Device for obtaining stool samples

The device is usable by a patient to self-obtain a relatively constant volume stool sample for use in testing for gastro-intestinal bleeding. The device is a multi-layered pad which can be dispensed by a physician or the like to the patient and which the patient can use in privacy. The device may be used in the same manner as toilet tissue to obtain the stool sample after defecation or the stool may be indirectly applied to the device. Excess stool sample is discarded in the toilet and an appropriate amount of the stool sample is retained on the pad. The pad is then sealed and returned to the physician or testing laboratory hermetically sealed. The seal is broken, the test is performed, and then the pad is resealed hermetically and discarded.

This invention relates to a stool sampling device which can be used by a 
patient, in the same manner as toilet tissue, to obtain a relatively 
constant volume stool sample which can then be tested for signs of 
gastro-intestinal bleeding. The device of this invention is an improvement 
of stool sampling devices disclosed in my co-pending applications, Ser. 
Nos. 55,636, filed July 9, 1979, now U.S. Pat. No. 4,259,964 and 110,437, 
filed Jan. 7, 1980, now U.S. Pat. No. 4,273,741. 
One medical procedure frequently used on physicians' patients involves the 
obtaining of a stool sample which is tested for traces of blood to 
determine the presence or absence of gastro-intestinal bleeding. This test 
is a conventional precaution for patients having an established history of 
gastro-intestinal bleeding and will also be used on patients who are 
anemic, and who complain of gastro-intestinal discomfort. This test is 
also used as a screening test during routine physical examinations. 
A manner most commonly used to obtain the stool sample is by the 
physician's donning a rubber glove and manually inserting a finger into 
the rectum of the patient to obtain a stool smear. The stool is then 
transferred to a piece of absorbent paper and effective amounts of 
detecting agents such as guaiac, ortho-tolidine, or ortho-dianisidine and 
hydrogen peroxide are applied to the stool whereupon the presence of blood 
in the stool will cause a bluish coloration to appear. No color change 
indicates the absence of occult blood in the stool, and therefore, the 
absence of gastro-intestinal bleeding. This method of obtaining the stool 
sample is not sanitary and unpleasant for the patient and for the 
physician. 
Another method for obtaining the required stool samples involves the use of 
a kit sold under the brand name Hemoccult by Smith Kline Diagnostics. The 
kit includes a packet made of paper and formed somewhat similarly to a 
match book. The packet has a tab-slot interlock which can be opened so 
that the packet can be unfolded. Inside of the packet there is disposed a 
sample-receiving pad which has been treated with guaiac, one of the 
detecting chemicals referred to above. A sample-obtaining wooden stick is 
included with the kit. The kit is designed for use by the patient in 
privacy as follows. The kit is given to the patient by the physician, or 
obtained at a pharmacy upon directive of the physician. The patient takes 
the kit home, and it is used subsequent to defecation. A scraping of the 
bowel movement is obtained by the patient from the toilet with the stick 
and some of the scraped material is transferred to the pad from the stick. 
The contaminated stick must then be discarded by the patient. The packet 
flap is then reclosed and the packet and sample are then returned to the 
physician's office for examination. It will be appreciated that this 
procedure is to some extent more desirable than the first above-described 
procedure in that it may be performed in privacy. Nevertheless, it is also 
an unclean procedure with no provision for guarding against contamination, 
and the manner of disposition of the specimen on the pad is somewhat 
distasteful in that the stool-contaminated pad is generally discarded in 
the trash in an unsealed state. Furthermore, the patient is instructed to 
bring or mail the stool-contaminated pad to the physician. The mailing of 
the stool-contaminated pad in a non-hermetically sealed state is 
unsanitary and contrary to U.S. postal regulations. 
Other prior art stool sampling devices are disclosed in U.S. Pat. Nos. 
3,718,431; 3,672,351; and 3,996,006. 
I have devised a device which is used to procure stool samples, and which 
may be used in a conventional manner, in the privacy of one's home, or 
toilet in a physician's clinic or office, and which is clean and 
contamination-free and which is disclosed in my co-pending applications 
referred to above. 
This invention relates to an improvement in my earlier concept which 
earlier concept enables a relatively constant volume of stool to be 
obtained when the sampling device is used. This improvement thereto 
results in a highlighting of the blue color observed when blood is present 
in the stool sample. Briefly, the device of this invention is a pad or 
packet having a number of constituent layers, the pad being used to obtain 
the stool specimen in the same manner as toilet tissue after defecation. 
