URINE SPECIMEN COLLECTING DEVICE

Abstract: A device for collecting a urine specimen, which is par­ ticularly adapted for females, is configured and adapted for use while the user is sitting on a toilet in the normal posi­ tion for voiding. The device (10) comprises a collector (12) and a specimen container (14), preferably integrally assembled together. In use the device selectively collects the clean, contaminant-free mid-stream portion of urine in the container. The urine specimen container (14) is releas­ ably secured to the collector (12) at a bleed-off conduit (22) extending from a collection exit (28) in a urine receiving chamber (20) of the collector (12). This exit (28) is positioned in the chamber above a urine bleed-off exit (26) in the conduit (22) adapted for receiving and discarding the first-voided portion of urine at a controlled rate. Means (24,26) are provided for directing into the toilet all of the voided urine in excess of that which is retained in the specimen container (14), including the discarded first-­ voided portion. A suitable handle (18) extends radially outward from the collector (12) to facilitate holding the device (10) in the preferred attitude for use.

Description: IMPROVED URINE SPECIMEN COLLECTING DEVICE This invention relates to devices for collecting urine specimens for analysis in the detection and diagnosis of infection and disease. Urine analysis is such a simple, common and useful diagnostic aid that the taking of a urine specimen is generally included in even the simplest of physical examinations. It is important not only as an indicator or detector of certain physical conditions and diseases, but it is also particularly useful in connection with the treatment of infections related to the urinary tract, which are much more common in females than males. However, the problem of collecting a suitable specimen is considerably more complex when a female patient is involved. Thus, in the collecting of a urine specimen from a female patient, it is important to take the specimen as a "mid-stream" sample. When a female patient voids in the normal manner, the initial portion is more likely to contain contamination from foreign matter than that portion which follows. This is because the initial portion is expelled with less force and usually is voided as a mere trickle which is likely to trail along the labia and pick up whatever contamination is present in those areas. e The mid-stream portion is expelled with the greatest force and is most likely to leave the urethral meatus directly as a stream without contacting the labia or, if it does, the labia will have had most of the contamination washed off by the initial portion. Some practitioners go to considerable lengths in an effort to obtain an uncontaminated urine sample from a female patient. With the patient in a reclining position, an attendant cleanses the area adjacent the urethral meatus with a suitable solution in an effort to wash off the contamination which is generally present in that area. Even with such precautions, however, contamination may develop in the collected urine sample to a level sufficient to give a false or misleading indication of the bacteria level in the sample. Moreover, taking a sample under such conditions is an extremely awkward and uncomfortable experience for the patient and is fairly costly, since the patient is required to be present in the physician's office or a hospital with a special attendant, usually a nurse, administering the procedure. What has been needed is some simple but effective, fool-proof device, preferably disposable after a single use, which a patient can use with a minimum of instructions and without assistance, while voiding in the normal manner. The device should have the capability of receiving the entire amount of voided urine, rejecting the initial portion, selecting a portion corresponding to the mid-stream sample and transferring it to a specimen container, and rejecting the remainder of the voided urine by directing it, together with any overflow from the specimen container, into the toilet on which the patient is positioned in the normal attitude. Devices in accordance with the present invention are highly efficient in isolating and collecting contaminant-free urine and are particularly adapted for convenient use by a female patient while she is sitting on a toilet. Thus, she can void urine into the device, and the desired mid-stream sample of urine can be easily and automatically collected. For such purposes the improved device of the invention comprises a collector and a specimen container, the collector comprising a urine-receiving chamber having a urine-receiving opening at its upper end and exit openings at different levels for separating the first-voided portion of urine from the remainder. The first exit is adjacent the lower end of the chamber in a downwardly depending exit conduit. This is for bleeding first-voided urine from the collector at a slow controlled rate into the toilet so that as voiding continues the urine level rises to the second exit which is above the first exit and preferably shielded from the first-voided urine. Thus, the second exit