Baths – closets – sinks – and spittoons – Flush closet – With disposable container
Reexamination Certificate
2001-12-17
2002-07-09
Eloshway, Charles R. (Department: 3751)
Baths, closets, sinks, and spittoons
Flush closet
With disposable container
C004S479000, C004S484000, C383S033000, C383S072000, C604S317000
Reexamination Certificate
active
06415455
ABSTRACT:
TECHNICAL FIELD
This invention relates generally to an apparatus for collecting biological specimens. More particularly, the invention relates to an apparatus for the collection and transportation of stool specimens.
BACKGROUND OF THE INVENTION
Stool specimens are used with increasing frequency for the screening and diagnosis of disease. Evidence of parasitic, infectious, or inherited disease may be found in stool. For example, the presence of carcinoembryonic antigen or blood in stool is indicative of colorectal cancer. Stool-based assays for parasitic organisms are also widely available.
A significant problem with using stool specimens in screening or diagnosis arises in the collection of the specimen. Depending on its physical state, the specimen may be difficult to collect into a container. Moreover, the handling of a specimen raises sanitary concerns. Merely obtaining a specimen may increase the risk of disease transmission, especially if sanitary procedures are not followed. This is especially true if the patient is responsible for obtaining the specimen. The odor often associated with a stool specimen, and the frequent need to transport the specimen also contribute to the problems associated with sample collection.
Attempts have been made to solve these problems. For example, Aslam, U.S. Pat. No. 4,101,279, reports a disposable bowl adapted to fit onto a toilet for collection of stool. Such a device eliminates the need for the patient to handle the specimen directly. However, the patient (or technician) is still exposed to the sample, resulting in possible contamination and the presence of odor. Moreover, the Aslam device contains blades for homogenization that may present a danger to the patient.
Paulin, U.S. Pat. No. 4,309,782, also reports a bag adapted to fit onto a toilet for collection of stool. The device reported by Paulin also provides for scraping excess stool out of the bag after use.
While these and other devices of the art have attempted to solve the problems associated with collection of stool, none have provided a solution that minimizes handling of the specimen, minimizes odor and contamination, and provides for easy transport of the specimen. Accordingly, there remains a need in the art for a device for safe and secure collection of stool.
SUMMARY OF THE INVENTION
The present invention provides an apparatus for a collecting, storing, and/or shipping a stool specimen. Generally, the invention provides a housing having attached thereto a retractable bag for collecting the specimen. The bag is retracted by a draw string or cord (e.g., a lanyard) attached thereto, or preferably by a slider attached to the housing and to which the draw string is attached for moving the slider. In use, the patient places a device of the invention on a toilet, deposits stool into the bag, and pulls the draw string thereby to engage the slider to retract the bag. The patient may then urinate or further defecate. In a preferred embodiment, the bag is retracted into a portion of the housing. An advantage of a device of the invention is that the bag can be closed by the patient while the patient is still seated on the device.
Also in a preferred embodiment, the housing is shaped to fit onto a toilet seat. A preferred housing releasably attaches to the toilet seat or may comprise a non-slip surface for contacting the toilet. The housing may comprise padding to increase patient comfort. A preferred housing is preferably constructed of cardboard or plastic but may be constructed of any useful material. The housing may comprise supports for resting the apparatus on a toilet seat. The supports may be folded over the housing for compact transportation of the apparatus.
A stool specimen collector of the invention comprises a bag for collection, storage, and/or transport of the specimen. Preferably, a bag for use in an apparatus of the invention is releasably attached to the housing, preferably on the underside of the housing. In a preferred embodiment, the bag may be movably attached in a groove in the housing in order to facilitate closure of the bag. However, the bag may be fixedly attached to the housing at the convenience of the manufacturer or the technician. The bag is constructed of any suitable material such as polyethylene or PVC, and is preferably opaque. In a preferred embodiment, the bag may contain a buffer, or other additives to retard degradation of the specimen, and to optionally reduce odor.
A preferred apparatus comprises a slider attached to a draw string for closing the bag. In a preferred embodiment, the bag comprises a spring beam holding the bag in an open position. The spring beam deforms to a closed position under the housing when the bag is closed. The slider is preferably engaged on the underside of the housing, such that when the draw string is pulled the slider sweeps the underside of the housing, thereby gathering the perimeter of the bag and causing the bag to close. In an alternative embodiment, the draw string itself is attached to the bag for closure and no separate slider is used. Thus, the draw string may be any material or configuration that is capable of closing the bag. It is not necessary for the draw string to remain attached to the bag after closure. Thus, the draw string may be detachable. A preferred draw string is constructed of nylon, and may be a loop, straight chord, braided, or any other configuration capable of closing the bag. Preferred bag closure mechanisms include a flexible tongue and groove assembly, a zipper, a thermal seal, an adhesive, a “zip-lock” assembly and others known in the art to effect closure of the open perimeter of a collection bag.
Also in a preferred embodiment, instructions for using the apparatus are attached to or printed on the housing.
Another embodiment of the invention provides methods for obtaining a stool specimen. In one embodiment, methods comprise placing a stool collector apparatus over a toilet, sitting over or on the apparatus, evacuating a stool into the collection bag, pulling the draw string to close the collection bag, and retracting the collection bag under the housing or bracket. A particular advantage of this embodiment is the collection bag is closed while the patient is still seated.
Additional aspects and advantages of the invention are apparent upon consideration of the following detailed description thereof.
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Lapidus Stanley N.
Slaon, III Walker M.
Eloshway Charles R.
Exact Sciences Corporation
Testa Hurwitz & Thibeault LLP
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