Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2001-01-03
2002-10-08
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128SDIG008, C600S029000
Reexamination Certificate
active
06460542
ABSTRACT:
The present invention is broadly concerned with an apparatus and method for controlling urinary incontinence in human females. More particularly, it is directed to a prosthesis which can be inserted intravaginally to reposition and support the urinary bladder.
Urinary incontinence (UI), or involuntary loss of urine from the bladder, is prevalent among adult women. According to the Agency for Health Care research and Quality of the Department of Health and Human services, more than 11 million American women suffer from some form of urinary incontinence. More than $16 billion is spent every year in the United States on incontinence related care. UI is more common in women because pregnancy and childbirth may weaken the bladder supporting muscles in the pelvic floor and cause pelvic organ prolapse. It is also more prevalent in postmenopausal women, who have lower blood levels of estrogen, which helps to maintain muscle tone around the urethra. There are four primary types of UI: stress, functional, urge and overflow incontinence.
Stress incontinence occurs when the urethra fails to keep the neck of the bladder closed during exertion. It occurs during sudden increases in intra-abdominal pressure, for example, during physical exertion, lifting, laughing, coughing and sneezing. Urge incontinence, also known as “overactive bladder”, is the result of involuntary contractions of the detrusor muscle. Functional incontinence is the result of impaired mobility or mental function, which may arise for example, secondary to Alzheimer's disease. Overflow incontinence is the result of weak bladder muscles, which may arise for example, secondary to nerve damage, or blockage of the urethra. Stress and urge incontinence are most common in women, and often occur together as so-called “mixed” incontinence.
Therapeutic treatment of UI in women varies according to type. Functional incontinence is treated by addressing the underlying impairment, if possible. Overflow incontinence is rare in women. While urge incontinence may be treated by anticholinergic drugs, these drugs are not effective in treating stress incontinence.
Stress incontinence is caused by loss of muscular support to the urethra and neck of the bladder. It may be treated surgically, by rehabilitation of the pelvic muscles, and by use of prosthetic devices, known as pessaries, which are inserted into the vagina to support the prolapsed neck of the bladder and urethra. Prosthetic devices are particularly suitable for use by patients who are not surgical candidates or who decline surgery.
Previous prosthetic devices have attempted to achieve normal bladder support by applying pressure to the anterior wall of the vagina and adjacent neck of the bladder and urethra. Such anterior pressure does not provide lateral alignment of the urethra and may serve to exacerbate any lateral urethral deviation. Moreover, when such a device exerts pressure on the tissue in excess of 32 mm Hg, the capillaries close, cutting off the cellular blood supply and eventually resulting in necrosis of the adjacent tissue, manifested as vaginal pressure ulcers. Even where such devices do not damage the tissue by exerting excessive pressure, the pressure they do cause results in occlusion of the urethra, setting up a local irritation and attendant patient discomfort. An increase in the incidence of urinary tract infections has been reported in patients who use such prosthetic devices for extended periods of time.
Known intravaginal support devices are of two general types. So-called support pessaries are generally ring shaped, and are retained in place by the pubic bone to exert a spring action against the anterior vaginal wall. So-called space-filling pessaries are held in place by their size or by a suction action against the vaginal walls. There is a need for an intravaginal prosthetic support device or pessary which will align the urethra and reposition and support the bladder in a normal anatomical position. There is also a need for such a support device which does not occlude the urethra or exert excessive pressure on the surrounding tissues.
The apparatus of the present invention is specifically designed to provide an intravaginal prosthetic device which can support the urinary bladder and align the urethra in correct anatomical position without discomfort or excessive pressure on the urethra or surrounding tissues.
SUMMARY OF THE INVENTION
The present invention is directed to a female incontinence device and method for placement of an intravaginal device for repositioning and supporting the prolapsed neck of the urinary bladder and realigning the urethra both vertically and laterally to achieve normal anatomical position enabling a patient to remain stress-continent. The incontinence device of the present invention includes an open, generally droplet-shaped base coupled with a pair of elongate spaced parallel legs shaped to extend in a predetermined configuration in orthogonal relationship to the plane of the base. Upon installation in the vaginal canal, the legs provide support for the anterior wall of the vagina and adjacent neck of the urinary bladder at a preconfigured variable distance from the posterior vaginal wall, as well as lateral and vertical alignment and support of the adjacent urethra. Alternatively, the base may be coupled with a single leg having a predetermined configuration and extending orthogonal to the plane of the base and attached to the base at both ends.
OBJECTS AND ADVANTAGES OF THE INVENTION
The principal objects of the present invention are: to provide an improved apparatus and method for controlling urinary incontinence in women; to provide such an apparatus and method for repositioning and providing lateral and subjacent support to the neck of the bladder and the urethra; to provide such an apparatus and method for supporting the bladder and urethra while providing a templet for lateral alignment of the urethra; to provide such an apparatus and method for supporting the bladder and urethra while correcting the lateral alignment of the urethra; to provide such an apparatus which does not occlude the urethra; to provide such an apparatus which does not require flexed positioning behind the pubic bone to remain in place; to provide such an apparatus which may be positioned manually without surgical intervention; to provide such an apparatus which is available in an array of sizes so that an appropriate size can be selected to fit the pelvic anatomy of a patient; providing such an apparatus which can be easily installed and removed by a patient without assistance; to provide such an apparatus having a pair of spaced parallel legs for receiving and aligning an adjacent urethra therebetween; to provide a method for inserting such an apparatus intravaginally, positioning the device so that the superior aspects of the legs reposition and support the prolapsed neck of a urinary bladder and the legs laterally align and support the urethra for controlling urinary incontinence in women, and permitting the device to remain in place for an extended period of time; providing such an apparatus and method which are relatively easy to use, inexpensive to produce and particularly well-suited for their intended usage.
Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of the invention.
The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.
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Brown Michael A.
Medical Technology & Innovations, Inc.
Rodgers Marcia J.
Shughart Thomson & Kilroy P.C.
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