passes clean, contaminant-free mid-stream urine to a detachable urine specimen container positioned to receive urine from the second exit. As voiding continues the urine level in the chamber may rise above the second exit, particularly when the specimen container becomes filled. Any excess urine passes through an overflow passage from the device to the toilet. Thus, the clean mid-stream urine is retained in the specimen container while the rest is discarded. At cessation or diminishing of voiding rate, the excess urine trapped in the chamber exit conduit bleeds out through the first exit until only the urine sample in the specimen container remains. In one arrangement in accordance with the invention, the collector (apart from the specimen container) is much like a funnel in configuration with a handle extending from the edge thereof. The cone-shaped portion of the funnel corresponds to the collection chamber; the lower central tube of the funnel constitutes the bleed-off conduit and is closed off at the lower end thereof except for an aperture of limited size to control the bleed-off of the first-voided urine at a limited rate. Near the juncture of the collection chamber and the bleed-off conduit is a plurality of apertures or windows, equally spaced about the periphery of the bleed-off conduit, constituting the second exit for communicating with and transferring urine to a specimen container when the specimen container is in place. The specimen container is toroidal in planar cross-section, has both inner and outer walls, and (when mounted together with the collector) surrounds the bleed-off conduit. The specimen container is provided with a flexible lid having a central opening. Mating lip and recess surfaces around the periphery of the specimen container and lid, respectively, provide an effective circumferential seal between lid and container. The portion of the lid surrounding the central opening is spaced upwardly from the upper end of the inner wall of the container, thus defining a circumferential opening which is adjacent the windows at the base of the cone-shaped portion of the collector so as to admit urine therethrough. A mating ring and recess serve to retain the specimen container on the bleed-off conduit, while permitting the collector and container to be separated easily, when desired. Preferably a plurality of upwardly extending shields or dams are located about the base of the collecting chamber in registration with the second exit apertures so as to shield those apertures from urine being voided into the collector until after the first-voided portion fills the bleed-off conduit. An overflow conduit connecting with the chamber at an overflow exit positioned significantly above the second exit is provided to remove any excess urine from the collector and prevent it from running over its uppermost rim. This overflow exit is also provided with a shield to block urine as voided from passing through the overflow exit. In a first alternative arrangement of the embodiment described, the overflow exit and overflow conduit connect to the side of the collection chamber in a position radially displaced from the central axis of the device. In a second alternative arrangement, the overflow conduit is centrally positioned as a standpipe extending upwardly from the closed off exit of the bleed-off conduit. In the latter case, the bleed-off exit opening may be radially displaced arj positioned between the wall of the overflow conduit and the inner wall of the bleed-off conduit. In still another arrangement, the collector has one or more of the exit windows blocked off and is molded with one or more aligned recessed troughs extending downwardly along the bleed-off conduit. This serves in conjunction with the adjacent opening in the specimen container as an overflow passage. Also a flow director or deflector is mounted interiorly of the collector in the region of the exit windows to direct urine initially into the bleed-off conduit from whence it flows into the specimen container. When the specimen container is filled to overflowing, urine flows out of the specimen container at the overflow passage and down tfle recessed trough(s) and into the toilet. Any further voided urine follows this overflow path out of the device. In accordance with an aspect of the invention, the flexible lid of the specimen container and the upper edge of the inner wall of the container are configured to mate in sealing relationship when the central portion of the lid is pushed downwardly to engage the inner wall of the container. This serves to complete the closure of the specimen container after the selected urine sample has been collected therein. To facilitate the sealing operation, the height of the specimen container is made to exceed the length of the bleed-off conduit by approximately 1/4 to 1/2 inch. The collector is provided with a circumferential shoulder surrounding the bleed-off conduit near the juncture of the bleed-off conduit and the collection chamber. This shoulder is provided with a circumferential recess capable of receiving the upper edge of the inner wall of the specimen container when the two are pushed together. When