Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1999-12-14
2002-03-12
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06355004
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a urinary catheter assembly comprising at least one urinary catheter having a proximal end, and a flexible tubular catheter package comprising a hose member with a cavity narrowly surrounding said at least one catheter, the package further comprising a tubular compartment connected with said hose member for accommodation of said proximal end of the at least one catheter.
2. Description of the Related Art
Urinary catheters of the kind contemplated by the invention are increasingly used for so-called intermittent catheterization of the bladder. A typical use is for post-operative urine retention of newly operated patients in hospitals, for whom intermittent catheterization performed with intervals of 3 to 6 hours has brought a significantly reduced risk of infection of the urethra and the bladder compared to permanent catheterization.
Another typical use is with patients suffering from severe cases of urinary incontinence as for disabled individuals like para- or tetraplegics who frequently have no control permitting voluntary urination.
For such users intermittent catheterization have become increasingly common also in daily life situations outside the clinical environment of a hospital, whereby a significantly improved quality of life has been obtained for this group of patients.
For many such users it is necessary, however, to connect the catheter with a urine collection bag through a hose connected in one end with the bag and in the other end with the proximal terminal member of the catheter with the inherent disadvantage that several connecting operations must be performed prior to use of the catheter.
To overcome this problem it is known e.g. from GB-A-2,284,764, U.S. Pat. No. 2,856,932, U.S. Pat. No. 4,379,506, U.S. Pat. No. 4,204,527, U.S. Pat. No. 4,246,909, WO 94/06377, WO 97/26937 and Danish Design Registration No. 0932-1986 to integrate the catheter with the urine collection bag, typically by arranging the catheter inside the bag combined with a bag design permitting partly withdrawal of the catheter from the bag to provide a projecting catheter of a length sufficient for insertion through the urethra into the bladder.
Whereas catheter-bag combinations of this kind have undoubtedly facilitated the use of intermittent catheterization, they have not remedied the disadvantage associated with disposal of the collected urine.
In a disposable male urethral catheter assembly known from U.S. Pat. No. 4,246,909 the catheter-bag combination is made into a single integrated unit which is disposable after use. A catheter having an enlarged or bulbous discharge end is contained in a sterile environment in an upper chamber of a flexible bag. The upper chamber is detachably connected in one end with a lower sample chamber for collection of a urine sample and is partly defined in the opposite end by two chevrons defining an opening which is reduced in size relative to the enlarged discharge end of the catheter.
In use the penis is inserted into an open top of the bag outside the two chevrons and by manipulation of the upper chamber without touching the catheter a guided non-contaminating insertion of the catheter into the urethra may be effected, until the enlarged discharge end contacts the opening defined by the two chevrons, whereby the upper chamber forming a short extension in flow communication with the catheter will direct a urine sample flowing through the catheter to the lower sample chamber.
This disposable solution suffers, however, from significant cost disadvantages.
Guided non-contaminating insertion of a catheter into the urethra for intermittent catheterization of the bladder is further obtainable by use of a catheter assembly disclosed in applicants international patent application WO 96/30277 comprising a catheter placed in a package designed an functioning as an applicator for the insertion of the catheter. The package is composed of two plastic foil blanks joined in peeling zones along their edges. When the catheter is to be put in use the package is first opened at a distal end zone to expose the distal end of the catheter and subsequently gradual complete separation of the walls of the package is effected in a direction away from the distal end zone by pulling the walls of the package in opposite directions substantially perpendicular to the longitudinal direction of the package.
Although a more cost-effective solution is provided by this catheter assembly, practical experience has shown that some users such as elderly and disabled persons having a severely reduced dexterity may have difficulties with the applicator function of the package due to the pull force required to effect separation of the walls thereof.
SUMMARY OF THE INVENTION
On this background it is the object of the invention to provide a simple and relatively inexpensive catheter set permitting disabled users even when wheel chair bound to perform a safely guided non-contaminating insertion of the catheter.
To achieve this object a urinary catheter assembly according to the invention is characterized in that said compartment is closed in a first open end by a detachable cover member, whereas in a second opposite end it is detachably connected with said hose member, said compartment being further formed with walls of a thin flexible material so as to permit arrangement of said compartment on the at least one catheter for use as an applicator for guided non-contaminating insertion of the catheter into the urethra after detachment of said cover member and detachment of the compartment from the hose member.
By this design the compartment forming an integrated part of the package for the catheter in its supply condition may easily be broken-off and removed from the hose member and, after detachment of the cover member the compartment may be arranged on the catheter shaft. The thin flexible walls of the compartment may now be used as a finger grip applicator by being gently squeezed against the catheter by a moderate outside pressure.
In a preferred embodiment of the catheter assembly a further advantageous possibility may be obtained for using the hose member of the package as an extension of the catheter in flow communication therewith, so that urine drained from the bladder by intermittent catheterization may directed into a toilet or other available drainage means, is obtained by closing a distal end of the hose member remote from its connection with said compartment by a detachable closure, said proximal end of the at least one catheter being formed for connection with said distal end of the hose member such that after removal of said closure and detachment of said cover member, the hose member is connectable by its distal end with said proximal end of the at least one catheter to form an extension member in flow communication with the catheter.
Preferably, the proximal end of the at least one catheter is connected with a connector member. This design is particularly advantageous in combination with another embodiment of the invention, in which the distal end of the hose member is inseparably connected with a hose connector matching said connector member, said closure being detachably connected with said hose connector.
In another advantageous embodiment, the hose member is, at its proximal end, inseparably connected with an end member which is detachably connected with said compartment. Preferably, the detachable connection is provided by means of a weakening line, and the connection between the compartment and the end member may be re-established by twisting and/or pushing the compartment into the end member, the weakening line forming a substantially liquid-tight seal. By this design, it is possible to close the package after use in a simple manner.
The catheter assembly of the invention is suitable, in particular, for use with catheters having a hydrophillic surface coating throughout the part of their length intended for insertion into the urethra. Thus, in a further preferred embodiment the catheter is pro
Jensen Lars Bogelund
Pedersen Jens Kristian
Coloplast A/S
Jacobson & Holman PLLC
Szmal Brian
Winakur Eric F.
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