Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2000-09-18
2002-10-29
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128SDIG008, C600S029000
Reexamination Certificate
active
06470890
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an inflatable vaginal pessary suitable for treating urinary incontinence, cystoceles, rectoceles, enterocelles, and uterine prolapse. The invention also relates to a method for installation and removing of the aforementioned inflatable pessary.
BACKGROUND
Continence, or normal control of urine retention in the bladder, involves the coordination of the bladder, bladder neck and urinary sphincter. The body stores urine in the bladder by maintaining a closed bladder neck and a contracted urinary sphincter muscle. To pass urine the bladder contracts while the bladder neck opens and the urinary sphincter muscle relaxes.
Urinary incontinence (UI) occurs when one or more of the anatomical structures related to urine storage malfunctions and leads to a loss of control of urination. The most common type of incontinence is caused by hypermobility of the bladder neck and urethra due to weakening of the tissues surrounding these structures. In females, pelvic trauma associated with child birth is a common cause of tissue weakening. Another cause of incontinence is a deficiency in urinary sphincter muscle control, intrinsic sphincter deficiency (ISD). It is estimated that approximately 8.5 million women suffer from UI in the United States. Up to 75% of female nursing home patients experience some degree of urinary incontinence, creating a tremendous economic, as well as hygienic, burden.
Female incontinence is currently treated using behavioral techniques, various devices, surgical techniques, and pharmaceuticals. Among devices widely used for alleviating the above problem, a device, which is known as pessary, is a useful alternative or an adjunctive aid rather than a substitute for gynecological surgery. A pessary is a device, which is inserted into the vagina for controlling uterine prolapse, uterine retrodisplacement, or stress urinary incontinence via the walls of the vagina.
A great variety of vaginal pessary device is known and is available on the market. Some pessaries are made in the form of a rigid, i.e., non-inflatable rings, dishes, hodges, donuts, etc. Such devices are produced, e.g., by Millex Products, Inc., Chicago, U.S.A. The aforementioned pessaries are inserted and removed manually which present a problem for inserting and removing by the patient. Insertion and removal of such pessary by the doctor or nurse is easy in most cases. In the past, doctors and nurses would fit the patient with a type of pessary, insert it into the patients vagina and leave it there for 3 months. The patient comes back to the doctor's office in 3 months and remove, clean and insert the pessary again or use a new one. But the doctor or nurse always insert and remove the pessary. Such a practice is seldom used now because pessaries left for weeks and months usually cause irritation and infection in the vagina and produce bad odor and significant vaginal discharge. Therefore most doctors and patient have abandoned this method.
The new approach is to use the pessary on a daily basis by having the patient insert the pessary in the morning and removing it in the evening. She cleans the pessary with special solution, and then re-insert it the next morning. This is the same idea as intermittent catheterization that is now done three-four times per day by the patient rather than having an indwelling Foley catheter in the bladder for usually four weeks, and the doctor insert and remove the catheter.
The problem with this new method of daily insertion and removal is that the patient has to learn how to insert and remove the pessary herself. However, as has been mentioned above, the aforementioned rigid pessaries are difficult to insert and likewise, very difficult to remove by the patient.
Attempts have been made to solve the above problem by providing an inflatable pessary consisting of a donut-type inflatable portion which is manually inserted into the vagina and which is connected via a flexible tube with an externally located pumping bulb. The donut portion is individually fitted and adjusted into a required place of the vagina and then is inflated to a proper size by means of the pumping bulb via the flexible tube. The donut portion is provided with a check valve for maintaining the pessary in an inflated state. Upon completion of inflation, the bulb is disconnected leaving a short piece of the flexible tube protruding out from the vagina, so that this protruding end can then be used for removing the inflated donut portion of the pessary from the vagina. Such a device is also produced by Millex Products, inc., Chicago, U.S.A. A disadvantage of this device is that it is still manually inserted and that the end of the flexible tube protruding from the vagina creates discomfort for the patient. Another disadvantage is that the donut portion is removed in an inflated state.
U.S. Pat. No. 5,611,768 issued in 1997 to R. Tutrone discloses a pessary device comprising two sequentially arranged inflatable chambers, one of which is placed into the anterior part of the vaginal cavity and another to the posterior part of the vaginal cavity. Both chambers are inflated separately via separate valves located outside the vagina and remaining attached to the device after the inflation. At least one of the chambers is intended for pressing via the vaginal wall on the urethra thus combating female incontinence.
This device entails the same disadvantages as the previously described pessaries, i.e., the pessary removing means remain permanently attached to the pessary. Another disadvantage is that this device has a complicated construction. It has top be manually inserted and removed.
OBJECTS OF THE INVENTION
It is an object of the invention to provide a mechanically insertable and removable inflatable vaginal pessary which is easily insertable and removable by a patient, which is disconnected from the insertion and removal device after inflation and during the use of the pessary, and which can be easily reconnected to the aforementioned device, and can be adjusted to a required position within the patient's vagina. It is another object to provide a mechanical device, which is connectable to a pessary for its insertion, disconnectable from the inserted pessary after insertion, and reconnectable for removal of the pessary for replacement. It is a further object to provide the aforementioned mechanical device with means for inflation and deflation of the inflatable pessary. Another object is to provide a method for easy and reliable insertion of the pessary by the patient herself.
SUMMARY OF THE INVENTION
An inflatable vaginal pessary of the invention, which can be mechanically inserted into and removed from the patient's vagina, comprises a tapered body inflatable at its large-diameter side and having an axial channel for inflation of the pessary. This channel passes from the small-diameter end to the inflatable chamber and has a check valve at the outer end of the channel for inflation of the pessary. The pessary can be connected to and disconnected from a mechanism for insertion and removal of the pessary into and from the vaginal cavity. This mechanism has a hollow tubular housing with a funnel-like finder for engagement with the tapered end of the pessary. On the bottom of the finder the pessary installation mechanism has a threaded tubular stem that could be screwed into the threaded opening on the tapered end of the pessary. On the proximal end the mechanism has a pumping bulb for inflating the pessary via the check valve by squeezing the bulb, in the same manner as inflation of the occlusive cuff in a manually-operated blood pressure measuring apparatus. The pessary of the invention can be easily installed into the patient's vagina by the patient herself. For this purpose, the pessary is connected to the aforementioned mechanism, inserted by the patient into an appropriate position inside her vagina, inflated to a required degree in order to fix the pessary in place, and is then disconnected from the mechanism for use during the day. In its inflate
Borodulin German
Diokno Ananias
Shkolnik Alexander
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