this is done, the central ring portion of the flexible lid is pushed downwardly to engage a circumferential lip surrounding the inner wall of the container, thus retaining the central portion of the lid in the downward position and effectively closing off and sealing the circumferential opening which previously existed between the lid and the upper edge of the inner wall of the container. By virtue of this arrangement, it is intended that after the patient has used the collector device and left it for the nurse or other medical assistant, the nurse simply pushes downward on the upper circumferential edge of the cone-shaped collecting chamber, thereby driving the lid of the specimen container into sealing relationship with the inner wall of the container. This not only serves to seal the previously existing opening between the lid and the inner wall, but it reinforces the outer circumferential seal between the lid and the outer wall of the container by developing a downward bias on the lid. Thereafter, the nurse simply grasps the specimen container and lid with one hand and removes the collector portion by pulling it upward and away from the specimen container portion. Later, when it is desired to open the specimen container, the lid is simply unsealed by lifting upward relative to the specimen container at the circumferential edge thereof. This serves to release both the inner and outer seals so that the lid can be removed from the container. These various features and aspects of the present invention result in an improved urine specimen collecting device which is extremely effective in collecting the desired contaminant-free mid-stream portion during use, is readily sealable and separable for retention of the specimen container while the collector proper can be thrown away, is simple, lightweight, cheap to manufacture and easy to use without elaborate instruction. In still another arrangement in accordance with the invention, an upwardly and outwardly curved handle is disposed on the device on the side opposite the first and third urine exits to facilitate urine run-off into the toilet and the correct positioning of the device. The handle may be serrated to have a finger stop. The second exit is preferably centrally located as, for example, in a central vertical standpipe in the chamber, and a urine-deflecting shield may be releasably attached over the standpipe and a second exit to prevent inadvertent entry of the first-flow urine into the second exit. In the accompanying drawings: Fig. 1 is an elevational view of one particular arrangement in accordance with the invention Fig. 2 is an exploded view of the arrangement shown in Fig. 1; Fig. 3 is a plan view of the arrangement of Fig. 1; Fig. 4 is a quarter-sectional view of a portion of the arrangement depicted in Fig. 2, taken along the line 4-4 thereof; Fig. 5 is a quarter-sectional view of a portion of the arrangement of Fig. 1, taken along the line 5-5 of Fig. 3; Fig. 6 is a sectional view similar to Fig. 5, showing the assembly of the various elements making up the arrangement of the invention; Fig. 7 is a plan view of an alternative embodiment of the invention; Fig. 8 is an elevational view, partially broken away, of a portion of the alternative embodiment of Fig. 7; ; Fig. 9 is an exploded elevational view of still another arrangement in accordance with the invention; Fig. 10 is a sectional view of a portion of the arrangement depicted in Fig. 9 taken along the plane of the drawing and looking upward from the drawing plane; Fig. 11 is a bottom view of the portion of the collector element shown in Fig. 10; Fig. 12 is an upper plan view of the portion of the collector shown in Fig. 10; Fig. 13 is a schematic side elevation, partly broken away, of another embodiment of the present invention; Fig. 14 is a schematic top plan view of the device of Fig. 13; Fig. 15 is a schematic cross-section taken along the section line 15-15 of Fig. 14; and Fig. 16 is a schematic bottom plan view of the device of Fig. 13. One preferred embodiment of the present invention is depicted in Figs. 1-3 of the drawings. As is shown particularly in the exploded view of Fig. 2, the collecting device 10 comprises a collector 12, specimen container 14 and specimen container lid 16. The collector 12 is a generally funnel-shaped element having a handle 18, a cone-shaped receiving chamber 20, a bleed-off conduit 22 at the lower end of the cone-shaped receiving chamber 20, and an overflow conduit 24 which extends through the sidewall of the receiving chamber 20 and is attached thereto. The collector 12 is provided with three exits for the release of urine therefrom. The first exit is a bleed-off exit 26 comprising a small hole at the bottom of the bleed-off conduit 22, the bottom of which is otherwise closed off and thereby constitutes a pocket or recess for receiving the first-voided urine from the chamber 20. The second exit comprises a plurality of apertures or windows 28 near the bottom of the cone-shaped portion of the chamber 20. As will be shown in detail hereinbelow, these windows 28 communicate with the interior of the specimen container 14 when the constituent elements are assembled