Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of my earlier application U.S. Ser. No. 07/844,619, filed Mar. 27, 1992, now U.S. Pat, No. 5,265,620, which was a continuation-in-part of my earlier copending application PCT/US90/04414, filed Aug. 7, 1990, which was a continuation-in-part of my earlier copending application U.S. Ser. No. 07/487,928, filed Mar. 5, 1990, abandoned, which was a continuation-in-part of my earlier application U.S. Ser. No. 07/390,602, filed Aug. 7, 1989, abandoned. 
    
    
     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. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of the sleeve and thermometer, partially in phantom, of one embodiment according to the present invention. 
     FIG. 2 is a side elevation of the sleeve and cap of one embodiment according to the present invention. 
     FIG. 3 is a cross-sectional view of the sleeve taken along the lines  3 — 3  of FIG.  2 . 
     FIG. 4 is a side elevation view of a thermometer in an embodiment of the present invention. 
     FIG. 5 is a side elevation of a plunger in accordance with one embodiment of the present invention. 
     FIG. 6 is a cross-sectional view taken along lines  6 — 6  of FIG.  5 . 
     FIG. 7 is a side elevation of a thermometer in an embodiment of the present invention. 
     FIG. 8 is a side elevation of an alternate sleeve of the present invention having an inwardly radially extending shoulder at a distal end and vent holes. 
     FIG. 9 is a side elevation of an alternate sleeve of the present invention without an inwardly radially extending shoulder. 
     FIG. 10 is a side elevation of an alternate sleeve of the present invention having longitudinal fins along the walls of the bore. 
     FIG. 11 is a cross-sectional of the sleeve of FIG. 10 along the lines  11 — 11 . 
     FIG. 12 is a side elevation of an embodiment of the present invention, wherein the sleeve is adapted for insertion into a test tube. 
     FIG. 13 is a side elevation of the test tube adapted for receiving the embodiment of the present invention shown in FIG.  12 . 
     FIG. 14 is a side elevation of the present invention in partial cross-section showing the sleeve of FIG. 12 inserted into the test tube of FIG. 13 with temperature measuring device removed and the proximal end cleaved. 
     FIG. 15 is an enlarged cross-sectional view of the distal end of the embodiment of FIG. 12 as seen along the lines  15 — 15 . 
     FIG. 16 is a side view, partially in section, of the embodiment seen in FIG. 14 showing an automatic stirrer mixing a fecal specimen in the scoop with an analyzing solution in the test tube. 
     FIG. 17 is a side sectional view of the test tube of FIG. 16 with the stirrer removed and a microscope slide wetted at a meniscus of the mixed analyzing solution. 
     FIG. 18 is a partial cross-sectional view of the present invention showing the sleeve of FIG. 12 inserted into a cap with the temperature measuring device removed, the proximal end cleaved and a manual stirrer inserted into the interior bore. 
     FIG. 19 shows the sleeve and cap of FIG. 18 with the manual stirrer removed and a slide wetted by the meniscus of the mixed analyzing solution. 
     FIG. 20 illustrates another embodiment of the thermometer and sleeve assembly of the present invention. 
     FIG. 21 is an end view of the sleeve of FIG. 20 as seen along the lines  21 — 21 . 
     FIG. 22 is a side sectional view of a vial for use with the device of FIGS.  20 - 21 . 
     FIG. 23 is an enlarged section of the vial of FIG. 22 after insertion therein of the device of FIGS.  20 - 21 . 
     FIG. 24 is an end view of the vial of FIG. 22 as seen along the lines  24 — 24 . 
     FIG. 25 is a side sectional view of the distal end of the device of FIGS.  20 - 21  secured in the vial of FIGS.  22 - 24  for mixing the fecal specimen with the analyzing solution. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to the drawings in which like reference numerals indicate like parts and features, in FIG. 1, there is shown a combined fecal specimen sampling and temperature measuring device  1  which includes a fecal specimen sampling sleeve  10 . 
