Catheter for self-catheterization with guiding mirror

Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...

Reexamination Certificate

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C604S544000

Reexamination Certificate

active

06544240

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to the field of urology, in particular to a catheter for self-catheterization.
BACKGROUND OF THE INVENTION
Patients who require intermittent self-catheterization may have low-motor and/or sensory type neurogenic bladders, detrusor-sphincter dyssynergia or underactive bladder from non-neurogenic causes such as obstruction or overdistention that result in the retention of urine. The urinary retention may be due to interference of nerve pathways in the brain or spinal column, or the peripheral nerves where nerve impulses control detrusor function and the process micturition. Neurologic bladder disease is frequently found in paraplegia, multiple sclerosis, cerebral vascular accidents, brain injuries, spinal cord lesions, trauma, infection or discogenic diseases affecting the sacral area of the spinal cord, extensive abdominal surgical operations and diabetes. non-neurogenic disturbences may be found in patients with infrequent voiding syndrome and post-operative or post-partum urinary retention.
It is customary for women with urinary retention to be prescribed intermittent catheterization by inserting a urethral catheter to void in the bathroom on a predetermined time schedule. Self-catheterization is normally performed every four to six hours because urine that remains in the bladder is prone to infection or stone formation.
However, some patients with multiple sclerosis often have fine-motor neuron dysfunction accompanied by visual impariment. Some patients are overweight and have a big belly which makes it difficult to see the urethral opening for insertion of the catheter into the urethra. This makes intermittent self-catheterization difficult if not impossible since the process generally requires the ability of the patient to have fine motor skills and good vision to locate the urethral meatus.
With presently available devices the patient accomplished self-catheterization with the aid of a separate mirror held at an appropriate angle, inserting the catheter along the urethra (about 3-4 cm) until its end reaches the bladder. The mirror must be held by the patient so that the self-catheterization thus becoming a two-handed operation, or the mirror must be supported in front of the patient in some way in a position whereby the patient has the required view. Additionally the catheter can be difficult to grip and manipulate, being only a thin, flexible plastic tube with a special slippery surface to aid insertion.
Attempts have been made to solve this problem by providing a catheter with a handle arrange essentially perpendicular to the catheter for manipulation of the catheter during insertion of the catheter into the urethra (see U.S. Pat. No. 5,653,700 Issued Aug. 5, 1997 to P. Byrne et al.). The handle has on its front surface a mirror made in the form of a thin film. According to the authors of the above patent, this mirror may be used to facilitate finding the meatus of the urethra for insertion of the catheter.
However, the handle makes the catheter, which is substantially a unidimensional thin tube, a two-dimensional device which occupies a large space in storage and is inconvenient for a self-catheterization patient who has to carry the catheter with her all the time. Furthermore, the handle is relatively thin and therefore the mirror cannot be wide enough to be practical for finding the location of the urethral meatus. In order to increase the size of the mirror, it would be necessary either to make the handle wider or to provide the handle with a special mirror attachment device. The device of the aforementioned patent is complicated in construction and expensive to manufacture.
It is known that the first part of the urethra is a harbor for infection. Therefore, during catheterization the urethral flora is pushed into the bladder, and this can initiate a urinary infection. An attempt has been made to solve the above problem by providing a device for self-catheterization with infection prevention means. Such a device is described in U.S. Pat. No. 5,147,341 issued to R. Starke in Sep. 15, 1992. This patent discloses a self-catheterization device comprising a flexible bag made of a thin transparent film, a sterilized cap attached to the bag, and a sterilized catheter located inside the bag and insertable into the urethra through the sterilized cap. In use, the sterilized cap, which is normally coated with a protective cover, is first inserted into the infectious part of the urethra and then the catheter is inserted into the bladder through the opening of the cap.
However, the device of U.S. Pat. 5,147,341 does not have means for finding the location of the urethral opening and therefore requires the use of a separate mirror. Furthermore, self-catheterization with this device is a two-handed operation.
OBJECTS OF THE INVENTION
It is an object of the present invention to provide a device for self-catheterization which combines means for finding the position of the urethral meatus with means for protection against infection and for making self-catheterization a single-handed operation. Another object is to provide a self-catheterization device of the aforementioned type which is simple in construction, reliable and practical in operation, and which releases the second hand for use in pushing the catheter into the urethra, if necessary.


REFERENCES:
patent: 5653700 (1997-08-01), Byrne et al.

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