Incorporated
Marshall Gerstein & Borun
Reichle Karen
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