     The sleeve  10 , also seen in FIG. 2, has an interior bore  24  and cylindrical wall  16  with a diameter suitable for insertion into the rectum. The sleeve  10  preferably comprises a cylindrical, elongated and substantially rigid tube. The bore  24  includes a thermometer  30  or a plunger  40  inserted therein. The sleeve  10  is designed so that the interiorly inserted thermometer  30  is removably secured and inhibited from sliding in the sleeve  10 , but can be easily inserted before use and withdrawn after use, and yet the plunger  40  can easily slide therein. 
     The sleeve  10  has a proximal end  14  and distal end  12 . In the embodiment illustrated in FIG. 2, a shoulder  17  at the proximal end  14  extends radially inwardly narrowing the diameter of the bore  24 . An annular groove  23  corresponding to the shoulder  17  is cut radially inwardly into the thermometer  30 . The shoulder  17  and the groove  23  provide one preferred means for inhibiting sliding of a thermometer  30  in the sleeve  10 . 
     In another embodiment illustrated in FIG. 9, a sleeve  90  has no shoulder  17  and the preferred slide inhibiting means is provided by the bore  24  which has a diameter closely dimensioned to a diameter of the thermometer  70 . In a preferred embodiment, the bore  24  is slightly out of round, or of oval transverse cross-section to removably secure a thermometer inserted therein, wherein the thermometer  70  has, for example, a triangular transverse cross-section to tightly engage at the small-diameter surfaces of the bore  24 , or release therefrom for removal of the thermometer  70  from the bore  24  by suitable rotation of the thermometer  70 . 
     In a further embodiment illustrated in FIG. 8, a distal end shoulder  84  of the sleeve  80  extends radially inwardly. The shoulder  84  is suitable for receiving a groove  72  on the thermometer  70  to inhibit free sliding of the thermometer  70  in the sleeve  80 . 
     In yet a further embodiment illustrated in FIGS.  10 - 11 , a sleeve  100  is provided with a plurality of radially distributed longitudinal fins  102  projecting inwardly into the interior walls of bore  24 . The fins  102  engage the outside surface of a thermometer  104  (having, for example, a mercury core  106 ) to removably secure the thermometer  104  inserted therein. The fins  102  have, for example, dimensions of about 0.25 mm width and about 0.38 mm length. Other removably securing means known in the art may also be suitable. 
     At an open distal end  12  of sleeve  10 , the cylinder wall  16  is partially cut away longitudinally and transversely to form a scoop  20 . The scoop  20  preferably comprises a partial cylinder wall  18  having an arc of about 180° as best seen in FIGS. 1,  2  and  3 . The scoop  20  preferably has rounded sides  22  to smooth out rough edges and sharp points to minimize contusions or lacerations from insertion of the sleeve  10  into the rectum. 
     The sleeves  10 ,  80  or  90  can include one or more vent holes  82  (see FIG. 8) to allow air to escape from the sleeve when a cap  60  is used to cover the sleeve and the plunger  40  is inserted therein. 
     The sleeve  10  can be manufactured from a thermoplastic material exemplified by polyacrylics, e.g. acrylic-Br, polycarbonates, polyolefins, e.g. polyethylene and polypropylene, and the like; metallic material such as aluminum, stainless steel, and the like; or glass. 
     When device  1  is utilized to measure temperature and obtain a fecal specimen, the thermometer  30  or other temperature measuring implement is inserted into the central bore  24  of sleeve  10 . In one embodiment shown in FIG. 4, the thermometer  30  has a bulbous distal end  34  and a proximal flange end  36  wider in diameter than the bore  24 . The flange  32  facilitates withdrawal of the thermometer  30 . In another embodiment shown in FIG. 7, the thermometer  70 , well known in the art as a rectal thermometer, has a bulbous distal end  34  which defines the groove  72  but no flange end. 
     In a preferred embodiment, the sleeve  90  is manufactured by extrusion as an elongated, rigid tube. For use with a CORNELL thermometer, for example, the outside diameter is nominally 6.5 mm and the bore diameter is 4.95 mm; the cut-away scoop  20  has a nominally 19 mm length and the overall sleeve length is nominally 10.2 cm. These dimensions can, of course, be varied for use with other conventional thermometers. The off-the-shelf rectal thermometer  70 , as seen in FIG. 7, is removably secured in the interior bore  24  so that the temperature sensing end  34  is adjacent the distal sleeve end scoop  20 . The overall length of the sleeve is preferably shorter than the inserted thermometer  70  and the plunger  40 . The length of the scoop  20  is sufficient to provide adequate volume in the scoop end to hold the fecal specimen. 
