Chemistry: analytical and immunological testing – Including sample preparation
Reexamination Certificate
2000-10-16
2003-11-25
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Including sample preparation
C604S317000, C604S358000, C604S385010
Reexamination Certificate
active
06653149
ABSTRACT:
FIELD OF THE INVENTION
The invention is directed generally to a device and method for the collection of a stool sample.
BACKGROUND OF THE INVENTION
A properly collected sample of stool (feces) is necessary in certain diagnostic assays. For many illnesses, particularly stomach and intestinal tract disorders, examining and testing a patient's feces is needed for diagnostic and treatment purposes. In addition, some postoperative monitoring procedures also require periodic examination of the patient's feces. Pediatricians may instruct parents to monitor various characteristic of their child's feces. For example, fecal material may be macroscopically examined for size, shape, color, odor, consistency, and concretions (gallstones and fecaliths). Gross macroscopic examination can also be directed at finding parasites (whole worms or their fragments), and undigested food, and evaluating the amount of blood, pus, mucus, and fat. Microscopic examination of the fecal material may be for undigested food particles (starch, muscle fibers, elastic fibers, etc.), parasite eggs and segments of parasites, fats, and yeasts. Cultures of fecal material may be taken to determine the presence of bacteria, fungi, viruses and protozoa. Chemical examinations may include the determination of pH and electrolytes, qualitation and quantitation of occult blood, bilirubin and some of its derivatives, ingested iron, trypsin, total fat, fatty acids, vitamin A and carotene, and tests for absorption of lactose and D-xylose.
Collection of the stool by the patient, with or without assistance, is often found to be unpleasant. The stool sample is most favorably obtained from a toilet after defecation. The expelled stool, however, may reside on the bottom of the toilet bowl and, if the stool is semi-liquid, obtaining the sample becomes even more difficult.
Currently, there are two general ways to address the problem of stool collection.
The first method for stool collection is by use of a sheet of flexible material that forms a receptacle, using attachments to secure it to a toilet seat. Some of these devices either have holes, or are made of a mesh-like material which allows liquid to pass through while retaining fecal material. After defecation, the individual obtains a sample from the feces residing on the material, breaks the attachments, and then flushes the remaining feces and material in the toilet. The use of such collection devices requires dexterity and hand contact with both the toilet seat and the device prior to and after defecation.
The second method for stool collection is by use of a sheet material that floats on the water in the toilet bowl. The sheet is hydrophillic and flotation is due either to the action of surface tension or to the generation of contained gas or foam, as disclosed in U.S. Pat. No. 4,705,050. After obtaining a sample from the feces residing on the material, the floating material and remaining fecal material are flushed In the toilet. When adding the sheet material to the toilet, however, the individual's hands are in the bowl, close to the edges and sides of the bowl, thus risking unsanitary contact. Furthermore, the deposit of the stool, or pressure exerted on the stool when obtaining the sample, can cause the sheet and stool to become submerged. This makes the sampling process difficult and contaminates the fecal sample with material present in the toilet bowl.
Another problem with currently available devices is the backup of contaminated water in the toilet bowl. This problem particularly occurs with devices made of hydrophilic sheets with moisture activated foaming material. Such sheets may plug the drainage pipes due to shear mass.
A need thus exists to make the process of obtaining a stool sample simple, easy, and as non-distasteful as possible. A need also exists to minimize or eliminate the potential for unsanitary contact with the toilet bowl itself and its contents (water, chemicals, etc), and to have a collection device that is disposed of in both a simple and environmentally friendly manner.
SUMMARY
The invention is directed to a method for forming a stool collection device, and a method of collecting a stool sample using the inventive device.
A sufficient amount of a liquid absorbent or hydratable polymer is hydrated to form a gel-like matrix in the bowl, simply by adding the polymer to a toilet bowl. This matrix, formed in situ, is capable of supporting stool upon defecation into the prepared bowl. Because the stool is supported on the matrix, it is not contaminated by bowl water and may be easily sampled, collected, or evaluated. The polymer may be, for example, an acrylic acid polymer or a starch graft copolymer of 2-propenenitrile.
The device and method avoids the need for a pre-manufactured receptacle. Such receptacles have attendant problems, for example, the need for attachment to a toilet seat, which may be difficult for some individuals and which allow for hand contamination during attachment. Such receptacles may also clog pipes if disposed by flushing. In contrast, the inventive device is easily formed without any manipulation by the user, and is readily degraded upon flushing, posing no disposal problems.
The polymer may be added to water contained in any toilet bowl, even bowls containing sanitized water. For additional convenience, the polymer may be pre-measured in packets, which may be dropped into the bowl and which may be easily and discretely carried and used by an individual.
These and other embodiments will be apparent with further reference to the following detailed description and examples.
DETAILED DESCRIPTION
A stool (feces) collection device and method to form and use the collection device is disclosed. The collection device contains a hydratable polymer or resin, also referred to as a liquid absorbent or superabsorbent polymer or resin, that forms a matrix of a gel-like substance when in contact with water, such as water within the toilet bowl itself. The liquid absorbent or superabsorbent polymers and resins are generally acrylamide based and are commercially available. Examples of the polymers and resins that may be used in the invention include the following: polyacrylic acid salts, copolymers of acrylic acid salts and methacrylic acid salts, saponification products of methylacrylate-vinyl acetate copolymers, saponification products of starch-ethylacrylate graft copolymers, starch-acrylic acid graft copolymers, saponification products of starch-methyl methacrylate graft copolymers, acrylate homopolymers, acrylate copolymers, alkali acrylate polymers, crosslinked polyacrylic acid salts, crosslinked copolymers of acrylic acid salts and methacrylic acid salts, crosslinked saponification products of methyl acrylate-vinyl acetate copolymers, crosslinked saponification products of starch-ethyl acrylate graft copolymers, crosslinked starch-acrylic acid salt graft copolymers, crosslinked saponification products of starch methyl methacrylategraft copolymers, crosslinked saponification products of starch acrylonitrile graft copolymers and crosslinked sodium carboxymethyl cellulose, crosslinked products of polyacrylates, crosslinked products of hydrolysates of starch-acrylonitrile graft copolymers, crosslinked products of carboxymethylcellulose, crosslinked products of polyvinyl alcohols, crosslinked products of hydrolysates of methyl (meth)acrylate-vinyl acetate copolymers, crosslinked products of cellulose-sodium acrylate graft copolymers, polyethylene oxide, polyvinyl-pyrrolidine, hydroxyethyl cellulose, hydroxypropylcellulose, polymerized &agr;,&bgr;-unsaturated carboxylic acids, crosslinked acrylic acid salt polymers, saponification products of crosslinked acrylic acid ester-vinyl acetate copolymers, saponification products of crosslinked starch-acrylonitrile graft copolymers, crosslinked polyvinyl alcohols grafted with maleic anhydride, saponified polymers or copolymers or starch graft copolymers of 2-propenenitrile, 2-methyl-2-propenenitrile, saponified crosslinked homopolymers of acrylonitrile or methacrylonitrile, sapo
Pack Todd Denison
Tao Yuan
Tung Ker-kong
Applied Biotech Inc.
Cole Monique T.
Warden Jill
Wood Herron & Evans L.L.P.
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