Surgery – Diagnostic testing – Temperature detection
Reexamination Certificate
1993-11-29
2001-01-09
Rimell, Sam (Department: 3712)
Surgery
Diagnostic testing
Temperature detection
C600S562000
Reexamination Certificate
active
06171259
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a fecal specimen sampling device and more particularly to a fecal specimen sampling device having analyzing and temperature measuring elements.
BACKGROUND OF THE INVENTION
The medical care field has increasingly moved towards the use of disposable implements for conducting routine invasive testing because of the increased availability of new inexpensive plastic materials and an awareness of the difficulty and high cost of sterilizing reusable equipment.
Disposable medical implements are not, however, totally free of problems because disposability means increased supply costs and much more waste being produced. Medical waste is typically more expensive to dispose of than ordinary waste.
Medical practice upon certain patients such as children (or dogs and cats in the case of veterinary practice) can be more difficult due to uncooperativeness of the patient. It would be beneficial to adopt shortcuts in testing procedures where feasible to limit patient discomfort.
It is also desirable that the pathology of biological specimens be evaluated within the container in which the specimen is obtained and/or transported. This eliminates the need for additional transferring steps. Pathology evaluations can thus be undertaken in a less costly and waste-producing fashion which is quick, convenient, and safe.
There are various temperature-taking implements and feces sampling devices having a variety of special features in the prior art. Applicant, however, is not aware of such separate use implements having been previously combined to enable a medical practitioner to both take the temperature and remove a specimen of feces from a patient by means of a single rectal penetration, wherein the feces specimen can then promptly be evaluated within the sampling implement.
U.S. Pat. No. 3,822,593 to Oudewaal discloses a clinical thermometer probe with a disposable cover. The probe is made of a cylindrical tube with a thermistor probe contained in the hollow interior. A disposable cover with a membrane terminus engages the tube at the temperature sensing end.
U.S. Pat. No. 4,263,921 to Trugillo discloses a temperature sensing endotracheal tube. A thermistor is mounted on the distal end portion through the side wall of the tube.
U.S. Pat. No. 4,312,950 to Snyder et al. discloses a disposable swab and culture unit made of a two-piece telescoping plastic cylinder which forms a disposable container for the swab and a liquid culture medium.
U.S. Pat. No. 4,707,450 to Nason discloses a specimen collection and test unit which has a fibrous swab tip at one end of an elongated hollow shank for use in collecting biological specimens. Test reagents can be pumped through the shank to the swab tip.
U.S. Pat. No. 3,826,259 to Bailey discloses a self-contained disposable swab-type medication applicator with an encapsulated topical medicine. The medicine is released by squeezing the capsule and a cover material is removed to expose the medicated swab.
U.S. Pat. No. 2,969,141 to Katzin discloses a disposable plastic cover for a thermometer.
U.S. Pat. No. 4,562,043 to Mennen et al. discloses a tubular test device for testing occult blood in fecal matter using hydrogen peroxide in an ampoule adjacent a swab.
Other U.S. Patents of interest include No. 3,190,436 to Diamant; No. 738,960 to Vaughan; No. 4,351,616 to Farnstrom et al.; No. 4,297,944 to Catlin; No. 3,800,781 to Zalucki; No. 3,783,998 to Brush et al.; and No. 3,650,153 to Schwab.
SUMMARY OF THE INVENTION
A combination thermometer and fecal specimen sampling device permits the concurrent sampling of a fecal specimen and the measuring of body temperature from a single penetration of the rectum. Furthermore, a fecal specimen analyzing means is provided for performing a quick and simple on-the-spot analysis of the fecal specimen, or preserving means for maintaining integrity of the fecal specimen for later laboratory work.
In one embodiment, the present invention provides a device for simultaneously sampling a fecal specimen and measuring rectal temperature. The device comprises a rigid and elongated disposable tubular sleeve having open proximal and distal ends, the distal end having rounded edges adapted for rectal insertion and at least partially cut away longitudinally and transversely to form an open-ended scoop for collecting and containing a fecal specimen from the rectum. An interior bore is formed throughout the sleeve and a temperature measuring device is removeably inserted in the bore so that a temperature sensing end is thermally exposed adjacent the scoop. The temperature sensing end concurrently measures body temperature while the fecal specimen is obtained. A securing means inhibits longitudinal sliding of the temperature measuring device in the bore. An enclosure is sealably secured around the scoop after rectal insertion to contact the fecal specimen in the scoop with an analyzing solution contained by the enclosure.
In a preferred embodiment, the enclosure comprises a vial having an interior seat sealably locking with an exterior surface of the disposable tubular sleeve. The enclosure can also comprise a cap suitable for sealing the scoop end of the sleeve. The sleeve can further include a score or weakened section formed thereon for cleaving the proximal end from the distal end lodged in the vial. The device can further comprise a mixing rod inserted in the interior bore for mixing the fecal specimen with the analyzing solution.
In another embodiment, the present invention provides a method for sampling a fecal specimen and measuring rectal temperature. The method includes inserting the device as described above into the rectum; sampling the fecal specimen; measuring the temperature; and withdrawing the device from the rectum.
In a preferred embodiment, the method also includes steps for analyzing the fecal specimen. The analyzing steps can include: removing the thermometer from the sleeve; contacting the fecal specimen in the scoop with an analyzing solution; and reading a test result. The contacting step preferably comprises enclosing the scoop in a test tube and mixing the fecal specimen and analyzing solution using a mixing rod inserted in the interior bore.
As another aspect, a complete kit is provided for rectal insertion, fecal sampling, and fecal analysis including the sleeve and vial as mentioned above, and optionally including a thermometer or thermistor, a stirring rod, a hand-held appliance for mechanically rotating the stirring rod, and/or various reagents and solvents for analysis or preservation of the fecal specimen.
REFERENCES:
patent: 738960 (1903-09-01), Vaughn
patent: 2969141 (1961-01-01), Katzin
patent: 3190436 (1965-06-01), Diamant
patent: 3640268 (1972-02-01), Davis
patent: 3650153 (1972-03-01), Schwab
patent: 3783998 (1974-01-01), Brush et al.
patent: 3800781 (1974-04-01), Zalucki
patent: 3822593 (1974-07-01), Oudewaal
patent: 3826259 (1974-07-01), Bailey
patent: 3857384 (1974-12-01), Watson
patent: 4197944 (1980-04-01), Catlin
patent: 4263921 (1981-04-01), Trugillo
patent: 4312950 (1982-01-01), Snyder et al.
patent: 4351616 (1982-09-01), Farnstrom et al.
patent: 4476872 (1984-10-01), Perlin
patent: 4562043 (1985-12-01), Mennen et al.
patent: 4707450 (1987-11-01), Nason
patent: 4862899 (1989-09-01), Bucaro
patent: 5031635 (1991-07-01), Koll
patent: 5269316 (1993-12-01), Spitalny
Lundeen Daniel N.
Rimell Sam
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