     In another embodiment of the present invention, the interior bore  24  of the fecal specimen sampling sleeve  10  has a cylindrical shaped plunger  40  inserted therein. The plunger  40  has a fecal specimen analyzing means  51  disposed at a distal end  48 . As seen in FIGS. 5 and 6, the plunger  40  also has a proximal end flange  42  wider in diameter than the bore  24 . The flange  42  facilitates insertion and withdrawal of the plunger  40  into and from the sleeve  10 . The distal end  48  of the plunger  40  has mounting surface  50  for holding the analyzing means  51 . The analyzing means  51  is suitable for performing tests on the fecal specimen sample obtained by the sleeve  10 . The analyzing means  51  generally comprises a blanket or gauze member  54  wetted by liquid, such as, for example, cotton or another fiber wetted by an analyzing solution. The solution can be absorbed on the fibers, or contained in a frangible ampoule  52  embedded therein. Examples of such tests include a Guaiac test for occult blood, analysis for the presence of microorganisms such as yeast, viruses, rickettsia, bacteria and parasites, preparation for staining, and the like well known in the art. When the frangible ampoule  52  contains the Guaiac test fluid, the analyzing fluid typically comprises a weak hydrogen peroxide solution in ethanol. The ampoule  52  can also contain an enrichment broth such as nutrient agar for culturing. Prior to microscopic examination for parasites and/or parasite eggs, the ampoule  52  can contain a preservation fluid. Examples of preservatives include polyvinyl alcohol, isopropyl alcohol, buffered glycerol, saline and formalin. Staining can also be effected by using a stain in the ampoule  52 . An ordinary practitioner in the art will be familiar with these and other tests which can be conducted on fecal specimens and appropriate reagents utilized therefor which can be contained in the frangible ampoule  52 . 
     In the practice of the present invention, when a medical or veterinary practitioner desires to sample a fecal specimen, a sufficient length of the fecal specimen sampling device  1  is inserted into the rectum to gently sample a fecal specimen within the distal scoop  20 . The device  1  may have to be gently swiveled and/or pivoted in order to withdraw a sufficiently large specimen for the desired fecal analysis. The thermometer is read and removed from the sleeve. The specimen contained in the scoop  20  is covered with the cap or vial  60  to prevent outside contact with the sample and exterior surfaces of the sleeve  10  that have penetrated the rectum. The cap  60  typically has an inside diameter closely matching the outside diameter of sleeve  10  so that the cap  60  covering the sleeve  10  is firmly engaged. The sample can then be analyzed by the analyzing means and/or sent to a laboratory for analysis. 
     When it is desired to conduct a quick single-step test on the fecal specimen contained in the sleeve  10 , either with or without an earlier temperature measurement with the device  1 , the plunger  40  can be used to bring the analyzing reagents in the cupped region  50  on plunger  40  into contact with the fecal specimen in the scoop  20  of sleeve  10 . In this manner, the fecal specimen may be quickly analyzed without the need of sending the specimen to a laboratory for analysis. The analyzing reagents in frangible ampoule  52  are released, typically, by breaking the ampoule  52  under hand pressure. Generally, the sleeve  10  is covered by the cap  60  and the plunger  40  is inserted into the bore  24  of sleeve  10  until the analyzing reagents are in contact with the fecal specimen in the distal scoop  20 . The cap  60  minimizes loss of analyzing solution and facilitates good contact with the specimen. The plunger  40  is withdrawn and analysis is typically indicated by color change in the blanket  54  soaked with the analyzing reagents in contact with the fecal specimen. Both plunger and sleeve can be conveniently disposed of, or the capped sleeve can be sent to a lab for further analysis. 
     When it is desired to simultaneously measure rectal temperature and take a fecal specimen, the device  1  of the present invention includes the temperature measuring implement inserted into the bore  24  of sleeve  10 . To obtain an accurate temperature reading, the thermometer  30 , for example, should be inserted into the sleeve  10  so that the temperature sensing bulbous end  34  resides in the distal scoop end  12  of sleeve  10 . Device  1  is then inserted into the rectum for a period of time sufficient to obtain an accurate temperature measurement. Following the sampling procedures mentioned above, the device  1  is withdrawn and temperature read from the thermometer  30 . The analyzing procedure can be followed as described above. 
