Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1994-03-21
2004-09-28
Dawson, Glenn K. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S330000, C128S832000
Reexamination Certificate
active
06796973
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to feminine hygiene devices, and more particularly to a vaginal discharge collection device for collecting vaginal discharge. The present invention also relates generally to the intravaginal delivery of drugs and other substances.
From the time after World War I, when bandages were marketed as sanitary napkins, to the present, there have been essentially only two types of commercially available menstrual collection products: sanitary napkins and tampons. Sanitary napkins, including the newer pads and shields, have the disadvantages of bulk, odor and leakage. They also present disposal problems, and they are sometimes detectable to others. Their absorbent nature can also create problems of contamination and infection. Tampons are also disadvantageous. The basic design of the tampon does not stop leakage and the externally worn string can lead to contamination. Tampons have fibers which irritate the vaginal mucosa. Absorptive tampons can also contribute to serious infections.
U.S. Pat. No. 3,983,874 (Davis), U.S. Pat. No. 3,128,767 (Nolan), and U.S. Pat. No. 3,216,422 (Steiger) disclose absorptive cup-shaped vaginal tampons. These devices are bulky and would be difficult to use and uncomfortable to wear, and would have the same dangers of infection presented by conventional absorptive tampons. Other internal vaginal discharge collection devices are disclosed in U.S. Pat. No. 3,845,766 (Zoller), U.S. Pat. No. 3,841,333 (Zalucki), U.S. Pat. No. 3,626,942 (Waldron), U.S. Pat. No. 3,404,682 (Waldron), U.S. Pat. No. 2,616,426 (Gordon), U.S. Pat. No. 2,534,900 (Chalmers), U.S. Pat. No. 1,986,504 (Cubbon), and U.S. Pat. No. 71,414 (Rohleder). These devices all suffer from poor ergonomic design. They would be difficult to insert and remove, uncomfortable to wear, and/or unreliable.
The Waldron and Chalmers devices are worn in a lower region of the vaginal canal and generate suction, particularly during removal. These devices would cause irritation and pressure, and would damage the delicate vaginal tissue. The suction generated by the devices would also make the devices difficult to remove, and would tend to cause spillage.
Further, the Davis, Nolar, Gordon and Rohleder devices have rims with springs embedded therein. Such springs make the devices unnecessarily complicated and expensive to manufacture. The Zoller, Zalucki, Waldron and Chalmers devices have complicated configurations that would be relatively expensive to manufacture. The exterior configurations of these devices may also cause irritation when worn internally. The Cubbon device has a small flat loop vulcanized to the under edge of a rubber ring. Providing this loop complicates the device unnecessarily. The loop may also cause irritation during use. With or without the loop, the Cubbon device suffers from poor ergonomic design.
Accordingly, there is a need in the art for a vaginal discharge collection device that avoids the problems associated with napkins and tampons, and that is convenient, comfortable, reliable and economical.
Prior art systems for delivering drugs and other substances into the vaginal canal are disclosed by U.S. Pat. No. 4,895,170 (Tlapek), U.S. Pat. No. 4,589,880 (Dunn), U.S. Pat. No. 4,526,578 (Wong), U.S. Pat. No. 4,311,543 (Strickman), U.S. Pat. No. 4,286,587 (Wong), U.S. Pat. No. 4,219,016 (Drobish), U.S. Pat. No. 4,200,090 (Drobish), U.S. Pat. No. 4,198,976 (Drobish), and U.S. Pat. No. 4,198,965 (Strickman), and British Patents Nos. 260,600 (Fiessler) and 21,588 (Fickert). These devices are structurally unsatisfactory. For example, the Tlapek device has a semi-circular loop used for removal. This loop unnecessarily complicates the Tlapek device and may cause irritation during use. The Wong ('587) device has a circular cross section. As a result, this device would tend to twist upon compression, making insertion of the device difficult. All of the prior art systems would be difficult to insert and remove, uncomfortable to wear, unreliable, and/or uneconomical to manufacture and market.
Accordingly, there is a need in the art for an intravaginal substance delivery system that can be conveniently and reliably used, and that can be used without discomfort, particularly during menses.
SUMMARY OF THE INVENTION
The present invention alleviates to a great extent the disadvantages of the known vaginal discharge collection devices by providing a vaginal discharge collection device including an elastomeric rim with a generally rectangular cross section which creates a collection space for collecting vaginal discharge, and a flexible film reservoir attached to the rim.
In one aspect of the invention, the reservoir is collapsible so as to be substantially enclosed within the rim when the device is located within the vaginal canal.
In another, separate aspect of the invention, the rim and the reservoir of a vaginal discharge collection device are arranged such that compressing diametrically opposed portions of the rim toward each other causes a leading portion of the rim to dip downwardly to facilitate proper insertion of the device under the cervix.
In another aspect of the present invention, the dimensions and materials of the device, including the dimensions and materials of the rim, are selected so as to optimize the device's convenience, comfort and reliability.
In another aspect of the invention, the collector includes a closure structure for at least partially covering the opening for inhibiting the exit of vaginal discharge from the collection space. One embodiment of the closure structure includes a membrane extending over the area within the rim. The membrane is slit or divided into two approximately equal parts approximately along a line extending across the diameter of the rim and approximately through the radial center of the rim. The two parts of the membrane may each have an area larger than half of the circular area defined by the rim so as to overlap along the slit and/or extend loosely and not be stretched tightly across the area defined by the rim. This loose and/or overlapping structure is to allow collection of fluid into the device through the slit but to inhibit exit of the fluid from the device. Forces on the device during removal will tend to close together the overlapping parts of the slit membrane to prevent the exit of fluid.
Because a substantially looser fit is needed to inhibit the passage of menstrual fluid than to inhibit the passage of sperm, the structure of the present invention may be smaller than the contraceptive diaphragm type devices to increase comfort during wearing while still being held in position by compression of the vaginal wall on the rim. The comfort is achieved by a rim that will conform to the individual and that will be more flexible and less rigid than that of the diaphragm type devices. Thus, a single size of the collector according to the present invention will be adequate for use for a range of sizes of vaginal canals, unlike the diaphragm type devices which must be individually fit by a medical doctor or specially trained nurse and which are available only by prescription. Moreover, the diaphragm type devices must last for long periods of time and must be constructed of heavyweight materials. Therefore, the invention may be less expensive than the diaphragm type devices and may be disposable.
Another advantage of the present invention is that, because it may be made of an elastomeric material that is chemically inert and non-toxic, the present invention should not be prone to health problems that the current products seem to cause. Moreover, this soft material will allow for adjustment to individual shapes and afford excellent comfort while maintaining its original form. The present invention seals off the blood environment to inhibit the growth of bacteria and entry of air and thus hinders the odor which results from the oxidation and decomposition of the menstrual flow.
In another aspect of the invention, the collector may effect intravaginal drug delivery of time release a
Contente Audrey
Potter Richard C.
Ross Bruce F.
Dawson Glenn K.
Dickstein , Shapiro, Morin & Oshinsky, LLP
Instead, Inc.
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