in the configuration shown in Fig. 1. A third exit 30 is located in the side of the chamber 20 above the second exit 28 and communicates with the interior of the overflow conduit 24. The overflow exit 30 is provided with a shield 32 to block the overflow of urine via that exit 30 until the urine level in the collector 12 rises to the overflow exit 30. As seen in Fig. 4, which is a quarter-sectional view of a portion of the arrangement of Fig. 2, taken along the line 4-4 and looking in the direction of the arrows, the specimen container 14 is somewhat toroidal in form, having an upstanding hollow center section surrounded by an inner cylindrical wall 42 and an outer cylindrical wall 44. The storage space for urine collected in the container 14 is between the inner and outer walls 42, 44. This space 46 is open at the top of the container 14. Legs 47 are mounted at the base of the container 14. Near the top of the outer cylindrical wall 44 is an outwardly protruding lip or rim 48 which extends circumferentially about the specimen container 14. A similar protruding lip or rim 50 projects radially inwardly from the inner wall 42 and extends circumferentially about the hollow space defined by the wall 42. Near the top of the wall 42 in the side facing the space 46 is a recess or slot 52 which extends circumferentially about the specimen container inner wall 42. The lid 16 is provided with an inner circumferential recess 54 which serves to mate with the rim 48 of the container 14 when the lid 16 is mounted on the container 14, thus retaining the lid thereon in sealing relationship about the outer edge of the container 14. The lid 16 is provided with a plurality of downwardly depending, projecting stop pins 55 which, when the lid 16 is first placed on the container 14, bear against a ledge 56 on the inner wall 42 of the container 14 and maintain a space between the ring 58 about the central opening of the lid 16 and the upper edge 59 of the inner wall 42 of the container 14. These stop pins 55 are flexible, as is the lid 16, so that upon the application of downward force sufficient to bend the pins 55, they give way and permit an inwardly projecting rim 60 of the lid 16 to move downwardly into engagement with the circumferential recess 52, thus establishing a seal between the inner rim 60 of the lid 16 and the upper end of the inner wall 42 of the container 14. When mounted in such fashion, the storage space 46 for the urine which is collected in the container 14 is completely sealed--at the outer edge by the seal between the outer rim 48 and the recess 54, and at the inner edge by the seal between the inner rim 60 and the recess 52. Referring now to Fig. 5, a sectional view taken along the line 5-5 of Fig. 3 and looking in the direction of the arrows, certain structural details of the collecting device of our invention are shown therein. Fig. 5 shows the sidewall of the receiving chamber 20 in the region of the overflow conduit 24 and the collecting exit comprising the windows or apertures 28. The overflow exit 30 may be seen extending through the sidewall of the receiving chamber 20 and communicating with the overflow conduit 24. As shown, the exit 30 is protected by the shield 32 to minimize the splashing of urine through the exit 30. Shields or barriers 64 serving as tiny dams are mounted respectively above the windows 28 to interfere with the flow of the first-voided urine through the windows 28. These barriers 64 channel the urine through the passages between adjacent barriers 64, thus diverting the urine from the windows 28 until the urine rises in the bleed-off conduit 22 to the level of the windows 28. The sidewall of the bleed-off conduit 22 is provided with a circumferential recess 66 positioned just below the windows 28. This serves to receive the inner rim 50 of the container 14, thus retaining the container 14 in sealing relationship to the collector 12 when the two are affixed together. Of course, the lid 16 will be positioned between the collector 12 and container 14 when mounted in this fashion (see Fig. 6). The collector 12 is provided with a downwardly depending, circumferential skirt or lip 68 which defines, with the wall of the bleed-off conduit 22, a circumferential recess 69. Fig. 6 is a sectional view similar to that of Fig. 5 but showing the container 14, lid 16 and collector 12 assembled together as prepared for shipment and for operative use in selectively collecting a mid-steam urine specimen. The lid 16 is shown in place on the container 14 with the outer periphery of the lid sealed to the container 14 by virtue of the mating of the rim 48 in the circumferential recess 54. Similarly, the inner wall of the specimen container 14 is sealably engaged to the bleed-off conduit 22, and thereby retained thereon, by the mating relationship of the inner rim 50 in the circumferential recess 66. The central circmferential ring 58 of the cover 16 surrounding the central opening thereof is partially within the recess 69 and bearing against the skirt 68. A stop pin 55 is shown bearing against the ledge 56, thus maintaining the space between the upper edge 59 of the wall 42 and the lid 16. This space is