     FIGS.  12 - 19  refer to alternative embodiments of the present invention and alternative means of contacting the fecal specimen with the analyzing solution. 
     A sleeve  110 , as seen in FIGS. 12 and 15 has an interior bore  112  forming a wall  113  and an exterior surface with a diameter suitable for insertion into the rectum. As mentioned previously the sleeve  110  is preferably an elongated, cylindrical, substantially rigid tube having an appropriate length to gather the fecal specimen. The sleeve has a distal end  114  formed into a scoop  116  and a proximal end  118  preferably including a flange  120  for handling the sleeve  110  and facilitating insertion of the sleeve  110  into the rectum. The scoop  116  shown in greater detail in FIG. 15 preferably has a bevel  144  forming a hollow annular shoulder  146  to facilitate specimen collection and minimize retention of fecal matter on the thermometer as it is withdrawn from the bore  112 . The shoulder  146  serves to scrape and collect such fecal material from the surface of the thermometer or thermistor. 
     In FIG. 12, a body temperature measuring device  122  is inserted into the interior bore  112  so that a temperature measuring end  124  is removably secured adjacent the scoop  116  inside the rectum. Examples of suitable temperature measuring devices include both mercury-type thermometers and electronic devices such as thermocouple and thermistor wires. A thermistor is conveniently employed in this embodiment and has an electrical connection end  125 , suitably connected, for example, to a conventional digital display (not shown). While different means previously described can be used to secure the position of the temperature measuring device  122  in the interior bore  112 , a preferred securing means is provided by closely dimensioning the diameter of the temperature measuring device  122  (e.g. a thermistor wire) to the diameter of the bore  112 . 
     The sleeve  110  is adapted for analyzing the fecal specimen in the scoop  116  following the fecal sampling procedure. Thus, additional transfer steps are not necessary to conduct many of the common medical tests for which a fecal specimen is necessary (e.g. occult blood test, presence of parasite eggs, and the like). At an approximate mid-position, the sleeve  110  has an exteriorly extending shoulder  126  separating the distal and proximal ends  114 ,  118 . The shoulder  126  is designed to sealably lock the distal end  114  of the sleeve  110  in a test tube or vial  130  (see FIGS.  13 - 14 ). 
     The test tube  130 , as seen in FIGS.  13 - 14 , has a lower section  132  for receiving the distal end  114  of the sleeve  110  and an upper section  134  having a larger diameter. An interiorly extending shoulder  138  in the upper test tube section  134  forms a seat  140  at a junction  136  of the upper and lower sections  134 ,  132 . The seat  140  receives the shoulder  126  and locks the distal end  114  of the sleeve  110  in the lower section  132  of the test tube  130 . A ring member  142  is attached to a lip on the test tube  130  for increasing the strength of the lip where a stopper (not shown) can be used to seal the contents of the test tube  130 . 
     To enhance the ease of storing and analyzing the fecal specimen once the sleeve  110  containing the fecal specimen is inserted into the test tube  130  and seated therein, the proximal end  118  of the sleeve  110  is preferably cleaved from the distal end  114  (see FIG. 14) by applying hand pressure to the sleeve  110  at a pressure point comprising a scoring  148 . The scoring  148  is preferably made in the sleeve  110  just above the shoulder  126  so that proximal end  118  can be conveniently separated from the distal end  114 , except, possibly, for a small tab end  149 . The tab end  149  is preferably entirely contained in the test tube  130  and is disposed adjacent the interiorly extending shoulder  138 . 
     The test tube  130  is preferably made of a plastic material such as polystyrene, polyethylene or polypropylene, which normally should be the same material as the sleeve  110 . 
     As an alternative embodiment, the sleeve  110  containing the fecal specimen can be covered with a cap or vial  170  seen in FIGS.  18 - 19 , thus enclosing the region around the specimen for containment of the analyzing solution contacting the fecal specimen. The cap  170  can be made of a rubber such as latex having an appropriate diameter for sealing against the exterior surface of the sleeve  110  to prevent loss of analyzing fluids. 
