Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-04-05
2002-12-10
Garbe, Stephen P. (Department: 3727)
Surgery
Instruments
Sutureless closure
C604S378000, C128S885000
Reexamination Certificate
active
06491713
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an applicator or placement device for use in placing a bladder output control device on the body of a user. The present invention particularly relates to an applicator used for placing a bladder output control device, such as in external incontinence device, on the urinary meatus of a female user. Further, the present invention also relates to a placement device used for placing a bladder output device, such as a urinary catheter, through the urinary meatus and into the bladder.
BACKGROUND OF THE INVENTION
In the course of normal bodily activity, the bladder functions to cyclically store and evacuate urine and thereby effectuate the removal of liquid waste from the body. Although it is not uncommon for the human bladder to operate properly throughout the entire life of an individual, with increasing frequency, individuals are encountering a condition whereby the storage and release of urine is difficult to control with the desired success. Such a condition has been named urinary incontinence and is believed to be one of the most widespread and costly medical conditions prevailing in modem society.
The cause of urinary incontinence is found in the underlying conditions of the bladder or urinary sphincter muscles, which conditions may have varying degrees of complexity. For example, in women, urinary incontinence may be caused by multiple pregnancies, childbirth, and aging that causes a relaxation in the pelvic muscles, which in turn causes incontinence. On the other hand, other causes may include multiple sclerosis, stroke, and spinal cord injuries, all of which disrupt the nerves that control the muscles which control urine retention and evacuation.
Urinary incontinence may be temporary or chronic and there are several options for managing and treating the problem ranging from simply wearing an absorbent pad all the way to submitting to an invasive surgical procedure. Nearly every case of urinary incontinence, however, can be treated with substantial success. As such, it is somewhat surprising that of the approximately 13 million individuals in the United States alone that are suffering from urinary incontinence, less than half seek any medical attention, and fewer than one in ten afflicted individuals are actually treated.
One of the reasons that many instances of urinary incontinence go untreated is that the treatment may be obtrusive, embarrassing or simply inconvenient to the effected patient given the manageability of the condition. Another reason is likely due to costs and the ease with which a particular treatment may be obtained. Accordingly, there have been several previous attempts to arrive at a cost effective, unobtrusive treatment that is readily available to the user, particularly as such treatment relates to female incontinence.
Examples of such treatments may be found in U.S. Pat. No. 5,074,855 and U.S. Pat. No. 5,336,208 which each disclose a device for controlling urinary incontinence in a human female by way of a resilient pad configured to seal against and occlude the urinary meatus of the user. In both patents an adhesive is provided to seal the body of the device against the urinary meatus to hold urine in the bladder. The device is removed and discarded when the user must urinate. Then, after urination, a new device is applied.
Further examples may be found in International Application Nos. 96/39,989, 96/39,990 and 96/39,991, each of which disclose a female urinary incontinence device in the form of a urethral cap with a partially deformable body portion, a hand gripping portion and a body contacting surface. The body portion defines a chamber which allows for a vacuum seal when applied to the patient's body. This device too is removed when the user urinates, at the completion of which the device is then reapplied.
Yet still further examples are found in U.S. Pat. Nos. 6,056,687 and 6,200,261 which are hereby incorporated by reference in their entirety into the present application. These devices are also applied to the body of a female user over the urinary meatus, however, since these devices incorporate an integral valve mechanism, the user need not replace the device with each occurrence of urination but need only open the valve at the time of urination and then close the valve after urination is complete.
Another condition commonly diagnosed in individuals and opposite to urinary incontinence is urinary retention. Urinary retention (whether acute or chronic) may be caused by either an outflow obstruction or poor bladder contractibility. In each case, the oufflow resistance exceeds the pressure generated by contraction of the detrusor muscle that, under normal functioning, pushes the urine out.
Urinary catheterization is a procedure commonly employed to treat and relieve urinary retention. The procedure involves passing a catheter through the urinary meatus and into the bladder. Once the catheter is in the bladder, the balloon is inflated to position and secure the catheter in place. The catheter is then connected to a urine collection bag for closed urinary drainage.
The above-described devices for treatment of urinary incontinence and urinary retention (and other similar products not specifically described) offer many advantages to potential users, including cost effectiveness, availability and convenience. However, it has been discovered that one obstacle or disadvantage to such devices is the potential difficulty encountered in correctly placing and applying such devices to the female body. The location of the urinary meatus is oftentimes very difficult for a user of the device to visualize without assistance, which, in turn, leads to difficulty in placing the incontinence device at the precise location over the urinary meatus, necessary to ensure proper functioning of the device. Specifically for cases involving urinary incontinence, this difficulty is increased if the user is fully clothed and finds herself needing to place the device in the confines of a public restroom facility.
In view of the above, it is apparent that there is a need to provide assistance to the user of bladder output control devices such as those described above that ensures the proper operation of the device and thereby successfully treats the incontinence and retention. Such assistance includes providing better visualization to the user without increasing the effort already required to apply the device. It further includes ensuring that the placement task can be achieved within limited space constraints.
OBJECTS AND SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to provide a placement device that addresses the obstacles and disadvantages associated with the consistent and reliable placement of bladder output control device on the body.
A further object of the present invention is to provide a placement device that enables a user to easily visualize the site at which the bladder output device must be placed in order to ensure proper operation of the device.
A further object of the present invention is to provide a placement device that enables the user to place an external incontinence device on the body within the restricted confines of a bathroom facility such as a public toilet stall.
A further object of the present invention is to provide a placement device that is economical to produce and which is readily accessible to potential users.
A further object of the present invention is to provide a placement device that may be used without the assistance of medical care personnel.
A further object of the present invention is to provide a placement device that enables the user to place a catheter through the urinary meatus to the bladder for relief of acute or chronic urine retention.
These and other objects not specifically enumerated herein are believed to be addressed by the present invention which contemplates a device for placement of an external incontinence device which has at least a handle and a surface fixed to the handle which receives the external incontine
Cabak James E.
Deininger Steven T.
AMS Research Corporation
Garbe Stephen P.
Hohenshell Jeffrey J.
Ngo Lien
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