adjacent the windows 28 and extends circumferentially about the assembly, interrupted only by the spaced-apart pins 55. When the collector device is used by a patient, urine is voided into the receiving chamber 20 of the collector 12. The first-voided urine flows down into the bleed-off conduit 22 and begins bleeding out the bleed-off exit opening 26; if the urine initially drops onto the wall of the receiving chamber 20, it flows down the wall and in the channels between the barriers or dams 64, as indicated by the arrows 70. When the urine level rises to the windows 28, as indicated by the line 72, urine then begins flowing through the windows 28 and through the entrance space between the lid 16 and the inner wall 42 of the specimen container 14, as further indicated by the arrows 70. As voiding continues, the mid-stream portion of the voiding is directed in the manner described into the specimen container 14. As the specimen container 14 fills with urine, the air which was initially in the empty container 14 is permitted to escape out the same entrance space and the windows 28. Further voiding after the specimen container 14 is full backs up into the receiving chamber 20 until the level of the overflow exit 30 (Fig. 5) is reached, after which the oveflow urine runs out the overflow conduit 24. When voiding is terminated, the urine remaining in the collector bleeds off through the bleed-off conduit 22 and exit 26, until the collector 12 is emptied. At this point, the patient will normally deliver the collector and specimen container with the specimen contained therein to the nurse or other medical assistant who thereafter places the device 10 on a counter, table or other horizontal surface and bears down on the upper edge of the collector 12. This causes skirt 68 to bear down against the adjacent surface of the lid 16 as the ring 59 of the lid moves further into the recess 69 and causes the semi-flexible pins 55 to bend and slip off the ledge 56. Further downward movement of the collector 12 relative to the specimen container 14 causes the inner rim 60 of the lid 16 to move downwardly into engagement with the circumferential recess 52, effecting the seal between the rim 60 and the recess 52 and thus preventing any escape of the specimen collected within the container 14. The collector 12 is then pulled upwardly, relative to the lid 16 and container 14, releasing the retention of the container 14 on the bleed-off conduit 22 at the recess 66 and separating the collector from the specimen container. The collector 12 is then discarded and the specimen container retained for processing of the collected specimen. An alternative embodiment of the invention is shown in Figs. 7 and 8. In this embodiment, the elements of the collecting device 10 are the same as shown in Figs. 1-6, except that the overflow conduit 24A is centrally located within the bleed-off conduit 22. The bleed-off exit opening 26A is shown at the bottom of the bleed-off conduit 22 (see Fig. 7) but located between the wall of the overflow conduit 24A and the inner wall of the bleed-off conduit 22. The bottom of the overflow conduit 24A is of course open to permit the escape of urine overflowing through the conduit 24A. Utilization of this alternative embodiment of the collector 12A, when assembled in combination with the specimen container 14 and the lid 16, is the same as has been described for the use of the embodiments of Figs. 1-6 The device depicted in Figs. 9-12 is a variant of the arrangement shown in Figs. 1-6. Where like elements are included, the same reference numerals have been employed. As shown particularly in Figs. 9 and 10, the device 10A includes a collector 12A and an integral specimen container 14 and associated lid 16. The notable difference is the lack of an overflow conduit per se such as the conduit 24 shown in Fig. 1. The collector 12A has a receiving chamber 20 in the upper portion of the generally funnel-shaped configuration opening into a downwardly depending bleed-off conduit 22A, near the bottom of which is a first or drain exit 26 for draining urine from the collector. A second or transfer exit is provided by the window openings 28 which are spaced about the periphery of the upper portion of the exit or bleed-off conduit 22A except on the side in line with the handle 18. At this point, the periphery of the collector 12A is closed and, further, the collector is molded with a recessed trough 94 (see Fig. 10) extending downwardly along the bleed-off conduit 22A. This trough 94 serves to provide an overflow passage for any urine tending to overflow the specimen container 14, thus permitting such excess urine to flow downwardly and outwardly from the urine collecting device 10A and directly into the toilet. To provide more effective control of the flow of urine being voided into the collecting device 10A, a diverter or deflector insert 80 may be mounted in the device at the bottom of the receiving chamber 20. This deflector 80 is configured to adapt to the interior shape of the collector 12A, i.e. the diverter 80 is also generally funnel-shaped, and is provided with an outer lip 88 to collect urine flowing down the walls of the