Surgery – Female reproductory tract shields – supports – or birth...
Reexamination Certificate
1999-02-16
2001-04-17
Brown, Michael A. (Department: 3733)
Surgery
Female reproductory tract shields, supports, or birth...
C128S834000
Reexamination Certificate
active
06216698
ABSTRACT:
TECHNICAL FIELD
This invention relates generally to an improved pessary for effective support of a cystocele, or rectocele, or prolapse, or a combination of geritourinary abnormalities. The improved pessary is preferably of a generally horseshoe shape, and is capable of being reshaped by intrauterine forces while in place within the uterus. The pessary is comprised of a frame completely enclosed by an inert material, such as a silicone. This reshapability of the pessary while in the uterus is the result of placing a flexible segment, such as a spring-type means, along the two central arms of the frame.
BACKGROUND OF THE INVENTION
Various devices, generally known as pessaries, are utilized for the treatment of prolapse of internal female organs, including the organs of the digestive tract and sex organs. Increased age is a risk factor for women for uterine or other prolapse. The use of pessaries is indicated where the correction of prolapse by surgery is inadvisable, as for example where a woman is in generally poor physical condition, or where she is of advanced age.
The first known pessaries are believed to have been small oranges, and may have been in use since 2,000 years ago. Modem literature describing pessaries dates back to a period prior to the 1850's. More recent patents of interest and relating to pessaries include U.S. Pat. Nos. 4,031,886, 4,307,716, 4,516,570, 4,579,110, 4,607,630, 4,724,832, 4,823,814, 5,014,722, 5,224,494, and 5,224,495. The pessaries shown in these patents and otherwise known in the prior art can be of many shapes, including ring shaped, spherical, horseshoe, helical, cylindrical, and ovoid, among others. The inner part of the pessary generally includes a structural support. Such a support may be mechanical, such as a metal frame, or pneumatic, i.e., air supported. The outside surface of the pessary is generally made of an inert, biocompatible material, such as rubber or silicone. A pessary of the horseshoe type is known as a “Gehrung” pessary. One example of such a “Gehrung” pessary is shown at page 14 of a catalog by Milex Products, Incorporated, the assignee of the present application.
The prior art “Gehrung” pessaries provide generally effective support in cases of cystocele and rectocele. The solid metal frame of these prior art devices permits these devices to be bent somewhat into a new shape more precisely meeting the needs of a particular patient. In addition, a lesser flexing of the frame, to an extent that does not permanently change the shape of the device, facilitates insertion.
After insertion into the patient, the shape of these devices does not change, but remains identical to that shape into which it the supporting frame was bent, i.e., the shape just prior to insertion. This tendency to resist changes in shape is generally advantageous for some patients, particularly those patients whose anatomy or general physical conditions do not worsen over time.
However, for those patients whose condition does worsen over time, the convention “Gehrung” pessary may not be ideal. When internal organs undergo further shifts, additional weight and pressure may be placed onto the pessary. As a result of this increased pressure, the pessary may shift within the uterus of the patient. These shifts may in turn increase the pressure on the uterine walls upon which the pessary rests. As a result, a pessary which was comfortable when initially fitted may, at a later time, become uncomfortable for the patient.
SUMMARY OF THE INVENTION
The invention is an improved pessary, comprising a frame made of an elongated material of generally circular cross-section. This elongated material is then formed into a closed figure of a generally rectangular shape. The frame is then formed into a configuration which has a generally horseshoe shape, in side view. The frame comprises four arms, including a first, second, third, and fourth arm. With the frame in its initial rectangular shape, ,the first and second arms are generally parallel to each other. In this initial rectangular shape, the third and fourth arms are also generally parallel to each other. In addition, these third and fourth arms are generally perpendicular to the first and second arms. The first and second arms include flexible segments, such as springs that are crimped onto each of the first and second arms. A preferred, but not mandatory, position for these flexible segments or springs is generally in the middle of each of the first and second arms. The springs permit flexing of the first and second arms.
In another embodiment, the third and fourth arms include flexible segments, such as springs, crimped onto each of the third and fourth arms, at a position preferably, but not necessarily, in the middle of each of the third and fourth arms. These springs also permit flexing of the third and fourth arms.
In general, the frame is totally enclosed within a thin and flexible biocompatible material. The biocompatible material is preferably selected from the group including silicone, rubber, or polyvinylchloride.
REFERENCES:
patent: 40949 (1863-12-01), Scattergood
patent: 1083721 (1914-01-01), Asch
patent: 4031886 (1977-06-01), Morhenn
patent: 4307716 (1981-12-01), Davis
patent: 4516570 (1985-05-01), Taban
patent: 4579110 (1986-04-01), Hamou
patent: 4607630 (1986-08-01), Spits
patent: 4724832 (1988-02-01), Strubel et al.
patent: 4823814 (1989-04-01), Drogendijk et al.
patent: 5014722 (1991-05-01), Bauer
patent: 5224494 (1993-07-01), Enhorning
patent: 5224495 (1993-07-01), Robinson
Brown Michael A.
Milex Products, Inc.
Wallenstein & Wagner Ltd.
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