     To analyze the fecal specimen collected in the scoop  116  of the sleeve  110 , the specimen is contacted with an appropriate analyzing solution  164 . The distal end  114  of the sleeve  110  can be inserted directly into the analyzing solution contained in the test tube or the solution can be added afterwards through the interior bore  112 . The proximal end  118  of the sleeve  110  is preferably separated and the fluid/specimen contents of the test tube are mixed. An automatic mixer  150  with an on/off switch  152  comprising a rotating rod  154  is shown in FIG. 16, wherein the stirring rod  154  is inserted into the interior bore  112  of the sleeve  110 . Rotation of the rod  154  swirls the liquid contents of the test tube. Alternatively, a manual mixing rod  156  with a handle  158  is seen in FIG.  18 . 
     Following mixing, a microscope slide  160  can be wetted with the liquor  166  to determine presence of ova, parasites and/or bacteria, under a microscope (FIGS.  17  and  19 ). Generally, the mixing rod  154  or  156  is withdrawn and additional liquid is added, if necessary, by eye-dropper, for example, to increase the liquid level in the test tube  130  (FIG. 17) or the interior bore  112  (FIG. 19) so that the slide can be contacted with an exposed liquid meniscus (not shown). The wetted slide can then be prepared for observation under a microscope. A screen  162  can be installed across the diameter of the test tube upper section  134  if desired to help prevent particles of fecal matter from adhering to the slide  160 . 
     Another preferred embodiment of the present invention is illustrated in FIGS.  20 - 25 . A sleeve  200  comprises a proximal section  202  and a distal section  204  which are joined together at the rabbet joint  206  to form an elongated tube. The proximal section  202  has a generally uniform outside diameter which terminates adjacent the distal section  204  at a thin-walled end  208  having a reduced outside diameter. The section  202  has a generally uniform inside diameter along its length, but can optionally include inward protrusions (not shown) to facilitate frictional engagement of a thermometer or other temperature-measuring device. 
     The distal section  204  has a scoop  214  adjacent one end opposite the rabbet joint  206  and a generally uniform outside diameter. A generally uniform inside diameter terminates at a thin-walled end  216  having an enlarged inside diameter. The inside diameter of the end  216  closely matches the outside diameter of the end  208  for frictional, cemented, welded, glued or like engagement in the rabbet joint  206 . The scoop  214  is formed by rounding the distal tip  217  and cutting away one side of the section  204  adjacent the tip  217  along a relatively short length of the section  204 . As seen in FIG. 21, the tip  217  is cut away to form a longitudinal or axial opening into a longitudinal bore  218  visible from the end perspective to facilitate fecal sampling. 
     The sections  202  and  204  can be made from a molded thermoplastic such as polyethylene, polypropylene, polystyrene, or the like. The molded sections  202  and  204  are then assembled by inserting the end  208  into the end  216  to form the joint  206 . The joint  206  can be held together by friction between the tightly matched diameters, thermal fusion, solvent fusion (e.g. methylene chloride for polystyrene), the use of an adhesive or glue between the opposed surfaces, mechanical coupling devices such as pins or rivets, or the like. All that is required is that the joint  206  hold the sections  202  and  204  together during rectal insertion, specimen sampling and removal. 
     For specimen sampling with temperature measurement, a thermometer  220  is inserted in proximal section  202  through the bore  218  and into distal section  204  until the thermometer  220  is thermally exposed adjacent the scoop  214 . The thermometer  220  preferably has an outside diameter to match the diameter of the bore  218  for frictional engagement thereby, e.g. the thermometer has a slightly longer transverse dimension to be tightly but releasably gripped in the bore  218 . The thermometer  220 , or other temperature sensing element, can leave sufficient volume in the scoop  214  for the fecal specimen, but can alternately or additionally be withdrawn from the sleeve  200  while the sleeve  200  is held in the rectum or other sampling region. The temperature indication can be read after the thermometer has been inserted for a sufficient time period to reach thermal equilibrium, either visually after withdrawing the thermometer  220  from the rectum, or on a conventional local or remote readout (not shown) in the case of a thermistor or thermocouple, for example, a digital readout. When the thermometer  220  is used, the sleeve  200  can also provide magnification to facilitate the reading by construction from the materials having the appropriate optical properties. 