receiving chamber 20 and direct it into the bleed-off conduit 22A through the lower opening 90 of the diverter 80. The interior of the collector 12A is provided with a circumferential wall 82 projecting upwardly by a sufficient distance to engage and retain the diverter 80. This wall is provided with an inwardly projecting ring 84 adapted to mate with a corresponding circumferential recess 86 in the diverter 80. Thus, the diverter 80 is retained in the position shown in Fig. 10 after it is simply snapped in position by downward pressure on the diverter 80 during assembly. The portion of the collector 12A shown in Fig. 12 is as it appears prior to insertion of the diverter 80. The diverter 80, in use, serves to prevent urine from flowing out the windows 28 and into the specimen container 14 until after the urine has entered the bleed-off conduit 22A, thus insuring that none of the unwanted, first-voided urine can inadvertently enter the specimen container. In use, the collecting device 10A is held by the female subject, grasped by the handle 18 between thumb and forefinger and held in a proper position for receiving voided urine while the subject is sitting on a toilet. Use in the normal attitude thus orients the device at an angle which locates that portion of the opening between the portion 50 of the specimen container 14 and the inner ring portion 58 of the lid 16 which is adjacent the trough 94 somewhat higher than the remainder of the opening. This thus provides for the escape of air which might otherwise be entrapped within the specimen container 14 and prevent it from being adequately filled with the desired specimen. Furthermore, this portion, in conjunction with the recessed trough 94, establishes an overflow passage, permitting excess urine to flow out of the device, once the specimen container 14 is substantially filled. Thus, any excess urine is rapidly directed out of the device and into the toilet via this overflow passage including the trough 94 until voiding is terminated. At that point, the subject need only wait a very brief interval until the small amount of urine in the bleed-off conduit 22A drains out through the drain hole 26 before she can turn the collecting device 10A with specimen contained therein over to the nurse or other attendant. As particularly shown in Fig. 10, urine received into the collector 12A flows downwardly in the direction of the arrows A into the bleed-off conduit 22A. Thereafter, the flow divides as shown by arrows B and C. A portion of the urine flows out through the drain 26 (arrow B) while the remaining portion is directed upwardly (arrows C) to fill the bleed-off conduit 22A and ultimately begin overflowing into the region 92 and entering the specimen container 14. When the level of urine in the specimen container 14 reaches the overflow passage on the left-hand side of Fig. 10, it flows outwardly (arrows D) from the specimen container 14 and downwardly through the space between the bleed-off conduit 22A and the wall 42 of the specimen container 14 via the trough 94. When voiding is finished, any urine remaining in the collector 12A drains through the drain opening 26 until the collector per se is empty. The only urine remaining is in the specimen container 14. Thereafter, the collecting device 10A is processed as previously described to seal the lid 16 on the container 14 and remove the specimen and container from the collector, which is discarded. In another embodiment of Figs. 13 - 16, the device 110 is shown in side elevation in Fig. 13. Device 110 includes a generally cylindrical housing 112 comprising an open-topped upper urine-receiving chamber 114 integrally secured to a lower hollow support base 116, and a urine specimen container 118 disposed within base 116 and releasably attached to chamber 114 by a depending conduit 120. Chamber 114 is defined by the vertical annular sidewall 122 of housing 112 and by a curved closed bottom 124 (Fig. 15). Bottom 124 generally slopes down toward the base of a central vertical hollow standpipe 126 (Figs. 13 and 15). However, a ramp portion 128 is provided in bottom 124, which ramp slopes down from the base of standpipe 126 to a generally vertical narrow pocket or recess 130 defined in part by a portion of the periphery (sidewall 122) of device 110. Recess 130 as a generally horizontal wall or bottom 132 adjacent its lower end and the lower end of device 110, which wall 132 defines a narrow vertical urine bleed hole 134 down through which urine exits device 110. Recess 130 is also defined by a pair of spaced, hollow, open-topped vertical columns 136 disposed on opposite sides of recess 130 and which extend to the bottom 138 of device 110 and which also rise above the upper level of standpipe 126 in chamber 114. Columns 136 are each defined by intersecting walls 140 and 142 terminating at sidewall 122 (Fig. 14). Columns 136 define passageways 144 which channel excess urine from chamber 114 and device 110, such urine exiting from the bottom 138 of device 110. Standpipe 126 comprises a joined pair of hollow open-topped vertical tubes 146 and 148, tube 146 terminating at a higher level than tube 148 above bottom 124 and serving