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.