Excess amounts of stool are removed from the pad by tearing off one of the 
constituent layers and discarding that layer in the toilet, that layer 
being biodegradable. The layer which is torn from the pad includes a 
perforated portion which overlies a stool retention portion whereby the 
perforated portion ensures that a relatively constant volume of stool is 
deposited on the retention portion when the device is used. The pad is 
then hermetically sealed and returned to the physician's office. The 
device is thus contamination and odor-free during transport. A sheet of 
absorbent material preferably coated with the guaiac reagent is included 
in the pad at an appropriate location. To examine the specimen for blood, 
the pad is opened and a second reagent, hydrogen peroxide, is applied to 
the guaiac impregnated sheet overlying the stool sample. Inspection for 
color change is made through the transparent outer cover of the device 
after which the pad is resealed and discarded. In this manner, the test is 
performed quickly, and the discarded pad is both contamination and odor 
free. 
The outermost layer of the pad, which layer provides the hermetic seal, is 
a layer of transparent impermeable plastic. This layer underlies the stool 
retention layer so as to be adjacent to the side of the stool retention 
layer which is obverse to the surface upon which the stool is deposited. 
When the diagnostic reagents are added to the stool sample, the test 
result can be observed on the reverse side of the stool retention layer 
due to the transparency of the outermost layer of the pad and the seepage 
of fluids through the stool retention layer. When occult blood is present 
in the stool sample, there is visible through the transparent layer a 
plurality of dark stool spots, each of which spots is surrounded by a blue 
halo. The presence of the blue halos highlights the positive result and 
eliminates the possible masking of the blue color by the dark color of the 
stool, which occasionally happens with the prior art stool sampling 
procedures. Thus, the positive test result is rendered easier to see 
through the use of the transparent outer layer on the pad. 
It is, therefore, an object of this invention to provide a device for the 
taking of stool samples to be used in performing blood-detecting testing. 
It is an additional object of this invention to provide a device of the 
character described which can be used by a patient in the privacy of his 
home and at his convenience. 
It is yet another object of this invention to provide a device of the 
character described which is used in a conventional manner, and which is 
contamination and odor free. 
It is a further object to provide a device of the character described which 
enables a relatively constant volume of stool to be taken for testing when 
the device is used. 
It is an additional object of this invention to provide a device of the 
character described wherein masking of a positive result is prevented.

Referring now to the drawings, there is illustrated a preferred embodiment 
of the stool sampling device of my invention. The device, denoted 
generally by the numeral 2, is a multi-layered assemblage which has the 
general pliancy and feel of a thickened piece of toilet tissue. The upper 
layer 4 is a sheet of semi-flexible material such as polyethylene plastic; 
paper-plastic laminate, or the like. On one side of the upper sheet 4, 
there is disposed an area comprising a plurality of small openings 6. The 
half of the sheet 4 which contains the openings 6 has deposited thereon a 
layer 8 of soft fibrous cellulosic material which is flocked onto the 
sheet 4 and provides the flocked half thereof with a soft texture similar 
to tissue paper. Thus, one half of the sheet 4 will have a soft, 
tissue-like texture, and the other half will have a smooth, shiny texture, 
like plastic. The flocking, of course, could be extended over the entire 
sheet 4, or deleted, if desired, without departing from the spirit of the 
invention. 
Disposed beneath the openings 6, there is a somewhat enlarged pad 10 of 
absorbent paper, or the like. The pad 10 may cover the entire area of the 
sheet 14 if required for ease of manufacturing. A double-sided adhesive 
material layer provided with a window 13 overlies the pad 10 and serves to 
secure the pad 10 and the perforated half of the overlying sheet 4 to a 
bottom sheet 14, the latter of which is formed from a transparent 
impermeable plastic material. The bottom sheet 14 is also semi-flexible so 
as to maintain the overall flexibility and pliability of the entire 
laminate. The layer 12 may take the form of a double-sided sticky tape. 
Disposed on the half of the bottom sheet 14 not covered by the adhesive 
layer are a plurality of adhesive buttons 16 which serve to releasably 
adhere the non-perforated half of the sheet 4 to the sheet 14. The sheet 
14 is provided with an opening 18 on one of its halves, and the opening 18 
is closed and sealed by means of a conforming closure member 20 made from 
a similar impermeable material as the sheet 14. The closure member 20 
includes a pull tab 22 and a border 24 of resealable adhesive which serves 
to secure the closure member 20 to the sheet 14. On the inside surface of 
the sheet 14 and overlying the opening 18 is a sheet 15 of absorbent 
material which is relatively transparent and porous. This sheet 15 is 
pre-impregnated with the guaiac reagent in dry form. This sheet 15 may be 
made from the type of tissue commonly used for cleaning lenses. 