to relieve air from the specimen container 118 as urine enters through the tube 148. Both tubes 146 and 148 terminate well below the top of columns 136. Tubes 146 and 148 depend below chamber 114 and form a dual conduit 150 received within a central opening 152 (Fig. 17) in the removable cover portion 154 of urine specimen container 118 to permit the filling of container 118 from chamber 114. Thus container 118 is slidably releasably received over conduit 150. Preferably, a portion 156 of the lower end 158 of conduit 150 is tapered so that container 118 can be easily slipped on and off conduit 150. A releasable closure 151 is connected to the top of cover 154 via a flexible strip which permits opening 152 to be sealed when container 118 is filled. A protective urine shield 160 is preferably releasablir disposed in the upper end 162 of tube 146. Shield 160 is mushroom shaped. Thus, it comprises a protective dome 164 with an index tab 166 to help align depending blade or stem 168 slidably received in end 162 so that a portion of dome 164 will extend over the open upper ends 170 of tube 148 and 171 of tube 146. It will be noted that stem 168 may be vertically asymmetrically disposed relative to dome 164 to permit dome 164 to extend far enough over to protect ends 170 and 171. This when urine is voided down into chamber 114, dome 164 prevents it from running or splashing directly into ends 170, 171. End 170 forms a urine collection exit which continues as tube 148 of conduit 150. Thus, it will be noted that chamber 114 is, in part, characterized by the presence of three separate urine exits at different levels: namely, exit 134 at the bottom of recess 130 near bottom 138 of device 110; exit 170 at the top of tube noP well above the level of exit 134 and exit 174 at the open upper ends 172 of columns 136 well above the level of exit 170 When urine voiding into device 110 is initiated, preferably while the female patient is sitting on a toilet holding device 110 immediately below her urethra, the contaminated first portion of urine passes down into chamber 114, and may strike dome 164 in doing so, but in any event passes down into recess 130 and begins to leave device 110 through exit 134. Since exit 134 is small (preferably about 2.5 mm. diameter), urine leaves device 110 slowly enough so that recess 130 becomes filled and, by the time mid-stream urine is being voided, urine rises to the level of exit 170 in chamber 114 and begins to pass down conduit 150 and into container 118. The urine which passes down conduit 150 is largely that of the mid-stream portion, so that the urine specimen collected in container 118 is essentially contaminant free. Once container 118 is filled, urine backs up in conduit 150 and the level of urine in chamber 114 rises above exit 170 to the level of overflow exit 172, passes into columns 136 and exits device 110 from bottom 138. Preferably exit 170 is remote from exit 134. Moreover, although exit 134 could theoretically be dispensed with, it is highly desirable in order to remove the most contaminated urine (first flow) immediately from device 110 so as to enhance the purity of the specimen ultimately passed to container 118. Items alS - - - ### he collecting chamber 114 after the specimen c ':# ,# t,.#;#.?#;#:#.#. -# · In order to ¯.--#'r#0-##±##fl¯0¯ copvententty in the right position, a handle 174 is provided which is curved outwardly and upwardly from housing 112 in the area of chamber 114 (Fig. 13) and which preferably terminates at a point level with the top of chamber 114. This is to facilitate molding of handle 174, chamber 114, conduit 150, standpipe 126 and base 116 from rubber, polyethylene, polyvinyl, plastic or the like into a single unitary body in a single, inexpensive, one-step high-speed molding operation. Shield 160 and container 118 can be separately formed in high-speed forming operations from plastic, rubber or the like and thus are also inexpensive. Handle 174 preferably has serrations 176 along the upper surface 178 to facilitate gripping of handle 174 with the user's thumb, and a finger stop 180 adjacent the outer end 182 thereof, again to facilitate gripping of handle 174. This arrangement is symmetrical to facilitate use by both right-handed and left-handed persons. Handle 174 permits device 110 to be easily packaged, stocked and stored, and also to be placed upside down to fit container 118 in place. In addition, base 116 is cut away at a number of spaced locations to provide finger openings 184 to facilitate gripping container 118 while device 110 is in the upright position, for example in removing a urine filled container 118 from device 110. Closure 151 may also be used to help pull container 118 free of conduit 150, whereupon closure 151 can be secured to opening 152 to seal urine in container 118 against contamination or leakage before testing thereof. It is preferred to have exits 134 and 172 on the side of device 110 away from (that is, opposite) the handle 174 so that the slight tilt usually given by the patient to device 110 held in the normal position during voiding will help to keep urine flowing from exits 134 and 172 until the chamber 114 is empty.

