Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-09-02
2001-12-25
Ruhl, Dennis (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C600S582000, C128S830000
Reexamination Certificate
active
06332878
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates generally to devices and methods for the collection of menstrual flow and other discharge from female humans, particularly during a menstrual period.
Menstrual flow from the uterus of female humans has traditionally been collected through the use of an absorbent material. The absorbent material has been formed into a tampon or sponge that is inserted into the vagina to receive and absorb the menstrual flow. See, e.g., U.S. Pat. No. 4,374,522 to Olevsky for a “Tampon with Central Reservoir.” Tampons or sponges do not entirely eliminate leaks and must be replaced periodically when the absorptive capacity of the tampon or sponge is reached.
Furthermore, extended wear of high absorbency tampons may lead to an increased risk of toxic shock syndrome (TSS). TSS is believed to be caused by the ingress of bacteria cultured in the absorbent material into the body through lesions or lacerations of the vaginal lining. High absorbency tampons may cause such lesions or lacerations by drying the vaginal wall. In addition, tampons or sponges expose the vagina to bleaches and other chemicals contained in their absorbent material.
Another disadvantage of tampons and sponges is that they must be removed in order to permit sexual intercourse; intercourse, however, will be inevitably messy because the menstrual flow will no longer be checked.
In the alternative, the absorbent material may be formed into a pad that is positioned immediately below the introitus or opening of the vagina to receive and absorb the menstrual flow. See, e.g., U.S. Pat. No. 5,718,699 to Brisebois for “Disposable Absorbent Product with Secondary Liquid-Containment Structure.” These devices are large and bulky and may allow leakage when disarranged by the wearer's movement or improperly worn.
Other devices have been devised over the years for the purpose of collecting or at least blocking menstrual flow. These include menstrual cups that abut the walls of the vagina and block the passage of fluids from the cervix to the exit of the vagina. See, e.g., U.S. Pat. No. 3,845,766 to Zoller for “Cup-Shaped Device for the Collection of Menstrual Fluids and Intended for Internal Use.” Such devices are uncomfortable and can leak or overflow when removed. Also, these devices are reusable and must be washed after use.
Other internally placed devices have structures like the diaphragms used for contraception. Such devices are thus large and round in order to cover the cervix and a large part of the upper vaginal wall. See, e.g., U.S. Pat. No. 5,295,984 to Contente, et al. for “Vaginal Discharge Collection Device and Intravaginal Drug Delivery System” and U.S. Pat. No. 4,848,363 to Cattanach for “Valved Vaginal Collection Device.” All such devices, as with tampons, will be messy upon extraction, will increase the risk of toxic shock syndrome, or will interfere with sexual intercourse.
A device for collecting and containing menstrual flow therefore is needed that will not have the disadvantages noted above.
SUMMARY OF THE INVENTION
The invention provides a device for capturing and containing menstrual flow, comprising a cup shaped to substantially cover the cervix and having an intravaginal reservoir for collecting menstrual flow. Preferably, the cup has a first side substantially shaped and sized for sealing contact with the cervix and a port adjacent the external os of the cervix in order to permit the egress of menstrual flow discharged by the external os of the cervix from the first side of the cup into a reservoir defined by the cup and a pouch attached to the cup. The pouch is shaped to comfortably fit into the upper end of the vaginal canal below the cervix. An absorbent material, which may be treated with an antibacterial solution, may be placed in the reservoir for absorbing the menstrual flow received in the reservoir.
The cup and the pouch preferably are made of a flexible, resilient, and biocompatible plastic. The absorbent material preferably is made of an absorbent material such as polymer fibers. The cup and the pouch preferably will be separately formed by injection-molding or other forming process and then fastened together.
Resilient rings molded into the cup and the pouch-shaped wall may be provided to maintain the position of the device against and over the cervix and to maintain the seal of the cup of the device around the os of the cervix. Preferably, the device will contain a “posterior fomix spacer” that engages the posterior fomix (at the rear of the cervix) in order to maintain the position of the device.
The port preferably will be provided with a permeable cover in order to prevent captured menstrual flow from contacting the cervix. The permeable cover, which preferably will be a small piece of fabric or other material, also prevents the absorbent material from contacting the vaginal walls and thus reduces the risk of toxic shock syndrome. In addition, the permeable cover stops leakage of captured menstrual flow and thus contributes to the reduction of mess after removal of the device. Disposal of the device after use therefore will be less troublesome.
The device preferably will be equipped with a string in order to facilitate removal from the vagina.
The device preferably will be inserted using an applicator. The applicator is a plastic cylinder having a piston mounted inside. The device preferably is folded into an open end of the cylinder above the piston. The open end of the cylinder is inserted through the introitus or opening of the vagina until it is near the top of the vagina and adjacent the cervix. The cylinder is then withdrawn while not moving the piston so that the device is ejected from the cylinder. The device then unfolds and glides into the end of the vagina and automatically locks onto the cervix. Preferably, the device is coated with lubricant either when it is stored in the applicator or while it is being released from the applicator. The lubricant coating on the device will assist it to slip into place against the cervix.
OBJECTS AND ADVANTAGES OF THE INVENTION
It is an object of this invention to provide a device and method for capturing and containing menstrual flow that will isolate the captured menstrual flow from the vaginal lining and the cervix.
Another object of this invention is to provide a device and method of capturing and containing menstrual flow that will substantially reduce the risk of toxic shock syndrome.
A further object of this invention is to provide a device and method for capturing and containing menstrual flow for an extended period of time.
Yet another object of this invention to provide a device and method for capturing and containing menstrual flow that will permit little or no leakage of menstrual flow past the device.
An additional object of this invention is to provide a device and method for capturing and containing menstrual flow that will encapsulate the captured menstrual flow upon removal from the vagina.
Still another object of this invention is to provide a device for capturing and containing menstrual flow that will permit sexual intercourse while the menstrual flow is being captured and contained.
Yet an additional object of this invention is to provide a device and method for capturing and containing menstrual flow that is comfortable and convenient to use.
REFERENCES:
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patent: 3845766 (1974-11-01), Zoller
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patent: 4359357 (1982-11-01), Friese
patent: 4374522 (1983-02-01), Olevsky
patent: 4381771 (1983-05-01), Gabbay
patent: 4401534 (1983-08-01), Goepp et al.
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pate
Billups Robert S.
DeArmond Robert L.
Haavind Cher
Kasum Lara A.
Knudsen Harold L.
Brotman Harris F.
Moonstruck, LLC
Ruhl Dennis
The Brotman Group
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