Surgery – Female reproductory tract shields – supports – or birth... – Pessaries
Reexamination Certificate
1993-04-02
2001-02-20
Brown, Michael A. (Department: 3764)
Surgery
Female reproductory tract shields, supports, or birth...
Pessaries
C128S836000, C128S837000
Reexamination Certificate
active
06189535
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a deflatable vaginal pessary to control urinary incontinence or a prolapse, and more particularly to a vaginal pessary having a rubber-like hollow body which, when the air pressures inside and outside of the hollow body are the same, has a normal operational size; the pessary also including an elongated air tube that permits the hollow body of the pessary to be transformed into a smaller size when air is actively sucked out of the rubber-like hollow body through the air tube.
BACKGROUND OF THE INVENTION
Relaxation of the pelvic tissue may result in prolapse of either the uterus, bladder, rectum, or intestines; it may result in stress incontinence; or it may result in a combination of the above. Surgery may effectively control the above conditions; but if the patient is very old, or for other reasons is a poor operative risk, a vaginal pessary may be considered. However, in this group of women, the introitus, the inlet to the vagina, may be narrow making it painful to insert the pessary.
Various prolapse devices have been in use for several decades. They are usually made of a solid material and, to ensure that they function adequately, they have to be as large as possible to serve as a mechanical barrier, preventing the organs from being extruded through the introitus. That makes it difficult and painful to insert the device and then remove it for cleaning. To overcome the forgoing problem, an inflatable prolapse device, the “Inflatoball”, has been developed by Milex Products, Inc., 5915 Northwest Highway, Chicago, Ill. 60631. The mechanism for deflation and inflation of the “Inflatoball” includes a tube attached to a spherical body, which tube extends to just outside the vagina when the spherical body has been properly inserted. The tube ends with a valve which can be readily opened for deflation. It can also be connected with a pump when inflation is desired.
A vaginal pessary for control of urinary incontinence also needs to be large to perform well. As a consequence, insertion and removal of the incontinence device can be painful. An inflatable pessary for controlling incontinence, particularly stress incontinence, is disclosed in U.S. Pat. No. 5,007,894 issued on Apr. 16, 1991. The device consists of an inflatable oval-shaped body with two projections, the oval-shaped body having a central aperture to allow drainage to migrate from the uterus and out of the vagina. The two projections offer support on each side of the urethra and prevent the device from exerting a direct pressure on the urethra. This pessary, when inflated, with the exception of the two projections used for control of urinary incontinence, is somewhat similar to prior art prolapse devices, in the form of donuts, used for control of vaginal prolapse.
Other prior art pessaries that have inflatable portions are shown in U.S. Pat. Nos. 2,638,093, 3,646,929, 4,019,490 and 4,920,986, British Patent 1,115,727, Australian Patent Application 152,363 and European Patent Application 0 274 762. All of these devices, as well as other prior art inflatable devices, have the disadvantage in that air may leak from within the inflatable body, thus reducing its effectiveness.
Another prior art prolapse device is shown in U.S. Pat. No. 4,019,498. This device may be made from an open cell resilient foam material and has the shape of a mushroom. Thus, this device differs from the prior art referred to above because it is a compressible device. When inserted, the head of the mushroom-shaped device will bear against the anterior wall of the vagina at a location adjacent a mid-portion of the urethra, and the stem of the mushroom-shaped device will rest upon the opposed posterior wall of the vagina. This patent teaches that the device may be compressed prior to insertion within the vagina by inserting it within a flexible, air impervious envelope, and that the air may then be driven out of the device, the envelope then being sealed prior to insertion. After the compressed device has been inserted into the vagina, the compression can be released on the device by piercing the envelope with a needle or scalpel, thus letting air enter the envelope. However, once the device has expanded to its normal size, no means are provided for again compressing the device for removal.
OBJECTS AND SUMMARY OF THE INVENTION
It is an object of the present invention to provide a vaginal pessary which may be easier to insert and to remove for cleaning, which pessary is intended for control of urinary incontinence and/or prolapse of the uterus, bladder, rectum, and intestines, and which vaginal pessary does not give the wearer the discomfort of prior art vaginal pessaries.
More specifically, it is an object of the present invention to provide a vaginal pessary which has a hollow body that may be deflated by reducing the air pressure within it below ambient air pressure, making it possible to insert the hollow body into the vagina when deflated, the hollow body resuming its normal operational size when inserted in the vagina by letting ambient air into the hollow body.
In summary, a vaginal pessary is provided which includes a hollow body and an air tube, preferably coiled, which is operatively connected to the hollow body. The volume of the hollow body may be reduced from its normal operational size for relatively easy insertion and removal. The hollow body is preferably formed of a rubber-like material which will have a normal operational size when the air pressure within the hollow body is the same as the air pressure outside of the hollow body. The size of the hollow body may be reduced by withdrawing air from it, and to do this a syringe is connected to the free end of the elongated coiled air tube. After either insertion or removal, the hollow body is permitted to expand to its normal operational size by letting air flow back into it, the resilient material of the hollow body returning it to its normal operational size.
The foregoing will become more apparent after a consideration of the following detailed description taken in conjunction with the accompanying drawings in which a preferred embodiment of this invention is illustrated.
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patent: 4920986 (1990-05-01), Biswas
patent: 5007894 (1991-04-01), Enhorning
patent: 0152343 (1953-07-01), None
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patent: 0274762 (1987-01-01), None
patent: 1115727 (1968-05-01), None
patent: 1115727 (1969-05-01), None
Brown Michael A.
Thompson John C.
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