Claims: CLAIMS 1. A device for selectively collecting a mid-stream portion of voided urine comprising an integral collector and specimen container, the collector having a first drain exit and a second transfer exit for different portions of the voided urine, the first exit being positioned near the bottom of the collector for bleeding off the first-voided urine, the second exit being positioned above the first exit for transferring urine following the first-voided urine to the specimen container, the collector including a bleed-off conduit extending between the first and second exits, the specimen container being releasably coupled to the collector to receive urine from the transfer exit, and an overflow passage for disposing of urine in excess of the specimen to be retained in the container. 2. The device of claim 1 wherein the collection chamber is generally funnel-shaped with a cone-shaped portion constituting a receiving chamber and a downwardly depending tubular portion connected to the receiving chamber and constituting the bleed-off conduit, the bleed-off conduit being closed off at its lower end except for a bleed-off exit of limited opening size to limit the rate of urine flow therethrough. 3. The device of claim 1 or claim 2 wherein the second exit comprises a plurality of circumferentially spaced windows extending about the collector in the vicinity of the juncture between the bleed-off conduit and the receiving chamber. 4. The device of any of claims 1-3 further including means for diverting urine from the receiving chamber away from the second exit until the bleed-off conduit is filled with the first-voided portion. 5. The device of claim 4 wherein the diverting means comprise a generally funnel-shaped diverter configured to be inserted in retained juxtaposition in the lower portion of the receiving chamber and extending downwardly into the bleed-off conduit to overlap the windows and divert urine therefrom. 6. The device of claim 4 wherein the second exit is disposed in a standpipe and wherein the diverting means comprise a shield disposed over the standpipe. 7. The device of any of claims 1-5 wherein the specimen container is toroidally-shaped and configured for releasable mounting on the bleed-off conduit in position surrounding said conduit for receiving urine flowing through the second exit, and further comprising a flexible lid sealingly mounted on the specimen container about the periphery thereof and having a central ring opening spaced from the container to define an opening adjacent the second exit for transferring a specimen of urine into the container. 8. The device of any of claims 1-5 and 7 wherein the specimen container includes inner and outer circumferential walls defining a specimen storage space closed at the bottom and open at the top, the inner wall defining a hollow open space and having an inwardly directed, circumferential rim near the upper end of the inner wall for engaging a mating circumferential recess on the bleed-off conduit of the collector. 9. The device of claim 7 or claim 8 wherein the outer wall includes an outwardly extending circumferential rim near the upper end of the outer wall for engaging a mating circumferential recess in the inner surface of the lid about the periphery thereof. 10. The device of any of claims 7-9 wherein the inner wall is provided with a circumferential recess near the upper end of the wall for sealingly engaging a mating portion of the container lid. 11. The device of any of claims 9-10 wherein the lid is flexible and comprises a downwardly depending outer wall having a circumferential recess extending about the inner surface thereof for mating in sealing relationship with the corresponding circumferential rim of the container. 12. The device of any of claims 8-11 wherein the lid further comprises an inner circumferential ring defining a central opening, said ring having an inwardly projecting circumferential rim for mating in sealing relationship with a corresponding circumferential recess extending about the inner wall of the container. 13. The device of any of claims 8-12 -wherein the collector further comprises a circumferentially extending, downwardly directed skirt configured to bear against the central portion of the lid upon the application of force upon the collector in the direction toward the container to deflect the inner portion of the lid into sealing engagement with the inner wall of the container. 14. The device of any of claims 1-5 and 7-13 further including a solid wall portion extending between a pair of adjacent windows in the vicinity of the opening between the lid and container, the wall portion being recessed radially inwardly, the recessed portion extending downwardly along the bleed-off conduit to define, with said opening, the overflow passage for excess urine. 15. The device of any of claims 1-13 wherein the overflow passage includes a third collector exit positioned above the second exit. 16. A container for receiving and storing liquid therein comprising inner and outer circumferential walls defining a storage space closed at the bottom and open at the top, the inner wall defining a hollow open space; and a flexible lid for releasably mounting on said container in sealing relationship therewith, the outer peripheral portions of the lid and container having mating surfaces for releasably engaging adjacent portions in sealing relationship. 17. The device of claim 16 wherein the lid includes an inner circumferential ring defining a central opening, the lid and inner wall of the container having mating surfaces for engaging together in sealing relationship. 18. The device of claim 16 or claim 17 further comprising means for spacing the central portion of the lid apart from the inner wall of the container in a first position of the lid, said means defining an opening between the lid and the inner wall of the container for transferring material through said opening between the interior and exterior of the container.

Inventors: INGRAM, JAMES ANTHONY, KUNTZ, DAVID H.
Applicants: SHS ENTERPRISES, LTD.
Application year: 1979
Main classification: A61B10
IPC codes: G01N1, A61B10