     Fecal specimen collection is effected by filling the scoop  214  during rectal insertion and/or by rotation, pivoting or otherwise working the proximal section  202  which is not completely inserted into the rectum to facilitate such manipulation. Leaving a portion of the proximal section  202  uninserted also facilitates removal when specimen collection and/or temperature measurement are completed. As desired, the distal section  204  and/or the rectum can be lubricated as for conventional rectal thermometers, although care should be exercised to avoid blocking or filling the scoop  214  with the lubricant. 
     Preferably, after thermometer removal, the distal section  204 , containing the specimen in the scoop  214 , can be separated from the proximal section  202  by breaking along the fracture line  222 . The fracture line  222  is created at the thin wall  208  adjacent the termination of the larger outside diameter of the proximal section  202 . There is preferably a gap between the end  216  and the end of the outside diameter of the proximal section  202  such that the thin wall  208  is exposed for a longitudinal dimension approximately from 0.5 to 5 times the thickness of the wall  208 , more preferably from 1 to 3 wall thicknesses, especially where the material is polystyrene. 
     A vial  224  can be conveniently used for specimen analysis with the sleeve  200  as shown in FIGS.  22 - 25 . The vial  224  is elongated with a cap  226  at one end and an opening  228  at the other. The cap  226  has a length and diameter sufficient to receive the distal section  204  therein. At a base of the opening  228 , a shoulder  230  is preferably formed by a reduction in the inside diameter adjacent the cap  226 . A plurality of inwardly extending longitudinal fins  232  are disposed in the cap  226  adjacent to the shoulder  230 . A pair of opposed flanges  234  extend radially outwardly from adjacent the opening  228  to lips  236 . The vial  224  is conveniently molded from the same material as the sleeve  200 . 
     The vial  224  receives the sleeve  200 , and the distal section  204  is forced into the cap  226  so that the fins  232  tightly engage the outside diameter of the distal section  204  containing the fecal specimen in the scoop  214 . Then secured in the vial  224  by friction, the sleeve  200  is bent by twisting the proximal section  202  against the vial  224 , to induce fracture of the sleeve  200  at the fracture line  222  comprising the thin wall  208  between the end  216  and the larger outside diameter of the proximal section  202 . Then, with the proximal section  202  removed and the distal section  204  retained in the vial  224 , the fecal specimen can be examined, as described above, for parasites, ova, viruses, yeast or bacteria, or the like, using the opposed flanges  234  and lips  236  to hold the microscope slide. If desired, a paddle  240  can be inserted into the distal section  204  as shown in FIG. 25, and manipulated, by rotation and/or reciprocation, for example, manually or by an electrically powered, hand-held driver (not shown) to mix the fecal specimen with reagent or solvent fluid in the cap  226 . 
     The fecal specimen sampling sleeve  200  can also be used for fecal sampling and analysis where the temperature measurement is not required, for example, by rectal insertion, and also from patient stools as in bedpans or fecal specimen cups. In this mode of use, the sleeve  200  sans thermometer is grasped by the proximal section  202  and the distal section  204  is inserted in the stool or other fecal material to be sampled to collect a fecal specimen in the s scoop  214 . The distal end  202  is then inserted into the vial  226 , locked by the fins  232  and the proximal end  202  broken off. The fecal specimen in the scoop  214  is thus secured in the vial  224  for fecal analysis. The analysis can be done immediately as described above, or the vial  224  can be optionally sealed, stoppered or otherwise plugged adjacent the flanges  234  for shipment to an analysis lab and/or later analysis. 
     Test reagent, preservative or the like can also be pre-placed in the bottom of the cap  226 , e.g. in a vial or sealed by a membrane (not shown) which is broken or pierced by the scoop  214  to release the reagent or preservative when the sleeve is inserted into the vial  224 . 
     The foregoing description of the invention is illustrative and explanatory thereof. Various changes in the materials, apparatus, and particular parts employed will occur to those skilled in the art. It is intended that all such variations within the scope and spirit of the appended claims be embraced thereby.

Technology Category: 3