The appearance of the device 2 as dispensed by the physician, pharmacy, or 
the like, in its ready-to-use condition, is shown in FIG. 2. 
The device 2 is used to obtain a stool sample in the following manner. 
Immediately after defecation, the device is used in the same manner as one 
uses toilet tissue, and the flocked portion of the device is drawn across 
the anus, whereby a stool smear is obtained on the flocking 8 and on the 
portion of the pad 10 which underlies the openings 6. It will be 
appreciated that the openings 6 will act to screen the stool from the pad 
10 so that the stool sample will be deposited on the pad 10 in a plurality 
of spots which will be volumetrically controlled by the area of each 
opening 6. The sheet 4 is then pulled away from the remaining portions of 
the device and discarded into the toilet where it is flushed away with the 
stool. It will be noted that the adhesive buttons 16 will easily allow the 
corresponding half of the sheet 4 to be removed from the sheet 14 (as 
shown partially in phantom in FIG. 2) whereupon the remainder of the sheet 
4 and the flocked portion 8 thereon will be peeled off of the resealable 
adhesive layer 12. 
It will be appreciated that in circumstances where it is medically 
necessary to obtain a stool specimen from only the central portion of the 
stool, the stool may be collected separately and the required portion 
smeared upon the perforated portion of sheet 4. In this case, although 
full advantage is not taken of the sanitary aspects of the invention, the 
merits of relative quantitation of stool and sanitary transportation as 
well as sanitary disposal are maintained. 
After the sheet 4 has been removed from the device 2, the latter appears as 
shown in FIG. 3. It will be noted that the pad 10, upon which multiple 
spots of stool will have been deposited, remains adhered to the sheet 14 
by the adhesive layer 12. The half S of the sheet 14 is then folded over 
on top of other half S' of the sheet 14 to form a pouch configured as 
shown in FIG. 4. The folded-over half S is pressed against the exposed 
surface of the adhesive layer 12 so as to hermetically seal the resulting 
pouch whereby contamination and odor from the encased stool sample is 
prevented. It will be noted that the folding operation brings the sealed 
opening 18 into overlying relationship with the pad 10. It will also be 
noted that the folding operation brings the guaiac impregnated paper sheet 
15 into overlying relationship with the stool spots on the pad 10. 
The sealed pouch is then delivered to the physician's office testing 
laboratory, or the like, wherein the encased stool sample will be tested 
for occult blood. To expose the stool sample for testing, the closure 
member 20 is peeled back from the opening 18, as shown in FIG. 5. The 
hydrogen peroxide is then applied to the stool sample on the pad 10 
through the guaiac sheet 15. Application of the hydrogen peroxide to the 
sheet 15 places the guaiac in solution whereby both reagents are applied 
to the stool spots. The presence of occult blood in the sample will be 
indicated by a blue color which will be visible through the transparent 
sheet 14 or directly through the relatively transparent reagent sheet 15. 
After the test has been performed, the closure member 20 is resealed over 
the opening 18 and the used pouch is discarded, in an hermetically sealed 
condition, for subsequent disposal, as by incineration or the like. In 
some applications, such as for use in testing hospitalized patients, where 
adequate disposal facilities exist and cost is a major factor, closure 
member 20 could be made non-resealable to reduce production costs. 
Additionally, the reagent-impregnated paper 15 could be omitted to allow 
the ready use of special testing reagents. Neither of these modifications 
departs from the intended purpose of this invention. It will be noted 
that, during the testing procedure, the underlying portion of the sheet 14 
provides a transparent impermeable barrier which prevents reagents, fecal 
material, viruses, bacteria, or the like from seeping through the pouch 
onto the laboratory bench, etc., while at the same time permitting visual 
observation of the results of the reagent application if the pad is turned 
over. The results observed through the transparent sheet 14, when the test 
is positive, are a plurality of dark spots, each of which is surrounded by 
a halo of blue color. 
It will be readily appreciated that the device of this invention provides a 
means for obtaining a relatively constant volume stool sample which is 
simple and natural to use, which can be used by a patient in privacy, and 
which circumvents the embarrassing aspects of the prior art devices and 
procedures. The sample, once obtained, is hermetically sealed whereby 
contamination and odor problems are avoided. Still further, the device 
enables the actual test to be performed without the possibility of reagent 
or contamination leakage occurring, eliminates the possibility of the 
stool color masking or otherwise obscuring the blue color which is present 
in a positive test result, and also enables the discarded tested stool 
sample to be contained in an hermetically sealed pouch. 
Since many changes and variations of the disclosed embodiments of the 
invention may be made without departing from the inventive concept, it is 
not intended to limit the invention otherwise than as required by the 
appended claims.