Surgery – Tampons
Reexamination Certificate
2001-06-05
2003-05-06
Ruhl, Dennis (Department: 3761)
Surgery
Tampons
C600S029000
Reexamination Certificate
active
06558370
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a urinary incontinence device for alleviating female urinary incontinence and a method of making the same. More specifically, this invention relates to a urinary incontinence device for alleviating female urinary incontinence during episodes of increased intra-abdominal pressure.
BACKGROUND OF THE INVENTION
The primary etiological factor producing genuine stress urinary incontinence is the incomplete transmission of abdominal pressure to the proximal urethra due to displacement from its intra-abdominal position. Some women, especially women who have given birth to one or more children, and older women, can experience incidences of involuntary urine loss due to stress urinary incontinence or combined stress and urge incontinence. A sneeze or cough can increase the intra-abdominal pressure impinging on a person's bladder and cause the involuntary release of urine. The frequency and severity of such urine loss can increase as the muscles and tissues near the urethro-vaginal myofascial area grow weaker. It has also been recognized that the urinary sphincter muscle, which is located at the upper end of the urethra, adjacent to the bladder, works well at sealing off the passing of urine from the bladder to the urethra when it has a round or circular cross-sectional configuration. Support of the proximal urethra elevates it above the pelvic floor and subjects it to increases in intra-abdominal pressure, thus allowing compression and maintenance of continence. However, when this passageway becomes distorted into a cross-sectional configuration having more of an elliptical or oval appearance, the sphincter muscle can not close properly, therefore, the tendency for involuntary urine loss increases. One must remember that the urethra and vagina are not separate structures. Because of their common derivation from the urogenital sinus, they are fused in the distal two thirds of the urethra. In this region, they are bound together by the endopelvic connective tissue so that the support of the urethra depends not only on the attachments of the urethra itself to adjacent structures but also on the connection of the vagina and periurethral tissues to the pelvic wall.
As the world's female population ages, there is an ever-increasing need for a non-surgical method or measure to reduce the involuntary urine loss commonly associated with stress urinary incontinence. Today, there are a number of specialized products available for this purpose. Most of these products can only be purchased with a prescription and they need to be properly sized, physically inserted and/or adjusted by a medical doctor or a nurse practitioner in order for them to perform correctly. Few, if any, products are commercially available in the United States, without a prescription, to prevent involuntary urine loss from stress urinary incontinence.
In view of the lack of commercially available, non-prescription urinary incontinence prevention or mitigation devices, it is recognized that there is a need for a urinary incontinence device that can be purchased without a prescription. There is also a need for a urinary incontinence device that is uncomplicated and therefore more user friendly and can be managed by the consumer without the intervention of a medical practitioner. Furthermore, there is a need for a urinary incontinence device which is easy for women to insert into and remove from their bodies, be more comfortable to wear and provide psychological and realistic assurance that it is capable of properly performing over an extended period of time.
SUMMARY OF THE INVENTION
Briefly, this invention relates to a urinary incontinence device for alleviating female urinary incontinence. The urinary incontinence device includes a resilient member and a non-absorbent positioned adjacent to the resilient member. The non-absorbent is constructed from a fibrous material wherein the fibers do not absorb significant quantities of moisture within the fibers. The resilient member and the non-absorbent are rolled into an elongated softwind with the resilient member located adjacent to an end thereof. The softwind has a larger diameter at one end. The softwind is then radially compressed into an elongated pledget having an insertion end, a trailing end and a uniform cross-sectional area therebetween. The resilient member is capable of expanding the insertion end of the pledget to provide a supportive backdrop for a woman's urethra when inserted into a woman's vagina.
The general object of this invention is to provide a urinary incontinence device for alleviating female urinary incontinence. More specifically, this invention relates to a urinary incontinence device for alleviating female urinary incontinence during episodes of increased intra-abdominal pressure.
A more specific object of this invention is to provide a urinary incontinence device that is placed in a woman's vagina and provides support to a woman's urethra to prevent involuntary urine loss commonly associated with stress urinary incontinence.
Another object of this invention is to provide a urinary incontinence device that is simple to use, easy to insert and remove, and which is comfortable to wear.
A further object of this invention is to provide a urinary incontinence device that can be manufactured and sold for a reasonable cost.
Still another object of this invention is to provide a urinary incontinence device that can be purchased by a consumer without a prescription.
Still further, an object of this invention is to provide a urinary incontinence device that does not disrupt the availability of normal vaginal secretions, which are necessary for a healthy vaginal environment.
Other objects and advantages of the present invention will become more apparent to those skilled in the art in view of the following description and the accompanying drawings.
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Anderson C. Lynne
Connelly Thomas J.
Kimberly--Clark Worldwide, Inc.
Ruhl Dennis
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